The FDA approves a monkeypox vaccine developed by Pfizer.
Social media users are circulating a claim that Pfizer developed a monkeypox vaccine and that it was approved by the U.S. Food and Drug Administration (FDA). The claim comes following reports of the virus in the Americas, Europe, and Oceania.
Misbar investigated the claim and found it to be misleading, as Pfizer did not develop a vaccine for monkeypox and therefore the U.S. Food and Drug Administration (FDA) did not approve any such vaccine.
FDA Approved Jynneos Vaccine for Smallpox and Monkeypox in 2019
Misbar's team investigated credible sources, including official Pfizer and FDA channels, but found no evidence of the claim. Furthermore, an FDA-approved vaccine for smallpox and monkeypox has been available since September 2019. The Jynneos Smallpox and Monkeypox vaccine is a "live, non-replicating" vaccine that protects adults who are at high risk of infection from the two viruses. "This is the only currently FDA-approved vaccine for the prevention of monkeypox disease," according to the FDA. The Danish company Bavarian Nordic, not Pfizer, developed the Jynneos vaccine. The vaccine is also included in the FDA's "Strategic National Stockpile (SNS), the nation's largest supply of potentially life-saving pharmaceuticals and medical supplies for use in a public health emergency severe enough to deplete local supplies." This ensures that the vaccine is available and easy to obtain if it is required in the country. The press release can be seen below.
Photo Description: FDA press release from September 2019.
Increase in Monkeypox Purchases
Following the confirmation of over 550 monkeypox cases outside of West and Central Africa, where the virus is endemic, there has been an increase in monkeypox vaccine purchases. According to Bavarian Nordic, the biotech company that manufactures the vaccine, the United States has placed a $119 million order for vaccines for 2023 and 2024. The US placed an order with the option to purchase an additional $180 million. If the second option is chosen, it would amount to approximately 13 million doses.
Photo Description: U.S. places order for smallpox/monkeypox vaccine.
Vaccine supplies are limited, but despite increased purchases, the World Health Organization (WHO) states that "mass vaccination of the population is not required nor recommended for monkeypox; every effort must be made to control the human-to-human spread of monkeypox through early case-finding and diagnosis, isolation, and contact-tracing."
Moderna Investigates Potential Monkeypox Vaccine
Pfizer is not currently developing a monkeypox vaccine, but Moderna has stated that it is investigating potential monkeypox vaccines at the preclinical trial stage. The statement was issued via their official Twitter account, as seen below.
Photo Description: Moderna investigating potential monkeypox vaccine.
Based on these findings, Misbar confirms that Pfizer did not recently develop a Monkeypox vaccine, nor did the FDA approve any vaccine for the virus. There is currently one FDA-approved vaccine called Jynneos produced by Bavarian Nordic.