Pfizer applies for full Food and Drug Administration (FDA) approval on their Coronavirus vaccine. This will allow the vaccine to be studied and given access for full approval, which would be the first in The United States.
Pfizer, Moderna, and Johson & Johnson are all being used as an authorized users of emergency or Emergency Use Authorization (EUA). According to the FDA, a EUA is a mechanism to facilitate the availability and use of medical countermeasures, including vaccines, during public health emergencies, such as the current COVID-19 pandemic. Under a EUA, FDA may allow the use of unapproved medical products, or unapproved uses of approved medical products in an emergency to diagnose, treat, or prevent serious or life-threatening diseases or conditions when certain statutory criteria have been met, including that there are no adequate, approved, and available alternatives. For more information on EUA, you can visit the FDA website here https://www.fda.gov/vaccines-blood-biologics/vaccines/emergency-use-authorization-vaccines-explained.
With the spread of the COVID-19 pandemic at a high rate back in 2020, killing millions, there needed to be a vaccine to contain the virus from spreading. That’s when Pfizer came together to create, test, and distribute their vaccine to the world; not only for adults but for children as well, which has been effective.
Pfizer submitted an application requesting information to introduce their vaccine. They will need to submit data on manufacturing processes, facilities, and other information. Additional information will need to be provided as the process continues throughout the next several weeks.
Pfizer is asking the FDA to review and respond within six months.