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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 informing companies for some time, says Dr. Peter Marks, director of the Center for Biological Evaluation and Research, the division of the FDA that approved vaccines.
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.”
The agency said it wants to make sure any vaccine is safe before authorizing its administration to millions of people.
“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.
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.
“The FDA has already communicated with individual manufacturers about their expectations, what data the agency intends to consider, and what we expect to see in an emergency use authorization request to demonstrate safety and efficacy,” an FDA spokesperson told CNN by email.
Most adverse reactions to vaccines occur between two to three months after people receive them, Marks said at a vaccine symposium sponsored by Johns Hopkins University and Washington University on Tuesday. “For example, Guillain-Barre, it might be six weeks, but for transverse myelitis, it’s more like three months,” Mark 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.”
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.
