This from page 12 of the letter from the FDA August 23 2021. So how does this mean it’s approved??
Page 12 – Pfizer Inc.
• This product has not been approved or licensed by FDA, but has been authorized for emergency use by FDA, under an EUA to prevent Coronavirus Disease 2019 (COVID-19) for use in individuals 12 years of age and older; and
• The emergency use of this product is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of the medical product under Section 564(b)(1) of the FD&C Act unless the declaration is terminated or authorization revoked sooner.
This from page 12 of the letter from the FDA August 23 2021. So how does this mean it’s approved?? Page 12 – Pfizer Inc. • This product has not been approved or licensed by FDA, but has been authorized for emergency use by FDA, under an EUA to prevent Coronavirus Disease 2019 (COVID-19) for use in individuals 12 years of age and older; and • The emergency use of this product is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of the medical product under Section 564(b)(1) of the FD&C Act unless the declaration is terminated or authorization revoked sooner.
Yah, I didn't see anywhere in there that didn't state it was an approval, but just an extension of the EUA
Check the 1st paragraph of page 2. Im pretty sure that's what is being pointed at as proof of approval.