Multiple social media posts have claimed that the U.S. Food and Drug Administration (FDA) has recently approved a vaccine against monkeypox made by Pfizer. We fact-checked and found the claim to be False.
A Facebook post claimed ‘Miracle: Pfizer Announces They Just So Happened To FInish Monkeypox Vaccine Yesterday’.
A similar claim has been shared on a media website.
Did FDA approve the Pfizer vaccine for monkeypox?
It does not seem so. No evidence proves that the FDA has recently approved the Pfizer vaccine for monkeypox. We could not find any evidence on the Pfizer website that can prove the claim in the question. On September 24, 2019, FDA approved the Jynneos vaccine against smallpox and monkeypox infection.
FDA website shows that the Jynneos vaccine is manufactured by Bavarian Nordic A/S for the ‘prevention of smallpox and monkeypox disease in adults 18 years of age and older who are at high risk for smallpox or monkeypox infection’.
Our trusted sources confirm that the FDA has not approved the Pfizer vaccine against monkeypox infection for public use. But Moderna is investigating potential vaccines that can treat monkeypox. Even a tweet made public from the official account of Moderna confirms the same.
What is the process of approving a vaccine by the FDA?
The process of approval begins with submitting a Biologics License Application (BLA) to the FDA. BLA is a comprehensive submission that includes ‘preclinical and clinical data and information, as well as details of the manufacturing process and facility(ies)’. Once a BLA report is submitted, FDA evaluates the data to determine the safety and effectiveness of the vaccine and confirm whether the manufacturing process ensures quality and consistency. If approved, then the vaccine hits the markets for public use.
After the evaluation of BLA, FDA holds sole power to licence a vaccine. The FDA website shows that the decision of approving a vaccine is made after assessing the associated benefits and risks for the population who will receive the vaccine and the disease to be prevented. The process of approving a vaccine is explained in detail on the FDA website.
THIP MEDIA TAKE: No official evidence confirms if FDA has approved the Pfizer vaccine against monkeypox. The FDA-approved treatments for monkeypox are the Jynneos vaccine by Bavarian Nordic and TPOXX Tecovirimat by SIGA Technologies. Hence, the claim remains false until proven otherwise.
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