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WHO study reveals new discovery about remdesivir drug’s effect on Covid-19 patients

The study found that the regimens appeared to have little or no effect on 28-day mortality or the length of the in-hospital course.

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A World Health Organization (WHO) study has discovered that Gilead Sciences Inc’s remdesivir had little or no effect on COVID-19 patients’ length of stay in the hospital or chances of survival.

The only antiviral drug authorized for treatments of Covid-19 in the US failed to prevent deaths among patients.

The antiviral medication, among the first to be used as a treatment for COVID-19, was one of the drugs recently used to treat U.S. President Donald Trump’s coronavirus infection.

The results are from WHO’s Solidarity trial, which evaluated the effects of 4 potential drug regimens, including remdesivir, hydroxychloroquine, anti-HIV drug combination lopinavir/ritonavir and interferon, in 11,266 adult patients across more than 30 countries.

The study found that the regimens appeared to have little or no effect on 28-day mortality or the length of the in-hospital course among patients hospitalized with COVID-19, the WHO said on Thursday.

The results of the trial, which were posted online on Thursday, October 15, 2020, are yet to be peer-reviewed or published in a scientific journal

Earlier this month, data from a U.S. study of remdesivir by Gilead showed that the treatment cut COVID-19 recovery time by five days compared with patients who got a placebo in a trial comprising 1,062 patients.

Gilead told Reuters, “The emerging (WHO) data appears inconsistent, with more robust evidence from multiple randomized, controlled studies published in peer-reviewed journals validating the clinical benefit of remdesivir.

“We are concerned the data from this open-label global trial has not undergone the rigorous review required to allow for constructive scientific discussion, particularly given the limitations of the trial design.”

Remdesivir, which was originally developed as a treatment for Ebola and Hepatitis C, interferes with the reproduction of viruses by jamming itself into new viral genes.

WHO chief scientist Soumya Swaminathan said on Wednesday that during the study, hydroxychloroquine and lopinavir/ritonavir were stopped in June after they proved ineffective, but other trials continued in more than 500 hospitals and 30 countries.

Swaminathan said, “We’re looking at what’s next. We’re looking at monoclonal anti-bodies, we’re looking at immunomodulators and some of the newer anti-viral drugs that have been developed in the last few months.”

Remdesivir received emergency use authorization from the U.S. Food and Drug Administration on May 1, and has since been authorized for use in several countries.

Gilead, however, disputed the conclusions of the W.H.O. study on Thursday, noting that a variety of drugs and drug combinations had been evaluated under a wide range of circumstances and that more rigorous studies had found a benefit.

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Coronavirus

COVID-19: WHO warns against Gilead’s remdesivir drug approved by US FDA

WHO has expressed concern over the health implication of Gilead Science Inc’s recently approved remdesivir vaccine.

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The World Health Organization (WHO) has warned health officials reviewing Gilead Science Inc’s GILD.O remdesivir against COVID-19 to consider all evidence, including a trial where the medicine failed, before giving its approval to the anti-viral drug.

While making the disclosure during a news conference, Chief Scientist at WHO, Soumya Swaminathan, said that the US regulators, the Food and Drug Administration (FDA), appeared not to have considered the evidence when approving the drug this week.

Backstory

It was reported earlier that the US Food and Drug Administration on Thursday, granted full approval to Gilead’s antiviral drug for treating patients hospitalized with COVID-19, making it the first and only drug approved for the disease in the United States.

The approval came days after a WHO study had discovered the remdesivir anti-viral drug had little or no effect on COVID-19 patients’ length of stay in the hospital or chances of survival. WHO said it failed to prevent deaths among patients.

Swaminathan said that the FDA did not appear to have taken the global health body’s study into account in its approval.

When asked about the FDA move during the news conference, Swaminathan said, “We believe our results are very robust. We hope that people who are doing treatment guidelines in other countries, as well as regulators around the world, will take note of our study results, in addition to the other evidence.”

“Because you need to look at the global evidence for a drug before you make decisions,” she added.

For the remdesivir arm of the WHO’s Solidarity trial, 2,743 patients were given the treatment, compared to 2,708 in the control group.

Gilead’s own study of 1,062 participants, produced data indicating that the treatment cut COVID-19 recovery time by 5 days and helped reduce the risk of death in some patients who were getting oxygen.

The WHO said that the company, which has raised the possibility of bias in the unblinded WHO study because patients and their doctors were aware of which treatments were being used, got initial data showing that remdesivir failed the Solidarity trial in late September. However, the U.S. company said that it had told the FDA about initial Solidarity results.

The FDA did not immediately comment on Swaminathan’s statement that the U.S. agency did not take Solidarity data into account in its approval.

The WHO also disclosed on Friday that its formal guidelines on the use of remdesivir for COVID-19 should be ready for release in 3 to 4 weeks after a separate group within the United Nations health agency would have reviewed data from the study.

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Covid-19: US FDA grants full approval to remdesivir as first vaccine to treat coronavirus

Remdesivir has become the first drug to obtain formal clearance for treating the coronavirus disease.

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The US Food and Drug Administration (FDA) on Thursday granted full approval to Gilead Sciences Inc. for its antiviral drug, remdesivir, making it the first drug to obtain formal clearance for treating the coronavirus disease after conditional authorization was given in May.

The regulators had granted an emergency use authorization for remdesivir earlier this year, and since then, the drug has become a widely used therapy for hospitalized Covid-19 patients. It was also reportedly given to President Donald Trump this month, when he was diagnosed with the coronavirus disease.

This was disclosed in a statement by Gilead Sciences on Thursday.

In its statement, Gilead said, “Veklury is now the first and only approved Covid-19 treatment in the United States.’’ While the drug was in short supply initially, Gilead said that the medicine is now widely available in hospitals across the country as manufacturing capacity has rapidly expanded.

This is coming some days after the World Health Organization (WHO) study had discovered that the remdesivir anti-viral drug had little or no effect on Covid-19 patients’ length of stay in the hospital or chances of survival. The WHO said it failed to prevent deaths among patients.

However, Gilead has criticized the WHO study. In a letter posted on the company’s website, Chief Medical Officer Merdad Parsey said the findings didn’t negate other results.

The approval of remdesivir, sold under the brand name Veklury, will allow Gilead to market the drug and talk about its benefits to doctors, nurses, and patients. That could help solidify its position as a go-to medicine for Covid-19 patients, even as other drugs for the disease begin to reach the market.

Other treatments have received authorization for emergency use, although that approval can be revoked once the public health emergency caused by the coronavirus pandemic is over. Other medications like the steroid dexamethasone are also being used in the fight against Covid-19.

Shares of Gilead gained 4.1% in trading after the close of regular market hours on Thursday. According to 13 analysts surveyed by Bloomberg, it is estimated that remdesivir will have sales of $2.17 billion this year.

The company said in June that it would charge U.S. hospitals roughly $3,120 for most patients who need remdesivir.

The approval is based on a U.S. government-sponsored trial involving over 1,000 hospitalized coronavirus patients that found that those who received the drug recovered about five days faster than those who got a placebo.

The overall side-effect rate was similar to the placebo in the government study. The most common side effects are nausea and elevated liver enzymes, according to the product’s label.

What this means: This will be a very huge boost to the global search for a vaccine for the coronavirus pandemic which has negatively impacted on the global economy with over 1 million deaths. This also appears to be a boost for Donald Trump, who had sought the development of a Covid-19 vaccine before the US Presidential election.

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COVID-19: US to have enough vaccines for vulnerable Americans by end of 2020

The US said it is likely to have enough safe and effective COVID-19 vaccines to inoculate Americans by the end of 2020.

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The United States, On Wednesday, revealed that the country is likely to have enough safe and effective COVID-19 vaccines available to inoculate the most vulnerable Americans by the end of 2020.

The U.S. government is cautiously optimistic that one or two vaccines, likely from Pfizer Inc or Moderna Inc, will be available by the end of the year, and can begin to be distributed to Americans, officials said during a news conference.

This was disclosed by the US Secretary of Health and Human Services, Alex Azar, on Wednesday, October 22, 2020.

Azar said he expected that all seniors, healthcare workers, and first responders would be able to receive vaccines as soon as January, with the rest of the American public able to get vaccines by April.

Companies participating in the U.S. government’s effort to develop vaccines for COVID-19, dubbed “Operation Warp Speed”, have begun developing manufacturing capabilities even before any vaccination has been authorized by regulators.

Backstory

It was reported that in an open letter, the Chief Executive Officer of Pfizer Inc, Albert Bourla, disclosed that it could seek emergency authorization to use the COVID-19 vaccine in the US by late November, after the US Presidential election.

The coronavirus outbreak has been worseningin recent weeks as cold weather pushes Americans indoors, raising the chance of contracting the virus. Some 38 U.S. states and two territories have reported rising case counts. More than 8 million Americans have been infected with the novel coronavirus and more than 200,000 have died.

What this means

This announcement rules out the assertion by US President, Donald Trump, that a COVID-19 vaccine would be ready before the Presidential election. However, this news is still a huge boost for the country, which has been one of the most hit globally from the pandemic.

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