In January, a group of former Food and Drug Administration (FDA) advisers asked the agency to make critical changes to Covid-19 vaccine warning labels. The FDA rejected almost every recommendation.
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We tried to improve COVID vaccine labeling — the FDA said ‘no thanks’ | The Hill | Peter Doshi, Linda Wastila, & Kim Witczak:
June 9, 2023 - "Health care providers rely on product labeling for accurate, unbiased and up-to-date information on medical products. But current Food and Drug Administration (FDA)-approved labels for the Pfizer and Moderna COVID-19 vaccines are obsolete, misleading and out of touch with regulators elsewhere....[P]eople are now getting boosted indefinitely with little reliable information about scientific developments....
"In January, a group of us — current and former FDA advisers and academics from around the country — tried to fix this problem by asking the FDA to make critical changes to official product labels. But four months later, in a 33-page response letter, the agency denied almost every single request. In doing so, the FDA failed to follow the lead of regulators elsewhere, including in Europe and Japan.
"For instance, we cited the European regulator’s addition of heavy menstrual bleeding to product information as a potential vaccine adverse reaction. The FDA’s response was a sophisticated version of “who cares!” “Foreign regulatory agencies’ expectations and regulations regarding product labeling can differ from those of the U.S. FDA,” the agency wrote. The FDA also said the European Medicines Agency hadn’t proven causality with respect to that side effect.
"The FDA also failed to warn about the documented risk of sudden death, even though myocarditis is now a well-recognized side effect, particularly among young men. To support adding 'sudden death' to product labeling, we pointed to multiple autopsy studies on lethal vaccination-associated myocarditis.... The FDA again rejected our request, arguing that ... 'alternative causes of death…may not be apparent on autopsy.'
"Federal law requires that product labeling lists adverse reactions that recipients may potentially experience. Of course, not every adverse event type reported in the postmarketing period needs be listed on the label ... but instead 'only those adverse events for which there is some basis to believe there is a causal relationship.' With this in mind, we asked the FDA to add seven adverse event types to product labeling: multisystem inflammatory syndrome in children (MIS-C), pulmonary embolism, sudden cardiac death, neuropathic and autonomic disorders, decreased sperm concentration, heavy menstrual bleeding and detection of vaccine mRNA in breastmilk.... The FDA rejected our request, once again arguing that causality had not been definitively established. In other words, the FDA is not following its own rules....
"As to whether the vaccines block viral transmission, we thought it was fairly obvious that there is substantial public confusion.... We pointed to messaging from public health leadership. Anthony Fauci, until recently director of the National Institute of Allergy and Infectious Diseases, stated the vaccine turns individuals into virus 'dead ends' and Rochelle Walensky, director of the Centers for Disease Control and Prevention (CDC), declared 'vaccinated people do not carry the virus'....
"But the FDA instead fired back, alleging we chose 'selective statements' when quoting Fauci and Walensky.... 'Dr. Fauci has stated that the vaccines were not developed to protect against infection, and Dr. Walensky has stated that high viral loads in vaccinated individuals "suggest an increased risk of transmission."' Meanwhile, the CDC’s website still informs people the vaccines are effective at 'limiting the spread of the virus.' Despite all the mixed messages, the FDA apparently thinks the public is somehow clear-eyed about all this....
"The FDA’s double standard — failing to warn about potential harms, while simultaneously doing nothing to stop a sister agency from making unproven claims of benefit — harms patients and undermines the public’s trust in governmental institutions established to act in their interest. Product labeling should be informative and accurate, not promotional. The law requires it, and following the law shouldn’t be optional."
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