Why Does Pfizer’s FDA Approval Matter? What Does It Mean For Vaccine Requirements?

The Food and Drug Administration has given the Pfizer-BioNTech COVID-19 vaccine its complete approval, describing it as a “major achievement for public health.”

For people aged 16 and up, the two-dose vaccine is now fully licensed. The vaccine is still accessible under an FDA emergency use permission for children aged 12 to 15, as well as those who are immunocompromised and require a booster shot.

“The public may be extremely sure that this vaccination meets the rigorous requirements for safety, effectiveness, and manufacturing quality that the FDA expects of an approved product,” according to the FDA.

How does the FDA give a medicine its final approval?

The FDA approved the use of the Pfizer vaccine under an emergency use authorization in December 2020. In May, Pfizer and BioNTech submitted a full application for approval.

This final stamp of approval means the Pfizer vaccine can now be marketed alongside other approved vaccines and pharmaceuticals after undergoing a thorough evaluation by US authorities.

The FDA’s final approval procedure necessitates a review of the drug’s advantages, as well as an examination of its hazards and a review of the drugmaker’s clinical trials. When the FDA approved the vaccine’s emergency use, much of this had already been completed.

However, data on how people fared six months after being fully vaccinated was one of the measures the FDA wanted for full approval that wasn’t required for emergency use. In the interim, the FDA conducted inspections of production sites.

The Pfizer vaccination now has a brand name: Comirnaty (pronounced koe-mir ‘-na-tee, according to the FDA).

Should children under the age of 12 be exempt from vaccination?

The Pfizer vaccination is still not recommended for youngsters under the age of 12.

Woodcock said it would be “very concerning” for children under the age of 12 to receive the vaccination since the FDA lacks data on the right dosage or the vaccine’s safety in younger children.

“They aren’t simply teenagers. That is something we have learned again and again, “she stated.

The FDA’s Center for Biologics Evaluation and Research director, Peter Marks, stated that vaccine trials for children under the age of 12 are still ongoing and that the agency is awaiting findings.

Doctors should not deliver vaccines to children under the age of 12 until the FDA has approved them, according to the American Academy of Pediatrics.


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