Headlines about COVID-19 vaccine boosters have slowed. However, the possibility of omicron-targeting boosters rolling out this week has reignited the booster buzz.
Yesterday, the FDA granted emergency use authorizations (EUAs) of both the Moderna COVID-19 vaccine and the Pfizer-BioNTech COVID-19 vaccine to authorize new formulas. The bivalent formula, or “updated boosters,” will now contain two mRNA components of SARS-CoV-2 virus. The first is the original strain of SARS-CoV-2. The second is common between the BA.4 and BA.5 lineages of the omicron variant of SARS-CoV-2.
The goal is to provide better protection against COVID-19 caused by the omicron variant. The BA.4 and BA.5 lineages of the omicron variant are currently causing most cases of COVID-19 in the United States and are predicted to circulate this fall and winter. In June, the agency’s Vaccines and Related Biological Products Advisory Committee voted overwhelmingly to include an omicron component in COVID-19 booster vaccines.
“The COVID-19 vaccines, including boosters, continue to save countless lives and prevent the most serious outcomes (hospitalization and death) of COVID-19,” said Robert M. Califf, MD, FDA Commissioner, “As we head into fall and begin to spend more time indoors, we strongly encourage anyone who is eligible to consider receiving a booster dose with a bivalent COVID-19 vaccine to provide better protection against currently circulating variants.”
For each bivalent COVID-19 vaccine, the FDA based its decision on the totality of available evidence, including extensive safety and effectiveness data for each of the monovalent mRNA COVID-19 vaccines, safety and immunogenicity data obtained from a clinical study of a bivalent COVID-19 vaccine that contained mRNA from omicron variant BA.1 lineage that is similar to each of the vaccines being authorized, and nonclinical data obtained using a bivalent COVID-19 vaccine that contained mRNA of the original strain and mRNA in common between the BA.4 and BA.5 lineages of the omicron variant.
The updated Moderna COVID-19 vaccine is authorized for use as a single booster dose in individuals 18 years of age and older. The updated Pfizer-BioNTech COVID-19 vaccine is authorized for use as a single booster dose in individuals 12 years of age and older. Also, given the new formulations, the monovalent mRNA COVID-19 vaccines are not authorized as booster doses for individuals 12 years of age and older.
Who is eligible to receive the new boosters? Anyone 18 or older is eligible for a single booster dose of the updated Moderna COVID-19 vaccine if it has been at least two months since they have completed primary vaccination or have received the most recent booster dose with any authorized or approved monovalent COVID-19 vaccine.
People 12 years of age and older are eligible for a single booster dose of the updated Pfizer-BioNTech COVID-19 vaccine if it has been at least two months since they have completed primary vaccination or have received the most recent booster dose with any authorized or approved monovalent COVID-19 vaccine.
Pfizer-BioNTech notes that an omicron-adapted bivalent vaccine for children 5 through 11 years of age is planned for submission to the FDA in early October and the companies are working with the FDA to prepare an application for an Omicron-adapted bivalent vaccine in children 6 months through 4 years of age.
“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 Peter Marks, MD, PhD, director of the FDA’s Center for Biologics Evaluation and Research. “The public can be assured that a great deal of care has been taken by the FDA to ensure that these bivalent COVID-19 vaccines meet our rigorous safety, effectiveness, and manufacturing quality standards for emergency use authorization.”