FDA says some kids won’t get the latest COVID booster until next year

Almost all Americans Latest COVID-19 vaccinefollowing the decision to extend emergency use authorization for shots from Moderna and Pfizer-BioNTech to most children 6 months of age.

The Food and Drug Administration extended approval On Thursday, it will clear all recipients of Moderna’s COVID-19 vaccine to get a booster dose from the company’s latest “bivalent” vaccine (tailored to the recent Omicron variant). At least two months after the last “monovalent” shot.

But only some of the youngest children vaccinated by Pfizer-Biontech will be eligible for the latest COVID vaccine this year.

The FDA had previously approved Pfizer’s shots for this age group as a three-time “primary series.”

Now the FDA says only children who have not yet completed their third dose can replace their last dose with the updated vaccine. Early adopters will have to wait until the FDA receives more data next year.

“Data supporting the updated bivalent booster dose for these children will be available in January, and the agency is committed to evaluating these data as soon as possible,” the FDA said in a statement. Stated.

Officials said they expect children in this age group to continue to receive “protection against the most severe consequences” from the current variant.

Pfizer spokeswoman Julia Michelle Cohen said in an email, “Due to the lack of clinical data at this time regarding the third priming followed by the fourth (booster) dose of the first vaccine in this age group, It cannot be estimated,” he said. .

The final hurdle to clearing vaccinations formulated for the youngest children comes from the Centers for Disease Control and Prevention.

CDC spokesperson Kristen Nordlund said in an email, “We are aware of the FDA approval and the next step will be a review of the data by the CDC, after which injections will be available for children. .

Nordlund declined to say whether the agency plans to skip consulting outside vaccine advisers before making decisions, as has happened with some recent booster eligibility expansions.

Jurisdictions closed pre-orders for the updated bivalent shot for youngest children earlier this week. planning document Published by the CDC. The agency said there would be “ample but finite supply” of shots available.

Only a fraction of the latest COVID-19 vaccines purchased by the Biden administration from Pfizer and Moderna have been used to date.

less than 15% Americans ages 5 and older who were previously eligible to obtain a renewed booster have now obtained one. Less than a third of her older people, the most vulnerable age group, have received the new immunizations. first expanded in September.

Among children under the age of 5, less than 5% Completed the primary series of COVID vaccinations.

“I think the uptake was terribly slow,” CDC’s Barbara Mahon, director of the CDC’s Proposed Coronavirus and Other Respiratory Viruses Division, said at a meeting Wednesday.

More changes are likely to come soon, Mahon said.

US health officials, as European regulators, had previously planned to switch all COVID-19 vaccines to bivalent formulations. recently decided to allowCDC officials say changes will be necessary as much of the US monovalent vaccine stock is expiring.

“We also look forward to some future policy discussions regarding the use of boosters and bivalent vaccines in children under 5, and the transition of the primary series from monovalent to bivalent COVID 19 vaccines,” Mahon said. said.

https://www.cbsnews.com/news/covid-19-vaccine-booster-kids-fda-bivalent-shots-next-year/ FDA says some kids won’t get the latest COVID booster until next year

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