Ask Dr. Nandi: FDA vaccine advisers reject Pfizer's booster request

Posted at 4:54 PM, Sep 17, 2021
and last updated 2021-09-17 17:20:04-04

(WXYZ) — The FDA’s advisory panel voted today on COVID-19 vaccine booster shots for Americans aged 16 and up. The answer…an overwhelming no.

I have to admit, I am surprised. The FDA’s advisory committee voted 16 to 2. That is a clear message sent not only to Pfizer but also to Moderna and possibly Johnson & Johnson.

Now the voting question was regarding Pfizer’s booster dose starting at least six months after the second shot. And it was for ages 16 and up. Now, this decision comes after a long day of intense discussion and debate.

The committee would have looked at data from Israel that showed Israelis who were first vaccinated with the two-dose regimen were found to have a higher chance of breakthrough infection. And a recently published Israeli study showed that those who received the third shot this summer were much less likely to get infected.

But what the FDA really wanted to focus on, was not what was going on in Israel, but more what is going on here in the US. And when you look at CDC’s numbers, there have been over 14,000 fully vaccinated people hospitalized because of the virus. Of those, 2,675 people died.

Now, it’s sad when anyone dies, but that number is so small when you compare it to the 176 million people who are fully vaccinated. Also, on top of all that, is another published paper that found vaccines continue to be substantially protective when it comes to severe disease and hospitalization. And it concluded that most folks don’t need a booster.

I am relieved to say that the vaccine advisors voted yes on the second question. They unanimously agreed to recommend emergency use authorization allowing people aged 65 and up and those who are at high risk of severe COVID-19, to get Pfizer’s booster shot.

Why I’m relieved is because of all the vaccinated people who have died from COVID, 87% of them are people aged 65 and older. Now, the FDA does not have to accept what the advisor panel recommends. But they tend to because this group is made up of experts and includes infectious disease doctors.

So once the FDA rules on Pfizer’s application, then it’s up to the CDC to meet and decide how the doses should be used.

Additional Coronavirus information and resources:

View a global coronavirus tracker with data from Johns Hopkins University.

See complete coverage on our Coronavirus Continuing Coverage page.

Visit our The Rebound Detroit, a place where we are working to help people impacted financially from the coronavirus. We have all the information on everything available to help you through this crisis and how to access it.