CHD Warns FDA of Insufficient Safety Evidence to Support Authorization of COVID Shots for Infants and Young Children

CHD Warns FDA of Insufficient Safety Evidence to Support Authorization of COVID Shots for Infants and Young Children

Moderna and Pfizer seek COVID-19 Vaccine Emergency Use Authorizations for young children while COVID poses virtually zero threat to this age group

WASHINGTON, DC, USA, May 10, 2022 / — On April 26, Pfizer submitted an application for a COVID vaccine booster for children five through eleven years of age.

This was followed by an announcement on April 28 from Moderna that it is filing for authorization of its COVID vaccine for children six months to under six years of age. Neither request warrants approval based on the available scientific evidence, especially as young children are at extremely low risk of serious complications or death from COVID.

While the media frequently portray parents as impatient to vaccinate their young children, according to the CDC, as of April, 65% of parents have chosen not to have their 5- to 11-year-olds vaccinated against COVID-19 and 72% did not give their children the second shot. Additionally, according to the CDC, by February 2022, 75.2% of kids aged 0-11 already have COVID antibodies indicating that they also likely have some natural immunity to the virus.

“Parents are waking up to the reality that COVID vaccines are about profits, not health,” said Children’s Health Defense (CHD) president and general counsel Mary Holland. “It’s becoming increasingly apparent that the risk of injury from these rushed-to-market vaccines outweighs any potential benefit, especially to young children.”

Reports of injury and death continue to pour into the U.S. government’s database, the Vaccine Adverse Events Reporting System (VAERS). Between mid-December 2020 and April 29, 2022, 1,255,355 adverse events have been reported, including 226,703 serious injuries and 27,758 deaths following COVID vaccinations. VAERS reports for children aged 5-17 include:

47,736 Adverse Events
106 Deaths
430 Permanently Disabling Adverse Events
1,293 Myocarditis Reports
595 Life Threatening Adverse Reactions
3,734 Hospitalizations
4,717 Emergency Room Visits
8,560 Did Not Recover From Adverse Reactions

These sobering statistics are not unique to the U.S. In the United Kingdom, according to the Office for National Statistics (ONS), data from January 1, 2021 through January 31, 2022 analyzed in May 2022 by Dr. Wayne Winston, Ph.D., Professor Emeritus of Decision Sciences at the University of Indiana’s Kelley School of Business, suggests that vaccinated children are more likely to die from any cause than unvaccinated children. The data show that vaccinated children ages 10–14 are 28 times more likely to die than unvaccinated, and the vaccinated 15–18 year olds are 1.82 times more likely to die than unvaccinated teens of the same age.

According to New England Journal of Medicine editor-in-chief and U.S. Food and Drug Administration (FDA) Vaccines and Related Biological Products Advisory Committee (VRBPAC) voting member Eric Rubin, “…we’re never going to learn about how safe this vaccine is unless we start giving it. That’s just the way it goes.”

“Even the hand-picked VRBPAC members acknowledged at their previous meeting that the vaccines don’t have ‘correlates of protection’ that would allow them to assume what the health outcomes from antibody measurements are,” said Holland. “Since the FDA has now admitted that antibody titers are not a predictor of immunity, it is requiring clinical trial data that shows at least 50% efficacy which is required to issue an Emergency Use Authorization. Moderna was able to perform some sleight of hand to claim the vaccine’s efficacy for babies six months up to two years old rose from 44% to 51% between March and April. Yet CDC says that 75% of children have already had COVID. That means that perhaps 3/4 of the children who get this vaccine will receive no benefit, but still risk all the side effects.”

The FDA said it plans to convene its outside panel of vaccine experts on June 8, 21, and 22 to review Moderna and Pfizer applications for childhood vaccines. “There will be no delays,” FDA Commissioner Robert Califf told reporters at a health journalism conference last week. “We’ll review the data, hold an advisory committee meeting and make a decision as quickly as possible once we get the applications.”

According to Holland, “The bottom line is that there is no evidence to warrant an Emergency Use Authorization vaccine for these children.”

Children’s Health Defense is a 501(c)(3) non-profit organization. Its mission is to end childhood health epidemics by working aggressively to eliminate harmful exposures, hold those responsible accountable, and establish safeguards to prevent future harm. For more information, visit

Rita Shreffler
Children’s Health Defense
+1 202-599-1461
[email protected]
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