When will the vaccines get FDA approved?
In the United States, we have 3 vaccines in use. Two of these, Moderna and Janssen (J&J), have emergency use authorization, and one, Pfizer-BioNTech, was recently approved by the FDA. An emergency use authorization (EUA) is a way to make it possible for medical treatments and vaccines, to be made more quickly available during public health emergencies, such as the current COVID-19 pandemic.
- Pfizer-BioNTech COVID-19 vaccine was granted full approval by the FDA on August 23, 2021. The vaccine will now be marketed as Comirnaty for the prevention of COVID-19 in individuals 16 years or older. Additionally, the emergency use authorization will continue to cover adolescents 12 through 15 years of age.
- Moderna COVID-19 Vaccine received emergency use authorization by the FDA on December 18, 2020. The EUA allows the Moderna vaccine to be used in individuals who are 18 years or older. Moderna applied for full FDA approval in August.
- Janssen COVID-19 Vaccine, commonly referred to as the J&J vaccine, received emergency use authorization by the FDA on February 27, 2021. The EUA allows the Janssen COVID-19 Vaccine to be used in individuals who are 18 years or older.
COVID-19 vaccines have undergone a rigorous development process that includes hundreds of thousands of study participants. And under the emergency use authorization, almost 200 million people have been safely and successfully vaccinated. The FDA has already approved one vaccine and is reviewing a second. J&J has said they will be applying for full approval soon.
Last update: August 31, 2021, 10:59am ET
Science review: HAY, JAB