FDA Expert Panel to Weigh Approval of Moderna, Johnson & Johnson Booster Shots
Panel will consider whether third Moderna shot should contain half the original dose, best timing for second shot of single-dose J&J vaccine
WEDNESDAY, Oct. 13, 2021 (HealthDay News) -- This Thursday and Friday, an advisory panel to the U.S. Food and Drug Administration will consider approval of booster shots for the Moderna and Johnson & Johnson COVID-19 vaccines.
The panel's deliberations will be the first step in deciding whether extra doses of the two vaccines should be given. Once the FDA advisers make their recommendation, the agency itself will make a decision on whether to authorize boosters for those shots. If the FDA approves the extra doses, a panel convened next week by the U.S. Centers for Disease Control and Prevention will recommend more specifics.
When the FDA panel meets this week, experts will discuss whether a third Moderna shot should contain just half the original dose, as well as the best timing for a second shot of the single-dose J&J vaccine, the Associated Press reported. The panel will also look into the safety and effectiveness of mixing and matching different brands of vaccine, something regulators have not endorsed so far.
In the new review of the latest Moderna data, the FDA said that vaccines used in the United States still provide protection, and it raised questions about some of the Moderna efficacy data, the AP reported. The two initial Moderna shots contain 100 mcg of vaccine each. But the drugmaker said in documents filed with the FDA that 50 mcg ought to be enough for a booster for healthy people.
In a company study, 344 people were given a 50-mcg shot six months after their second dose, and levels of virus-fighting antibodies jumped. Moderna said the booster triggered a 42-fold rise in antibodies able to target the highly contagious delta variant. Side effects were similar to the fevers and aches that Moderna recipients commonly experience after their second regular shot, the company said.
J&J has submitted data to the FDA for two different options: a booster shot at two months or at six months. The company said in its FDA submission that a six-month booster is recommended but that a second dose could be given at two months in some situations, the AP reported. J&J released data in September showing that a booster given at two months provided 94 percent protection against moderate-to-severe COVID-19 infection. The company has not disclosed patient data on a six-month booster, but early measures of virus-fighting antibodies suggest it provides even higher protection. Even without a booster, J&J says, its vaccine remains about 80 percent effective at preventing COVID-19 hospitalizations.