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

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 ( no code or urls allowed, 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

populist / nationalist anti-immigration AfD most popular party among young voters, CDU second
Barr had previously said he would jump off a bridge before supporting Trump
illegal alien "asylum seeker" migrants are a crime wave on both sides of the Atlantic

HbAD1

Decision is a win for election integrity. NC should do the same.
Biden regime intends to force public school compliance as well as colleges
prosecutors appeal acquittal of member of parliament in lower court for posting Bible verse
Biden abuses power to turn statute on its head; womens groups to sue
The Missouri Senate approved a constitutional amendment to ban non-U.S. citizens from voting and also ban ranked-choice voting.
Democrats prosecuting political opponets just like foreign dictrators do
populist / nationalist / sovereigntist right are kingmakers for new government

HbAD2

18 year old boy who thinks he is girl planned to shoot up elementary school in Maryland
Biden assault on democracy continues to build as he ramps up dictatorship
One would think that the former Attorney General would have known better
UNC board committee votes unanimously to end DEI in UNC system
Police in the nation’s capital are not stopping illegal aliens who are driving around without license plates, according to a new report.
Davidaon County student suspended for using correct legal term for those in country illegally
Lawmakers and privacy experts on both sides of the political spectrum are sounding the alarm on a provision in a spy powers reform bill that one senator described as one of the “most terrifying expansions of government surveillance” in history

HbAD3

 
Back to Top