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Experts question CDC approval of under-5 vaccines over efficacy concerns; Pfizer study used 3 children

June 19, 2022 | | Print Article

After authorization from the U.S. Food and Drug Administration (FDA) and unanimous approval from the Centers for Disease Control and Prevention (CDC) for children aged six-months to five-years-old to receive COVID-19 shots, experts have questioned the studies used to arrive at this conclusion.

The argument offered by an infectious diseases expert being, in part, that “we should just assume we don’t have efficacy data.”

Available shots from Moderna and Pfizer-BioNTech were authorized and recommended by the respective panels of the FDA and CDC over recent days, but the data used for those decisions is leaving some with doubts on whether the series of shots is worth it for their child. The New York Times reported on the efficacy of the different products and found that it could be as low as 37 percent for some young children.

According to the studies, Moderna reported after two does of their shot, children between six- and 23-months old were provided with about 51 percent efficacy whereas those aged two- to five-years old only received 37 percent efficacy. The Times wrote in comparison, “two doses of Pfizer’s vaccine did not even meet the Food and Drug Administration’s bar for an immune response,” and so they were required to provide data from a third dose as previously reported. In comparison, Moderna and Pfizer had reported around 95 percent efficacy when their shots were administered to adults.

“In news releases and in data reported to federal regulators, Pfizer has estimated an efficacy of 80 percent for three does of its vaccine. But that calculation was based on just three children in the vaccine group and seven who received a placebo, making it an unreliable metric, the C.D.C’s advisers noted at a meeting on Friday,” the New York Times reported.

The Times noted, “The vaccines seem safe for children and are likely to protect against severe illness. But data on efficacy are thin, and most children have already been infected.”

In fact, the CDC’s own estimates stated, “As of February 2022, approximately 75% of children and adolescents had serologic evidence of previous infection…with approximately one third becoming newly seropositive since December 2021.”

Dr. Sarah Long, an expert on infectious diseases at Drexel University College of Medicine told the Times, “We should just assume we don’t have efficacy data.” However, she did stipulate that other data on the vaccine’s left her “comfortable enough” with their recommendation.

Long is among a minority of those “comfortable” with providing the shots to young children as at least one poll found only around 20 percent of parents are seeking to get their child the first dose when it is available while nearly 40 percent are taking a wait-and-see approach. Additionally, nearly a third remain completely opposed to the shots for their children.

Similar to the questionable data used to approve the shots for children under five-years-old, Sen. Rand Paul (R-KY) recently railed against Dr. Anthony Fauci Thursday as to the data used to justify providing anyone over the age of five with a COVID-19 booster.

After Paul asked if Fauci was “aware of any studies that show reduction in hospitalization or death for children who take a booster?” he later responded to his own question by stating, “So there are no studies and American should all know this. There are no studies on children showing a reduction in hospitalization or death with taking a booster, the only studies that were permitted, the only studies that were presented were antibody studies so they say if we give you a booster, now, a lot scientists would question whether or not that’s proof of efficacy of a vaccine.”

Meanwhile, Dr. Joseph Ladapo, the surgeon general of Florida, had some questions of his own for the studies the CDC used to unanimously approve the use of COVID-19 shots for children under the age of five.

“Did the COVID-19 vaccine trials for kids <5 show a reduction in severe illness? Did the trials show a benefit for those with a prior COVID-19 infection? Is there a benefit for kids with no pre-existing conditions?” he wrote on Twitter.

Ladapo concluded by adding, “Florida puts data over ideology. That’s not going to change.” His stance stood in stark opposition to CDC Director Rochelle Walensky who signed off on the recommendation for the “primary series” of shots Saturday.

“Parents, I strongly encourage you to get your children vaccinated against COVID-19,” she wrote in part.

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