FDA Pfizer vaccine Comirnaty BLA approval letter August 23, 2021 shocking contents, Vaccine does not prevent Covid or spread, 16 and older, Pediatrics deferred to 2023-24, Required studies: myocarditis pericarditis pregnancy
“two papers published May 19 in the journal of Hospital Pediatrics found pediatric hospitalizations for COVID were overcounted by at least 40%, carrying potential implications for nationwide figures used to justify vaccinating children.”...The Defender
“it is universally known that children virtually never die from COVID-19 and given that children have a very strong immune system, they are more likely than adults to have an over-reaction to the shot.”…Dr. Steven Roth
“There is not yet enough evidence on the use of vaccines against COVID-19 in children to make recommendations for children to be vaccinated against COVID-19. Children and adolescents tend to have milder disease compared to adults. However, children should continue to have the recommended childhood vaccines.”…WHO
Only an idiot or agent of evil would approve a vaccine that does not prevent Covid or its spread and include the requirements for case studies post marketing of the impact of myocarditis, pericarditis and pregnancy problems.
From the FDA Pfizer BLA Comirnaty approval letter August 23, 2021.
“Please refer to your Biologics License Application (BLA) submitted and received on
May 18, 2021, under section 351(a) of the Public Health Service Act (PHS Act) for
COVID-19 Vaccine, mRNA.
LICENSING
We are issuing Department of Health and Human Services U.S. License No. 2229 to
BioNTech Manufacturing GmbH, Mainz, Germany, under the provisions of section
351(a) of the PHS Act controlling the manufacture and sale of biological products. The
license authorizes you to introduce or deliver for introduction into interstate commerce,
those products for which your company has demonstrated compliance with
establishment and product standards.
Under this license, you are authorized to manufacture the product, COVID-19 Vaccine,
mRNA, which is indicated for active immunization to prevent coronavirus disease 2019
(COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)
in individuals 16 years of age and older.”
“You may label your product with the proprietary name, COMIRNATY, and market it in
2.0 mL glass vials, in packages of 25 and 195 vials.
We did not refer your application to the Vaccines and Related Biological Products
Advisory Committee because our review of information submitted in your BLA, including
the clinical study design and trial results, did not raise concerns or controversial issues
that would have benefited from an advisory committee discussion.”
“We are deferring submission of your pediatric studies for ages younger than 16 years
for this application because this product is ready for approval for use in individuals 16
years of age and older, and the pediatric studies for younger ages have not been
completed.
Your deferred pediatric studies required under section 505B(a) of the Federal Food,
Drug, and Cosmetic Act (FDCA) are required postmarketing studies. The status of
these postmarketing studies must be reported according to 21 CFR 601.28 and section
505B(a)(4)(C) of the FDCA. In addition, section 506B of the FDCA and 21 CFR 601.70
require you to report annually on the status of any postmarketing commitments or
required studies or clinical trials.
Label your annual report as an “Annual Status Report of Postmarketing Study
Requirement/Commitments” and submit it to the FDA each year within 60 calendar
days of the anniversary date of this letter until all Requirements and Commitments
subject to the reporting requirements under section 506B of the FDCA are released or
fulfilled. These required studies are listed below:
1. Deferred pediatric Study C4591001 to evaluate the safety and effectiveness of
COMIRNATY in children 12 years through 15 years of age.
Final Protocol Submission: October 7, 2020
Study Completion: May 31, 2023
Final Report Submission: October 31, 2023
2. Deferred pediatric Study C4591007 to evaluate the safety and effectiveness of
COMIRNATY in infants and children 6 months to <12 years of age.
Final Protocol Submission: February 8, 2021
Study Completion: November 30, 2023
Final Report Submission: May 31, 2024
3. Deferred pediatric Study C4591023 to evaluate the safety and effectiveness of
COMIRNATY in infants <6 months of age.
Final Protocol Submission: January 31, 2022
Study Completion: July 31, 2024
Final Report Submission: October 31, 2024”
“POSTMARKETING REQUIREMENTS UNDER SECTION 505(o)
Section 505(o) of the Federal Food, Drug, and Cosmetic Act (FDCA) authorizes FDA to
require holders of approved drug and biological product applications to conduct
postmarketing studies and clinical trials for certain purposes, if FDA makes certain
findings required by the statute (section 505(o)(3)(A), 21 U.S.C. 355(o)(3)(A)).
We have determined that an analysis of spontaneous postmarketing adverse events
reported under section 505(k)(1) of the FDCA will not be sufficient to assess known
serious risks of myocarditis and pericarditis and identify an unexpected serious risk of
subclinical myocarditis.
Furthermore, the pharmacovigilance system that FDA is required to maintain under
section 505(k)(3) of the FDCA is not sufficient to assess these serious risks.
Therefore, based on appropriate scientific data, we have determined that you are
required to conduct the following studies:
4. Study C4591009, entitled “A Non-Interventional Post-Approval Safety Study of
the Pfizer-BioNTech COVID-19 mRNA Vaccine in the United States,” to evaluate
the occurrence of myocarditis and pericarditis following administration of
COMIRNATY. ”
Read more:
https://www.fda.gov/media/151710/download
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