Fact Check-False claim that ‘FDA approval does not mean scientifically proven’

Social media users are falsely claiming that U.S. Food and Drug Administration (FDA) approval does not mean that the COVID-19 vaccines are scientifically proven to be safe or effective.

Examples can be seen here and here .

The text in the posts read: “FDA approved does not mean scientifically proven. It means business deal made.”

On Aug. 23, 2021, the FDA granted full approval to the Pfizer/BioNTech COVID-19 vaccine, the first vaccine to receive the approval after being authorized for emergency use in December 2020. (here)

The vaccine was first granted emergency use authorization (EUA) due to the urgent need for vaccines during the pandemic. The FDA’s vigorous safety and efficacy requirements for this process can be seen here and here .

The FDA has an extensive process for vaccine development and approval, which is outlined on its website here . The Center for Biologics Evaluation and Research (CBER) ensures the vaccine developer’s adherence to “rigorous scientific and regulatory processes”, as explained by the FDA.

Pfizer/BioNTech’s phase three trial began in late July 2020 and the results were published in December 2020 (here ). The trial enrolled 46,331 participants at 153 sites around the world: Argentina, Brazil, Turkey, South Africa and the U.S., according to Pfizer (here).

As more data became available that the vaccine’s benefits were greater than its risks, FDA approval was granted. Throughout the process, scientific data on safety and efficacy was relied upon to provide this evidence (here).

Johns Hopkins Medicine explains on its website here that laboratories conducting the required clinical trials are independent from the government or the vaccine company to provide unbiased results.


False. COVID-19 vaccines with FDA approval are proven to be safe and effective.

This article was produced by the Reuters Fact Check team. Read more about our fact-checking work  here  .