The U.S. Food and Drug Administration today announced it amended the emergency use authorizations of the updated (bivalent) Moderna and Pfizer-BioNTech COVID-19 vaccines to include use in children as young as six months of age.
“Based on available data, the updated, bivalent vaccines are expected to provide increased protection against COVID-19,” said Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research, in a press release on December 8, 2022.
“Parents and caregivers can be assured that the FDA has taken a great deal of care in our review, and we encourage parents of children of any age who are eligible for primary vaccination or a bivalent COVID-19 vaccine booster dose to consider seeking vaccination now as it can potentially help protect them from COVID-19 during a time when cases are increasing.”
For the authorization of a single booster dose of the Moderna COVID-19 Vaccine, Bivalent for children six months through 5 years of age, the FDA relied on immune response data that it had previously evaluated from a clinical study in adults.
In addition, the FDA analyzed data from a clinical study that compared the immune response among 56 study participants 17 months through 5 years of age who received a single booster dose of monovalent Moderna COVID-19 Vaccine at least six months after completion of a two-dose primary series of the vaccine to the immune response among approximately 300 study participants 18 through 25 years of age who had received a two-dose primary series of monovalent Moderna COVID-19 Vaccine in a previous study which determined the vaccine to be effective in preventing COVID-19.
The immune response to the booster dose of the monovalent Moderna COVID-19 Vaccine in the 17 months through 5 years age group was comparable to the immune response to the two-dose primary series in the adult participants.
With today’s action, the monovalent Pfizer-BioNTech COVID-19 Vaccine is no longer authorized as the third dose of the three-dose primary series in children six months through 4 years of age.
The amended authorizations were issued to Moderna TX Inc. and Pfizer Inc.