Posted on Aug 25, 2021
Pentagon announces COVID-19 vaccine mandate, but no set deadline
4.35K
12
8
8
8
0
Posted >1 y ago
Responses: 3
SGT (Join to see)
SGT (Join to see)
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 (COVID-
19 Vaccine, mR
8 The licensed vaccine has the same formulation as the EUA-authorized vaccine and the products can be used
interchangeably to provide the vaccination series without presenting any safety or effectiveness concerns. The
products are legally distinct with certain differences that do not impact safety or effectiveness.
Sounds different to me
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 (COVID-
19 Vaccine, mR
8 The licensed vaccine has the same formulation as the EUA-authorized vaccine and the products can be used
interchangeably to provide the vaccination series without presenting any safety or effectiveness concerns. The
products are legally distinct with certain differences that do not impact safety or effectiveness.
Sounds different to me
(0)
(0)
SFC Kelly Fuerhoff
SGT (Join to see) - What's your point? No vaccine is 100% and never has been. So I don't know what you're trying to say with that.
The FDA press release seemed to make it seem as COMIRNATY is the brand name - since a lot of medications or vaccines have a brand or generic name. I deal with it with my daughter's immunosuppression meds since I have to make sure the brand name gets ordered through the pharmacy.
However this is on the Pfizer website:
COMIRNATY® (COVID-19 Vaccine, mRNA) is an FDA-approved COVID-19 vaccine made by Pfizer for BioNTech.
It is approved as a 2-dose series for prevention of COVID-19 in individuals 16 years of age and older
It is also authorized under Emergency Use Authorization (EUA) to be administered for emergency use to:
prevent COVID-19 in individuals 12 through 15 years, and
provide a third dose to individuals 12 years of age and older who have been determined to have certain kinds of immunocompromise
The Pfizer-BioNTech COVID-19 Vaccine has received EUA from FDA to:
prevent COVID-19 in individuals 12 years of age and older, and
provide a third dose to individuals 12 years of age and older who have been determined to have certain kinds of immunocompromise
The FDA-approved COMIRNATY® (COVID-19 Vaccine, mRNA) and the EUA-authorized Pfizer-BioNTech COVID-19 Vaccine have the same formulation and can be used interchangeably to provide the COVID-19 vaccination series. An individual may be offered either COMIRNATY® (COVID-19 Vaccine, mRNA) or the Pfizer-BioNTech COVID-19 Vaccine to prevent coronavirus disease 2019 (COVID-19) caused by SARS-CoV-2.
That says that COMIRNATY and the Pfizer-BioNTech COVID-19 Vaccine have the same formulation and can be used interchangeably to provide the covid-19 vaccination series. So in a sense they are similar as they can be used interchangeably.
The FDA press release seemed to make it seem as COMIRNATY is the brand name - since a lot of medications or vaccines have a brand or generic name. I deal with it with my daughter's immunosuppression meds since I have to make sure the brand name gets ordered through the pharmacy.
However this is on the Pfizer website:
COMIRNATY® (COVID-19 Vaccine, mRNA) is an FDA-approved COVID-19 vaccine made by Pfizer for BioNTech.
It is approved as a 2-dose series for prevention of COVID-19 in individuals 16 years of age and older
It is also authorized under Emergency Use Authorization (EUA) to be administered for emergency use to:
prevent COVID-19 in individuals 12 through 15 years, and
provide a third dose to individuals 12 years of age and older who have been determined to have certain kinds of immunocompromise
The Pfizer-BioNTech COVID-19 Vaccine has received EUA from FDA to:
prevent COVID-19 in individuals 12 years of age and older, and
provide a third dose to individuals 12 years of age and older who have been determined to have certain kinds of immunocompromise
The FDA-approved COMIRNATY® (COVID-19 Vaccine, mRNA) and the EUA-authorized Pfizer-BioNTech COVID-19 Vaccine have the same formulation and can be used interchangeably to provide the COVID-19 vaccination series. An individual may be offered either COMIRNATY® (COVID-19 Vaccine, mRNA) or the Pfizer-BioNTech COVID-19 Vaccine to prevent coronavirus disease 2019 (COVID-19) caused by SARS-CoV-2.
That says that COMIRNATY and the Pfizer-BioNTech COVID-19 Vaccine have the same formulation and can be used interchangeably to provide the covid-19 vaccination series. So in a sense they are similar as they can be used interchangeably.
(1)
(0)
Read This Next