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IPFS News Link • Vaccines and Vaccinations

FDA Has 'Gone Rogue' In Its Approval Of New COVID-19 Boosters: Dr. Robert Malone

• by Tom Ozimek and Joshua Philipp

The Food and Drug Administration (FDA) has "gone rogue," according to virologist Dr. Robert Malone, who accused the federal agency of sacrificing its own rules and regulations with its decision to recommend the latest batch of COVID-19 boosters, which only have limited clinical trial data attesting to their efficacy and safety.

Dr. Malone made the remarks in an interview with EpochTV's "Crossroads" program on Sept. 11, the day that the FDA cleared new COVID-19 vaccines in a bid to counter the waning effectiveness of the currently available shots.

"It's difficult to conclude anything other than the FDA is no longer feeling bound by their own rules and regulations," Dr. Malone said. "The term is—they've gone rogue."

Dr. Malone said the lack of human clinical trial data demonstrating effectiveness and safety of the updated vaccines should have precluded their approval by the FDA.

He said that, essentially, the FDA authorized the new vaccines on the premise that "neutralizing antibodies as detected in mice and their cross-reactivity are correlative protection," which he said "is a lie, there are no established correlates of protection for SARS-CoV-2."

FDA officials didn't respond by press time to a request by The Epoch Times for comment.

The agency cleared Moderna's and Pfizer's newest mRNA vaccines on Sept. 11 without analyzing data from any human trials.

In a statement announcing its approval, the FDA said that the decision was supported by its evaluation of "manufacturing data" from vaccine producers and "non-clinical immune response data on the updated formulations including the XBB.1.5 component."