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(CNN) – The US Food and Drug Administration made clear Tuesday that it will want to see two months of follow-up data after volunteers receive their second dose of vaccine as part of clinical trials testing potential coronavirus vaccines. .
That would make it difficult, if not impossible, for any vaccine manufacturer to apply for an emergency use authorization before Election Day, as President Trump suggested, or by the end of October, as the Pfizer CEO hinted.
The process will also make it “pretty tough for shenanigans,” said Dr. Francis Collins, director of the National Institutes of Health.
The agency released new guidance for manufacturers that says they must provide at least two months of follow-up safety data after vaccinating volunteers before even asking the FDA to consider granting an emergency use authorization (EUA) for a vaccine.
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I made similar suggestions in documents for an October 22 meeting that has long been scheduled for vaccine advisers to meet and discuss the requirements for emergency use authorization or a full biological license application for any potential vaccine against the coronavirus.
“Data from Phase 3 studies should include a mean duration of follow-up of at least two months after completing the full vaccination regimen to help provide adequate information to assess the benefit-risk profile of a vaccine, including: events adverse events; severe COVID-19 cases among study subjects and COVID-19 cases occurring during the period when adaptive (rather than innate) and memory immune responses to the vaccine would be responsible for a protective effect “, said the FDA in the guide.
The two-month number shouldn’t surprise us. The FDA has been briefing companies for some time, says Dr. Peter Marks, director of the Center for Biological Evaluation and Research, the division of the FDA that approves vaccines.
“We made it clear that we want to see a median of about two months of follow-up for any of the vaccines that come in, and while it would be nice to have many more, we have to balance the safety we get early on with the need to try to save lives. with a vaccine that helps prevent a virus that is killing 1,000 or more people a day in the United States, “Marks said in a YouTube interview with the Journal of the American Medical Association published Monday.
The two vaccines that are most advanced in clinical trials, those made by Moderna and Pfizer, require two doses each. Moderna’s is given to volunteers in two doses 28 days apart; Pfizer’s is given in two doses 21 days apart.
Researchers testing vaccines are waiting to see how people eventually become infected with the virus and if fewer people who receive the actual vaccine become infected compared to those who are injected with placebo.
The FDA also wants to wait to make sure people don’t report side effects after that second injection.
“Security is what keeps me awake at night,” Marks said in the JAMA interview. “Because the way that we are going to overcome Covid-19 is if we get a vaccine that is 70% or 80% effective and we can implement it in 70 or 80% of the population, we actually have a chance of having a herd immunity, and we can be back in restaurants and banks … and doing what we normally do, “he added.
“It will only happen if people are confident enough to get vaccinated and we have a crisis in confidence in vaccines.”
FDA officials have been clear in saying they want to have discussions with vaccine manufacturers, rather than setting strict rules that must be followed, to provide an emergency use authorization for any vaccine.
“In general, FDA guidance documents, including this guidance, do not establish legally enforceable responsibilities. Instead, the guidelines describe the Agency’s current thinking on an issue and should be considered as recommendations only, unless requirements are cited. specific statutory or statutory regulations. The use of the word should in Agency guidance means that something is suggested or recommended, but is not required, “the meeting document reads.
The FDA will also hold public meetings of its Advisory Committee on Vaccines and Related Biologics. “That group, the VRBPAC, will make a recommendation,” Collins of the NIH said during a vaccine symposium sponsored by Johns Hopkins University and the University of Washington on Tuesday.
“The FDA will decide whether to accept it, and only then would we be in a circumstance where an emergency use authorization would be approved,” Collins said. “So, following all those steps, even though I know there is a lot of anxiety about mischief here, it would be quite difficult for mischief to derail this process.
Most adverse reactions to vaccines occur two to three months after people receive them, Marks said at the symposium. “For example, Guillain-Barre, it might be six weeks, but for transverse myelitis, it’s more like three months,” Marks said.
“We picked two months as something that was reasonably aggressive, but also something, something in between,” Marks said. “Not too aggressive, not too conservative, in the middle.”
White House resistance?
A senior White House official told CNN that the Management Office and the budget had approved the guide. The FDA does not generally request permission from the White House to release guidance, but the Trump administration took a special interest in this case.
Scientists applauded the new FDA guidance as a sign that the regulator was struggling to maintain its independence even under pressure from the White House.
“They’re standing here. It’s really cool to see this,” said Dr. Eric Topol, executive vice president of Scripps Research. “It’s really important to the public’s confidence.”
Topol said he thought the White House was forced to back down. “I think they were stuck in a corner and had no other choice,” Topol said. “Publicly, it would have been horrible if this guide had been canceled.”
Dr. Paul Offit of the Children’s Hospital of Philadelphia, who will serve on the FDA’s independent vaccine advisory board, noted that such documents typically arrive within days of a scheduled meeting, not weeks before.
“I think they did it as a run for the White House. Good for them,” he said.
“Doing things like this makes me feel like the FDA stands up for itself,” Offit added.
Marks has said that staff are trying to filter out political arguments while targeting data from clinical trials involving tens of thousands of volunteers.
The FDA requirements for an EUA are less stringent than for a full Biological License Application. The process for a USA will take weeks, while the process for a BLA takes months, he said.
“That still means that the safety profile of a vaccine that will be implemented in millions of people has to be incredibly clean,” he said. An EUA for a vaccine will be stricter than an EUA for a drug designed to rescue sick and dying people, because a vaccine is given to healthy people, so the risk-benefit ratio is different.
“We need to have a strong efficacy signal,” he said. If people get vaccinated, they may stop taking other precautions against infection.
“If we tell them it’s 70% effective, they can change their behavior, and if they’re going to let their guard down a little bit, we better make sure it does what it says it should do,” Marks said.
FDA officials have repeatedly said that they will not skimp on safety considerations for a coronavirus vaccine, even as Trump tries to promise one by Election Day.
There are currently 10 candidates for the Covid-19 vaccine in large late-stage clinical trials around the world, according to the World Health Organization. Five candidates in the United States are in advanced phase 3 trials and two of them have been in phase 3 trials since the end of July.
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