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Coronavirus: Remdesivir’s failure is a warning for Covid-19 vaccines

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remdesivir injection

Less than a month ago, the Food and Drug Administration said hospitals could use remdesivir, a drug manufactured by Gilead Sciences Inc., to treat patients with Covid-19. Remdesivir, sold under the brand name Veklury, was said to shorten recovery times and reduce the need for ventilators to facilitate breathing. Yesterday, the World Health Organization hit the brakes: It recommended that doctors avoid using the drug altogether.

“There is currently no evidence that remdesivir improves survival and other outcomes in these patients,” the WHO noted, citing detailed studies it sponsored. “The evidence suggested no important effect on mortality, need for mechanical ventilation, time to clinical improvement, and other patient-important outcomes.”

A group of experts gathered by the WHO concurred, reporting their findings in a well-regarded medical journal. Remdesivir offers “small and uncertain benefits” outweighed by the “possibility of important harms,” they wrote. Gilead pushed back, saying it stands by remdesivir and citing other studies supporting its efficacy.

Speed is prized in the race to beat back Covid-19 — as it should be. The world is also fortunate to have innovative and dedicated public and private researchers able to produce coronavirus vaccine candidates in record time. But the WHO’s thumbs-down on remdesivir is also a reminder that hasty drug development and approval is risky. It highlights why the FDA has to do more than merely rubber-stamp Covid-19 treatments in the face of heavy White House pressure to move quickly.

As my colleague Max Nisen recently observed, it’s perplexing that the FDA gave formal approval to remdesivir as a Covid-19 treatment in October. The drug was already available to hospitals and patients under a federal emergency use authorization granted in May. Since then, data supporting its benefits had become murky, and an FDA sign-off was unlikely to significantly expand its use. As I noted in an earlier column, remdesivir is also expensive — perhaps not as costly as other blockbuster drugs the pharmaceutical industry sells, but still expensive.

Two writers for Science magazine, Jon Cohen and Kai Kupferschmidt, offered some answers to these mysteries in a deeply reported piece published late last month. They found that the FDA and the European Union both had approved the use of remdesivir despite some glaring procedural gaps. The FDA didn’t consult the outside experts it keeps on tap to analyze approvals for complex antiviral drugs. The EU approved remdesivir’s pricing just a week before lackluster results from a major WHO trial of the drug were published — and then seemed clueless about the new data. (Gilead was aware; it had donated drug to the trial and knew the results were poor.)

The Science writers pointed out that the FDA’s inaction around remdesivir “stands in sharp contrast to its handling of potential Covid-19 vaccines.” For remdesivir, the agency failed to convene an advisory to study the drug. Several prominent medical researchers voiced skepticism about remdesivir in the Science article, including Martin Landry of Oxford University, who said the drug was useless for treating the sickest patients. In any case, most people with Covid-19 recover without medical treatment.

“The argument that the earlier you use it the better is great until you realize what the implications of that are: You won’t save many lives, and you’ll have to treat a lot of patients,” Landry told Science. “It’s very inconvenient, and it’ll cost you a fortune.”

Perhaps it was inevitable that Gilead would receive special treatment. In May, when remdesivir was given its EUA, the company’s chief executive officer, Daniel O’Day, was welcomed into the Oval Office for a photo op with President Donald Trump and FDA Commissioner Stephen Hahn. Trump, who was treated with remdesivir after contracting Covid-19 himself, has described it as one of a handful of drugs he received that were like “miracles coming down from God.”

Hospitals have been less enthusiastic and have been sharply cutting back their use of remdesivir due to its expense and its value for only the most seriously ill patients — which makes the FDA’s enthusiasm for the drug and its manufacturer all the more curious. The FDA approved remdesivir based on three trials, the most weighty of which was conducted by the National Institutes of Health. Both the NIH and the FDA are housed under the Department of Health and Human Services.

Perhaps it was just fine that the FDA relied on what was essentially an in-house trial to approve remdesivir and that Hahn has been unusually amenable to Trump’s demands for approving sketchy Covid-19 treatments. And perhaps it’s fine that Alex Azar, a former pharmaceutical executive and Big Pharma lobbyist who is a Trump loyalist, runs HHS and supervises Hahn.

In case any of this isn’t fine, we should bear it in mind as HHS and the FDA continue to play pivotal roles overseeing the approval, rollout and regulation of more crucial drugs: the Covid-19 vaccines that Pfizer Inc. and Moderna Inc. have put on the table.

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May vaccinate those infected with Covid or having its antibodies: Govt

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Vaccine Covid

New Delhi, Dec 1: The Union Health Ministry hinted on Tuesday that the people infected with Covid-19 or those who have recovered and exhibit antibodies against the viral disease could also come under the ambit of vaccination drive for the immunisation of people against the coronavirus infection.

Union Health Secretary Rajesh Bhushan said that this process is already in the mandate of a national expert group for vaccine administration, headed by V.K. Paul, member, NITI Aayog (health). “They are contemplating the issue, but nothing is concrete as yet,” he said while addressing a press conference.

Bhushan also said that many countries are contemplating the matter of whether patients suffering from Covid-19 or those who have developed its antibodies should be included in the immunisation drive.

Meanwhile, divulging into the technicalities of the matter, Balram Bhargava, Director-General (DG), Indian Council of Medical Research (ICMR), said, “There are two important issues linked with the immunisation of such a set of people. If someone has antibodies against the Covid-19 infection, and a vaccine is given to that person, would he or she develop any vaccine associated adverse reaction? Secondly, if we consider the presence of antibodies and avoid the administration of vaccines to the person, would we be able to spare our vaccine doses?”

However, answering the points raised, Bhargava said that there are enough data from different trials that show that the vaccine related adverse reaction does not happen even if the dose is administered to a person having active Covid infection. “However, the discussion is still going on internationally regarding its implementation,” he added.

Bhargava also said that the World health Organization (WHO) has clearly stated after assessment of the solidarity trials of the vaccines that one does not need to measure the antibodies before administering the vaccine or even find out if the person receiving the dose has contracted the Covid-19 disease. “The current mandate of WHO gives a go-ahead for vaccination to such a set of people,” he added.

The Centre has formed tentative guidelines for vaccine administration to the priority groups. The government has divided the prioritisation under four groups — healthcare workers, people above 65 years of age, people aged between 50 and 65 years, and lastly, people below 50 years with underlying conditions.

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Moderna Says Vaccine 100% Effective Against Severe Covid, Seeks Clearance

COVID-19 Vaccine: Moderna said it expects to have approximately 20 million doses of the vaccine, called mRNA-1273, available in the US by the end of the year.

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Covid 19 Vaccine

Washington: Moderna Inc will apply for US and European emergency authorization for its COVID-19 vaccine on Monday after full results from a late-stage study showed it was 94.1% effective with no serious safety concerns, the company said. Moderna also reported that the vaccine’s efficacy rate was consistent across age, race, ethnicity and gender demographics as well as having a 100% success rate in preventing severe cases of a disease that has killed nearly 1.5 million people.

The filing sets Moderna’s product up to be the second vaccine likely to receive US emergency use authorization this year following a shot developed by Pfizer and BioNTech which had a 95% efficacy rate in trials. “We believe that we have a vaccine that is very highly efficacious. We now have the data to prove it,” Moderna Chief Medical Officer Tal Zaks said.

“We expect to be playing a major part in turning around this pandemic.”

Of the 196 volunteers who contracted COVID-19 in the trial with more than 30,000 people, 185 received a placebo while 11 got the vaccine.

Moderna reported 30 severe cases — all in the placebo group — which means the vaccine was 100% effective in preventing severe cases.

“As the numbers of cases reported grows, confidence grows that this amazing protection will be maintained in a product that can be rolled out to protect the public,” said Alexander Edwards, associate professor in biomedical technology at Britain’s University of Reading.

In addition to filing its US application, Moderna said it would seek conditional approval from the European Medicines Agency, which has already begun a rolling review of its data, and would continue to talk with other regulators.

Pfizer has already applied for emergency use authorization in the United States and Europe, putting it about a week ahead of Moderna.

Moderna said it was on track to have about 20 million doses of its vaccine ready to ship in the United States by the end of 2020, enough to inoculate 10 million people.

Both of the vaccines use a new technology called synthetic messenger RNA (mRNA) whereas others, such as Britain’s AstraZeneca, are using more traditional methods to develop their vaccines.

AstraZeneca has announced an average efficacy rate of 70% for its shot and as much as 90% for a subgroup of trial participants who got a half dose, followed by a full dose.

But some scientists have expressed doubts about the robustness of the 90% efficacy figure for the smaller group.

Moderna’s latest efficacy result is slightly lower than an interim analysis released on Nov 16 of 94.5% effectiveness, a difference that Mr Zaks said was not statistically significant.

“At this level of effectiveness, when you just do the math of what it means for the pandemic that’s raging around us, it’s just overwhelming,” said Zaks, who said he cried when he saw the final results over the weekend.

Both the Moderna and Pfizer vaccines proved more effective than anticipated and were far superior to the 50% benchmark set by the US Food and Drug Administration (FDA).

The past few weeks of positive vaccine results have ignited hopes for an end to a pandemic that has battered economies and comes as new infections and COVID-19 hospitalizations are at record levels across the United States.

Independent advisers to the FDA are scheduled to meet on December 17 to review Moderna’s trial data and make a recommendation to the FDA.

They will meet on December 10 to review Pfizer’s data. Shortly after gaining emergency use authorization, Moderna expects the vaccine to be shipped to distribution points throughout the United States by the government’s Operation Warp Speed program and McKesson Corp, a drug distributor contracted by the US government.

Its distribution is expected to be easier than Pfizer’s because while it needs to be stored in a freezer, it does not require the ultra-cold temperature needed by Pfizer’s vaccine.

Moderna said the 196 COVID-19 cases in its trial included 33 adults over 65 years old and 42 volunteers from racially diverse groups, including 29 Latinos, 6 Blacks, 4 Asian Americans and 3 multiracial participants. There was one death related to COVID-19 in the placebo group.

Azra Ghani, chair in infectious disease epidemiology at Imperial College London, said Monday’s details from Moderna confirmed the vaccine was highly efficient, including against severe cases. “Whilst this does not exclude some risk of severe disease after vaccination given the relatively small number of severe cases, these results suggest very high efficacy,” she said.

Zaks said the vaccine has been developed during a period of “political acrimony” and having a highly effective vaccine may go a long way toward erasing some of that distrust. “This is as black and white as an effect on a population will be. Your chances of actually being sick if you’ve been vaccinated are decreased 20-fold,” he said.

Moderna reported no new side effects since its interim analysis. Based on that analysis, the most common side effects were fatigue, injection site redness and pain, headache and body aches, which rose after the second dose and were short-lived.

Zaks said the vaccine caused significant flu-like symptoms in some participants, which, he said, “goes hand-in-hand with having such a potent vaccine.” But it has not caused any significant safety concerns so far.

Moderna plans to start a new trial to test the vaccine in adolescents before the end of the year, followed by another in even younger volunteers early in 2021.

It hopes to have the vaccine available for adolescents by September, Zaks said.

Other vaccine makers have said they are studying their vaccines in young people as well.

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Modi interacts with 3 teams developing corona vaccines

The Prime Minister also asked the companies to come out with their suggestions and ideas regarding the regulatory processes and related matters.

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Narendra Modi

New Delhi, Nov 30: Prime Minister Narendra Modi on Monday held virtual meetings with three teams working on the development and manufacture of vaccines against Covid-19, and discussed the potential of various platforms for vaccine development.

The teams are from Gennova Biopharmaceuticals Ltd at Pune, and Biological E Ltd and Dr Reddy’s Laboratories Ltd at Hyderabad.

Their potential vaccines are in different stages of trials and detailed data and results are expected from early next year onwards, a Prime Minister’s Office (PMO) statement said on Monday.

“The potential of various platforms for vaccine development was also discussed,” the statement said.

The Prime Minister also asked the companies to come out with their suggestions and ideas regarding the regulatory processes and related matters.

He also suggested that they should make extra efforts to inform the general public in simple language about the vaccine and related matters such as its efficacy.

Matters relating to logistics, transport and cold chains in respect of delivery of the vaccines were also discussed.

The Prime Minister advised all departments concerned to engage with the manufacturers and seek to resolve matters so that the efforts by these companies bear fruit in order to serve the needs of the country and the entire world.

The Prime Minister praised the efforts made by scientists and researchers in these companies to come out with a vaccine solution to tackle the ongoing coronavirus pandemic, which so far has infected 94,31,692 people across the country, and led to deaths of 1,37,139 patients.

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