FDA delays meeting on COVID-19 vaccines for kids under 5

the covid pandemic maybe wreaking havoc on most industries. But for companies like Pfizer known the world over for having not only one of the flagship Covid vaccines, but also one of the leading Covid treatment pills business is booming in 2022 alone, the drug company expects to sell $54 billion of its Covid vaccine and treatment pilpacks loaded with a total $102 billion worth of pharmaceuticals being sold under all of the companies brands and the covid pandemic may continue to be a lucrative time for the drug manufacturer. The company recently began trials for a vaccine that works specifically with the omicron variant, which the company's ceo says should be ready next month and trials are set to begin for Covid vaccine testing in Children under five years old, which CNBC reports is the last age group yet to get the green light. Still, while the company projects its highest earnings likely ever in 2022 it underperformed revenue wise last year with Pfizer's stock dropping around 3% after posting fourth quarter results. Yeah,

U.S. regulators on Friday put the brakes on their push to speed Pfizer's COVID-19 to children under 5, creating major uncertainty about how soon the shots could become available.The Food and Drug Administration had urged Pfizer and its partner BioNTech to apply for authorization of extra-low doses of its vaccine for the youngest children before studies were even finished — citing the toll the omicron variant has taken on children.Next week, FDA advisers were supposed to publicly debate if youngsters should starting getting two shots before it's clear if they'd actually need a third.But Friday, the FDA reversed course and said it had become clear it needed to wait for data on how well that third shot works for this age group. Pfizer said in a statement that it expected the data by early April.FDA’s vaccine chief Dr. Peter Marks said he hoped parents would understand that the decision to delay was part of the agency’s careful review and high scientific standards."We take our responsibility for reviewing these vaccines very seriously because we’re parents as well," Marks told reporters during a teleconference.Pfizer’s early data showed two of the extra-low doses were safe for kids under 5 and strong enough to give good protection to babies as young as 6 months. But once tots reached the preschool age — the 2- to 4-year-olds — two shots didn’t rev up enough immunity.And a study of a third dose isn’t finished yet — meaning the FDA was considering whether to authorize two shots for now with potentially a third cleared later, something highly unusual.Friday, the FDA didn’t say exactly what new data Pfizer was providing except that it involved the critical issue of a third dose."We believe additional information regarding evaluation of a third dose should be considered as part of our decision-making," the agency said in a statement.The nation’s 18 million children under 5 are the only age group not yet eligible for vaccination.

WASHINGTON —

U.S. regulators on Friday put the brakes on their push to speed Pfizer's COVID-19 to children under 5, creating major uncertainty about how soon the shots could become available.

The Food and Drug Administration had urged Pfizer and its partner BioNTech to apply for authorization of extra-low doses of its vaccine for the youngest children before studies were even finished — citing the toll the omicron variant has taken on children.

Next week, FDA advisers were supposed to publicly debate if youngsters should starting getting two shots before it's clear if they'd actually need a third.

But Friday, the FDA reversed course and said it had become clear it needed to wait for data on how well that third shot works for this age group. Pfizer said in a statement that it expected the data by early April.

FDA’s vaccine chief Dr. Peter Marks said he hoped parents would understand that the decision to delay was part of the agency’s careful review and high scientific standards.

"We take our responsibility for reviewing these vaccines very seriously because we’re parents as well," Marks told reporters during a teleconference.

Pfizer’s early data showed two of the extra-low doses were safe for kids under 5 and strong enough to give good protection to babies as young as 6 months. But once tots reached the preschool age — the 2- to 4-year-olds — two shots didn’t rev up enough immunity.

And a study of a third dose isn’t finished yet — meaning the FDA was considering whether to authorize two shots for now with potentially a third cleared later, something highly unusual.

Friday, the FDA didn’t say exactly what new data Pfizer was providing except that it involved the critical issue of a third dose.

"We believe additional information regarding evaluation of a third dose should be considered as part of our decision-making," the agency said in a statement.

The nation’s 18 million children under 5 are the only age group not yet eligible for vaccination.

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