CDC, FDA Shouldn’t Have Cleared and Recommended COVID-19 Vaccines for Young Children: Complaint
Top U.S. health agencies should not have authorized and recommended COVID-19 vaccines for children under 5, a complaint lodged on Aug. 9 says.
The Food and Drug Administration (FDA) and Centers for Disease Control and Prevention (CDC) appeared to violate their own standards when the agencies granted emergency authorization for the Pfizer and Moderna vaccines, and then recommended virtually all children aged six months to four years get a jab, a watchdog said in the complaint.
The FDA scientific integrity policies say that the agency should be free “from political influence” and that the agency is dedicated to “protect[ing] the integrity of scientific data and ensuring its accurate presentation, including the underlying assumptions and uncertainties.”
The CDC’s scientific integrity policies say that its research and services “are based on sound science” and that officials “prize scientific integrity and professional excellence” and will not be influenced by political issues.
A memorandum President Joe Biden issued in early 2021 says that his administration’s scientific findings “should never be distorted or influenced by political considerations.”
But the agencies may have been pressured into clearing and recommending the COVID-19 vaccines, the nonprofit Protect the Public’s Trust said.
Data, Analyses
The core of the complaint is based on clinical trial data and analyses from the CDC and FDA.
The data showed substandard efficacy for Moderna’s shot and unreliable efficacy for Pfizer’s shot in terms of protection against infection, and were not able to establish estimates of shielding against severe disease. The regulatory actions were instead based on kids’ immune systems generating similar levels of antibodies to adults, with the adult levels established in the original trials completed in 2020. Officials believe antibodies help protect people against COVID-19.
CDC analysts graded (pdf) the evidence that Pfizer’s vaccine prevented COVID-19 as “very low certainty,” expressing “very serious concerns
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