Fact Check-COVID-19 vaccines are authorized by the FDA for emergency use

Posts saying COVID-19 vaccines are not approved by the Food and Drug Administration (FDA) are missing context. The three COVID-19 vaccines produced by Pfizer-BioNTech, Moderna and Johnson & Johnson have been granted authorization for emergency use by the FDA in the United States due to the severity of the COVID-19 pandemic, after going through trials to establish their safety and efficacy.

Examples can be seen here and here . The text on one post reads: “It’s pretty disturbing to find out how many people didn’t know that these shots are not FDA approved.”

As of this article’s publication, the FDA has authorized COVID-19 vaccines produced by three companies, Pfizer-BioNTech, Moderna and Johnson & Johnson, for emergency use in the U.S. (here).

Emergency use authorization (EUA) in the U.S. has been issued as a result of the severity of the pandemic. When the pandemic is over, the EUA will cease and vaccine manufacturers will need to apply for full U.S. Food and Drug Administration (FDA) approval (here).

All three vaccines have gone through the necessary steps required by the FDA to ensure safety and efficacy before receiving the emergency use authorizations, visible here .

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 in Argentina, Brazil, Turkey, South Africa and the U.S., according to Pfizer (here).

Johnson & Johnson recruited 44,325 people for its phase three clinical trial between September 2020 and January 2021 (here ,  here), while Moderna had 30,420 volunteers for the same phase of testing between July and October 2020 (here).

Reuters has debunked false claims about the safety and trials of the COVID-19 vaccines approved by the FDA for emergency use (and what this means), here , here , here and here .


Missing context. The COVID-19 vaccines produced by Pfizer-BioNTech, Moderna and Johnson & Johnson were granted authorization for emergency use by the FDA after following the required steps for safety and efficacy.

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