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Pfizer asks FDA to authorize third dose for youngsters 5 to 11 years outdated


Dr. Sandra Hughes prepares to manage a primary dose of the Pfizer-BioNTech coronavirus vaccine (COVID-19) to Elise Langevina, 6, in Storrs, Connecticut, U.S., November 3, 2021.

Michelle McLoughlin | Reuters

Pfizer on Tuesday requested the Meals and Drug Administration to authorize a 3rd dose of its Covid vaccine for youngsters ages 5- to 11-years-old.

The applying comes after Pfizer launched knowledge earlier this month from a small lab examine of blood samples from 30 children within the age group, which confirmed a 36-fold enhance in antibody ranges towards the omicron variant in comparison with two doses of the vaccine.

The booster shot is a 10-microgram dose, the identical stage as the first vaccination collection. The third shot didn’t exhibit any new security issues within the trial, in accordance with Pfizer.

The FDA beforehand approved Pfizer booster doses for youngsters 12 to 15-years-old in January because the omicron variant swept the nation. The safety the vaccines present towards an infection has declined over time, notably within the context of omicron, which is adept at evading the antibodies that block the virus from infecting human cells. Nevertheless, the vaccines are nonetheless offering sturdy safety towards extreme sickness.

It is unclear whether or not the FDA’s advisory committee will meet to debate the info and make a suggestion. The FDA didn’t name conferences of the surface skilled panel earlier than authorizing third pictures for youths ages 12 to fifteen in January and fourth pictures for individuals ages 50 and older final month.

A number of members of the FDA panel in addition to the Facilities for Illness Management and Prevention’s advisory committee have criticized the agencies for repeatedly shifting ahead with expanded booster eligibility with out consulting them.

That is breaking information. Please verify again for updates.

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