dr Sandra Hughes prepares to manage a primary dose of the Pfizer-BioNTech coronavirus vaccine (COVID-19) to Elise Langevina, 6, in Storrs, Connecticut, US, November 3, 2021.
Michelle McLoughlin | Reuters
Pfizer and BioNTech on Tuesday requested the Meals and Drug Administration to authorize a 3rd dose of its Covid vaccine for youngsters ages 5 to 11.
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 improve in antibody ranges in opposition to the omicron variant after a 3rd dose in contrast with two doses of the vaccine.
The booster shot is a 10-microgram dose, the identical degree as the first vaccination sequence for the age group. The third shot didn’t reveal any new security issues within the trial, in line with Pfizer.
Solely about 28% of youngsters ages 5 to 11 had acquired their main sequence of two doses as of April, in line with CDC knowledge.
The FDA in January licensed Pfizer booster doses for youngsters 12 to fifteen years previous because the omicron variant swept the nation. The safety the vaccines present in opposition to 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. Nonetheless, the vaccines are nonetheless offering sturdy safety in opposition to 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 skin professional panel earlier than authorizing third photographs for youths ages 12 to fifteen in January and fourth photographs for individuals ages 50 and older final month.
Members of the FDA panel in addition to the Facilities for Illness Management and Prevention’s advisory committee have criticized the businesses for repeatedly transferring ahead with expanded booster eligibility with out consulting them. A number of specialists on the CDC committee, in a public assembly final week, stated attempting to cease infections with the present vaccines is an unachievable purpose. The CDC committee members largely agreed that public well being authorities ought to inform the general public extra clearly that the purpose of the vaccines is to stop extreme sickness, which the photographs have largely achieved.
Pfizer can be looking for FDA authorization for its three-shot vaccine for youngsters below 5 years previous, the one age group left within the US that’s not eligible for vaccination. CEO Albert Bourla, in a podcast interview final week, stated he hopes the vaccine for that age group will obtain authorization in June. The photographs for the youngest children have a a lot smaller, 3-microgram dosage degree.
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