Fact Check: Did FDA approve the Pfizer vaccine for monkeypox?

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Quick Take

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.

The Claim

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.

A Twitter user shared an article titled, ‘FDA Approves New Intravenous Monkeypox Drug Treatment From PFIZER-Linked SIGA Technologies’ published at GATEWAYPUNDIT on May 20, 2022. 

Fact Check

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’.

While searching for other treatment options available in the market, we found FDA-approved TPOXX Tecovirimat manufactured by SIGA Technologies against smallpox, monkeypox and cowpox.

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.

Disclaimer: Medical Science is an ever evolving field. We strive to keep this page updated. In case you notice any discrepancy in the content, please inform us at [email protected]. You can futher read our Correction Policy here. Never disregard professional medical advice or delay seeking medical treatment because of something you have read on or accessed through this website or it's social media channels. Read our Full Disclaimer Here for further information.

Disclaimer
Medical Science is an ever evolving field. We strive to keep this page updated. In case you notice any discrepancy in the content, please inform us at [email protected]. You can further read our Correction Policy here. Never disregard professional medical advice or delay seeking medical treatment because of something you have read on or accessed through this website or it's social media channels. Read our Full Disclaimer Here for further information.

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