Originally published June 14, 2023 6:00 pm PDT
In the ongoing debate surrounding the labeling of COVID-19 vaccines, a trio of healthcare professionals has raised concern over the Food and Drug Administration’s (FDA) refusal to update its labels to reflect potential health risks.
Peter Doshi, Linda Wastila, and Kim Witczak—respected figures in the medical field—have criticized the FDA for keeping what they see as obsolete, misleading, and non-informative labels for the Pfizer and Moderna vaccines.
Their complaints, detailed in an opinion piece for The Hill, center around several key issues, starting with the notion that “people are now getting boosted indefinitely with little reliable information about scientific developments.”
Their particular concern was the ambiguous evidence surrounding whether the vaccines could reduce viral transmission.
They claimed that, despite asking the FDA to clarify this on labeling, the request was denied.
The FDA has “repeatedly stated that effectiveness against transmission remains unproven,” the trio write, noting that the agency’s website maintains: “the scientific community does not yet know if Comirnaty will reduce such transmission.”
The group also castigated the FDA for not following the lead of foreign regulators who updated their labels to include potential adverse reactions.
In their opinion piece, the authors cited the European regulator’s addition of heavy menstrual bleeding to product information as a potential vaccine adverse reaction.
However, their request was met with resistance from the FDA, which argued that “foreign regulatory agencies’ expectations and regulations regarding product labeling can differ from those of the U.S. FDA.”
The authors also highlighted the FDA’s failure to warn about the documented risk of sudden death, particularly related to myocarditis, a side effect recognized among young men.
They noted “multiple autopsy studies on lethal vaccination-associated myocarditis” to support their request for adding “sudden death” to product labeling.
The FDA responded by stating the evidence was not sufficient to prove a causal association between sudden cardiac death and vaccination.
They further asked the FDA to include seven potential adverse effects in the 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.”
Their requests were repeatedly rejected by the FDA, which argued that causality had not been definitively established.
The authors accused the FDA of failing to adhere to its own rules and federal law, which calls for labeling to include “those adverse events for which there is some basis to believe there is a causal relationship.”
They argued that “100 percent proof of causality is a nearly impossible standard to meet, and the ‘some basis to believe’ evidentiary standard was amply met by the peer-reviewed publications that we cited.”
Despite mixed messaging about whether vaccines block viral transmission, the FDA stated it was not convinced there was any widespread misconception about this.
The FDA did agree to add data on the results from the manufacturers’ randomized trials of bivalent boosters, but only for Pfizer’s vaccine.
The group concluded by criticizing the FDA’s “double standard,” arguing it was harming patients and undermining public trust.
They urged that “product labeling should be informative and accurate, not promotional,” adding that “the law requires it, and following the law shouldn’t be optional.”
