FDA to Warn About Severe Reactions with Covid Vaccine: Marks
FDA plans to warn patients who’ve had previous severe reactions after being vaccinated about such risks with Pfizer-BioNTech’s Covid-19 vaccine if granted an Emergency Use Authorization, according to CBER director Peter Marks. The vaccine is headed to an advisory committee review and vote 12/10.
Addressing an Alliance for a Stronger FDA conference call 12/9, Marks said it was premature for European regulators to report on the first day of vaccinating the public that two severe reactions had occurred without knowing all the facts and fully investigating exactly what happened. A history of severe reactions to vaccines was a contraindication in the clinical trial, and one of the individuals who had a severe reaction had such a history, Marks said.
“We'll continue to keep the public informed and I think we have to help people understand that we're going to see some side effects with these vaccines, and that's normal,” Marks said. “But to the extent that we mitigate these and avoid vaccinating people who might be at a very high risk and that's the kind of way we mitigate risk.” The adverse events being reported by European regulators will be discussed during the advisory committee meeting, he said.
Marks emphasized that the public will need to get two vaccinations if relying on the Pfizer or Moderna vaccine. Marks also said that there is misinformation being spread about vaccine protection after administration of the first dose. He said there are reports that the vaccine is 92% effective after a single dose. However, he said the vaccine is 92% effective if the second dose is administered. “If you don't get the second dose, we don't really know the effectiveness and we don't know how long the protection lasts, so we got to be careful here, and I'm sure this misinformation will be virally spread,” he said.
Joining Marks on the call was FDA commissioner Stephen Hahn. He noted that safety and effectiveness data that would normally take three to six months to review has been reviewed in a matter of weeks using an “all hands on deck approach.” Reassuring listeners on the call, Hahn said no corners were cut in FDA’s assessment or scientific review, and if authorized he would be willing to be vaccinated first.
Asked how soon an Emergency Use Authorization decision will be made, Marks said it will be days to up to a week to render a decision, depending on the outcome of the advisory committee meeting.