A coalition of experts is calling for U.S. officials to update the labels for the Pfizer and Moderna COVID-19 vaccines to acknowledge limitations to clinical trials, including stating clearly that the phase III trials that led to clearance didn’t provide evidence of efficacy against death.
“Incomplete, inaccurate, or misleading labeling of any medical product can negatively impact the health and safety of Americans, with global ramifications considering the international importance of FDA [Food and Drug Administration] decisions,” Peter Doshi, an associate professor at the University of Maryland School of Pharmacy whose expertise includes clinical trials, and eight other experts wrote in a petition.
The group, known as the Coalition Advocating for Adequately Labeled Medicines, sent the petition to the FDA, which authorized the vaccines in late 2020 and approved them in 2021.
The experts note that the clinical trials that led to the authorization “were not designed to determine and failed to provide substantial evidence of vaccine efficacy against SARS-CoV-2 transmission or death.” As evidence, they cited the FDA’s review memorandums, which stated, in part, that “data are limited to assess the effect of the vaccine against transmission of SARS-CoV-2 from individuals who are infected despite vaccination.”
SARS-CoV-2 is the pathogen that causes COVID-19.
The FDA states on its website that “the scientific community does not yet know” if the vaccines will reduce such transmission.
“While language in labeling that states what a product has not been proven to do is uncommon, it is necessary when caregivers and patients may inaccurately assume something that is untrue,” the coalition stated, citing how Dr. Anthony Fauci, a former top U.S. health official; President Joe Biden; and others have falsely suggested that the vaccines prevent transmission and would lead to herd immunity.
People should also be informed that the efficacy of Pfizer’s vaccine wanes after just two months, according to the experts. They pointed to Pfizer’s interim results from the trial, which were available in April 2021 but not disclosed to the public until July 2021.
