A Dangerous Time for America’s Children: Part I

Robert F. Kennedy Jr. has shown disdain for vaccines. Here are some legislative measures that would put our children at unnecessary risk.

Perhaps no one has benefited more from the Covid-19 pandemic than the anti-vaccine movement. Donations have poured in. For example, an anti-vaccine group called the Informed Consent Action Network (ICAN) reported receiving $23 million in revenue for 2023, a 74% increase from the previous year. Because they can afford it, ICAN has hired a high-priced attorney to try and suspend the distribution of 14 vaccines, challenge or quash Covid-19 vaccine mandates, sue the federal government for disclosure of records on vaccine approvals, and subject accomplished scientists to grueling, lengthy videotaped depositions. RFK Jr., who had worked with this lawyer during his presidential campaign, praised him saying, “There’s nobody who’s been a greater asset to the medical freedom movement than him.”

This lawyer has filed several petitions to the FDA that he believes will make vaccines safer but will only sow more distrust. For example:

Petition #1: In 2022, the lawyer filed a petition to the FDA requesting “the FDA withdraw or suspend the approval for IPOL [inactivated polio vaccine] for infants, toddlers, and children until a properly controlled and properly powered double-blind trial of sufficient duration is conducted to assess the safety of this product.” He was arguing that absent a proper, placebo-controlled trial, the manufacturer can’t claim that the vaccine is either safe or effective. A closer look reveals the absurdity of this request. First, IPOL is made using the same strategy as Jonas Salk used to make his inactivated polio vaccine in 1955. Take polio virus, grow it up in laboratory cells, purify it, and kill the virus with formaldehyde. IPOL is no different. And the Salk polio vaccine was subjected to the largest placebo-controlled trial in the history of vaccines and arguably the history of medical products. About 420,000 children received Salk’s vaccine; 200,000 received a harmless placebo; and 1.2 million children served as observed, uninoculated controls.

Further, no academic institution could ethically perform the study that the lawyer requested. Polio still exists in the world. Even children in the United States remain at risk as evidenced by a case of paralysis caused by polio that occurred in Rockland County, New York, in 2022 in a man who had never left the United States. A study that included a placebo group would place those children at unnecessary risk of a preventable infection.

The petition to the FDA to remove IPOL from the market evoked the immediate ire of lawmakers. In an apparent warning to RFK Jr., Mitch McConnell (R, Kentucky), a polio survivor said, “Efforts to undermine public confidence in proven cures are not just uninformed—they’re dangerous.” President-elect Donald Trump, who was born ten years before the polio vaccine—and undoubtedly remembered how much the disease was feared—said “You’re not going to lose the polio vaccine. That’s not going to happen.”

At this point, the lawyer probably realized he had stepped on a landmine. In a letter to the Wall Street Journal, he tried to backtrack, arguing that several combination vaccines, which included IPOL together with other vaccines, were still available. And he wasn’t saying that you couldn’t use those. This made even less sense. If the lawyer was arguing that IPOL hadn’t been appropriately tested, why would its presence in combination vaccines be considered safe and effective.

Petition #2: ICAN’s lawyer’s efforts to derail vaccines weren’t limited to the polio vaccine. A couple of years earlier, in 2020, the lawyer had petitioned “the FDA to withdraw or suspend the approval for Engerix-B and Recombivax [hepatitis B] vaccines for infants and toddlers until a double-blind placebo-controlled trial of sufficient duration is conducted to assess the safety of these products.” Both the Engerix-B and Recombivax hepatitis B vaccines were licensed in the late 1980s. But there was another hepatitis B vaccine, the so-called plasma-derived vaccine, which had been licensed in 1981. It is unethical to give a placebo vaccine to a child when there was an existent vaccine that had clearly been shown to be safe and effective.

Again, the lawyer was trying to fix a problem that didn’t exist. The hepatitis B vaccines mentioned in the petition for suspension (Engerix-B and Recombivax) had been routinely recommended for all newborns in 1991. At the time, about 18,000 children less than 10 years of age were infected with hepatitis B, half of whom contracted the virus from their mothers. Children infected with hepatitis B virus in infancy have a high likelihood of developing chronic liver disease (cirrhosis) and liver cancer. Since the introduction of the hepatitis B vaccine for newborns in the United States, the disease has been virtually eliminated in children.

Petition #3: In 2021, the anti-vaccine lawyer petitioned the FDA to withdraw 13 vaccines from the market, which prevented a wide range of diseases. The issue was the adjuvant aluminum, which enhanced the immune responses to a variety of vaccines. The lawyer claimed that the quantity of aluminum, as determined by a researcher in the United Kingdom, was not exactly what was written on the product label. He asked that the FDA withdraw those vaccines until the labels were corrected.

A closer look at the UK study, however, showed differences in quantities of aluminum in the label compared with the laboratory that were only fractions of a milligram (a milligram is one-thousandth of a gram). In other words, a distinction without a clinical difference. Aluminum is the most abundant metal on earth, comprising about 9 percent of the earth's crust. It’s found in plants, soil, water and air and, therefore, is present in much of what we eat and drink. There is no avoiding aluminum. Because we are always exposed to aluminum, studies have shown that the quantity of aluminum in biological specimens obtained from those receiving aluminum-containing vaccines is indistinguishable from unvaccinated subjects or from those receiving more or fewer vaccines.

ICAN’s lawyer’s efforts targeting vaccines will do nothing to make vaccines safer. And with the possibility that his close associate, RFK Jr., might be confirmed as Secretary of Health and Human Services, his efforts to frighten parents that vaccines aren’t adequately tested or labeled might make vaccines less available, again putting children at unnecessary risk.