The U.S. Food and Drug Administration (FDA) released a new version of the regulatory guidance for the new coronavirus vaccine booster shot on Tuesday, setting stricter approval standards for healthy people. According to the guidance document published in the New England Journal of Medicine, the FDA will implement grading evidence standards based on the patient's risk of severe disease. The document was co-authored by FDA Commissioner Marty Makary and vaccine regulatory chief Vinay Prasad, an academic known for his criticism of the pharmaceutical industry.
The policy change comes as Health and Human Services Secretary Robert F. Kennedy Jr., a noted vaccine skeptic, overhauls the nation's health agency.
For seniors aged 65 and over, and patients over 6 months old with certain underlying medical conditions, the FDA stated that it can accept immunogenicity data (proving that the vaccine can stimulate a sufficient antibody response) as the basis for determining that the benefits outweigh the risks. However, for healthy people aged 6 months to 64 years old without risk factors, the agency requires evidence of clinical endpoints from randomized controlled trials, including actual efficacy data such as reducing infection rates or hospitalization rates, before they can be approved.
When a vaccine for high-risk groups is approved, the FDA will require pharmaceutical companies to commit to conducting randomized controlled trials in healthy adults as post-marketing research. Previously, the FDA mainly relied on immunogenicity data to approve annual booster shots against new circulating strains. This model is similar to the influenza vaccine approval mechanism.
"The new policy reflects the balance between regulatory flexibility and scientific rigor," the FDA said in the document, "not only ensuring timely access to vaccines for high-risk groups, but also requiring the provision of gold standard data for healthy groups." Makari and Prasad will explain the new framework through an online meeting at 1 p.m. ET on Tuesday.