FACT CHECK: Viral Post Claims The FDA Did Not Approve Pfizer’s COVID-19 Vaccine
An image shared on Instagram claims the Food and Drug Administration (FDA) extended the emergency use authorization (EUA) for Pfizer’s COVID-19 vaccine rather than approved it.
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The FDA approved Pfizer’s COVID-19 vaccine for people aged 16 years and older. The EUA still remains in place for use of the vaccine for people between 12 years and 15 years old.
An Aug. 24 Instagram post shows what appears to be a screen grabbed conversation in which one participant alleges the FDA did not approve the Pfizer COVID-19 vaccine but rather just extended its EUA. “The media is lying,” the post’s caption reads. “The vaccines were not approved.” This, however, is not accurate.
The vaccine was approved by the FDA. Several media outlets, such as the Associated Press, Reuters and NPR all reported that the vaccine had received full approval from the FDA for people aged 16 and older. The FDA posted the approval letter for Pfizer’s vaccine on its website.
“Under this license, you are authorized to manufacture the product, COVID-19 Vaccine, mRNA, which is indicated for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 16 years of age and older,” reads part of the approval letter.
In addition, a FDA spokesperson referred Check Your Fact to an Aug. 23 press release about the approval of Pfizer’s COVID-19 vaccine, which explained the vaccine will be marketed under the name Comirnaty. (RELATED: Will The FDA Not Authorize Or Approve Any COVID-19 Vaccine?)
“FDA-approved vaccines undergo the agency’s standard process for reviewing the quality, safety and effectiveness of medical products,” the press release reads, in part. “For all vaccines, the FDA evaluates data and information included in the manufacturer’s submission of a biologics license application (BLA).”
Vaccines go through a multi-step approval process which includes conducting clinical trials, filling out a Biologics License Application and presenting findings to the FDA’s Vaccines and Related Biological Products Advisory Committee, according to the Centers for Disease Control and Prevention. Pfizer told the Associated Press that the process of getting the vaccine approved required a 360,000-page application along with inspections.
The claim may stem from a misunderstanding of the Pfizer COVID-19 vaccine fact-sheet for healthcare providers posted on the FDA website. The fact-sheet refers to the vaccine as both unapproved and approved, since the vaccine is only approved for those 16 years and older. The EUA remains in place for those aged 12 to 15 and for a third dose for some immunocompromised people, according to the FDA.