Post by icemandios on Sept 20, 2023 18:32:06 GMT
FDA Has 'Gone Rogue' In Its Approval Of New COVID-19 Boosters: Dr. Robert Malone
Tyler Durden's Photo
by Tyler Durden
Tuesday, Sep 19, 2023 - 06:05 PM
Authored byh Tom Ozimek and Joshua Philipp via The Epoch Times (emphasis ours),
Dr. Robert Malone, inventor of mRNA vaccines, speaks at the Conservative Political Action Conference in Dallas at the Hilton Anatole on Aug. 5, 2022. (Bobby Sanchez for The Epoch Times)
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."
The benefit-risk profile of earlier versions of the vaccines is "well understood," the FDA claimed, adding 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."
The Centers for Disease Control and Prevention (CDC) followed with its own recommendation on Sept. 12, urging nearly all Americans to get the new vaccines. The shots will be available to children as young as 6 months old this month.
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. However, the XBB.1.5. subvariant has already largely been displaced by newer strains of the quickly evolving virus, including EG.5, according to the CDC.
'Lot of Red Flags'
"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.
"Not only that, but there are a lot of red flags," Dr. Ladapo added, while pointing to studies finding that the effectiveness of the vaccines turns negative over time.
“There'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."
He also noted that studies have linked previous versions of the COVID-19 vaccine to cardiac problems such as heart inflammation.
"It's truly irresponsible for FDA, CDC, and others to be championing something ... when we don't know the implications of it," Dr. Ladapo said.
'Most Americans Take Them'
While acknowledging the current vaccines' waning effectiveness, CDC Director Mandy Cohen penned an op-ed in 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."
"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."
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."
She didn't address criticism, such as the little trial data that's been made available.
Tyler Durden's Photo
by Tyler Durden
Tuesday, Sep 19, 2023 - 06:05 PM
Authored byh Tom Ozimek and Joshua Philipp via The Epoch Times (emphasis ours),
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."
The benefit-risk profile of earlier versions of the vaccines is "well understood," the FDA claimed, adding 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."
The Centers for Disease Control and Prevention (CDC) followed with its own recommendation on Sept. 12, urging nearly all Americans to get the new vaccines. The shots will be available to children as young as 6 months old this month.
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. However, the XBB.1.5. subvariant has already largely been displaced by newer strains of the quickly evolving virus, including EG.5, according to the CDC.
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.
Florida Surgeon General Dr. Joseph Ladapo in Tampa, Fla., on Oct. 15, 2022. (York Du/The Epoch Times)
"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.
"Not only that, but there are a lot of red flags," Dr. Ladapo added, while pointing to studies finding that the effectiveness of the vaccines turns negative over time.
“There'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."
He also noted that studies have linked previous versions of the COVID-19 vaccine to cardiac problems such as heart inflammation.
"It's truly irresponsible for FDA, CDC, and others to be championing something ... when we don't know the implications of it," Dr. Ladapo said.
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."
While acknowledging the current vaccines' waning effectiveness, CDC Director Mandy Cohen penned an op-ed in 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."
"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."
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."
She didn't address criticism, such as the little trial data that's been made available.