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US: FDA authorises COVID-19 vaccines for children under 5

The US Food and Drug Administration (FDA) has authorised two COVID-19 vaccines for children under five, opening the door to vaccinating millions of the country’s youngest children once the Centers for Disease Control and Prevention (CDC) agrees.

The FDA on Friday authorised Pfizer-BioNTech’s vaccine for children aged six months to four years and Moderna’s shot for those aged six months to 17 years. Pfizer’s is already authorised for those over the age of five.

US President Joe Biden said vaccines could be rolled out to the under-five age groups as early as next week across the United States. The CDC needs to make its recommendations on how the jabs should be administered before a vaccination campaign can begin in earnest, however.

“For parents across the U.S., today is a day of relief,” Biden said in a tweet.

“As early as next week, pending CDC recommendations, parents will be able to offer their youngest the protection of a COVID-19 vaccine,” he said.

Still, it remains uncertain how many parents want their youngest vaccinated. By some estimates, three-quarters of all children have already been infected. And only about 30 percent of children aged five to 11 have been vaccinated since Pfizer’s shots opened to them last November.

A panel of outside advisers began meeting on Friday to consider a recommendation to the CDC on the jabs for those under five years old and will vote on Saturday, likely followed by the CDC itself greenlighting the recommendation.

The final signoff will be made by 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.

COVID-19 is generally milder in children. Still, since March 2020 it has been the fifth-leading cause of death in children aged one to four, and the fourth-leading cause of death in children under one year, according to the CDC.

Roughly 440 children under age five have died from COVID-19, federal data showed.

“Although the number of deaths in children is small by adult standards, any death of a child is tragic and should be prevented if possible,” FDA Commissioner Robert Califf said at a news conference on Friday.

“By vaccinating our youngest children, we hope to prevent the most devastating consequences of COVID.”

Public health officials and experts have said that even though a large portion of small children was infected during the winter surge due to the Omicron variant of the coronavirus, natural immunity wanes over time and vaccinations should help prevent hospitalisations and deaths when cases rise again.

The CDC advisers will meet again next week to consider whether to back the use of Moderna for older children, aged six to 17. There has been some concern about the rate of rare cases of heart inflammation in young men from the Moderna vaccine, and the advisers were expected to consider that data.

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