FDA clears updated COVID boosters for 5-year-olds


The Food and Drug Administration announced Wednesday that it has granted emergency use authorization for updated COVID-19 vaccine boosters for Americans as young as 5 years old. Revaccination can be given at least two months after the previous vaccination with the vaccine.

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

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 be reconvened “to avoid delays” in expanding vaccination eligibility.

“As children have returned to school in person and people are returning to pre-pandemic behaviors and activities, there is the potential for increased exposure to the virus that causes COVID-19,” Dr. Peter Marks, the FDA’s chief vaccine officer. , said Va claim.

The FDA said it took into account immune response and safety data from injections in children who received the previous formulation’s booster in making the decision.

These new bivalent shots are produced by a nearly identical process from Pfizer-BioNTech and Moderna, except for the addition of a component designed to target the BA.4 and BA.5 variants.

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

Last week, pre-ordering was completed for new vaccines from Pfizer and BioNTech formulated for this younger age group. A Pfizer spokesman said they are able to ship up to 6 million doses for younger children over the next week after their final quality check.

A spokesman for the Department of Health and Human Services did not respond to a request for comment on how many injections were required of Pfizer’s new vaccines for younger age groups.

Moderna booster for children is simply a smaller dose in the same formulation that is already distributed for older age groups and did not need to be pre-ordered.

Compared to adults, a smaller proportion of children will be eligible for an updated booster because fewer have received the vaccine to begin with.

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

Marks acknowledged that the virus “tends to be less severe in children than in adults,” but cautioned that children still faced risk hospitalization or long-term effects of the virus and would benefit from the injections.

CDC recently estimated that approximately 86.3% of children in the US have survived at least one COVID-19 infection, based on a survey of antibodies in blood samples.

“We encourage parents to consider vaccinating children at baseline and follow-up with an updated booster if appropriate,” Marks said.

Wednesday’s ruling leaves only children under the age of 5 ineligible to receive an updated COVID booster.

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

Moderna said on Wednesday release that it expects to complete its emergency use permit application in this youngest age group “later this year.”



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