FDA Authorizes Bivalent Boosters for Children

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On October 12, 2022, the U.S. Food and Drug Administration (FDA) amended the Emergency Use Authorizations (EUAs) for the bivalent COVID-19 vaccine boosters. The updated EUAs for the Moderna and Pfizer-BioNTech bivalent COVID-19 vaccine boosters now permit children between the ages of 5-11 to receive the updated vaccine. Individuals may receive the bivalent booster at least two months after completion of the primary vaccination series or two months after receiving their last booster. Review our Vaccine Eligibility Guide to access up-to-date eligibility information about the COVID-19 vaccines and boosters.

The FDA first authorized the bivalent COVID-19 vaccine boosters for adults on August 31, 2022. At that time, the bivalent boosters replaced the original monovalent boosters, which are no longer available. The bivalent boosters feature an updated formulation that provides broader protection against the highly infectious BA.4 and BA.5 sub-lineages of the omicron variant, in addition to the original strain of COVID-19. To support amending the EUA for the bivalent vaccines and expanding eligibility for children, the FDA assessed clinical trial data from a bivalent vaccine candidate that was tailored towards the BA.1 variant and found that it elicited a strong immune response while meeting the agency’s safety standards. The agency also considered how children tolerated the monovalent vaccine boosters previously and concluded that their immune response was comparable to adults who completed the primary vaccination series. The most common side effects reported by children who received either the monovalent or bivalent vaccine boosters include pain, redness and swelling at the injection site, tiredness, headache, muscle pain, chills, joint pain, underarm swollen lymph nodes in the same arm as the injection, nausea, vomiting and fever.

Interim results from a study sponsored by Moderna indicate that bivalent boosters tailored towards the BA.1 variant stimulate a strong antibody response against the omicron variant without raising any significant safety concerns. Study participants with no prior history of COVID-19 infection who received a BA.1 bivalent vaccine booster produced a stronger antibody response against the BA.1, BA.4, and BA.5 omicron sub-lineages compared to study participants who received the original monovalent vaccine booster. Recipients of the bivalent vaccine also produced a stronger antibody response to the alpha, beta, gamma, and delta variants. Based on this preliminary data, it appears that the bivalent vaccine booster may provide broader protection against several different variants of COVID-19 compared to the original monovalent vaccine.

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