FDA clears updated COVID boosters for children up to 5 years of age

The Food and Drug Administration announced Wednesday that it has granted an emergency use permit for updated COVID-19 vaccine boosters; for Americans aged 5 years. Boosters can be given at least two months after their previous vaccination.

The Centers for Disease Control and Prevention is expected to sign off on the shots soon, clearing the last hurdle before eligibility for the bivalent vaccines can be extended to these younger age groups.

A CDC spokesman said the agency’s outside vaccine advisers had “already reviewed the relevant data” at a previous meeting and would not need to reconvene, “to avoid delays” in expanding eligibility for the shots.

“As children have returned to school in person and people are resuming pre-pandemic behaviors and activities, there is a potential for increased risk of exposure to the virus that causes COVID-19,” said Dr. Peter Marks, the FDA’s top vaccine official. . , said in a statement.

The FDA said it had reviewed data on the immune response and safety of vaccinations in children who had received a booster of the previous formulation to make its decision.

These new bivalent shots are made using almost the same process by Pfizer-BioNTech and Moderna, except with the addition of a component designed to target the BA.4 and BA.5 variants.

“As families across the country partake in the fall festivities and plan for the upcoming holiday season, we aim to provide school-aged children with additional protection against the Omicron BA.4/BA.5 sub-variants, which continue to account for more than 80% of cases in the US,” Pfizer CEO Albert Bourla said in a statement.

Pre-ordering ended last week for new vaccines from Pfizer and BioNTech designed for this younger age group. A Pfizer spokesman said they have the ability to ship up to 6 million doses for younger children within the next week, after final quality checks.

A spokesman for the Department of Health and Human Services did not respond to a request for comment on the number of shots requested for the new Pfizer vaccines for younger ages.

Moderna’s booster for children is simply a smaller dose of the same formulation already distributed for older age groups and did not require a pre-order.

Compared to adults, a smaller percentage of children will be eligible to receive the updated booster because fewer have had the vaccine to begin with.

Only about 60.8% of teens 12 and older and 31.5% of children 5 and older have so far received even the first two doses of the COVID vaccine, according to CDC data.

Marks acknowledged that the virus “tends to be less severe in children than adults,” but warned that the children still faced a danger hospitalization or long-term effects from the virus and would benefit from vaccines.

The CDC recently estimated that about 86.3% of children in the US have survived at least one COVID-19 infection, based on testing for antibodies in blood samples.

“We encourage parents to consider primary vaccination for children and follow-up with an updated booster dose when eligible,” said Marks.

Wednesday’s decision doesn’t just let kids under 5 get the updated COVID booster.

Federal health officials previously said they expected those shots could be available for the next youngest age group, up to 6 months old, by winter.

Moderna said Wednesday in a statement that it expects to complete its application for emergency use in this younger age group “later this year.”

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