Health Care

The FDA Is Endangering America’s Children

A student wearing a protective mask attends class on the first day of school amid the coronavirus pandemic at St. Lawrence Catholic School in North Miami Beach, Fla. August 18, 2021. (Marco Bello/Reuters)
Its refusal to give kids access to COVID vaccines is unconscionable.

During the past week, 200,000 American children under age 12 tested positive for COVID-19. As the Delta variant spreads and schools reopen, these numbers are set to explode.

To date, only about 500 American children have died of COVID, but many thousands have experienced severe symptoms that could cause lifelong damage to their health. In the last week alone, more than 2,000 children were hospitalized for COVID-related illnesses, many from a serious, inflammatory syndrome known as MIS-C, and 37 have died from it.

Why is the FDA denying America’s children access to life-saving vaccines?

Make no mistake about it, the vaccines are life savers. As of this writing, more than 640,000 Americans have died of COVID. Over 70 percent of Americans have now been vaccinated. If the chances of death from COVID were equal regardless of vaccination status, the majority of deaths would be among the vaccinated, because they outnumber the unvaccinated more than two-to-one. However, of the 640,000 deaths, 636,000 were unvaccinated patients. In contrast, only about 6,000 of the vaccinated have died.

If a person is not vaccinated, his or her chance of dying from COVID increases more than a hundredfold. Yet the FDA is forcing all American children to remain in the at-risk category.

The FDA claims that it must perform not only further safety testing, but also effectiveness testing (which takes far longer with a preventative drug), before it can responsibly authorize use of COVID vaccines in children. But this is nonsense. Safety testing of the Pfizer and Moderna vaccines was completed in August 2020. Is the FDA so irresponsible that it didn’t bother to collect safety data on minors? Regardless, hundreds of thousands of 12-year-olds have received the vaccines, with no pattern of side effects commensurate with the risk of the disease itself. There is no scientific basis for assuming that the response of 11-year-olds would be radically different from that of 12-year-olds. The only real issue is what size to make the recommended vaccine dose. Certainly scaling it in proportion to the child’s weight makes more sense that arbitrarily setting it at zero.

Public-health experts do not support the FDA’s position. “While the FDA worries about the small possibility of long-term risks of vaccinating children, we’re accumulating a real long-term burden of COVID19 infection in children,” says professor Zoe McLaren of the University of Maryland Baltimore County. “There is little doubt that vaccination is safer than infection.” On August 5, Dr. Lee Savio Beers, president of the American Academy of Pediatrics, sent a letter to the FDA begging them to stop stalling. “We understand that the FDA has recently worked with Pfizer and Moderna to double the number of children ages 5-11 years included in clinical trials of their COVID-19 vaccines,” Dr. Beers said. “While we appreciate this prudent step to gather more safety data, we urge FDA to carefully consider the impact of this decision on the timeline for authorizing a vaccine for this age group. In our view, the rise of the Delta variant changes the risk-benefit analysis for authorizing vaccines in children. The FDA should strongly consider authorizing these vaccines for children ages 5-11 years based on data from the initial enrolled cohort, which are already available.”

Not only is the FDA blocking access to vaccines, it is not being transparent about its process for approval. In August, 108 members of Congress wrote to the FDA demanding that it reveal its timetable. The FDA refused to offer specifics. “We understand that it is essential that the public have full trust in the F.D.A.’s review process, complete confidence in whatever products we approve or authorize, and faith in F.D.A. and our commitment to protecting public health,” the agency said.

There’s the rub. For the FDA, it’s all about “the review process,” which may well take until winter to conclude, merely to approve a drug that will be not one bit safer than it is today. In the interim, more than 100,000 kids who could have been protected are likely to be hospitalized, and thousands may be dead.

The FDA would rather see this happen than risk taking the blame for a few cases of side effects. After all, if the disease kills thousands, that’s not their fault. It’s the fault of the disease. This callous, irresponsible behavior is nothing new for the FDA. In the 1980s, they caused the needless deaths of tens of thousands of American gays by blocking use of AIDS treatments that had been shown effective in Europe for years, even going so far as to prosecute anyone smuggling such life-saving medicines into the USA.

They got away with it then, because the sympathy of most Americans for the plight of gay AIDS victims was limited. But will we let the FDA kill our children?

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