On August 23, 2021, having concluded that revising this EUA is appropriate to protect the public
health or safety under section 564(g)(2) of the Act, FDA is reissuing the August 12, 2021 letter
of authorization in its entirety with revisions incorporated to clarify that the EUA will remain in
place for the Pfizer-BioNTech COVID-19 vaccine for the previously-authorized indication and
uses, and to authorize use of COMIRNATY (COVID-19 Vaccine, mRNA) under this EUA for
certain uses that are not included in the approved BLA. In addition, the Fact Sheet for
Healthcare Providers Administering Vaccine (Vaccination Providers) was revised to provide
updates on expiration dating of the authorized Pfizer-BioNTech COVID-19 Vaccine and to
update language regarding warnings and precautions related to myocarditis and pericarditis. The
Fact Sheet for Recipients and Caregivers was updated as the Vaccine Information Fact Sheet for
Recipients and Caregivers, which comprises the Fact Sheet for the authorized Pfizer-BioNTech
COVID-19 Vaccine and information about the FDA-licensed vaccine, COMIRNATY (COVID19 Vaccine, mRNA).
We REALLY need a lawfag to help on this. What does "under this EUA for
certain uses that are not included in the approved BLA" mean?
This reads to me like the COMIRNATY shot is now included in the EUA ... and NOT "Fully Authorized".
We REALLY need a lawfag to help on this. What does "under this EUA for certain uses that are not included in the approved BLA" mean?
This reads to me like the COMIRNATY shot is now included in the EUA ... and NOT "Fully Authorized".
I believe what it means is that COMIRNATY is included in this EUA for purposes that it was not approved for in its BLA.
So basically, they can experiment on us with comirnaty also.