A watchdog group has accused the Food and Drug Administration and the Centers for Disease Control and Prevention of violating their own scientific integrity policies in authorizing and recommending infants and toddlers to take COVID-19 vaccine doses.
Protect the Public’s Trust, a conservative watchdog group, made the allegations in a letter sent to Health and Human Services Inspector General Christi Grimm. In the letter, the group claims both agencies issued recommendations for children aged 6 months through 5 years to be vaccinated to make parents feel better about returning to normal activity.
“This leads to inescapable concerns that the CDC’s recommendation was based on factors other than the scientific evidence, particularly evidence demonstrating an actual benefit to a child’s health or likelihood of avoiding hospitalization or death due to COVID-19,” the letter claimed.
Yale Medicine reported earlier this year that interim test results “show that the [Moderna] vaccine was 51% effective against symptomatic infection among children ages 6 months to 2 years, and 37% effective among those 2 to 5 years”. For Pfizer, “following a third dose, children 5 and under elicited a strong immune response, and efficacy was 80.3% in preventing symptomatic infection.”
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The watchdog group noted that the CDC’s Advisory Committee on Immunization Practices determined in June with low confidence that the Pfizer and Moderna vaccines were slightly better at preventing symptomatic COVID-19 cases than placebos.
“The CDC’s own data provides very little support for the notion that Pfizer vaccine is effective in children,” PPT wrote in its letter. “The stated goal of a COVID vaccine is preventing symptomatic infection. Yet, the CDC itself noted that it has ‘very low confidence’ that the Pfizer vaccine actually prevents symptomatic infection.”
“While the evidence in support of the Moderna vaccine is better, it still falls short of what is to be expected for such a far-reaching recommendation,” the letter added.
The CDC’s advisory committee publicly acknowledged that nonmedical data played a factor in its decision to recommend infants and toddlers take the COVID-19 vaccine.
“COVID-19 vaccination in this age group may provide parents with increased confidence to return to prepandemic activities, improving social interactions in young children,” the ACIP reported in July.
The PPT said such language shows the CDC violated its own scientific integrity policies, as well as a January 2021 directive from President Joe Biden ordering his administration never to allow scientific findings to be distorted or influenced by political considerations.
PPT isn’t the first to take the CDC and FDA to task for the underlying data used to approve and recommend COVID-19 vaccine doses for infants and toddlers.
Johns Hopkins School of Medicine researcher Dr. Marty Makary and Florida Department of Health epidemiologist Dr. Tracy Beth Høeg criticized the CDC and FDA in a Substack post published in July for basing its sweeping childhood vaccination recommendation on “extremely weak, inconclusive data provided by Pfizer and Moderna.”
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While no one has disputed the accuracy of the figures presented in the post, some said Makary and Høeg’s criticism missed the point.
“The critical thing in this is that even if the vaccines aren’t very effective in protecting against mild disease … that doesn’t mean they won’t be effective in protecting against severe disease,” former deputy FDA chief for vaccines Dr. Philip Krause told FactCheck. “That was really the FDA’s goal in making the vaccines available.”
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