The Food and Drug Administration today released briefing documents for tomorrow’s convening of the agency’s 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’s application is the drug maker’s request that FDA approve a booster shot program that would vary the timing of the booster’s administration based on patients’ individual circumstances. Such circumstances include individuals’ 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 “low-risk” 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.