FDA letters to Pfizer Inc. and BioNTech Manufacturing GmbH
On 23 August, FDA issued two letters – one addressed to Pfizer Inc. and the other to BioNTech Manufacturing GmbH.
In the first letter, addressed to Pfizer Inc., FDA states that the EUA will remain in place for the Pfizer-BioNTech COVID-19 vaccine for the previously-authorised indication and uses, while authorising use of COMIRNATY (COVID-19 Vaccine, mRNA) under the same EUA for certain uses that are not included in the approved BLA (biologics licence application). In other words, the Pfizer vaccine that is currently available has not been fully approved by FDA.
Final_Pfizer LOA to issue with BLA approval 08.23.21_v2
In the second letter, marked BLA APPROVAL and addressed to BioNTech Manufacturing GmbH, FDA authorises the company to introduce or deliver for introduction into interstate commerce, those products for which it has demonstrated compliance with establishment and product standards. This licence gives authorisation to manufacture the mRNA COVID-19 Vaccine, which is indicated for active immunisation to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 16 years of age and older. This product may be marketed under the label COMIRNATY.
Under this authorisation, the company must submit the final ‘content of labeling‘ within 14 days. (page 3)
This licence also carries the obligation by the part of the manufaturer to carry out post-marketing studies and to report back to FDA their trial results up till 2024. (page 5)
August 23, 2021 Approval Letter - Comirnaty
Package insert for COMIRNATY, as presented to FDA
Package Insert - COMIRNATY