The FDA did NOT grant full approval to the Pfizer shots
Aug 26, 2021 16:45:56 GMT -5
Post by Honoria on Aug 26, 2021 16:45:56 GMT -5
August 26, 2021
The FDA did NOT grant full approval to the Pfizer shots
By Carl Schwitzer
You may have heard that the Pfizer-BioNTech COVID-19 shot received FDA approval this past Monday. Politicians, national health officials, and journalists are breathless with excitement about how this approval will finally induce the remaining "vaccine-hesitant" into stepping forward to receive their jab. The FDA even has a press release on its website about it.
There's just one problem.
If you read the actual letters that the FDA sent to Pfizer on August 23, 2021, you'll see that the FDA did no such thing. In the sense that the term "FDA approval" is generally understood, this drug is not approved by the FDA. It is still under EUA (Emergency Use Authorization). It is still an experimental drug.
The FDA sent two letters. The first one was a letter of BLA (Biologics License Application) approval, and the second was a letter of EUA extension to COMIRNATY.
The BLA approval letter approves Pfizer's application for a license to label its COVID-19 drug with the brand name COMIRNATY. This letter also spells out the terms and requirements for nine additional clinical trials over five years, and yearly status reports, to study the acknowledged occurrences of myocarditis and pericarditis that have followed the administering of the Pfizer shots. This license to label and manufacture is not a full approval of the drug, which clearly is still subject to many years of clinical trials.
The EUA extension letter extends the term of the EUA for the current drug and authorizes (licenses) the experimental use of the brand-name drug COMIRNATY. In the first paragraph on page 2, this letter references the license approval letter. In the second paragraph on page 2, the August 12 EUA is re-issued to include the name-branded drug in the emergency use authorization, and to add "language regarding warnings and precautions related to myocarditis and pericarditis." In the last paragraph on page 4, the EUA nature of the drugs is re-iterated, and COMIRNATY is additionally authorized for use for individuals aged 12 through 15 years.
Continued at link
The FDA did NOT grant full approval to the Pfizer shots
By Carl Schwitzer
You may have heard that the Pfizer-BioNTech COVID-19 shot received FDA approval this past Monday. Politicians, national health officials, and journalists are breathless with excitement about how this approval will finally induce the remaining "vaccine-hesitant" into stepping forward to receive their jab. The FDA even has a press release on its website about it.
There's just one problem.
If you read the actual letters that the FDA sent to Pfizer on August 23, 2021, you'll see that the FDA did no such thing. In the sense that the term "FDA approval" is generally understood, this drug is not approved by the FDA. It is still under EUA (Emergency Use Authorization). It is still an experimental drug.
The FDA sent two letters. The first one was a letter of BLA (Biologics License Application) approval, and the second was a letter of EUA extension to COMIRNATY.
The BLA approval letter approves Pfizer's application for a license to label its COVID-19 drug with the brand name COMIRNATY. This letter also spells out the terms and requirements for nine additional clinical trials over five years, and yearly status reports, to study the acknowledged occurrences of myocarditis and pericarditis that have followed the administering of the Pfizer shots. This license to label and manufacture is not a full approval of the drug, which clearly is still subject to many years of clinical trials.
The EUA extension letter extends the term of the EUA for the current drug and authorizes (licenses) the experimental use of the brand-name drug COMIRNATY. In the first paragraph on page 2, this letter references the license approval letter. In the second paragraph on page 2, the August 12 EUA is re-issued to include the name-branded drug in the emergency use authorization, and to add "language regarding warnings and precautions related to myocarditis and pericarditis." In the last paragraph on page 4, the EUA nature of the drugs is re-iterated, and COMIRNATY is additionally authorized for use for individuals aged 12 through 15 years.
Continued at link