The First Step on the Covid Shots

The First Step on the Covid Shots
by Clayton J. Baker, MD at Brownstone Institute

The FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) is holding a very important meeting on May 22, 2025. Under consideration at this meeting is the fate of the Covid booster shots. There has been considerable anticipation as well as media claims that current recommendations and authorization for these products’ use, particularly in children and pregnant women, may be discontinued. 

Public comments are currently being solicited for the meeting, and wide public interest surrounds this event. Unfortunately, I have received reports from colleagues that some comments submitted to the committee calling for discontinuation of these vaccines have disappeared from the FDA website.

Furthermore, an important article from the FDA published today in the New England Journal of Medicine acknowledges the huge discrepancies in Covid vaccine recommendations in the US vs. other countries – as I describe in detail below. The article hints yet again at possible changes in official recommendations regarding the Covid vaccines. In terms of actual changes, however, none have yet been made official 

My appeal to the VRBPAC committee is graciously printed here by Brownstone, both to prevent its untimely disappearance, and to emphasize the serious issue of vaccine-related toxicities, which were left unaddressed by the FDA in its article.

Dear VRBPAC Committee members:

Thank you for reading and considering this letter.

I am a board-certified Internal Medicine physician with more than a quarter-century in clinical practice, as well as a long career in academic medicine. Over the course of my career, I have cared for tens of thousands of patients and administered numerous vaccines. I cared for hundreds of patients on the front lines throughout the entire COVID pandemic. I have written and published a book about COVID. I am thoroughly qualified to speak on the topic of the COVID vaccines.

In my professional opinion, and in light of my considerable experience, I firmly believe that the COVID-19 vaccines should be removed from use, especially for children and pregnant women.

There are numerous reasons why this needs to happen. For a comprehensive review of the myriad harms of the COVID-19 shots, I refer you to this peer-reviewed review article which – correctly, in my view – calls for a complete removal of all COVID-19 vaccine products from the market.

For the purposes of this letter, I will focus on several simple, common sense reasons why, at an absolute minimum, these injections must not be given to children and pregnant women. I shall list my reasons first, then add detail about each one in order below.

Common sense reasons why COVID-19 vaccines should NOT be recommended to children or pregnant women:

1. Numerous other countries do not recommend or administer COVID boosters to children and healthy young persons, and have not done so for years. The WHO agrees. No harm has occurred from those countries’ policies. The US needs to follow suit.
2. Despite CDC recommendations, uptake of the COVID boosters is extremely low in these groups. The American people already know the truth.
3. Given its nature as a low-virulence, highly transmissible, and rapidly mutating virus, the SARS CoV-2 virus is a very poor candidate for vaccination.
4. The risk-benefit analysis regarding the COVID vaccines is extremely unfavorable, especially for children and pregnant women.
5. There is ample evidence that the COVID vaccines negatively affect fertility and pregnancy. They should not be used in women who are pregnant or wish to become pregnant.

Numerous other countries do not recommend or administer COVID boosters to children and healthy young persons, and have not done so for years. The WHO agrees. No harm has occurred from these policies. The US needs to follow suit.

Many foreign countries do not recommend the COVID-19 vaccines for children. Some have not done so for over two years. As recently reported by CNN:

Unlike countries such as the United Kingdom, Canada and Australia, the US alone recommends an annual Covid-19 vaccine for healthy younger adults and children. The World Health Organization also doesn’t routinely recommend annual Covid-19 vaccines for healthy adults under 65 or healthy children.

The WHO has not recommended COVID-19 inoculations in healthy children for over two years. In March of 2023, the WHO’s Strategic Advisory Group of Experts on Immunization (SAGE) panel on immunizations stated in a press release:

“The public health impact of vaccinating healthy children and adolescents [for COVID] is comparatively much lower than the established benefits of traditional essential vaccines for children – such as the rotavirus, measles, and pneumococcal conjugate vaccines.”

Countries following these policies have not seen increased pediatric COVID deaths or increased morbidity as a result of these common sense policies. The US needs to follow suit.

Despite CDC recommendations, uptake of the COVID boosters is very low. American citizens already know the truth. The CDC and FDA should follow suit.

Estimates of the percentage of Americans who got the last round of COVID boosters are very low, despite current CDC recommendations that they continue to get them. This is especially true for children.

An estimated 81% of Americans received COVID vaccines at the height of the pandemic.

However, for adults, uptake of the most recent COVID boosters was an estimated 22.5%. By comparison, uptake for the flu shot was estimated at 46.7%. 

For children, uptake of the most recent COVID boosters was an estimated 6.7%. By comparison, uptake for the flu shot was 49.2%. 

Why the discrepancy? It is nonsensical, dishonest, and defamatory to patients to attribute it to “vaccine hesitancy” when 81% got the initial COVID shot, and Americans still are accepting the flu shot at or near historical averages. The reason is that patients correctly realize that COVID boosters are not in their best interest.

Trust in public health authorities and medicine in general are at historic lows. Continuing to push unnecessary and harmful treatments on the public will worsen this.

The problem lies with the COVID shots, and with the authorities who insist on pushing them. The American people know they are not indicated. The CDC and FDA need to follow suit.

Given its nature as a low-virulence, rapidly mutating virus, the SARS CoV-2 virus is a very poor candidate for vaccination.

Just because it is a good idea to wear a helmet when you ride a motorcycle, that does not mean it is necessary when you ride in an automobile.

Some viruses, by their very nature, are good candidates for vaccines. Others are not.

Smallpox, for example, is a good viral candidate for a vaccine. The COVID-19 virus, SARS CoV-2, is not.

Smallpox is deadly, with a reported case fatality rate of nearly 1 in 3. A vaccine developed against a deadly disease, if effective, prevents contracting a lethal illness, making the inherent risk of taking it much more worthwhile. In other words, the risk-benefit analysis of any medical treatment is much more likely to be favorable if the disease it prevents or treats is deadly.

Smallpox also mutates slowly. Thus, an effective vaccine developed even years ago is likely to remain effective, and the immune response it evokes is more likely to remain effective over time.

By contrast, SARS CoV-2 is a very poor viral candidate for a vaccine, especially in children and pregnant women. 

COVID hardly ever kills children, or even makes them seriously ill. Even at the height of the pandemic, an article in the prestigious journal Nature described pediatric COVID deaths as “incredibly rare.” A very large population-based Korean study from 2023 found a death rate in children from COVID of only 0.85 in 100,000 cases. 

For an illness with virtually zero mortality – like COVID in children – only an extremely safe vaccine would be worth even considering. However, the COVID vaccines are in fact highly toxic to children.

SARS Cov-2 also mutates very rapidly. Therefore, a vaccine developed a year or even several months beforehand, may well be useless by the time it is administered. This (as well as the profit motive) is why repeated boosters are proposed. Each successive booster raises the odds of toxicity, while the futile chase for immunity to a rapidly changing virus continues forever.

Respiratory viruses in general are poor candidates for vaccines. SARS CoV-2 is a textbook example of this. Given its inevitable, continued, rapid mutation into a less and less virulent pathogen, the potential benefits of repeated vaccination lessen every day, while the futility and toxicity persist.

In biological terms, even the SARS CoV-2 virus knows the COVID vaccine is futile. The CDC and FDA should follow suit.

The risk-benefit analysis of COVID vaccines is extremely unfavorable, especially for children and pregnant women.

No sane person would accept a therapy that might kill them, merely to prevent them from catching a cold.

Any preventative treatment for a disease with a near-zero death rate must be extremely safe to be appropriate for use – especially with children, who as we have seen, almost never die from COVID infection. However, the COVID vaccines – especially the mRNA-based versions from Pfizer and Moderna – are highly toxic and often deadly, including in children. 

Throughout the initial COVID vaccine rollouts and continuing until now, the public has been barraged with the blanket assurance that COVID vaccines are “safe and effective.” Repeated without evidence, that mantra has turned out to be a lie.

By August 2022, internal Pfizer documents revealed 1.6 million adverse events from their COVID mRNA products, many of them deadly, involving the cardiovascular, neurologic, vascular, and reproductive systems, among others. Safe and effective?

By June 2023, the Johnson & Johnson COVID vaccine was pulled from the market – because it killed people. By May 2024, the AstraZeneca jab was pulled as well – after more than 3 billion doses were administered worldwide. Safe and effective?

By May 2024, the CDC’s own Vaccine Adverse Event Reporting System (VAERS) had catalogued over 38,000 COVID vaccine-related deaths and over 1.5 million significant vaccine-related adverse reactions in the US. Europe’s analogous Eudravigilance system posted similarly terrifying findings. Safe and effective?

By April 2025, VAERS reports over 96,000 cases of permanent disability and over 49,000 deaths. Safe and effective?

Myocarditis is the perhaps best-known and most widely acknowledged serious toxicity that the COVID mRNA shots cause. It is unfortunately quite common in boys and young men. It is not rare, and it is not mild, as was falsely claimed early in the vaccine rollout period. 

Multiple studies have shown an excess incidence of myocarditis after COVID mRNA vaccination in young males ranging from 6 to 37 extra cases per 100,000 vaccinated individuals. In a country the size of the United States, this constitutes a completely avoidable vaccine-induced epidemic of serious heart disease in young men numbering in the tens of thousands. And myocarditis kills.

In the four decades prior to the rollout of the mRNA COVID vaccines in 2021, on average about 29 elite European athletes died each year on the pitch due to cardiac arrest. Since the COVID vaccines arrived, the number has increased tenfold to 283 per year. The number of young people who have died in their sleep from sudden cardiac death is not included in these numbers, and far exceeds it.

And myocarditis is just one of the potentially fatal toxicities these injections possess. Repeat this assessment dozens and dozens of times – for clotting disorders, immune disorders, malignancies, etc. – and you will begin to appreciate the cumulative toxicity that these products present.

It is frankly insane to claim to “protect” patients with such a toxic remedy, against a disease that poses essentially zero threat of death.

There is ample evidence that the COVID vaccines adversely affect fertility and pregnancy. They should not be used in women who are pregnant or wish to become pregnant.

One of the cardinal rules of Maternal-Fetal medicine is that, as much as possible throughout pregnancy, one should leave the mother and developing child alone. In most cases, the mother provides everything the child needs to grow and develop. The rapidly developing fetus is highly susceptible to toxicities and injuries, especially from medications and other medical therapies. 

For many decades, medications were carefully stratified in terms of known, suspected, or unknown toxicity to the developing fetus, and only a small number were accepted for regular use in pregnant women. Deviations from this approach could end in disaster, as shown in the case of thalidomide.

This fundamental, common sense rule of medicine is once again being egregiously violated by giving COVID vaccines to pregnant women. 

On page 12 of Pfizer’s post-market analysis of its COVID-19 mRNA product, which both Pfizer and the FDA attempted to conceal for 75 years, findings regarding pregnant recipients of the shots concerning pregnant recipients were:

Miscarriage rate of 81% 

Five-fold increase in stillbirth 

Eight-fold increase in neonatal death 

14% incidence of breast-feeding complications

A recent population study in the Czech Republic showed that the total fertility rate in the Czech Republic decreased from 1.83 births per 1,000 women in 2021, to 1.62 in 2022, and 1.45 in 2023. The COVID vaccines, of course, were rolled out in early 2021. Furthermore, the study showed that successful conception rates were 33% lower in vaccinated women compared to unvaccinated women.

These are just 2 examples of the large and ever-growing body of evidence that the COVID-19 mRNA injections have had disastrous effects on fetal health and human fertility. They must immediately be removed from use in pregnant women. 

As mentioned previously, it is an ethical scandal of historic proportion that these shots were ever recommended for use in children and pregnant women. This horrible wrong has gone on far too long and must be corrected immediately.

Beyond children and pregnant women, there are numerous reasons the COVID-19 vaccines should be removed from the market entirely. Perhaps the most egregious is that the COVID mRNA products are adulterated with highly toxic and potentially carcinogenic plasmid DNA. On the basis of this adulteration alone, the FDA should pull them from the market, as it is compelled to do with all adulterated products under its regulatory purview.

At the very least, it is past time to pick the low-hanging fruit. Please perform this obvious, correct, and long overdue action. Right a terrible wrong. Remove the COVID vaccines from use in children and pregnant women.

The First Step on the Covid Shots
by Clayton J. Baker, MD at Brownstone Institute – Daily Economics, Policy, Public Health, Society