Vaccine update: FDA releases new information on J&J, Moderna COVID-19 booster applications

The Food and Drug Administration today released for tomorrow鈥檚 convening of the agency鈥檚 Vaccines and Related Biological Products Advisory Committee, which will consider COVID-19 vaccine booster shot applications from Moderna and Johnson & Johnson. One notable aspect of J&J鈥檚 application is the drug maker鈥檚 request that FDA approve a booster shot program that would vary the timing of the booster鈥檚 administration based on patients鈥 individual circumstances. Such circumstances include individuals鈥 risk level related to their health or employment. For example, J&J recommends a booster two months after the first dose for high-risk individuals, including health care providers and front-line workers at high risk of exposure, severely immunocompromised people and those with certain underlying conditions who may not have mounted a sufficient immune response to one dose. Other so-called 鈥渓ow-risk鈥 individuals might be recommended for a booster six months after their initial dose.
Moderna, meanwhile, suggests that a 50-microgram booster dose of its vaccine yielded a comparable immune response to a 100-microgram dose; in doing so, the potential for adverse reactions was limited.
In addition to the Moderna and J&J booster discussions, the committee will review National Institutes of Health data on mix-and-match booster doses, in which people who were initially immunized with one brand's vaccine could get another manufacturer's booster.