“Vaccine efficacy against confirmed COVID-19 occurring at least 7 days after Dose 2 was 94.6%, with 9 and 169 cases in the BNT162b2 (the vaccine’s experimental name) and placebo groups respectively,” the FDA review document reads.
In other words, nine people who got the vaccine developed coronavirus infections with symptoms after the second shot, while 169 people who got placebo shots became infected.
The committee will run through all this data, but members will have read it all before Thursday’s meeting, which will be livestreamed on YouTube
and the FDA’s website.
Staff at the FDA’s Office of Vaccines Research and Review will run down the FDA’s study of Pfizer’s data. Dr. Nancy Messonnier, who heads the US Centers for Disease Control and Prevention’s National Center for Immunization and Respiratory Diseases, will review the CDC’s plans for safety monitoring and other CDC officials will update on the pandemic itself and plans for distributing the vaccine.
Stanford University’s Dr. Steven Goodman will talk about what it means for clinical trials going forward if a vaccine is approved. He’ll address the question of asking people to forgo getting a vaccine known to be protective in order to test an unproven one.
Other possible questions are whether to include pregnant women and children in an EUA.
“At this point I would say, we may not have the data we need to actually be able to advise pregnant women, and we may need additional study,” Hahn said.
The committee members will almost certainly discuss allergy warnings
out of Britain’s vaccination campaign, as well.
And the National Vaccine Advisory Committee
asked the FDA to leave children out of an EUA.
“The NVAC warns against issuing an Emergency Use Authorization (EUA) for COVID-19 vaccines in children, considering that children typically experience generally mild disease, except for multisystem inflammatory syndrome in children (MIS-C), a rare but serious condition that causes inflammation and various symptoms such as abdominal pain, vomiting, diarrhea, neck pain, rash, tiredness, and bloodshot eyes,” the group said last week.
Pfizer will also present its data.
Then the committee votes whether to recommend authorization.
But that doesn’t mean the vaccine will be authorized immediately. The decision comes from the FDA, which typically follows the advisory committee’s recommendation.
“One question that will come up is how fast will we see a vaccine authorized after that,” FDA’s Marks told the AMA.
“It will depend on the discussion at the advisory committee but we are hoping that within about a week afterwards we will see an authorization if everything goes well for each of those,” Marks said.
It could come even sooner. In anticipation of an EUA, the CDC’s Advisory Committee on Immunization Practices
has scheduled emergency meetings for Friday and Sunday. This committee — which is separate from FDA’s advisory committee — will recommend whether the CDC should offer the vaccine to the American public.
Once the CDC accepts that recommendation, healthcare workers may start giving people their fisrt doses of Pfizer vaccine.
The VRPBAC is scheduled to do it all over again next week, with a meeting December 17 to discuss Moderna’s EUA application.