FDA’s policy of shots first, questions later, does not allow for informed consent | Eastern North Carolina Now

On June 28, 2022, FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) met to vote on COVID strain replacement in the shots. Stand for Health Freedom was selected to make oral public comment at the meeting. We took this opportunity to remind the federal government of American’s fundamental right to informed consent in medical decisions. This right does not disappear when a pandemic is declared. Listen and read below for full text of the comment made, with references.

 

Written prepared statement:

Thank you for this opportunity to comment. My name is Valerie Borek, I am Policy Analyst for Stand for Health Freedom, a national grassroots organization of over a half million Americans who are advocates for informed consent and no medical mandates.

Americans have a Constitutional right to informed consent. I urge you to uphold your mission to ensure safety and efficacy of COVID shots before voting on strain replacement without FDA-reviewed clinical trials.

Informed consent requires disclosure of risks, benefits, and alternatives, in terms a patient or guardian can understand – they must be able to ask questions and get answers from providers who have the information they need to answer those questions.

The FDA claims Americans aren’t entitled to informed consent for EUA products, but this is not true. Health professionals have a duty to their patients, including informed consent. EUA products are not fully approved by the FDA and are therefore experimental, requiring informed consent under US law.

In one of the first US Supreme Court Cases addressing COVID policy the Court affirmed that, quote, “We don’t cut the Constitution loose in a pandemic.” Chief Justice Roberts wrote, “As more medical and scientific evidence becomes available…courts should expect policies that more carefully account for constitutional rights.”[i] End quote.

Over the last two years the FDA has lowered their standards. Using antibody response instead of effectiveness when you do “not have the clinical data that we’d all love to have,” to quote Dr. Rubin in the April VRBPAC meeting[ii], is not legally, medically, or scientifically sound. Regarding waning immunity and boosters, Dr. Weir admitted, quote, “there’s just an awful lot we don’t know.” Dr. Meissner asked why SARS-CoV-2 mutates more than other viruses, and was told the spike protein in the shots is “driving the rate of evolution,” in other words, the shots made the mutations–yet the FDA has not investigated this. In CDC’s ACIP meeting on June 23, members asked about the difference between the Pfizer and Moderna formulations for our babies and toddlers, but no one could answer. This is not informed consent.

The FDA has not explored known potential risks, which is required for an EUA, and therefore cannot legally authorize any shots. The FDA is ignoring massive safety signals from VAERS, and reports of injury or death from shots, made in advisory committee meetings, in congressional hearings, and in the federal register. The shots were rushed at “Warp Speed,” with expedited FDA review, and clinical trials are ongoing through 2024. There is no long-term safety data for this novel mRNA technology.

The FDA has not addressed data fraud allegations made by Dr. Peter Doshi[iii], or Pfizer employee Brook Jackson[iv], nor has it answered US lawmaker concerns about authorization of shots for babies and toddlers. Studies were unblinded, confusing data, and eliminating controls. VRBPAC and ACIP members continually say they need more information about natural immunity and safety. How can the FDA tell parents or doctors that benefits outweigh the risks when you do not know the risks?

Even less is known about strain replacements for COVID shots. Americans need this missing data to make informed medical decisions. The more trustworthy your data, the more confidence Americans can have in your advice.

It is illegal for the FDA to authorize COVID shots without adequate safety or efficacy data. The FDA’s policy of shots first, questions later, does not allow for informed consent. On behalf of Stand for Health Freedom, I thank you for your time.