Did industry capture help silence COVID shot safety warnings? The BMJ’s findings demand an answer from lawmakers.
The Independent Medical Alliance (IMA), a national coalition of independent physicians, researchers and clinicians, today called on Congress to end the regulatory capture that may have contributed to the COVID vaccine safety failures documented by The BMJ.
The BMJ found that CDC and FDA officials were warned that the data mining tool they relied on to scan vaccine injury reports was blind to signals from the Pfizer and Moderna mRNA shots. Officials kept the tool and told the FDA scientist who raised the problem to back off. Then they assured the public there were no safety signals.
Pfizer and Moderna had record years. Pfizer’s Comirnaty brought in roughly $37 billion to $38 billion in each of 2021 and 2022. Moderna went from $803 million in revenue in 2020 to more than $18 billion in 2021, almost entirely from Spikevax.
The CDC didn’t run its second promised analysis until 2022. When it did, the analysis flagged myocarditis and other events as safety signals week after week, even as the CDC director publicly described the results as showing nothing unexpected.
Throughout the rollout, the federal government acted as regulator, largest buyer, liability shield, and, with Moderna, development partner. Several senior officials who oversaw these products later took high-paying jobs in the pharmaceutical industry.
“Congress needs to connect the dots and find out exactly where the pressure to overlook this data came from,” said Dr. Joseph Varon, President and Chief Medical Officer of the Independent Medical Alliance. “Frontline doctors, me included, were speaking up about the injuries we were seeing from the COVID shot. They used flawed FDA and CDC data to shut us down.”
IMA is calling on Congress to enact five reforms.
1. Separate the functions. The FDA’s biologics center authorized the mRNA shots and also controlled the safety analysis that could have raised questions about them. The CDC promoted vaccine uptake while co-running VAERS. Post-market vaccine safety should sit in an office that does not answer to the people responsible for vaccination rates, and whose findings cannot be overruled because they might fuel “rhetoric.”
2. Slow the revolving door. Senior officials who personally handled authorization, labeling or safety-signal decisions for a class of products should be barred for a set number of years from taking a paycheck, consulting contract or board seat with any manufacturer of that class. The FDA should also publish an annual accounting of where its departing medical reviewers go.
3. Make safety analyses public from day one. Any emergency product that floods VAERS should automatically trigger at least two pre-specified data mining methods, including one designed to catch effects shared across a product class. Post weekly results to a public docket the same week they’re produced. If a method is known to be insensitive, every official statement that cites it should say so.
4. Protect the scientist who brings bad news. Ana Szarfman was a career FDA officer. She was told to hold off, and when she persisted, to stop. Congress should give federal safety scientists who flag defects in active surveillance systems statutory protection, including a private right of action if they are removed from the work for speaking up.
5. Put practicing physicians in the room. Safety rules that affect every household shouldn’t be written only by people who will never treat the 24-year-old with chest pain. Frontline doctors need a real seat at the table.
“We’re done accepting ‘trust us’ from agencies that kept a broken alarm running and then pointed to the silence,” Varon said. “If they want the public’s trust back, they can start by taking the fox out of the henhouse.”
The BMJ investigation is available at bmj.com. To arrange an interview with one of our doctors, contact [email protected].
