Monday, September 18, 2023

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

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

He said that, essentially, the FDA allowing the new vaccines to be used under an emergency use authorization on the premise that “neutralizing antibodies as detected in mice and their cross-reactivity are a correlative protection—That's 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.

However, 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 previously approved 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 Control and Prevention (CDC) followed with their own recommendation on Sept. 12, urging nearly all Americans to get the new vaccines, which 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.

"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.

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 that the updated vaccines haven't been subjected to clinical trials.

In its green-light 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 news 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 didn't 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 conceded 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.


Dr. Marty Makary Weighs in on the New COVID Vaccines Biden Is Pushing

Dr. Marty Makary — a rare voice of reason and sanity throughout the COVID-19 pandemic — is out with a review of the "real data" behind the new vaccines being pushed by the Biden administration and Democrat leaders around the country.

Makary, along with Dr. Tracy Høeg, open their analysis of the new vaccines Biden & Co. are pushing for Americans as young as six months old with an alarming scenario that's anything but hypothetical.

What if I told you one in 50 people who took a new medication had a 'medically attended adverse event' and the manufacturer refused to disclose what exactly the complication was — would you take it?

And what if the theoretical benefit was only transient, lasting about three months, after which your susceptibility goes back to baseline?

And what if we told you the Food and Drug Administration cleared it without any human-outcomes data and European regulators are not universally recommending it as the Centers for Disease Control and Prevention is?

Writing in The New York Post, Makary and Høeg say that's all scientists know about the new vaccines from Pfizer and Moderna that are being more than recommended by the Biden administration.

"The push is so hard that former White House COVID coordinator Dr. Ashish Jha and CDC head Mandy Cohen are making unsupported claims the new vaccine reduces hospitalizations. long COVID and the likelihood you will spread COVID," the doctors' analysis explains. "None of those claims has a shred of scientific support," and "if the manufacturers said that, they could be fined for making false marketing claims beyond an FDA-approved indication."

Yet, the Biden administration is plunging ahead with another push to drive up the use of these new vaccines, a push that blows past what The Science™ says or The Experts™ have concluded.

"The questions surrounding Moderna’s new COVID vaccine approved this week are still looming," Makary and Høeg say of the reality being ignored by the White House. "Pfizer’s version, approved this week as well, also has zero efficacy data and has not been tested on humans at all," they note. "We only have data about antibody production from 10 mice."

Does the Biden administration view the American people as any better than lab rats? It seems not based on this situation.

What's more, the doctors note that neither the FDA nor Moderna have disclosed "what happened to the patient who took the new vaccine and had a complication that required medical attention."

Were there contributing factors to the complication? How serious was it? Are there any long term effects from the complication?

None of these answers have or are likely to come from the Biden administration in their push to get the new vaccine administered far and wide. Why even have regulators if they are apparently unwilling to scrutinize the things they approve?

Despite the White House's refusal to give Americans the full, honest picture, Makary and Høeg are among those reminding America's leaders that "[t]he public has a right to know." Indeed.




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