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Dr. Malone made the remarks in an\u00a0interview with<\/a>\u00a0EpochTV’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.<\/p>\n “It’s difficult to conclude anything other than the FDA is no longer feeling bound by their own rules and regulations<\/strong>,” Dr. Malone said. “The term is\u2014they’ve gone rogue.”<\/p>\n 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.<\/p>\n He said that, essentially, the FDA authorized the new vaccines on the premise that \u201cneutralizing antibodies as detected in mice and their cross-reactivity are correlative protection,\u201d\u00a0which he said \u201cis a lie, there are no established correlates of protection for SARS-CoV-2.”<\/strong><\/p>\n FDA officials didn’t respond by press time to a request by The Epoch Times for comment.<\/p>\n The agency cleared Moderna’s and Pfizer’s newest mRNA vaccines on\u00a0Sept. 11<\/a>\u00a0without analyzing data from any human trials.<\/p>\n In a\u00a0statement announcing<\/a>\u00a0its 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.”<\/p>\n The benefit-risk\u00a0profile of earlier versions of the vaccines is “well understood,” the FDA claimed,<\/strong>\u00a0adding that the similar manufacturing process for the updated vaccines “suggests that the vaccines are a good match for protecting against the currently circulating COVID-19 variants.”<\/p>\n The Centers for Disease Control and Prevention (CDC) followed with its own recommendation\u00a0on Sept. 12,<\/a>\u00a0urging nearly all Americans to get the new vaccines. The shots will be available to children as young as 6 months old this month.<\/p>\n The new vaccines target XBB.1.5, a sub-type of the Omicron variant of the SARS-CoV-2 virus, which causes the disease COVID-19.<\/strong>\u00a0However, the XBB.1.5. subvariant has already largely been displaced by newer strains of the quickly evolving virus, including EG.5,\u00a0according to\u00a0the CDC.<\/p>\n While FDA documents show the agency did not include any trial data in its review of the new shots, data from a Moderna trial was considered by the CDC before it issued its recommendation. The trial featured just 50 people receiving a new shot, and found the vaccine induced levels of neutralizing antibodies that authorities said would protect against COVID-19. One of the 50 people suffered a vaccine-related adverse reaction.<\/p>\n “There’s essentially no data,” Florida Surgeon General Dr. Joseph Ladapo said at a recent news conference, where he suggested that people might be better off passing on the new round of shots.<\/p>\n<\/div>\n “Not only that, but there are a lot of red flags,”<\/strong>\u00a0Dr. Ladapo added, while pointing to\u00a0studies<\/a>\u00a0finding<\/a>\u00a0that the effectiveness of the vaccines turns negative over time.<\/p>\n \u201cThere’s been no clinical trial done in human beings showing that it benefits people, there’s been no clinical trial showing that it is a safe product for people.”<\/p>\n He also noted that studies have linked previous versions of the COVID-19 vaccine to cardiac problems such as heart inflammation.<\/p>\n “It’s truly irresponsible for FDA, CDC, and others to be championing something … when we don’t know the implications of it<\/strong>,” Dr. Ladapo said.<\/p>\n Asked to comment on Dr. Ladopo’s remarks, Dr. Malone pointed to a growing body of studies that show negative vaccine effectiveness, which he said suggests that, in the risk-benefit analysis, “there’s no discernible benefit, or there’s negative benefit, but there’s clearly risk.”<\/p>\n While acknowledging the current vaccines’ waning effectiveness, CDC Director Mandy Cohen\u00a0penned an op-ed<\/a>\u00a0in The New York Times on Sept. 13, in which she called the updated COVID-19 vaccines “one of the most effective tools in combating the virus.”<\/p>\n<\/div>\n “Covid-19 vaccines are the best way to give the body the ability to keep the virus from causing significant harm. Extensive studies and real-world experience have shown that they are safe and they work,” she wrote. “And most Americans take them.”<\/p>\n Dr. Cohen said the vaccines were put through extensive clinical trials before they were introduced in 2021 and “since then, their safety has been intensely monitored.”<\/p>\n She didn’t address criticism, such as the little trial data that’s been made available.<\/p>\n Read more\u00a0here…<\/strong><\/a><\/em><\/p>\n![\"\"](\"https:\/\/assets.zerohedge.com\/s3fs-public\/styles\/inline_image_mobile\/public\/inline-images\/fl%20sur.JPG?itok=BKSW0oP3\")
‘Lot of Red Flags’<\/h2>\n
‘Most Americans Take Them’<\/h2>\n