FDA panel to weigh boosters for Pfizer’s Covid-19 vaccine
Covid-19 vaccines updates
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Members of the US Food and Drug Administration’s vaccine advisory committee will meet on Friday to issue a closely watched judgment on whether an application to offer widespread booster shots of the BioNTech/Pfizer Covid-19 vaccine should be accepted.
Pfizer is seeking authorisation to offer adults a booster of their two-dose mRNA jab roughly six months after receiving their second shot.
If the committee recommends approving the application, the FDA is likely to give its final sign-off within days. Once the US Centers for Disease Control and Prevention has issued guidelines for who should be eligible, Americans should be able to start getting booster jabs next week.
US health officials announced last month they wanted to start giving people booster shots after the release of data that suggested the effectiveness of mRNA vaccines such as Pfizer’s can decline within months after a second dose.
In its submission to the FDA, Pfizer said the efficacy of its vaccine fell about 6 per cent every two months after the second dose. Data from Israel, which will be presented to the advisory panel on Friday, shows severe Covid cases began to decline sharply around 10 days after the booster programme started.
The FDA has already authorised booster shots of mRNA vaccines for people with weakened immune systems. But the idea of allowing booster shots more broadly is controversial, both because of the limited data available about the vaccines’ long-term effectiveness in the real world, and because many countries are still struggling to secure initial supplies.
In a report published Wednesday, FDA staff said the data were not conclusive on whether the vaccine’s ability to stop symptomatic infection declined significantly over time, a sign of internal frictions within the regulator about whether boosters are needed.
“Overall, data indicate that currently US-licensed or authorised Covid-19 vaccines still afford protection against severe Covid-19 disease and death in the United States,” the agency said in a briefing document also published on Wednesday.
This week, two senior FDA scientists who have already announced their resignations co-authored a paper in The Lancet arguing against a booster programme. One of those, Marion Gruber, will speak at the beginning of Friday’s advisory committee meeting.
Others argue that US regulators should act quickly to stem the recent spike in cases.
Ali Mokdad, professor of global health at University of Washington, said: “The data is strong. We need to get a booster for everyone and to move on. Once we have boosters out then we can donate vaccines.”
In an open letter published Thursday ahead of the FDA meeting, Pfizer chief executive Albert Bourla said the booster decision should be based on scientific evidence, and argued that allowing people in high-income countries to get boosters would not divert supplies from low- and middle-income countries.
“If the data demonstrates their need, safety, and efficacy then they should be approved. If not, then they should not be approved. I believe, however, that the introduction of booster doses should not change the number of doses that each country receives,” he wrote.