FDA OKs Pfizer’s bivalent COVID-19 booster for young children with three monovalent shots

Key takeaways:

• The FDA expanded its emergency use authorization for Pfizer-BioNTech’s bivalent COVID-19 vaccine to include infants and toddlers who have previously received three monovalent vaccine doses.
• Children aged 6 months to 4 years who completed a three-dose primary series of the monovalent vaccine 2 or more months ago are now eligible for the bivalent booster.
• Patients in the same age group who received two primary series doses of the monovalent vaccine are advised to complete their series with a dose of bivalent vaccine and are not eligible for a booster.

The FDA said children aged 6 months to 4 years who completed a three-dose series of Pfizer-BioNTech’s monovalent COVID-19 vaccine can now receive the company’s bivalent booster under an expanded emergency use authorization.

Children who have received three monovalent doses were excluded from the initial authorization of Pfizer’s bivalent shot for this age group in December. The shot protects against both the original strain of SARS-CoV-2 and the omicron variant.

Under the expanded EUA, the bivalent booster dose may be given to children at least 2 months after they received a third dose of Pfizer’s monovalent vaccine. The FDA said children who have not yet completed their primary series should complete it with a dose of bivalent vaccine and are not eligible for a bivalent booster.

“[This] authorization provides parents and caregivers of children aged 6 months through 4 years of age who received the three-dose primary series with the monovalent Pfizer-BioNTech COVID-19 vaccine an opportunity to update their children’s protection by receiving a booster dose with the Pfizer-BioNTech COVID-19 bivalent vaccine,” Peter Marks, MD, PhD, director of the FDA’s Center for Biologics Evaluation and Research, said in a press release.

In the release, the FDA said immune response data from a study of 60 children aged 6 months to 4 years showed that participants had an immune response to both strains 1 months after receiving the bivalent shot.

It also detailed findings from a clinical study that included 24 participants aged 6 months through 23 months and 36 participants aged 2 years through 4 years of age. Common side effects in the former group included irritability, drowsiness, injection site redness, pain and swelling, decreased appetite, fatigue and fever; and the most common side effects in the latter group included fatigue, injection site pain, redness and swelling, diarrhea, vomiting, headache, joint pain and chills.

As of March 1, the CDC reported that approximately 2 million children aged 6 months to 4 years in the U.S. had received a single dose of COVID-19 vaccine, representing just 12% of that population. About 15 million children in that age group have yet to receive their first dose.

According to the AAP, 17,843 new pediatric COVID-19 cases were reported in the U.S. during the week ending March 9, representing 10.8% of all weekly reported cases, bringing the total number of pediatric cases to 15,493,835.

“Currently available data show that vaccination remains the best defense against severe disease, hospitalization and death caused by COVID-19 across all age groups, and we encourage all eligible individuals to make sure that their vaccinations are up to date with a bivalent COVID-19 vaccine,” Marks said.

References:

Children and COVID-19: State-level data report. https://www.aap.org/en/pages/2019-novel-coronavirus-covid-19-infections/children-and-covid-19-state-level-data-report/. Published March 9, 2023. Accessed March 15, 2023.

Summary of data publicly reported by the Centers for Disease Control and Prevention. https://www.aap.org/en/pages/2019-novel-coronavirus-covid-19-infections/children-and-covid-19-vaccination-trends/. Published March 1, 2023. Accessed March 15, 2023.