NewsYour Health MattersAsk Dr. Nandi


Moderna asks for booster clearance ahead of FDA panel meetings

Posted at 3:17 PM, Oct 13, 2021
and last updated 2021-10-13 17:28:24-04

(WXYZ) — Pfizer’s COVID vaccine booster shot was granted emergency use by the FDA.  And now Moderna and Johnson & Johnson are waiting to hear if they will be given the green light too.   

Our Chief Health Editor Dr. Partha Nandi tells us the latest.

Question: What can you tell us?

Dr. Nandi: Moderna is urging the FDA to grant emergency use authorization.

The drugmaker says its vaccine weakens over time. And its booster shot increases antibodies and strengthens protection.'

Now Moderna submitted data to the FDA back in September, however, some questions have been raised. First of all, Moderna’s trial had a small sample size. Only 171 people were given a booster shot, six months after the second dose. So there were not a lot of participants. Also, efficacy against symptomatic illness was not evaluated. What they did was look at antibody levels. Participants in the trial were given 50 micrograms of the vaccine. That’s half a dose. To be fully vaccinated, a person needs two doses of Moderna’s vaccine - each dose is 100 micrograms. Now, according to Moderna’s data, antibody levels jumped considerably following the third dose – an impressive 42-fold rise was seen in virus-fighting antibodies. But on the flip side, scientists are pointing to data that shows Moderna’s two-shot vaccine is still providing good immunity and say a third dose is not needed. So, the FDA and its Advisory group will have a lot to review and deliberate before they decide if Moderna’s booster is a go. And they could determine - like they did for Pfizer's booster – that only specific groups of people would be eligible.

Question: What about J&J’s booster shot, what have you heard about their data? 

Dr. Nandi: J&J submitted two different options to the FDA. One option is for a booster shot at two months. The other is six months. Now, the company’s data shows that its one-shot vaccine is still highly effective against COVID-19 – it’s about 80% effective at preventing hospitalization. But J&J says a booster shot revs up immunity, providing even higher protection.

They haven’t released data for the six-month booster shot, but the two-month booster provided 94% protection against moderate to severe infection from COVID-19. So, with both these numbers being high, many are wondering if J&J’s booster request will also be a difficult decision for the FDA. It could be. Right now, all of our COVID vaccines continue to offer strong protection.

If we look at the numbers, 103 million Americans are vaccinated with Pfizer’s vaccine, 69 million with Moderna and 15 million with J&J. And so far, breakthrough cases are still uncommon. But that doesn’t mean that certain groups of people, like the elderly, the immunocompromised and those in high-risk jobs don’t need extra protection. But again, it’s up to the FDA and the CDC to scrutinize the data and decide what’s best for the American public.