FDA Pretends it Cares–but leaves out the most important information

1. PHARMACOVIGILANCE:  the practice of monitoring the effects of medical drugs after they have been licensed for use, especially in order to identify and evaluate previously unreported adverse reactions.

   
   

Pages 34-35 of the FDA review of Pfizer’s data for the 5-11 year olds provides the pretense of truly caring about identifying and quantifying adverse events from the vaccine. Just look at all the “activities” Pfizer and its partner must do.  Well, of course they have to do them, since their clinical trial was so underpowered (not enough subjects) and only ran 2 months for about half the kids and 2.5 weeks for the rest.  Duh?   

Not only that, but Pfizer presented its data to FDA on October 6, and FDA already had completed its review and written its 39 page report by October 23, 17 days later. Fast work.  But then again, we are only talking about the health of 28 million elementary school kids.  And millions more overseas whose countries follow FDA advice.

And lest I forget, we are also talking about their education, because it seems they won’t be able to attend school soon, if unjabbed. Gavin Newsome said so.  And a bill is being introduced in the District of Columbia for the same purpose.

Clearly, the stakes are pretty low, so a pretend Pfizer clinical trial and a pretend FDA review are good enough, right?

Below is part of FDA’s presentation.  What is missing is the most important information, revealed in an Aug 23 letter from FDA.  And that is, that the trials FDA demands Pfizer undertake to find out how dangerous its vaccines actually are, will not be reported to FDA until 2024, 2025 and 2027–presumably after most of the world’s children have already received 2 or 4 or 6 or 8 doses.

9 PHARMACOVIGILANCE ACTIVITIES 

Pfizer submitted a revised Pharmacovigilance Plan (PVP) to monitor safety concerns that could
be associated with BNT162b2 in individuals 5-11 years of age. The PVP includes the following
safety concerns: 

• Important Identified Risks: anaphylaxis, myocarditis, and pericarditis 

• Important Potential Risks: Vaccine-associated enhanced disease (VAED), including
vaccine-associated enhanced respiratory disease (VAERD). 

Pfizer-BioNTech plans to conduct passive and active surveillance to monitor the postauthorization safety for the Pfizer-BioNTech COVID-19 Vaccine, including:
35 

• Mandatory reporting by the Sponsor under the EUA for the following events to VAERS
within 15 days: SAEs (irrespective of attribution to vaccination); COVID-19 disease resulting
in hospitalization or death; multisystem inflammatory syndrome (MIS) 

• Adverse event reporting in accordance with regulatory requirements for the licensed
vaccine, COMIRNATY 

• Additionally, following approval of COMIRNATY, the Sponsor was also asked to submit
reports of myocarditis and pericarditis as 15-day reports to VAERS. 

• Periodic safety reports containing an aggregate review of safety data including assessment
of AEs; vaccine administration errors, whether or not associated with an AE; and newly
identified safety concerns. 

• Post-authorization observational studies, that would be modified to encompass the
evaluation of children 5-11 years of age include active surveillance safety studies using
large health insurance claims and/or electronic health record database(s): 

– Study C4591009: A non-interventional post-approval safety study of the Pfizer-BioNTech
COVID-19 mRNA Vaccine in the United States 

Objective: To assess the occurrence of safety events of interest, including myocarditis
and pericarditis, in the general U.S. population of all ages, pregnant women, the
immunocompromised, and persons with a prior history of COVID-19 within selected data
sources participating in the U.S. Sentinel System. 

– Study C4591021: Post-conditional approval active surveillance study among individuals
in Europe receiving the Pfizer-BioNTech Coronavirus Disease 2019 (COVID-19) Vaccine 

Objective: To assess the potential increased risk of AESIs, including
myocarditis/pericarditis, after being vaccinated with at least one dose of the PfizerBioNTech COVID-19 Vaccine. 

– Study C4591021 Substudy: Substudy to describe the natural history of myocarditis and
pericarditis following administration of COMIRNATY 

Objective: To describe the natural history of post-vaccination myocarditis/pericarditis,
including recovery status, risk factors, and/or identification of serious cardiovascular
outcomes within one year of myocarditis/pericarditis diagnosis among individuals
vaccinated with BNT162b2 as well as individuals not vaccinated with a COVID-19
vaccine. 

– Study C4591036: Prospective cohort study with at least 5 years of follow-up for potential
long-term sequelae of myocarditis after vaccination (in collaboration with Pediatric Heart
Network [PHN]). Working title: Myocarditis/pericarditis follow-up study within the
Pediatric Heart Network 

Objective: To characterize the clinical course, risk factors, resolution, long-term
sequelae, and quality of life in children and young adults <21 years with acute postvaccine myocarditis/pericarditis.
Pfizer-BioNTech also plans to include vaccine effectiveness analyses among individuals 5-11
years of age in Study C4591014 entitled “Pfizer-BioNTech COVID-19 BNT162b2 Vaccine
Effectiveness Study Kaiser Permanente Southern California.”