Moderna testing COVID-19 vaccine on infants nationwide despite 'negligible' risk from virus

Vaccine safety pioneer challenges trial leader's claim about COVID risk to children under age 1.

Published: November 9, 2021 6:31pm

Updated: November 10, 2021 1:49pm

The Moderna COVID-19 vaccine is being tested on infants across the country, even as medical experts question the wisdom of moving so fast on novel vaccine development in a population with such low risk from COVID.

Seventy-nine locations in 31 states are listed as participating in the so-called KidCOVE study, which started with children ages 6 to "less than 12," followed by ages 2 to less than 6, and finally 6 months to less than 2 years. 

The infant trials have received sporadic media attention. CBS Miami and WCNC Charlotte ran features on local infant participants a month ago, followed by features last week for Colorado's KDVR and Oklahoma's Fox 23.

New attention came Monday when the University of Wisconsin medical school announced that "dozens" of children under age 6 were participating in its trial at American Family Children's Hospital.

The ages 5-11 trial in Madison was full just days after enrollment opened in August, the med school said. About 4 in 5 participants in its Moderna trials are from "underserved populations meaning they might face barriers based on race, ethnicity, income, geography and health outcomes."

"Our very youngest children need to get the vaccine and we need to make sure they are safe," said Dr. Bill Hartman, co-principal investigator of its KidCOVE trial. 

The announcement came less than a week after the CDC approved the Pfizer vaccine for children ages 5-11, and two weeks after FDA approval. 

More than 13,000 children will receive "up to 3 dose levels" of the vaccine or a placebo, according to Moderna's KidCOVE summary. Excluded from eligibility: children with a "known history" of COVID infection or "close contact" with an infected person within two weeks of the trial, as well as those who have received monoclonal antibodies in the past six months.

Asked about the ethical implications of testing a vaccine on a population at such low risk, especially relative to their risk from seasonal influenza, Hartman wrote in an email that "many kids" have developed COVID due to the Delta variant.

"This kept them out of daycare, out of school, and/or they went on to infect the people around them, including immunocompromised relatives," he said, claiming 30,000 children were hospitalized in August.

He compared child COVID deaths to date — nearly 600 — with the flu season directly before COVID, which killed 188. COVID is arguably in its third season, having circulated in the U.S. as early as December 2019.

"Babies under age 1 might be at higher risk of severe illness with COVID-19 than older children, likely due to their immature immune systems and smaller airways, which make them more likely to develop breathing issues with respiratory virus infections," Hartman wrote.

He didn't respond to a subsequent query about the documented difficulty of young children transmitting COVID; why he compared multiple seasons of COVID to one flu season; or a request for the underlying health of children who died from the flu versus COVID.

Brain development risk

Harvard Medical School epidemiologist Martin Kulldorff, a pioneer in vaccine safety and vocal critic of White House COVID advisor Anthony Fauci, reviewed Hartman's responses at the request of Just the News.

It's true that children are "about as likely to be infected as adults," including from Delta, but there's "more than a thousand-fold difference in mortality risk between the old and the young," he wrote in an email. The risk is "minuscule" even for children under one.

It's wrong to blame the infection for keeping them out of school, "since most children are either asymptomatic or only mildly symptomatic," he said. "What kept them out of school were the misguided pandemic restrictions."

They are also "not major spreaders of COVID," and vaccination is "not a burden that we should put on children" when older, high-risk people can be protected through vaccination, Kulldorff said.

He emphasized the CDC has never studied how many of the reported child COVID deaths were incidental to the virus versus caused by it; the 576 deaths cover the entire 0-17 age range; and flu season deaths among children vary widely from year to year.

Shortly before the FDA's Pfizer approval last month, experimental drug researchers cited "urgent reasons to apply the brakes" on broadly vaccinating children against COVID.

An anti-miscarriage medication commonly prescribed in the 1940s "was recalled 30 years later after it was connected to a rare tumor that appeared in the next generation of daughters of women who had taken it," Larry Kwak, Steven Rosen and Idit Shachar wrote in The Washington Times.

They cited unknown long-term risks of mRNA vaccines, whose active viral sequences and inactive manufacturing ingredients do not have "a prior favorable safety track record in healthy adults or children." Due to their developing brains, the latter face "potential consequences of vaccines crossing the natural blood-brain barrier," and they have safer treatments available.

Kwak and Rosen, both hematologist-oncologists, lead the comprehensive cancer center at California's City of Hope, which is funded by the National Cancer Institute. Rosen pioneered monoclonal antibody treatments, while Time named Kwak one of its "100 most influential people in the world" for his pioneering cancer vaccine research.

Their affiliation is not mentioned in the op-ed. City of Hope told Just the News it referred queries to the doctors but did not answer why it left them off its COVID experts page, which includes another hematologist-oncologist.

Kwak told Just the News the case for vaccinating infants was even weaker, "especially given the growing number of reasonable alternatives" with longer safety records, such as monoclonal antibodies and antiviral pills "related to Tamiflu."

He warned that classifying these "genetic therapies" as "vaccines" shields manufacturers from liability for "unanticipated long-term complications." Congress must "drastically" reform the existing vaccine injury compensation program, which rejects nearly all claims, "given the social pressure being put on the individual at this moment to take the treatment."

International researchers questioned the need to vaccinate children, whose vaccine trials had "poor predictive power because of their small size," in the Elsevier medical journal Toxicology Reports in September.

"COVID-19 attributed deaths per capita are negligible in children," while their "normalized post-inoculation deaths are small, but not negligible," they wrote. The trials ignored "changes in biomarkers that could serve as early warning indicators" and "long-term effects that, if serious, would be borne by children/adolescents for potentially decades."

Under a "novel best-case scenario cost-benefit analysis," there are "very conservatively" five times more deaths "attributable to each inoculation vs those attributable to COVID-19 in the most vulnerable 65+ demographic," they wrote.

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