FDA: Licensed Vaccines Do Not Need to Prevent Infections or Transmission

by TrialsiteNews |Apr 26, 2023

Recently, during the Food and Drug Administration (FDA) contemplated changes to the COVID-19 vaccine status, they elicited a commenting period. An organization called the Coalition Advocating for Adequately Labeled Medicines (CAALM) tracked by TrialSite filed a petition requesting that the agency update the COVID-19 vaccine product labeling –for both Pfizer and Moderna products—to reflect their actual safety and efficacy more accurately. The third entry was titled “Requests that the FDA require that the sponsors of Comirnaty, Spikevax, Pfizer-BioNTech COVID-19 Vaccine and Moderna COVID-19 Vaccines (collectively, ‘Pfizer and Moderna COVID-19 vaccines’) amend current product labeling.” While the principals behind CAALM are experts and offer the FDA valid points in their comments, the FDA flatly rejects the organizations requests, declaring that a licensed vaccine doesn’t need to demonstrate that they prevent infection or transmission nor does a vaccine authorized under provisional emergency use authorization need to demonstrate infection prevention or transmission.

Before delving into the FDA’s response, a brief reminder on the importance of CAALM. Led Linda Wastila, BSPharm, MSPH, Ph.D., a Professor and Parke-Davis Chair in Geriatric Pharmacotherapy, Department of Practice Sciences, and Health Outcome Research; Director of Research, also with Peter Lamy Center on Therapy and Aging, University of Maryland, TrialSite reported on the group’s first notable effort to pressure the FDA to modify the COVID-19 vaccine labels. See “University of Maryland Pharma Professor Introduces ‘CAALM’—for FDA Updates of COVID-19 Vax Labels for Transparency.

Linda Wastila and others at CAALM are at it again. This time they are using their expertise in pharmaceutical product labeling to request that the regulatory agency modify the mRNA—based COVID-19 vaccine product labels more accurately to reflect the actual nature of the still investigational vaccine products.

A note here, the FDA in an unorthodox manner approved the vaccines—first, Pfizer by approving Comirnaty, yet keeping BNT162b2 (investigational) as the only vaccine in distribution.

TrialSite hypothesized on that move that the Biden administration sought to kill the proverbial birds with one stone—the action would generate more confidence in the market, thereby reducing any vaccine hesitancy while also providing the legal grounds for imminent forthcoming mandates at the federal and local levels (of course much of the federal mandate announced by Biden was tossed by the courts).

The FDA response

In a telling letter to the organization (CAALM), the FDA declared, “FDA authorization and licensure standards for vaccines do not require demonstration of the prevention of infection or transmission…Similarly, a vaccine can meet the EUA standard without any evidence that the vaccine prevents infection or transmission.

Linda Wastila sent TrialSite comments on the FDA’s response that “The vaccines are not licensed or authorized for prevention of infection with the SARS-CoV-2 virus or for prevention of transmission of the virus, nor were the clinical trials supporting the approvals and authorizations designed to assess whether the vaccines prevent infection or transmission of the virus.”

Professor Wastila wrote to TrialSite: “Yet, FDA, CDC, NIH, the White House, the media aggressively promote these products as preventing infection and transmission. This is what the majority of Americans believe; this is the message they trust. So they go out and get vaccinated and boosted to protect grandma, to travel safely, and to get back to normal. Yet the actual ‘standard’ the FDA officially documents is that “the Pfizer and Moderna COVID-19 vaccines have been licensed or authorized for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by SARS-CoV-2.” (P. 12 of their response). The top-down messaging from our government and media is egregious to me. Irresponsible. Misinformation of the highest degree.”

The expert with over two decades of research focusing on prescription drug policy, quality and outcomes further communicated:

“As well, the timing of the FDA’s response is curious—it coincides with FDA’s announcement that they no longer recommend the original 2-series monovalent product. This means there are no BLA Pfizer C-19 vaccines effectively available on the market, which (presumably) includes Comirnaty and Spikevax, the fully licensed products. The ONLY products recommended are EUA products. And where is the emergency?”

See a pdf of the letter below, on page 11

It is important to note that FDA’s authorization and licensure standards for vaccines do not require demonstration of the prevention of infection or transmission. A vaccine can meet the licensure standard if the vaccine’s benefits of protecting against disease outweigh the vaccine’s risks for the licensed use. There is no requirement that the vaccine also prevents infection with the pathogen that can cause the disease or transmission of that pathogen to others. Similarly, a vaccine can meet the EUA standard without any evidence that the vaccine prevents infection or transmission.

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Call to Action: Check out the link for the entire FDA docket.


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