FDA and CDC clarify updated COVID booster for children under 5

The Food and Drug Administration announced Wednesday that it has granted emergency use authorization for Updated COVID-19 Vaccine Booster For Americans under the age of 5, and the Centers for Disease Control and Prevention officially signed off on their use. booster The vaccine may be given at least two months after your last shot.

“The FDA’s authorization of updated (bivalent) COVID-19 vaccines for this young age group, and CDC’s recommendation for use, are important next steps in our nation’s immunization program — a program that has provided protection against serious COVID-19 disease. and death,” CDC Director Dr. Rochelle Valensky said in a statement.

“As children individually go back to school and people resume pre-pandemic behaviors and activities, there is a potential for increased exposure to the virus that causes COVID-19,” Doctor. Peter Marks, the FDA’s top vaccine official, said in a statement.

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

Aside from adding a component designed to target the BA.4 and BA.5 variants, these new bivalent shots are manufactured in a nearly identical process from Pfizer-BioNtech and Moderna.

“As families across the country participate in the fall festivals and plan for the upcoming holiday season, we aim to provide school-age children with additional protection against the Omicron BA.4/BA.5 subvariant, which is more than 80 percent of the time.” continues to account for more.% of cases in the US,” Pfizer CEO Albert Boerla said in a statement.

New vaccines from Pfizer and BioNTech, designed for this young age group, were pre-ordered last week. A Pfizer spokesperson said they have the capacity to ship up to 6 million doses for young children in the coming weeks after a final quality control check.

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

Moderna’s Booster for Children is a smaller dose of the same formulation already being distributed for older age groups, and does not need to be pre-ordered.

Compared to adults, a smaller proportion of children will be eligible to receive an updated booster, as fewer people have received the vaccine initially.

According to CDC data, only 60.8% of adolescents 12 and over and 31.5% of children 5 and older have received their first two COVID vaccine doses so far.

Marx acknowledged that the virus is “less severe in children than in adults,” but warned that Children still faced risk Long-term effects from hospitalization or the virus and shots will benefit.

The CDC recently estimated that about 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 primary vaccination for children and follow up with an updated booster dose if eligible,” Marks said.

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

Federal health officials have previously said they hope these shots can be made available to the next youngest age group, those under 6 months old, by winter.

Moderna said in a release Wednesday that it expects to complete its application for emergency use authorization in this youngest age group “at the end of this year.”

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