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Additional Vaccine Boosters Moving Through Authorization Process

A Food and Drug Administration (FDA) advisory panel unanimously endorsed both the Moderna and Johnson & Johnson (J&J) booster vaccines last week. This week, the FDA will authorize their use, and then the Centers for Disease Control and Prevention's (CDC) Advisory Committee on Immunization Practices (ACIP) will meet to consider them. It will be up to the CDC to authorize and make recommendations for their use.

At this time, Moderna booster eligibility will likely mirror the Pfizer booster requirement of six months after the primary mRNA series. Eligible populations include those age 65+, those with health conditions that pose an increased risk of COVID-19, and workers in settings that put them at risk of COVID-19. The FDA advisory panel endorsed J&J booster eligibility for all individuals who received the primary dose, with eligibility starting two months after the first dose.

The CDC is also considering the mixing and matching of booster doses. Added protection of an mRNA booster may provide additional protection to those who received the J&J single shot. At this time, there is no requirement from New York or the federal government for booster doses, though making them available to staff and residents is required for nursing homes and adult care facilities (ACFs). State guidance on this requirement is available here.

The FDA is also moving on oral antiviral (pill-based) drug treatments for COVID-19. On Oct. 14th, the FDA announced an upcoming meeting of its Antimicrobial Drugs Advisory Committee (AMDAC) to discuss Merck and Ridgeback’s request for an emergency use authorization (EUA) for molnupiravir, an investigational antiviral drug to treat COVID-19. On Nov. 30th, the Committee will meet to discuss the available data supporting the use of molnupiravir to treat mild to moderate COVID-19 in adults who have tested positive for COVID-19 and who are at high risk for progression to severe COVID-19, including hospitalization or death.

Contact: Meg Everett, meverett@leadingageny.org, 518-929-9342