NVIC to FDA: mRNA COVID-19 Shots Should Not Be Recommended for Anyone 

By Barbara Loe Fisher 

Published June 13, 2025 in Government

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On May 23, 2025, NVIC submitted a written public comment to the US Food and Drug Administration’s Vaccines & Related Biological Products Advisory Committee (VRBPAC) signed by two former consumer members of VRBPAC, Barbara Loe Fisher, NVIC Co-founder & President and Vicky Pebsworth, PhD, RN, NVIC board member and volunteer Director of Research and Patient Safety. NVIC registered opposition to the  recent FDA recommendation that mRNA COVID shots should be given to individuals over age 65 and those with one or more poor health conditions that raises risks for severe COVID.

NVIC stated that FDA should not be recommending mRNA COVID-19 shots for anyone until adequate scientific evidence demonstrates safety and effectiveness for both the healthy and those who are elderly or chronically ill. The public comment was made in response to discussions at the May 22 VRBPAC meeting at which selection of SARS-CoV-2 strains for 2025/2026 COVID shots was discussed.

NVIC’s public comment contains a selection of revealing statements made by Barbara and Vicky during VRBPAC meetings about vaccine safety science while they separately served as consumer members on the FDA’s vaccine advisory committee between 1999 and 2015. They made four other recommendations, citing:  

     (1) limitation of public access to background information on topics before the meeting, and unreasonable deadlines for making oral and written public comments;
      (2) the inclusion of too many VRBPAC committee members with conflicts of interest who cannot vote during all VRBPAC meetings and the temporary replacement of absent members with DHHS employees who vote;
      (3) failure to enforce four-year term limits for VRBPAC members;
      (4) appointment of doctors or medical professionals to serve as consumer members rather than individuals who are truly representative of the public at large.  

   mRNA Vaccines Have Not Been Proven “safe, pure and potent.” In calling for the FDA to stop recommending the mRNA COVID shots for anyone until true placebo controlled clinical trials and biological mechanism scientific evidence has been produced, Barbara and Vicky cited

(1) too few animal studies conducted before the EUA was granted to manufacturers in December 2020;

(2) the fast tracking of clinical trials in humans that were not methodologically sound

(3) failure to prove the mRNA and nanoparticle technology utilized by Pfizer and Moderna to manufacture COVID-19 shots was safe and effective before the biological was released for public use and failure to acknowledge subsequent published studies that have provided scientific evidence that mRNA COVID shots are causing injury and death;

(4) failure to adequately investigate the more than 1.6M COVID shot adverse events reported to VAERS; and

(5) failure to respond to congressional reports revealing that the federal government withheld information from the public about the reactivity of COVID-19 vaccines.
  

Pointing out the need to protect vulnerable populations from being harmed by COVID shots, they said: “Demonstrating that a vaccine is “safe, pure and potent” for use by the very young, the elderly and the chronically ill and disabled is equally important as demonstrating that it is “safe, pure and potent” for those who are healthy.”

Read the entire referenced public comment here.