A group called the Public Health and Medical Professionals for Transparency (PHMPT) submitted a Freedom of Information Act (FOIA) request to the Food and Drug Administration (FDA) for the data used to evaluate and grant Pfizer authorization for use of their COVID-19 vaccine. After one month with no reply from the FDA, the PHMPT sued and filed the request in a Texas court.
The FDA and Pfizer asked the judge for 75 years to release all of the documents to the public. The FDA lost this battle and the judge ruled they were required to release the data at a rate of 55,000 pages per month starting March 1, 2022. Two large data releases have been made available since.
What have these batches of documents revealed thus far?
Safety and Adverse Events
Adverse events were reported between December 1, 2020, and February 28, 2021. During the first three months of the vaccine roll out, there were 42,086 adverse cases reported containing 158,893 events including 1,223 deaths. The total number of vaccine doses administered during this time period was recently revealed in the April data release in which they estimated that “approximately 126,212,580 doses of BNT162b2 were shipped worldwide” during those three months. Using this data, we can calculate an adverse event rate per dose. By dividing the doses by 158,893, the adverse event rate per dose comes out to be nearly 1 in 800.
Vaccine side effects were more prevalent among younger age groups and with an increasing dose:
“Reactogenicity and AEs tended to increase in incidence and/or severity with increasing dose of BNT162b2. Reactogenicity and AEs were generally milder and less frequent in participants in the older group (>55 years of age) compared with the younger group (≤55 years of age).”
Processing Large Numbers of Adverse Events
Due to the reporting of large numbers of adverse events, Pfizer documented a need to hire an unprecedented amount of additional employees to manage it:
“Due to the large numbers of spontaneous adverse event reports received for the product…Pfizer has also taken multiple actions to help alleviate the large increase of adverse event reports. This includes significant technology enhancements, and process and workflow solutions, as well as increasing the number of data entry and case processing colleagues. To date, Pfizer has onboarded approximately 600 additional full-time employees (FTEs). More are joining each month with an expected total of more than 1,800 additional resources by the end of June 2021.”
Effect on Pregnancy, Fertility, Birth Defects, Nursing Children
There is inadequate information to deem the vaccine harmless to reproductive health, fertility, birth defects and nursing children. Effects on reproductive health were unknown then and still remain unknown now. There is no data available on the long-term effects as stated in the released consent form:
“The effects of the COVID-19 vaccine on sperm, a pregnancy, a fetus, or a nursing child are not known.”
Natural immunity from infection was initially a silenced topic but is now becoming a part of the conversation. Was this part of the conversation during the approval process of the vaccination?
Data released from the Pfizer Phase 1/2 trial showed they had used titers from natural infection as a benchmark for vaccine protection and assumed natural infection did provide protection against COVID-19:
“Assuming that neutralization titers induced by natural infection provide protection from COVID-19 disease, comparing vaccine-induced SARS-CoV-2 neutralization titers to those from sera of convalescent humans provides a benchmark for the magnitude of the vaccine-elicited response and the vaccine’s potential to provide protection.”
According to both CDC and FDA endpoints of severe disease, there was not a single case of severe disease among participants with natural immunity:
“Among participants without evidence of SARS-CoV-2 infection before and during the vaccination regimen (evaluable efficacy population), the estimated VE against FDA-defined severe COVID-19 (protocol definition) occurring at least 7 days after Dose 2 was 95.3% (2-sided 95% CI: 71.0%, 99.9%), with 1 and 21 cases in the BNT162b2 and placebo groups, respectively.
Similarly, the estimated VE was also 95.3% (2-sided 95% CI: 70.9%, 99.9%) among participants with or without evidence of SARS-CoV-2 infection, also with 1 and 21 cases in the BNT162b2 and placebo groups, respectively.”
There was one severe case in the trial group and 21 in the placebo group and by mixing together the results of those with and without prior infection, the numbers are identical, meaning those with prior infection had zero cases of severe disease in both the trial and placebo groups. This demonstrates the protection offered by natural immunity.
Immunosuppression from the Vaccine
In the first week after the shot, people of all ages experienced transient immunosuppression, meaning a period of weakening of the immune system due to the decline of immune fighting cells. This may have skewed results as people were not considered partially vaccinated until 14 after shot one and 14 days after shot two to be considered fully vaccinated. Any adverse outcomes within that time frame of this immunosuppression from the shot was thus allotted to unvaccinated statistics. As stated in the data:
“Clinical laboratory evaluation showed a transient decrease in lymphocytes that was observed in all age and dose groups after Dose 1, which resolved within approximately one week.”
Vaccine-Associated Enhanced Disease
Antibody-dependent enhancement (ADE) or vaccine-associated enhanced disease (VAED) means a vaccine predisposes an individual to more severe disease. VAED was undetermined then and has yet to be ruled out now. As listed in the Post-Authorization Adverse Event Report, VAED is listed as an “Important Potential Risk.” Pfizer had reported 138 suspected cases of VAED in which 75 were “severe, resulting in hospitalization, disability, life-threatening consequences or death.” A significant portion of the cases, 65, remained unresolved and 38 were lethal. Pfizer concluded, “VAED remains a theoretical risk for the vaccine. Surveillance will continue.”
Myocarditis risk is higher than previously reported. The pediatric informed consent form for the vaccine shows the risk of myocarditis is between 1 in 1,000 and 1 in 10,000. This does not take into account gender or age group and as young males are more frequently affected, this risk is significantly higher.
This also does not take into account subclinical myocarditis which the FDA reported in a Comirnaty pharmacovigilance review in which they noted a previous study on the smallpox vaccine, suggesting the following:
“Incidence of subclinical myocarditis and potential long-term sequelae following COMIRNATY are unknown.” In their review, the FDA referenced a previous study of the smallpox vaccine that “suggested an incidence of possible subclinical myocarditis (based on cardiac troponin T elevations) 60-times higher than the incidence rate of overt clinical myocarditis.”
FDA reviewers deemed this warranted further safety studies as the data available to them presented “known risks for myocarditis and pericarditis and an unexpected serious risk for subclinical myocarditis.” However, Pfizer expressed “challenges in proposing a potential prospective study of subclinical myocarditis because of absence of a definition of subclinical myocarditis and unknown background incidence of troponin abnormalities.” This study was initiated after the authorization of the vaccine and is to be completed in July of 2023.
Important questions regarding the vaccine remain unanswered and many will remain unanswered for years. Obtaining transparent information is critical when considering the benefits and risks of anything we decide to put into our bodies. With each month, more data will be released to the public, offering more transparency than had been made available for years. As more data becomes available and Covid-19 continues to mutate, it is wise to take the time to review the evidence and decide what is best for you.