US FDA authorises 1st Covid-19 vaccine shots for infants, preschoolers

Agencies |
Jun 18, 2022 05:10 AM IST

While young children generally don’t get as sick from Covid-19 as older kids and adults, their hospitalisations surged during the Omicron wave and FDA’s advisers determined that benefits from vaccination outweighed the minimal risks.

US regulators on Friday authorised the first Covid-19 shots for infants and preschoolers, paving the way for vaccinations to begin next week.

FILE PHOTO: Vials with Pfizer-BioNTech and Moderna coronavirus disease (COVID-19) vaccine labels are seen in this illustration picture.(REUTERS)
FILE PHOTO: Vials with Pfizer-BioNTech and Moderna coronavirus disease (COVID-19) vaccine labels are seen in this illustration picture.(REUTERS)

The Food and Drug Administration’s action follows its advisory panel’s unanimous recommendation for the shots from Moderna and Pfizer. That means US kids under 5 — roughly 18 million youngsters — are eligible for the shots, about one and a half years after the vaccines first became available in the US for adults, who have been hit the hardest during the pandemic.

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There’s one step left: The Centers for Disease Control and Prevention recommends how to use vaccines. Its independent advisers began debating the two-dose Moderna and the three-dose Pfizer vaccines on Friday and will make its recommendation Saturday. A final signoff would come from CDC director Dr Rochelle Walensky.

At a Senate hearing on Thursday, Walensky said her staff was working over the Juneteenth federal holiday weekend “because we understand the urgency of this for American parents”.

She said paediatric deaths from Covid-19 have been higher than what is generally seen from the flu each year.

“So I actually think we need to protect young children, as well as protect everyone with the vaccine and especially protect elders,” she said. The FDA also authorised Moderna’s vaccine for school-aged children and teens. Pfizer’s shots had been the only option for those ages.

For weeks, the Biden administration has been preparing to roll out the vaccines for little kids, with states, tribes, community health centres and pharmacies pre-ordering millions of doses. FDA’s emergency use authorization allows manufacturers to begin shipping vaccine across the country. Vaccinations could begin early next week.


US President Joe Biden on Friday hailed the approval of Pfizer and Moderna vaccines against Covid-19 for younger children as a “huge relief”.

“Today is a day of huge relief for parents and families across America,” Biden said in a statement, adding that it will help “our nation continue to move forward safely”.

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