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The battle in the US for VE (vaccine efficacy) day?

Following RFKj, Marty Makary being appointed to front the FDA was one of the Trump regime’s surprising appointments. Neither a true believer nor an auto-naysayer of vaccines, he was appointed despite having been very critical of the process by which the covid “vaccines” were approved. A vocal advocate of proper trialling and testing.

How he got past.the pharma-sponsored senators, I don’t know but I expect statements (I bet nether RFKj nor Makary write about vaccines in quotes) that future vaccines would only be subjected to genuine safety and efficacy tests offered senators reassurances that were more steeped in their own beliefs than knowledge of the science.

How such testing will be done is a fascinating and crucial question. Generally most indicators for previous vaccines are that the drawbacks for the immune system (measured eg by doctor visits in children, and counting relevant diagnoses in vaxed vs unvaxed) appeared to outweigh the potential benefits.

As in the case of Dr Paul Thomas who did just that - he made his point comissioning an external study of his practice records, after which he felt the forces of retribution. costing him his medical career.

For Covid “vaccines”, the benefits in terms of the disease when there is a plandemic are claimed to be greater - but these are hard to verify/quantify. OTOH, as posted endlessly here, there has been a lack of interest or acknlowledgement in the apparent drawbacks. This may have induced a false complacency among senators.

If the testing is worth its salt they are likely in for a rude awakening - how are they going to disguise this:

A Systematic Review Of Autopsy Findings In Deaths After COVID-19 Vaccination

However there will have been some discussions and horse trading. If pharma supporters have their way this investigative research will be de-fanged and re-routed into the safe ground with the reality disguised and the final verdict and narrative under the control of the vested interests, as indeed it is at the moment.

Boosters are a first testing ground for the new policy. It’s hard to see which way this will play out, however if it is left to to Pharma to ‘show’; efficacy there can only be one outcome. Is it Kennedy and Makary that have been de-fanged? We need to watch and wait.

ED

30/4/25 Makary: FDA Won’t Approve COVID Boosters Without ‘Some Good Data’

FDA Commissioner Marty Makary on Tuesday said the agency is still considering whether or not to approve COVID-19 vaccines for this winter, citing a lack of data. Makary’s approach marks a change from how the FDA previously approved COVID-19 boosters each year, CBS News reported.

by Suzanne Burdick

The head of the U.S. Food and Drug Administration (FDA) on Tuesday said the agency is still considering whether to approve COVID-19 vaccines for this winter, citing a lack of data on booster shots.

In an interview this week with the editor-in-chief of MedPage Today, Dr. Marty Makary said, “Look, 85% of healthcare workers declined the latest Covid booster vaccine last fall. Should we accept that and just keep pounding on parents to get their healthy 12-year-old daughter a 7th Covid jab this fall? Or should we make evidence-based recommendations based on a meaningful study showing a clinical benefit today?”

The FDA has received “a bunch of applications” from COVID-19 vaccine manufacturers for their 2025 booster products, Makary, who formerly served as editor-in-chief of MedPage Today, told CBS News. He said:

“We’re taking a look. I can’t comment on any particular application. … I think there’s a void of data. And I think rather than allow that void to be filled with opinions, I’d like to see some good data.”

The FDA has now asked several COVID-19 vaccine makers, including Novavax, to do clinical studies “so we can educate the population and have information to work with,” Makary told CBS News.

Pfizer and Moderna did not immediately respond when The Defender asked if they have been asked to complete a clinical trial for their 2025-2026 COVID-19 booster. Novavax declined to comment on the topic.

Makary said, “It’s my general feeling, not with this particular product, which I can’t discuss in depth, but with drugs in general, that we need to know if they work today in order to be able to recommend them.”

Makary’s comments come a week after internal sources told Politico that U.S. Secretary of Health and Human Services Robert F. Kennedy Jr. is advocating to remove the COVID-19 shot from the Centers for Disease Control and Prevention’s (CDC) list of recommended vaccines for children, arguing there is little scientific evidence that the shot provides a benefit to babies and young children.

The CDC currently recommends that everyone 6 months and up get an annual COVID-19 shot.

Makary’s approach to COVID-19 vaccine approvals marks a change from how the FDA was run during the Biden administration, when the agency routinely approved COVID-19 boosters each year, CBS News reported.

Under the Biden administration, the FDA sometimes approved COVID-19 shots with little or no data showing benefit. For example, the FDA in October 2022 amended the emergency use authorizations for the Pfizer and Moderna COVID-19 Omicron boosters for children as young as 5, despite having no direct data on the safety or effectiveness of the shots in children.

The CDC may soon narrow its COVID-19 vaccination recommendations. At its latest meeting earlier this month, the agency’s independent vaccine advisory committee discussed switching from a universal to a risk-based approach for its COVID-19 recommendations.

A risk-based approach might mean changes to the CDC’s current recommendation that all kids 6 months and up get vaccinated for COVID-19, as kids are considered at low risk of severe illness from the virus. The committee is expected to vote on the issue in June.

‘I’d rather have a sound decision a few days after the target date than have another Vioxx’

Makary faced criticism earlier this week when the FDA told Novavax it must do a clinical trial for its new COVID-19 booster before the agency approves the new shot.

According to The Associated Press, it’s unlikely Novavax could complete the trial before fall.

NBC News, under the headline “FDA appears to be slow-walking vaccine approvals,” claimed the FDA had missed an April 1 deadline for approving the shot.

Makary pushed back against that claim, telling MedPage that the FDA has “target dates,” rather than “deadlines,” for approval decisions.

FDA scientists sometimes say that certain targets will or won’t be met, depending on how complex a product application may be, Makary said. “I’d rather have a sound decision a few days after the target date than have another Vioxx that potentially killed 38,000 Americans.”

In 1999, the FDA approved Vioxx, a painkiller sold by Merck, even though Merck’s internal scientists knew the drug could cause deadly heart attacks and strokes. The FDA later issued a public health advisory about the drug. In 2004, Merck withdrew it from the market.

According to Makary, a big part of his job is “rebuilding public trust.”

COVID-19 vaccination rates would likely be higher if there were a study showing that COVID-19 boosters helped keep people out of the hospital, he said.

Makary said his special assistant, Dr. Tracy Beth Høeg, is one of the FDA staff reviewing datasets in Novavax’s application. Høeg and colleagues in 2022 published a peer-reviewed study that showed teenage boys faced greater risk than benefit from getting two doses of an mRNA COVID-19 vaccine.

‘It’s like a judge issuing a verdict and then having lawyers make their arguments’

It could cost Novavax “tens of millions of dollars” to do a new randomized trial for its COVID-19 booster, according to The Wall Street Journal.

“But my job,” Makary told MedPage, “is upholding gold standard science and rebuilding public trust, not to save pharma companies tens of millions of dollars.”

Makary pointed out in an April 26 X post that the product Novavax wants to bring to market this winter isn’t the same product it brought to market in 2021. “New products require new clinical studies,” he said.

Moreover, the study Novavax conducted in 2020 to 2021 for its COVID-19 shot excluded people with natural immunity to COVID-19, he told MedPage. “Today, there is broad population immunity, and the big question is does it provide a benefit?”

Makary added, “Without a study on the new formulation and product, we can’t give an honest evidence-based answer to that question.”

The move drew criticism from former FDA officials Phil Krause and Luciana Borio, who argued in a commentary that the FDA “should stick to its normal processes.”

However, according to Makary, in recent years, the FDA’s processes failed to adequately gather data before making a decision. For instance, on March 29, 2022, Makary wrote a scathing series of X posts criticizing the FDA for authorizing a fourth COVID-19 shot without sufficient data.

Rather than calling for more data, the FDA authorized the shot by bypassing a vote of the agency’s external experts, and later convening the experts to “discuss” the shot afterward.

“It’s like a judge issuing a verdict and then having lawyers make their arguments,” Makary wrote.

The Defender asked the FDA how soon it estimates issuing decisions on the COVID-19 booster applications, but did not receive a response by the deadline.

For what it’s worth, I think they have both been “defanged” to use @Evvy_dense euphemism. I would have said compromised.

There is just such an overwhelming amount of evidence about the Convid shots and vaccines in general, an intelligent 12 year old could understand. Therefore to talk about ‘seeing the data’ or ‘considering’ the benefits, they must both be compromised.

Compromised by Epstein style video, the Zionist lobby, or just their clinging to office regardless of the cost, JFK junior and Makary are just more puppets in the Trump show.

Perhaps I should apologise if I sound like Mr Angry :joy::joy:

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Well there must have been some compromise or they would never have got past the senate. RFKj knows enough to scupper the covid “vaccine” programme in public; to me it remains to be seen whether he has fought and will keep fighting to keep enough of a hand on the wheel to stop the ship from veering away from the straight course.

It could be he has already accepted enough limits to avoid real harm to the golden goose. Maybe he still has personal presidential ambitions and mainly has a mind to win approval.

But I personally think he wants to achieve something definite for US public health and the outcome might depend on the fight, assuming it’s a real one.

Sorry if I sound like Mr Naive :innocent:

If you think ‘RFKj’ and ‘straight course’ belong in the same sentence there really is little hope for you.

“Everybody in the world is bent Camp Freddie. They just have a price”

Mr. Bridger The Italian Job

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Breaking: RFK Jr. Removes All Members of CDC Vaccine Advisory Committee

HHS Secretary Robert F. Kennedy Jr. announced late today that he is retiring all 17 members of the CDC vaccine advisory committee. “A clean sweep is needed to re-establish public confidence in vaccine science,” Kennedy wrote in an op-ed published today in The Wall Street Journal.

Here’s the thing - RFKj seemed to have been cornered into making promises to the key “swing senator”, Bill Cassidy, a Rep Dr with pharma funding to protect.
RFKj has broken these promises.

RKKj has explained that pre-departure Biden stuffed the vaccine committee with …you know what, which meant that the MAGA government coud not have achieved, by normal means, an overall majority on that committee for 3 years until 2028.

Dr Cassidy, unsurprisingly, is not happy; he is also being blamed as he held the power in his hands to stop RFKj’s ascension.

He can sniff all he likes,.he doesn’t get my sympathy. All that’s at stake is they get an evaluation process for vaccines - many compulsory - and people deciding that are less biased than the Pharma reps who were obviously ruling based on their own interests; as Cassidy himself will already know. But a fair process for handling vaccines is Pharma’s biggest fear.

A thought…sometimes (as here, seemingly) a “straight course” would only have led to oblivion. Due to the opposing forces…(I’m not recommending deceit as a lifelong sport :slightly_smiling_face:)

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The sirens are a-blazing and the knives are out. The nerve! Fancy putting vaccines through a fair test. It’s like attacking soft toys.

RFKj is a national emergency, so naturally CNN has to lead the defense of the profits nation.

Luckily it has the spin all ready; but the downside to this is that somehow they seemed unprepared for RFKj’s response.

CNN’s false gotcha:

RFK Jr. Rips CNN Over Claims on Vaccines and Placebo-Controlled Trials

“CNN is wrong,” Kennedy wrote. “No routine injected vaccine on CDC’s schedule was licensed for children based on a placebo-controlled trial. In instances where a vaccine was used as a control, it too was never licensed based on a placebo-controlled trial. That is not conjecture. It is a fact based on FDA’s clinical trial data.”

The only trouble is, it being the US most people will not get as far as reading RFKj’s response and will mostly just hear the sleights and shrill condemnation from the media, backed by the medical community - who should of course know better; but in both cases, they know on what side their bread is buttered.

For fucks sake…

I think these are for flu jabs; short hop to covid jabs from there I guess.

They have so many irons in the fire. I wonder what’s cooking… our goose? :grimacing:

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It was approved in Japan in Jan 2024

The First Self-Amplifying mRNA Vaccine

https://www.science.org/content/blog-post/first-self-amplifying-mrna-vaccine

The replication still doesn’t have an off-switch.

If viruses didn’t exist, they would have to be invented.
I mean, spike proteins, unlimited self-replication, untested in humans…

What could go wrong?

Japanese doctors oppose new coronavirus vaccine: ‘Replicon vaccine’

Arab News Japan

TOKYO: A group of Japanese doctors and university professors, united under the name “The United Citizens for Stopping mRNA Vaccines,” have raised serious concerns about the Replicon vaccine. This vaccine, scheduled to be administered to Japanese citizens in October, is being opposed due to what they branded as identified risks.

Replicon vaccine is a novel coronavirus vaccine developed by US company Arcturus Therapeutics after clinical trials involving 17,000 participants.

At a press conference, Dr. MURAKAMI Yasufumi, professor emeritus at the Tokyo University of Science, said there were problems with the Replicon vaccine for the JN.1 mutant strain scheduled in the fall, noting that “the self-amplifying mRNA vaccine is genetically modified and has never been tested on humans.”

“The Replicon vaccine is a self-amplifying, gene-engineered (mRNA) vaccine that mankind has never experienced before,” said Dr. Murakami.

This replicon vaccine uses a self-replicating function called replicase to replicate the mRNA in the body, but without the function of a brake, the recipient may continue to produce large amounts of spike protein. It has also been pointed out that the vaccine components may be transmitted from the recipient to other people or animals; therefore, Dr. Murakami has called for the vaccine to be unlaunched until its safety has been confirmed.

Dr. SANO Shigetoshi, a professor at Kochi University and a dermatologist, believes COVID-19 vaccines endanger people’s health. “After the COVID-19 vaccination, I saw an increase in patients complaining of vitiligo and other unprecedented symptoms,” Dr. Sano said. “The spike protein can disturb the immune system.”

Dr. Sano said he successfully detected spike proteins from skin disease sites. The vaccinated patients Sano examined showed a strong association between the disease site and the spike protein.

The group’s doctors point to 777 vaccine-related deaths and 7,970 health hazard certificates in Japan. The cases applied to the health hazard certificates undergo a careful double review from a medical standpoint. The most common cases are neuropathy, autoimmune diseases, and cardiac diseases, including myocarditis/pericarditis.

In contrast, the more serious cases include sudden death, myocardial infarction, and abdominal aortic dissection, according to the Ministry of Health, Labor, and Welfare.

Opponents of the vaccine have pointed to a “disturbing” trend: deaths that they claim are directly linked to the vaccine. They argue that many vaccine recipients do not recover well, and their health deteriorates gradually. In some tragic cases, they die immediately after vaccination.

The group asked why the government is going ahead with the use of the Replicon vaccine, whose safety cannot be confirmed.

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Correct. Maybe that one was for flu jabs, but the smoke and mirrors tricks being played by the MAHA crowd in respect of mRNA jabs don’t stand up to detailed scrutiny. It seems clear to me that RFK and Makary are as weak and compromised as all the previous incumbents of their respective positions. Perhaps that explains why they got through the nomination process.

Makary is a moderate in the political health field, probably as radical as they would be allowed to appoint. RFKj is more a true believer IMO.

Of course they can be called “weak” in comparison to the powerful forces they are opposing.
The true MAHAs are right to press RFK for more of course. I think we need to remember that these forces restrict every action.

I wonder what went wrong between Shannon Joy and Malone. Here is them together, just last October (I think)

image
https://rumble.com/v3ndz74-your-mind-is-the-battlefield-in-5g-war-dr.-robert-malone.html

To me this ugly public fallout shows that a lot of people have been stirring it to fragment the movement and separate those with firm ideological convictions (which IMO are not incorrect) from those trying to make progess via pragmatic steps. Where “separate” means “get at each others throats”.
Pharma of course will be pleased Malone didn’t sign the MAHA letter.

I must admit one of the most depressing things for me is that people opposing something as big and serious can be so easily presuaded to spend their time, resources and angst opposing each other rather than on the enemy. Seen all this before in the antiwar movement (such as it was), but known since Python coined the People’s Front of Judea vs Judean People’s Front.

Cheers