FDA authorizes updated COVID-19 boosters to combat omicron subvariants
The BA.4 and BA.5 lineages of the omicron variant are currently causing most cases of COVID-19 and are predicted to circulate this fall.
Photo: Zoranm/Getty Images
The U.S. Food and Drug Administration on Wednesday amended the emergency use authorizations of the Moderna and Pfizer-BioNTech COVID-19 vaccines to authorize updated boosters to combat omicron subvariants.
The FDA approved bivalent formulations of the vaccines for use as a single booster dose at least two months following primary or booster vaccination. The bivalent vaccines are updated boosters containing components of the original strain of SARS-CoV-2 and the BA.4 and BA.5 lineages of the omicron variant, the FDA said.
The authorized bivalent COVID-19 vaccines, or updated boosters, include an mRNA component of the original strain to provide an immune response that is broadly protective against COVID-19 and an mRNA component in common between the omicron variant BA.4 and BA.5 lineages to provide better protection against COVID-19 caused by the omicron variant.
The Moderna COVID-19 vaccine, bivalent, is authorized for use as a single booster dose in individuals 18 years of age and older. The Pfizer-BioNTech COVID-19 vaccine, bivalent, is authorized for use as a single booster dose in individuals 12 years of age and older.
The Centers for Disease Control and Prevention needs to sign off on the new vaccines, an action reportedly expected as soon as this weekend.
WHY THIS MATTERS
The BA.4 and BA.5 lineages of the omicron variant are currently causing most cases of COVID-19 in the U.S. and are predicted to circulate this fall and winter, according to the FDA. COVID-19 vaccines to fight the original strain of the coronavirus have been in use since December 2020 and administered to millions of people in the United States. A second booster was shown to offer short-term protection, according to the New England Journal of Medicine.
In June, the agency's Vaccines and Related Biological Products Advisory Committee voted overwhelmingly to include an omicron component in COVID-19 booster vaccines. Based on the data supporting each of these authorizations, the updated boosters are expected to provide increased protection against the omicron variant, the FDA said.
With today's authorization, the FDA has also revised the EUA of the Moderna COVID-19 vaccine and the Pfizer-BioNTech COVID-19 vaccine to remove the use of the monovalent Moderna and Pfizer-BioNTech COVID-19 vaccines for booster administration for individuals 18 years of age and older and 12 years of age and older, respectively.
The monovalent vaccines continue to be authorized for use for administration of a primary series for individuals 6 months of age and older.
The amendments to the EUAs were issued to Moderna TX Inc. and Pfizer Inc.
THE LARGER TREND
Individuals who receive the updated booster may experience side effects commonly reported by individuals who receive the original vaccine.
Among the study participants who received the bivalent Moderna vaccine, the most commonly reported side effects included pain, redness and swelling at the injection site, fatigue, headache, muscle pain, joint pain, chills, swelling of the lymph nodes in the same arm of the injection, nausea/vomiting, and fever.
Among the study participants who received the Pfizer bivalent vaccine, the most commonly reported side effects included pain, redness and swelling at the injection site, fatigue, headache, muscle pain, chills, joint pain, and fever.
ON THE RECORD
"The FDA has been planning for the possibility that the composition of the COVID-19 vaccines would need to be modified to address circulating variants. We sought input from our outside experts on the inclusion of an omicron component in COVID-19 boosters to provide better protection against COVID-19. We have worked closely with the vaccine manufacturers to ensure the development of these updated boosters was done safely and efficiently. The FDA has extensive experience with strain changes for annual influenza vaccines. We are confident in the evidence supporting these authorizations," said Dr. Peter Marks, director of the FDA's Center for Biologics Evaluation and Research.
Twitter: @SusanJMorse
Email the writer: SMorse@himss.org
