Vaccine Integrity Project Releases Viewpoint on FDA's New Restrictions on COVID Vaccines

The Vaccine Integrity Project (VIP) published a viewpoint on the FDA’s decision to “issue new, more restrictive, COVID-19 vaccine recommendations.” CIDRAP has the news.

The FDA recently stated that “seasonal COVID vaccines will be available only to adults 65 years and older and those at risk for severe COVID-19 complications owing to underlying health conditions.”

The leaders of the FDA presented these recommendations in an opinion piece in the New England Journal of Medicine. Bruce Gellin, a consultant to the VIP, criticized the agency for not “seeking broad input into a proposed new vaccine policy which would help FDA to understands its implications and feasibility.” The VIP’s viewpoint suggests that the way the rules were issued undercuts the authority of the FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) and the CDC’s Advisory Committee on Immunization Practices (ACIP).

VRBPAC met yesterday, May 22, “the first such meeting during the Trump administration, and ACIP [will meet] in June to discuss vaccine recommendations.” The announcement of these rules in an opinion piece may cause “chaos.” Moderna has already had to quickly halt a phase 3 trial of its combination flu and COVID-19 vaccine after the new rules were issued.

Gellin also said that “the new rules take away the option for vaccination of healthy people who may want to reduce the risk they transmit COVID to vulnerable family members, and those who want to reduce the chance of developing long COVID.” He also mentioned the laxness of the new rules, suggesting people could “claim they are physically inactive” since one of the underlying conditions the CDC recognizes is inactivity.