by Suzanne Burdick, Ph.D., Childrens Health Defense:
According to the two people who spoke to Politico on condition of anonymity, HHS Secretary Robert F. Kennedy Jr. has advocated internally to have the CDC stop recommending COVID-19 vaccines for children, arguing there is little scientific evidence that the shot provides a benefit to babies and young children.
U.S. Department of Health and Human Services (HHS) Secretary Robert F. Kennedy Jr. is considering pulling the COVID-19 vaccine from the Centers for Disease Control and Prevention’s (CDC) list of recommended vaccines for children, two people familiar with the situation told Politico.
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Children’s Health Defense (CHD) CEO Mary Holland said she was “thrilled” with the news.
“CHD challenged the U.S. Food and Drug Administration’s [FDA] decision to make these shots available to children at all. The science does not show their safety or effectiveness,” Holland said.
“Indeed, children have died, developed myocarditis, paralysis and all manner of other harms from these shots,” she added. “CHD believes this is the start of what needs to be a thorough reassessment of the CDC’s childhood vaccine recommendations.”
Attorney Ray Flores, senior outside counsel for CHD, agreed. He said removing COVID-19 shots is “the obvious place to start” if the CDC is going to modify its childhood immunization schedule.
The CDC’s current Child and Adolescent Immunization Schedule recommends that children as young as 6 months old get vaccinated against COVID-19 with three doses of Pfizer’s shot or two doses of Moderna’s shot.
The CDC also recommends children 6 months and up receive an annual booster dose at least eight weeks after the most recent dose.
Removing the COVID-19 shot from the CDC schedule wouldn’t bar kids from receiving the vaccine, Politico said.
However, the move would likely have large ramifications as state and local authorities look to the CDC schedule when deciding vaccine requirements for students.
Insurers, including Medicaid — which covers 40% of all children in the U.S — also use the CDC’s schedule when deciding which vaccines to cover.
In many states, pediatricians who treat children enrolled in Medicaid must participate in the CDC’s Vaccines for Children Program. The program requires participating doctors to administer all of the shots, including COVID-19 vaccines, on the childhood schedule.
“No final decision has been made,” HHS spokesperson Andrew Nixon told Politico on Tuesday. An HHS spokesperson on Wednesday told The Defender that a decision still hadn’t been made.
According to the two people who spoke to Politico on condition of anonymity, Kennedy has advocated internally to stop having the CDC recommend the COVID-19 vaccine for children. He argues that there is little scientific evidence that the shot provides a benefit to babies and young children.
At its latest meeting last week, the CDC’s independent vaccine advisory committee discussed switching from a universal to a risk-based approach for its COVID-19 recommendations.
A risk-based approach might mean changes to the CDC’s current recommendation that all kids 6 months and up get vaccinated for COVID-19, as kids are considered at low risk of severe illness from the virus. The committee is expected to vote on the issue in June.
No licensed COVID shots for kids under 12
As The Defender reported, there are no licensed COVID-19 vaccines for kids under 12. The CDC-recommended shots for youngsters have been granted only emergency use authorization (EUA) by the FDA.
The FDA’s EUA process doesn’t require the same safety or efficacy testing as its licensing process.
The FDA website on EUA for medical products states that EUA vaccines only have to meet the standard of “may be effective” as long as, “based on the totality of the scientific evidence, it is reasonable to believe that the product may be effective for the specified use.”
“The ‘may be effective’ standard for EUAs provides for a lower level of evidence than the ‘effectiveness’ standard that FDA uses for product approvals,” the website states.
Before a vaccine can be fully licensed, the vaccine maker typically must conduct numerous clinical trials to demonstrate that the product is safe. However, the safety requirements for EUA are more flexible.
“The amount and type(s) of safety information that FDA recommends be submitted as part of a request for an EUA will differ depending upon a number of factors, including whether the product is approved for another indication and, in the case of an unapproved product, the product’s stage of development.”
U.S. an outlier in still recommending the shot for kids
The COVID-19 vaccine’s benefit to kids is questionable as children are unlikely to get severely ill or die from COVID-19.
Currently, most U.S. parents choose not to give their kids the COVID-19 vaccine. A mere 13% of U.S. children have received the most recent COVID-19 shot, according to CDC data.
Most European countries no longer recommend annual COVID-19 shots for healthy kids, Politico noted.
For instance, Germany recommends against the shots for babies, kids and adolescents without an underlying condition. Germany’s rationale is that healthy young people typically experience only a mild course of disease, “with a very low likelihood” of hospitalization.
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