Updated Guidance for COVID-19

On August 22, 2024, the United States Food and Drug Administration (FDA) approved and authorized updated versions of mRNA vaccines from Pfizer-BioNtech and Moderna. The FDA approved the vaccine for people 12 and older and provided emergency use authorization for children 6 months to 11 years old. The stated target of these boosters is the Omicron variant which is not causing a significant number of infections.

The most recent booster approval was granted in the absence of booster-specific clinical trial data performed in humans. Furthermore, this booster does not protect against the currently dominant strain, accounting for approximately 37% of infections in the United States. There are currently limited data to inform whether these boosters offer any substantial protection against the virus and subsequent circulating variants. Although randomized clinical trials are normally used to approve therapeutics, the federal government has not required COVID-19 vaccine manufacturers to demonstrate their boosters prevent hospitalizations or death from COVID-19 illness.