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

When do you expect a cure/vaccine for Covid-19 to be found?

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MenInG said:
A drug championed by the US president as a possible cure for COVID-19 has been shown to provide no benefit and possibly a higher risk of death.

Hydroxychloroquine had been championed by Mr Trump after anecdotal reports that the drug, which is also used to treat lupus and rheumatoid arthritis, could help coronavirus patients.

However the new study found it might actually be harmful to those with the disease.

The American research analysed the records of 368 male patients with confirmed coronavirus.

They were all at veterans' hospitals in the US and died or were discharged by 11 April, according to a version of the study posted online.

Some 28% of 97 patients given hydroxychloroquine and standard care died, while 22% of the 113 patients who were given hydroxychloroquine and antibiotic azithromycin died.

But the death rate among the 158 patients who received only standard care - without hydroxychloroquine - was 11%.

The study, which took patients' individual characteristics into account, has not yet been accepted for publication in a medical journal but it has been submitted for expert review.

Hydroxychloroquine also appeared to have no effect on whether a patient needed breathing support: 13% of those who got the drug needed ventilation, versus 14% of those who received only supportive care.

Only 7% of those given the hydroxychloroquine and azithromycin needed help to breathe.

Dr Jeremy Falk, a pulmonary specialist at Cedars-Sinai Medical Center in Los Angeles, said the study was one of a few in the past few weeks to have placed doubt on whether hydroxychloroquine is beneficial.

Dr Falk, who was not involved in the study, said: "We were using it on just about everybody early on. Now we are using it more sparingly."

There are no proven treatments for COVID-19, but hydroxychloroquine, an old malaria drug, has been getting a lot of attention after Mr Trump promoted it as a "game changer".

"What do you have to lose? Take it," he said earlier this month, adding that - while he has no medical or scientific training - his "common sense" qualified him to make such claims.

However, because of a lack of conclusive scientific studies, the US government's top infectious disease specialist, Dr Anthony Fauci, had urged caution.

https://news.sky.com/story/coronavi...t-research-finds-11976830?dcmp=snt-sf-twitter
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This is not a good study. The guideline regarding hydroxychloroquine is that it should be administered well before mechanical support is needed.

Although yeah, it alone isn't that much effective if a few studies are to be believed but there is nothing concrete from them too.

We need to wait a few weeks before the data from proper studies by US, France and WHO is released.
 
The first human trial in Europe of a coronavirus vaccine has begun in Oxford.

Two volunteers were injected - the first of more than 800 people recruited for the study.

Half will receive the Covid-19 vaccine, and half a control vaccine which protects against meningitis but not coronavirus.

The design of the trial means volunteers will not know which vaccine they are getting, though doctors will.
 
No success yet.

It is possible that there will never be a true vaccine because this virus can mutate.
 
Why do I think this Coronavirus is a manmade virus?

I feel the vaccination will be released in early September...
 
Mueez said:
Why do I think this Coronavirus is a manmade virus?

I feel the vaccination will be released in early September...
Click to expand...

UK vaccine could be out in Sept but will most likely be used in the UK only. However I feel this will not come to fruition as those powers to be want a global vaccine , one which is digital in order to track individuals.

If you're still only thinking , I would watch this.

https://www.youtube.com/watch?v=jZ3rh0JRuIo
 
sweep_shot said:
No success yet.

It is possible that there will never be a true vaccine because this virus can mutate.
Click to expand...

Every virus mutates. The family which is known as coronaviruses doesn't mutate as much as say the influenza virus, which makes it a prime candidate for vaccines.

It will work, we have the science, the knowledge and the willpower to make it work.
 
Mueez said:
Why do I think this Coronavirus is a manmade virus?

I feel the vaccination will be released in early September...
Click to expand...

No for general use. It will at best will be a phase three trail or a first, limited batch for the general public. The best case scenario is 9 months but that assumes that we will have mass manufacturing throughout the world and then it gets delivered to the poorer nations.

China and Pakistan are entering phase two trails this month though. But I would still push the general use back to December atleast even if it's super promising. They need to look at every variable possible before declaring safety and efficacy.
 
The world’s biggest manufacturer of disinfectants has issued a stark rebuttal of President Trump’s suggestion that injecting them could help treat coronavirus.

RB, the makers of Dettol and Lysol, warns against any internal use of the products.

“As a global leader in health and hygiene products, we must be clear that under no circumstance should our disinfectant products be administered into the human body (through injection, ingestion or any other route).”

The statement adds that disinfectant and hygiene products “should only be used as intended and in line with usage guidelines”.
 
Bill Gates, the Microsoft tycoon, has said the global coronavirus pandemic is his “worst nightmare”, and he will fund the manufacture of several vaccines even prior to their being approved so they are ready to distribute as quickly as possible.

In an interview with the Times, the billionaire – whose charitable foundation is reportedly the biggest funder of the World Health Organization – said he had been concerned about the impact of a viral pandemic for years.

Gates told the Times the global health charity in his name will arrange funding to build factories to produce billions of doses of different potential vaccines, so it is ready to distribute around the world. In particular, he said, he was speaking to pharmaceutical companies about scaling up production of a vaccine under development at Oxford university, for which human trials have begun.

They are going to put it in humans fairly soon . . . if their antibody results are one of the ones that are promising then we and others in a consortium will help make sure that massive manufacturing gets done.

… Fortunately nobody doing the vaccines expects they’re going to make money on them … They know this is a public good — partly because they will need indemnification as part of the regulatory approval, which will have to be expedited. Three months after you dose the humans you will see those responses and you will know at that point. Maybe there will be four or five that we will build factories for even though in the end we may only use one or two of them. That compresses the time.

Source Guardian
 
While we may not yet be at the point of having a tried-and-tested vaccine against the novel coronavirus, experts say that governments must start looking now for an ethical and equitable distribution process.

With vaccines seen as one of the few real routes out of the coronavirus crisis, fears of “vaccine nationalism” are already increasing.

Each step of creating, testing and mass-producing a vaccine is an epic challenge – but the political and ethical decisions around its subsequent distribution pose another.

How will any eventual vaccine be shared out? Who decides? Will supplies go to the highest bidder?
 
Vaccine shows promise in monkey trials, says Chinese company

BEIJING: A novel coronavirus vaccine has for the first time “largely protected” monkeys from infection during an animal trial, data from a Chinese pharmaceutical giant showed.

It is among a slew of vaccines being developed around the world as countries race to stop an outbreak that has infected around 2.7 million people globally and killed more than 190,000.

Nasdaq-listed Sinovac Biotech said it injected two different doses of its vaccine into eight rhesus macaque monkeys and exposed them to the virus three weeks later, and they did not develop infections.

All the monkeys “were largely protected against SARS-CoV-2 infection”, Sinovac said in its findings.

Four macaques who received a high dose of the vaccine had “no detectable” amounts of the virus in their lungs seven days after they were administered the pathogen.

Another four monkeys given low doses showed an increase in the viral load in their bodies, but appeared to have controlled the virus on their own, it said.

In contrast, four monkeys who were not given the vaccine fell ill from the virus and suffered severe pneumonia.

Sinovac published its results on the online server bioRxiv on April 19, three days after it began human trials, but its findings have yet to be peer-reviewed by the global scientific community.

The vaccine, like most others, uses a chemically inactivated novel coronavirus pathogen to help the body build immunity against the real disease.

Tests had shown “good efficacy” and the Beijing-based company was confident about the vaccine’s potential, Sinovac spokeswoman Yang Guang said.

The company had given “the first serious pre-clinical data I have seen for an actual vaccine candidate”, said Florian Krammer, a virologist at the Icahn School of Medicine at Mount Sinai in New York.

Krammer recently co-authored a survey of different coronavirus vaccine projects for the journal Cell. He said on Twitter that the vaccine’s use of inactivated viruses was “old-fashioned technology” which would make it easier to scale up production.

Several strains of the novel coronavirus have been found by researchers, showing that the pathogen slowly mutates, potentially making the development of a vaccine harder. But Sinovac said its experiment so far had shown its vaccine can “neutralise” widely different strains found among patients in China, Italy, Switzerland, Spain and Britain.

“This provides strong evidence that the virus is not mutating in a way that would make it resistant to a #Covid19 vaccine,” immunologist Mark Slifka from Oregon Health & Science University tweeted.

However, vaccines with inactive pathogens need boos*ter shots to stay effective and it remained to be seen whether Sinovac’s research would provide “long-lasting protection”, said Lucy Walker of the University College London.

https://www.dawn.com/news/1552041/vaccine-shows-promise-in-monkey-trials-says-chinese-company
 
French researchers are preparing to launch a human trial to test their hypothesis that nicotine can help the body combat the infection, Reuters reports.

The trial will involve groups of healthcare workers and patients wearing nicotine patches and other groups wearing placebo patches. Then they will be tested to see if there is a difference in how their bodies respond to the virus.

The trial is a follow-up to a French study, published this month, of public health data which appeared to show that people who smoke are 80% less likely to catch Covid-19 than non-smokers of the same age and sex.
 
Lo jee zindagi bhar Ami said stay away from cigarettes and here cigs are saving lives. :danish


Suttay laga hi lehta.
 
Groups sow doubt about COVID vaccine before one even exists

NEW YORK (AP) — A coronavirus vaccine is still months or years away, but groups that peddle misinformation about immunizations are already taking aim, potentially eroding confidence in what could be humanity’s best chance to defeat the virus.

In recent weeks, vaccine opponents have made several unsubstantiated claims, including allegations that vaccine trials will be dangerously rushed or that Dr. Anthony Fauci, the nation’s top infectious diseases expert, is blocking cures to enrich vaccine makers. They’ve also falsely claimed that Microsoft founder Bill Gates wants to use a vaccine to inject microchips into people — or to cull 15% of the world’s population.

Vaccine opponents in the U.S. have been around for a long time. Their claims range from relatively modest safety concerns about specific vaccines or the risk of side effects to conspiracy theories that border on the bizarre.

The movement is receiving renewed attention, especially as it aligns itself with groups loudly protesting restrictions on daily life aimed at controlling the spread of the virus. Health professionals say vaccine misinformation could have lethal consequences if it leads people to opt for bogus cures instead.

“Only a coronavirus vaccine can truly protect us from future outbreaks,” said Dr. Scott Ratzan, a physician and medical misinformation expert at the City University of New York and Columbia University. “But what if the effort succeeds and large numbers of people decide not to vaccinate themselves or their children?”

While vaccines for diseases such as polio, smallpox and measles have benefited millions, some skeptics reject the science, citing a distrust of modern medicine and government. Others say mandatory vaccine requirements violate their religious freedom.

Rita Palma, the leader of the anti-vaccine group in Long Island called My Kids, My Choice, is among those who say their families won’t get the coronavirus vaccine.

“Many of us are anxiety stricken at the thought of being forced to get a vaccine,” Palma said. “I will never choose to have a COVID-19 vaccine. I don’t want the government forcing it on my community or my family.”

From the outset of the coronavirus pandemic, vaccine skeptics have tailored several long-standing claims about vaccine safety to fit the current outbreak. When the first U.S. case was announced in January, some alleged the coronavirus was manufactured and that patents for it could be found online.

https://apnews.com/3287934e9316b008e2a6c7735b7b01df
 
No clinical benefits from remdesivir, study finds

Treating coronavirus patients with the antiviral drug remdesivir showed no “significant clinical benefits” in the first randomised trial of its kind, according to research released on Wednesday, AFP reports.

In a study among more than 200 Covid-19 patients in Wuhan, China, published in The Lancet, doctors found no positive effects of administering the drug compared with a control group of adults.

The findings were released after US pharmaceutical giant Gilead, which makes remdesivir, said a separate large-scale trial with the drug had showed positive results.

“Unfortunately, our trial found that while safe and adequately tolerated, remdesivir did not provide significant benefits over placebo,” said Bin Cao from China-Japan Friendship Hospital and Capital Medical University in China, who led the research.

“This is not the outcome we hoped for.”
 
MenInG said:
No clinical benefits from remdesivir, study finds

Treating coronavirus patients with the antiviral drug remdesivir showed no “significant clinical benefits” in the first randomised trial of its kind, according to research released on Wednesday, AFP reports.

In a study among more than 200 Covid-19 patients in Wuhan, China, published in The Lancet, doctors found no positive effects of administering the drug compared with a control group of adults.

The findings were released after US pharmaceutical giant Gilead, which makes remdesivir, said a separate large-scale trial with the drug had showed positive results.

“Unfortunately, our trial found that while safe and adequately tolerated, remdesivir did not provide significant benefits over placebo,” said Bin Cao from China-Japan Friendship Hospital and Capital Medical University in China, who led the research.

“This is not the outcome we hoped for.”
Click to expand...


US drug trial shows 'clear cut' effect, says top medic

We reported earlier that a Chinese trial had demonstrated no “significant clinical benefits” to administering the antiviral drug remdesivir to Covid-19 patients.

But a separate trial in the US has shown a “clear-cut” effect, according to the head of the US National Institute of Allergy and Infectious Diseases, Dr Anthony Fauci.

He hailed it as proof a drug can block the coronavirus shortly after the medicine’s maker, Gilead Sciences, revealed it had met its primary goals. Fauci said “the data shows that remdesivir has a clear-cut, significant, positive effect in diminishing the time to recovery,” adding that it proves “that a drug can block this virus.”

The institute he leads is expected to release a detailed summary of the results soon. While it is not yet possible to quantify the drug’s effectiveness, the trial would represent the first time any medication has been shown to improve outcomes.

Dr Fauci said the Chinese test, which had to be halted early for a lack of subjects, was “not an adequate study”. The US-led trial is the largest to investigate remdesivir.
 
German company begins human trials of coronavirus vaccine

German pharmaceutical company BioNTech has begun testing a potential vaccine for the new coronavirus on volunteers.

BioNTech, which is working with the US-based Pfizer, said on Wednesday that 12 participants of a clinical trial in Germany received doses of the vaccine candidate BNT162 since April 23.

Numerous pharmaceutical companies are racing to deliver a vaccine for the virus that has caused a pandemic and led to more than 215,000 deaths worldwide and sickened at least three million people.

BioNTech said in a statement that in the next step, it will begin increasing the dose of BNT162 in a trial involving about 200 participants aged 18 to 55.

The company said it expects to receive regulatory approval to begin trials in the United States soon.

While a safe, effective vaccine is still more than a year away, researchers are rushing to repurpose existing drugs and non-drug therapies as well as testing promising experimental drugs that were already in clinical trials.

Even moderately effective therapies or combinations could dramatically reduce the crushing demand on hospitals and intensive care units, changing the nature of the risk the new pathogen represents to populations and healthcare systems.

New drugs, together with new diagnostics, antibody tests, patient- and contact-tracing technologies, disease surveillance and other early-warning tools, mean the anticipated next "wave" of the global pandemic does not have to be nearly as bad as the first.

As many as 100 potential COVID-19 candidate vaccines are now under development by biotech and research teams around the world, and at least five of these are in preliminary testing in people in what are known as Phase 1 clinical trials.

Scientists in the United Kingdom began clinical trials of a potential COVID-19 vaccine on April 23 as other vaccine developers across Europe stepped up work on experimental shots.

The team at the UK's Oxford University dosed the first volunteers in a trial of their vaccine - called "ChAdOx1 nCoV-19" - while Italy's ReiThera, Germany's Leukocare and Belgium's Univercells said they were working together on another potential shot and aimed to start trials in a few months.

The UK's GSK and France's Sanofi have announced a similar agreement to develop a COVID-19 vaccine, with trials starting in the second half of the year.
https://www.aljazeera.com/news/2020...ials-coronavirus-vaccine-200429111230419.html
 
<blockquote class="twitter-tweet" data-lang="en"><p lang="en" dir="ltr">Chief executive of pharmaceutical giant AstraZeneca has told Sky News it should know if a potential COVID-19 vaccine it is working on with a team of scientists from the University of Oxford works "by June to July"</p>— Sky News Breaking (@SkyNewsBreak) <a href="https://twitter.com/SkyNewsBreak/status/1255794414410137601?ref_src=twsrc%5Etfw">April 30, 2020</a></blockquote>
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AstraZeneca teams up with Oxford University to develop COVID-19 vaccine

(Reuters) - Britain’s AstraZeneca (AZN.L) joined forces with the University of Oxford on Thursday to help develop, produce and distribute a potential COVID-19 vaccine, as drugmakers around the world race to find a solution to the deadly disease.

UK Business Secretary Alok Sharma welcomed the tie-up as a vital step to making the Oxford vaccine available as soon as possible if it succeeds in clinical trials.

A team of British scientists last week dosed the first volunteers, and earlier this month said large-scale production capacity was being put in place to make millions of doses even before trials show whether it is effective.

Only a handful of the vaccines in development have advanced to human trials, an indicator of safety and efficacy - and the stage where most vaccines fail.

“Our hope is that, by joining forces, we can accelerate the globalisation of a vaccine to combat the virus and protect people from the deadliest pandemic in a generation,” AstraZeneca Chief Executive Pascal Soriot said.

The drugmaker did not give details on when it plans to start producing the vaccine “ChAdOx1 nCoV-19”, being developed by the Jenner Institute and Oxford Vaccine Group.

Though the firm is not a major player in vaccine development unlike European peers GSK (GSK.L) and Sanofi (SASY.PA), who are working on their own vaccine, it has deep pockets and a $6-billion-strong R&D budget.

The AstraZeneca-Oxford partnership is looking to produce 100 million doses by the end of the year and prioritise supply in the UK, Soriot told here the Financial Times.

Cambridge-based AstraZeneca is also testing two of its approved treatments as a therapy to help in the outbreak that has so far infected over 3 million people and killed more than 215,000.

Its shares rose 2% on London's FTSE 100 .FTSE by 0923 GMT as the main index fell, outpacing rival GSK.

Governments, drugmakers and researchers are working on around 100 vaccines for the virus. Industry experts say a successful vaccine will likely take more than a year to be developed but that is much faster than the average development time of 5-7 years.

There are currently no treatments or vaccines approved for the highly-contagious respiratory illness caused by the coronavirus, but healthcare workers have been trying many approaches to treat patients.

India's Serum Institute, the world's largest maker of vaccines by volume, has already said here it would produce millions of doses of the Oxford University shot.

The vaccine, a type known as a recombinant viral vector vaccine, uses a weakened version of the common-cold virus spiked with proteins from the novel coronavirus to generate a response from the body’s immune system.

Other drugmakers testing possible COVID-19 vaccines include Pfizer (PFE.N), Moderna (MRNA.O), Johnson & Johnson (JNJ.N) and Novavax (NVAX.O).

https://www.reuters.com/article/us-...ity-to-develop-covid-19-vaccine-idUSKBN22C0UK
 
There is a simple, but crucial number at the heart of understanding the threat posed by the coronavirus. It is guiding governments around the world on the actions needed to save lives, and it gives us clues to the extent that lockdown can be lifted.

It is called the basic reproduction number or simply the R0 (pronounced R-nought).

What is an R0?

The reproduction number is a way of rating a disease's ability to spread.

It's the number of people that one infected person will pass the virus on to, on average, assuming that nobody is immune and people don't change their behaviour to avoid getting ill.

Measles has one of the highest numbers in town with a reproduction number of 15. It can cause explosive outbreaks.

The new coronavirus, known officially as Sars-CoV-2, has a reproduction number of about three, but estimates vary.

Why is a number above one dangerous?

If the reproduction number is higher than one, then the number of cases increases exponentially - it snowballs like debt on an unpaid credit card.

But if the number is lower, the disease will eventually peter out as not enough new people are being infected to sustain the outbreak.

Governments everywhere want to force the reproduction number down from about three to below one.

This is the reason you've not seen family, have had to work from home and the children have been off school. Stopping people coming into contact with each other to cut the virus's ability to spread.

The reproduction number is not fixed. Instead, it changes as our behaviour changes or as immunity develops.

Mathematical modellers at Imperial College London are attempting to track how the number has changed as isolation, social distancing and the full lockdown were introduced.

Before any measures came in, the number was well above one and the conditions were ripe for a large outbreak. Successive restrictions brought it down, but it was not until full lockdown that it was driven below one.

It's a bit technical but by this point scientists refer to the Rt, rather than R0, as the number is changing over time.

The figure now seems to be about 0.7. There is always some uncertainty in this type of work, but there is a high degree of confidence from the government's scientific advisers that the figure is below one overall.

The situation is different in some hospitals and care homes where the virus is spreading.

So how does this inform lifting lockdown?

As countries think about how to lift lockdown, the aim will be to keep the reproduction number below one.

Dr Adam Kucharski, from the London School of Hygiene and Tropical Medicine, told the BBC: "It's a big challenge making sure you're not loosening too much and increasing transmission."

However it has taken a monumental effort, one that has caused damage to people's lives, to get the number from three to 0.7.

"It doesn't give you a lot of room to play with [to keep the number below one]", Dr Kucharski added.

Earlier in April, Germany's reproduction number fell to about 0.7, the same as the UK's now.

But the Robert Koch Institute said that number had increased in recent days to one, before dropping back to 0.75.

"The number should stay below one, that is the big goal," said Prof Lothar Wieler, head of the institute.

Which measures could be lifted?

Unfortunately there is no confirmation how much each intervention affects the virus's spread, although there are estimates.

"Opening schools versus workplaces versus other gatherings - understanding how much they increase the reproduction number is going to be the challenge," said Dr Kucharski.

Another issue is that people's behaviour changes over time, so the number can creep up even if lockdown policies remain unchanged.

What is likely to be needed are new ways of controlling the virus, such as more extensive testing and tracing or location-tracking apps.

These can suppress the reproduction number in a more targeted way, allowing some of the other measures to be lifted.

Is it the most important number?
The reproduction number is one of the big three.

Another is severity - if you have a very mild disease that does not cause many problems then you can relax a bit. Coronavirus, and the disease it causes, Covid-19, is severe and deadly, unfortunately.

The last is the number of cases, which is important for deciding when to act. If you have a high number, but ease restrictions so the reproduction number is about one then you will continue to have a high number of cases.

What about a vaccine?

Having a vaccine is another way to bring down the reproduction number.

A coronavirus patient would naturally infect three others on average, but if a vaccine could protect two of them from infection then the reproduction number would fall from three to one.

https://www.bbc.com/news/health-52473523?ocid=wsnews.chat-apps.in-app-msg.whatsapp.trial.link1_.auin
 
Coronavirus trial drug remdesivir's maker aims for wide distribution: Gilead CEO

WASHINGTON (Reuters) - Gilead Sciences (GILD.O), which manufactures remdesivir, is focused on making the experimental coronavirus drug accessible and affordable to as many people as possible once it is approved, Chief Executive Daniel O’Day said on Friday.

Gilead has already said it will donate the first 1.5 million doses of remdesivir and O’Day told NBC’s “Today” show that the company understood its responsibility to make a difference during the coronavirus pandemic.

“I can assure you that we’re all focused on making sure that we make this accessible and affordable to patients around the globe,” he said.

He said there had been “terrific” collaboration with the U.S. Food and Drug Administration and expects action soon.

“We’re moving very quickly with the FDA,” he said.

Gilead said on Thursday it will work with international partners to expand production of the potential COVID-19 treatment.

The company said it expects to have more than 1 million remdesivir treatment courses manufactured by December and plans to produce several million treatment courses in 2021.

https://www.reuters.com/article/us-...or-wide-distribution-gilead-ceo-idUSKBN22D5D1
 
1 million by December is too less. We need them right now. I know it's hard to make but surely they can outsource it to others to speed up manufacturing which in hinted in the article.

By December we could have a billion vaccine doses. The time for therapeutics is right now.
 
Tocilizumab is another potential treatment for severe cases with cykotine syndrome.

And I have to read good stuff about Ivermectin as well. That's the one if it work and to the extent that the first study showed, will be a game changer. It's cheap, well known, easy to manufacture and widely available. Could really transform the current situation.
 
The US's Food and Drug Administration (FDA) has authorised the emergency use of the Ebola drug remdesivir for treating the coronavirus.

The authorisation means the anti-viral drug can now be used on people who are hospitalised with severe Covid-19.

A recent clinical trial showed the drug helped shorten the recovery time for people who were seriously ill.

But emergency FDA authorisation is not the same as formal approval, which requires a higher level of review.

Experts have also warned the drug - which was originally developed to treat Ebola, and is produced by Gilead pharmaceutical company - shouldn't be seen as a "magic bullet" for coronavirus.

What is the most promising coronavirus drug?

During a meeting with US President Donald Trump in the Oval Office, Gilead Chief Executive Daniel O'Day said the FDA authorisation was an important first step. The company would donate 1.5 million vials of the drug, he said.

FDA Commissioner Stephen Hahn also said at the meeting: "It's the first authorised therapy for Covid-19, so we're really proud to be part of it."

What do we know about remdesivir?

President Trump has been a vocal supporter of remdesivir as a potential treatment for the coronavirus.

In its clinical trial, the US National Institute of Allergy and Infectious Diseases (NIAID) found that remdesivir cut the duration of symptoms from 15 days down to 11. The trials involved 1,063 people at hospitals around the world. Some were given the drug and others were given a placebo (dummy) treatment.

Dr Anthony Fauci who runs NIAID, said that remdesivir had "a clear-cut, significant, positive effect in diminishing the time to recovery".

However, although remdesivir may aid recovery - and possibly stop people having to be treated in intensive care - the trials did not give any clear indication whether it can prevent deaths from coronavirus.

https://www.bbc.com/news/world-us-canada-52511270
 
In a worst-case scenario, a Covid-19 vaccine may never be developed: CNN report

As countries lie frozen in lockdown and billions of people lose their livelihoods, public figures are teasing a breakthrough that would mark the end of the crippling coronavirus pandemic: a vaccine.

But there is another, worst-case possibility: that no vaccine is ever developed. CNN reports that this possibility is taken very seriously by many experts — because it's happened several times before.

According to a CNN report, if that happens, instead of wiping out Covid-19, societies may instead learn to live with it.

Cities would slowly open and some freedoms will be returned.

Testing and physical tracing will become part of our lives in the short term, but in many countries, an abrupt instruction to self-isolate could come at any time.

Treatments may be developed — but outbreaks of the disease could still occur each year, and the global death toll would continue to tick upwards.
 
Pope calls for Covid-19 vaccine to be shared worldwide

Pope Francis has called for international scientific cooperation to discover a vaccine for the coronavirus and said any successful vaccine should be made available around the world, Reuters reports.

“In fact, it is important to unite scientific capabilities, in a transparent and impartial way to find vaccines and treatments,” he said when delivering his Sunday address from the papal library in the Vatican City, a measure necessitated by the Italian lockdown. He added that it was also important to “guarantee universal access to essential technologies that allow each infected person, in every part of the world, to receive the necessary medical treatment”.

The pope also backed a proposal by an inter-religious group known as the Higher Committee on Human Fraternity for an international day of prayer and fasting on 14 May to ask God to help humanity overcome the pandemic.
 
MenInG said:
In a worst-case scenario, a Covid-19 vaccine may never be developed: CNN report

As countries lie frozen in lockdown and billions of people lose their livelihoods, public figures are teasing a breakthrough that would mark the end of the crippling coronavirus pandemic: a vaccine.

But there is another, worst-case possibility: that no vaccine is ever developed. CNN reports that this possibility is taken very seriously by many experts — because it's happened several times before.

According to a CNN report, if that happens, instead of wiping out Covid-19, societies may instead learn to live with it.

Cities would slowly open and some freedoms will be returned.

Testing and physical tracing will become part of our lives in the short term, but in many countries, an abrupt instruction to self-isolate could come at any time.

Treatments may be developed — but outbreaks of the disease could still occur each year, and the global death toll would continue to tick upwards.
Click to expand...

This is very very unlikely. A vaccine will be developed sooner rather than later. We have over hundred candidates, a dozen of them in trails. It may not be september, which would be ideal scenario but we will get a vaccine by early next year. It's been done before and there is no reason we can't do it again.
 
Gilead Sciences exporting remdesivir, says CEO

The head of the maker of remdesivir, an anti-viral shown to reduce recovery times in Covid-19 patients, said the company has been exporting the drug and is making it available to patients in the United States through the government, AFP reported.

Gilead Sciences CEO Daniel O'Day said the company is donating its entire existing supply of the drug — 1.5 million vials, enough to treat 100,000 to 200,000 patients.

“We have been exporting for clinical trials and for compassionate use thousands of treatment courses,” O'Day said on CBS's Face the Nation.
 
Two US biotech companies have identified a drug candidate for treating Covid-19 and plan to begin human testing by the end of the year, the companies said on Monday.

Vir Biotechnology Inc and Alnylam Pharmaceuticals Inc said the therapy candidate makes use of RNA interference (RNAi) technology that targets and “silences” specific genetic material, blocking the production of deadly proteins that cause diseases.
 
Boris Johnson to ask European countries to pull together for vaccine

As coronavirus continues to spread around the world and claim more lives, there is an ever-pressing need for a vaccine to stop the disease.

Currently, there is no proven prevention or cure. But there is hope that could change. Today, Europe is hosting a virtual conference for world leaders and philanthropists in an effort to raise €7.5bn (£6.6bn; $8.3bn) to drive vaccine research.

UK Prime Minister Boris Johnson, who is co-hosting the event, is expected to ask countries to pull together.

Johnson will explain how a coronavirus vaccine is “the most urgent shared endeavour of our lifetime”. There are more than 90 vaccine candidates being tested around the world, but only some will become front-runners.

Even with more financial commitment, it will take time to know which ones might work and how well. Most experts think it could take until mid-2021, about 12-18 months after the new virus first emerged, for a vaccine to become available.
 
The European Commission has launched a global effort to fund research on a vaccine and other tools to combat the coronavirus.

It is hosting a virtual conference for world leaders and philanthropists in a bid to raise €7.5bn (£6.6bn; $8.3bn).

European leaders have pledged support for the fundraising plan in a joint open letter.

The Brussels-led initiative was set out by European Commission President Ursula von der Leyen on Friday.

The European Commission has pledged $1bn to fund research on a vaccine. Norway has matched the European Commission's contribution, and France has pledged €500m, as have Saudi Arabia and Germany. The US, China and Russia are not taking part.

In her opening remarks at the summit, Ms von der Leyen said everyone must chip in to finance "a truly global endeavour".

"I believe 4 May will mark a turning point in our fight against coronavirus because today the world is coming together," she said.

"The partners are many, the goal is one: to defeat this virus."

UK Prime Minister Boris Johnson, another co-host of the conference, said the "more we pull together" in sharing expertise, "the faster our scientists will succeed" in developing a vaccine.

Mr Johnson, who spent three nights in intensive care with Covid-19, was to confirm the UK's pledge of £388m for vaccine research, testing and treatment during the conference.

Along with the European Commission, the conference is being co-hosted by the UK, Canada, France, Germany, Italy, Japan, Norway and Saudi Arabia.

Italian Prime Minister Giuseppe Conte, French President Emmanuel Macron and German Chancellor Angela Merkel are also among those who have signed up to the initiative.

In the open letter published in weekend newspapers, the leaders said the funds raised would "kickstart an unprecedented global co-operation between scientists and regulators, industry and governments, international organisations, foundations and healthcare professionals".

"If we can develop a vaccine that is produced by the world, for the whole world, this will be a unique global public good of the 21st Century," they added.

At the same time, the signatories gave their backing to the World Health Organization in the face of US criticism of its handling of the outbreak.

https://www.bbc.com/news/world-europe-52525387
 
Vaccine funding drive hits $8bn target, US fails to contribute

World leaders and organisations have pledged $8bn to research, manufacture and distribute a possible vaccine and treatments for COVID-19, but the United States has refused to contribute to the global effort.

Organisers included the European Union and non-EU countries the United Kingdom, Norway and Saudi Arabia.

Leaders from Japan, Canada, South Africa and dozens of other countries joined the virtual event on Monday, while China, where the virus is believed to have originated, was only represented by its ambassador to the EU.

Governments aim to continue raising funds for several weeks or months, building on efforts by the World Bank, the Bill and Melinda Gates Foundation and wealthy individuals, and to turn the page on the fractious and haphazard initial response to the pandemic around the world.

"In the space of just [a] few hours we, have collectively pledged 7.4 billion euros ($8.1bn) for [a] vaccine, diagnostics and treatment" against COVID-19, the head of the European Commission, Ursula von der Leyen, said after chairing the online event.

"This will help kick-start unprecedented global cooperation," she added.

It was however unclear what was new funding, as commitments made earlier this year may also be included, EU officials said.

Donors included pop singer Madonna, who pledged one million euros ($1.08m), von der Leyen said.

British Prime Minister Boris Johnson, who has recovered from a life-threatening battle with COVID-19, said the search for a vaccine was "the most urgent shared endeavour of our lifetime", calling for "an impregnable shield around all our people".

EU diplomats said the US, which has the world's most confirmed COVID-19 cases, was not taking part.

A senior US administration official declined to say specifically why the US was not participating.

"We support this pledging effort by the EU. It is one of many pledging efforts that are going on and the United States is at the forefront," the official told reporters by telephone.

President Donald Trump last month said he would halt funding to the World Health Organization (WHO), whose director-general addressed the conference, over its handling of the pandemic.

Norwegian Prime Minister Erna Solberg said she regretted that decision, as well as Washington's absence on Monday.

"It is a pity the US is not a part of it. When you are in a crisis, you manage it and you do it jointly with others," Solberg told Reuters News Agency in an interview, pledging $1bn to support the distribution of any vaccine developed against COVID-19, and for vaccines against other diseases.

"We've had several discussions with our American partners and I'm convinced the Americans will eventually commit to this dynamic because it's the way forward for the world," French President Emmanuel Macron said.

Global reach
Many leaders stressed that any vaccine must be available to everyone. Canadian Prime Minister Justin Trudeau said it should not just be for rich countries.

"Those who invent it of course will be fairly paid, but access will be given to people across the globe by the organisation we choose," Macron said.

EU officials said pharmaceutical companies that receive the funding will not be asked to forgo intellectual property rights on the new vaccine and treatments, but they should commit to making them available worldwide at affordable prices.

The $8bn-goal was in line with expectations but is only an initial figure. Von der Leyen has said more money will be needed over time.

The Global Preparedness Monitoring Board, a UN-backed body focusing on health crises, estimates that of the $8bn immediately needed, $3bn will have to be spent to develop, manufacture and distribute a possible vaccine against COVID-19, the EU Commission said.

Another $2.25bn is needed to develop treatments for COVID-19, $750m for testing kits, and another $750m to stockpile protective equipment, such as face masks. The remaining $1.25bn would go to the WHO to support the most vulnerable countries.

The UK will hold an online donor summit on June 4 for GAVI, the Global Alliance for Vaccines and Immunizations.
https://www.aljazeera.com/news/2020...-target-fails-contribute-200505082811475.html
 
HYDERABAD: A coronavirus patient at the city's Civil Hospital has shown improvement after being given plasma therapy, a senior official at the health facility said on Tuesday.

The Sindh Health Department on Thursday had allowed three hospitals in the province — two in Karachi and one in Hyderabad — to start experimental use of COVID-19 convalescent plasma for the treatment of patients who are infected with the novel coronavirus and are showing moderate to severe symptoms.

Convalescent plasma is taken from the blood of patients who have already recovered from the disease; in this case, COVID-19. It is rich in antibodies and can help other patients recover faster if it is administered properly and in the right circumstances.

Dr Shahid Junejo, Medical Superintendent at the Civil Hospital, said that the patient on whom the therapy was trialed has shown improvement.

Read also: No record of Karachi doctor being brought to hospital: SIUT spokesperson

"The decision for the trial was taken after consultation with the vice chancellor of the Liaquat University of Medical and Health Sciences Jamshoro, Prof Bikha Ram Devrajani,” he said.

"Patient's pulse rate and oxygen saturation are normal after the procedure," Dr Junejo added.

The three health facilities that have been allowed by the provincial government to start clinical trials are the Dr Ruth KM Pfau Civil Hospital Karachi (CHK), the National Institute of Blood Diseases (NIBD) and Hyderabad’s Liaquat University Hospital.

“Following Punjab, Balochistan and Khyber Pakhtunkhwa [KP], the Sindh Health Department has also allowed clinical trials of convalescent plasma for the treatment of COVID-19 patients at three of the province’s hospitals,” NIBD head Prof Dr Tahir Shamsi had earlier told The News.

“We are now going to select 350 COVID-19 patients under treatment at nine health facilities in the country and start clinical trials of convalescent plasma on them,” said the eminent haematologist.

Read also: CJP expresses indignation at lack of transparency in govt's coronavirus response

Dr Shamsi said the Drug Regulatory Authority of Pakistan had allowed medical professionals to start clinical trials of the use of convalescent plasma in the country.

Following that, he added, the health departments of Punjab, KP, Balochistan and Sindh had allowed them to use the technique, also known as passive immunisation, to treat patients infected with COVID-19.

“Our aim is to prevent COVID-19 patients under treatment at different hospitals from going onto life support. We believe convalescent plasma taken from healthy COVID-19 patients, which is rich in coronavirus antibodies, can reduce the viral load in the bodies of infected patients and help them recover faster.”

Dr Shamsi said the technique is used when there is a high risk of infection and insufficient time for the body to develop its own immune response or to reduce the symptoms of ongoing or immunosuppressive diseases.

“A team of health experts including haematologists, infectious disease specialists, intensivists (or ICU specialists) and a representative of the Sindh Blood Transfusion Authority will supervise the clinical trials at the three hospitals.”

He said that mainly patients undergoing treatment at the CHK in Karachi and the Liaquat University Hospital in Hyderabad would be given convalescent plasma with the hope of recovery from COVID-19.

Passive immunisation is an old technique used in the absence of a vaccine to treat infectious diseases, he added.

“We believe that with the transfusion of convalescent plasma of healthy COVID-19 patients to active patients, viral load in the bodies of the patients would reduce to an extent where they would not require the support of ventilator and they would recover from the disease.”

He said these trials would also be conducted at the Hayatabad Medical Complex in Peshawar, the Shaikh Zayed Hospital in Quetta, the Pakistan Institute of Medical Sciences in Islamabad, the Benazir Bhutto Shaheed Hospital in Rawalpindi, and Lahore’s Pakistan Kidney & Liver Institute and Postgraduate Medical Institute.

Replying to a query, Dr Shamsi said healthy COVID-19 patients who have tested negative twice can donate their blood for plasma extraction after two weeks of recovery, adding that with one donation, they can treat two such patients.

https://www.geo.tv/latest/286522-coronavirus-patient
 
Pfizer, BioNTech set to begin U.S. coronavirus vaccine trial

(Reuters) - Pfizer Inc (PFE.N) and BioNTech SE (22UAy.F) said on Tuesday they have begun delivering doses of their experimental coronavirus vaccines for initial human testing in the United States.

The U.S. drugmaker and German partner said if the vaccine proves to be safe and effective in trials, it could potentially be ready for wide U.S. distribution by the end of the year, shaving several years off the typical vaccine development timeline.

The vaccine, which uses messenger RNA (mRNA) technology, has the potential to be among the first vaccines against the virus that has infected more than 1 million people in the United States and killed some 68,000.

There are currently no approved treatments or vaccines for the new coronavirus, though some drugs are being used on patients under an emergency use authorization.

The U.S. study is part of a broader, global program already underway in Germany, where BioNTech is based. Dosing there began last month.

Moderna Inc (MRNA.O) is using similar technology for its vaccine being developed along with the U.S. government. Phase I testing of that vaccine candidate has also begun, with mid-stage trials planned in the current quarter.

Pfizer said last week it hopes to receive emergency authorization from the U.S. Food and Drug Administration as early as October, and could distribute up to 20 million doses by the end of 2020, with an eye toward producing hundreds of millions of doses next year.

“Even going from a few million to 20 million will allow you to protect the epicenters of the virus, and then drive out the virus from our society as we ramp up to hundreds of millions,” Pfizer research chief Mikael Dolsten told Reuters in an interview.

Using synthetic mRNA technology can enable the vaccine to be developed and manufactured more quickly than traditional vaccines, the companies said.

Pfizer said last week it expects to make safety data on the vaccine available by late May.

The trial will initially aim to test different dosing regimens of four potential vaccine candidates on around 360 healthy volunteers divided into a younger cohort and a group of seniors.

The trial will expand to more subjects after researchers determine which compounds and dosing regimens are most effective, said Kirsten Lyke, a director at the University of Maryland’s Center for Vaccine Development and Global Health, which is participating in the trial.

Doses have already been administered to some volunteers at NYU Grossman School of Medicine and the University of Maryland School of Medicine.

Pfizer plans to expand the trial to sites across the United States in early July, and may ultimately enroll more than 8,000 participants, a company spokeswoman said.

If successful, the U.S. clinical trial would be one of the fastest ever progressions of a vaccine from early stage studies to regulatory approval, compressing a development process that often takes as much as a decade to just over 9 months.

“This is the equivalent of doing phases one, two and three of a typical clinical trial but all compressed into the May through October time frame,” Lyke said.

BioNTech is producing the vaccine for the trials in its European manufacturing facilities. Pfizer is investing in developing its own manufacturing capacity for the vaccine, and is preparing sites in Massachusetts, Michigan, Missouri and Belgium to begin producing it.

Both companies will jointly commercialize the vaccine, if approved.
https://www.reuters.com/article/us-...n-u-s-coronavirus-vaccine-trial-idUSKBN22H180
 
California-based Gilead Sciences has said it was negotiating long-term voluntary licenses with several generic drugmakers in Pakistan and India to produce experimental COVID-19 drug remdesivir for developing countries.

The drugmaker also said it was in discussions with chemical and drug manufacturers to produce its antiviral drug remdesivir for Europe, Asia and the developing world through at least 2022.

Gilead last week received the US Food and Drug Administration’s emergency use authorisation for using remdesivir as a treatment against COVID-19, the respiratory illness caused by the new coronavirus.

Read also: Remdesivir approved as experimental drug for coronavirus patients

The approval was the latest step in a global push to find viable treatments and a vaccine for the coronavirus.

"It is really a really promising situation," President Donald Trump had said at the White House, where he was joined by Gilead's CEO Daniel O'Day.

"We are humbled with this first step for hospitalised patients," said O'Day, adding: "We want to make sure nothing gets in the way of these patients getting the medicine."

The company has previously announced it was donating some 1.5 million doses for free.

This amounts to about 140,000 treatment courses based on 10-day treatment duration.

Remdesivir, which is administered by an injection, was already available to some patients who enrolled in clinical trials, or who sought it out on a "compassionate use" basis.

Read also: Remdesivir shows 'clear-cut' effect in treating coronavirus, say US officials

The new move allows it to be distributed far more widely and used in both adults and children who are hospitalised with a severe form of COVID-19.

The Food and Drug Administration, which authorised the approval, defines severe as having low blood oxygen levels, requiring oxygen therapy, or being on a ventilator.

In a trial involving more than 1,000 people, the US National Institute of Allergy and Infectious Diseases (NIAID) found that hospitalized COVID-19 patients with respiratory distress got better quicker than those on a placebo.

Specifically, patients on the drug had a 31% faster time to recovery.

"Although the results were clearly positive from a statistically significant standpoint, they were modest," Anthony Fauci, the scientist who leads the NIAID told NBC News.

While not considered a miracle cure, remdesivir's trial achieved a "proof of concept," according to Fauci that could pave the way for better treatments.

Remdesivir incorporates itself into the virus's genome, short-circuiting its replication process.

It was first developed to treat Ebola, a viral hemorrhagic fever, but did not boost survival rates as other medicines.

https://www.geo.tv/latest/286627-gi...produce-experimental-covid-19-drug-remdesivir
 
Triple-drug trial reports hopeful results

Researchers in Hong Kong have revealed positive results from a trial involving a three-drug antiviral cocktail.

A new study, published on Friday in the medial journal The Lancet, said patients with milder forms of Covid-19 appeared to recover faster if they were given the treatment.

The study involved 127 adults, including 86 who were given the combination of three medicines: interferon beta-1b, opinavir-ritonavir and ribavirin.

The authors described the findings as "early but important" and have called for further research, including on more seriously ill patients.

"Our trial demonstrates that early treatment of mild to moderate Covid-19 with a triple combination of antiviral drugs may rapidly suppress the amount of virus in a patient's body," said Kwok-Yung Yuen, who led the research.
 
NEW DELHI: An Indian pharmacist died and his boss was left hospitalised after the pair drank a chemical concoction they had developed in an effort to treat coronavirus, police said Saturday.

The men worked for a herbal medicine company and were testing their treatment — a mix of nitric oxide and sodium nitrate — at a home in southern Chennai city.

K Sivanesan, 47, died on the spot, said local police chief Ashok Kumar.

His colleague Rajkumar was recovering from the poisoning.

Kumar said Sivanesan bought the chemicals from a local market and developed the formula after conducting research on the internet. There are no approved medicines or vaccines for treating COVID-19, triggering a global race for a new drug for the disease that has killed nearly 300,000 people.

Nearly 60,000 cases have been detected in India, which has imposed a drastic nationwide lockdown in an effort to halt the spread of the disease.
 
Arsal_AK said:
This is very very unlikely. A vaccine will be developed sooner rather than later. We have over hundred candidates, a dozen of them in trails. It may not be september, which would be ideal scenario but we will get a vaccine by early next year. It's been done before and there is no reason we can't do it again.
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A vaccine will be developed, but it will take at least a few more months. There has been so much testing, research etc. So surely something will be developed soon.
 
Fauci: Multiple candidates for vaccine being tested

The top US infectious disease specialist, Dr Anthony Fauci, says at least eight potential vaccines are being tested - if successful, one could be available before next year.

"If we are successful, we hope to know that in the late fall [autumn] and early winter," he tells the senate committee hearing, which is titled "Covid-19: Safely Getting Back to Work and Back to School".

Director of the Centers for Disease Control and Prevention (CDC) Robert Redfield says that "rapid testing" must be "widely available", before Americans can safely resume their lives as normal.

On Monday, Trump said all Americans who want a test can get one.

Brett Giroir, an assistant secretary at the Department of Health and Human Services, who is in charge of coronavirus testing, clarified that only Americans who have symptoms of Covid-19 can be tested.

But people without symptoms, who may be carriers of the coronavirus, are still not easily able to access a test.
 
On Tuesday, biopharmaceutical company Moderna announced that the Food and Drug Administration is fast tracking its experimental preventative COVID-19 vaccine through the regulatory process.

The Cambridge, Massachusetts-based company plans to start a phase two trial of the vaccine at the beginning of summer, though they did not announce when the vaccine may be available to consumers.

Moderna has received $500 million in federal cash to back development of the vaccine, according to Forbes.

Fast track is a “process designed to facilitate the development, and expedite the review of drugs to treat serious conditions and fill an unmet medical need,” according to the FDA, doing so by increasing frequency of communication with the FDA, which can approve fast-tracked drugs on priority and rolling bases, if needed.

There is no vaccine or cure for coronavirus, and the vaccine is held up by top experts as the best hope of returning to life pre-COVID-19.

The phase two trial will test the vaccine on “several hundred” volunteers to assess whether it effectively makes them immune to COVID-19; phase one of testing started in Seattle on March 16, according to USA Today.

KEY BACKGROUND

When the genomic makeup of COVID-19 was released by Chinese researchers on January 11, the Moderna team had a vaccine design ready 48 hours later, according to Forbes, and shipped a batch of its first vaccine candidate to the National Institutes of Health 42 days later for a phase one study. Vaccines typically take years to decades to go from design to market. Coronavirus has been an exception—with pharma companies racing alongside governments around the world to develop a vaccine to battle the pandemic.
 
Lovely to see our pharma industry starting to take off


<blockquote class="twitter-tweet"><p lang="en" dir="ltr">Welcome news: "Gilead signed nonexclusive licensing agreements with five generic drug makers operating in India and Pakistan to produce COVID-19 therapy remdesivir for 127 countries." <a href="https://twitter.com/GileadSciences?ref_src=twsrc%5Etfw">@GileadSciences</a> <a href="https://t.co/HNPHZ4Ri0B">https://t.co/HNPHZ4Ri0B</a></p>— Saad B. Omer (@SaadOmer3) <a href="https://twitter.com/SaadOmer3/status/1260475284786200577?ref_src=twsrc%5Etfw">May 13, 2020</a></blockquote> <script async src="https://platform.twitter.com/widgets.js" charset="utf-8"></script>
 
Cuba is betting a biotech sector begun by the late revolutionary leader Fidel Castro can give it an edge in a global race to find effective treatments for the new coronavirus, Reuters reports.

It is especially touting an interferon it produces, a decades old antiviral agent that boosts the immune system. The island nation says the drug has been successful in treating Covid-19 at home and in China, and that 80 countries have already expressed an interest in buying its interferon alpha 2b.

The government is hoping its interferon and other treatments it is developing will provide a lift to its struggling economy, which is subject to a six-decade-old US trade embargo.

“We have good products like interferon alpha 2b that we are exporting and that open possibilities,” the trade minister, Rodrigo Malmierca, said during a recent televised roundtable.

Interferons have long been used internationally to treat dengue fever, cancer and hepatitis B and C. Studies during the Sars epidemic in 2003 suggested interferons might also be useful against coronaviruses.

Interferons can cause serious side effects when administered in their usual forms – injections or infusions – some of which may mirror Covid-19 symptoms, such as fever and breathing difficulty.

Cuba, however, says it has treated nearly all of its patients with interferon injections and credits the medicine for helping it achieve a lower mortality rate among its 1,804 confirmed Covid-19 cases – 4.1% versus an average of 5.9% for the rest of the Americas.

On Wednesday, Cuba reported six new cases of coronavirus and one death.
 
Syed1 said:
Lovely to see our pharma industry starting to take off


<blockquote class="twitter-tweet"><p lang="en" dir="ltr">Welcome news: "Gilead signed nonexclusive licensing agreements with five generic drug makers operating in India and Pakistan to produce COVID-19 therapy remdesivir for 127 countries." <a href="https://twitter.com/GileadSciences?ref_src=twsrc%5Etfw">@GileadSciences</a> <a href="https://t.co/HNPHZ4Ri0B">https://t.co/HNPHZ4Ri0B</a></p>— Saad B. Omer (@SaadOmer3) <a href="https://twitter.com/SaadOmer3/status/1260475284786200577?ref_src=twsrc%5Etfw">May 13, 2020</a></blockquote> <script async src="https://platform.twitter.com/widgets.js" charset="utf-8"></script>
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Ferozsons Laboratories announced on Wednesday that its subsidiary BF Biosciences Ltd (BFBL) has signed a non-exclusive license agreement with Gilead Sciences Inc for manufacturing and selling remdesivir — an experimental antiviral drug that is being used to treat coronavirus patients.

In a notice to the Pakistan Stock Exchange, the company said that Gilead had signed non-exclusive voluntary license agreements with five South Asian manufacturers, including Hetero Drugs, Jubilant Life, Cipla, Mylan and BFBL, to "manufacture remdesivir for distribution in 127 countries".

"Under the agreements, the companies have the right to receive a technology transfer of Gilead's manufacturing process for remdesivir to enable them to scale up production."

The company added that it was "confident" that the subsidiary would produce sufficient quantities of the drug to cater to the needs of Pakistan's Covid-19 patients as well as export it to other countries.

"The BFBL management is actively taking up the matter with the relevant stakeholders for the necessary regulatory approvals and API [active pharmaceutical ingredient] arrangements so that remdesivir is made available to patients on an urgent basis," the notice added.

Remdesivir is an experimental antiviral drug used to treat patients with the coronavirus and was recently approved by the US Food and Drug Administration (FDA).

On May 6, Gilead had said it was in the process of "negotiating long-term voluntary licenses with several generic drugmakers in India and Pakistan to produce remdesivir for developing countries", adding that the company will provide "appropriate technology transfers to facilitate this production".

Last month, Gilead had said the drug had helped improve outcomes for patients with Covid-19, the disease caused by the coronavirus, and provided data suggesting it worked better when given earlier in the course of infection.

A clinical trial of the drug in the United States showed that patients recovered about 30 per cent faster than those on a placebo, in the first proof of successful treatment against the new disease.

However, remdesivir failed in trials against the Ebola virus and a smaller study, released last week by the World Health Organisation, found limited effects among patients in Wuhan, China, where the illness was first detected in December.

https://www.dawn.com/news/1556856/f...or-manufacturing-experimental-drug-remdesivir
 
So four Indian companies.
1 pakistani
And atleast 1 Bangladeshi company will produce remdesivir.

That should mean low cost production and big quantity.
 
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Trump to tap ex-Glaxo exec, U.S. general for coronavirus vaccine effort

President Donald Trump is expected to tap a former GlaxoSmithKline executive and a U.S. general to spearhead the government’s effort at developing a coronavirus vaccine on an accelerated schedule, officially called “Operation Warp Speed,” an administration official said on Wednesday.

The former head of Glaxo’s vaccines division, Moncef Slaoui, will serve as chief adviser on the operation and U.S. General Gustav Perna will act as its chief operating officer. Trump previously said he would be the top boss on the effort to develop, test and produce on a shortened timeline a vaccine against the deadly coronavirus that has caused a global pandemic.

The White House has set a target of having 300 million vaccine doses by the end of 2020. No such vaccine for this pathogen has been approved though a number are under development, and producing and distributing an effective vaccine are seen as key steps to jumpstarting the U.S. economy.

When Slaoui retired nearly three years ago from the drugmaker, its vaccines unit had 15 products in development, including one for Ebola, another killer virus. Slaoui then went on to join Medicxi, a biotech venture capital firm.

https://www.reuters.com/article/us-...-for-coronavirus-vaccine-effort-idUSKBN22P35S
 
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A US pharmaceutical firm has signed agreements with drug makers in South Asia to expand supply of the drug remdesivir for treating Covid-19.

The agreement between Gilead and five generic pharmaceutical companies in India and Pakistan will help make the medicine for 127 countries.

Remdesivir cut the duration of symptoms from 15 days to 11 in clinical trials at hospitals around the world.

The antiviral drug was originally developed as an Ebola treatment.

It works by attacking an enzyme that a virus needs in order to replicate inside our cells.

Under the licensing agreement, the five companies have the "right to receive a technology transfer of the Gilead manufacturing process for remdesivir to enable them to scale up their production quickly", a statement from Gilead said.

The licences would be royalty-free until the World Health Organization (WHO) declares the end of the public health emergency arising out of Covid-19, or until another pharmaceutical product or a vaccine is approved to treat or prevent the disease, the statement said.

The agreements allow the Cipla Limited, Ferozsons Laboratories, Hetero Labs Ltd, Jubilant Lifesciences and Mylan to manufacture the drug.

The managing director of the privately-owned Hyderabad-based Hetero Labs told the BBC that it is "too early" to determine the pricing of the drug and when the manufacture will begin.

"Things will be clearer by June. We anticipate controlled usage [of the drug] through government institutions. Our main aim is that India should be self-sufficient in the drug if India chooses to use it," Vamsi Krishna Bandi said.

The $1bn firm is one of the world's largest producers of anti-retroviral drugs, supplying to nearly five million patients of HIV-Aids. Hetero Labs makes some 300 products at 36 manufacturing facilities worldwide.

Indian medical science and drug control authorities will have to first decide how they want to use the drug on patients.

A senior scientist at the Indian Council of Medical Research (ICMR) has said that it will consider using the drug if Indian firms are able to make it.

"Initial data based on an observational study shows that the drug is effective. We will wait for the results from the WHO solidarity trial and also see if some other companies can work on this to proceed further," Raman Gangakhedkar said.

The clinical trial of remdesivir was run by the US National Institute of Allergy and Infectious Diseases (NIAID) in which 1,063 people took part. Some patients were given the drug while others received a placebo.

D Anthony Fauci who runs the NIAID said: "The data shows remdesivir has a clear-cut, significant, positive effect in diminishing the time to recovery."

He said the results proved "a drug can block this virus" and were "opening the door to the fact that we now have the capability of treating" patients.

The impact on deaths, though, is not as clear-cut. The mortality rate was 8% in people given remdesivir and 11.6% in those given a placebo, but this result was not statistically significant, meaning scientists cannot tell if the difference is real.

The BBC's health and science correspondent James Gallagher says it is also not clear who is benefiting from the drug and poses a few questions.

Is it allowing people who would have recovered anyway to do so more quickly? Or is it preventing people from needing treatment in intensive care? Did the drug work better in younger or older people? Or those with or without other diseases? Do patients have to be treated early when the virus is thought to peak in the body?

These will be important factors when the full details are eventually published, our correspondent says.

https://www.bbc.com/news/world-asia-india-52659052
 
World leaders demand free coronavirus vaccine for all

World leaders past and present have insisted that any eventual COVID-19 vaccines and treatments should be made available to everyone, free of charge.

South African President Cyril Ramaphosa and Pakistani Prime Minister Imran Khan were among more than 140 signatories of an open letter to the World Health Assembly saying any vaccine should not be patented while the science should be shared between nations.

"Governments and international partners must unite around a global guarantee which ensures that, when a safe and effective vaccine is developed, it is produced rapidly at scale and made available for all people, in all countries, free of charge," the letter said.
 
Coronavirus vaccine could be ready in a year: EU agency

A vaccine for the coronavirus could be ready in a year's time under an "optimistic" scenario, based on data from trials that are under way, the European Medicines Agency said.

"We can see the possibility if everything goes as planned that some of them (vaccines) could be ready for approval in a year from now," Marco Cavaleri, the EMA's head of biological health threats and vaccines strategy, told a video news conference.

Cavaleri said he was, however, "a bit sceptical" about reports that a vaccine could be ready as soon as September.
 
This timescale for producing a vaccine is unprecedented. It takes years going through safety and efficacy tests.

However what helped is that much of the background work was done already after the SARS and MERS outbreaks.

Hopefully no corners are being cut despite the urgency of the situation. Patient safety must never be compromised.
 
Seen a few questions where people are asking whether we'll need an annual COVID-19 shot like we have annual flu shots.

The influenza virus mutates frequently hence why annual vaccinations are necessary in at risk group. However the COVID-19 virus is still being researched and it's not certain how quickly this virus mutates.
 
<blockquote class="twitter-tweet"><p lang="en" dir="ltr">Prime Minister <a href="https://twitter.com/ImranKhanPTI?ref_src=twsrc%5Etfw">@ImranKhanPTI</a> has joined the World leaders in a call for “People’s Vaccine against COVID19” demanding that once a Vaccine is created, it must be made available to all the people, in all countries, free of charge<a href="https://twitter.com/UNAIDS?ref_src=twsrc%5Etfw">@UNAIDS</a> <a href="https://twitter.com/hashtag/COVID19?src=hash&ref_src=twsrc%5Etfw">#COVID19</a> <a href="https://t.co/E2QUijTm9T">pic.twitter.com/E2QUijTm9T</a></p>— Prime Minister's Office, Pakistan (@PakPMO) <a href="https://twitter.com/PakPMO/status/1260941900560969733?ref_src=twsrc%5Etfw">May 14, 2020</a></blockquote> <script async src="https://platform.twitter.com/widgets.js" charset="utf-8"></script>
 
Markhor said:
Seen a few questions where people are asking whether we'll need an annual COVID-19 shot like we have annual flu shots.

The influenza virus mutates frequently hence why annual vaccinations are necessary in at risk group. However the COVID-19 virus is still being researched and it's not certain how quickly this virus mutates.
Click to expand...

Other question.

Would you be first in line for this vaccine? or will you let a few million take it to see if there are any potential side-effects that scientists didnt know about?
 
French backlash mounts over Sanofi vaccine research

France's prime minister and president have weighed into a vaccine row prompted by remarks made by the British chief executive of French drugs giant Sanofi.

Paul Hudson infuriated French political leaders when he said on Wednesday that if Sanofi developed a vaccine then the "US government has the right to the largest pre-order because it's invested in taking the risk".

The French pharmaceutical giant is based in ParisImage caption: The French pharmaceutical giant is based in Paris
Sanofi has received funding from the US health department's biomedical research arm Barda reputed to be worth some $30m (£25m). It's working with UK pharmaceutical giant GlaxoSmithKline on one of a number of vaccine projects around the world.

But it also gets an estimated €150m ($162m;£133m) in annual tax credits from the French government. So Prime Minister Edouard Philippe has hit back insisting that equal access for all to any eventual vaccine is "non-negotiable". And President Macron has insisted no vaccine should be subject to market forces.

Sanofi's head in France, Olivier Bogillot, said on Thursday the aim was to have a vaccine in the US and Europe "at the same time" and Paul Hudson has now apologised for sparking the row.
 
LONDON (Reuters) - Britain has given the green light to Abbott Laboratories (ABT.N) to produce a COVID-19 antibody test, shortly after it gave the same approval to Swiss drugmaker Roche Holding (ROG.S), health officials said on Friday.

Mass antibody testing with millions of kits is being considered by many countries as a way to speed the reopening of economies devastated by lockdowns and to introduce more tailored social distancing measures.

==

LONDON (Reuters) - Britain is in talks with Swiss drugmaker Roche Holding AG to buy an accurate COVID-19 antibody test, following the lead of the European Union and United States which have already given preliminary approval to the tests.

Mass antibody testing with millions of kits is being considered by many countries as a way to speed the reopening of economies devastated by lockdowns and to introduce more tailored social distancing measures.

Tests carried out by Public Health England at Porton Down, a laboratory that provides sensitive and specialist scientific services to the government, concluded on May 7 that the Roche test detected the exact antibodies prompted by the virus. The findings were only made public late on Wednesday.

“This is a good test that will stand us in good stead, moving forwards, and I think it will be incredibly important as the days, weeks and months go by,” said Jonathan Van-Tam, the government’s deputy chief medical officer.

“I anticipate that it will be rapidly rolled out in the days and weeks to come, as soon as it is practical to do so. I also anticipate that the focus will be on the National Health Service and on carers in the first instance,” he told a news briefing.

Van-Tam cautioned, however, that scientists still had limited understanding of whether antibodies provided immunity, to what extent and for how long.

A spokesman for Prime Minister Boris Johnson said the test was an important breakthrough which had the potential to be a game-changer.

The spokesman said there was the possibility of issuing some kind of certificate based on immunity but that scientists still needed to know more about that subject area.

The Roche test received a conformity assessment, known as Conformité Européenne, or CE mark, from the European Union on April 28 and received Emergency Use Authorization from the U.S. Food and Drug Administration on May 2.

Roche said it was able to produce hundreds of thousands of the tests per week for the United Kingdom. Germany is getting 3 million of them this month, and 5 million a month after June.

The Daily Telegraph newspaper, which first reported the findings, said the government was in negotiations with Roche to buy millions of kits.

Transport Minister Grant Shapps was asked at the government’s daily news briefing whether there was any exclusive deal between Roche and the United Kingdom.

“Of course we’ll want to get as many tests as possible - we’ve never restricted ourselves with that regard,” Shapps said, describing the approval of the Roche test as “very exciting”.

The antibody tests - also known as a serology test - show who has been infected, although it is not yet clear whether the presence of antibodies to the new coronavirus, SARS-CoV-2, confers permanent immunity.

They require a blood test that can be run on fully-automated equipment in laboratories to provide results in just 18 minutes.

Britain’s health ministry did not answer questions about how many tests it would order.

“We are exploring the use of antibody testing across the NHS and ultimately the wider public,” a ministry spokesman said, adding that the government was “actively working on our plans for rolling out antibody testing”.

Similar antibody tests have also been developed by companies including U.S.-based Abbott Laboratories and Italy’s DiaSorin. Abbott and Germany’s Siemens Healthineers have separately laid out plans to produce 20 million tests or more per month for the global market from June.

Based in Basel, Switzerland, Roche said it is ramping up capacity to produce high double-digit millions of tests per month to serve countries accepting the CE mark and the United States.

Switzerland is nonetheless circumspect about the value of antibody testing in helping craft a strategy to ease restrictions.

Instead, Switzerland is counting on a plan that includes trimming new infections to manageable levels, testing everybody who is symptomatic for active infections, and rigorous contact tracing to find those who may have come into contact with infected individuals.

“The government up to now has not bought any antibody tests,” a Federal Health Ministry spokesman told Reuters. “Their ability to inform us remains simply too uncertain for them to be part of an easing strategy.”
 
Coronavirus vaccine: Macaque monkey trial offers hope

A vaccine against coronavirus appears to have provided protection against the disease Covid-19 in six rhesus macaque monkeys.

It gives early hope for the vaccine, which is now undergoing human clinical trials.

There is no guarantee this result will translate to people, though.

The animals who had been given the vaccine, and were then exposed to SARS-CoV-2, had less of the virus in their lungs and airways.

That's compared with the control group of monkeys which was not given the vaccine.

The trial took place in the US, involving researchers from the US government's National Institutes of Health (NIH) and from the University of Oxford.

The vaccine appeared to protect the animals against developing pneumonia.

Rhesus macaques have similar immune systems to humans.

Promisingly, they also didn't develop "immune-enhanced disease" - which BBC medical correspondent Fergus Walsh describes as a "theoretical risk". That's when the vaccine triggers a worse response to a disease.

This response was seen in some early animal vaccine trials against SARS - another coronavirus - and proved a stumbling block in developing a vaccine for that disease.

The study hasn't yet been reviewed by other scientists and formally published, but Prof Stephen Evans at the London School of Hygiene and Tropical Medicine, described it as "high quality" and "very encouraging".

Meanwhile, trials in the UK on more than 1,000 human volunteers are currently taking place through the University of Oxford.

There are more than 100 experimental coronavirus vaccines currently being developed.

Dr Penny Ward, a visiting professor in pharmaceutical medicine at King's College London, said it was "helpful" to see that the vaccine didn't cause a worse disease response in these monkeys, and that they didn't develop pneumonia after being vaccinated.

The vaccine is based on a small part of the virus's distinctive "spike". The idea is that by getting the body to recognise a unique part of the virus, when it is exposed to the whole thing it will know how to react, and produce the right antibodies to fight it off.

That did seem to be happening to the vaccinated macaques, which produced antibodies capable of fighting the virus.

https://www.bbc.com/news/health-52674739
 
Two health advocacy groups have written to the Indian government asking it to rescind patents given to Gilead Sciences for the drug remdesivir so it can be distributed more fairly to coronavirus patients around the world, particularly in poorer nations.

Drug patents in India are an important issue as many countries depend on generic drugmakers to manufacture and sell cheaper versions of critical drugs to them. Gilead's three patents in India for remdesivir stem from 2009, when the drug was in development to treat Ebola.

Remdesivir is the only drug approved to treat COVID-19 after promising early trial results prompted United States regulators to grant emergency use authorisation on May 2.

To expand its access, Gilead said this week that it had signed nonexclusive licensing pacts with five generic drugmakers based in India and Pakistan, allowing them to make and sell remdesivir for 127 countries.

But health access groups say the pacts mean cheaper forms of the drug may not become available in nations seen as nonprofitable to the five drugmakers.

"The licences divide the global market into two, and profitable markets are retained with Gilead and less profitable markets are given to the five generic companies," said K Gopakumar, senior legal researcher at Third World Network, which sent a letter to the Indian government on Wednesday.

The letter by Third World Network, a Malaysia-based non-profit group, followed a similar appeal by India's Cancer Patients Aid Association last week.

The aid group Doctors Without Borders (Medecins Sans Frontieres, or MSF) has also opposed Gilead's patents on remdesivir, saying such licensing pacts are "not acceptable" amid a global health emergency.

Gilead's patents on remdesivir in India allow it to exclusively make and sell the drug in the country until 2035 unless it licenses those rights out.

A Gilead spokeswoman told Reuters in an email that the company is "actively considering every potential pathway" to make the drug available to those who need it as fast as possible.

She said the company was in talks with the United Nations-backed Medicines Patent Pool and the United Nations Children's Fund to expand access to it.'

"Compulsory licensing will not solve the challenge of limited supply," the spokeswoman said, referring to a provision under which countries can allow manufacturers to make certain drugs without the patent owner's consent.

India's commerce and health ministries did not immediately respond to emails seeking comment.

Cancer Patients Aid Association said it might pursue legal action, noting that cancer patients have compromised immunity and are highly susceptible to the virus.

"It is imperative at a time like this that no monopoly rights be granted, so that more manufacturers can produce the drug to be made available to all the people who need it, at affordable costs," it said.

Except for remdesivir, there are currently no other drugs or vaccines approved to fight coronavirus, which has killed nearly 300,000 people globally.

https://www.aljazeera.com/ajimpact/...ead-covid-19-drug-patent-200514163450703.html
 
US to stockpile vaccine candidates as trials continue: Health secretary

The US government plans to stockpile hundreds of millions of doses of vaccines that are under development to combat the novel coronavirus with the goal of having one or more vaccines ready to deploy by the end of the year, the health secretary has said.

"We've got over 100 vaccine candidates that have been discovered," Health and Human Services Secretary Alex Azar told Fox Business Network.

"What we're doing now is we're narrowing those down to the core group that we're going to place huge multi-hundred million dollar bets on and scale massive vaccine domestic production so that we by the end of the year, we hope, would have one or more safe and effective vaccines and hundreds of millions of doses."
 
Markhor said:
Seen a few questions where people are asking whether we'll need an annual COVID-19 shot like we have annual flu shots.

The influenza virus mutates frequently hence why annual vaccinations are necessary in at risk group. However the COVID-19 virus is still being researched and it's not certain how quickly this virus mutates.
Click to expand...

Rna virus has high probability of mutation from what I have read.( not necessarily deadlier)

Another issue is eventhough Polio is a RNA virus, no RNA vaccine is currently in use , if Moderna’s vaccine works it might be the first.( and may help influenza , not sure)
 
Canadian Prime Minister Justin Trudeau says his government has approved the first clinical trials in the country of a potential vaccine for corornavirus.

He told reporters the trials would be held at the Canadian Centre for Vaccinology at Dalhousie University, in Nova Scotia.

Trudeau did not reveal who was developing the vaccine, but said that if trials were successful, the National Research Council of Canada would assist production and distribution.

Canada has reported over 75,000 cases of coronavirus, along with 5,595 virus-related deaths.
 
Trump selects Muslim American to hunt for vaccine as global research intensifies

US President Donald Trump has selected Muslim American Moncef Mohamed Slaoui to head a fast-track programme called for finding a vaccine for Covid-19.

“Operation Warp Speed’s chief scientist will be Dr Moncef Slaoui, a world-renowned immunologist who helped create 14 new vaccines,” President Trump announced at a White House news briefing on Friday afternoon. “That’s a lot of our new vaccines — in 10 years, during his time in the private sector,” he added.

Born in 1959 in Agadir, Morocco, Dr Slaoui headed GlaxoSmithKline’s vaccines department, and worked for the company for thirty years.
 
The British government will invest up to £93m to bring forward construction of a new vaccine manufacturing centre, PA media reports.

The funding will ensure the new centre opens in summer 2021, a year ahead of schedule. The Vaccines Manufacturing and Innovation Centre (VMIC) is a key component of the UK government’s programme to ensure that once a coronavirus vaccine is available, it can be rolled out quickly in mass quantities, according to the Department for Business, Energy and Industrial Strategy.

The not-for-profit facility on the Harwell science and innovation campus in Oxfordshire will have the capacity to produce enough doses for the entire UK population in as little as six months.
 
Plans are in place to roll out a COVID-19 vaccine to 30 million people by September if trials are successful, Business Secretary Alok Sharma has said.

It comes as the UK announced a further 170 deaths of people with coronavirus - the lowest since the day after lockdown began.

Speaking at Sunday's Downing Street news conference, which was delayed due to technical difficulties, the cabinet minister said work by the University of Oxford to find an effective drug was "progressing well".

But while pointing out the government had now committed more than a quarter of a billion pounds towards developing a COVID-19 vaccine in the UK, Mr Sharma warned there was no certainty one would ever be found.

Mr Sharma said: "In order to definitively conquer this disease we need to find a safe, workable vaccine.

"Last month I announced a new vaccine task force to co-ordinate the efforts of government, academia and industry in the critical mission to find a vaccine.

"I'm very proud of how quickly our scientists and researchers have come together in their efforts developing a vaccine that will combat coronavirus."

https://news.sky.com/story/coronavi...tember-if-trial-succeeds-says-sharma-11990039
 
The head of the European Union’s medicines agency, Guido Rasi, has said initial authorisation for remdesivir as a Covid-19 treatment could be granted in coming days

“It might be that a conditional market authorisation can be issued in the coming days,” Rasi told a hearing in the EU parliament in Brussels.

The European Medicines Agency has already recommended the compassionate use of US pharmaceutical company Gilead’s remdesivir, which allows a drug to be administered to patients even before it has been fully authorised
 
MenInG said:
Other question.

Would you be first in line for this vaccine? or will you let a few million take it to see if there are any potential side-effects that scientists didnt know about?
Click to expand...

Yes, but it's not going to be given to me first unless I volunteer and I don't think I can here.

The first million doses will be for health care workers, first responders and then high risk people like those working in supermarkets etc. Then students going back to universities and schools etc. I will take it as I am currently studying at this stage if its not available before.
This is how it should and will be rolled out. We will have ample data by then for rolling out to general public.

What people don't realize is by doing this we will cut the legs of the virus. If you can stop clusters from emerging, then the outbreak falls dramatically.

JaDed said:
Rna virus has high probability of mutation from what I have read.( not necessarily deadlier)

Another issue is eventhough Polio is a RNA virus, no RNA vaccine is currently in use , if Moderna’s vaccine works it might be the first.( and may help influenza , not sure)
Click to expand...

Not this one, it has a self correcting gene which limits the mutations it can have.

On mRNA vaccines, yeah none is in use but the technology is super safe and easy to scale up. They need to show efficacy, if they can do that it will be good news. Still will take longer than other candidates like the Oxford vaccine to come out because it is a new technology.
 
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In race to COVID-19 drugs, EU may fast track remdesivir sale before U.S

BRUSSELS (Reuters) - The European Union may give an initial green light in the coming days for sale of the drug remdesivir as a COVID-19 treatment, the head of its medicines agency said on Monday, fast-tracking the drug to market amid tight global competition for resources.

The United States, which has angered the EU with aggressive tactics in a procurement race during the global pandemic, has yet to issue a similar approval for the drug, made by U.S. pharmaceutical company Gilead (GILD.O).

Demand for remdesivir has been growing as there are currently no approved treatments or vaccines for COVID-19, the respiratory illness caused by the new coronavirus.

“It might be that a conditional market(ing) authorisation can be issued in the coming days,” the head of the European Union’s medicines agency Guido Rasi said on Monday at a hearing in the EU Parliament in Brussels.

An EU conditional marketing authorisation allows a drug to be sold for a year in the 27-nation bloc before all necessary data are available on its efficacy and side effects.

The European Medicines Agency (EMA) has already recommended the compassionate use of remdesivir, which allows a drug to be administered to patients even before its sale has been authorised.

EMA’s recommendation on compassionate use matched an emergency authorisation granted by the U.S. Food and Drug Administration (FDA) earlier in May, after Gilead provided data showing the drug had helped COVID-19 patients.

But the EU is now moving rapidly to the next step in the authorisation procedure.

The equivalent procedure in the U.S. is called “accelerated approval”, as opposed to the standard authorisation that the FDA grants to medicines which pass all tests before their marketing.

As pressure mounts to ramp up production of the drug, Gilead has said it was in discussions with chemical and drug manufacturers to produce remdesivir for Europe and Asia until at least 2022.

The company is also negotiating long-term licenses with several generic drugmakers in India and Pakistan to produce remdesivir for developing countries.

But it is still unclear how soon sufficient amounts of the drug could be available to meet the world’s need for a treatment.

Apart from remdesivir, Rasi said other possible treatments against COVID-19 that may be available quickly are those based on monoclonal antibodies, which can “neutralise” the new coronavirus that causes COVID-19.

He also warned that Europe could face shortages of a COVID-19 vaccine if it were developed in a year’s time, echoing concerns raised by EU health ministers and officials earlier in May.

Because the vaccine could be developed outside of the EU, and the bloc’s production capacity may be insufficient to meet all needs, he said the EU should have a common strategy to deliver shots first to people most in need, such as medics and nurses.
https://uk.reuters.com/article/uk-h...rack-remdesivir-sale-before-u-s-idUKKBN22U0WJ
 
The first hints that a vaccine can train people's immune system to fight coronavirus have been reported by a company in the US.

Moderna said neutralising antibodies were found in the first eight people who took part in their safety trials. It also said the immune response was similar to people infected with the actual virus.

Larger trials to see whether the jab actually protects against infection are expected to start in July.

Work on a coronavirus vaccine has been taking place at unprecedented speed, with around 80 groups around the world working on them.

A vaccine would provide some protection by training people's immune systems to fight the virus so they should not become sick. This would allow lockdowns to be lifted more safely, and social distancing to be relaxed.
 
Shock as Trump reveals hydroxychloroquine use

President Trump's announcement that he has been taking hydroxychloroquine - a malaria drug - to stave off the coronavirus has caused a flurry of shock, surprise and in some instances - horror.

Scientists have said there is no definitive evidence the drug works when used in treatment of patients with Covid-19. There are also risks of serious side effects, including renal and liver damage.

"I'm a scientist. I don't care about your political preferences but please don't take hydroxychloroquine. It's quite harmful and statistically is not likely to help you recover from Covid-19," said one person on Twitter.

Following Mr Trump's reference to the drugs in late March, there was a sharp increase reported in prescriptions in the US for both chloroquine and hydrochloroquine, although demand has since declined.
 
Thailand says it expects vaccine next year after tests in mice

Thailand expects to have a coronavirus vaccine ready next year, a senior official said, after finding positive trial results in mice.

Thailand will begin testing the mRNA (messenger RNA) vaccine in monkeys next week after successful trials in mice, said Taweesin Wisanuyothin, spokesman for the government's Centre for COVID-19 Situation Administration.

"The Thai vaccine is expected to be used next year,” he said.

The Thai vaccine is being developed by the National Vaccine Institute, the Department of Medical Science and Chulalongkorn University’s vaccine research centre.
 
Monkey studies encouraging for coronavirus vaccine

Two studies in monkeys offer some of the first scientific evidence that surviving COVID-19 may result in immunity from reinfection, as well as a positive sign that vaccines under development may succeed.

In one of the new studies, researchers infected nine monkeys with the new coronavirus. After they recovered, the team exposed them to the virus again and the animals did not get sick.

In the second study, the same researchers treated 25 monkeys with experimental vaccines and then exposed them to the coronavirus. In the vaccinated animals, "we saw a substantial degree of protection," said Dr Dan Barouch.
 
UK begins hydroxychloroquine trial

A trial to see whether two anti-malarial drugs could prevent Covid-19 has begun in Brighton and Oxford.

Chloroquine, hydroxychloroquine or a placebo will be given to more than 40,000 healthcare workers from Europe, Africa, Asia and South America.

All the participants are staff who are in contact with Covid-19 patients.

"We really do not know if chloroquine or hydroxychloroquine are beneficial or harmful against Covid-19," said one of the study's leaders, Prof Nicholas White.

But, he said, a randomised controlled trial such as this one, where neither the participant nor the researchers know who has been given the drug or a placebo, was the best way to find out.

It comes after US President Donald Trump said earlier this week that he had been taking the controversial drug, despite warnings that it could be unsafe.
 
Top HIV scientist says he wouldn't count on a vaccine for coronavirus soon

A top US scientist said on Wednesday that governments should not count on a successful vaccine against Covid-19 being developed anytime soon when deciding whether to ease restrictions imposed to curb the pandemic.

William Haseltine, a groundbreaking researcher of cancer, HIV/AIDS and human genome projects, said the better approach now is to manage the disease through careful tracing of infections and strict isolation measures whenever it starts spreading.

While a Covid-19 vaccine could be developed, he said, “I wouldn’t count on it.”

Vaccines developed previously for other types of coronavirus had failed to protect mucous membranes in the nose where the virus typically enters the body, he said.

Even without an effective treatment or vaccine, the virus can be controlled by identifying infections, finding people who have been exposed and isolating them, he said. He urged people to wear masks, wash hands, clean surfaces and keep a distance.

He said China and some other Asian countries used that strategy successfully, while the United States and other countries did not do enough to “forcibly isolate” all who were exposed to the virus.

China, South Korea and Taiwan have done the best at curbing infections, he said, while the United States, Russia and Brazil have done the worst.

Tests on animals of experimental Covid-19 vaccines had been able to reduce the viral load in organs like lungs although the infections remained, he said.

For treatment, patients have been getting antibody-rich plasma donated by people who recovered from Covid-19, and drugmakers are at work producing refined and concentrated versions of that serum.

Known as hyperimmune globulin, those products are “where the first real treatments are going to be,” he said, predicting success also with research into monoclonal antibodies that home in on and neutralise the ability of the virus to enter human cells.
https://www.dawn.com/news/1558698/t...uldnt-count-on-a-vaccine-for-coronavirus-soon
 
<blockquote class="twitter-tweet" data-lang="en"><p lang="en" dir="ltr">Scientists say the first treatment for coronavirus could be ready by next month &#55357;&#56458; <a href="https://t.co/LCkhMKl7n6">https://t.co/LCkhMKl7n6</a></p>— The Telegraph (@Telegraph) <a href="https://twitter.com/Telegraph/status/1263534110246670336?ref_src=twsrc%5Etfw">May 21, 2020</a></blockquote>
<script async src="https://platform.twitter.com/widgets.js" charset="utf-8"></script>
 
Bangladesh-based Beximco Pharmaceuticals has become the world’s first company to produce a generic version of the antiviral drug remdesivir, originally developed by US-based Gilead Sciences.

Remdesivir was originally designed as an Ebola treatment. It works by attacking an enzyme that a virus needs in order to replicate inside our cells.

A recent clinical trial in the US showed the drug helped shorten the recovery time for people who were seriously ill.

However, it did not significantly improve survival rates. Experts have warned that the drug should not be seen as a "magic bullet" for coronavirus.

But in the absence of any clear treatment for Covid-19, many countries are willing to try remdesivir.

Beximco's production of the generic version will ensure quick supply of the drug to many countries in the South Asia.

Unconfirmed reports say that Beximco is likely to find manufacturing partners in India and Pakistan as well.
 
Malaria drug touted by Trump tied to increased risk of death: study

The Malaria drug hydroxychloroquine, which US President Donald Trump says he has been taking, was tied to increased risk of death in a study in 96,000 COVID-19 patients, according to a paper published in the Lancet.

The study found that people treated with hydroxychloroquine, or the closely related drug chloroquine, had higher risk of in-hospital death when compared to those who had not been given the drug.
 
A study of nearly 100,000 coronavirus patients has shown no benefit in treating them with anti-viral drugs hydroxychloroquine and chloroquine.

According to the new study, published on Friday in The Lancet, the drugs actually increased the likelihood of patients with Covid-19 dying in hospital.

Hydroxychloroquine is normally used to treat arthritis but pronouncement from public figures including the US president, Donald Trump, who announced this week he is taking the drug, has prompted governments to bulk buy the medicine.

Chloroquine is an anti-malarial. Both drugs can produce potentially serious side effects, particularly heart arrhythmia.

“Treatment with chloroquine or hydroxychloroquine does not benefit patients with COVID-19,” said Mandeep Mehra, lead author of the study and executive director of the Brigham and Women’s Hospital Center for Advanced Heart Disease in Boston.

“Instead, our findings suggest it may be associated with an increased risk of serious heart problems and increased risk of death.”

The authors estimated that the drugs put patients at up to 45% higher risk of dying from COVID-19 compared with underlying health issues.
 
How one Indian company could be world's door to a COVID-19 vaccine

If the world is to gain access to a vaccine for COVID-19, there’s a good chance it will pass through the doors of Serum Institute of India.

Serum Institute, the world’s largest manufacturer of vaccines by volume, is working on several candidates for the novel coronavirus - including potentially mass-producing the AstraZeneca/Oxford university one that has garnered global headlines - as well as developing its own.

The efforts are partly being shepherded by Umesh Shaligram, the head of research and development. His employer is a private company but every day, shortly before midnight, he receives a WhatsApp message from the government asking for updates, and about any new hurdles he faces.

The message is usually from K. VijayRaghavan, Prime Minister Narendra Modi’s top scientific adviser - an indication of the critical, and even strategically important, nature of the race to develop the vaccines the whole world is waiting for.

Shaligram promptly responds with a progress report and details any bottlenecks.

“Any delays, you just tell them,” said Shaligram, adding the government has been doing everything it can to fast-track clearances, and resolve import delays and other issues.

“We have begun to see approvals come through in days, even on a Sunday night, for trials and things like that,” he said, noting some of these processes typically took 4 to 6 months.

While most of the attention regarding vaccines typically goes to the pharmaceutical developer, India quietly plays a key role in manufacturing 60%-70% of all vaccines sold globally with the Serum Institute playing a lead role, said the company’s Chief Executive Adar Poonawalla.

At the company’s sprawling, 150-acre campus in the western Indian city of Pune, Shaligram and his team are working flat-out. Dozens of buses ferry in hundreds of workers each day to the grounds, which are buzzing with activity even as the city around it remains largely under lockdown.

The push comes as the number of cases of COVID-19, both globally and domestically, continue to surge and world leaders look to vaccines as the only real way to restart their stalled economies, even though none have yet been proven to be effective against the coronavirus.

Poonawalla, whose family owns he vaccine maker, said scientists, drugmakers and manufacturers were collaborating at an unparalleled scale to spur development and availability.

“We are all in a race to battle the disease, there is no one-upmanship here,” he told Reuters, sitting in his office beside his family’s 74-year-old stud farm.

VACCINE CANDIDATES
Serum, founded in 1966 by Adar’s father Cyrus Poonawalla, has partnered with U.S. biotech firm Codagenix, its U.S. rival Novavax (NVAX.O) and Austria’s Themis to potentially manufacture three COVID-19 vaccine candidates that are still in development.

Another candidate in the works is the experimental vaccine developed by a team at the University of Oxford and now licensed to drugmaker AstraZeneca (AZN.L), with whom Serum are in talks to mass produce the vaccine, which is now in the clinical trial stage.

The United States has secured almost a third of the first 1 billion doses planned for the potential vaccine, initially known as ChAdOx1 and now as AZD1222, by pledging up to $1.2 billion.

Poonawalla aims to initially produce 4-5 million doses a month, beginning from June, and then gradually ramp up to 350-400 million doses a year.

“Hopefully we will build a stock of a few million doses to give to our country and other high-risk areas across the globe come October-November when the trials ought to be concluded,” the 39-year-old said, while giving Reuters rare access to tour his facilities.

He added he had been given to understand by the development team that the trials had an 80% chance of success, given that the vaccine is based on a tried-and-tested platform.

Based on the information currently available, Poonawalla also said he anticipated AZD1222 would be a single-dose vaccine and not require a booster dose.

He sees AZD1222 potentially priced at about 1,000 rupees ($13) per dose in India, but expects it will be procured and distributed by governments without charge.

Serum is also working on developing its own in-house vaccine options to tackle the disease, Poonawalla said.

VIALS, TUBES, CHEMICALS
Even if a vaccine does succeed, a treatment to fight COVID-19 would still be required, said Poonawalla, noting some people do not get the desired immune response, even if vaccinated.

“You may get mild symptoms, you may get severe symptoms. It depends on your system, but there is a chance,” he added. “Not all vaccines are fully effective.”

The Serum Institute produces more than 1.5 billion doses of vaccines every year, for everything from polio to measles.

Poonawalla says that gave the company an edge in securing supplies of vials and high-quality chemicals required to make a vaccine in bulk once all approvals are in place.

“We have partnered with many of our suppliers to have one to two-year inventories of glass vials and tubing glass stocked in advance, so luckily for us that won’t be an issue.”

Slideshow (4 Images)
Any successful vaccine is however bound to be in short supply at first, he stressed.

India recorded more than 6,000 new cases of the coronavirus on Friday, bringing its total to over 118,000 cases with more than 3,500 deaths, even as it gradually begins to ease its nearly two-month long nationwide lockdown.

There have been more than 5 million infections and over 330,000 deaths reported worldwide.

The Indian government stands ready to cover the costs of trials of any vaccine in the country, said Poonawalla, adding that the government had also expressed interest in placing advance orders for a potential vaccine.

“We’ve reached out and they have been very positive,” he added. “But we’ve said hold on ... as we don’t want to take government money until we are very confident we can deliver.”

UNLOCKING VALUE IN THE ‘HYPE’
Serum, one of the few companies ramping up hiring during the health crisis, is also designing a separate facility to make vaccines for pandemic-level diseases that could handle 90% of the current vaccine candidates being developed, beyond just the COVID-19 ones.

That facility, which will be ready in the next two to three years, would be able to potentially churn out 700-800 million doses a year, according to Poonawalla.

The CEO said he considered taking the company public some years ago to fund some large acquisitions, but changed course when the deals fell through.

Now he’s considering a different approach. He is exploring creating a holding entity that will host the company’s pandemic-level technologies, including manufacturing rights, intellectual property and the sale of all of Serum’s COVID-19-related candidates, and selling a minority stake in the venture.

“That will unlock value in the main hype,” he said.

Poonawalla said he had engaged bankers to test the waters on this, but stressed he would only consider selling a stake to ethical, long-term funds or sovereign funds that do not expect huge returns and want to “make a difference to the world”.

“After getting them onboard, I don’t want to be in a situation where I have to charge high prices to give them returns.”
https://www.reuters.com/article/us-...rlds-door-to-a-covid-19-vaccine-idUSKBN22Y2BI
 
Anti-viral drug remdesivir cuts recovery times in coronavirus patients.

Complete results from the research, which was carried out by US government agency the National Institute of Allergy and Infectious Diseases (NIAID), were published by leading medical periodical the New England Journal of Medicine.

The United States authorized the emergency use of remdesivir in hospitals on May 1, followed by Japan, while Europe is considering following suit.

The study found that remdesivir, injected intravenously daily for 10 days, accelerated the recovery of hospitalized COVID-19 patients compared to a placebo in clinical tests on just over a thousand patients across 10 countries.

NIAID director Anthony Fauci has said preliminary evidence indicated remdesivir had a "clear-cut, significant and positive effect in diminishing the time to recovery".
 
Project leader: Oxford's COVID-19 vaccine trial has 50% chance of success - Telegraph

The University of Oxford's COVID-19 vaccine trial has only a 50% chance of success as the coronavirus seems to be fading rapidly in Britain, the professor co-leading the development of the vaccine told the Telegraph newspaper bit.ly/2LQTNos.

Adrian Hill, director of Oxford’s Jenner Institute, which has teamed up with drugmaker AstraZeneca Plc to develop the vaccine, said that an upcoming trial, involving 10,000 volunteers, threatened to return “no result” due to low transmission of COVID-19 in the community.

“It’s a race against the virus disappearing, and against time”, Hill told the British newspaper. “At the moment, there’s a 50% chance that we get no result at all.”

The experimental vaccine, known as ChAdOx1 nCoV-19, is one of the front-runners in the global race to provide protection against the new coronavirus causing the COVID-19 pandemic.

Hill’s team began early-stage human trials of the vaccine in April, making it one of only a handful to have reached that milestone.

https://uk.reuters.com/article/us-h...-50-chance-of-success-telegraph-idUKKBN22Z0XC
 
The World Health Organization (WHO) has temporarily suspended testing of the malaria drug hydroxychloroquine in COVID-19 patients due to safety concerns, WHO Director-General Tedros Adhanom Ghebreyesus said during a news conference on Monday.

Meanwhile, Mike Ryan, head of the WHO emergencies programme, warned in the same virtual news conference that, despite countries easing lockdowns, the world is "right in the middle of the first wave" of the outbreak, and a there could be a second peak within the wave.

The statements come days after US President Donald Trump announced he had been taking hydroxychloroquine as a preventive measure against the virus. The president, who has said he has since stopped taking the drug, had long touted its benefits as a possible treatment for COVID-19, the disease caused by the novel coronavirus, even as health experts warned it might not be safe.

"The executive group has implemented a temporary pause of the hydroxychloroquine arm within the Solidarity trial while the safety data is reviewed by the data safety monitoring board," Tedros said in the online briefing.

The WHO had previously recommended against using hydroxychloroquine to treat or prevent coronavirus infections, except as part of clinical trials.

Ryan added the decision to suspend trials of hydroxychloroquine had been taken out of "an abundance of caution".

Other arms of the WHO's so-called "Solidarity Trial" - a large international initiative to hold clinical tests of potential treatments for the virus - would continue, the officials said.

No date for China mission
The WHO's Ryan also told reporters on Monday that he has been in daily discussions with China on the origins of the coronavirus, but said there was still currently no date set for a scientific mission to the country.

The US and Australia have been the most vocal proponents of such an investigation, and have accused Beijing of not being transparent.

Trump and other US officials have also pushed the theory in recent weeks that the virus emerged from a lab in Wuhan, the Chinese city where the outbreak began. China has strongly denied the claims, but said it would be open to an independent examination after the pandemic has been brought under control worldwide.

During last week's World Health Assembly, member states passed a resolution calling for a probe into the international response to the pandemic, an intentionally broad mission which would include examinations of the responses of individual countries and the WHO.

To date, more than 5.4 million infections have been confirmed worldwide since the virus first emerged in December of last year, with over 345,000 deaths globally.

Despite an apparent downward trend in new deaths and cases in many hard-hit countries, Ryan urged countries across the world to remain vigilant.

"We need also to be cognizant of the fact that the disease can jump up at any time," he said. "We cannot make assumptions that just because the disease is on the way down now, it is going to keep going down and we get a number of months to get ready for a second wave. We may get a second peak in this wave."

'Silent epidemic'
Also on Monday, WHO special envoy Samba Sow warned that Africa could face a "silent epidemic" if its leaders do not prioritise coronavirus testing.

Africa has confirmed more than 112,000 cases and more than 3,300 deaths, a rate considered remarkably low. However, experts have warned the full impact of the pandemic could not be known without more widespread testing.

"My first point for Africa, my first concern, is that a lack of testing is leading to a silent epidemic in Africa. So we must continue to push leaders to prioritise testing," said Sow.
 
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