As the end date of the national COVID-19 health emergency in the U.S. nears, the FDA has tweaked its emergency use authorizations for vaccines to streamline vaccination guidance.
Pfizer and Moderna’s initial monovalent COVID-19 vaccines are no longer authorized. Their bivalent vaccines, which target the original COVID-19 strain as well as omicron BA.4 and BA.5 strains, are now cleared as a single-dose series for first-time recipients, the FDA said in a Tuesday statement.
Depending on age, most individuals who previously got a monovalent vaccine but haven’t received a bivalent jab “may receive a single dose” of a bivalent shot. Most individuals who have gotten a dose of a bivalent vaccine are not eligible for another.
Meanwhile, adults 65 years and older can receive an additional bivalent dose at least four months after their initial bivalent shot. Further, most immunocompromised individuals can get a second bivalent dose at least two months after their first one.
“At this stage of the pandemic, data support simplifying the use of the authorized mRNA bivalent COVID-19 vaccines and the agency believes that this approach will help encourage future vaccination,” Peter Marks, M.D., Ph.D., the director of the FDA's Center for Biologics Evaluation and Research, said in a statement.
The agency will make decisions about future vaccinations after an advisory committee votes on this year’s fall strain composition in June. The latest changes are the result of a January meeting with the committee.
The COVID-19 public health emergency will end on May 11. Already, President Joe Biden signed a bill to end the U.S. national emergency related to the pandemic.