(WSYM) — The FDA has released new data from Pfizer that suggests vaccine immunity can wane over time and that COVID-19 booster doses are not only safe, but necessary.
Chief Health Editor Dr. Partha Nandi says the FDA's advisory committee will meet in two days to discuss booster shots.
Pfizer’s data from both the US and Israel shows that its COVID-19 vaccine begins to wane and lose protection sometime around six to eight months. And the drugmaker says research suggests that a third shot, given six months after the second dose, can restore protection from the coronavirus to 95%.
And that’s why they are requesting the FDA approves third doses for everyone aged 16 and up. Right now, only Americans who are immunocompromised can get a third dose. And that’s because research has shown people with compromised immune systems can have trouble building an optimal immune response to fight off the virus.
Nandi says the FDA has not taken a stance on boosters, which makes sense because the Vaccines and Related Biological Products Advisory Committee is meeting this Friday.
That’s the FDA’s independent group of experts. And they’ll dig into all of the research, not just Pfizer’s, to determine if it’s really necessary for Americans to get a third shot.
They’ll also look at safety, as well. Having said that, the FDA did release a staff report. This report is to brief the advisory committee before they meet. And it mentions a few things that could indicate what the federal agency is thinking.
It said: “While observational studies can enable understanding of real-world effectiveness, there are known and unknown biases that can affect their reliability.” It also said, “US-based studies of post-authorization effectiveness of [Pfizer’s vaccine] BNT162b2 may most accurately represent vaccine effectiveness in the US population.”
In a nutshell, the FDA is acknowledging that observational studies are not the same as clinical studies. And may have different outcomes. And what happens in another country’s population, like in Israel, may not be what happens here in America. In my opinion, the decision on boosters could be tough. On one hand, you have Pfizer’s data showing immunity wanes. On the other, you have a recently published paper by a group of scientists that says COVID vaccines still offer strong protection against severe illness.
One thing is for certain, we have a virus that continues to change. So it’s also important that Americans and the world is prepared if the virus mutates into a new more dangerous variant. And if we start seeing many vaccinated folks getting severely sick or dying due to waning immunity.