Connect with us

Breaking News

FDA OKs Pfizer Booster Dose for at-Risk Americans



Close up of doctor hands holding covid-19 vaccine booster shot with syringe | FDA OKs Pfizer booster dose for At-Risk Americans | featured

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. 

RELATED: Scientists Say Most People Don’t Need COVID Booster Shots

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. 

Consolation Prize

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:

What do you think about third COVID-19 shots or booster doses?

View Results

Loading ... Loading ...

Do you support giving booster doses for senior Americans and those at-risk? Will you get a booster even if you don’t fall under the above categories?

Tell us what you think about COVID-19 vaccine boosters. Share your comments below.

Continue Reading
Click to comment

Leave a Reply

Your email address will not be published. Required fields are marked *

Copyright © 2022 Breaking News Alerts. This copyrighted material may not be republished without express permission. The information presented here is for general educational purposes only. MATERIAL CONNECTION DISCLOSURE: You should assume that this website has an affiliate relationship and/or another material connection to the persons or businesses mentioned in or linked to from this page and may receive commissions from purchases you make on subsequent web sites. You should not rely solely on information contained in this email to evaluate the product or service being endorsed. Always exercise due diligence before purchasing any product or service. This website contains advertisements.