FDA Releases New Guidelines for COVID-19 Vaccine Approval: What to Know
- The FDA released guidelines of what’s required for emergency authorization of a COVID-19 vaccine.
- The stricter guidance makes it unlikely that a vaccine could be approved — even for emergency use — before Election Day on Nov. 3, something President Trump has been pushing for.
- The White House had blocked the release of the FDA’s guidelines for 2 weeks, according to the New York Times.
The Food and Drug Administration (FDA) released tough new guidelines Tuesday outlining what’s required for the emergency authorization of a COVID-19 vaccine.
The stricter guidance makes it unlikely that a vaccine could be approved — even for emergency use — before Election Day on Nov. 3, something President Trump has been pushing for.
Herschel Nachlis, PhD, a research assistant professor of government and a policy fellow in the Nelson A. Rockefeller Center for Public Policy and the Social Sciences at Dartmouth College, says the FDA’s new guidelines are a “win” for the FDA, vaccine makers, and the American public.
“In the end, science, expertise, and sound regulation win out over politics and partisanship,” he said.
Nachlis adds that the guidance is not perfect, either for emergency COVID-19 vaccine approval or emergency approval of future treatments.
“But it’s an important clarification, and provides more robust standards and transparency,” he said.
Tougher standards for vaccine approval
The FDA’s
This faster process is reserved for public health emergencies. This regulatory route was used earlier this year for hydroxychloroquine and
The FDA later revoked the EUA for hydroxychloroquine after data showed that the drug offered little benefit for people with COVID-19 and potentially serious risks.
According to the new guidelines, vaccine makers are asked to follow clinical trial participants for an average of at least 2 months after they receive their final vaccine shot.
Several of the candidate vaccines under development require a second dose 1 month after the first injection in order to generate a stronger immune response.
However, this timeline won’t catch all adverse effects.
Dr. Jon Andrus, adjunct professor of global vaccinology and vaccine policy at the Milken Institute School of Public Health of George Washington University, says 2 months of follow-up should be viewed as a “minimum.”
“We have numerous [vaccine] examples where rare side effects that were very serious did not emerge until a longer period of time,” he said.
He points to the dengue vaccine, which the World Health Organization recommended in 2016 for children ages 9 to 16.
Additional safety information later came out showing that the vaccine increased the risk of hospitalization and leakage of fluid from blood vessels in children who had no prior exposure to dengue.
To catch less common adverse reactions, people given the vaccine will need to be monitored for longer, says Andrus.
The new FDA guidelines call for ongoing follow-up of people enrolled in the COVID-19 vaccine trials to look for additional adverse events.
The guidance also asks that companies wait until at least five severe cases of COVID-19 have occurred in volunteers who received the placebo.
Trial participants are randomly assigned to receive either the candidate vaccine or an inactive placebo. By comparing the two groups, researchers can see if the vaccine protects people from infection with the coronavirus or reduces the severity of illness.
They can also determine whether a candidate vaccine increases the risk of adverse events.
In the United States, four candidate vaccines are in phase 3 clinical trials, large-scale testing of the vaccines’ safety and efficacy. A fifth is expected to start phase 3 testing this month.
Politicization of vaccine process
The White House had blocked the release of the FDA’s guidelines for 2 weeks, according to the New York Times.
However, NPR reports that two administration officials said the guidance was not blocked but was being reviewed before release.
The FDA published the guidelines as part of a briefing package ahead of the Vaccines and Related Biological Products Advisory Committee
The release of the guidelines is aimed at building public trust in the vaccine approval process.
“Being open and clear about the circumstances under which the issuance of an emergency use authorization for a COVID-19 vaccine would be appropriate is critical to building public confidence and ensuring the use of COVID-19 vaccines once available,” said Marks in an FDA news release.
Vaccine makers have also tried to reinforce the integrity of the vaccine approval process. In September, executives from nine companies pledged to listen to the science before submitting for emergency authorization or formal approval by the FDA.
In spite of this, on Tuesday, President Trump lashed out at the new guidelines.
“New FDA Rules make it more difficult for them to speed up vaccines for approval before Election Day. Just another political hit job!” he tweeted, tagging FDA Commissioner Dr. Stephen M. Hahn.
Trump’s continued push for a pre-election vaccine comes alongside rising public concerns about how the safety and effectiveness of vaccines will be reviewed.
In an August STAT-Harris survey, 72 percent of Republicans and 82 percent of Democrats worried that the vaccine approval process is being driven more by politics than science.
By publishing their guidelines, the FDA seems to be trying to shift more of the focus back to the career FDA scientists who have the expertise needed to review the vaccines.
“The agency’s efforts to create and publicize this EUA-plus guidance should help to bolster the public’s confidence in the FDA’s review of COVID-19 vaccines for safety and efficacy,” said Nachlis.
He co-authored an article in the journal
Andrus points out that, even with several vaccines nearing the regulatory review stage, there’s still no guarantee that a safe and effective vaccine will emerge.
“The data has to play out to make that conclusion,” he said. “In the meantime, there are a lot of things we can do to save lives. We just aren’t doing them consistently everywhere.”
He says this includes physical distancing,
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