On Wednesday, the US Food and Drug Administration (FDA) granted emergency use authorization for Pfizer’s COVID-19 booster dose. However, the approval does not cover all Americans as requested.
Instead, the shot aims to provide additional protection against COVID-19 for Americans 65 years and older. In addition, at-risk Americans and those working high-risk jobs can also avail themselves of the additional vaccine dose.
FDA Allows Booster Dose For Certain Populations
Acting FDA Commissioner Dr. Janet Woodcock issued a statement on the booster shots approval. “After considering the totality of the available scientific evidence and the deliberations of our advisory committee of independent, external experts, the FDA amended the EUA for the Pfizer-BioNTech COVID-19 Vaccine to allow for a booster dose in certain populations such as health care workers, teachers, and daycare staff, grocery workers and those in homeless shelters or prisons, among others,” she said.
Last Friday, the FDA’s vaccine advisers unanimously recommended EUA for the booster dose made by Pfizer and BioNTech. The recommendation applies to 65 and older and those at risk of severe disease. These people can take them six months after they get full vaccination.
Dr. Peter Marks, director for the FDA’s Center for Biologics Evaluation and Research, also welcomed the decision. “The FDA considered the committee’s input and conducted its own thorough review of the submitted data to reach today’s decision.
We will continue to analyze data submitted to the FDA pertaining to the use of booster doses of COVID-19 vaccines and we will make further decisions as appropriate based on the data,” he said.
However, many health experts say that the EUA was a consolation prize for Pfizer. The pharmaceutical giant requested FDA approval for issuing its booster dose to everybody 16 years and above.
The company argued that there was enough evidence to show that immunity starts waning six months after full vaccination. It restores the immunity to its optimal levels.
CDC Next To Review Booster Dose
After the FDA’s approval, the US Centers for Disease Control and Prevention will now tackle the boosters. Vaccine advisers for the CDC will meet Thursday and pick up where the FDA left off.
Before it reaches the public, the CDC must also give its approval. The agency’s Advisory Committee on Immunization Practices can still make changes to the recommendations.
As a result, the CDC urged local and state health officials to wait for their signoff before issuing any booster doses.
Previously, boosters already secured approvals for use by certain immunocompromised people. However, there are no policies regarding its use for the general public. According to the CDC, around 2.3 million Americans already received third doses from Pfizer-BioNTech.
Other vaccine manufacturers are also scrambling to get approvals from the FDA and CDC. Moderna already applied for approval to issue booster shots, but reviews remain pending.
Johnson & Johnson, who created a single-dose vaccine, conducted trials for a second dose as a booster. However, the company has yet to apply for EUA. In addition, there are medical data on the effectiveness of mixing vaccine brands.
Watch the TODAY show video reporting that FDA panel backs Pfizer COVID-19 booster shots for adults 65 and older:
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