Pfizer says its COVID-19 vaccine is safe, effective for children ages 5 to 11

JACKSONVILLE, Fla. – Pfizer said Monday its COVID-19 vaccine works for children ages 5 to 11.

Dr. Bill Gruber, a Pfizer elder vice president, said Pfizer and its German spouse BioNTech purpose to use to the Food and Drug Administration by the extremity of the period for exigency usage successful this property group.

Pfizer’s vaccine already is disposable for anyone 12 and older.

For simple school-aged children, Pfizer tested a overmuch little dose — a 3rd of the magnitude that’s successful each changeable fixed now. Yet aft their 2nd dose, children ages 5 to 11 developed coronavirus-fighting antibody levels conscionable arsenic beardown arsenic teenagers and young adults getting the regular-strength shots, Gruber said.

The kid dosage besides proved safe, with akin oregon less impermanent broadside effects — specified arsenic sore arms, fever oregon achiness — that teens experience, helium said.

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Dr. Mobeen Rathore, a pediatric infectious illness specializer astatine UF Health Jacksonville, said helium was expecting these results.

“There was nary crushed to judge the vaccine would not beryllium harmless oregon not beryllium efficacious,” Rathore said Monday.

Pfizer said it studied the little dose successful 2,268 kindergartners and simple school-aged children who were fixed 2 doses 3 weeks apart. The proceedings utilized 10-microgram doses compared to the 30-microgram doses for radical 12 and older.

“They’re utilizing a little dose of the vaccine — which is what each of the vaccines that are being considered for younger property groups are looking at,” Rathore said.

The FDA required what is called an immune “bridging” study: grounds that the younger children developed antibody levels already proven to beryllium protective successful teens and adults. That’s what Pfizer reported Monday successful a quality release, not a technological publication. The survey inactive is ongoing, and determination haven’t yet been capable COVID-19 cases to comparison rates betwixt the vaccinated and those fixed a placebo — thing that mightiness connection further evidence.

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“I’m definite that the FDA advisory committee volition beryllium weighing the hazard benefits. We cognize determination are tons of cases successful children, but the hazard of dying is inactive very, precise low, truthful that hazard payment is going to beryllium precise important to beryllium weighed,” said Admiral Dr. Brett Giroir, erstwhile adjunct caput of U.S. Department of Health and Human Services.

The survey isn’t ample capable to observe immoderate highly uncommon broadside effects, specified arsenic the bosom inflammation that sometimes occurs aft the 2nd dose, mostly successful young men. FDA main Dr. Peter Marks said the pediatric studies should beryllium ample capable to regularisation retired immoderate higher hazard to young children. Gruber said that erstwhile the vaccine is authorized for younger children, they’ll beryllium cautiously monitored for uncommon risks conscionable similar everyone else.

If Pfizer’s vaccine is approved for children ages 5 to 11, that would mean much than 28 cardinal further radical would beryllium eligible to get vaccinated against COVID-19.

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A 2nd U.S. vaccine maker, Moderna, besides is studying its shots successful simple school-aged children. Pfizer and Moderna are studying adjacent younger tots arsenic well, down to 6-month-olds. Results are expected aboriginal successful the year.

According to the Centers for Disease Control and Prevention, 46% of each 12- to 17-year-olds person been vaccinated.

The announcement follows a Friday FDA advisory committee meeting, wherever a sheet recommended Pfizer booster shots for patients 65 and older and for radical who are astatine hazard of terrible illness.

“This is simply a radical of different doctors who counsel the FDA, fundamentally voted to say, listen, absolutely. Booster vaccines for Pfizer is simply a bully thought for those implicit 65,” explained Dr. Jonathan Kantor.

Kantor pointed retired that the CDC inactive hasn’t made a proposal connected that.

Notably, a caller CDC-led survey finds Moderna is 93% effectual astatine keeping COVID patients retired of the hospital, Pfizer is 88% effectual and the J&J changeable is 71% effective.

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