With its decision to recommend the latest batch of COVID-19 boosters without clinical trials attesting to efficacy and safety, 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 on the altar of blind vaccine enthusiasm.

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 objected to the lack of clinical trial data on humans demonstrating effectiveness and safety of the updated vaccines, arguing that this should preclude their approval by the FDA.

He said that, essentially, the FDA authorized the new vaccines on the premise that “neutralising 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."

The FDA, which did not immediately return a request for comment for this story from The Epoch Times, approved Moderna's and Pfizer's newest mRNA vaccines on Monday, despite a lack of data from human clinical trials.

However, in a statement announcing approval of the new vaccines, the FDA said that its 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 previously authorized mRNA COVID-19 vaccines is "well understood," the FDA said, 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."

Advisers to the Centers for Disease and Prevention (CDC) followed with their own recommendation on Tuesday, urging nearly all Americans to get the new vaccines, which will be available to children as young as 6 months old later 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. Yet 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 press conference in which he suggested 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," Dr. Ladapo continued.

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 showing 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 continued.

"And most Americans take them," she added, suggesting that vaccine uptake popularity under conditions of a massive propaganda push should be viewed as a genuine endorsement.

Dr. Cohen said that the vaccines were put through extensive clinical trials before they were introduced in 2021 and "since then, their safety has been intensely monitored."

She did not address criticism, such as that the updated vaccines have not been subjected to clinical trials.

In its authorizing statement, the FDA said it's "confident in the safety and effectiveness of these updated vaccines and the agency's benefit-risk assessment demonstrates that the benefits of these vaccines for individuals 6 months of age and older outweigh their risks."

That FDA endorsement, however, stands in contrast to remarks made by Dr. Paul Offit, an FDA adviser, who suggested to the UK's Daily Mail that younger, healthy people who have already been vaccinated don't need one of the new doses.

"We are best served by targeting these booster doses to those who are most at risk of severe disease," such as people older than 75, Dr. Offit said. "Boosting otherwise healthy young people is a low-risk, low-reward strategy."

In his remarks at the press conference, Dr. Ladapo asked people to make decisions based on their “resonance of truth” rather than depending on “very educated people telling you what you should think.”

“When they try to convince you to be comfortable and agree with things that don't feel comfortable and don't feel like things you should agree with, that's a sign … And I encourage you and certainly beg and hope that you do listen to it because it will serve you right,” he said.

A January–July 2023 study that analyzed data from 33 California state prisons found that individuals who received new COVID-19 booster shots were more likely to contract COVID-19 compared to those who did not receive the jabs.

The infection rate among the group that received the bivalent booster shots came in at 3.2 percent—higher than the 2.7 percent among the unvaccinated.

Late last month, the CDC admitted that the new BA.2.86 strain can cause infection even among people who have previously been vaccinated against COVID-19.

“The large number of mutations in this variant raises concerns of greater escape from existing immunity from vaccines and previous infections compared with other recent variants,” the agency said in its assessment.

Zachary Stieber contributed to this report.