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The Food and Drug Administration (FDA) has authorized bivalent COVID-19 vaccine boosters from two manufacturers, one of which could be used for children as young as 12 years.
The Centers for Disease Control and Prevention’s (CDC’s) vaccine committee will discuss the boosters Thursday, and the CDC director could sign off that evening.
The bivalent vaccine boosters contain both the original strain of SARS-CoV-2 and the omicron BA.4/5 variant. About 89% of circulating strains are BA.5, and nearly all the rest are BA.4, according to the CDC. Officials have been preparing for a possible surge this fall and winter as people spend more time indoors.
During a press conference Wednesday, FDA Commissioner Robert M. Califf, M.D., said the updated boosters provide an opportunity to get ahead of a predicted wave of COVID-19.
“These updated boosters are critical in helping protect teens and adults from the most serious outcomes of COVID-19 caused by the currently circulating variant,” he said.
Under the emergency use authorization (EUA), the Pfizer-BioNTech bivalent booster could be used for people ages 12 and older, and the Moderna bivalent booster could be used for those ages 18 and older. A booster could be given as a single dose at least two months after a primary series or booster with any authorized monovalent COVID-19 vaccine.
Safety and immunogenicity data came from clinical studies of bivalent COVID-19 vaccine that contained mRNA from omicron BA.1 lineage, which the FDA considers similar to BA.4/5. People who received a bivalent booster had better immune responses against BA.1 than those who received a monovalent booster, according to the FDA. Officials also looked at animal data using the BA.4/5 strain.
The most common side effects among human study participants receiving a bivalent booster with the BA.1 strain were injection site pain, fatigue, headache, muscle/joint pain, chills, swelling of the lymph nodes, nausea/vomiting and fever.
FDA officials noted most of the components in the updated boosters are the same as the vaccines that have been given to more than 200 million people in the U.S. They also noted flu vaccine strains change annually without clinical trials.
“Ultimately the public can rest assured that a great deal of care has been taken by the FDA to ensure these updated boosters meet our rigorous safety, effectiveness and manufacturing quality standards for emergency use authorization,” said Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research.
The FDA’s authorization of the monovalent vaccines also has changed. They no longer can be used for boosters in age groups eligible for a bivalent booster. However, they still are authorized for use as a primary series in people 6 months and older. The monovalent Pfizer-BioNTech vaccine also can continue to be used as a single booster for children ages 5-11 years at least five months after a Pfizer-BioNTech primary series.
- CDC planning guide for bivalent COVID vaccine boosters
- CDC information on COVID-19 vaccine boosters
- CDC clinical considerations for administering COVID-19 vaccines
- Information from the CDC on COVID-19 vaccination of children and teens
- AAP COVID vaccination resources
- AAP pediatric COVID-19 vaccine dosing quick reference guide
- AAP/Health and Human Services COVID vaccine toolkit
- Information from HealthyChildren.org on preparing children for a COVID-19 vaccine