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Russia becomes first country to approve a COVID-19 vaccine [Update Post #339]

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Head of China's CDC gets injected with experimental Covid-19 vaccine

The head of the Chinese Centre for Disease Control and Prevention says he has been injected with an experimental coronavirus vaccine in an attempt to persuade the public to follow suit when one is approved.

“I’m going to reveal something undercover: I am injected with one of the vaccines,” Gao Fu said in a webinar on Sunday hosted by Alibaba Health, an arm of the Chinese e-commerce giant, and Cell Press, an American publisher of scientific journals. “I hope it will work.”

The Associated Press reported earlier this month that a state-owned Chinese company injected employees with experimental shots in March, even before the government approved testing in people — a move that raised ethical concerns among some experts.

Gao did not say when or how he took the vaccine candidate, leaving it unclear whether he was injected as part of a government-approved human trial. He did not respond to requests for comment.

The claim underscores the enormous stakes as China competes with US and British companies to be the first with a vaccine to help end the pandemic — a feat that would be both a scientific and political triumph.

China has positioned itself to be a strong contender. Eight of the nearly two dozen potential vaccines in various stages of human testing worldwide are from China, the most of any country.

Gao declined to say which of the vaccines he was injected with, saying he didn’t want to be seen as “doing some kind of propaganda” for a particular company.

Last month, Gao was a co-author on a paper introducing one candidate, an “inactivated” vaccine made by growing the whole virus in a lab and then killing it. That candidate is being developed by an affiliate of state-owned SinoPharm.

The company previously said in an online post that 30 employees, including top executives, helped “pre-test” its vaccine in March, before it was approved for its initial human study. Scientists vehemently debate such self-experimentation, because what happens to one or a few people outside a well-designed study is not usable evidence of safety or effectiveness.

Chinese state media have also reported that employees of state-owned companies going abroad are being offered injections of the vaccine.

Gao said he took the injection to instil public confidence in vaccines, especially amid a tide of rising mistrust that has fueled conspiracy theories and attacks on scientists.

“Everybody has suspicions about the new coronavirus vaccine,” Gao said. “As a scientist, you’ve got to be brave. […] If even we didn’t do it, how can we persuade the whole world — all the people, the public — to be vaccinated?”

Andrew Rennekamp, an editor at Cell and one of the moderators of Gao’s webinar, said, “This is a brave thing to do, and it shows his faith in what he believes is the safety of the vaccine and his commitment to the science and to public health.”

Even as China is among the leaders in the global race for a vaccine, it is also striving to overcome years of drug scandals — the latest coming in 2018 when authorities recalled a rabies vaccine and later announced that batches of children’s DPT vaccines, for diphtheria, pertussis and tetanus, were ineffective.

Gao himself had also been under heavy scrutiny for the China CDC’s initial handling of the coronavirus outbreak, both at home and abroad. He largely vanished from public view for months, resurfacing again in an interview with state media in late April.

Recently, Gao has been involved in research on the coronavirus.

As vaccine research continues, China’s CDC is now looking into potential immunisation programmes, trying to figure out whether to prioritise children, the elderly or healthcare workers, he said.

Gao’s revelations come at a time of heightened geopolitical tensions fueled by the outbreak. Beijing’s delays in warning the public and releasing data at the beginning of the outbreak contributed significantly to the coronavirus’s spread, while US President Donald Trump and other American politicians have made unsubstantiated claims that the virus escaped from a laboratory in Wuhan, the central Chinese city where it was first detected.

Tensions have flared to the point where it’s now disrupting research, leading to frustration among scientists who work with Chinese collaborators. The Trump administration has moved to withdraw the US from the World Health Organisation (WHO), and has cut funding to research initiatives studying coronaviruses in China.

Gao said repeatedly in his lecture that he wanted more cooperation between the US and China, pleading for unity even as relations between Beijing and Washington plummet to new lows.

“We don’t want to have China and the US separated scientifically,” Gao said. “We’ve got to work together.”
https://www.dawn.com/news/1571611/h...s-injected-with-experimental-covid-19-vaccine
 
Virology institute launches Russia's second COVID-19 vaccine human trial

A Russian state virology institute has started human trials of the country’s second potential COVID-19 vaccine, injecting the first of five volunteers with a dose on July 27, the RIA news agency reported on Tuesday.

The individual was feeling fine, the agency reported.

The next volunteer in the trial by the Vector virology institute in Siberia would receive an injection on July 30, RIA cited consumer safety watchdog Rospotrebnadzor as saying.

A government register of all clinical trials shows that the institute, which is overseen by Rospotrebnadzor, is testing a peptide vaccine using a platform first developed for Ebola.

The trial is then expected to scale up to 100 volunteers between the ages of 18 and 60, the clinical trials register shows. Vector is working on six different potential COVID-19 vaccines, World Health Organisation (WHO) records show.

A separate state research facility in Moscow, the Gamaleya Institute, completed early human trials of an adenovirus-based vaccine earlier this month and expects to enter large-scale trials in August.

More than 100 possible vaccines are being developed around the world to try to stop the coronavirus pandemic. At least four are in final Phase III human trials, according to WHO data - including three developed in China and another in Britain.

https://uk.reuters.com/article/us-h...nd-covid-19-vaccine-human-trial-idUKKCN24T2MZ
 
US President Donald Trump has again defended the use of hydroxychloroquine to ward off coronavirus, contradicting his own public health officials.

He said the malaria medication was only rejected as a Covid-19 treatment because he had recommended its use.

His remarks come after Twitter banned his eldest son for posting a clip promoting hydroxychloroquine.

There is no evidence the drug can fight the virus, and regulators warn it may cause heart problems.

Last month, the US Food and Drug Administration (FDA) cautioned against the use of the drug for treatment of the coronavirus, following reports of "serious heart rhythm problems" and other health issues.

The FDA also revoked its emergency-use authorisation for the drug to treat Covid-19. The World Health Organization (WHO) says "there is currently no proof" that it is effective as a treatment or prevents Covid-19.

In other developments:

Coronavirus deaths in the US hit their highest level in months, with nearly 1,600 deaths recorded in 24 hours. Six states in the south and west, including Florida and California, reported record daily death tolls. But Mr Trump claimed that large parts of the US were "corona-free"

The US biotech company Moderna said its experimental coronavirus vaccine had induced a strong immune response in a study on monkeys. It said the vaccine protected against infection in the lungs and nose and prevented lung disease

Better known for making cameras, Kodak has moved into drug making and has just secured a $765m (£592m) loan from the US government. The fallen giant of the photography industry will make ingredients used in generic drugs to help fight the virus

What did Mr Trump say?

Studies commissioned by the WHO, the US National Institutes of Health and other researchers around the world have found no evidence that hydroxychloroquine - when used with or without the antibiotic azithromycin, as repeatedly recommended by President Trump - helps treat coronavirus.

Hydroxychloroquine was first touted by Mr Trump in March. Two months later he surprised journalists by saying he had begun taking the unproven medication to ward off the virus.

On Tuesday the president told reporters at the White House: "I can only say that from my standpoint, and based on a lot of reading and a lot of knowledge about it, I think it could have a very positive impact in the early stages.

"I don't think you lose anything by doing it, other than politically it doesn't seem too popular."

He added: "When I recommend something, they like to say 'don't use it.'"

On the wider situation in the US, the president said large numbers of masks and gowns were being produced and 55 million tests had been carried out - "more than anybody in the world".

Why has hydroxychloroquine come up again?

President Trump and his son Donald Trump Jr were among social media users who shared video late on Monday of a group called America's Frontline Doctors advocating hydroxychloroquine as a Covid-19 treatment.

Facebook and Twitter removed the content, flagging it as misinformation, but not before more than 17 million people had seen one of the clips.

Twitter also banned the US president's eldest son from tweeting for 12 hours as a penalty for sharing the clip. In the past, Twitter has declined to remove tweets by President Trump himself and other world leaders, citing public interest and newsworthiness.

The video in question showed doctors speaking outside the US Supreme Court building at an event organised by Tea Party Patriots Action, a group that has helped fund a pro-Trump political action committee.

In the video, Dr Stella Immanuel, a doctor from Houston, says she has successfully treated 350 coronavirus patients "and counting" with hydroxychloroquine.

The president said on Tuesday: "I think they're very respected doctors. There was a woman who was spectacular in her statements about it."

According to the Daily Beast, Dr Immanuel has previously claimed the government is run by "reptilians" and that scientists are developing a vaccine to stop people being religious, among other bizarre views.

America's Frontline Doctors' founder Simone Gold accused social media companies of censorship for removing the hydroxychloroquine video.

"Treatment options for COVID-19 should be debated, and spoken about among our colleagues in the medical field," she tweeted. "They should never, however, be censored and silenced."

Late on Monday, Mr Trump also retweeted several tweets critical of Dr Anthony Fauci, a leading member of the White House coronavirus task force.

But in Tuesday's briefing the president denied he was criticising the director of the National Institute of Allergy and Infectious Diseases, insisting: "I get along with him very well."

Asked about hydroxychloroquine earlier on Tuesday, Dr Fauci said the medication was not an appropriate treatment for Covid-19.

He told ABC News' morning show that the drug was "not effective in coronavirus disease".

At Tuesday's briefing, Mr Trump questioned why the White House coronavirus expert and his fellow task-force member Dr Deborah Birx were popular, but his administration was not.

He said: "They're highly thought of but nobody likes me. It can only be my personality, that's all."

The US now has more than 4.3 million reported cases of Covid-19, and more than 149,000 deaths.

https://www.bbc.com/news/world-us-canada-53575964
 
India's Hetero wins approval to launch COVID-19 drug favipiravir

India's Hetero Labs Ltd said it received local regulatory approval to launch its version of anti-viral drug favipiravir for the treatment of COVID-19.

The drug, priced at 59 rupees (79 US cents) per tablet, will be available at drug stores from Wednesday, privately held Hetero said.
 
Moderna vaccine worked well in monkeys: Study

Moderna's experimental COVID-19 vaccine worked well in monkeys and prevented the virus from replicating in their noses and lungs, according to a study published in the New England Journal of Medicine.

In the Moderna study, three groups of eight rhesus monkeys received either the vaccine or a placebo at two different dosages.

All those who were given the vaccine developed high levels of antibodies to attack parts of the SARS-CoV-2 virus. Scientists said monkeys that got the vaccine even at the lower dosage produced more antibodies than people who had recovered from the virus, and that it appeared to stimulate an immune response from so-called T-cells.

The study also found that two days after the vaccinated monkeys were exposed to the virus that causes COVID-19 through the nose and directly to the lungs, no replicating virus was found in the lungs of seven of the eight animals regardless of dosage while those that had been given the placebo all still had the virus.
 
The University of Health Sciences (UHS) Punjab has collaborated with the United Kingdom (UK)'s renowned Oxford University to conduct trials for the latter's coronavirus vaccine in Pakistan.

According to UHS Vice-Chancellor Dr Javed Akram, registration of volunteers for the COVID-19 vaccine trial has already begun and about 20,000 people will be registered in total.

He added that it could take two months for the vaccine to be tested in Pakistan, adding that permission would be sought from the Government of Pakistan upon confirmation of the vaccine being dispatched from the UK.

With surging cases of coronavirus, efforts are being made across the world to develop an effective vaccine against the deadly virus, but so far scientists have not been able to achieve complete success in this regard.

Various drugs are being tested on humans and animals by different countries all over the world.

Earlier on July 20, AstraZeneca and Oxford University's experimental vaccine produced an immune response in early-stage clinical trials against coronavirus, preserving hopes it could be in use by the end of the year.

The vaccine, called AZD1222, has been described by the World Health Organisation's chief scientist as the leading candidate in a global race to halt a pandemic that has killed more than 600,000 people.

The vaccine from AstraZeneca and the University of Oxford prompted no serious side effects and elicited antibody and T-cell immune responses, according to trial results published in The Lancet medical journal, with the strongest response seen in people who received two doses.

https://www.geo.tv/latest/300644-co...ine-trials-with-oxford-university-in-pakistan
 
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The University of Health Sciences (UHS) Punjab has collaborated with the United Kingdom (UK)'s renowned Oxford University to conduct trials for the latter's coronavirus vaccine in Pakistan.

According to UHS Vice-Chancellor Dr Javed Akram, registration of volunteers for the COVID-19 vaccine trial has already begun and about 20,000 people will be registered in total.

He added that it could take two months for the vaccine to be tested in Pakistan, adding that permission would be sought from the Government of Pakistan upon confirmation of the vaccine being dispatched from the UK.

With surging cases of coronavirus, efforts are being made across the world to develop an effective vaccine against the deadly virus, but so far scientists have not been able to achieve complete success in this regard.

Various drugs are being tested on humans and animals by different countries all over the world.

Earlier on July 20, AstraZeneca and Oxford University's experimental vaccine produced an immune response in early-stage clinical trials against coronavirus, preserving hopes it could be in use by the end of the year.

The vaccine, called AZD1222, has been described by the World Health Organisation's chief scientist as the leading candidate in a global race to halt a pandemic that has killed more than 600,000 people.

The vaccine from AstraZeneca and the University of Oxford prompted no serious side effects and elicited antibody and T-cell immune responses, according to trial results published in The Lancet medical journal, with the strongest response seen in people who received two doses.

https://www.geo.tv/latest/300644-co...ine-trials-with-oxford-university-in-pakistan

Why Dr Javed Akram? Why 20,000 volunteers? That's ridiculous. Pakistan need to be careful.
 
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The most senior infectious diseases expert in the US, Dr Anthony Fauci, has told US lawmakers he was hopeful an effective Covid-19 vaccine will be readily available by the end of 2020.

“We hope that by the time we get into late fall and early winter, we will have in fact a vaccine that we can say that would be safe and effective,” Dr Fauci told a House of Representatives subcommittee on Friday.

“One can never guarantee the safety or effectiveness unless you do the trial, but we are cautiously optimistic this will be successful.”

Dr Fauci expressed scepticism of vaccine efforts in China and Russia, telling lawmakers he did not believe “we will have to depend on other countries to get us vaccines”.

Governments around the world have pledged billions of dollars for a Covid-19 vaccine, some of which have entered late-stage human trials.

However, it is still uncertain which, if any, of the vaccines may work until more testing has been done.

Source BBC
 
This vaccine is to make us zombies. Welcome to the NWO.
 
Pune-based Serum Institute of India (SII) has been given a green light by the Drugs Controller General of India (DCGI) for conducting the Phase 2 and 3 human clinical trials of the Covid-19 vaccine candidate developed by Oxford University, news agency PTI has reported.

The news agency reported citing unnamed government officials as saying that the approval to SII was granted by Dr VG Somani late on Sunday after a thorough evaluation based on the recommendations of the Subject Expert Committee (SEC) on Covid-19.

"The firm has to submit safety data, evaluated by the Data Safety Monitoring Board (DSMB), to the CDSCO before proceeding to Phase 3 clinical trials," a senior official was quoted as saying by PTI.

"As per the study design, each subject will be administered two doses four weeks apart (first dose on day one and second dose on day 29) following which the safety and immunogenicity will be assessed at predefined intervals," the official said.

SII, the world's largest vaccine maker, has signed an agreement to manufacture the potential vaccine developed by University of Oxford’s Jenner Institute in collaboration with British-Swedish company AstraZeneca.

Phase 2 and 3 clinical trials of the Oxford vaccine candidate is on in the United Kingdom, Phase 3 in Brazil and Phase 1 and 2 in South Africa.

The officials, according to PTI, said Serum Institute had submitted a revised proposal on Wednesday after the SEC on July 28 had asked it to revise its protocol for the Phase 2 and 3 clinical trials besides seeking some additional information.

The panel had also recommended that the clinical trial sites which have been proposed for the study be distributed across India.

The expert panel at the Central Drugs Standard Control Organisation (CDSCO) on Friday, as a rapid regulatory response, had recommended granting permission for phase 2 and 3 clinical trials of the potential vaccine, 'Covishield', on healthy adults in India.

Serum Institute has said in its revised proposal that 1,600 people above 18 years of age will participate in the trials across 17 selected sites, including All India Institute of Medical Sciences (AIIMS) in Delhi, BJ Medical College in Pune, Rajendra Memorial Research Institute of Medical Sciences (RMRIMS) in Patna, Post Graduate Institute of Medical Education and Research in Chandigarh, AIIMS in Jodhpur, Nehru Hospital in Gorakhpur, Andhra Medical College in Visakhapatnam and JSS Academy of Higher Education and Research in Mysore.

"According to the application, it would conduct an observer-blind, randomised controlled study to determine the safety and immunogenicity of 'Covishield' on healthy Indian adults," the official said.

https://www.hindustantimes.com/heal...uman-trials/story-yvVh4H4NU3x9VbyKa0jWhO.html
 
India's Wockhardt strikes deal to supply COVID-19 vaccines to UK

Indian drugmaker Wockhardt Ltd will supply millions of doses of multiple COVID-19 vaccines, including that being developed by AstraZeneca and Oxford University, under a deal with the UK government.

The company has reserved fill-and-finish capacity - the final manufacturing step of putting vaccines into vials or syringes and packaging them - as part of the agreement, it said.

"Fill finish is a critical step in the process to get the vaccine in a form to be given to patients. The agreement with Wockhardt will boost our capability to ensure that," Kate Bingham, chair of UK Vaccines Task Force, said in a statement.
 
Russia is pushing ahead with a coronavirus vaccine, working with manufacturers in Brazil and India to produce it in what it says is "very large amounts".

Kirill Dmitriyev, head of Russia's Direct Investment Fund, said it was expected to be registered in the next 10 days.

He said reports in the West that it may be unsafe were an example of "dishonest competition". Mass vaccine production in September is Russia's goal. They have more than one such vaccine in the pipeline.

But Dr Elisabetta Groppelli, a virologist and lecturer in global health at St George's, University of London, told BBC Radio 4's PM no data had yet been shared about the safety and efficacy of the vaccine.

"It's quite worrying that the claims have been made without showing data," she said.

The scientific community felt there has been an element of rushing - and the possibly of shortcuts having been taken - when it comes to a Russian vaccine, she added.
 
Where are we with other vaccines?

As we've already reported, Russia is planning to go ahead with mass vaccinations in October - something the World Health Organization (WHO) has raised concerns about.

But what is happening with the race to create vaccines across the world?

About 140 are in early development, and around two dozen are now being tested on people in clinical trials, including the Russian vaccine.

There are generally three main phases of human testing before a vaccine can be approved for general use. The final stage, phase 3, involves trials among a much larger group of volunteers.

Six potential vaccines have reached this third stage. One, developed by the University of Oxford, appears safe and triggers an immune response in humans.

Early results from two trials in the US, run by the pharmaceutical giant Pfizer and biotech company Moderna, also appear to produce a good immune response in volunteers.

However, they are all still under testing and none have received approval.

So where does this leave the Russian vaccine? According to a document release by the WHO last week, the jab, which has been developed by the Gamaleya Research Institute, remains far behind and is still in phase 1.
 
Canada signs deals for experimental COVID-19 vaccines

Canada has signed separate deals with Pfizer Inc and Moderna Inc to supply millions of doses of their experimental coronavirus vaccines, a top official said.

Procurement Minister Anita Anand also told a news conference that Ottawa was negotiating with other potential domestic and international vaccine suppliers but did not give details.

There are no approved vaccines for COVID-19, the illness caused by the new coronavirus, but 19 vaccines are being tested in humans around the world.

Moderna will provide its mRNA-1273 vaccine candidate, she said. Pfizer - which is working with German biotech firm BioNTech SE - said separately it planned deliveries of the BNT162 mRNA-based vaccine candidate over the course of 2021.
 
German-Chinese coronavirus vaccine trial begins in China

Clinical trials on humans have begun in China for a potential coronavirus vaccine developed by German pharmaceutical group BioNTech with Chinese company Fosun Pharma, the companies said.

Seventy-two participants have already received their first dose following approval for the phase one trial from Chinese regulatory authorities, BioNTech and Fosun Pharma said in a statement.

The vaccine candidate, known as BNT162b1, is one of four based on BioNTech's proprietary mRNA technology.

Another, BNT162b2, is being evaluated in a global phase three trial conducted by BioNTech and US giant Pfizer which started on July 27.

The phase one trial in China involves 144 participants who will receive two doses 21 days apart. Those aged 18-55 will be the first to take part, followed by older people.
 
Human trials of virus vaccine set to begin in Indonesia

Human trials on a potential coronavirus vaccine are due to start in Indonesia next week as part of a collaboration between state-owned pharmaceutical company Bio Farma and China's Sinovac Biotech Ltd, a senior researcher said.

The launch of the vaccine trial comes as Indonesia has struggled to contain the spread of the novel coronavirus, with a consistently escalating number of cases.

The phase 3 clinical trial is set to begin on August 11 and will involve 1,620 volunteers aged between 18 and 59, Professor Kusnandi Rusmil, head researcher at Bandung’s Padjadjaran University, told reporters.
 
US's Azar says any vaccine would be shared once national needs met

US Health Secretary Alex Azar said that any US vaccine or treatment for COVID-19 would be shared fairly with the rest of the world, once the US needs have been satisfied.

"Our first priority of course is to develop and produce enough quantity of safe and effective FDA-approved vaccines and therapeutics for use in the United States," Azar told reporters while on a visit to Taiwan.

"But we anticipate having capacity that, once those needs are satisfied, those products would be available in the world community according to fair and equitable distributions that we would consult in the international community on."
 
Drug company eyes 500-600 million doses of vaccine by 2021

The US-listed drug company, Novavax Inc, said that its manufacturing capacity is sufficient to meet the US demand for COVID-19 vaccines in 2021, according to reports.

Executives of the company said that demand of vaccines could be as high as 500 million to 600 million doses.

Last week, Novavax said that its experimental COVID-19 vaccine produced high levels of antibodies against COVID, according to initial data from a small, early-stage clinical trial.

Novavax expects to be able to produce well over 2 billion doses of its vaccine annually overall, the executives told reporters.
 
Russia becomes first country to approve a COVID-19 vaccine, says Putin

(Moscow) President Vladimir Putin said on Tuesday that Russia had become the first country in the world to grant regulatory approval to a COVID-19 vaccine after less than two months of human testing, a move hailed by Moscow as evidence of its scientific prowess.

The development paves the way for the mass inoculation of the Russian population, even as the final stage of clinical trials to test safety and efficacy continue.

The speed at which Russia is moving to roll out its vaccine highlights its determination to win the global race for an effective product, but has stirred concerns that it may be putting national prestige before sound science and safety.

Speaking at a government meeting on state television, Putin said the vaccine, developed by Moscow’s Gamaleya Institute, was safe and that it had even been administered to one of his daughters.

“I know that it works quite effectively, forms strong immunity, and I repeat, it has passed all the needed checks,” said Putin.

He said he hoped the country would soon start mass producing the vaccine.

https://www.brecorder.com/news/4001...ntry-to-approve-a-covid-19-vaccine-says-putin
 
WHO – not enough information to evaluate Russian vaccine

The World Health Organization has not received enough information on the Russian vaccine to evaluate it, the assistant director of its regional branch the Pan American Health Organization has said.

Asked about plans to produce the potential vaccine in Brazil, Jarbas Barbosa said that should not be done until phase 2 and 3 trials are completed to guarantee its safety and effectiveness.

Any vaccine producer has to follow this procedure that guarantees it is safe and has the WHO’s recommendation.
 
Our friends next door already had a cure available and widely in use.
 
Russia says allegations COVID-19 vaccine is unsafe are groundless

Russian Health Minister Mikhail Murashko said allegations that Russia's COVID-19 vaccine was unsafe were groundless and driven by competition, the Interfax news agency reported.

Moscow's decision to grant it approval has raised concerns among some experts. Only about 10 percent of clinical trials are successful and some scientists fear Moscow may be putting national prestige before safety.
 
I don't believe in Russia's vaccine. LOL.

If it really worked, other countries would've used it probably.
 
Russia says allegations COVID-19 vaccine is unsafe are groundless

Russian Health Minister Mikhail Murashko said allegations that Russia's COVID-19 vaccine was unsafe were groundless and driven by competition, the Interfax news agency reported.

Moscow's decision to grant it approval has raised concerns among some experts. Only about 10 percent of clinical trials are successful and some scientists fear Moscow may be putting national prestige before safety.

Give it to Putin 1st
 
WHO – not enough information to evaluate Russian vaccine

The World Health Organization has not received enough information on the Russian vaccine to evaluate it, the assistant director of its regional branch the Pan American Health Organization has said.

Asked about plans to produce the potential vaccine in Brazil, Jarbas Barbosa said that should not be done until phase 2 and 3 trials are completed to guarantee its safety and effectiveness.

Any vaccine producer has to follow this procedure that guarantees it is safe and has the WHO’s recommendation.

is WHO trustable?
 
They've jumped the gun': scientists worry about Russia's Covid-19 vaccine

In 1977, Scott Halstead, a virologist at the University of Hawaii, was studying dengue fever when he noticed a now well-known but then unexpected feature of the disease.

Animals that had already been exposed to one of the four closely related viruses that cause dengue and produced antibodies to it, far from being protected against other versions, became sicker when infected a second time, and it was the antibodies produced by the first infection that were responsible, allowing the second infection to hitchhike into the body.

The effect was called antibody-dependent enhancement (ADE). The reason it matters today, in the midst of the coronavirus pandemic, is that unexpected glitches such as ADE are the kind of problems vaccine developers look for in phase-3 testing of vaccines – testing that has yet to be carried out on Russia’s newly approved Sputnik V vaccine.

In recent weeks, as announcements on the development of scores of vaccines around the world have come in rapid succession, the still poorly understood mechanisms of ADE have been thrust into the spotlight as scientists speculate on whether vaccine-produced antibodies could trigger this effect.

ADE “is a genuine concern”, Kevin Gilligan, a virologist and senior consultant with Biologics Consulting, told Nature Biotechnology in June. “Because if the gun is jumped and a vaccine is widely distributed that is disease-enhancing, that would be worse than actually not doing any vaccination at all.”

This week, following Russia’s announcement that it is pushing ahead with mass production of Sputnik V and mass inoculation , the fears expressed by the likes of Gilligan became a chorus, underlining the concerns among scientists that Russian researchers have jumped the gun.

Russia has described claims that the vaccine is unsafe as groundless, and on Wednesday vowed to roll it out in two weeks. But criticism has continued to build.

Among those mentioning ADE as a concern was Danny Altmann, a professor of immunology at Imperial College. He said part of the problem was that the work behind Russia’s vaccine development had been so opaque that no one really knows how safe or even how effective it will be.

“I don’t think the Russian researchers have done anything wrong, but I think they’ve jumped the gun,” he told the Guardian. “If we are talking about safety then you have to be looking at issues like ADE, which was a concern that scuppered some efforts to develop a Sars vaccine, where it exacerbated an asthma-like response in lungs.”

It is not just the potential for issues such as ADE that concerns people like Altmann, who is optimistic that the hunt for a vaccine for Covid-19 is not “intractable”. He said the ideal approach would have been to compare 150 or so different vaccine candidates transparently, using the same testing criteria, to ensure the world gets the best vaccine, not simply the first.

“No two of these candidates is going be alike in terms of safety, how effective they are or how cheap they are to produce,” he said. “The reason we’re crying out for transparency and peer review is because those factors are very serious. There have been too many debacles in this pandemic. This is not another occasion to blunder in. You want to line up the candidates side by side.”

The lack of effective testing throws up other issues. “I think there is enough general background data … to assume the [Russian] vaccine itself will be safe at the usual doses,” Ian Jones, a professor of virology at the University of Reading, said in a statement posted on the Science Media Centre website. “The bigger risk, however, is that the immunity generated is not sufficient to give protection, leading to continued virus spread even among immunised individuals.

“And although only a possibility, less than complete protection could provide a selection pressure that drives the virus to evade what antibody there is, creating strains that then evade all vaccine responses. In that sense, a poor vaccine is worse than no vaccine. Careful virus tracking will therefore need to accompany any early release.”

Even before Russia’s announcement, some were warning about accelerated vaccine development programmes in Russia and in the US. In an opinion piece for the New York Times, Natalie Dean, an assistant professor of biostatistics at the University of Florida, flagged up many of the same issues, adding that she would hesitate to take a vaccine that appeared to have been rushed through without proper testing.

“[The] benchmark [of phase-3 testing] is crucial because a weak vaccine might be worse than no vaccine at all,” she said. “We do not want people who are only slightly protected to behave as if they are invulnerable, which could exacerbate transmission. It is also costly to roll out a vaccine, diverting attention away from other efforts that we know work, like mask-wearing, and from testing better vaccines.”

The last thing phase-3 trials do is examine safety. Earlier trials do this too, but larger trials allow for rarer side effects to be detected. One such effect is a paradoxical phenomenon known as immune enhancement, in which a vaccinated person’s immune system overreacts to infection. Researchers can test for this by comparing the rates of disease severe enough to require hospitalisation across two groups.

“A clear signal that hospitalisation is higher among vaccinated participants would mark the end of a vaccine,” Dean said.

https://www.theguardian.com/world/2...no-vaccine-the-challenges-faced-by-scientists
 
Russia says medics to get anti-COVID shots in two weeks, some Russians wary

MOSCOW (Reuters) - Russia said on Wednesday the first batch of the world’s first COVID-19 vaccine would be rolled out within two weeks and rejected as “groundless” safety concerns aired by some experts over Moscow’s rapid approval of the drug.

The vaccine, called “Sputnik V” in homage to the world’s first satellite launched by the Soviet Union in 1957, has yet to complete its final trials and some scientists said they feared Moscow may be putting national prestige before safety.

“It seems our foreign colleagues are sensing the specific competitive advantages of the Russian drug and are trying to express opinions that in our opinion are completely groundless,” Health Minister Mikhail Murashko said the day after President Vladimir Putin announced it had won regulatory approval.

On the streets of Moscow, some Russians said they would be too scared to try the vaccine, while others agreed with their government that scepticism expressed by foreign experts was driven by jealousy.

“I don’t trust Russian vaccines in general, I definitely won’t get vaccinated,” said Ekaterina Sabadash, 36, speaking outside Moscow’s Bolshoi Theatre.

Alexander, a photographer, was also wary. “Until it goes through (final) clinical trials and we get some confirmed results, I would be scared to get it done,” he said.

Others said they understood why Russia was in a hurry to get a new vaccine and trusted it, but doubted they would really have a say in whether to have it.

“I’m a teacher and they’ll recommend we get it,” said Irina Fashchevskaya, a Moscow resident. “We’ll be forced to do it.”

Officials have said that the vaccine, developed by Moscow’s Gamaleya Institute, would be administered to people, including doctors, on a voluntary basis in the final trial. Mass roll-out in Russia is expected to start in October.

Scientists from Germany the United States and Britain have queried the wisdom of approving the vaccine before testing is complete, saying it was risky from a safety point of view.

Kirill Dmitriev, head of Russia’s RDIF sovereign wealth fund, has spoken of an information war against his country, an assertion that finds sympathy with Russians weary of what they regard as years of Western condescension.

Mikhail Mechyov, a 42-year-old Moscow resident, said he saw jealousy behind Western warnings.

“It’s natural to be cautious, but they are aimed at belittling the achievement of our country,” he said. “I think a lot has been done and it’s great there is a vaccine.”

Read more: https://www.reuters.com/article/us-...in-two-weeks-some-russians-wary-idUSKCN25821K
 
Russia says medics to get anti-COVID shots in two weeks, some Russians wary

MOSCOW (Reuters) - Russia said on Wednesday the first batch of the world’s first COVID-19 vaccine would be rolled out within two weeks and rejected as “groundless” safety concerns aired by some experts over Moscow’s rapid approval of the drug.

The vaccine, called “Sputnik V” in homage to the world’s first satellite launched by the Soviet Union in 1957, has yet to complete its final trials and some scientists said they feared Moscow may be putting national prestige before safety.

“It seems our foreign colleagues are sensing the specific competitive advantages of the Russian drug and are trying to express opinions that in our opinion are completely groundless,” Health Minister Mikhail Murashko said the day after President Vladimir Putin announced it had won regulatory approval.

On the streets of Moscow, some Russians said they would be too scared to try the vaccine, while others agreed with their government that scepticism expressed by foreign experts was driven by jealousy.

“I don’t trust Russian vaccines in general, I definitely won’t get vaccinated,” said Ekaterina Sabadash, 36, speaking outside Moscow’s Bolshoi Theatre.

Alexander, a photographer, was also wary. “Until it goes through (final) clinical trials and we get some confirmed results, I would be scared to get it done,” he said.

Others said they understood why Russia was in a hurry to get a new vaccine and trusted it, but doubted they would really have a say in whether to have it.

“I’m a teacher and they’ll recommend we get it,” said Irina Fashchevskaya, a Moscow resident. “We’ll be forced to do it.”

Officials have said that the vaccine, developed by Moscow’s Gamaleya Institute, would be administered to people, including doctors, on a voluntary basis in the final trial. Mass roll-out in Russia is expected to start in October.

Scientists from Germany the United States and Britain have queried the wisdom of approving the vaccine before testing is complete, saying it was risky from a safety point of view.

Kirill Dmitriev, head of Russia’s RDIF sovereign wealth fund, has spoken of an information war against his country, an assertion that finds sympathy with Russians weary of what they regard as years of Western condescension.

Mikhail Mechyov, a 42-year-old Moscow resident, said he saw jealousy behind Western warnings.

“It’s natural to be cautious, but they are aimed at belittling the achievement of our country,” he said. “I think a lot has been done and it’s great there is a vaccine.”

Read more: https://www.reuters.com/article/us-...in-two-weeks-some-russians-wary-idUSKCN25821K

Very low standard article from Reuters to be honest. It feels like above is a high school assignment for report writing.
 
Argentina, Mexico to produce AstraZeneca vaccine

Argentina and Mexico will produce the AstraZeneca COVID-19 vaccine for most of Latin America, Argentine President Alberto Fernandez after a meeting with company executives involved in the project.

An agreement signed between British pharmaceutical company AstraZeneca and the biotechnology company mAbxience of the INSUD Group includes transfer of technology to initially produce 150 million doses of the vaccine to supply all of Latin America with the exception of Brazil, according to the Argentine government.

"Latin American production will be handled in Argentina and Mexico and that will allow timely and efficient access for all countries in the region," Fernandez said.
 
AstraZeneca says could begin COVID-19 vaccine production early in 2021

Production of a COVID-19 vaccine under an agreement between the Mexican and Argentine governments and pharmaceutical company AstraZeneca could begin in the first quarter of 2021, an AstraZeneca executive announced.

Sylvia Varela, head of AstraZeneca Mexico, said at the Mexican president's daily news conference that Phase III trials were expected to conclude by November or December.
 
EU to enter contract talks with J&J over 200 million doses of potential COVID-19 vaccine

BRUSSELS (Reuters) - The European Commission has concluded exploratory talks with Johnson & Johnson to buy 200 million doses of a potential COVID-19 vaccine, the EU executive and the U.S. pharmaceutical company said on Thursday.

The EU executive arm said this paved the way for contractual talks and the possible purchase of the vaccine on behalf of all 27 EU states once it has proven safe and effective. The commission also said it could purchase an additional 200 million vaccine doses.

Johnson & Johnson, through its Belgian subsidiary Janssen, “will now enter into contract negotiations with the European Commission,” J&J said in a statement, confirming the volumes indicated by the Commission.

“If regulatory approval for the company’s vaccine is received, the Commission would be expected to facilitate a process for allocation of the vaccine doses among the member states,” Johnson & Johnson said.

J&J could produce up to 1 billion doses of its vaccine by the end of 2021, a company executive told Reuters on Tuesday. Its vaccine is likely to be administered in a single shot, the executive said.

Reuters exclusively reported in June that the U.S. company was in advanced talks with the EU for the supply of its COVID-19 vaccine under development.

“Our citizens’ lives and our economy need a safe and effective vaccine against the coronavirus. Today’s talks bring us closer to achieving this,” the President of the European Commission Ursula von der Leyen said in a statement.

The move follows similar announcements in July about the conclusion of preliminary talks between the EU and Sanofi SA for the purchase of 300 million doses of its potential COVID-19 vaccine that it is developing together with GlaxoSmithKline Plc.

The EU is using about 2 billion euros ($2.4 billion) from an emergency fund to strike advance purchase deals with several vaccine makers in a bid to have enough shots for its population of 450 million.

It is also in talks with Pfizer, Moderna, AstraZeneca and CureVac to buy upfront their potential COVID-19 vaccines, EU officials told Reuters in July.

https://www.reuters.com/article/us-...s-of-potential-covid-19-vaccine-idUSKCN2592FU
 
Sputnik V: What we know about Russia's coronavirus vaccine

Russia is set to roll out the world's first approved coronavirus vaccine amid scepticism about its effectiveness and safety after less than two months of human testing.

President Vladimir Putin announced on Tuesday that Russia had become the first country to grant regulatory approval to a COVID-19 vaccine, which showed "stable immunity" against the new coronavirus and had "passed all the necessary checks".

However, the vaccine, named "Sputnik V" in homage to the world's first satellite launched by the Soviet Union, has not yet completed its phase-three trial, which involves wide-scale testing with thousands of participants.

Across the globe, more than 200 vaccine candidates are being developed and trialled, with at least 24 in the human clinical trial phase, according to the World Health Organization (WHO).

Here is what we know so far about Russia's vaccine:

What is Sputnik V?

The "Sputnik V" is a vaccine developed by the Gamaleya research institute in coordination with the Russian defence ministry. It is based on a proven vaccine against adenovirus - the common cold.

The vaccine is expected to provide immunity from SARS-CoV-2, the virus that causes COVID-19, for up to two years, according to the Russian health ministry. But the results of the limited trials have yet to be made public.

The vaccine is administered in two doses and consists of two serotypes of human adenovirus, each carrying an S-antigen of the new coronavirus, which enter human cells and produce an immune response.

It is a so-called viral vector vaccine, meaning it employs another virus to carry the DNA encoding of the needed immune response into cells.

The platform used for the vaccine was developed by Russian scientists over 20 years and had formed the basis for several vaccines in the past, including those against Ebola.

Gamaleya's vaccine is based on similar technology to the coronavirus vaccine prototype developed by CanSino, a Chinese vaccine-making company.

Health Minister Mikhail Murashko has said clinical trials involving several thousand participants would follow.

The first batch of the vaccine will be made available for medical personnel in the next two weeks, he said on Wednesday.

The vaccine could be available for mass use in October, according to the country's health ministry.

What is the world's reaction?

While numerous experts and governments have raised concerns that Russia is racing to be the first with an approved vaccine and compromising safety, some countries have shown interest in Sputnik V.

The WHO said on Wednesday it was looking forward to reviewing the clinical trials.

Scientists in Russia and elsewhere have questioned the speed of the development and lack of transparency, saying offering the vaccine to the public before the important final-stage testing could pose serious problems.

"We have no idea that the claims that are being made about the safety and immune response of this virus are true or not," Peter Drobac, infectious disease medic at Oxford University, told Al Jazeera.

He said the "geopolitics - being able to claim victory - may put pressure on other countries to cut corners on safety and effectiveness as well. That could put all in danger".

Meanwhile, the Philippines plans to start trialling the vaccine in October, with President Rodrigo Duterte expected to be inoculated as early as May next year, the presidential spokesman said on Thursday.

A Brazilian technology institute said on Wednesday it expected to produce the controversial vaccine by the second half of 2021, shortly after the state of Parana signed a memorandum of understanding with Moscow.
https://www.aljazeera.com/news/2020/08/sputnik-russia-coronavirus-vaccine-200813070859021.html
 
The UK government has signed deals for a further 90 million doses of coronavirus vaccine - increasing its potential stockpile to 340 million jabs.

The vaccines are being developed by the Belgian pharmaceutical company Janssen and the US biotech company Novavax.

It means the UK has placed orders for six experimental vaccines - meaning, in theory, there should be enough for everyone in the UK to get five doses.
 
US eyes controversial human challenge trials for COVID-19 vaccine

US government scientists have begun efforts to manufacture a strain of the novel coronavirus that could be used in human challenge trials of vaccines, a controversial type of study in which healthy volunteers would be vaccinated and then intentionally infected with the virus, according to the Reuters news agency.

The work is preliminary and such trials would not replace large-scale, phase-three trials such as those now under way in the United States testing experimental COVID-19 vaccines from Moderna Inc and Pfizer Inc, according to a statement emailed to Reuters by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health.
 
COVID-19 vaccine makers must deliver on time to get paid by US

The United States is tying payments for COVID-19 vaccines to timing milestones for production and approval, according to public documents and a Trump administration official, putting pressure on drugmakers including Moderna Inc to meet ambitious targets.

In a deal with Moderna announced this week, federal agencies negotiated a sliding scale of payments. The Cambridge, Massachusetts, biotech's $1.5bn deal pays out in full if its vaccine receives regulatory clearance by January 31, 2021, according to filings. It receives $1.2bn if it falls short of that timing goal.

Moderna also receives $600m when it can demonstrate it has built out industrial-scale manufacturing capabilities for its vaccine, even if that happens before the drug is authorised by regulators, the filings show.
 
UK secures 90 million more doses of potential virus vaccine

The United Kingdom has secured access to 90 million doses of two "promising" coronavirus vaccines, the government said, taking its total orders of potential COVID-19 vaccines to nearly 350 million doses.

The country has struck agreements to buy 60 million doses from US biotech firm Novavax, and another 30 million doses from Janssen pharmaceuticals, which is part of US giant Johnson & Johnson.
 
BREAKING: Russia launches production of new vaccine

Russia's health ministry says it has begun production of a new vaccine. In a press release, the ministry said the vaccine would be rolled out at the end of the month.

Many experts fear that Russia may be compromising safety by fast-tracking the vaccine. In Russia, an independent poll has revealed that over a half of medics said were not ready to get vaccinated as they do not trust it.

President Vladimir Putin previously said it had passed all the required checks, adding that his daughter had already been vaccinated.

The vaccine has been named Sputnik V in honour of the world's first satellite. Sputnik is the Russian word for satellite.
 
DUBAI: Last week, Russia surprised the world by announcing that it had developed and authorized production of a vaccine — Sputnik V — to combat COVID-19. Many experts and media commentators criticized the Russians for being quick to claim credit for the first vaccine at the expense of sufficient testing, specifically phase 3 testing on humans.

The Russian Direct Investment Fund (RDIF) played a key role in developing Sputnik V. In an exclusive interview with Arab News, CEO Kirill Dmitriev explained the reason for the rapid registration of the vaccine, and why he thinks the West has been less than welcoming to this potential breakthrough against the pandemic.

AN: Have you been surprised by the reaction in some parts of the international media?

KD: We understood that the world would be divided. There has been a division between ordinary people who want the vaccine and who understand it’s good news in all countries. And also some politicians, some pharma companies and some media, there’s a division there.

Then there’s a division between countries. We’ve seen a very negative, I’d call it very jealous reaction in the US, the UK and some other places in Europe. But we’ve seen very positive reaction in the Middle East, in Asia, and extremely positive reaction in Latin America. I think the reaction is different in those geographies, and we were expecting this.

I think it’s very important to understand the position of Russia. We aren’t forcing our vaccine on anyone. As of now only Russians will be vaccinated, but we just want to share the fact we have this technology. There are some unique features. Maybe I can go into why we did it, how we did it so quickly and the science behind it.

We saw that some countries would want to explore it, would want to do it. But other countries, just because it’s Russian they have a mental block on anything that’s Russian. I have this analogy: If we were to offer to distribute water to the US, we’d get articles in the media that maybe it’s poisoned, or the recipe is stolen, or maybe it has some vodka in it.

AN: But some of the scientific criticism focused on the very rapid development of Sputnik V and lack of data.

KD: Some of the points are legitimate, and they’ll be answered by data we publish in August. In all the criticism, there’s a valid point about making data available, and I wish we could’ve done it earlier. But data will start to become available at the end of August, and it will be published — data about phase 1, phase 2, animal studies etc. And we’ve already started doing phase 3. So more data will be coming out, and it’s a fair criticism.

We know the technology works, and let me go into what’s unique about it. Russia has always been very strong in vaccines. Catherine the Great was vaccinated 30 years before the first American vaccine appeared — 1762 I think it was . And the Soviet Union was always strong in vaccines.

On this specific vaccine, basically our scientists had a head start. They were working on the Ebola vaccine, which got approved, then they used the same method — human adenovirus vector — on the MERS vaccine. When coronavirus appeared, they just happened to have this proven platform. MERS is very close to coronavirus, and they were able to use an already proven and researched platform.

This adenovirus vector stuff is basically the human adenovirus vector. It has been studied in the world the last 20 years. There have been dozens of studies, tens of thousands of people, and it has been proven that human adenovirus is safe and doesn’t have long-term consequences.

It’s very different from mRNA, very different from monkey adenovirus, which haven’t been studied for 20 years and haven’t been the subject of dozens of clinical studies. Frankly they’re novel approaches, and we hope they work, but they’re much less studied approaches. So the fact we had this proven platform allowed us to move forward.

AN: Why not wait until the end of August to announce it when all the data could be made available?

KD: There’s an ethical responsibility that once you have a technology that you know works, to make it available to people in a safe manner. It’s irresponsible to delay something that you know works and then deny it to people who need protection.

We want all countries to do all the necessary checks. Our Ministry of Health has done it for Russia, and they determined that the vaccine is safe and efficient. And when they determined that, they wanted to make it available to Russian people right away. People are dying from coronavirus and we want to protect them. There was a clinical and human need.

AN: What about the lack of phase 3 tests?

KD: We have a law in Russia that at a time of epidemic you’re allowed to do phase 3 concurrently while administering the vaccine to people. Basically it’s invoked only for technologies that’ve been proven to be safe before.

So if we were to try to use mRNA or monkey adenovirus, it has never been shown to be effective before, and we’d never have done it without phase 3. But we have the vaccine already approved, based on Ebola, so we have data for the last six years and the world has data for the last 20 years of studying human adenovirus vectors.

Let me try to explain it very simply. You can think of vaccines as just coming in two parts. You have a code for the spike of coronavirus that needs to be delivered to cells so that antibodies get produced. Pretty much all the vaccines, simplified, more or less, have the same spike.

So the only thing that matters and is different is the delivery mechanism. Our delivery mechanisms are based on human adenovirus, which has been proven before to be safe long term. There have been studies for example that show it doesn’t cause cancer, over the past 20 years.

So we used technology safe and proven before to deliver the spike of coronavirus. So once you understand the science, you basically say, ‘OK, what could go wrong?’ Most of the problems that could go wrong come from the delivery mechanism.

For example, AstraZeneca (the multinational pharmaceutical group also working on a vaccine) uses monkey adenovirus, which has never been studied long term in the human population. So that’s very different, which the West is missing. mRNA (an alternative vaccine technique under development in the West) had never been studied before.

So it shows that the stuff that was approved in Russia, safe and chosen before, just delivers a spike of coronavirus.

AN: Can you tell me more about the agreement you have with Saudi Arabia to do tests there?

KD: We have an agreement in principle to have clinical trials in Saudi Arabia. We’ll have a visit by the Saudi Health Ministry to the Gamaleya Institute, which is part of the process. We already have a partner in the Kingdom, a very good Saudi company. I shouldn’t name them. It’s an experienced pharma company that’s working with us, and we’ve already shared phase 1 and 2 data with our Saudi partners.

We believe in a real strategic partnership with Saudi Arabia on the vaccine. We know that lots of countries look up to the Saudi position and their approach, and we’ll really engage with Saudi scientists, the Saudi Health Ministry, in the very deep understanding of our technology. We believe that Saudi will be a very strong partner for our joint work on the Sputnik V vaccine.

We’ve also shared data with the UAE. We expect to start trials there in August.

We expect to have clinical trials in Saudi, the UAE, the Philippines and Brazil, as well as Russia.

AN: So you have your vaccine. Do you care whether the rest of the world takes it up or not?

KD: Of course, our priority is the safety and security of our people, and we have a safe vaccine. Vaccinating our people will start massively in October. If it’s just Russia that gets vaccinated, it’s a great accomplishment because we gave the vaccine earlier and saved more lives. It’s very important to save our people.

Our other responsibility is to share with the world, openly, what we have and what we know works. It’s up to individual countries to explore it. If they want to take it or not take it, we won’t care so much because we aren’t going to do this for profit.

It’s on a not-for-profit basis, just to cover our expenses on the vaccine and cover our costs. This isn’t a money maker. It’s a humanitarian initiative. It’s our responsibility to tell the world we have it, this is how it works, and you have Sputnik V that has all the information, and more will be published. With that, we feel our responsibility to the world is complete.

We have requests already for 1 billion doses of vaccine. It’s huge. If other people show interest, it’s our responsibility to make it available, then we’ll work with five other countries to produce the vaccine and make sure we distribute it to countries that want it.

We aren’t trying to convince the US. We aren’t trying to convince Europe. We fulfilled our responsibility by developing it, vaccinating Russian people, letting other people know we have it, and letting countries that want it manufacture it in partnership with them.

We’re trying to do as much as we can without forcing this on anybody or trying to convince anybody.

AN: How much will it cost per dose?

KD: We’ll be able to talk about that in September or October because we’re scaling up manufacturing outside Russia and we want to get to the lowest price point, and we need to get to manufacturing in scale. We need a couple more months to do this.

All I can say now is that pricing will be very competitive. From some other estimates we saw from other people, we expect our pricing will be lower than we saw others circulate.

https://www.arabnews.com/node/1719931/business-economy
 
Chinese firm says vaccine ready by the end of the year

A Chinese pharmaceutical company has announced that it is expecting to have a vaccine by the end of the year.

The chairman of Sinopharm, Liu Jingzhen, has told media that one of the company’s Covid-19 vaccine candidates, currently undergoing Phase III clinical trials on humans in the United Arab Emirates, is expected to be on the market by the end of December.

Mr Liu himself has been injected with two doses of the vaccine, and told Global Times he has so far felt “no side effects”.

China has workshops in the cities of Beijing and Wuhan that are able to produce 120 million and 100 million doses a year respectively, and the vaccine is expected to be priced under 1,000 yuan ($144; £110) for two doses.

There are some concerns in the mainland at the price, with many on the Sina Weibo social media platform saying that it would be unaffordable to rural Chinese. However, given China is currently reporting no domestic cases, only imports, there is limited concern an outbreak would reach smaller, rural communities.

There are more than 200 vaccine candidates currently in development around the world, and more than 20 are at the stage of being used in human clinical trials.
 
Brazil approves human trials for potential Johnson & Johnson COVID-19 vaccine

BRASILIA (Reuters) - Brazil’s health regulator Anvisa on Tuesday said it had approved human clinical trials for a potential COVID-19 vaccine developed by Johnson & Johnson’s pharmaceutical subsidiary Janssen.

Brazil is the second-worst hit country for coronavirus cases and deaths after the United States, leading many vaccine developers to seek out clinical trials here.

Brazil had registered 3.4 million cases of the disease and more than 108,000 related deaths as of Monday.

The Johnson & Johnson vaccine candidate is the fourth to be approved for human trials in Brazil, Anvisa said in its statement.

Brazil has already approved phase 3 human trials of potential vaccines developed by AstraZeneca in partnership with the University of Oxford, China’s Sinovac Biotech and Pfizer in partnership with BioNTech.

China’s Sinopharm also aims to carry out trials for a possible vaccine in Brazil in a deal with the southern state of Parana pending regulatory approval.

https://www.reuters.com/article/us-...ohnson-johnson-covid-19-vaccine-idUSKCN25E1MP
 
Australia signs deal with AstraZeneca for possible COVID-19 vaccine

SYDNEY (Reuters) - Australia has signed a deal with drugmaker AstraZeneca to secure a potential COVID-19 vaccine, the Prime Minister said on Tuesday, joining a growing list of countries lining up supplies of the drug.

AstraZeneca’s candidate is seen as a frontrunner in the global race to deliver an effective vaccine against the coronavirus that has killed more than 770,000 people and infected nearly 22 million, according to a Reuters tally.

With several countries moving to secure supplies that some fear may lead to a global shortage, Australia said it had signed a letter of intent with AstraZeneca to produce and distribute enough doses for its population.

“Under this deal we have secured early access for every Australian,” Prime Minister Scott Morrison said in an emailed statement.

“If this vaccine proves successful we will manufacture and supply vaccines straight away under our own steam and make it free for 25 million Australians.”

Countries around the world are looking to secure supplies of Astrazeneca’s potential vaccine. Most recently Argentina and Mexico said last week they would produce it for much of Latin America.

Morrison, however, cautioned that while AstraZeneca’s candidate is showing early promise, there was no guarantee it would materialise as an effective tool in preventing COVID-19.

Once heralded as a global leader in combating COVID-19, Australia has seen a surge of new infections in the past month. Yet its tally of nearly 24,000 cases and 438 deaths is still far fewer than many other developed nations.

Morrison said Australia is also committed to ensuring early access to a vaccine for Pacific countries, which are increasingly wooed by China, much to Canberra’s concern.

Earlier, Australia’s biggest biotech company CSL Ltd said it was in talks with AstraZeneca to determine if the potential COVID-19 vaccine being developed by the British drugmaker could be manufactured locally.

In addition to pressing ahead with securing a potential vaccine, Australia said it had also signed a A$24.7 million ($17.9 million) deal with U.S. medical technology company Becton Dickinson to buy 100 million needles and syringes.

https://www.reuters.com/article/us-...a-for-possible-covid-19-vaccine-idUSKCN25E1MD
 
German institute says coronavirus vaccinations could start in early 2021

The head of Germany’s vaccines regulator said some groups of people living in Germany could be vaccinated early next year against the coronavirus that has killed almost 800,000 worldwide and wreaked havoc on the global economy.

More than half a dozen drugmakers around the world are conducting advanced clinical trials, each with tens of thousands of participants, and several expect to know if their Covid-19 vaccines work and are safe by the end of this year.

Klaus Cichutek, head of the Paul Ehrlich Institut, told the Funke group of newspapers that data from Phase I and Phase II trials showed some vaccines triggered an immune response against the coronavirus.

“If data from Phase III trials shows the vaccines are effective and safe, the first vaccines could be approved at the beginning of the year, possibly with conditions attached,” he said.

“Based on assurances from manufacturers, the first doses for people in Germany will be available at that time, in accordance with the priorities set by the Standing Committee on Vaccination,” Cichutek said, referring to the group that makes recommendations for the use of licensed vaccines in Germany.

Infections in Germany have risen in recent weeks and data from the Robert Koch Institute (RKI) for infectious diseases on Wednesday showed the number of confirmed coronavirus cases climbing by 1,510 to 226,914.

The RKI said 39% of cases were probably imported, with Kosovo, Turkey and Croatia most often reported as the likely source of infection in recent weeks.

Several companies, including Moderna, AstraZeneca, and Pfizer Inc, say they each expect to make more than 1 billion doses of a vaccine next year.

German biotechnology firm CureVac has not ruled out a speedy approval process for its prospective vaccine and expects to have it on the market by mid-2021.

Russia has said its vaccine will be rolled out by the end of this month.
https://tribune.com.pk/story/226023...avirus-vaccinations-could-start-in-early-2021
 
EU, CureVac in talks on 225 milion doses of potential vaccine

The European Commission said on Thursday it had concluded exploratory talks with CureVac regarding the purchase of 225 million doses of the German biotech firm's potential COVID-19 vaccine.

"Today we concluded talks with the European company CureVac to increase the chances of finding an effective coronavirus vaccine," EU Health Commissioner Stella Kyriakides said.

The EU will now begin talks on a contract with CureVac aimed at securing the supply of its potential vaccine for all 27 EU member states should the shot prove safe and effective against COVID-19.
 
Coronavirus will be with us forever, UK Sage scientist warns

Coronavirus will be present "forever in some form or another", a member of the UK government's Scientific Advisory Group for Emergencies (Sage) has said.

Sir Mark Walport said people would need to be vaccinated at regular intervals.

His comments come after the head of the World Health Organization (WHO) said he hoped the pandemic would be over within two years, as the Spanish flu had taken two years to overcome.

Sir Mark said denser populations and travel meant the virus spread easily.

He also said the world population was now much larger than in 1918.

Speaking to BBC Radio 4's Today programme, Sir Mark said that, in order to control the pandemic, "global vaccination" would be required, but coronavirus would not be a disease like smallpox "which could be eradicated by vaccination".

"This is a virus that is going to be with us forever in some form or another, and almost certainly will require repeated vaccinations," he said.

"So, a bit like flu, people will need re-vaccination at regular intervals."

Tedros Adhanom Ghebreyesus, head of the WHO, has said that the Spanish flu of 1918 took two years to overcome, and that advances in technology could allow the world to halt coronavirus "in a shorter time".

The flu of 1918 killed at least 50 million people.

So far, coronavirus has killed nearly 800,000 people and infected almost 23 million.

Sir Mark warned that it was "possible" coronavirus would get "out of control" again, but said more targeted measures could now be used instead of a generic lockdown.

Coronavirus cases have been increasing in European countries in recent weeks. Some nations, which had appeared successful in suppressing the initial outbreaks, are now seeing infections rise again.

As of 22 August, the UK recorded 21.5 coronavirus cases per 100,000 people over the last fortnight, according to the European Centre for Disease Prevention and Control.

Sir Mark said: "We know that less than one in five people around the country have been infected, so 80% of the population are still susceptible to this virus.

"It is this terrible balance between trying to minimise the harm to people from the infection and protecting people, whilst keeping society going."

He said he was worried about the rise in the number of cases in Europe and other parts of the world.

Meanwhile, tourists returning to the UK spent thousands of pounds arranging new flights in a race to get home before new travel rules came into force.

From 04:00 BST on Saturday, travellers coming back from Croatia, Austria and Trinidad and Tobago must quarantine for 14 days.

There were similar scenes last weekend when new rules kicked in for those returning from countries including France and the Netherlands.

https://www.bbc.com/news/uk-53875189
 
Trump accuses FDA of delaying vaccine release

President Donald Trump has accused the body that authorises drugs and medical treatments in the US of stalling vaccine trials until after the presidential election.

Mr Trump provided no evidence for his claims against the Food and Drug Administration.

<blockquote class="twitter-tweet"><p lang="en" dir="ltr">The deep state, or whoever, over at the FDA is making it very difficult for drug companies to get people in order to test the vaccines and therapeutics. Obviously, they are hoping to delay the answer until after November 3rd. Must focus on speed, and saving lives! <a href="https://twitter.com/SteveFDA?ref_src=twsrc%5Etfw">@SteveFDA</a></p>— Donald J. Trump (@realDonaldTrump) <a href="https://twitter.com/realDonaldTrump/status/1297138862108663808?ref_src=twsrc%5Etfw">August 22, 2020</a></blockquote> <script async src="https://platform.twitter.com/widgets.js" charset="utf-8"></script>
 
The US Food and Drug Administration (FDA) has given emergency authorisation for the use of plasma to treat coronavirus patients.

The technique uses antibody-rich blood plasma from people who've recovered from the disease, and has already been used on over 70,000 people in the US.

President Donald Trump said the treatment could reduce deaths by 35%.

It comes a day after he accused the FDA of impeding the rollout of vaccines and therapeutics for political reasons.

The announcement comes on the eve of the Republican National Convention, where Mr Trump will launch his campaign to win a second term in the White House.

"This is what I've been looking forward to doing for a long time," the president told reporters on Sunday. "I'm pleased to make a truly historic announcement in our battle against the China virus that will save countless lives."

President Trump described the procedure as a powerful therapy and he appealed for Americans to come forward to donate plasma if they've recovered from Covid-19.

The FDA has given the treatment "emergency use authorisation", rather than full approval, saying that early research suggests blood plasma can decrease mortality and improve patient health if it's administered within the first three days of their hospitalisation. However, more trials are needed to prove its effectiveness.

The agency said it concluded it was safe after an extensive review of data collected during recent months. In a statement, it added that the benefits of the treatment outweighed any risks.

"It appeared that the product is safe and we're comfortable with that and we continue to see no concerning safety signals," said Peter Marks, director of the FDA's Center for Biologics Evaluation and Research, according to Reuters news agency.

But several experts, including Anthony Fauci, a member of the White House's coronavirus task force, have expressed reservations about the robustness of studies so far.

The FDA has already approved the use of plasma transfusions on coronavirus patients under certain conditions, like those who are gravely ill or taking part in clinical trials.

In a tweet on Saturday, President Trump said "the deep state, or whoever, at the FDA is making it very difficult for drug companies to get people in order to test the vaccines and therapeutics.

"Obviously, the are hoping to delay the answer until after [the US presidential election]," he added.

Earlier this year, US regulators gave emergency authorization to Gilead Science Inc's remdesivir as a therapeutic treatment for coronavirus.

Meanwhile, a report by the Financial Times suggests the White House is considering granting emergency authorisation for a vaccine being developed by Oxford University and pharmaceutical giant AstraZeneca, ahead of the US presidential election on 3 November. The White House has not commented on the story, but a spokesperson for AstraZeneca told Reuters that efficacy results for its trials were not expected until later this year.

More than 176,000 people have died from coronavirus since the start of the outbreak in the United States, according to a tally by Johns Hopkins University. Nearly 5.7 million cases have also been confirmed nationwide.

https://www.bbc.com/news/world-us-canada-53884710
 
Italy has started human testing of a Covid-19 vaccine, developed by scientists at the Spallanzani hospital in Rome.

The first volunteer, a 50 year old woman, told Italian news agency ANSA she was “proud and hoped to be useful to our country”.

The vaccine has been produced by the Italian biotechnology firm, ReiThera, of Castel Romano, near Rome, and doctors say they hope to produce it by next spring. Testing is currently limited to 90 volunteers, selected from over 5,000 applicants.

The scientific chief of Spallanzani, Giuseppe Ippolito, has said “Italy will not be the slave of other countries” in the vaccine field.

Health Minister, Roberto Speranza, said “Italian research has met the challenge.”
 
AstraZeneca starts trial of antibody treatment for COVID-19

AstraZeneca said on Tuesday it started early stage trials for an antibody-based treatment for the prevention and treatment of COVID-19, as the British drugmaker also ploughs on with its vaccine candidate.

The trial will evaluate if AZD7442, a combination of two monoclonal antibodies, is safe and tolerable in up to 48 healthy participants between the ages of 18 and 55 years in the United Kingdom with the backing of the United States.
 
Russia prepares to approve second vaccine

Russia is preparing to approve a second vaccine against Covid-19 in late September or early October, the Russian deputy prime minister, Tatiana Golikova, said on Wednesday.

Speaking at a televised government meeting, Golikova told the president, Vladimir Putin, that early-stage clinical trials on the vaccine, developed by the Vector virology institute in Siberia, would be completed by the end of September.

“As of today there have been no complications among those vaccinated in the first and second stages of testing,” she said.

Earlier this month, Russia became the first country to grant regulatory approval to a Covid-19 vaccine after less than two months of human testing.

The vaccine, called “Sputnik V” in homage to the world’s first satellite launched by the Soviet Union, has been hailed as safe and effective by Russian authorities. But western experts have been sceptical about Russia’s approval of Sputnik V, warning against its use until all internationally approved testing and regulatory steps have been taken.

RDIF, Russia’s sovereign wealth fund, said on Wednesday the final phase of clinical trials on Sputnik V were beginning.

It said 40,000 people would take part in the final trials and that similar trials would also be carried out in five other countries. Sergei Sobyanin, the mayor of Moscow, said residents of the Russian capital could apply to take part in the trials.

These final trials, carried out on a large number of people, are normally considered essential precursors for a vaccine to receive regulatory approval.
 
Canada’s National Research Council (NRC) has ended its partnership for a coronavirus vaccine with CanSino Biologics, saying the Chinese company lacks the authority to ship the vaccine at this time.

CanSino in May had agreed to bring its vaccine candidate to Canada for testing through a partnership with the (NRC).

Because of the delay, NRC “has since moved on to focus our team and facilities on other partners,” the organisation said in a statement to Reuters.

“The process is not clear to the NRC, but CanSino does not have the authority to ship the vaccine at this time,” said NRC in its statement.

Earlier, CanSino cited bureaucratic indecision as the reason behind the failure for its vaccine partnership in Canada, the Globe and Mail reported, quoting the company’s chief executive officer.

Decisions in China on whether to send the vaccine to Canada were “caught in the bureaucracy”, and some divisions of the Chinese government were not clear if the vaccine should “go to global trials or how to handle it”, chairman and CEO of CanSino Biologics, Dr Xuefeng Yu, told the Globe and Mail in an interview.

NRC said its agreement with CanSino had been reviewed by the company’s Chinese government collaborators.

After the agreement was signed, the Chinese government changed the process required to ship vaccines to other countries.

CanSino’s vaccine candidate is one of the few being tested in a late-stage study, as companies race to develop a safe and effective vaccine for Covid-19.

It is based on a modified version of a common cold virus called adenovirus type 5 that was first developed by a Canadian researcher, Frank Graham.

CanSino’s Yu is a former Sanofi Canada executive. The company had previously worked with NRC on an Ebola vaccine based on the same technology, and with other Canadian researchers on an experimental tuberculosis vaccine.

Quebec-based Medicago is the only Canadian company with an experimental vaccine in human trials, with several other projects in earlier stages of development. The federal government recently announced deals to buy vaccine doses from Moderna and Pfizer.
 
A group of South America presidents have agreed to information sharing and coordination on access to eventual Covid-19 vaccines to counter the virus which has the continent within its grip, Chile’s foreign minister said.

Andres Allamand said there would be multiple benefits to a coordinated approach to obtaining a vaccine by members of the Prosur bloc, made up of Chile, Argentina, Brazil, Colombia, Paraguay, Peru, Ecuador and Guyana.

“A joint effort would bring benefits, particularly in terms of access, quantities and guaranteed prices,” he said.

The discussions reflect the intense jockeying for position of developed and developing nations to ensure their citizens get early and affordable access to Covid-19 vaccines.

More than 150 vaccines are currently being developed and tested around the world, according to the World Health Organization, with 25 human clinical trials.

Trials of vaccines including those developed by Johnson & Johnson, Sinovac and AstraZeneca are already underway or due to start shortly in Latin America, a current hotspot of the pandemic.

Allamand said the bloc discussed the production in Argentina and Mexico of the vaccine created by British pharmaceutical company AstraZeneca, and the “very advanced” production work in Brazil, and the potential for those initiatives to benefit the wider region.

He said Chile was also conducting its own vaccine diplomacy further afield.

“We in Chile are following the evolution of at least five projects and we have been in contact with some of those laboratories and countries specifically to be able to get access to those vaccines at reasonable prices and as quickly as possible,” he said.

Allamand said the Prosur leaders also agreed to coordinate the eventual reopening of their borders, putting together a technical commission that will report back on how this could be done within 10 days, potentially including stricter entry requirements such as a negative PCR Covid-19 test.
 
The US biotech company Novavax has reached an agreement in principle with the Canadian government to supply up to 76 million doses of its experimental vaccine, it has said. The news sent the company’s shares up nearly 7%.

The deal is the latest example of countries rushing to secure access to vaccines, and comes weeks after Canada signed separate deals with Pfizer and Moderna.

Novavax said it expects to finalise an advance purchase agreement to supply doses of the vaccine, beginning as early as the second quarter of next year.

The agreement is subject to the vaccine getting a license from Health Canada, the company said. Financial terms of the agreement were not disclosed.
 
Scientists see downsides to top COVID-19 vaccines from Russia, China

TORONTO/CHICAGO (Reuters) - High-profile COVID-19 vaccines developed in Russia and China share a potential shortcoming: They are based on a common cold virus that many people have been exposed to, potentially limiting their effectiveness, some experts say.

CanSino Biologics’ vaccine, approved for military use in China, is a modified form of adenovirus type 5, or Ad5. The company is in talks to get emergency approval in several countries before completing large-scale trials, the Wall Street Journal reported last week.

A vaccine developed by Moscow’s Gamaleya Institute, approved in Russia earlier this month despite limited testing, is based on Ad5 and a second less common adenovirus.

“The Ad5 concerns me just because a lot of people have immunity,” said Anna Durbin, a vaccine researcher at Johns Hopkins University. “I’m not sure what their strategy is ... maybe it won’t have 70% efficacy. It might have 40% efficacy, and that’s better than nothing, until something else comes along.”

Vaccines are seen as essential to ending the pandemic that has claimed over 845,000 lives worldwide. Gamaleya has said its two-virus approach will address Ad5 immunity issues.

Both developers have years of experience and approved Ebola vaccines based on Ad5. Neither CanSino nor Gamaleya responded to requests for comment.

Researchers have experimented with Ad5-based vaccines against a variety of infections for decades, but none are widely used. They employ harmless viruses as “vectors” to ferry genes from the target virus – in this case the novel coronavirus - into human cells, prompting an immune response to fight the actual virus.

But many people already have antibodies against Ad5, which could cause the immune system to attack the vector instead of responding to the coronavirus, making these vaccines less effective.

Several researchers have chosen alternative adenoviruses or delivery mechanisms. Oxford University and AstraZeneca based their COVID-19 vaccine on a chimpanzee adenovirus, avoiding the Ad5 issue. Johnson & Johnson’s candidate uses Ad26, a comparatively rare strain.

Dr. Zhou Xing, from Canada’s McMaster University, worked with CanSino on its first Ad5-based vaccine, for tuberculosis, in 2011. His team is developing an inhaled Ad5 COVID-19 vaccine, theorizing it could circumvent pre-existing immunity issues.

“The Oxford vaccine candidate has quite an advantage” over the injected CanSino vaccine, he said.

Xing also worries that high doses of the Ad5 vector in the CanSino vaccine could induce fever, fueling vaccine skepticism.

“I think they will get good immunity in people that don’t have antibodies to the vaccine, but a lot of people do,” said Dr. Hildegund Ertl, director of the Wistar Institute Vaccine Center in Philadelphia.

In China and the United States, about 40% of people have high levels of antibodies from prior Ad5 exposure. In Africa, it could be has high as 80%, experts said.

Read more:

HIV RISK

Some scientists also worry an Ad5-based vaccine could increase chances of contracting HIV.

In a 2004 trial of a Merck & Co Ad5-based HIV vaccine, people with pre-existing immunity became more, not less, susceptible to the virus that causes AIDS.

Researchers, including top U.S. infectious diseases expert Dr. Anthony Fauci, in a 2015 paper, said the side effect was likely unique to HIV vaccines. But they cautioned that HIV incidence should be monitored during and after trials of all Ad5-based vaccines in at-risk populations.

“I would be worried about the use of those vaccines in any country or any population that was at risk of HIV, and I put our country as one of them,” said Dr. Larry Corey, co-leader of the U.S. Coronavirus Vaccine Prevention Network, who was a lead researcher on the Merck trial.

Gamaleya’s vaccine will be administered in two doses: The first based on Ad26, similar to J&J’s candidate, and the second on Ad5.

Alexander Gintsburg, Gamaleya’s director, has said the two-vector approach addresses the immunity issue. Ertl said it might work well enough in individuals who have been exposed to one of the two adenoviruses.

Many experts expressed skepticism about the Russian vaccine after the government declared its intention to give it to high-risk groups in October without data from large pivotal trials.

“Demonstrating safety and efficacy of a vaccine is very important,” said Dr. Dan Barouch, a Harvard vaccine researcher who helped design J&J’s COVID-19 vaccine. Often, he noted, large-scale trials “do not give the result that is expected or required.”
https://www.reuters.com/article/us-...d-19-vaccines-from-russia-china-idUSKBN25R19H
 
As we mentioned earlier, the Trump administration has indicated it will not be joining a WHO-backed coalition of 172 countries to share equitably any future vaccines against Covid-19 – and this has got some experts worried.

The Coalition for Epidemic Preparedness Innovations (CEPI) is one of the organisations supporting the initiative, called Covax, which plans to buy and distribute fairly some two billion doses of any vaccine in 2021.

Richard Hatchett, who heads CEPI, told the AFP news agency he is worried that the US, as well as other rich nations, are already reserving the first doses for themselves – at the expense of other countries.

"What we need to persuade global leaders is that as a vaccine becomes available in these initially limited quantities, it needs to be shared globally, that it shouldn't be the case that just a handful of countries get all of the vaccine that is available in the first half of 2021," he said.

The Trump administration said on Tuesday it would "continue to engage our international partners to ensure we defeat this virus". But it has signed contracts guaranteeing at least 800 million doses from six manufacturers which, Hatchett said, puts the US "potentially in a situation of oversupply if all of the vaccines that they've invested in are successful".
 
Johnson & Johnson said its experimental coronavirus vaccine prevented hamsters from getting severely ill, as the drugmaker seeks to begin large, late-stage studies in humans later this month.

In the pre-clinical study, vaccinated animals lost less weight and had less virus in their lungs and other organs than unvaccinated animals.

The company began early-stage human trials in the US and Belgium in July, after details of a study in monkeys showed its best-performing vaccine candidate offered strong protection in a single dose.

Depending on data from the early-stage trial, J&J plans to begin phase 3 testing in the second half of September.

In the pre-clinical study reported on Thursday, Syrian golden hamsters, which are more susceptible to diseases than monkeys, were first vaccinated and then exposed to the coronavirus after four weeks.

The researchers found low levels of antibodies that can neutralise the virus were tied to high levels of weight loss and viral replication in the lungs.
 
Widespread COVID-19 vaccinations not expected until mid-2021

WHO spokeswoman said the agemcy does not expect widespread vaccinations against COVID-19 until the middle of next year, undelining the significance of rigorous checks on their effectiveness and safety.

"We are not expecting to see widespread vaccination until the middle of next year," she told journalists at a briefing in Geneva.

"This Phase 3 must take longer because we need to see how truly protective the vaccine is and we also need to see how safe it is," added Harris, referring to vaccine clinical trials
 
Russia's Sputnik V vaccine produced antibodies without "serious adverse effects" in early trials, the Lancet reports
 
China's CNBG, Sinovac find more countries to test coronavirus vaccines

BEIJING (Reuters) - China National Biotec Group (CNBG) and Sinovac Biotech Ltd said on Saturday four more countries have agreed to run late-stage clinical tests of their coronavirus vaccine candidates, as China steps up its efforts in the global race.

Serbia and Pakistan are among the new countries agreeing to Phase 3 trials, as the two companies seek more data overseas amid dwindling new cases in China.

Serbia will test two vaccines developed by CNBG’s Wuhan and Beijing units, and Pakistan will test the Beijing unit’s candidate, the company told Reuters.

CNBG’s Phase 3 trials are expected to involve 50,000 people in about 10 countries, said CNBG vice president Zhang Yuntao. Trials have already begun in United Arab Emirates, Bahrain, Peru, Morocco, Argentina and Jordan.

Zhang said foreign countries have expressed interest in ordering a combined 500 million doses of its vaccines.

CNBG is expected to be able to produce 300 million doses of vaccine a year once it upgrades manufacturing techniques, and is working on a plan to raise its annual capacity to 1 billion doses, Zhang said.

Sinovac’s vaccine candidate CoronaVac, being tested in Brazil and Indonesia, also obtained approvals from two other countries for Phase 3 trials, said Helen Yang, senior director of global strategy and business development at Sinovac.

She declined to name the countries as the information is still confidential.

While the final stage of trials are still underway to prove the vaccines are safe and effective, China has already authorized the vaccine candidates from Sinovac and CNBG for emergency use for those in high-risk groups such as medical workers.

Several tens of thousand people have already taken CoronaVac through the emergency programme, Sinovac’s Yang said.

CNBG will soon begin providing its vaccines to Chinese staffers working in overseas embassies and consulates, Zhang said.

https://www.reuters.com/article/us-...es-to-test-coronavirus-vaccines-idUSKBN25W0BA
 
Coronavirus: Pharma firms unveil safety pledge over vaccine

A group of nine vaccine developers has announced a "historic pledge" to uphold scientific and ethical standards in the search for a coronavirus vaccine.

The firms, including Pfizer and Merck, said they would only apply for regulatory approval after vaccines went through three phases of clinical study.

It comes amid global debates about the safety of vaccines made this year.

US President Donald Trump has said he wants one available in the US before November's election.

No vaccine has yet completed clinical trials, according to the World Health Organization (WHO) - leading some scientists to fear the search for a vaccine is being politicised, and public trust could be damaged.

In their pledge, the nine biopharmaceutical firms did not mention Mr Trump but said they believed their action would "ensure public confidence" in the development of any inoculation.

They pledged to "always make the safety and well-being of vaccinated individuals our top priority".

Other signatories were industry giants Johnson & Johnson, BioNTech, GlaxoSmithKline, AstraZeneca, Moderna and Novavax.

"Together, these nine companies have collectively developed more than 70 novel vaccines that have helped to eradicate some of the world's most complex and deadly public health threats," the statement added.

Nearly 180 vaccine candidates are being tested around the world, the WHO says.

The organisation has said it does not expect a vaccine to meet its efficacy and safety guidelines in order to be approved this year because of the time it takes to test them safely.

None of the candidate vaccines in advanced clinical trials so far has demonstrated a "clear signal" of efficacy at the level of at least 50% sought by the WHO, spokeswoman Margaret Harris said last week.

"In terms of realistic timelines, we are really not expecting to see widespread vaccination until the middle of next year," she added.

Despite this, China and Russia have begun inoculating some key workers with domestically developed vaccines - all of them are still listed by the WHO as being in clinical trials.

Meanwhile, the US national regulator, the Food and Drug Administration (FDA), has suggested that coronavirus vaccines may be approved before completing a third phase of clinical trials. This phase can often involve thousands of participants and can last several years.

Last week it also emerged that the US Centers for Disease Control and Prevention had urged states to consider "waiving requirements" in order to be able to distribute a vaccine by 1 November - two days before the 3 November presidential election.

President Trump has hinted that a vaccine might be available before the election. But his Democratic rival Joe Biden has expressed scepticism that Mr Trump will listen to scientists and implement a transparent process.

https://www.bbc.com/news/world-54046157
 
Final clinical trials for a coronavirus vaccine, developed by AstraZeneca and Oxford University, have been put on hold after a participant had an adverse reaction in the UK.

AstraZeneca described it as a "routine" pause in the case of "an unexplained illness".

The outcome of vaccine trials is being closely watched around the world.

The AstraZeneca-Oxford University vaccine is seen as a strong contender among dozens being developed globally.

https://www.bbc.com/news/world-54082192
 
Final clinical trials for a coronavirus vaccine, developed by AstraZeneca and Oxford University, have been put on hold after a participant had an adverse reaction in the UK.

AstraZeneca described it as a "routine" pause in the case of "an unexplained illness".

The outcome of vaccine trials is being closely watched around the world.

The AstraZeneca-Oxford University vaccine is seen as a strong contender among dozens being developed globally.

https://www.bbc.com/news/world-54082192

Unfortunately one person developed transverse myelitis. This just shows how much caution we need to exercise while developing a vaccine.
 
Halt of coronavirus trial is 'safety valve' at work: Fauci

The top US infectious disease expert said AstraZeneca's suspension of final testing of its COVID-19 vaccine candidate shows "one of the safety valves" built into the studies to spot any potential problems.

"It's unfortunate that it happened and hopefully they'll be able to proceed along with the remainder of the trial. But you don't know — they need to investigate it further," Dr. Anthony Fauci, infectious diseases chief at the National Institutes of Health, told "CBS This Morning".

Late Tuesday, AstraZeneca announced its final-stage studies are on temporary hold while the company investigates whether a research volunteer's "potentially unexplained illness" is a side effect of the shot or a coincidence.
 
I am not an anti vaxxer however I’m a bit nervous when it comes to taking a vaccine which has been developed so quickly. Surely the drug development processes that we’ve created over the years is there for a reason and by cutting so many corners (regulation wise) like we have with Covid we’re just asking for trouble?

The virus has already changed significantly since earlier in the year and the effect on those who contract Covid isn’t as harsh as it used to be (especially if you’re youngish and have no major underlining health conditions).

I won’t take the vaccine for at least 6-12 months after it’s first use on the masses (at least tens of millions of people).
 
Delivering a COVID-19 vaccine around the world will require at least 8,000 jumbo jets, a trade body has warned.

The International Air Transport Association (IATA) is urging governments to begin planning now to ensure a vaccine reaches populations in every corner of the globe.
 
Turkey considers allowing Phase III testing of Russia's COVID-19 vaccine

ISTANBUL (Reuters) - Turkey is considering a request from Russia to conduct Phase III trials of Russia’s COVID-19 vaccine, Health Minister Fahrettin Koca said on Thursday, adding a decision would be made in the next week.

Russia announced the development of the “Sputnik-V” vaccine, the world’s first registered coronavirus vaccine as proof of its scientific prowess. But, Moscow’s decision to grant approval for its vaccine before finishing clinical trials has raised concerns among some experts.

Speaking to reporters after holding talks with local health officials in southeastern Turkey, Koca said Phase III work had already started on a vaccine from China and Pfizer (PFE.N), and added that the Russian request was being evaluated.

“We received a request regarding Phase III trials for this vaccine. We saw that this application dossier was sufficient, that pre-clinical efforts, as well as Phase I and II work were completed,” Koca said.

“Our vaccine science team will have made its evaluation on the issue in the coming days. We may probably allow Phase III work for the vaccine in Russia next week,” he said, adding 13 different Turkish vaccine efforts were underway in Turkey, but only at pre-Phase I levels so far.

Russian regulators licensed the vaccine for domestic use in early August after initial, small-scale human trials. It is now being tested on 40,000 people in Russia in a trial that launched on Aug. 26.

The Russian Sputnik-V vaccine is administered in two doses, with each based on a different vector that normally causes the common cold: human adenoviruses Ad5 and Ad26. Some experts have said using this delivery mechanism could make a COVID-19 vaccine less effective.

Russia has said it expects to produce between 1.5 million and 2 million doses per month by the end of the year, gradually increasing production to 6 million doses a month.

https://www.reuters.com/article/us-...f-russias-covid-19-vaccine-idUSKBN261392?il=0
 
Oxford University resumes vaccine trials

Oxford University has announced that clinical trials of its coronavirus vaccine, under development with the pharmaceutical giant AstraZeneca, are to resume in the UK.

The trials were suddenly halted last Sunday when a participant fell ill. Oxford refused to disclose information about the nature of the illness, but the New York Times claimed a “person familiar with the situation” said the patient was found to have transverse myelitis, an inflammatory syndrome that affects the spinal cord and is often sparked by viral infections.

In a press release circulated to journalists on Saturday, Oxford University said the pause had given time for a “review of safety data by an independent safety review committee, and the national regulators”. It went on:

The independent review process has concluded and following the recommendations of both the independent safety review committee and the UK regulator, the MHRA, the trials will recommence in the UK.

We cannot disclose medical information about the illness for reasons of participant confidentiality.

We are committed to the safety of our participants and the highest standards of conduct in our studies and will continue to monitor safety closely.
 
Monoclonal antibodies to begin UK trial

A new antibody treatment is to be trialled on Covid-19 patients in UK hospitals.

Monoclonal antibodies, which are potent, laboratory-made antibodies, will be given to about 2,000 people to see if they are effective against coronavirus.

It forms part of the UK Recovery Trial, which found that a cheap steroid called dexamethasone could save lives.

The first patients will be given the new drugs in the coming weeks.

Prof Martin Landray from the University of Oxford, who is co-leading the Recovery Trial, said: “This is the first type of treatment that's targeted for this specific virus.

“There are lots of good reasons for thinking it might well be effective - stopping the virus from reproducing, stopping the virus from causing damage, improving survival for patients.

“We need to know, and the way to know is to do the trials that will tell us whether that hope turns into reality.”

Read more: https://www.bbc.com/news/health-54120753
 
We've been reporting on the politics of vaccine development and distribution in the US - and the climate of claim and counter-claim involving President Trump and his top scientists. In Bahrain, meanwhile, the Crown Prince has stepped forward in the country's clinical trials by volunteering as a participant.

Around 6,000 people are taking part in the phase III trials, conducted by Abu-Dhabi based G42 Healthcare using a vaccine developed by Sinopharm CNBG, the sixth-largest producer of vaccines in the world.

Volunteers, including Prince Salman bin Hamad Al Khalifa, are then monitored to study the production of antibodies.
 
Putin vaunts Russian coronavirus vaccine at UN

President Vladimir Putin in a speech at the United Nations on Tuesday boasted of Russia's creation of the world's first coronavirus vaccine, though it has not completed large-scale clinical trials.

Putin in a video address to the General Assembly said that Russia was open to partnership with other countries over "the first vaccine in the world, Sputnik V."

"I repeat again that we are absolutely open and disposed for partnership," Putin said.

The Sputnik V vaccine was developed by Moscow's Gamaleya research center, and Russia announced in August that it was the world's first registered vaccine.

While the vaccine has shown promising results in early trials, Russia has not yet completed the final phase of clinical testing, in which large numbers of people receive either the vaccine or a placebo.

Nevertheless Russia has already vaccinated high-profile officials including the Defence Ministry Sergei Shoigu and Moscow Mayor Sergei Sobyanin. Putin has said that one of his daughters was vaccinated, suffering only a mild reaction.

The Russian Direct Investment Fund that has supported the vaccine's development said last month that 20 countries had pre-ordered supplies.

Putin urged an online conference to be held in the near future with other countries "interested in cooperating on creating a vaccine against coronavirus."

"We are ready to share our experience," Putin said, offering to supply other countries with "a Russian vaccine that has shown its reliability, safety and effectiveness."

He also vaunted Russia's speed in "developing a line of test systems and medications for diagnosing and treating coronavirus."

"Our country has played an active role in global and regional efforts to fight Covid-19 and gives help to the countries that have suffered the most," he said.

He cited cases of the coronavirus among UN staff and offered to give them the Sputnik V vaccine.

"Russia is ready to give the UN staff all the necessary professional help: in particular we propose offering our vaccine for voluntary vaccination of staff of the UN and its subsidiaries," Putin said.

Source: https://www.ctvnews.ca/health/coronavirus/putin-vaunts-russian-coronavirus-vaccine-at-un-1.5115301.
 
Trials involving 30,000 people in the US for the vaccine being developed by the University of Oxford and AstraZeneca remain on hold while the US Food and Drug Administration conducts its own investigation into a reported side effect in a UK patient.

The illness in a volunteer temporarily brought a halt to all the trials of the vaccine worldwide – which also involve thousands of people in the UK, South Africa and Brazil.

Oxford said at the time that it was "expected" that in large-scale trials some people would become ill, but after an investigation into whether the illness was linked to the vaccine it was deemed safe to continue. The vaccine is seen as a likely contender to be first to market.

Meanwhile, Johnson and Johnson has become the fourth pharmaceutical company to begin the final large-scale trials of a Covid-19 vaccine.

The company said the trials will involve 60,000 people, across the Americas and in South Africa.
 
Novavax is ready to start its Phase 3 trial of an experimental COVID-19 vaccine in the UK.

The US biotechnology firm plans to enrol up to 10,000 volunteers aged between 18 and 84 over the next four to six weeks.
 
Novavax is ready to start its Phase 3 trial of an experimental COVID-19 vaccine in the UK.

The US biotechnology firm plans to enrol up to 10,000 volunteers aged between 18 and 84 over the next four to six weeks.

Potential vaccine passes another hurdle as 10,000 UK volunteers to test jab

Novavax has started its Phase 3 trial of an experimental COVID-19 vaccine in the UK.

The US biotechnology firm is to enrol 10,000 people out of 250,000 volunteers aged between 18 and 84 over the next four to six weeks.

The company joins AstraZeneca, Pfizer, and Moderna as its coronavirus vaccine candidate enters the final step of the regulatory approvals process.

There are almost 40 potential vaccines being tested globally and more than 140 others in the early stages of testing, according to the World Health Organisation.

Half of the volunteers in the Novavax trial will have two shots of NVX-CoV2373 with Matrix-M, the company's adjuvant which is intended to strengthen the vaccine. Half will be given a placebo.

Up to 400 volunteers will get a seasonal flu vaccine and the COVID-19 vaccine to see the effectiveness of combining the two.

At least 25% of participants will be aged over 65 and the trial will prioritise groups most affected by COVID-19, including those from ethnic minorities, the company said.

In August, the UK government announced that support and infrastructure would be given to Novavax during its Phase 3 clinical trial.

This includes plans to manufacture the vaccine in the UK and the promise of 60 million doses for the UK if the vaccine turns out to be safe and effective.

And researchers are calling for more volunteers to take part in trials for other potential vaccine candidates expected to start before the end of the year.

The government said there was a particular need for more volunteers from black, Asian and minority ethnic backgrounds, along with people with underlying health conditions and the over 65s.

Business Secretary Alok Sharma said: "I am incredibly proud of the 250,000 volunteers who have signed up to play their part in the global fight against coronavirus.

"Our scientists and researchers are working day and night to find a vaccine that meets the UK's rigorous safety standards, but we need even more people from all backgrounds and ages to sign-up for studies to speed up this life-saving research.

"The more people that sign up, the quicker we can find a safe and effective vaccine, defeat this virus and protect millions of lives."

The Novavax candidate is the second vaccine to enter Phase 3 clinical trials in the country, the first being the potential vaccine being developed by Oxford University and AstraZeneca.

Gregory M Glenn, president of research and development at Novavax, said the team was "optimistic" that the trial would "provide a near-term view" of the vaccine's efficacy.

He added: "The data from this trial is expected to support regulatory submissions for licensure in the UK, EU and other countries.

"We are grateful for the support of the UK government, including from its Department of Health and Social Care and National Institute for Health Research, to advance this important research."

Novavax said pre-clinical trials showed the potential vaccine was "generally well-tolerated" and produced "robust antibody responses" greater than those seen in recovering patients.

Thomas Moore, Sky's science correspondent, said the Novavax vaccine candidate showed "huge promise".

Novavax shares were up more than 6% in after-hours trading in the US.

https://news.sky.com/story/coronavi...n-advanced-clinical-trials-in-the-uk-12080796
 
Quick Covid-19 test to roll out in 133 nations

A test that can diagnose Covid-19 in minutes will dramatically expand the capacity to detect cases in low- and middle-income countries, the World Health Organization (WHO) has said.

The $5 (£3.80) test could transform tracking of Covid-19 in less wealthy countries, which have shortages of healthcare workers and laboratories.

A deal with manufacturers will provide 120 million tests over six months.

The WHO's head called it a major milestone.
 
France to enrol 25,000 in COVID-19 vaccines clinical trials

PARIS (Reuters) - France called for 25,000 adult volunteers on Thursday to enrol in a series of large-scale clinical trials aimed at evaluating the safety and efficacy of several COVID-19 vaccine candidates.

The Phase II and III trials, which could start as soon as this month, will take place at 24 hospitals across the country. Volunteers are invited to register online.

There is currently no internationally approved vaccine to prevent COVID-19, the illness caused by the new coronavirus, which has killed over 1 million worldwide.

France’s public research body Inserm, which is in charge of the project, did not name the vaccines that would be assessed and said it was currently holding discussions with drugmakers, adding it would pick the “most promising” candidates for the trials.

More than 150 potential vaccines are being developed around the world and tested to stop the COVID-19 pandemic, with 38 in human trials, according to the World Health Organization (WHO).

https://www.reuters.com/article/us-...vid-19-vaccines-clinical-trials-idUSKBN26M6CH
 
Exclusive: New global lab network will compare COVID-19 vaccines head-to-head

LONDON (Reuters) - A major non-profit health emergencies group has set up a global laboratory network to assess data from potential COVID-19 vaccines, allowing scientists and drugmakers to compare them and speed up selection of the most effective shots.

Speaking to Reuters ahead of announcing the labs involved, Melanie Saville, director of vaccine R&D at the Coalition for Epidemic Preparedness Innovations (CEPI), said the idea was to “compare apples with apples” as drugmakers race to develop an effective shot to help control the COVID-19 pandemic.

The centralised network is the first of its kind to be set up in response to a pandemic.

In a network spanning Europe, Asia and North America, the labs will centralise analysis of samples from trials of COVID-19 candidates “as though vaccines are all being tested under one roof”, Saville said, aiming to minimise the risk of variation in results.

“When you start off (with developing potential new vaccines) especially with a new disease, everyone develops their own assays, they all use different protocols and different reagents - so while you get a readout, the ability to compare between different candidates is very difficult,” she told Reuters.

“By taking the centralised lab approach ... it will give us a chance to really make sure we are comparing apples with apples.”

The CEPI network will initially involve six labs, one each in Canada, Britain, Italy, the Netherlands, Bangladesh and India, Saville said.

Hundreds of potential COVID-19 vaccines are in various stages of development around the world, with shots developed in Russia and China already being deployed before full efficacy trials have been done, and front-runners from Pfizer PFE.N, Moderna MRNA.O and AstraZeneca AZN.L likely to have final-stage trial results before year-end.

Typically, the immunogenicity of potential vaccines is assessed in individual lab analyses, which aim to see whether biomarkers of immune response - such as antibodies and T-cell responses - are produced after clinical trial volunteers receive a dose, or doses, of the vaccine candidate.

But with more than 320 COVID-19 vaccine candidates in the works, Saville said, the many differences in data collection and evaluation methods are an issue.

As well as potential variations in markers of immunity, there are differences in how and where samples are collected, transported and stored - all of which can impact the quality and usefulness of the data produced, and make comparisons tricky.

And with a range of different vaccine technologies being explored - from viral vector vaccines to ones based on messenger RNA - standard evaluation of their true potential “becomes very complex”, she said.

“With hundreds of COVID-19 vaccines in development ... it’s essential that we have a system that can reliably evaluate and compare the immune response of candidates currently undergoing testing,” she said.

By centralising the analysis in a lab network, much of what Saville called the “inter-laboratory variability” can be removed, allowing for head-to-head comparisons.

CEPI says all developers of potential COVID-19 vaccines can use the centralised lab network for free to assess their candidates against a common protocol. For now, the network will assess samples from early-stage vaccine candidate testing and first and second stage human trials, but CEPI said it hoped to expand its capacity to late stage (Phase III) trial data in the coming months.

Results produced by the network will be sent back to the developer, with neither CEPI nor the network owning the data.

CEPI itself is co-funding nine of the potential COVID-19 vaccines in development, including candidates from Moderna, AstraZeneca, Novavax NVAX.O and CureVac.

https://www.reuters.com/article/us-...-covid-19-vaccines-head-to-head-idUSKBN26N0KC
 
Britain's spies defending COVID-19 vaccine work, MI5 chief says

LONDON (Reuters) - British spies are trying to defend COVID-19 vaccine work against hostile powers that seek to either steal or sabotage research data in the race for the global prize of a jab that could provide immunity, the head of MI5 said on Wednesday.

Oxford University’s vaccine candidate, which has been licensed to AstraZeneca, is in late stage trials, while a vaccine candidate being developed by Imperial College London is in early stage clinical trials.

“Clearly, the global prize of having a first useable vaccine against this deadly virus is a large one, so we would expect that a range of other parties around the globe would be quite interested in that research,” Security Service (MI5) Director General Ken McCallum told reporters.

McCallum, in his first major remarks since being named as the new boss of MI5 in March when the United Kingdom was under national lockdown, said there were a range of threats against the vaccine development work.

“I guess there are two bits we are on the lookout for: attempts either to steal unique intellectual property that’s been generated in that research, or potentially to fiddle with the data,” he said.

“And then the second risk we’ve got to be alive to is the possibility that the research is still high integrity and sound, but that somebody tries to sow doubt about its integrity.”

Britain’s National Cyber Security Centre (NCSC) said in July that hackers backed by the Russian state were trying to steal COVID-19 vaccine and treatment research from academic and pharmaceutical institutions around the world.

More than 150 potential vaccines are being developed and tested globally to stop the COVID-19 pandemic, with 42 in human trials, according to the World Health Organization (WHO).

Read more:

A CAULDRON OF THREATS

McCallum, a career spy who studied mathematics in Glasgow before spending more than two decades in MI5, said the United Kingdom was facing a cauldron of threats ranging from growing far-right terrorism to Chinese economic espionage.

“The right-wing terrorist threat is not on the same scale as the Islamist extremist threat - but it is rising,” he said.

Of 27 late-stage plots disrupted in Britain, eight were hatched by right-wing extremists, he said, adding that MI5 was also grappling with increasingly severe state-sponsored espionage.

“The varying threats from Russian, Chinese, Iranian and other actors are growing in severity and complexity.”

China has sought to hack commercially sensitive data and intellectual property as well as to interfere in politics, he said. Britain had disrupted Chinese espionage plot aimed against the European Union. He gave no further details.

McCallum defended MI5 over its role investigating possible Russian interference in the 2016 Brexit referendum, saying little of any great significance was found.

He did, though, give a rare insight into what it is to be a spy chief: “Terrorist attacks are always, without exception, sickening. Whenever my phone rings late in the evening, my stomach lurches in case it is one of those awful moments.”
https://www.reuters.com/article/us-...-19-vaccine-work-mi5-chief-says-idUSKBN26Z1QE
 
Russia receives renewed approval for COVID-19 vaccine trials in India: RDIF

MOSCOW (Reuters) - The Russian Direct Investment Fund (RDIF) and Dr Reddy’s Laboratories Ltd have received renewed approval to conduct late-stage clinical trials in India of the Russian COVID-19 vaccine, the sovereign wealth fund said on Saturday.

Large-scale trials of the Sputnik V vaccine in India were first announced and then knocked back by Indian regulators, who said the scale of Phase I and II trials conducted in Russia earlier this year was too small, requesting that they be repeated.

Following a new agreement, India will now carry out an adaptive phase II and III human clinical trial involving 1,500 participants, RDIF, which is marketing the vaccine abroad, said on Saturday. Under the deal, Dr Reddy’s will conduct the clinical trials and, subject to approval, distribute the finished vaccine in India. RDIF will supply 100 million doses to Dr Reddy’s.

Russia, the first country to grant regulatory approval for a novel coronavirus vaccine, is also conducting Phase III trials of Sputnik V in Belarus, Venezuela and the United Arab Emirates. RDIF has reached agreements with Indian manufacturers to produce 300 million doses of the shot.

A Phase III trial involving 40,000 participants is currently underway in Moscow, with 16,000 people having already received the first dose of the two-shot vaccine.

Interim results are expected to be published in early November.

Indian regulators have agreed to incorporate data, provided by Russia on a weekly basis, from the Moscow trial, a source close to the deal told Reuters.

Russia has also reached an agreement with the biotechnology department of India’s Science and Technology Ministry to use its laboratories as a base for the Indian clinical trial, the source said.

https://www.reuters.com/article/us-...19-vaccine-trials-in-india-rdif-idUSKBN2720FI
 
Covid: China's Sinovac vaccine to be included in Brazil immunisation plan

Brazil plans to use a Chinese-made coronavirus vaccine as part of a national immunisation programme, officials have announced.

São Paulo Governor João Doria said the federal government had agreed to buy 46 million doses of the vaccine CoronaVac.

He said the immunisation programme could begin as soon as January 2021, making it one of the first such efforts in the world to fight the pandemic.

Brazil has been one of the countries worst affected by coronavirus.

It has had nearly 5.3 million confirmed cases - the third highest tally in the world after the US and India - and is second only to the US in terms of deaths, with nearly 155,000 registered so far, according to data collated by Johns Hopkins University.

If approved by the country's health regulator, CoronaVac - developed by Chinese company Sinovac Biotech - will be one of two vaccines included in Brazil's immunisation programme.

The country also plans to administer a vaccine being created by England's Oxford University and the drug giant AstraZeneca.

Mr Doria has previously touted Sinovac's experimental vaccine, announcing plans to use it to inoculate residents of São Paulo.

The Chinese vaccine is being tested by São Paulo state's research centre Butantan Institute.

The institute announced on Monday that the two-dose vaccine appeared to be safe in a late-stage clinical trial.

However, it warned the result was only preliminary, with testing ongoing. It said data on how effective the vaccine is will not be released until the trial is over.

Trials are also being conducted in Turkey and Indonesia.

https://www.bbc.com/news/world-latin-america-54619730
 
Covid: US gives full approval for antiviral remdesivir drug

US regulators have given full approval for the antiviral drug remdesivir to treat Covid-19 patients in hospitals.

The US Food and Drug Administration (FDA) said Veklury, the drug's brand name, cut the recovery time on average by five days during clinical trials.

"Veklury is the first treatment for COVID-19 to receive FDA approval," the FDA said in a statement.

The World Health Organization (WHO) said last week remdesivir had little to no effect on patients' survival..

The WHO said this was based on its own study - but the drug's manufacturer Gilead rejected the findings of the trial.

Remdesivir had been authorised for emergency use only in the US since May.

It was recently given to President Donald Trump after he tested positive for Covid-19. He has since recovered.

What did the FDA say?
In the statement, the FDA said the drug was approved on Thursday "for use in adult and paediatric patients 12 years of age and older and weighing at least 40 kilograms (about 88 pounds) for the treatment of Covid-19 requiring hospitalisation".

"Today's approval is supported by data from multiple clinical trials that the agency has rigorously assessed and represents an important scientific milestone in the Covid-19 pandemic," said FDA Commissioner Stephen Hahn.

The regulator said its decision was supported by the analysis of data from "three randomised, controlled clinical trials that included patients hospitalised with mild-to-severe Covid-19".

One of the studies showed that that "the median time to recovery from Covid-19 was 10 days for the Veklury group compared to 15 days for the placebo group".

What about the WHO study?
For its Solidarity clinical trial, the WHO tested the effects four potential treatments - remdesivir was one, but they also looked at malaria drug hydroxychloroquine, auto-immune drug interferon, and the HIV drug combination of lopinavir and ritonavir.

Dexamethasone, a low-cost steroid now widely used on Covid patients in intensive care in the UK, was not included in this study.

The four drugs were tested with 11,266 adult patients in total, across 500 hospitals in more than 30 different countries.

The results, which are yet to be peer-reviewed, suggested that none of these treatments had a substantial effect on mortality or on the length of time spent in hospital, the WHO said.

Source: https://www.bbc.com/news/world-us-canada-54654635.
 
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