BOOM: FDA & CDC officially approve BIVALENT COVID-19 vaccines/boosters for children as young as 5 years old
Coronavirus (COVID-19) Update: FDA Authorizes Moderna and Pfizer-BioNTech Bivalent COVID-19 Vaccines for Use as a Booster Dose in Younger Age Groups
Today, the U.S. Food and Drug Administration amended the emergency use authorizations (EUAs) of the Moderna COVID-19 Vaccine, Bivalent and the Pfizer-BioNTech COVID-19 Vaccine, Bivalent to authorize their use as a single booster dose in younger age groups. The Moderna COVID-19 Vaccine, Bivalent is authorized for administration at least two months following completion of primary or booster vaccination in children down to six years of age. The Pfizer-BioNTech COVID-19 Vaccine, Bivalent is authorized for administration at least two months following completion of primary or booster vaccination in children down to five years of age.
These bivalent COVID-19 vaccines 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 mRNA in these vaccines is a specific piece of genetic material that instructs cells in the body to make the distinctive “spike” protein of the original virus strain and the omicron variant lineages BA.4 and BA.5. The spike proteins of BA.4 and BA.5 are identical.
“Since children have gone back to school in person and people are resuming pre-pandemic behaviors and activities, there is the potential for increased risk of exposure to the virus that causes COVID-19. Vaccination remains the most effective measure to prevent the severe consequences of COVID-19, including hospitalization and death,” said Peter Marks, M.D., Ph.D. “While it has largely been the case that COVID-19 tends to be less severe in children than adults, as the various waves of COVID-19 have occurred, more children have gotten sick with the disease and have been hospitalized. Children may also experience long-term effects, even following initially mild disease. We encourage parents to consider primary vaccination for children and follow-up with an updated booster dose when eligible.”
With today’s authorization, the monovalent Pfizer-BioNTech COVID-19 Vaccine is no longer authorized as a booster dose for individuals five through 11 years of age. Both the Moderna COVID-19 Vaccine and Pfizer-BioNTech COVID-19 Vaccine continue to be authorized for primary series administration in individuals six months of age and older.
For each of the bivalent COVID-19 vaccines authorized today, the FDA relied on immune response and safety data that it had previously evaluated from a clinical study in adults of a booster dose of a bivalent COVID-19 vaccine that contained a component of the original strain of SARS-CoV-2 and a component of omicron lineage BA.1. The FDA considers such data as relevant and supportive of vaccines containing a component of the omicron variant BA.4 and BA.5 lineages. In addition, the FDA has evaluated and considered immune response and safety data from clinical studies of the monovalent mRNA COVID-19 vaccines, including as a booster dose in pediatric age groups. These data and real-world experience with the monovalent mRNA COVID-19 vaccines, which have been administered to millions of people, including young children, support the EUA of the bivalent COVID-19 vaccines in younger age groups.
CDC Expands Updated COVID-19 Vaccines to Include Children Ages 5 Through 11
Today, CDC’s Director Rochelle P. Walensky, M.D., M.P.H., signed a decision memo expanding the use of updated (bivalent) COVID-19 vaccines to children ages 5 through 11 years. This follows the Food and Drug Administration’s (FDA) authorization of updated COVID-19 vaccines from Pfizer-BioNTech for children ages 5 through 11 years, and from Moderna for children and adolescents ages 6 through 17 years.
Updated COVID-19 vaccines add Omicron BA.4 and BA.5 spike protein components to the current vaccine composition, helping to restore protection that has waned since previous vaccination and targeting recent Omicron variants that are more transmissible and immune-evading.
FDA’s authorization of updated (bivalent) COVID-19 vaccines for this younger age group, and CDC’s recommendation for use, are critical next steps forward in our country’s vaccination program—a program that has helped provide increased protection against severe COVID-19 disease and death.
Get vaxxed. Get boosted. Wear a KN-95 mask when indoors at crowded public locations.