A group of independent experts will review data on the Pfizer and BioNTech vaccine Thursday in a Food and Drug Administration (FDA) meeting that could pave the way for the emergency rollout of the first doses of vaccine in the United States.
For those working in public health, the advisory committee meeting is as close to must-watch webcasting as bureaucracy can provide and it offers a moment that could mark a turning point in the pandemic’s trajectory.
FDA regulators found the Pfizer and BioNTech vaccine for the coronavirus that causes COVID-19 “highly effective” and identified “no specific safety concerns,” according to a briefing document released ahead of the public discussion. The Moderna vaccine will receive a similar public review next week.
In a brief conversation with The Seattle Times on Wednesday, FDA Commissioner Dr. Stephen Hahn sought to bolster trust in the FDA process, saying the meetings fulfill the FDA’s “commitment to the American people” and ensure transparency and scientific rigor in the emergency authorization process.
“No steps were missed, no scientific evidence needed was excluded,” Hahn said. “I will be first in line, when it’s appropriate, to receive that vaccine.”
The committee’s recommendations are not binding but important for confidence in the vaccine. The committee could request additional data or analysis from the FDA, but votes on key considerations are scheduled for Thursday.
Once the committee has weighed in, Hahn said the FDA will “not waste any time” in deciding whether or not to grant emergency authorization for use of the vaccine. After authorization, federal officials have said vaccination of health care workers and residents in long-term care facilities could begin within a few days’ time.
Should the Pfizer vaccine receive authorization, the federal government plans to ship 62,000 doses to Washington state next week, according Michele Roberts, the state Department of Health’s acting assistant secretary, who has oversight over the vaccines. If both vaccines are approved, Roberts said the federal government estimates Washington will receive a total of 222,000 doses of the Pfizer vaccine and 180,000 doses of the Moderna vaccine by the end of 2020. These doses will be prioritized for health care workers and residents in long-term care.
The FDA required the pharmaceutical companies applying for emergency authorization to provide data on safety and efficacy from clinical trials with tens of thousands of participants. It required safety data that followed those fully vaccinated for a median of two months, which is a compressed timeline in comparison to the typical vaccine licensure process.
Hahn said FDA scientists analyzed historical vaccine safety data and determined that most “adverse safety events” take place within the first two months after vaccination.
When weighing the pandemic’s urgency and the time it takes to identify safety events, Hahn said regulators determined that two months was the “sweet spot” that balanced those two concerns.
“This is an urgent situation with 1,000 to 2,000 people dying every day. And the vaccine, if safe, would reverse that and get the pandemic behind us,” Hahn said, adding that safety monitoring will continue after emergency authorization.
In its review of clinical trial data, FDA regulators found that the Pfizer and BioNTech vaccine offered some protection after its first dose, according to the briefing document. The vaccine had an efficacy rate of about 95% after a second dose, administered three weeks later. The data suggests the vaccine worked well across different age, race and ethnic groups, with the exception of children, who were not part of the initial clinical trial.
More research will be needed to better understand the nature of protection and how the vaccine will work in particular populations.
Among the key questions: It’s not clear how long protection will last, how effective the vaccine will be in children or if the vaccine prevents transmission of the novel coronavirus, the briefing document says.
“There are some areas we have really good data with respect to safety and efficacy and some which will likely include additional study,” Hahn said.
The Vaccines and Related Biological Products Advisory Committee meeting will be broadcast on YouTube beginning at 6 a.m. Thursday and is expected to run until 2:15 p.m., according to its draft agenda.