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FDA says some young children may not receive an updated COVID booster until next year

Nearly all Americans will be eligible to receive a dose of the updated COVID-19 vaccinesfollowing a decision to extend the emergency use authorization for injections from Moderna and Pfizer-BioNTech to most children 6 months and older.

The Food and Drug Administration announced the extended authorization on Thursday, authorizing all recipients of Moderna’s COVID-19 vaccine to receive a booster dose of the company’s newer “bivalent” vaccines, which are adapted to recent Omicron variants, at least two months after his last “monovalent” injection.

But only a portion of the youngest children who received the Pfizer-BioNTech vaccines will be eligible to receive a shot of their updated COVID vaccine this year.

The FDA had previously approved Pfizer’s injections in this age group as a “primary series” of three doses, after data suggested that children 6 months to 4 years needed a third child-sized dose to obtain the same protection as adults after two doses.

Now, the FDA says that only children who have not yet completed their third dose can switch from the last shot to an updated vaccine. Early adopters who already completed their third injection a few months ago should wait until the FDA receives more data next year.

“Data to support the administration of an updated bivalent booster dose for these children is expected in January. The agency is committed to evaluating those data as quickly as possible,” the FDA said in a statement.

The agency said it expects children in this age group to continue to have “protection against the most serious outcomes” of current variants.

“At this time, we do not have clinical data in this age group for a fourth (booster) dose of the original vaccine after the third dose of the primary series and therefore we cannot extrapolate yet,” the spokeswoman said. of Pfizer, Julia Michelle Cohen, in an email. .

The final hurdle in clearing vaccines formulated for the youngest children will come from the Centers for Disease Control and Prevention.

“We are aware of the FDA clearance and the next step is CDC review of the data before vaccines can be made available to children,” CDC spokeswoman Kristen Nordlund said in a statement. email.

Nordlund did not say whether the agency plans to skip consulting its outside vaccine advisers before the decision, as it has done for some recent booster eligibility expansions.

Jurisdictions finished placing pre-orders this week for the updated bivalent vaccines for the youngest children earlier this week, according to planning documents published by the CDC. “There will be a sufficient but finite supply” of available vaccines, the agency said.

To date, only a small fraction of the updated COVID-19 vaccines that the Biden administration purchased from Pfizer and Moderna have been used.

Less than 15% of Americans 5 and older, the ages previously eligible for an upgraded booster, have received one so far. Less than a third of older people, the most vulnerable age group, have received the new vaccine, which first released in September.

Among children under 5 years of age, Less than 5% have completed their primary COVID vaccination series.

“I think uptake has been woefully slow,” Barbara Mahon, chief of the CDC’s division of coronaviruses and other respiratory viruses, said in a meeting Wednesday.

More changes could be on the way soon, Mahon said.

US health authorities have previously submitted plans to switch all COVID-19 vaccines to the bivalent formulation, as regulators Europe recently decided to allow. CDC officials have said the change will be necessary as much of the US stock of monovalent vaccines is nearing expiration.

“We also anticipate several upcoming policy discussions around boosters and use of bivalent vaccines in children younger than 5 years, and on transitioning from the primary series of monovalent to bivalent COVID-19 vaccines,” Mahon said.

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