The U.S. FDA has agreed to expand Pfizer and BioNTech’s emergency use authorization of their COVID-19 vaccine to include a second booster dose in adults ages 50 years and older as well as for immunocompromised patients aged 12 or older.
The expanded EUA is based on research data that included immunogenicity data from an ongoing study that assessed the effects of receiving two booster doses during an omicron wave. The companies also shared data from the U.S. and elsewhere showing a decline in vaccine effectiveness against COVID-19 3 to 6 months after the initial booster, and further evidence from Israel that an additional booster dose can improve protection against severe disease and death.
The emergency use expansion came just two weeks after the companies made the request.
More recently, the partners announced they would also begin trials for a new, omicron-specific COVID-19 vaccine.