Report 97: Pfizer Obscured Myocarditis Safety Signal Specific to Young Men. FDA Took Five Months to Notice Pfizer’s Obfuscation.

By Joyce Allen, RN, and Linnea Wahl, MS - Team 5

Career scientists are struggling with attention to detail in fulfilling their vaccine safety duties. Their conclusions, marked by errors and oversights, have led to lives lost and debilitating disorders, as proven by the government scientists’ own review documents.

In spring 2021, the US Food and Drug Administration (FDA) granted emergency use authorization for the Pfizer mRNA COVID-19 drug to be given to children older than 12 years and renewed its approval for use in adults. These approvals came despite the fact that FDA officials had reviewed and signed off on data proving that Pfizer’s mRNA drug was dangerous, especially to young men and boys. Did FDA employees miss important safety signals? Given their mistakes, are these government employees the right people to be making life or death decisions affecting the well-being of Americans?

The FDA Professionals

Consider this description from the FDA website (https://www.fda.gov/vaccines-blood-biologics/vaccines/emergency-use-authorization-vaccines-explained) that defines the job description of the professionals evaluating vaccines for emergency use: “The FDA staff are career scientists and physicians who have globally recognized expertise in the complexity of vaccine development and in evaluating the safety and effectiveness of all vaccines intended to prevent infectious diseases. These FDA professionals are committed to decision-making based on scientifically driven evaluation of data. FDA staff are like your family—they are fathers, mothers, daughters, sons, sisters, brothers and more. They and their families are also directly impacted by the work that they do, and are exactly who you want making these important public health decisions for the United States.”

Consider that an FDA regulatory specialist provides “authoritative guidance and consultation regarding current good manufacturing practices (CGMPs) for pharmaceutical manufacturing in the context of on-site inspections; and, supports the human drug surveillance program through qualitative and quantitative regulatory assessments of quality metrics, quality management maturity, pharmaceutical quality system effectiveness, and other related quality intelligence available throughout the product lifecycle.” (https://www.fda.gov/media/175128/download) A drug surveillance program attempts to identify, evaluate, and address safety issues, or safety signals, related to new drugs (https://www.fda.gov/media/130216/download). A safety signal is “information arising from one or multiple sources that suggests a new potentially causal association or a new aspect of a known association between an intervention and an event or set of related events, either adverse or beneficial, judged to be of sufficient likelihood to justify verificatory action.” (https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9334375/)

Now consider these two examples of how the “globally recognized expertise” of FDA staff ignored safety signals that brought misery and even death to young men who developed heart disease after taking Pfizer’s mRNA COVID-19 drug.

Missing the Signal in Monthly Safety Data

From December 2020 until September 2021, Pfizer collected data on the safety of its mRNA COVID-19 drug and submitted summaries of the data to FDA each month. FDA employees, in turn, reviewed the Pfizer data summaries and prepared checklists documenting their reviews. FDA has released the data summary checklists for data from March through August 2021. These seemingly simple checklists reveal much, as discussed below.

But first, who are the FDA employees who prepared and reviewed these checklists?

• Deborah L. Thompson, MD, is documented as the monthly reviewer on each checklist during this six-month interval. Dr. Thompson is a preventive medicine physician in Silver Spring, Maryland. She received her medical degree from SUNY Upstate Medical University and has been in practice for more than 20 years. Her specialties include public health. (https://www.doximity.com/pub/deborah-thompson-md)

• Ramachandra Naik, PhD, professional biochemist, is the regulatory information specialist to whom Dr. Thompson submitted her checklists of data from March through June 2021. Dr. Naik’s stated credentials include over 10 years of experience in biochemistry, molecular biology, immunology, cell biology, protein biology, with special strength in experimental design, technology development, troubleshooting, and cross team coordination. His biography documents research experience in handling and analysis of DNA libraries, biomarker interactions, as well as experience with bacteria, cell/tissue culture, and yeast/fungi. (linkedin.com/in/ramachandra-naik-823a824b)

• Laura Gottschalk, PhD, is the regulatory information specialist who reviewed Dr. Thompson’s checklists of data from July and August 2021. According to her biography, Dr. Gottschalk has more than 10 years of experience working in molecular biology and genetics laboratories. “She received her PhD from Johns Hopkins School of Medicine in Cellular and Molecular Medicine, where her work focused on the genetics of cystic fibrosis.” (https://testsite215.wordpress.com/violence-risky-behavior/key-staff/)

Each month, Dr. Thompson answered checklist question 4: “Have there been any new safety issues identified by the reviewer in this PSUR [periodic safety update report]?” Each month, she marked the “YES” box and dutifully regurgitated text provided in Pfizer’s monthly data summary. Each month, Dr. Thompson concluded that “the contents of this PSUR/PAER [periodic adverse experience report] do not indicate a need for further regulatory action [emphasis added],” with either Dr. Naik or Dr. Gottschalk signing off on Dr. Thompson’s conclusion.

Each month, that is, except one. In the May 2021 data, Dr. Thompson finally noticed that Pfizer’s data signaled that heart disease — specifically, myocarditis — could be a safety issue for young men receiving the mRNA COVID-19 drug (6_IND_19736_366_24-Jun-2021_DEBORAH_DEBORAH__RO_.pdf at https://www.phmpt.org/pfizer-16-plus-documents/). Myocarditis was defined by the US Centers for Disease Control and Prevention (CDC) in 2021 as “a form of heart disease that results from inflammation of the muscles that comprise the heart. This inflammation can weaken your heart making it harder to pump blood to the rest of your body. Myocarditis may result in feeling shortness of breath, faster or irregular heartbeat, and chest pain. An episode of myocarditis may resolve completely or may cause long-lasting harm. The most common cause of myocarditis is a viral infection, but other types of infection can cause myocarditis. Certain chemicals have also been known to cause myocarditis.” (https://archive.cdc.gov/#/details?url=https://www.cdc.gov/dhdsp/myocarditis.htm)

How would the FDA’s “globally recognized career scientists” identify a safety signal like myocarditis with Pfizer’s mRNA COVID-19 drug? And how can a data reviewer determine if there is an association between an intervention, such as Pfizer’s mRNA COVID-19 drug, and an event like myocarditis? Pfizer’s monthly data summaries provide one such metric, the observed-to-expected (O/E) ratio. Simply stated, this ratio compares the number of people who are observed with an adverse event (such as myocarditis) after receiving an intervention (such as Pfizer’s mRNA COVID-19 drug) to the number of people who are expected to have the disease without receiving the drug. An O/E greater than 1 is a safety signal: more people are getting the disease after receiving the drug than is normal (https://onlinelibrary.wiley.com/doi/full/10.1002/pds.3918).

For myocarditis, European researchers had published expected values, based on 10 European healthcare databases, as of December 2020 (https://www.researchgate.net/publication/367982154_Background_Rates_of_41_Adverse_Events_of_Special_Interest_for_COVID-19_Vaccines_in_10_European_Healthcare_Databases_-_an_ACCESS_Cohort_Study). In this database, the lowest expected value for myocarditis was in the population of Spain. Yet the Pfizer monthly O/E values calculated for January through April 2021 (Pfizer did not calculate myocarditis O/E values in December 2020) used a much higher expected value for myocarditis, that of the population of Sweden published in 2007 (https://onlinelibrary.wiley.com/doi/abs/10.1111/j.1365-2796.2007.01843.x).

Worse, the Pfizer monthly O/E value calculated for May 2021 used an even higher expected value for myocarditis from the Italian population. The Italian expected value is more than double the Swedish expected value (19736_S0366_M1_smsr-30apr2021-31may2021.pdf at https://www.phmpt.org/pfizer-16-plus-documents/).

And even worse yet, for data from January to May 2021, Pfizer researchers made no attempt to identify myocarditis risks by age or sex. Using a single, all-ages, all-sexes expected value for myocarditis, Pfizer was able to obscure any safety signal specific to young men.

Finally, in her review of Pfizer’s May 2021 data summary, Dr. Thompson noticed Pfizer’s omission. She concluded that further regulatory action was needed. She stated in her checklist that the “background [expected] rates used in your [Pfizer’s] O/E analysis are relatively high for myocarditis . . .” (6_IND_19736_366_24-Jun-2021_DEBORAH_DEBORAH__RO_.pdf at https://phmpt.org/pfizer-16-plus-documents/).

The effect of using the Swedish and Italian all-ages/all-sexes expected values is an O/E less than one, so no myocarditis safety signal was detected. Was this a deliberate manipulation of the O/E metric by Pfizer researchers? Why didn’t Dr. Thompson, as the FDA data reviewer, identify the problem until she reviewed the May 2021 data? And why didn’t Dr. Naik and Dr. Gottschalk, as the FDA reviewers of Dr. Thompson’s checklist, identify the problem independently?

What prompted Dr. Thompson to finally notice Pfizer’s potential data manipulation? Perhaps it was Israeli researchers’ announcement in April 2021 that myocarditis was increased in young men who received Pfizer’s mRNA COVID-19 shot (https://www.reuters.com/world/middle-east/israel-examining-heart-inflammation-cases-people-who-received-pfizer-covid-shot-2021-04-25/). Yet it was not until late in June 2021 that FDA added a myocarditis warning to Pfizer’s patient fact sheet (https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-june-25-2021).

Clearly, the FDA employees with “globally recognized expertise” missed a critical safety signal. They are exactly NOT “who you want making these important public health decisions for the United States.”

Missing the Signal in the Pharmacovigilance Plan

Another example of FDA employees’ “globally recognized expertise” is Dr. Deborah Thompson’s review of Pfizer’s pharmacovigilance plan. Dr. Thompson documented her review in a memorandum sent to Dr. Ramachandra Naik on May 18, 2021 (51_Courtesy Copy_BLA 125742 0_Pharmacovigilance Plan Review Memo COMIRNATY.pdf). Note that these are the same FDA employees who missed the myocarditis safety signal in Pfizer’s monthly data summaries until it had become front page news.

On the second page of her memo, Dr. Thompson wrote: “The purpose of this review is to assess the adequacy of the sponsor’s [Pfizer’s] proposed pharmacovigilance plan (PVP) submitted under the original BLA 125742/0 for postmarketing safety monitoring for BNT162b2 (COVID-19 vaccine) and to identify potential safety issues associated with the use of BNT162b2 that may need to be addressed through additional pharmacovigilance activities including safety-related studies such as Post-Marketing Requirements (PMRs) and/or Post-Marketing Commitments (PMCs) or a Risk Evaluation and Mitigation Strategy (REMS).”

Although the memo is dated May 18, 2021, the text makes it clear that the memo was updated to at least the end of June 2021. Regarding the data related to myocarditis, Dr. Thompson wrote (p. 13): “After the issuance of the EUA [emergency use authorization], FDA and CDC [Centers for Disease Control and Prevention] received reports of myocarditis and pericarditis following administration of the Pfizer-BioNTech COVID-19 Vaccine. In accordance with FDA recommendations, the sponsor added myocarditis and pericarditis as important identified risks in the PVP. A VAERS [Vaccine Adverse Events Reporting System] search was performed for the timeframe from December 11, 2020 (the date of authorization) to June 21, 2021. The query was run on June 23, 2021 utilizing the PTs [preferred terms] autoimmune myocarditis, autoimmune pericarditis, eosinophilic myocarditis, hypersensitivity myocarditis, myocarditis, pericarditis, pericarditis adhesive, pericarditis constrictive, and pleuropericarditis. The query returned 1,023 reports (1012 U.S. reports), including 809 serious reports (seven were death reports concerning six unique individuals), of which 652 reports were in individuals under 30 years of age.”

At last, Dr. Thompson and Dr. Naik could not ignore the myocarditis safety signal in young men. Nor could they ignore the myocarditis O/E metric that signals a safety concern. In her review of Pfizer’s pharmacovigilance plan, Dr. Thompson notes (p. 14) that for myocarditis, “[t]he O/E analysis, stratified by age and dose number, indicates that the observed number of cases exceeds the expected number of cases (based on pre-COVID-19 pandemic US population-based background rates).”

So, Dr. Thompson acknowledged the myocarditis risk but despite her findings, she did not recommend halting administration of the mRNA COVID-19 drug. On page 29 of her review memo, she wrote: “During the post-authorization period, myocarditis and pericarditis following administration of the Pfizer-BioNTech COVID-19 Vaccine was reported to VAERS. Myocarditis and pericarditis emerged as a safety signal in VAERS, and there are ongoing analyses for further characterization of these risks.” And she concluded (p. 31) that “[b]ased on review of available data, there is a new safety signal for myopericarditis from post-authorization safety surveillance which warrants a FDAAA [FDA Amendments Act] Title IX PMR safety study to assess the important identified risk of myopericarditis.”

Unfortunately, Dr. Thompson concluded her memorandum with equivocation (p. 32): “At this time, the available safety data do not suggest a safety concern that would require a REMS.” No need for a REMS, which is a process focused on “preventing, monitoring, and/or managing a specific serious risk by informing, educating, and/or reinforcing actions to reduce the frequency and/or severity of the event”(https://www.fda.gov/drugs/drug-safety-and-availability/risk-evaluation-and-mitigation-strategies-rems). How many more deaths and severe disabilities from myocarditis are necessary to warrant a serious risk assessment?

Missing Accountability

Having missed the myocarditis safety signal repeatedly, Dr. Deborah Thompson attempted to avoid culpability for her errors by co-authoring a paper in the Journal of the American Medical Association in January 2022 (https://jamanetwork.com/journals/jama/fullarticle/2788346). The article, titled “Myocarditis Cases Reported After mRNA-Based COVID-19 Vaccination in the US From December 2020 to August 2021,” found that “the risk of myocarditis after receiving mRNA-based COVID-19 vaccines was increased across multiple age and sex strata and was highest after the second vaccination dose in adolescent males and young men” (p. 1). This conclusion could have been reached long before the article was published if Dr. Thompson had carefully reviewed Pfizer’s monthly data summaries and pharmacovigilance plan.

Instead, Dr. Thompson and her coauthors laid blame for missing the myocarditis safety signal in early 2021 on the assumption that the expected rate of myocarditis in young men under 30 who had not received mRNA COVID-19 drugs is normally greater than in men over 30. They wrote that “the greater frequency noted among vaccine recipients aged 12 to 29 years vs those aged 30 years or older was similar to the age distribution seen in typical cases of myocarditis. This pattern may explain why cases of myocarditis were not discovered until months after initial Emergency Use Authorization [emphasis added] of the vaccines in the US (i.e., until the vaccines were widely available to younger persons).” (p. 6)

Yet analysis of Dr. Thompson’s review checklists shows clearly that Pfizer chose expected values of myocarditis cases that were arbitrary and high—high enough to hide the myocarditis safety signal. Later in 2021 when the myocarditis signal was unmistakable and undeniable, Dr. Thompson stopped short of recommending a risk assessment in her review of Pfizer’s pharmacovigilance plan. Finally, to avoid taking responsibility for her errors, Dr. Thompson joined her coauthors in blaming the natural pattern of myocarditis in young men.

The Rest of the Story

This is but a small piece of the mRNA COVID-19 drug tragedy—a handful of FDA employees, a small subset of Pfizer and FDA documents, but countless lives lost or destroyed. What will the full story reveal? Are FDA’s “globally recognized career scientists” at fault? Are these really the people we want in charge of health care for ourselves, our families, and our neighbors?

---