The FDA has amended the emergency use authorizations of the Moderna and Pfizer COVID-19 vaccines to authorize bivalent formulations of these vaccines for use as a single booster dose at least two months following primary or booster vaccination.
Bivalent formulations – to be known as updated boosters – include components to target the original strain of COVID-19, as well as the omicron variant.
Based on the data supporting each of these authorizations, the bivalent COVID-19 vaccines are expected to provide increased protection against the currently circulating omicron variant. Individuals who receive a bivalent COVID-19 vaccine may experience side effects commonly reported by individuals who received either vaccine. This can include headache, fever, tiredness, muscle pain, chills, nausea, and pain, redness or swelling at the injection site.
To evaluate the effectiveness of a single booster dose of the Moderna COVID-19 Vaccine, Bivalent for individuals 18 years of age and older, the FDA analyzed immune response data among approximately 600 individuals 18 years of age and older who had previously received a two-dose primary series and one booster dose of monovalent Moderna COVID-19 Vaccine.
These participants received a second booster dose of either the monovalent Moderna COVID-19 Vaccine or Moderna’s investigational bivalent COVID-19 vaccine at least 3 months after the first booster dose. After 28 days, the immune response of the participants who received the bivalent vaccine was better than the immune response of those who had received the monovalent Moderna COVID-19 Vaccine.
To evaluate the effectiveness of a single booster dose of the Pfizer-BioNTech COVID-19 Vaccine, Bivalent for individuals 12 years of age and older, the FDA analyzed immune response data among approximately 600 adults greater than 55 years of age who had previously received a two-dose primary series and one booster dose with the monovalent Pfizer-BioNTech COVID-19 Vaccine.
These participants received a second booster dose of either the original Pfizer-BioNTech COVID-19 Vaccine or Pfizer-BioNTech’s investigational bivalent COVID-19 vaccine 4.7-13.1 months after their first booster dose. After one month, the immune response of the participants who received the bivalent dose was better than the immune response of those who had received the original Pfizer-BioNTech COVID-19 Vaccine.
