Almost all Americans will be eligible to receive a dose of the updated COVID-19 vaccinesfollowing a decision to extend emergency use authorization for Moderna and Pfizer-BioNTech injections to most children as young as 6 months old.
The Food and Drug Administration announced the expanded authorization on Thursday, allowing all recipients of Moderna’s COVID-19 vaccine to receive a booster dose of the company’s new “bivalent” vaccines – which are tailored to recent Omicron variants – at least two months after their last “monovalent” shot.
But only a portion of the youngest children who received the Pfizer-BioNTech injections will be eligible to receive an injection of their updated COVID vaccine this year.
The FDA previously greenlighted Pfizer injections in this age group as a three-dose ‘primary series’, after data suggested children 6 months to 4 years old needed a third dose for a child to obtain protection equivalent to that of adults after two doses.
Now the FDA says only children who haven’t yet completed their third dose can swap the latest vaccine for an updated vaccine. Early adopters who already completed their third injection several months ago should wait for the FDA to receive more data next year.
“Data supporting administration of an updated bivalent booster dose for these children is expected in January. The agency is committed to evaluating this data as soon as possible,” the FDA said. in a press release.
The agency said it expects children in this age group will still be “protected from the most severe consequences” of the 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 yet extrapolate,” said said Pfizer spokeswoman Julia Michelle Cohen in an email. .
The Centers for Disease Control and Prevention announced Friday that it has also approved updated recommendations to clear vaccines for this youngest age group, skipping a meeting of its outside vaccine advisers to weigh the expanded eligibility.
The federal Vaccines.gov portal should will be updated on Friday to allow parents to research the new plans formulated for this youngest age group.
Jurisdictions finished placing preorders this week for updated bivalent vaccines for younger children earlier this week, according to planning documents released by the CDC. “There will be a sufficient but limited supply” of available shots, the agency said.
Only a small fraction of the updated COVID-19 vaccines the Biden administration purchased from Pfizer and Moderna have been used to date.
Less than 15% of Americans ages 5 and older, the ages previously eligible to get an updated booster, have gotten one so far. Less than a third of older people – the most vulnerable age group – have received the new vaccine, which deployed for the first time in September.
Among children under 5, less than 5% have completed their first round of COVID vaccination.
“I think the uptake has been terribly slow,” said CDC’s Barbara Mahon, head of the agency’s proposed coronavirus and other respiratory viruses division, in a meeting Wednesday.
More changes could come soon, Mahon said.
US health authorities previously launched plans to switch all COVID-19 vaccines to the bivalent formulation, as European regulators recently decided to allow it. CDC officials said the change would become necessary because much of the U.S. monovalent vaccine stockpile is about to expire.
“We also anticipate several upcoming policy discussions on recalls and the use of bivalent vaccines in children under 5 years of age, and the transition from the primary series of monovalent vaccines to bivalent COVID 19 vaccines,” Mahon said.
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