Updated coronavirus boosters are now available for children as young as 5

Updated coronavirus booster shots are now available for children as young as 5, following emergency clearance Wednesday from the Food and Drug Administration.

Hours after the FDA action, Rochelle Walensky, director of the Centers for Disease Control and Prevention, recommended injections — the final step before vaccines could be given.

The reformulated boosters are bivalent – ​​they include components of the original strain of the virus and the omicron BA.4 and BA.5 subvariants, which account for approximately 80% of the virus circulating in the United States, According to the CDC.

Health officials said the redesigned boosters are needed to bolster protection that has waned since previous vaccinations and to counter new variants that are more transmissible and able to evade immune defenses.

The FDA has granted emergency use authorization for Pfizer-BioNTech’s updated booster shot for children ages 5 to 11. This shot has already been authorized for people aged 12 and over. The agency also licensed the updated Moderna booster for children ages 6-17. Previously, it was allowed for ages 18 and older.

“Since children have returned to in-person school and people are resuming their pre-pandemic behaviors and activities, there is an increased risk of exposure to the virus that causes covid-19,” said Peter Marks, the FDA’s top vaccine official. in a report. “Vaccination remains the most effective measure to prevent the serious consequences of covid-19, including hospitalization and death.”

The new Moderna boosters are available immediately at pharmacies and doctor’s offices, federal officials said. The Pfizer-BioNTech boosters should be available next week. Former monovalent boosters are no longer approved for these age groups, the FDA said.

The new recalls are “very good news for children and their families,” said James Campbell, professor of pediatrics at the University of Maryland School of Medicine. He said some adults are wrongly downplaying the risk that covid poses to children.

“It’s a mistake to believe that children don’t get sick, or seriously ill, from covid,” Campbell said. “And it’s a mistake to constantly compare the severity of covid in children to covid in adults.”

Instead, he said, covid should be compared to other pediatric diseases, adding that covid is the leading cause of death in children.

But whether parents will get their kids the boosters retrofitted is far from clear. From the FDA rushed bivalent reminders for older age groups in late August, adoption was disappointingly slow. Only about 11.5 million Americans received the updated snaps, according to CDC data through Oct. 6.

On Tuesday, Ashish Jha, the White House’s covid-19 coordinator, called on Americans to get the revamped boosters by Halloween so the protection goes into effect by Thanksgiving.

“If you are up to date with your vaccines and are being treated, if you have a breakthrough infection, your risk of dying from covid is now close to zero,” Jha said during a Tuesday briefing.

He and other Biden administration officials have expressed concern that the cooler weather will lead to an increase in covid cases as people move indoors and respiratory infections spread.

Vaccinations of children and adolescents with the two-shot primary series have also been delayed. According to an American Academy of Pediatrics, only 31% of children aged 5 to 11 received both injections and 58% of 12 to 17 year olds completed the series. CDC data analysis.

Updated boosters can be given at least two months after the initial two-shot series of the vaccine or after a previous booster.

In authorizing the new youth boosters, the FDA said it was relying on data on safety and immune responses it had previously evaluated in a clinical study involving adults who received a booster with components of the original strain and the omicron BA.1.

The FDA “considers these data to be relevant and supportive of vaccines containing a component of the BA.4 and BA.5 lines of the omicron variants,” the agency said. The FDA also reviewed other data, including the vaccine’s real-world performance.

FDA officials said approval of a bivalent booster for children under 5 is several months away.

The federal government has purchased more than 170 million booster doses of bivalent coronavirus vaccines for distribution as part of a campaign planned for the fall and early winter to increase protection against circulating strains of the virus.

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