US: FDA approves COVID-19 vaccines for children under 5 years old

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US President Joe Biden says jabs could be rolled out to that age group as early as next week, pending approval by the CDC.

The U.S. Food and Drug Administration (FDA) has approved two COVID-19 vaccines for children under the age of five, opening the door to vaccinating millions of the nation’s youngest children once the Centers for Disease Control and Prevention (CDC) reports CDC) agree.

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

US President Joe Biden said vaccines could be rolled out to under-fives in the United States as early as next week. However, the CDC must make its recommendations about how the shots should be administered before a vaccination campaign can begin in earnest.

“Today is a day of relief for parents across the US,” Biden said in a tweet.

“Pending CDC recommendations, parents can offer their youngsters the protection of a COVID-19 vaccine next week,” he said.

The development is because many parents in the US are eager to vaccinate their children.

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

A panel of outside advisors began meeting Friday to consider a recommendation to the CDC about the jabs for children under five and will vote on Saturday, likely followed by the CDC itself giving the green light to the recommendation.

The final sign-off will be made by CDC Director Dr. Rochelle Walensky.

During a Senate hearing on Thursday, Walensky said her staff worked over the June federal holiday weekend, “because we understand the urgency of this for American parents.”

She said the infant mortality rate due to COVID-19 is higher than what is generally seen with flu per year.

“So I actually think we need to protect young children, as well as everyone with the vaccine and especially the elderly,” she said.

It remains unclear how many parents will have their young children vaccinated [File: Hannah Beier/Reuters]

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

About 440 children under the age of five have died from COVID-19, federal data shows.

“While the number of child deaths 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 Friday.

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

Public health officials and experts have said that while a large proportion of small children have been infected during the winter wave due to the Omicron variant of the coronavirus, natural immunity wanes over time and vaccinations should help prevent hospitalizations and deaths when the number increases again.

The CDC advisers will meet again next week to consider supporting the use of Moderna for older children ages 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 consultants were expected to consider those data.





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