FDA expands bivalent COVID boosters to kids as young as 5

The US Food and Drug Administration (FDA) has updated the emergency use authorizations (EUA) for the bivalent Pfizer-BioNTech and Moderna COVID-19 boosters to expand their use to include children.

On 12 October, FDA announced that children as young as five are now eligible to receive Pfizer’s bivalent booster, while children as young as six may receive Moderna’s updated shot. The shots include a component of the original SARS-CoV-2 virus and a component of the Omicron BA.4 and BA.5 subvariants. The agency emphasized that while the bivalent vaccines were not studied in pediatric clinical trials, the decisions were based on data from clinical studies in adults to conclude the vaccines are safe and effective for children.

“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,” FDA said. “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,” the agency said. “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.”

FDA’s explainer for how it authorized the bivalent vaccines for young children contrasts with how the agency announced its authorization for adults back in August. At the time, regulators noted that their decision was largely based on non-clinical data including mouse studies which raised concerns about the strength of the data. (RELATED: FDA authorizes Pfizer and Moderna’s bivalent COVID vaccines, Regulatory Focus 31 August 2022)

Since then, Center for Biologics Evaluation and Research (CBER) Director Peter Marks has said that the agency’s communication could have been better at explaining that clinical studies of monovalent and other bivalent COVID-19 vaccines, as well as vast amounts of other data, played a large role in its decision to authorize the bivalent boosters. (RELATED: Convergence: Marks admits 'knucklehead' messaging missteps with bivalent boosters, touts RWE for vaccines, Regulatory Focus 13 September 2022)

In step with announcing the expanded EUAs, FDA also said it was no longer allowing Pfizer’s monovalent vaccine as a booster for those aged between five and 11 though both monovalent vaccines will still be authorized as the primary series vaccines for those six months and older.

Marks and other public health officials are concerned the fall season and relaxed COVID-19 rules around the country will lead to an increase in new infections allowing current strains of the virus to further mutate. They are encouraging everyone who is eligible to get vaccinated with the bivalent booster to help prevent spread of the disease and possibly stop the virus from mutating further. They worry that if the virus is allowed continue mutating, a future strain may become resistant to current vaccines.

“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,” said Marks. “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.”

The latest expanded EUA may also foreshadow how FDA plans to continue authorizing newer boosters based on past clinical and non-clinical studies. Marks has said he would like to adopt an annual vaccine update process, similar to how the influenza vaccine is updated, and that 2022 is a transitional year to help inform that process. (RELATED: Convergence: FDA officials on future COVID vaccine updates, remote inspections and hiring, Regulatory Focus 14 September 2022)

FDA expands bivalent COVID boosters to kids as young as 5

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