The FDA released a series of documents Oct. 12 detailing Moderna and Johnson & Johnson's applications for booster doses of their COVID-19 vaccines.
The briefing documents come ahead of the FDA Vaccines and Related Biological Products Advisory Committee's two-day meeting, to be held Oct. 14 and Oct. 15, to discuss the boosters as well as pediatric COVID-19 vaccines and whether people should be allowed to mix and match booster shots from different manufacturers.
Five key takeaways from the documents:
- Moderna is asking the FDA to approve a booster shot that is half the dose of its initial shot, at 50 micrograms of mRNA instead of 100 micrograms. The drugmaker said a half dose boosted antibody levels well with low risks of adverse events, and that a half dose would "result in a substantial increase in the world supply" of its vaccine, The New York Times reported.
- Unlike Pfizer, Moderna didn't say its vaccine is waning against severe disease or hospitalization, rather that it is waning against infection, citing an increase in breakthrough infections caused by the delta variant. The drugmaker is asking the FDA to approve its booster shot in the same population the FDA approved for Pfizer's vaccine.
- Johnson & Johnson concluded that a booster of its vaccine should be given to people ages 18 and older six months or longer after the first dose. The drugmaker also said that people at higher risk of COVID-19 could get a booster as soon as two months after the first, NPR reported.
- Johnson & Johnson's documents included an analysis of side effects from its vaccine, with the drugmaker noting a range of rare reports of side effects including acute liver failure, autoimmune disorders, blood clots and heart inflammation. None of the side effects were common enough to present a significant safety problem, according to NPR, and Johnson & Johnson pledged to continue monitoring vaccine recipients.
- The FDA released its own summary of the data from both drugmakers but didn't take a position on boosters. Its vaccine advisory committee is expected to vote at the meeting on whether to recommend boosters of Moderna and Johnson & Johnson vaccines. The FDA proposed the committee consider approving the boosters in essentially the same eligibility groups as Moderna booster recipients, the Times reported.