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.
‘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.
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.”
‘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.
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So the old “vaccine” which directly killed millions, is useless after just 2 years?
And this new “vax”?
What efficacy will IT offer by next year?
Sorry but the risk/benefit if taking or not taking endless injections says the safest path is to avoid all such injections.
No vaccines.
They do not work and were based on the research of a lying murderer Jenner, who LIED FAR AND WIDE that he had delivered lifetime immunity from small pox after his absurdly small and short study of less than two years.
How do you legitimately conclude you have given lifetime imunity after two years?
Where’s the video?
They cleared the product they stick into the bodies of men women and children without any human safety studies.
Yep, they no longer give a crap.
They have the public exactly where 100 years of progandizing has delivered them:
Sick, malnourished and ignorant.
Stupid lie…cow piss is the real shit!!!
There goes any possible claims of Hindian superiority.
They are drinking cow piss.
Even the nogs don’t do that.
Nogs only use cow piss as a hair care product.
And most important, they are safe and effective.
For the manufacturer, 100% safe and effective.
That’s safe if you don’t take them, and effective at killing you if you do.
Ergo, Pfizer had $2.3 billion to throw away to stay in biz.
Got it.
“Regulatory” agencies . . . ”
Abolish the state.
“since then, their safety has been intensely monitored.”
Read as: We know exactly whose lives we are attenuating.
We need to stand up and protect the kids(stupid adults are on their own),otherwise,might as well just die,time to get as hostile as necc.,just saying.
With each Covid vaccination, healthcare workers get sicker – applying for progressively more leave and taking more analgesic medication after each dose
“Inability to work following COVID-19 vaccination” is a modest paper just published in Public Health (paywalled, but available here as a preprint from last November), analysing data from the ‘CoVacSer’ cohort study, conducted out of Würzburg to monitor the effects of Covid infection and vaccination on healthcare workers. Of 1,831 CoVacSer participants who were surveyed on their experiences with vaccination between 29 September 2021 and 27 March 2022, 1,704 met criteria for inclusion in the present study. We’re looking therefore at the effects of the first, second and third doses…
The broader subset of healthcare workers who took medication to relieve post-vaccination symptoms paints the same picture. By the third dose, the vast majority of everyone in the sample (86%) were taking drugs to relieve the acute symptoms of the jabs:
The authors conclude that “COVID-19 vaccination has a non-negligible impact on the staff availability in the health sector” and that it is likely the enhanced immune response to each subsequent jab that is responsible for the escalating symptoms.
https://www.eugyppius.com/p/study-with-each-covid-vaccination
Mass sickness is how you know it’s working, bruh.
Malone is deep-seated deep state.