Have we been LIED to yet AGAIN? | Eastern North Carolina Now

Letter on Pfizer from FDA 8/23/2021

ENCNow

I may be misreading this but it does not sound like Pfizer got full approval only that the biologics license application was approved.  EUA keep coming up in the letter from the FDA to Pfizer.  

Page 2
"On August 23, 2021, FDA approved the biologics license application (BLA) submitted by BioNTech Manufacturing GmbH for COMIRNATY (COVID-19 Vaccine, mRNA) for active immunization to prevent COVID-19 caused by SARS-CoV-2 in individuals 16 years of age and older. 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)."
Page 7
"C. Pfizer Inc. will ensure that the terms of this EUA are made available to all relevant stakeholders (e.g., emergency response stakeholders, authorized distributors, and vaccination providers) involved in distributing or receiving authorized PfizerBioNTech COVID‑19 Vaccine. Pfizer Inc. will provide to all relevant stakeholders a copy of this letter of authorization and communicate any subsequent amendments that might be made to this letter of authorization and its authorized labeling."
E. Pfizer Inc. may request changes to this authorization, including to the authorized Fact Sheets for the vaccine. Any request for changes to this EUA must be submitted to Office of Vaccines Research and Review (OVRR)/Center for Biologics Evaluation and Research (CBER). Such changes require appropriate authorization prior to implementation.14"
Page 8-9
"J. Pfizer Inc. will submit to the EUA file Certificates of Analysis (CoA) for each drug product lot at least 48 hours prior to vaccine distribution. The CoA will include the established specifications and specific results for each quality control test performed on the final drug product lot. K. Pfizer Inc. will submit to the EUA file quarterly manufacturing reports, starting in July 2021, that include a listing of all Drug Substance and Drug Product lots produced after issuance of this authorization. This report must include lot number, manufacturing site, date of manufacture, and lot disposition, including those lots that
were quarantined for investigation or those lots that were rejected. Information on the reasons for lot quarantine or rejection must be included in the report.
M. Pfizer Inc. and authorized distributor(s) will make available to FDA upon request any records maintained in connection with this EUA."
 
And there is more like this through the entire letter. 

Go Back


Leave a Guest Comment

Your Name or Alias
Your Email Address ( your email address will not be published )
Enter Your Comment ( text only please )




Truckers vow to shut down Australia to force end to virus lockdowns Rant & Rave, Editorials, Beaufort Observer, Op-Ed & Politics Vaccine tyranny: Done being silent.


HbAD0

Latest Op-Ed & Politics

would allow civil lawsuit against judge if released criminal causes harm
"This highly provocative move was designed to interfere with our counter narco-terror operations."
Charlie Kirk, 31 years of age, who was renowned as one of the most important and influential college speakers /Leaders in many decades; founder of Turning Point USA, has been shot dead at Utah Valley University.
The Trump administration took actions against Harvard related to the anti-Israel protests that roiled its campus.
In remembrance of the day that will forever seer the concept of 'evil' in our minds, let's look back at that fateful morning, exactly 11 years ago today to that series of horrific events which unfolded before our unbelieving eyes......

HbAD1

faced 25 years in prison for "misgendering" a leftie tranny politician
illegal alien "asylum seeker" migrants are a crime wave on both sides of the Atlantic

HbAD2

It was a clear beautiful, royal blue sky day on Wall Street. The S & P futures were up markedly, awaiting a positive open, as I turn to get my first cup of coffee. I return to CNBC to get the morning business news, when I notice that the S & P futures are falling, and they're falling fast.
conservative youth leader was victim of political assassination
Harvard University is once again sending its students on delegations to China
In addition, Sheikha Al-Thani has "taken to promoting Mamdani’s mayoral candidacy on social media, boosting news of favorable polling on Instagram"

HbAD3

 
Back to Top