FDA to Vote on Moderna, J&J Booster Shot, Discuss Mixing Vaccines

Thai medical personnel receives a booster measure of COVID-19 Pfizer vaccine at the Bangkok Metropolitan Administration General Hospital in Bangkok. Vichan Poti/Pacific Press/LightRocket via Getty Images

Tens of millions of Americans who received Moderna or Johnson & Johnson’s COVID-19 vaccines will soon hear from the FDA and the CDC on whether they will need an additional booster shot, who is eligible, and whether it’s okay to mix and match vaccines from different brands.

A third booster shot of the Pfizer-BioNTech vaccine was approved last month for people older than 65 and younger people who have a medical condition or work in high-risk environments.

The FDA’s Vaccines and Related Biological Products Advisory Committee is scheduled to meet Thursday and Friday to discuss whether to authorize a third Moderna measure and a second J&J jab.

But scientists on the FDA panel will have limited data to work with. When the group evaluated the third Pfizer shot last month, they were provided with data from Israel, where the great majority of the population was vaccinated with Pfizer’s original two-shot regime and empowered to receive a third shot over the summer. However, there is no similar nationwide data for either the Moderna or J&J vaccines.

In September, Moderna released data from a small-extent study suggesting that a third shot has the similar effect to Pfizer’s booster in increasing immunity. The study, which followed up on more than 300 participants from an earlier phase 2 trial, found that an additional half measure given six months after the second measure helps raise waning antibody levels. But the results have not been reviewed by independent experts however.

Both the Moderna and Pfizer-BioNTech vaccines are based on the novel messenger RNA technology. Moderna’s vaccine contains a higher amount of mRNA, the effective ingredient, than Pfizer-BioNTech’s.

As for J&J, the company said last month a second measure given two months after the single shot provided 94 percent protection against moderate-to-harsh COVID-19 symptoms. A second measure given six months after the initial shot provided a substantial increase in immune responses.

The FDA advisory panel will also consider the safety and efficacy of combining different vaccines.

A recent study in the U.K. found mixing Oxford+AstraZeneca and Pfizer+BioNTech vaccines to be safe and effective. But the FDA will not take a vote on the matter this week.

If the agency authorizes a booster for either Moderna or J&J, a similar expert group advising the CDC will meet next week to decide should be eligible for the additional shot.

According to the CDC’s vaccination tracker, an estimated 103 million Americans are now fully vaccinated with the Pfizer-BioNTech vaccine, 69 million with Moderna’s and 15 million with J&J’s.

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