David Gortler, pharmacologist, former member of the US regulatory agency and former professor at Yale University, warns of agency negligence
From the beginning, the Food and Drug Administration (FDA), the US health regulatory agency, knew that vaccines developed with messenger RNA (mRNA) technology against covid-19 were linked to serious heart problems. An article written by David Gortler, pharmacologist, former FDA member, and former professor of pharmacology and biotechnology at the Yale University School of Medicine, warns that “US Anvisa” neglected information and did not keep the same regulatory standards, used in other medications and products, to validate the safety of anti-covid vaccines.
The review of Biological License Request submitted by the manufacturer BioNTech/Pfizer for analysis by the FDA already showed that “severe clinically important adverse reactions [incluídas] anaphylaxis and myocarditis/pericarditis,” that is—severe allergic reactions and inflammation of the heart—could occur as a result of the use of mRNA vaccines, says the article published on The Federalist website. The document was revised in August 2021.
Differences in FDA regulatory standard
The Vaccine Adverse Event Reporting System (VAERS), administered jointly by the FDA and the Centers for Disease Control and Prevention (CDC), lists a range of cardiovascular events in young and healthy people. While it is necessary to evaluate the reports to establish causal links in relation to these adverse events, Gortler says that there are already thousands of reports of heart attacks, myocarditis and pericarditis in the United States alone, which “should have encouraged manufacturers and the FDA to investigate further” the reported cases.
According to the article, epidemiologists responsible for drug safety at the FDA stated that the agency is rigorous about possible effects of medications and that a single well-documented event is sufficient to warrant further investigation. For example, in 2008, after less than 200 spontaneous reports of VAERS of tendon rupture after administration of an antibiotic known as a fluoroquinolone, the FDA added a “black box warning” and prescription restrictions for the drug.
However, thousands of reports from the VAERS to report serious, debilitating and deadly events after vaccination against covid are not receiving the same degree of requirement and regulatory standard, says the article.
In addition to VAERS, the CDC’s Vaccine Safety Datalink indicates excessive risk of myocarditis and pericarditis in people who have received both Pfizer and Moderna vaccines. The cardiovascular risk after any mRNA vaccine is high, but with Moderna it is approximately four times that of Pfizer, points out study.
