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

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The first human trial of a vaccine in the southern hemisphere has begun today in Melbourne, Australia.

The vaccine being tested - with the catchy name of NVX-CoV2373 - was made by US company, Novavax. It will be tested on a group of 130 healthy adults with the first results expected in July.

There are more than 100 vaccines being developed around the world, and around a dozen have begun human testing.
 
Britain will provide the anti-viral drug remdesivir to some Covid-19 patients after clinical trials found that it could shorten the recovery period by four days.

The UK government said it was working with the manufacturer, Gilead Sciences, to test the drug on an unspecified number of patients for whom it could provide the greatest benefit.

The US National Institutes of Health (NIH) last week said that data from its trial of remdesivir showed that the drug offers the most benefit for coronavirus patients who need extra oxygen but do not require mechanical ventilation.

The researchers also said that “given high mortality despite the use of remdesivir,” it is likely that the anti-viral drug would be more effective in combination with other treatments.

This comes after the news that the World Health Organization had suspended its trial of a different drug, hydroxychloroquine – the malaria drug Donald Trump said he is taking as a precaution — from its global study after safety concerns.

The WHO’s director general, Tedros Adhanom Ghebreyesus, said the decision was taken in light of that showed people taking hydroxychloroquine were at higher risk of death and heart problems than those who were not.
 
Some NHS patients with severe coronavirus symptoms will be treated with an Ebola drug after trials proved it led to a quicker recovery.

Health Secretary Matt Hancock hailed the development as the "biggest step forward in the treatment of coronavirus since the crisis began" on Tuesday.

The antiviral medicine remdesivir was developed for Ebola, but initial trials on COVID-19 patients showed it reduced the length of time they experienced symptoms from 15 days to 11.

It will now be prescribed for some adults and teenagers suffering serious coronavirus symptoms in NHS hospitals, having been given the green light as part of the the Early Access to Medicines Scheme.

The scheme, launched by the UK government in 2014, tries to make certain drugs available for the seriously ill before they have market authorisation.

Mr Hancock said during the Downing Street daily briefing on Tuesday: "Today I can announce we are beginning a new trial for selected NHS patients of an antiviral drug called remdesivir.

"There have already been some promising results on coronavirus patients, with early data suggesting it can shorten recovery time by around four days.

"As you can understand, we'll be prioritising the use of this treatment where it will provide the greatest benefit.

"This is probably the biggest step forward in the treatment of coronavirus since the crisis began."

The Department for Health and Social Care worked with pharmaceutical company Gilead Sciences, the NHS, and the Medicines and Healthcare Products Regulatory Agency to clear remdesivir for use in the UK, a government spokesman said.

It has already been made available under similar initiatives in the US and Japan, following trials on 1,000 patients from the UK, USA, France, Italy and China earlier this month.

President Donald Trump has said the US government is putting its "full power and might" behind remdesivir.

Mr Trump has promoted a number of existing disease treatments as possible options for coronavirus patients, most notably the anti-malaria drug hydroxychloroquine.

He has been criticised for taking the drug in a bid to ward off the virus, with the World Health Organisation having stopped trialling the treatment over fears it could cause more deaths in COVID-19 patients.

Innovation minister Lord Bethell said of the remdesivir decision: "This shows fantastic progress.

"As we navigate this unprecedented period, we must be on the front foot of the latest medical advancements, while always ensuring patient safety remains a top priority.

"The latest expert scientific advice is at the heart of every decision we make, and we will continue to monitor remdesivir's success in clinical trials across the country to ensure the best results for UK patients."

https://news.sky.com/story/coronavi...with-ebola-drug-to-speed-up-recovery-11994848
 
El Salvador president: Most world leaders taking 'Trump drug'

The president of El Salvador says "most world leaders" are taking hydroxychloroquine - the unproven drug President Trump said he was taking to "ward off" the virus.

Hydroxychloroquine is primarily a malaria medication. The WHO recently suspended trials of it as a coronavirus treatment because of safety concerns.

On Sunday, Mr Trump said he was no longer using it - but today Nayib Bukele said he, and other leaders, were taking it.

“I use it as a prophylaxis [prevention], President Trump uses it as a prophylaxis, most of the world’s leaders use it as a prophylaxis," he said.
 
France, Italy, Belgium act to stop use of hydroxychloroquine for COVID-19 on safety fears

PARIS (Reuters) - France, Italy and Belgium acted to halt the use of hydroxychloroquine to treat patients suffering from COVID-19, the illness caused by the new coronavirus, amid questions about the safety of the generic anti-malaria drug.

France on Wednesday cancelled a decree allowing hospital doctors to dispense the medicine, while the Italian Medicine Agency (AIFA) suspended authorization to use hydroxychloroquine for COVID-19 outside clinical trials.

Belgium’s medicine agency warned against using the drug to treat the virus any more except within ongoing clinical registered trials. It said trials aiming to evaluate the drug should also take potential risks into consideration.

The sudden changes highlight the challenge for governments as they scramble to find ways to treat patients and control a virus that has spread rapidly around the world over the past three months, killing more than 350,000 and infecting millions.

It also illustrates at least a temporary about-face for regulators on a drug that at the outset of the pandemic had been seen as a promising treatment option.

The moves by three of the countries hardest hit by coronavirus infections and deaths follow a World Health Organization decision on Monday to pause a large trial of hydroxychloroquine due to safety concerns.

France’s cancellation, which effectively bans the drug for COVID-19, was confirmed by the health ministry. It did not refer to the WHO suspension.

France in March allowed the use of hydroxychloroquine - which beyond malaria is approved to treat lupus and rheumatoid arthritis - in specific situations for hospital treatment of COVID-19.

The United States has issued an emergency authorisation for the drug promoted by U.S. President Donald Trump, among others, as a possible coronavirus antidote.

British medical journal The Lancet has reported patients getting hydroxychloroquine had increased death rates and irregular heartbeats, adding to several disappointing results for the drug as a COVID-19 option.

Italian health authorities concluded that the risks, coupled with little evidence hydroxychloroquine was beneficial against COVID-19, merited a ban outside of clinical trials.

“New clinical evidence on the use of hydroxychloroquine in subjects with SARS-CoV-2 infection...indicates an increased risk for adverse reactions with little or no benefit,” AIFA said.

The WHO said a safety panel would act by mid-June to evaluate the drug’s use in its multi-country trial of potential COVID-19 treatments.

Germany is looking at The Lancet study and the WHO’s decision but has not made any decision about new guidance on hydroxychloroquine, a spokeswoman for its drugs regulator said.

No vaccine or treatment has been approved for COVID-19.
https://www.reuters.com/article/us-...r-covid-19-on-safety-fears-idUSKBN233197?il=0
 
Healthcare professionals should closely monitor Covid-19 patients who are receiving malaria drug hydroxychloroquine, given the serious side effects associated with the medicine, the European health regulator said on Friday.

Several EU countries have paused trials of the drug in patients infected by the new coronavirus over safety concerns, the European Medicines Agency said, adding the drug’s benefits have not been established for the illness.

The World Health Organization also suspended testing the drug in COVID-19 patients last week.
 
US President Donald Trump and UK Prime Minister Boris Johnson discussed the global response to coronavirus during a phone call a little earlier.

Downing Street said the two men spoke about the "ongoing international co-operation to develop a vaccine".

Trials have begun on vaccines across the world, including in the US and UK.

A Number 10 spokesman said they also discussed the next G7 summit scheduled to be held in Washington next month and stressed the "importance of leaders meeting in the US in person if possible" .

Earlier this week, a White House spokeswoman said the US planned to hold the summit as planned “towards the end of June”.

The White House added that the two men also discussed "progress on reopening" their respective countries amid continued lockdowns.
 
Taiwan approves Gilead's remdesivir to treat COVID-19

Taiwan's government has approved remdesivir, Gilead Sciences' potential COVID-19 treatment drug.

Taiwan's Central Epidemic Command Centre said the Taiwan Food and Drug Administration took into account "the fact that the efficacy and safety of remdesivir has been supported by preliminary evidence" and its use is being approved by other countries.

The US regulators approved the medicine this month for emergency use. Japan and the UK as well have cleared the drug for use and moved to begin supplying it to patients.

California-based Gilead has said it will donate 1.5 million doses of remdesivir, enough to treat at least 140,000 patients, to combat the global pandemic.
 
Chinese vaccine could be ready by year-end, government body says

HONG KONG (Reuters) - A Chinese-made coronavirus vaccine could be ready for market as early as the end of this year, China’s State-owned Assets Supervision and Administration Commission (SASAC) said in a social media post.

In trials, more than 2,000 people have received vaccines developed by the Wuhan Institute of Biological Products and the Beijing Institute of Biological Products. A vaccine could be ready for the market as early as the end of this year or early 2021, according to the May 29 post on Chinese social media platform WeChat.

Vaccines from the Wuhan Institute of Biological Products and the Beijing Institute of Biological Products had entered Phase II clinical trials. Both groups are affiliated with state-owned pharmaceutical group Sinopharm, whose management is overseen by SASAC.

The Beijing Institute of Biological Products’ production line will have an annual manufacturing capacity of 100 million to 120 million doses, according to the article.

China has five coronavirus vaccines in human trials. Neither company could be reached for comment on Saturday evening.

https://www.reuters.com/article/us-...y-year-end-government-body-says-idUSKBN2360GJ
 
Health experts think coronavirus strain in Pakistan comparatively weaker to US, Europe

A fewer number of coronavirus cases in Pakistan and a comparatively low mortality rate has left top medical experts in the country wondering what seems to be working for the local population in the country.

Despite reporting its first case of COVID-19 on February 26 and first death from the virus in the second week of March this year, Pakistan has so far reported 1,483 deaths and around 67,000 cases of COVID-19 from the entire country of 220 million. On top of that, authorities implemented a highly-ineffective lockdown in the initial days which has largely been eased over the last two weeks.

“I don’t agree with the hypothesis that we have stronger immunity as compared to the rest of the world due to frequent vaccinations and having some special immunity,” said Prof Saeed Akhtar, an eminent transplant surgeon and a public health expert while talking to The News.

“People of Pakistani origin, who born and raised here, have higher mortality in the United States and the United Kingdom as compared to white people. There is a possibility that we have a different or less virulent strain of the virus. It may be possible that we have a less deadly strain of the virus as compared to the US and Europe.”

Professor Akhtar, who is also a trained and qualified epidemiologist with a degree in public health from the Yale University, USA, said there was a need to research the structure and virulence of the coronavirus and environmental factors that contribute to the spread or limit the infection. He, however, deplored that the method of data collection of COVID-19 cases and reporting of deaths in Pakistan was “not scientific at all”.

“I don’t agree that we only have 67,000 cases in our population. This is not possible at all. I challenge them, if they conduct 100,000 tests a day, there would be 10,000 to 15,000 positive cases from our population. There is an immediate need to enhance our testing capabilities and improve data collection to take appropriate measures,” said Akhtar, warning that exponential growth in a number of cases and deaths was expected in the country from the mid of June.

“What we have done with our people during Eid days is devastating after we lifted all restrictions and allowed people to mingle for three to four days. Its outcome is expected within the next two to four weeks in Pakistan. I fear an exponential growth in deaths due to COVID-19 by the mid or end of June,” Prof Akhtar warned but added that authorities should improve their system of data collection and start research on the nature and behaviour of the coronavirus in Pakistan.

Another renowned health expert, Dr Saqib Ansari, said why the number of deaths was less in Pakistan as compared to the rest of the world was a million-dollar question.

He called for initiating research to ascertain whether “the virus has lost its aggressiveness in Pakistan” and why it appeared to be lesser infectious and lethal for Pakistani people.

“What current data suggests is that instead of multiplying, an add-on effect of coronavirus is being observed in our society. Secondly, it appears that its secondary and tertiary infections are comparatively less lethal as compared to other parts of the world, especially in the US and the UK,” Dr Ansari said but added that “it does not mean that people should abandon all the precautionary measures as it is still resulting in 70 to 80 deaths in the country daily”.

He said as far as the immune system of the Pakistani population was concerned, they remained exposed to a large number of pathogens throughout the year and their immune system remains active most of the time as it has to fight infections daily.

“When children of Pakistanis living abroad visit Pakistan, they get sick by eating food and drinking water here but our children and people remain healthy. This is because we are exposed to pathogens a lot more as compared to people in the Western world,” he added.

“We have seen instances where people infected with coronavirus met with dozens of other people but when they were tested, they were negative. This is not the case in countries where we have acquired the virus. Coronavirus is a lot more aggressive and lethal in countries from where we have acquired it. There is something wrong or really good in the strain of coronavirus we have in our country, which needs to be looked into,” Dr Ansari added.

“There is some qualitative or quantitative change in the transmission of coronavirus in Pakistan. It appears that when this virus is transmitted from the primary source to other persons, the viral load remains less or it does not multiply as rapidly as in people of other countries or races in the world. Secondly, there may be some mutation in the strain of coronavirus in our country but all these possibilities need to be thoroughly looked into and researched in the labs,” Dr Ansari said and urged authorities to invest in virologists, public health experts and scientists instead of wasting money on buildings and purchasing equipment.

Another health specialist, Prof Muhammad Tariq Mehr, the in-charge of the COVID-19 treatment ward at the Hayatabad Medical Complex Peshawar and expert of anti-viral medicines, also believes that there is a possibility that the strain of coronavirus prevalent in Pakistan might be different from the rest of the world, while Pakistani population’s immunity might be different from the West seeing the diverse genetic makeup.

“There may be some environmental factors in our region due to which the virus appears to be less virulent here but it could also be because our reporting ability and testing capabilities are a lot different than the rest of the world,” Prof Mehr said, adding that it could also be a “wild guess as we still have not got any concrete knowledge about the illness”.

“The only thing that we know about COVID-19 this far is that we don’t know much about the disease and the virus,” Prof. Mehr said.

‘No change in virus'
But a leading virologist and molecular scientist, Prof Saeed Khan, from the Dow University of Health Sciences (DUHS), believes that there is no change in the coronavirus as it is 99% the same virus which originated from Wuhan, China. He said the gene of this virus had around 30,000 nucleotides and only 11 of them had been found different than the original virus that originated from China.

“Viruses do not change their virulence in a few years and it takes decades for a virus to become less or more virulent. COVID-19 transmission and mortality due to this virus are indeed less but it depends on the environmental and genetic factors also. There is a need to conduct thorough studies on it,” Prof Khan said but added that at the moment, all the leading researches in the country were busy in firefighting and testing instead of research.

“Scientists at all the labs, including ours at the DUHS and those at the Karachi University and in Lahore and Islamabad, are busy testing COVID-19 instead of doing any research. There is a need to conduct research which would benefit us more than utilising scientists for testing samples 24 hours a day,” Prof Khan added.
https://www.geo.tv/latest/290869-he...in-pakistan-comparatively-weaker-to-us-europe
 
Gilead Sciences Inc on Monday reported its antiviral drug remdesivir provided a modest benefit in patients with moderate COVID-19 given a five-day course of the treatment. In contrast, those who received the medicine for 10 days in the study did not fare as well.

Remdesivir, which is administered intravenously in hospital, is the first drug to show improvement in COVID-19 patients in formal clinical trials, and new information about its efficacy is being closely watched around the world, as nations battle the pandemic.

The late-stage study of nearly 600 patients evaluated the safety and efficacy of five- and 10-day treatment with remdesivir in addition to standard care for people who test positive with moderate COVID-19 - the disease caused by the new coronavirus - compared with standard care alone.

At day 11, around 76 percent of the patients in the 5-day treatment group showed improvement in clinical status versus 66 percent for standard care alone, Gilead said.

About 70 percent of the patients who received remdesivir for 10 days showed improvement, "trending towards but not reaching statistical significance", the drugmaker said.

Further study details than Gilead provided on Monday, such as more information on patient demographics, are needed to explain the difference in the two treatment groups, doctors and analysts said.

Remdesivir is being closely watched after the US Food and Drug Administration granted emergency use authorization (EUA)last month, citing results from a US government study that showed the drug reduced hospitalization stays by 31 percent, or about four days, compared with a placebo.

The FDA did not immediately respond to a request for comment on whether it would consider expanding the EUA, and Gilead told Reuters it was in discussions with the regulator to determine the appropriate patients to be treated under the authorization.

There are currently no treatments with US approval or vaccines for the new coronavirus that has infected more than 6 million people and killed nearly 373,000 worldwide, including more than 104,000 US deaths.

The drug has received approval by Japanese health regulators. US approval requires a rigorous, time-consuming FDA review, but EUAs can be used in a health crisis when other options are not available.

Dozens of companies are working on a variety of treatment and vaccine approaches for the illness.

The drug, which previously failed as a treatment for Ebola, is designed to disable the mechanism by which certain viruses, including the new coronavirus, make copies of themselves and potentially overwhelm their host's immune system.

Dr Daniel McQuillen, an infectious disease specialist at Lahey Hospital & Medical Center in Burlington, Massachusetts, said it was difficult to draw a conclusion on why the patients on the shorter course outperformed those on the longer one until the full data is released.

The trial results "confirm our and others' anecdotal experience,"

McQuillen said in an email. "The drug has promise in hospitalized patients treated early, when the illness is still in its viremic phase," meaning the virus is circulating in a patient's bloodstream.

Jefferies analyst Michael Yee said the improvements seen were only modest.

"This incrementally adds to a broader utilization of the drug into a more moderate population inside the hospital, but consensus already understands remdesivir is not a silver bullet," Yee wrote in a research note.

https://www.aljazeera.com/ajimpact/...ow-observe-black-tuesday-200602140008472.html
 
Reasonable to expect some coronavirus vaccine by year-end, Pentagon researcher says

A senior U.S. Army vaccine researcher said on Tuesday it was reasonable to expect that some sort of coronavirus vaccine could be available to part of the U.S. population by the end of the year.

Defense Secretary Mark Esper vowed on May 15 that the U.S. military and other parts of the government would, in collaboration with the private sector, produce a vaccine at scale to treat the American people and partners abroad by year-end.

Colonel Wendy Sammons-Jackson, director of the U.S. Military Infectious Disease Research Program, told a Pentagon news briefing it was “reasonable to expect that there will be some form of a vaccine that could be available at some level, to a certain population, by the end of the year.”

Another Army researcher, Dr. Kayvon Modjarrad, said researchers were learning about the new virus “faster than we have about any other virus before.”

“So, going to a vaccine in a matter of months, from concept all the way to Phase 3 clinical trials and potentially licensure is unprecedented. But in this case I think very much is possible.”

Army researchers said work was underway with U.S. and international companies, including AstraZeneca PLC (AZN.L), Johnson & Johnson (JNJ.N), Moderna Inc (MRNA.O) and Sanofi SA (SASY.PA), to develop anti-body drugs and vaccines and the military planned to test its own vaccine candidate on humans in the late summer.

Scientists leading U.S. efforts told Reuters in late May the United States plans a massive testing effort involving more than 100,000 volunteers and a half dozen or so of the most promising vaccine candidates to deliver a safe and effective one by the end of 2020.

Other U.S. authorities, including the National Institutes of Health and the Biomedical Advanced Research and Development Authority, are also helping companies develop vaccines and therapies.

https://uk.reuters.com/article/uk-h...d-pentagon-researcher-says-idUKKBN2392LT?il=0
 
Scientists are running a trial to see if ibuprofen can help hospital patients who are sick with coronavirus.

The team from London's Guy's and St Thomas' hospital and Kings College believe the drug, which is an anti-inflammatory as well as a painkiller, could treat breathing difficulties.

They hope the low-cost treatment can keep patients off ventilators.

In the trial, called Liberate, half of the patients will receive ibuprofen in addition to usual care.

The trial will use a special formulation of ibuprofen rather than the regular tablets that people might usually buy. Some people already take this lipid capsule form of the drug for conditions like arthritis.

Studies in animals suggest it might treat acute respiratory distress syndrome - one of the complications of severe coronavirus.
 
Novavax partners with contract drugmaker for COVID-19 vaccine manufacturing

US biotech firm Novavax Inc has entered into a deal with contract drugmaker AGC Biologics to manufacture its experimental COVID-19 vaccine.

An add-on component of Novavax's vaccine that could help enhance the immune response against the coronavirus would be manufactured by privately held AGC Biologics, the contract drugmaker said.
 
US billionaire Bill Gates has called for any successful coronavirus vaccine found in the future to be distributed "on a global basis”.

Gates was speaking to the BBC ahead of a virtual vaccine summit later in which world leaders and some of the wealthiest companies and individuals aim to raise upwards of $7.4bn (£5.9bn) to boost vaccine production.

He said help for vaccines was "more important today than it's ever been" and that every donation means "we can save more lives".

Any funds raised will be used to help get any successful coronavirus vaccine to the world's poorest countries, while also helping immunise against deadly diseases such as polio, typhoid and measles.

The coronavirus pandemic has disrupted vaccination campaigns worldwide, meaning about 80 million babies have missed out on routine immunisations.

But Gates warned that disinformation about vaccines (more on that here) posed a threat to efforts to tackle diseases - including Covid-19.

"Eventually, when we have the vaccine - we will want to develop the herd immunity to have over 80% of the population taken," he added.

"If they’ve heard its a plot or that vaccines are bad, and we don't have people willing to take the vaccine then that will let the disease continue to kill people."
 
Taking hydroxychloroquine does not protect people who have been close to someone with coronavirus from becoming infected, a study suggests.

Donald Trump told the world he was taking one pill a day to safeguard himself against the coronavirus, on the advice of his doctor. However, a study published in the New England Journal of Medicine suggests the drug is no more effective in protecting people exposed to the virus than a placebo.

The trial, which was carried out in the USand Canada, recruited people who were at moderate to high risk of contracting Covid-19. Most of them were deemed at high risk because they had been closer than 2 metres from somebody with the virus for more than 10 minutes without wearing any personal protective equipment. The hope was that the drug could be used to protect people where somebody in their family was infected.

This was a randomised, controlled trial – the so-called “gold standard” – and was set up to compare what happened in people given hydroxychloroquine within four days of exposure and those given dummy pills instead.

The researchers enrolled 821 mostly younger and healthy adults with an average age of 40 who had no symptoms at the time. Within four days of exposure, each received a delivery from a courier of a package containing either placebo or hydroxychloroquine. The pills were to be taken over five days, starting with a stronger dose on day one.

About one in eight (107 out of 821) of the participants developed Covid-19 over the 14-day follow-up period. Both confirmed cases and probable cases – those not tested but judged on symptoms – were included in the study owing to some lack of availability of diagnostic testing in the US.

Among those who received hydroxychloroquine, 49 developed Covid-19 (or compatible symptoms such as fever or cough), compared with 58 in the group that received the placebo. The difference is not considered to be significant. Two patients had to treated in hospital, one in each group and there were no deaths.

People given hydroxychloroquine were more likely to report side-effects such as nausea and stomach pain – 40% v 17%. But there were no serious reactions and no heart rhythm disturbances, which is a known issue with the drug.

“While we had hope this drug would work in this context, our study demonstrates that hydroxychloroquine is no better than placebo when used as post-exposure prophylaxis within four days of exposure to someone infected with the new coronavirus,” said Dr Todd Lee, an associate professor of medicine, division of infectious diseases at McGill University in Canada and one of the lead authors of the study.

“Our study’s results set politics aside and provide unbiased evidence to guide practice in the prevention of Covid-19 and reinforce the importance of randomised clinical trials as we work together nationally and internationally to combat the novel coronavirus,’’ said Dr Ryan Zarychanski, an associate professor of internal medicine at the University of Manitoba, Canada.

Other trials taking place will show whether there is a place for the drug in preventing infections in other settings. A very much larger trial is underway in healthcare workers, aiming to recruit 40,000 around the world, led by the Mahidol Oxford Tropical Medicine Research Unit in Bangkok.

https://www.theguardian.com/world/2020/jun/03/hydroxychloroquine-no-better-than-placebo-study-finds
 
Three authors retract Hydroxychloroquine study

Three of the authors behind a study in medical journal The Lancet that raised safety concerns over the use of the anti-malarial drug hydroxychloroquine to treat Covid-19 have retracted their paper.

Hydroxychloroquine is being studied by a number of scientists to see if it is a viable treatment for Covid-19. US President Donald Trump took a two-week course of the drug as a preventative measure.

The Lancet said the company that provided the data used in the study would not transfer the full statistics for an independent review.

They concluded they "can no longer vouch for the veracity of the primary data sources", a statement from the medical journal said.

The study claimed there were no benefits to treating coronavirus patients with the drug and said taking it might even increase the number of deaths among those in hospital with the disease.

Following the publication of the study, the World Health Organization (WHO) halted its trial, but it announced on Wednesday that this work would resume.
 
Japan aims to have coronavirus vaccines in use by June 2021

TOKYO (Reuters) - Japan aims to put coronavirus vaccines into use by June 2021, the health minister said on Friday, as the country strives to be fully ready to host the Tokyo Olympics, originally planned for this summer but postponed by one year due to the pandemic.

Drugmakers around the world are scrambling to develop a treatment or vaccine for COVID-19, the respiratory disease caused by the highly infectious new coronavirus which has so far killed nearly 400,000 people worldwide.

“We will be securing production facilities in parallel with expedited vaccine development,” Japan’s Health Minister Katsunobu Kato told reporters as he outlined plans to bring vaccines into use by the end of the first half of 2021.

Usually, plants for actual vaccine production are arranged only after the successful completion of development.

The Japanese government has earmarked 146 billion yen ($1.34 billion) for vaccine production and distribution in the second extra budget that Prime Minister Shinzo Abe’s cabinet approved last month.

Japanese pharmaceutical firms developing coronavirus vaccines include Shionogi & Co (4507.T) and AnGes Inc (4563.T).

The United States is planning massive clinical trials involving 100,000 to 150,000 volunteers in total, with the goal of delivering an effective vaccine by the end of this year.

Japan has not suffered the explosive surge of coronavirus infections seen in some other countries. It has reported around 17,000 confirmed cases and 900 known deaths to date.https://www.reuters.com/article/us-...us-vaccines-in-use-by-june-2021-idUSKBN23C1S0
 
AstraZeneca 'on track' to roll out virus vaccine in September

British pharma giant AstraZeneca is “on track” to begin rolling out up to two billion doses of a coronavirus vaccine in September if ongoing trials prove successful, its chief executive said.

The company is partnering with Oxford University, which has pioneered the vaccine, and is already manufacturing doses before seeking final regulatory approval once testing concludes in the coming months.

“So far we're still on track ... we are starting to manufacture this vaccine right now, and we have to have it ready to be used by the time we have the results,” AstraZeneca chief executive Pascal Soriot told BBC radio.

“Our present assumption is that we will have the data by the end of the summer, by August, so in September we should know whether we have an effective vaccine or not.”
 
AstraZeneca’s cancer drug Calquence has shown initial signs of helping hospitalised Covid-19 patients get through the worst of the disease, according to tests.

Results from the preliminary research involving 19 patients, which was backed by the United States National Institutes of Health, encouraged the British drugmaker to explore the drug’s new use in a wider clinical trial announced in April.

Eleven patients had been on oxygen when they started the 10-14 day Calquence course and eight of them could afterwards be discharged, breathing independently, according to results in a paper co-authored by Astra’s head of oncology research, Jose Baselga.

Eight patients were on mechanical ventilation when they were put on Calquence, and four of them could be discharged, though one died of pulmonary embolism.

“These patients were in a very unstable situation, they would have had a dire prognosis ... Within one to three days the majority of these patients got better in terms of ventilation and oxygen needs,” Astra’s Baselga told Reuters.

Severe cases of Covid-19 are believed to be triggered by an over-reaction of the immune system known as cytokine storm and initial research has brought Calquence, and other drugs that suppress certain elements of the immune system, into play.'
 
China will make any vaccine 'global public goods'

Chinese officials on Sunday promised to make any Chinese vaccine "global public goods" once available.

Minister of Science and Technology Wang Zhigang said China is involved in international cooperation on vaccine development and clinical trials.

Wang made the comment at a news conference to release a report on the nation's response to the coronavirus pandemic.


AP investigation: China withheld COVID-19 information
07:10 GMT - Bangladesh’s mini
 
MenInG said:
China will make any vaccine 'global public goods'

Chinese officials on Sunday promised to make any Chinese vaccine "global public goods" once available.

Minister of Science and Technology Wang Zhigang said China is involved in international cooperation on vaccine development and clinical trials.

Wang made the comment at a news conference to release a report on the nation's response to the coronavirus pandemic.


AP investigation: China withheld COVID-19 information
07:10 GMT - Bangladesh’s mini
Click to expand...

China to strengthen global cooperation in COVID-19 vaccine trials

BEIJING (Reuters) - China will strengthen international cooperation in future COVID-19 clinical vaccine trials, building on earlier collaboration in vaccine development, the science and technology minister said on Sunday.

China is expending great efforts in the global scramble to develop a vaccine for the new coronaries epidemic that began in its central city of Wuhan, with Chinese researchers conducting five separate clinical trials on humans, or half of all such trials globally, according to the data compiled by the World Health Organization.

President Xi Jinping vowed last month at the World Heath Assembly, the WHO’s governing body, that vaccines China’s develops will become a “global public good” once they are ready for use, and it will be China’s contribution to ensuring vaccine accessibility and affordability in developing countries.

Developing “a vaccine is still the fundamental strategy in our effort to overcome the new coronavirus,” Science and Technology Minister Wang Zhigang told a news conference in Beijing.

But vaccine development is very difficult and takes time, he said, when asked how China would initially prioritise shots by country when a vaccine is found.

“The rigour of vaccine development has been compared by some scientists to a dance involving precise steps and rehearsals,” Wang said.

In a white paper unveiled by the State Council Information Office at the news conference, the government urges global cooperation, saying the international community should resist finger-pointing and politicising the virus. It did not name any country.

U.S. President Donald Trump’s administration has accused China of cover-ups and lack of transparency regarding the pandemic. Beijing has repeatedly denied the allegations, saying it has been keeping the world informed from the start.

The head of the Chinese Center for Disease Control and Prevention briefed his U.S. counterpart by phone on the then-unknown virus as early as Jan. 4, according to the white paper.

In the white paper, the Chinese government said the medical cost of all the coronavirus patients in China totalled 1.35 billion yuan ($191 million) as of the end of May.

President Xi last month pledged $2 billion in financial support over the next two years to help deal with COVID-19, especially to help developing countries.

https://www.reuters.com/article/us-...tion-in-covid-19-vaccine-trials-idUSKBN23E02Z
 
British scientists thought to be leading the global race to develop a coronavirus vaccine are reportedly also close to a major breakthrough on a life-saving antibody treatment.
 
U.S. senator Scott says China trying to sabotage vaccine development

LONDON (Reuters) - The United States has evidence China is trying to slow down or sabotage the development of a COVID-19 vaccine by Western countries, Republican senator Rick Scott said on Sunday.

“We have got to get this vaccine done. Unfortunately we have evidence that communist China is trying to sabotage us or slow it down,” he said during an interview on BBC TV.

“China does not want us ... to do it first, they have decided to be an adversary to Americans and I think to democracy around the world.”

Asked what evidence the United States had, Scott declined to give details but said it had come through the intelligence community.

“This vaccine is really important to all of us getting our economy going again. What I really believe is whether England does it first or we do it first, we are going to share. Communist China, they are not going to share.”

https://www.reuters.com/article/us-...to-sabotage-vaccine-development-idUSKBN23E0B5
 
US government says remdesivir supply is running out

A top US official has warned that the government's supply of remdesivir - a drug shown to reduce recovery time for Covid-19 patients - could run out by the end of June.

US Department of Health and Human Services official Dr Robert Kadlec told CNN that the final shipment of remdesivir will go out on 29 June.

The government is now "waiting to hear" from Gilead Sciences - the company that makes remdesivir - on the drug's availability later into the summer, Dr Kadlec said.

Remdesivir - originally developed as an Ebola treatment - was authorised for emergency use for the treatment of Covid-19 by the US Food and Drug Administration (FDA) last month.

The news comes just as the UK pharmaceutical industry signals that some stockpiles of medical supplies have been depleted entirely by the virus.
 
Dr Amit Patel, co-author of an influential study on hydroxychloroquine and its effects on coronavirus patients, has left his faculty posting at the University of Utah.

In a statement to the BBC, the university said his unpaid adjunct appointment was officially terminated by "mutual agreement" on Friday.

It comes days after Dr Patel and two other co-authors retracted their study, which found that taking hydroxychloroquine increased the risk of death in coronavirus patients. The group said they could no longer vouch for its veracity after the healthcare firm behind their data would not hand over the dataset for independent analysis.

They study's findings influenced the World Health Organization's decision to suspend testing on the anti-malaria drug, but the UN body has since resumed trials.
 
BENGALURU (Reuters) - Indian biotech firm Panacea Biotec Ltd said on Wednesday it would partner with U.S.-based Refana Inc to make a potential vaccine for COVID-19.

The collaboration aims to make more than 500 million doses of the vaccine candidate, with over 40 million doses expected to be available early next year, Panacea said in a statement to stock exchanges

Panacea’s shares jumped 20% in morning trading on India’s National Stock Exchange after the news.
 
India has lifted its export ban on hydroxychloroquine, the drug that US President Donald Trump called a "game-changer" in the fight against Covid-19.

India's minister for chemicals and fertilisers tweeted the news on Wednesday night.

Hydroxychloroquine is very similar to chloroquine, one of the oldest and best-known anti-malarial drugs.

But the drug has also attracted attention over the past few decades as a potential antiviral agent.

Trump has repeatedly touted the drug as a possible cure for Covid-19, despite a lack of proof and reservations from medical experts.

India, one of the world's largest manufacturers of hydroxychloroquine, banned exports in March when its lockdown disrupted supply chains. However, the country did ease some restrictions and shipped 50 million tablets of the drug to the US in April, Reuters reported.
 
US company begins human testing of antibody treatment

Regeneron Pharmaceuticals has begun human testing of its experimental antibody cocktail as a treatment for Covid-19.

George Yancopoulos, chief scientific officer of the US biotechnology company, says the trial has an "adaptive" design and could quickly move from dozens of patients to eventually include thousands.

"If it goes perfectly well, within a week or two we'll move to the second phase," he told Reuters news agency. "Within a month or so of that we'll have clear data that this is or isn't working. By the end of summer, we could have sufficient data for broad utilisation."

The dual antibody, called REGN-COV2, is being compared to a placebo treatment in hospitalised patients and patients who have symptoms but are not sick enough to be hospitalised.
 
Moderna on track for large COVID-19 vaccine test in July

The first experimental COVID-19 vaccine in the US is on track to begin a huge study next month to prove if it really can fend off the coronavirus, its manufacturer has said.

The vaccine, developed by the US National Institutes of Health and Moderna Inc, will be tested in 30,000 volunteers - some given the real shot and some a dummy shot.

Moderna said it already has made enough doses for the pivotal late-stage testing. Still needed before those injections begin: results of how the shot has fared in smaller, earlier-stage studies.

But Moderna's announcement suggests those studies are making enough progress for the company and the NIH to get ready to move ahead.

Moderna launched its vaccine test in mid-March with an initial 45 volunteers. The company said it has finished enrolling 300 younger adults in its second stage of testing, and has begun studying how older adults react to the vaccine. These initial studies check for side effects and how well people's immune systems respond to different doses. But only the still-to-come huge trial can show if the vaccine works.
 
EU urges unity over vaccine purchases

The European Union has urged member states to work “together” after its executive branch was tasked with negotiating to buy coronavirus vaccines.

EU health official Stella Kyriakides said there was "overwhelming" support from EU governments for a European Commission plan to utilise a €2.4bn ($2.7bn; £2.15bn) fund to pay for vaccines.

Germany, France, Italy and the Netherlands have already started talks with pharmaceutical companies to buy vaccines, a move that could weaken the EU's approach.

Kyriakides said the initiatives had the same goal, adding: "Both tracks should converge for the benefits of all 27. This is about working together and not in competition."
 
Italy, Germany, France and Netherlands sign contract with Astrazeneca for COVID vaccine

ROME (Reuters) - Italy, Germany, France and the Netherlands have signed a contract with Astrazeneca to supply European citizens with a vaccine against the coronavirus, Italy’s health minister said on Saturday.

The contract is for 400 million doses of the vaccine, which was developed with the University of Oxford and whose experimentation phase is already advanced and expected to end in autumn, Roberto Speranza said in a Facebook post.

He added that a first batch of doses would be made available by the end of this year.

The European Commission received a mandate from EU governments on Friday to negotiate advance purchases of promising coronavirus vaccines, the EU’s top health official said, but it was unclear whether there would be enough money available.

https://www.reuters.com/article/us-...h-astrazeneca-for-covid-vaccine-idUSKBN23K0HW
 
Coronavirus: Blood clots targeted in treatment trial

Scientists are to test whether an experimental drug can prevent potentially deadly blood clots associated with Covid-19.

The trial, funded by the British Heart Foundation, will test the theory the clots are caused by a hormone imbalance triggered by coronavirus infection.

It will become one of several drugs currently being trialled to prevent the disease's worst effects.

A third of hospitalised coronavirus patients develop dangerous blood clots.

The drug, TRV027, works to rebalance hormones involved in blood pressure, water and salt.

Scientists from Imperial College London, involved in the trial, think that when the virus enters the body, it uses an enzyme as a "handle" to enter the cells.

But this disables the enzyme, which plays an important role in balancing the key hormones. When out of balance, the blood can become sticky, leading to clots.

They theorise that TRV027 - which won its creator a Nobel Prize in 2012 - can step in to play this rebalancing role.

Many of the treatments being trialled to treat Covid-19 focus on the body's inflammatory response.

But the hormonal imbalance is a "quite distinct problem" which may provide clues to the question of why some people get severely ill why others do not, says Dr David Owen, one of the study's leads.

Blood clotting could also explain why Covid-19 seems to particularly affect people who already have cardiovascular disease despite being a respiratory illness, according to the British Heart Foundation.

Different drugs trialled
Since Covid-19 is such a complex disease which effects many of the body's systems, this treatment could be used in combination with other drugs says Dr Kat Pollock, a joint lead on the study.

About 60 patients will be given either the new experimental drug, or a placebo, starting next month.

It has been shown to be safe in patients with acute heart failure, although it was not effective as a treatment for this condition.

TRV027 is just one of several different drugs being trialled to ease the disease's worst effects or help the body fight it off.

At least 10 different antiviral drugs including HIV treatment lopinavir/ritonavir are being, or have been trialled to see if they can help fight off the disease.

None has yet been shown to be effective on its own, although there is still hope several could be used together to shorten patients' illnesses.

Remdesivir, a drug that has shown promising effects, works by attacking an enzyme that a virus needs in order to replicate inside body cells.

Meanwhile plasma - the liquid part of blood - taken from people who have recovered from coronavirus might also help, by giving sick people who haven't recovered the right antibodies to fight it off.

And a number of other treatments are focusing on the body's dangerous inflammatory response to fighting Covid-19, known as cytokine release syndrome.
https://www.bbc.com/news/health-53045180
 
FDA revokes emergency use status of drug touted by Trump

The US Food and Drug Administration revoked the emergency use authorisation for malaria drug hydroxychloroquine as a treatment for COVID-19, the use of which has been championed by US President Donald Trump.

The FDA said based on new evidence, it was no longer reasonable to believe that oral formulations of hydroxychloroquine and the related drug chloroquine may be effective in treating COVID-19.
 
Trump touts hydroxychloroquine even as U.S. revokes emergency use status

President Donald Trump said on Monday other countries had provided great reports on the effectiveness of malaria drug hydroxychloroquine for treatment of the deadly coronavirus, complaining that only U.S. agencies have failed to grasp its benefit.

His remarks, delivered to reporters at the White House, came hours after the U.S. Food and Drug Administration revoked its emergency use authorization for hydroxychloroquine to treat COVID-19, despite Trump’s frequent praise of the drug’s usefulness for staving off the disease.

https://uk.reuters.com/article/uk-u...vokes-emergency-use-status-idUKKBN23M2V1?il=0
 
The first trial results of a coronavirus vaccine being developed by CureVac in Germany are expected in two months, German news website Focus Online reported on Friday.

Reuters reports that CureVac, an unlisted German company, said this week that the first meaningful results could be available in September or October and, under favourable conditions, it could be approved by the middle of next year.
 
A potential coronavirus vaccine being developed by China’s Clover Biopharmaceuticals using GlaxoSmithKline’s vaccine booster is now in early-stage testing in humans, the companies said on Friday.

Clover said initial safety data from the trial, which is enrolling about 150 adults and also investigating the vaccine in combination with Dynavax’s adjuvant, is expected in August this year, Reuters reports.
 
Chinese researchers launch phase-2 human test for possible coronavirus vaccine

Chinese researchers have started a second phase human trial of a possible coronavirus vaccine, the Institute of Medical Biology at Chinese Academy of Medical Sciences (IMBCAMS) said on Sunday, in efforts to further assess effectiveness and safety.

About a dozen vaccines are in different stages of human tests globally, as the World Health Organization warns the coronavirus pandemic is accelerating and “the world is in a new and dangerous phase”.

However, none of the vaccine trials have passed large-scale, late-stage phase 3 clinical trials, a necessary step before getting regulatory approval for sale.

IMBCAMS began on Saturday a phase 2 human test for its experimental shot, which is among six possible vaccines Chinese scientists are testing in humans, following an on-going phase-1 study that has recruited about 200 participants since May, the institute said on Sunday in its social media channel.

The phase-2 trial will determine the shot’s dose and continue to evaluate whether the potential vaccine can safely trigger immune responses in healthy people.

IMBCAMS said it expects to use a plant dedicated to producing a coronavirus vaccine this year to prepare for China’s future vaccine supplies.

As early as by the end of 2020, certain groups of people with special needs can use experimental vaccines under urgent circumstances, Gao Fu, director at the Chinese Center for Disease Control and Prevention, said last month.

The coronavirus, which was first detected in China late in 2019, has infected 8.81 million people globally and killed more than 460,000 people.

https://uk.reuters.com/article/uk-h...ssible-coronavirus-vaccine-idUKKBN23S087?il=0
 
Sanofi eyes vaccine approval by first half of 2021

The French drugmaker Sanofi says it hopes to get regulatory approval for the coronavirus vaccine it's developing with Britain's GlaxoSmithKline by the first half of next year.

There are currently no vaccines against the virus, and while a number of companies and institutions are in the race to develop one there is no guarantee of success.

Sanofi currently has two vaccine projects. Clinical trials of the GSK-linked project are due to start in September.
 
Fauci says vaccine may be ready by end of year

Continuing his testimony to congress, top US disease expert Dr Anthony Fauci says that he is “cautiously optimistic” a vaccine may be ready by the end of 2020.

He said it is a matter of “when and not if” the vaccine is ready, but added that it "might take some time".

Drug company Moderna has plans “to launch a Phase 3 clinical trial as early as July 2020, pending positive results from this Phase 2 trial,” Fauci added.

He added that it is crucially important that Americans get a flu jab this year.

Centers for Disease Control and Prevention (CDC) Director Robert Redfield also called on Americans to "embrace flu vaccinations with confidence".

"This single act will save lives," he said.
 
Volunteers have begun being immunised with a new UK coronavirus vaccine.

About 300 people will have the vaccine over the coming weeks, as part of a trial led by Prof Robin Shattock and his colleagues, at Imperial College London.

Tests on animals suggest the vaccine is safe and triggers an effective immune response.

Many traditional vaccines are based on a weakened or modified form of virus, but the Imperial vaccine is based on a new approach, using synthetic strands of genetic code, called RNA, which mimic the virus.

There are more than 120 coronavirus vaccines in early development across the world. A further 13 are now in clinical trials: five in China, three in the United States, two in the UK, one in Australia, Germany and Russia.

Vaccine teams are keen to stress that they are not in a race against each other, but against the virus.

If there are to be enough doses to protect the world, several vaccine approaches will need to be successful, writes the BBC's medical correspondent Fergus Walsh.
 
Vaccine not certain, maybe in a year: WHO

It is not certain that scientists will be able to create an effective vaccine against the coronavirus that has caused the COVID-19 pandemic, but it could take a year before one were to be invented, the head of the WHO has said.

Speaking by video-conference to deputies from the European Parliament's health committee, Tedros Adhanom Ghebreyesus said that if such a vaccine became a reality, it should become a public good available to all.

He said the WHO had already more than a 100 candidates for a vaccine of which one was at an advanced stage of development.

"Hoping that there will be a vaccine, the estimate is we may have a vaccine within one year. If accelerated, it could be even less than that, but by a couple of months. That's what scientists are saying," he said.
 
White House says vaccines could be ready by end of year

Alex Azar, the health and human services secretary, told the White House briefing, "America has never been readier to combat Covid-19."

In addition to surveillance and testing capabilities, Azar said the country now had "promising therapeutics that are benefiting tens of thousands of American patients and that have already saved thousands of lives".

He said provision of the most "promising" treatments, remdesivir and dexamethasone (the cheap and widely available drug which has shown promising results), had already begun, with 120,000 courses of remdesivir allocated to states and dexamethasone added to guidelines.

Convalescent plasma has been used on more than 25,000 patients, Azar said.

He added that there were more than 140 clinical trials in the US, with large investments in three vaccines - which have now reached human trials - "some with the potential to start delivering safe and effective doses before the end of the year"
 
World's first inactivated Covid-19 vaccine produces antibodies: Chinese experts

(Karachi) The phase one and two clinical trials of the world's first inactivated coronavirus vaccine have produced antibodies in participants, Chinese experts revealed on Sunday.

The vaccine is developed by Wuhan Institute of Biological Products under the China National Biotec Group (CNBG) affiliated to the China National Pharmaceutical Group (Sinopharm).

According to researchers, the results of the clinical trial showed that the vaccination is safe and has no serious reaction. They stated that after adopting different procedures and doses of vaccination, all 1,120 participants in the vaccine group produced high titers of antibodies.

"People who received two doses of the vaccine at an interval of 28 days, saw their neutralizing antibody positive conversion rate reach 100 percent," experts maintained.

On April 12, the vaccine obtained the world's first clinical trial approval, and phase one and two clinical trials were then launched in Wuzhi county of Henan province. The vaccine will prove to be a breakthrough to contain spread of Covid-19.

https://www.brecorder.com/news/4000...9-vaccine-produces-antibodies-chinese-experts
 
Gilead Sciences Inc has priced its COVID-19 drug candidate remdesivir at $2,340 for a five-day treatment in the United States and some other developed countries, potentially reflecting looming competition from a cheap steroid.

The price tag is below the $5,080 per course recommendation by the US drug pricing research group, the Institute for Clinical and Economic Review (ICER), last week.

But it is more in line with a lower range suggested by ICER of approximately $2,520-2,800, if cheap steroid dexamethasone, which is not patent-protected, is cleared for use in COVID-19.

Remdesivir is at the forefront of the fight against COVID-19 after the anti-viral treatment helped shorten hospital recovery times in a clinical trial. It has been approved for emergency use in some patients in the US.

But dexamethasone has since been hailed as a potential breakthrough treatment.

The remdesivir price for US private insurance companies will be $520 a vial, Gilead said, which equates to $3,120 for every patient for a treatment course of six vials.


The per-vial price outside of private insurance will be $390, Gilead added.

Analysts at Royal Bank of Canada said they saw revenue potential of $2.3bn from the drug in 2020, helping offset more than $1bn in development and distribution costs.

Still, the potential to lift Gilead shares was limited because vaccines and better treatments were on the horizon longer term, they added.

Gilead has entered into an agreement with the US Department of Health and Human Services (HHS), with the agency and states set to manage allocation to hospitals until the end of September.

HHS has secured more than 500,000 treatment courses of the drug for US hospitals through September, the agency said on Monday.

This represents 100 percent of Gilead's projected production for July of 94,200 treatment courses, 90 percent of production in August and September, in addition to an allocation for clinical trials, HHS said.

After this, once supplies are less constrained, HHS will stop managing the allocation, Gilead said.

Remdesivir's price has been a topic of intense debate since US regulators approved its emergency use in some COVID-19 patients in May. Experts have said Gilead would need to avoid appearing to take advantage of a health crisis for profits.

The European Union's healthcare regulator last week recommended conditional approval of the drug when used in the critically ill. The formal go-ahead by the European Commission is expected to follow soon.

Gilead has linked up with generic drugmakers based in India and Pakistan, including Cipla Ltd and Hetero Labs Ltd, to make and supply remdesivir in 127 developing countries.

Cipla's version is priced at less than 5,000 Indian rupees ($66.24), while Hetero Lab's version is priced at 5,400 rupees ($71.51).

https://www.aljazeera.com/ajimpact/...esivir-faces-competition-200629141223536.html
 
Bharat Biotech's COVID-19 vaccine has been approved for human trials, making it India's first domestic candidate to get the green light from the government's drug regulator as cases surge in a country with more than 1.3 billion people.

The Drug Controller General of India has approved the company's application to conduct a Phase I and II clinical trial of Covaxin, which was developed along with the Indian Council of Medical Research's National Institute of Virology, the company said in a statement on Monday.

Human clinical trials are scheduled to start across the country in July for the vaccine, which was developed and manufactured in Bharat Biotech's facility at Genome Valley in Hyderabad, India.

India, which lags only the United States, Brazil and Russia in total cases, reported close to 20,000 new infections on Monday, according to data from the country's federal Ministry of Health.

More than 16,000 people have died from the disease since the first case in India in January - low when compared with countries with similar numbers of cases.

But experts fear hospitals in the densely populated nation will be unable to cope with a steep rise in cases.

No vaccine has yet been approved for commercial use against the illness caused by the new coronavirus, but over a dozen vaccines from more than 100 candidates globally are being tested on humans.

China's military received the approval to use a COVID-19 vaccine candidate developed by its research unit and CanSino Biologics after clinical trials proved it was safe and showed some efficacy, the company said on Monday.

https://www.aljazeera.com/news/2020...ate-cleared-human-trials-200630030355733.html
 
Hydroxychloroquine trial to restart

The UK has approved the resumption of tests into whether a controversial malaria drug can be used to treat coronavirus.

Regulators say hydroxychloroquine and a similar drug, chloroquine, can be given to healthcare workers in a clinical study to test the theory.

Recruitment to the COPCOV trial was paused earlier this year due to concerns about the drug's side-effects. An influential article had found it increases the risk of death in coronavirus patients, but the article has since been retracted over data concerns.

Although other studies suggest hydroxychloroquine is not a life-saver for people who are already ill with coronavirus, researchers are keen to continue exploring whether it might prevent infections.

The COPCOV trial will see chloroquine, hydroxychloroquine or a placebo given to more than 40,000 healthcare workers from Europe, Africa, Asia and South America.
 
US buys almost all global supply of Covid-19 treatment drug remdesivir

The US has secured almost all of the forthcoming global supply of a drug shown to help people recover faster from Covid-19.

Remdesivir is produced by the US firm Gilead Sciences and is the first drug to have been approved by authorities in the US to be used to treat the disease.

The US administration is set to receive 500,000 doses - or 100% of the company's supply production in July, 90% of it in August and 90% in September.

On average, a course of remdesivir requires 6.25 vials.

A statement from the Department of Health and Human services praised President Donald Trump's "amazing deal" with Gilead.
 
On Wednesday it emerged that the US was buying nearly all the next three months' projected production of Covid-19 drug remdesivir from US manufacturer Gilead.

But a handful of generic drug makers in India, Pakistan and Egypt are also licensed to make the drug.

Tests suggest remdesivir cuts recovery times, though it is not yet clear if it improves survival rates.

Hetero Labs in the Indian city of Hyderabad told BBC Telugu's Deepthi Bathini that it was already manufacturing the drug. It said it had sent around 30,000 vials of the drug to hospitals across the country and planned to scale up production to 100,000 vials in the next two weeks.

In Pakistan, health authorities are hopeful that the drug will hit the local market soon. Officials told BBC Urdu's Umer Nangiana that remdesivir produced by Ferozsons Laboratories will be available from 15 July.

Gilead has reached agreements with these generic drug firms, allowing them to produce it for 127 low-income and lower-middle income countries, according to CNN.
 
EU approves Covid-19 drug remdesivir

The European Commission has approved the use of remdesivir for patients with Covid-19 in the EU.

The anti-viral drug was originally developed as a treatment for Ebola but has been found in studies to reduce the recovery times of people hospitalised with coronavirus.

Remdesivir has already been approved in a number of countries, including the US. There has been controversy, however, after the US announced earlier this week that it had bought almost all supplies of the drug from US producer Gilead for the next three months.
 
India's clinical research body defends timeline for coronavirus vaccine trials

MUMBAI (Reuters) - India’s leading clinical research agency said Saturday its decision to fast-track development of a potential coronavirus vaccine was in line with international standards, after health experts raised concerns about the schedule for clinical trials.

The Indian Council of Medical Research issued a statement after a letter was leaked on Friday showing ICMR Director General Balram Bhargava as saying the agency “envisaged” launch of the vaccine for public health use by Aug. 15, with the aim to begin patient enrolment for human trials by July 7.

The vaccine, being jointly developed by India’s Bharat Biotech and ICMR, is one of several candidates being tested globally to fight the coronavirus pandemic.

Vaccine trials usually take years to complete, though regulators have allowed testing on some potential vaccines to be fast-tracked in light of the public health emergency.

The ICMR's timeline drew criticism here from health experts in India, who expressed concern the trials would compromise patient safety and ethics.

“Everything will be dependent on the clinical trial results,” ICMR spokesman Lokesh Sharma told Reuters.

The ICMR’s statement said the leaked letter “was meant to cut unnecessary red tape, without bypassing any necessary process, and speed up recruitment of participants.”

The statement said the aim was “to complete these phases at the earliest, so that population-based trials for efficacy could be initiated without delay.”

It added: “In the larger public health interest, it is important for ICMR to expedite the clinical trials with a promising indigenous vaccine.

“ICMR’s process is exactly in accordance with the globally accepted norms to fast-track the vaccine development for diseases of pandemic potential wherein human and animal trials can continue in parallel.”

https://www.reuters.com/article/us-...-for-coronavirus-vaccine-trials-idUSKBN2450I0
 
We've been reporting on the rise in cases around India today, and now a group of scientists there have issued a warning about a potential vaccine.

The group say a 15 August deadline to launch a Covid-19 vaccine for public use is unfeasible.

The Indian Council of Medical Research (ICMR) had said it "envisaged" the vaccine to be launched by then, which is India's Independence Day.

But the Indian Academy of Sciences has warned against "any hasty solution that may compromise rigorous scientific processes and standards".

The ICMR has since said the date was "not a deadline".

A vaccine would normally take years, if not decades, to develop. However, researchers across the world are hoping to achieve the same amount of work in only a few months.
 
Regeneron COVID-19 treatment enters final stage trials

The pharmaceutical firm Regeneron announced it was entering the late stages of its human clinical trials investigating a drug to both treat and prevent COVID-19.

The drug, called REGN-COV2, is a combination of two antibodies that block the coronavirus' "spike protein", which it uses to invade human cells.

The company is moving to the final Phase 3 stage of a trial to determine if its drug can prevent infection among people recently exposed to the virus - for example through a person in their household. This trial, run jointly with the US National Institute of Allergy and Infectious Diseases (NIAID), is expected to enroll 2,000 patients in the US.

"We are pleased to collaborate with NIAID to study REGN-COV2 in our quest to further prevent the spread of the virus with an antiviral antibody cocktail that could be available much sooner than a vaccine," said Regeneron President George Yancopoulos.
 
Brazil trials of potential Chinese COVID-19 vaccine to begin July 20

João Doria, governor of Brazil's richest and most populous state São Paulo, said that trials of a new potential vaccine against COVID-19, developed by China's SinoVac, will start on July 20.

The trials, to be done in partnership with the Instituto Butantan, will involve 9,000 volunteers spread across 12 research centers located in Sao Paulo and four other states as well as the federal district Brasília.
 
US government awards Novavax $1.6 billion for coronavirus vaccine

The US government has awarded Novavax Inc $1.6 billion to cover testing, commercialisation and manufacturing of a potential coronavirus vaccine in the United States, with the aim of delivering 100 million doses by January 2021, Reuters reported.

The award is the biggest yet from “Operation Warp Speed”, the White House programme aimed at accelerating access to vaccines and treatments to fight the coronavirus.
 
Trump continues to see hydroxychloroquine as promising: White House

US President Donald Trump continues to see a malaria drug, hydroxychloroquine, as a promising drug to be used to prevent coronavirus infection, the White House has said, though the US Food and Drug Administration has said its efficacy and safety were unproven.

"The president has always said that he sees hydroxychloroquine as a very promising prophylactic but that every person should not take it unless they get a prescription from their doctor," White House spokeswoman Kayleigh McEnany said at a news conference.
 
Bill Gates calls for COVID-19 meds to go to people who need them, not 'highest bidder'

Billionaire philanthropist Bill Gates called for COVID-19 drugs and an eventual vaccine to be made available to countries and people that need them most, not to the "highest bidder," saying relying on market forces would prolong the deadly pandemic.

"If we just let drugs and vaccines go to the highest bidder, instead of to the people and the places where they are most needed, we'll have a longer, more unjust, deadlier pandemic," Gates, a founder of Microsoft, said in a video released during a virtual COVID-19 conference organized by the International AIDS Society.
 
India's Biocon Ltd has received regulatory approval for its drug Itolizumab to be used on coronavirus infected patients suffering from moderate to severe respiratory distress, the biopharmaceutical company said in a statement.

The drugm which is also used to cure the skin disease psoriasis, was cleared by the Drug Controller General of India (DCGI) for usage in India.

"The randomised control trial indicated that all patients treated with Itolizumab responded postiively and recovered," said Kiran Mazumdar-Shaw, the firm's executive chairperson.
 
One in three South Korean COVID-19 patients improve with remdesivir

One in three South Korean patients seriously ill with COVID-19 showed an improvement in their condition after being given Gilead Sciences Inc's antiviral remdesivir, Reuters news agency reported on Monday quoting health authorities.

More research was needed to determine if the improvement was attributable to the drug or other factors such as patients' immunity and other therapies, authorities said.

Remdesivir has been at the forefront of the global battle against COVID-19 after the intravenously administered medicine helped shorten hospital recovery times in a US clinical trial.
 
U.S. COVID-19 vaccine programme to start manufacturing by late summer, says U.S. official

Drugmakers partnered with the U.S. government are on track to begin actively manufacturing a vaccine for COVID-19 by the end of the summer, a senior administration official said on Monday.

“If you say exactly when will literally the vaccine materials be in production and manufacturing, it is probably four to six weeks away, but we will be actively manufacturing by the end of summer,” the official, who declined to be identified by name, said.

He added that the administration is already working with companies to equip and outfit manufacturing facilities and acquire raw materials.

The Trump administration has helped finance the development of four COVID-19 vaccines so far though its Operation Warp Speed Program, which aims to produce 300 million vaccine doses by the end of 2021.

The U.S. government has given grants ranging from several hundred million dollars to over $1 billion to Johnson & Johnson (JNJ.N), Moderna Inc (MRNA.O), AstraZeneca Plc (AZN.L) and Novovax Inc (NVAX.O).

It also signed a $450 million contract earlier this month with Regeneron Pharmaceuticals Inc (REGN.O) to help it supply therapies for patients who are sick with the virus.

Clinical trials for therapeutics can produce results in a matter of weeks, making it possible to produce hundreds of thousands of doses by fall, the senior administration official said.

“While we think is fair to say that vaccine progress is occurring at warp speed pace, faster than any vaccines have been developed in history, therapeutics are even faster,” the official said.

The “slate is not closed” for additional funding agreements and the administration plans to announce more in the future, the official said.

The novel coronavirus has infected more than 3 million people in the United States and killed more than 130,000.

https://uk.reuters.com/article/uk-h...e-summer-says-u-s-official-idUKKCN24E2WU?il=0
 
Global vaccine plan may allow rich countries to buy more

Politicians and public health leaders have publicly committed to equitably sharing any coronavirus vaccine that works, but the top global initiative to make that happen may allow rich countries to reinforce their own stockpiles while making fewer doses available for poor ones.

While no country can afford to buy doses of every potential vaccine candidate, many poor ones can't afford to place such speculative bets at all.

Activists warn that without stronger attempts to hold political, pharmaceutical and health leaders accountable, vaccines will be hoarded by rich countries in an unseemly race to inoculate their populations first.

After the recent uproar over the United States purchasing a large amount of a new COVID-19 drug, some predict an even more disturbing scenario if a successful vaccine is developed.
 
Moderna vaccine enters final stage of human trials

US biotech firm Moderna says it will enter the final stage of human trials for its Covid-19 vaccine on 27 July.

The company aims to enroll 30,000 people in its clinical trial - with participants receiving either the vaccine or a placebo.

Information about the trial, which was posted on clinicaltrials.gov, indicated that the study will run until October 2022.

Moderna's latest announcement comes after the New England Journal of Medicine published results from the first stage of the trial - which showed its first 45 participants all developed antibodies to the virus.

Moderna is one of a handful of companies that are now in a global race to develop a vaccine - including pharmaceutical giants like AstraZeneca and Pfizer.

It typically takes years to develop a vaccine.
 
Asian markets look to continue upward run on vaccine hopes

Asian shares look set to continue a march upwards as optimism over a coronavirus vaccine carry weight over the ongoing spread of the disease and simmering U.S.-China tensions.

Australian S&P/ASX 200 futures rose 0.37% in early trading. Japan’s Nikkei 225 futures added 0.07%, and Hong Kong’s Hang Seng index futures rose 0.25%.

E-mini futures for the S&P 500 rose 0.19%.

MSCI’s gauge of stocks across the globe closed up 1.16%.

A run of promising news in efforts to develop a COVID-19 vaccine ran through U.S. markets. An experimental vaccine produced by biotech startup Moderna Inc showed it was safe and provoked immune responses in volunteers, an early- stage trial showed on Tuesday. There were also reports of pending positive news on vaccine work from the University of Oxford.

“U.S. equities continued to defy all gravity as investor optimism revels amid the progress in developing a vaccine which continues to reign supreme,” wrote Stephen Innes, chief global markets strategist at AxiCorp, in an analyst note.

In the United States, stocks closed sharply higher on the vaccine news, buttressed by a strong quarterly report from Goldman Sachs.

A new report from the Federal Reserve also found U.S. businesses saw an uptick in activity as states relaxed restrictions, although uncertainty about the outlook remained with coronavirus cases spreading.

The Dow Jones Industrial Average rose 0.85%, while the S&P 500 gained 0.91% and the Nasdaq Composite grew 0.59%.

Oil prices rose thanks to a drop in U.S. crude inventories, but gains were limited by plans from OPEC and its allies to ease supply curbs. Brent crude settled up 89 cents, or 2.1%, at $43.79 a barrel.

Investors appeared willing to take on more risk in currency markets, pushing the safe-haven U.S. dollar to a one-month low. The dollar index fell 0.105%, dropping below 96 for the first time since June.

The risk appetite was also evident as U.S. Treasury yields rose and the yield curve steepened, indicating a wider spread between long- and short-term interest rates.

Investors will be watching for new economic data out of China, which will release figures on second-quarter GDP data on Thursday, along with June factory output, retail sales and fixed-asset investment. A Reuters poll found analysts expect China to report 2.5% economic growth, reversing a 6.8% first-quarter decline driven by the pandemic.

https://uk.reuters.com/article/us-g...nue-upward-run-on-vaccine-hopes-idUKKCN24G3BL
 
Novartis to provide 'no profit' COVID-19 drugs to developing countries

Swiss drugmaker Novartis will provide 15 generic drugs for treating the symptoms of coronavirus to developing countries on a not-for-profit basis.

The drugs range from antibiotics to steroids and pills for diarrhoea, and will be provided to 79 low- and lower-middle-income countries.

"We shouldn't underestimate the stress that COVID puts particularly on fragile health systems," Chief Operating Officer Lutz Hegermann told Reuters news agency in an interview.
 
Coronavirus: Russian hackers target Covid-19 vaccine research

Russian hackers are targeting organisations trying to develop a coronavirus vaccine, a group of national security services has warned.

The UK's National Cyber Security Centre (NCSC) said the hackers "almost certainly" operated as "part of Russian intelligence services".

It said the group used malware to try and steal information relating to Covid-19 vaccine development.

NCSC director of operations Paul Chichester said it was "despicable".

The warning was published by a group of security services:

- the UK's NCSC
- the Canadian Communication Security Establishment (CSE)
- the United States Department for Homeland Security (DHS) Cyber-security Infrastructure Security Agency (CISA)
- the US National Security Agency (NSA)

The hackers are part of a group called APT29, also known as "the Dukes" or "Cozy Bear".

They exploited software flaws to get access to vulnerable computer systems, and used malware called WellMess and WellMail to upload and download files from infected machines.

They also tricked individuals into handing over login credentials with spear-phishing attacks.

Phishing emails are designed to trick the recipient into handing over their personal information.

Spear phishing is a targeted and personalised form of the attack, designed to trick a specific individual. Often the email appears to come from a trusted contact, and may include some personal information to make the message seem more convincing.

"Throughout 2020, APT29 has targeted various organisations involved in Covid-19 vaccine development in Canada, the United States and the United Kingdom, highly likely with the intention of stealing information and intellectual property relating to the development and testing of Covid-19 vaccines," the report said.

It did not specify which organisations were targeted, or whether any information had been stolen.

https://www.bbc.co.uk/news/technology-53429506
 
India's Cadila to end late-stage trials of potential COVID-19 vaccine in March

India's Zydus Cadila plans to complete late-stage trials for its potential coronavirus vaccine in March 2021 and could produce up to 100 million doses a year if trials are successful, Chairman Pankaj Patel said.

Cadila's vaccine candidate, dubbed ZyCov-D, is one of dozens being developed around the world to fight the coronavirus
 
This is great news. Maybe a sign that Indian pharma is moving up the value chain from being mainly a producer of generics to new products.
 
This is good news, some development happening in vaccine generation. Hopefully, it won't be long before this nightmare ends.

Vaccine-English-1200x6000.jpg
 
"Early COVID-19 Vaccine Results Look 'Really Encouraging,' Says NIH Boss Dr. Francis Collins"

Collins has had a first-hand view of how this gargantuan coalition came together to expedite what is normally a glacial pace in the development of any new treatment. As the head of the largest medical research center in the world, he both closely monitors the detailed scientific progress of the effort and, as one of the highest-ranking health officials in the country, frequently communicates with the Trump Administration and Congress as the federal government tries to eliminate all the usual administrative speed bumps that can delay a vaccine. To put his role in perspective, he is Dr. Anthony Fauci’s boss.

https://www.msn.com/en-us/health/me...-says-nih-boss-dr-francis-collins/ar-BB16PTJl
Click to expand...
 
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Russia’s ambassador to the UK has rejected allegations that his country’s intelligence services tried to steal coronavirus vaccine research.

UK security services said hackers targeting vaccine developers “almost certainly” operated as “part of Russian intelligence services”.

Ambassador Andrei Kelin told the BBC’s Andrew Marr show: “I don’t believe in this story at all, there is no sense in it.”
 
<blockquote class="twitter-tweet"><p lang="en" dir="ltr">Oxford’s Covid-19 vaccine produces a good immune response, reveals new study. <br>Teams at <a href="https://twitter.com/VaccineTrials?ref_src=twsrc%5Etfw">@VaccineTrials</a> and <a href="https://twitter.com/OxfordVacGroup?ref_src=twsrc%5Etfw">@OxfordVacGroup</a> have found there were no safety concerns, and the vaccine stimulated strong immune responses: <a href="https://t.co/krqRzXMh7B">https://t.co/krqRzXMh7B</a> <a href="https://t.co/Svd3MhCXWZ">pic.twitter.com/Svd3MhCXWZ</a></p>— University of Oxford (@UniofOxford) <a href="https://twitter.com/UniofOxford/status/1285210154984710145?ref_src=twsrc%5Etfw">July 20, 2020</a></blockquote> <script async src="https://platform.twitter.com/widgets.js" charset="utf-8"></script>
 
'Very low' chance of vaccine before Christmas - Whitty

The UK's chief medical officer, Prof Chis Whitty, told MPs he would "very much doubt" that there would be a legal requirement to have a coronavirus vaccine in the future, and he would expect it to be free - but that is a policy decision.

“No one should be under any illusions - the chance of us getting a vaccine before Christmas that is actually is highly effective are, in my view, very low,” he says.

But his deputy, Prof Jonathan Van-Tam, says he is "cautiously optimistic" that there will be a vaccine this side of Christmas.

"If we do, we will not have any data on whether it can be given at the same time as flu vaccine," he says.

He adds that the development of a combined coronavirus and flu vaccine will take "many, many years in the future to achieve".
 
WHO scientist sees regulators cooperating to speed vaccine approval

Regulators that normally work within their own countries or regions will likely harmonise efforts on potential COVID-19 vaccines to speed up their approvals once they become available, WHO chief scientist Soumya Swaminathan said.

Swaminathan, answering questions on social media platforms, also said testing vaccines for safety and efficacy - usually a years-long process - could be accelerated to just six months in the midst of the pandemic, if data satisfied regulators that they have enough information to issue approvals.

Still, she said, safety would be paramount. "Whilst speed is important, it cannot be at the cost of compromising on the safety or the efficacy standards that one is setting for oneself," she said.

"It's not the case that the first vaccine is going to be rushed through into injecting millions of people without having established the fact whether it's really protecting you and whether it's safe enough for use in large populations."
 
The world's biggest COVID-19 vaccine study got underway Monday with the first of 30,000 planned volunteers helping to test shots created by the US government along with Moderna Inc - one of several candidates in the final stretch of the global vaccine race.
 
Moderna COVID-19 vaccine could be ready for use by end of year, US says

Moderna Inc's vaccine against COVID-19 could be rolled out by the end of this year, US officials said on Monday, after the drugmaker announced the start of a 30,000-subject trial to demonstrate it is safe and effective, the final hurdle prior to approval by global regulators.

The trial is the first such late-stage study under the Trump administration's program to speed development of measures against the novel coronavirus, adding to hope that an effective vaccine will help end the pandemic. Shares of Cambridge, Massachusetts-based Moderna rose 9%.

Moderna has received nearly $1 billion from the US government, which is helping to bankroll several vaccine candidates under its Operation Warp Speed program.

More than 150 coronavirus vaccine candidates are in various stages of development, with some two dozen prospects having advanced to human testing.

"Having a safe and effective vaccine distributed by the end of 2020 is a stretch goal, but it's the right goal for the American people," National Institutes of Health (NIH) Director Francis Collins said in a release announcing the start of the large Phase III trial.

Manufacturers are ramping up production while testing is underway in order to respond as soon as possible to virus, which is still spreading rapidly around the world. COVID-19 has killed more about 650,000 people worldwide and battered economies.

Moderna could have tens of millions of doses ready when and if the vaccine is deemed safe and effective, Collins told reporters on a call.

The large late-stage trial is designed to evaluate the safety of Moderna's mRNA-1273 vaccine and determine if it can prevent symptomatic COVID-19 after two doses.

Anthony Fauci, the top US infectious disease official, said a readout from the trial could come by November, December, or even earlier. Fauci said he was "not particularly concerned" about the vaccine's safety after seeing data from earlier, smaller trials.

The study also seeks to determine whether the vaccine can prevent coronavirus-related deaths.

Trial volunteers will receive two injections about 28 days apart of either 100 micrograms of mRNA-1273 or a placebo.

Results of a small early-stage study published earlier this month showed volunteers who got two doses of Moderna's vaccine had levels of virus-killing antibodies that exceeded the average seen in people who had recovered from COVID-19.

Moderna said it remains on track to deliver about 500 million doses a year, and possibly up to 1 billion doses a year, beginning 2021.
https://www.brecorder.com/news/4000...could-be-ready-for-use-by-end-of-year-us-says
 
I dont like Moderna's vaccine, its results are not that good, I feel government is trying to be too quick
 
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