Madison Area Lyme Support Group

FDA uses “parent choice” to override safety concerns.

The FDA language of parent choice is a lie. The message that parents need to be given the choice to vaccinate, just like the people who choose not to vaccinate get to exercise their choice, is a false comparison. There is no choice when choice is not informed. There is no choice when dangers are hidden and “messaging” is more important than data. There is no choice when compliance is coerced by fear of disease, financial loss, or segregation and bullying.

The fact is that the younger the child, the more parents make the choice not to vaccinate. The trend has nothing to do with access. It has to do with safety concerns that the FDA is ignoring. Parents must protect their children, the FDA will not.

At the Vaccines and Related Biological Products Advisory Committee (VRBPAC) meetings on June 14-15, 2022, the panel voted unanimously in four separate votes to reach the White House goal of FDA Emergency Use Authorization (EUA) of COVID shots for both Pfizer and Moderna for kids as young as 6 months. Members went out of their way to declare their “yes” vote was about making sure the choice on whether children get the COVID shots is in the hands of the parents.

FDA Mission

The Food and Drug Administration is responsible for protecting the public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, and medical devices; and by ensuring the safety of our nation’s food supply, cosmetics, and products that emit radiation.[i]

The FDA is supposed to regulate the safety and efficacy of drugs and vaccines that are sold in the United States. Period. No one questions that. But what happens when they don’t? What happens when the FDA fails in its duty to protect Americans?

The FDA has lost its way. Parents must call the shots.

Doctors rely on the investigations by FDA reviewers and advisory committees. Parents want to be able to turn to both doctors and the FDA to do their job to keep our families safe. But, they can’t do that when health providers and regulators can’t meet at least a minimum level of scientific and medical believability and reliability.

Why aren’t doctors and the FDA curious about the monumental number of injuries that have been reported to the Vaccine Adverse Event Reporting System (VAERS)? Why are they not questioning the need for a COVID shot for kids when it is openly acknowledged by the FDA and CDC that around 75% of children already have antibodies?

The FDA is not living up to its task – and it hasn’t for decades – as a recent Stand for Health Freedom blog revealed. The FDA is willing to “embrace uncertainty” with our children’s safety to push new pharmaceuticals to market. This is not new. As with Tamiflu, the FDA is willing to ignore fraud and faulty science while allowing unsafe and ineffective pharmaceuticals to be given to children and adults.

VRBPAC member Pamela McInnis was very clear her “yes” votes had nothing to do with safety nor efficacy, when she reminded everyone, “An EUA doesn’t certify that a vaccine is safe and effective.”

This begs the question: Why would a shot be authorized for emergency use if it hasn’t been proven necessary, safe, or effective?

The FDA made it clear that “messaging,” not safety, is their top priority and that they are passing the responsibility for risk assessment to parents.

Playing on fears has been a huge part of the COVID shots discussion. Health agencies call it “messaging”. Messaging has been a huge part of the discussion of both FDA’s VRBPAC and the Advisory Committee on Immunization Practices (ACIP) for the CDC. How does the government get people from hesitant or opposed to the COVID shots, to accepting the “new normal” of multiple shots and boosters each year?

William Grueber opened Pfizer’s presentation with concerns of compliance with a three-dose series. His job was to present Pfizer’s safety profile.

When explaining his vote to recommend COVID shots for infants and toddlers, Dr. Arthur Reingold declared: “My personal preferred wording is not to tell people something is safe. I think that’s the wrong messaging. I think nothing in life is perfectly safe – no drug, no vaccine, no personal choice to get on a plane or get into a car is, quote, safe. I think what we need to emphasize is its benefits outweigh the risks.”[ii]

Dr. Oveta Fuller reminded parents that the trials for these shots are ongoing even after millions of American children are being injected, and that parents must decide whether their children should participate. “The need for clear messaging to parents and guardians about the choice for having the vaccine or not is very important, and that the follow-up studies that are planned are very important,” she said. “…I would ask, should this pass, or should this be recommended by FDA advisory committee and passed by FDA and CDC, that parents really consult their pediatrician for their children…This is a decision that parents and grandparents and guardians will have to carefully weigh should this actually go through.”[iii]

This attitude of treating children as medical experiments has echoed throughout discussions since 2020. It has been more important to authorize shots quickly and collect safety data later on in our children, than to proceed with caution. Dr. Arthur Reingold emphasized the differences in priorities between parents and the FDA, saying, “One of the speakers in public session urged us to think of the children. Now I think he and I may think of the children in slightly different ways.”

To drive home the point, Dr. Ofer Levy explained safety surveillance after authorizing the shots was “key”.[iv] He said, “It’s possible we’ll see febrile seizures as this gets pushed out,” as well as other respiratory complications, “so those are areas where I think that knowledge, it needs to continue to evolve.” Read that again. the FDA’s “knowledge” of adverse reactions “needs to continue to evolve.” How does that weigh on a parent’s risk versus benefit scale?

Further, authorizing shots to appease fearful parents is reckless in a time where a growing number of states are allowing minors to make medical decisions without parental knowledge or consent. In December 2020, when VRBPAC considered the first COVID shot EUA for Pfizer, there was discussion about whether kids 16-18 should be included. Dr. Chatterjee stated the teens “would not be granting permission themselves. Their parents are responsible.”[v] No one disagreed.

When the FDA has a policy of shots first, questions later, parents must protect their children!

It was clear that whether the Moderna and Pfizer COVID shots for kids as young as six months would be recommended for FDA approval was never in question. Dr. Archana Chatterjee pointed out that she cast a “no” vote on a previous EUA expansion “and got in a lot of trouble for it.” To open discussion about the trials in children as young as 6 months, Dr. Arnold Monto reminded all the VBRPAC members of why they were there and who was in charge: “I’d like to call on Dr. Peter Marks, the Director of the Center for Biologics Evaluation and Research of the FDA to give us his welcome and tell us a little bit about what we are expected to do today.”[vi] (emphasis added) Dr. Marks heads the section of the FDA responsible for investigating the COVID shots, a post previously held by Dr. Marion Gruber until she publicly disagreed with the booster agenda in September 2021[vii] and was swiftly removed from heading the Pfizer COVID shot review. She then unexpectedly retired from the agency in October 2021 after a 32-year career.[viii] Before the first vote to expand the EUAs for shots down to our youngest, Dr. Monto reminded members again, “I’m glad to give you the final word that we should all get vaccinated…..OK we are ready for the voting question.”

Americans do not need to dig deeply into the employment rolls of the FDA to notice that people who slow or try to prevent drugs coming to market are not welcome at the FDA. The FDA cannot be trusted and parents need to protect their children.

Parents do not need to have a Ph.D., M.D., or any other letters behind their names to make medical decisions for their child. No one knows a child better than the people who love them most. No one is more attuned to their needs and no one is more invested in seeing them thrive. When it comes to medical decisions, your job as a parent is to ask questions until there are no more to ask. If a provider can’t answer, you ask another provider.

Justine Luzzi, who was excited to get her Moderna shots, developed vaccine injury after her second shot. In public comment she summed up the FDA’s role in allowing toxic COVID shots to be given to millions of Americans: “You are the ones that lie to the American people that vaccines are completely safe for the average person. You are offensive to actual science and medicine, lacking any type of curiosity of adverse events. … How do you sleep at night? You are a disgrace to humanity. You are narcissists cloaked in healer’s clothing. … Myself and millions [of] others will never stop fighting and telling the truth. Our resilience is bigger than your cowardice. Only cowards would avoid accountability as innocent people suffer. Approving this for children without fully researching the adverse effects is nothing short of criminal, extremely wicked, and shockingly evil.”[ix]

Parents must call the shots on their children’s health.

We know from comments that VRBPAC doesn’t believe that it is necessary to address safety concerns before the FDA allows a product to be used in the United States. Dr. Levy said he thinks the question needs to be whether benefits outweigh the risks. So how does the FDA evaluate benefits of a pharmaceutical product? It can’t be efficacy, as we see extremely low efficacy, breakthrough cases of COVID, quickly waning immunity from the shots, and acknowledgement that there is so little data it’s impossible to tell how effective the shots will be. So, what benefit does the FDA see that could outweigh risks they are ignoring?

Dr. Sawyer noted that many parents who made comments about wanting authorized COVID shots for their kids under five were isolating their children beyond even the federal government guidelines. There’s a huge mental health impact from this kind of isolation, so a “benefit” of the shot in his eyes is, “The availability of these vaccines will liberate these children to some extent whose parents will find relief and feel a little bit more comfortable as their children start to socialize in the appropriate environment.”[x] In other words, many parents are so scared out of their minds about the “messaging” the FDA and media have been streaming daily to Americans for 2 1/2 years that they are harming their children’s mental health, and the way the FDA will address this is by allowing these scared parents to “choose” to inject their children with an experimental pharmaceutical product with no proven safety or efficacy. This is absolutely not a scientifically- or medically-based benefit.

Coercion is not informed consent.

There is no way for a parent to give truly informed consent to these shots for their kids. Information is coming to light in landslides about suppressed information and manipulated studies. It’s unclear if even the FDA itself has all the information necessary to make a decision on safety and efficacy.

By painting a picture of authorization in the name of parental choice, the White House, through its federal agencies, is engaging in manipulative mental Jiu-Jitsu.

With access to the shots for babies and toddlers, parents’ hands will be just as tied as the VRBPAC members.

Thanks to the FDA’s unwillingness to do their jobs and investigate safety concerns as a threshold matter to access, parents need all the facts to make the risk-benefit analysis for themselves. This fact alone compounds the risk of the product right out of the gate.

In addition, parents are contending with potential financial losses through job loss or needing to change schooling. They’re faced with putting a target on their child’s back that says “unvaccinated” to face bullying and discrimination. These are real concerns. One child in a Chicago school killed himself because other students wrongly labeled him as unvaccinated and school officials did not step in to stop the bullying.[xi] There are places and activities around the country that prohibit children from participation if they are not vaccinated. This is nowhere near a “simple decision to not vaccinate” as one VRBPAC member said, and many scared parents echoed this in their public comments.

The public comments aired by VRBPAC were sharply divided. Some parents pleaded or demanded the authorizations, with statements like:

“Our government has abandoned the youngest children,” said Nicholas Giglia, with two kids in COVID shot trials. Another said the wait for authorization for shots in kids under five, “made me feel like vaccinating my kids was not a priority for the FDA.” Yet another said that American parents with kids under five were forced to “hang on white knuckled only to be continually left behind.”

COVID shots will go on the Childhood Immunization Schedule.

The FDA has had an eye toward putting the COVID shot on the pediatric schedule from the beginning. It was mentioned at the first VRBPAC meeting to look at the Pfizer shot in December 2020 before the FDA granted the first COVID shot EUA. There was debate over whether the shot should be approved for 16–18-year-olds. Members had concerns that there wasn’t enough safety data. Dr. Levy argued, however, “if we take away the 16– and 17-year–olds here, we lose what is the effort to climb down in age eventually.” The reason behind this was the FDA needed to collect more data on younger children more quickly. Authorizing the COVID shot in order to collect safety data in the general population was the fastest way to authorization of the shot in all children, eventually getting the COVID shot on the pediatric schedule.[xii]

The curtain is being pulled back on the FDA, just like it was on the “great and powerful Wizard of Oz.” Now is the time for parents to take back control of their family’s medical choices. The FDA is reminding parents that there’s no place like home for health care decisions.