A lot of commotion last week, especially by eight mice. Disabling the external reviews is therefore somewhat snowed under. For us in Europe, it didn't matter: the EMA then scrapped the conditions that the panel had enforced. A member of the FDA vaccine panel and prominent promoter of COVID vaccines, Prof. Dr. Paul Offit, is now complaining about the approval process of pfizer and Moderna's latest repeat injections. No more external parties are consulted. It's a widely shared video, see blckbx.tv for background info. The reason for the approval of the latest vaccines are, so was already known in August, based on studies on pilot populations of 8 and 10 mice, respectively.
Our disinformation think tank - or was it Maarten Keulemans?- has explained that this method is quite normal if a 100% safe vaccine does not change radically. Prof. Dr. Offit, who reviews vaccines for the FDA, appears to be unaware of this. Maybe they can call him to catch up with him.
Prof. Dr. Paul Offit explains why he finds it inconceivable that the bivalent repeat injections are allowed for emergency use.
Those mice can't do anything about it so I'll focus on Offit's other argument. What went wrong in the admissions process: No external vaccine advisory panels have been heard. The decision-making process does not involve independent peer reviewers who are not funded by the industry. This was still the case with the booster prick last year. I got there then comprehensive report of done. In short:
- Of the 16 experts with a clear opinion, 12 were outspokenly AGAINST approval of the boosters for anyone over the age of 16. (Their argumentation follows later).
- The panel then agreed to a conditional admission for over-65s and, in addition, only for over-16s with an increased risk.
A few days later, the verdict followed:
September 22, 2021 – FDA approval under emergency conditions for the booster for Over-65s and for 18-64 year olds at high risk to severe COVID-19 (immune problems and certain high-risk occupations).Check it on the FDA website
Who describes my bewilderment when the EMA, less than two weeks later (!), found everything OK on this basis, also for young people:
4 October 2021 – The EMA concludes that the boosters may be used for everyone from the age of 18 because Pfizer has observed an increase in antibodies. This also applies to people with a normal immune system.Check it on the EEA website
The external advisory panel was then able to temporarily stop those boosters for Americans under 65. In Europe, the EMA has simply dropped that age restriction immediately. The emergency conditions are also not mentioned. That could be of legal use to the FDA. ("It seemed really safe; Europe has even published unconditional approval.")
It gives me the impression that something is going completely wrong in the system of passing on responsibilities. There was really an age restriction on do booster. Road. Ignoring is the new pushing through. The FDA must have recognized that the panel was getting in the way of vaccine readiness (synonymous with "sales"). That had to be cleared. The pressure was too great.
In the US, there were already honest officials who could not live with this increasing corruption fraud (malpractice due to entanglement). In early September, the FDA had already announced the resignation of two top officials in the field of vaccine approval. The reason was the pressure that had been exerted on the approval of the boosters. Top officials Gruber and Krause left because they felt the CDC (referred to in other posts as "the Biden administration") was making decisions about vaccines that should have been left to the FDA. Biden promised all sorts of things about the vaccines when the FDA had yet to start. But Biden's point of contact is Fauci, who has undoubtedly guaranteed the approval. Then he must be able to rely on the approving organization. Querulants must be purified.
FDA cancels external advisory panel
Offit is now rightly getting worked up about not hearing an external advisory panel, but for Europe the intervention of that advisory panel did not matter at all. We have never heard anyone here, no expert, no journalist.
Offit also explains that, due to keeping the reviews strictly internal, the survey data has not now been made public. Disclosure should have taken place well in advance if external experts had been consulted.
The FDA has proceeded to consult only their own permanent advisors (list of names here), including Jay Portnoy, whose opinion of the booster at the time was largely based on the fact that he, like his wife, would love to get the next jab, but on-label rather than off-label and that's why he votes for approval. And that there are so many parents eager to have their children vaccinated.
So that's the motivation of a medical FDA official, whose colleagues were without exception pro-booster. (Arguments: myocarditis is harmless, vaccinations protect against lung covid, the previous injections no longer work so more injections are needed). If you read in a moment what the external experts said last year, it is not surprising that the FDA no longer consults them.
Meanwhile, the pharmaceutical companies and the FDA have their way: the mouse vaccine was approved yesterday, still for emergency use (!), for children from the age of six. An external panel was absolutely in favour of that because convincing evidence that this is a bad idea has piled up. The pharmaceutical companies did not want to run that risk. So the FDA changed that. There is no supervisor on them, they are supervisors themselves.
Now they're going after the children
Why do the pharmaceutical companies want to vaccinate children so badly? Children experience much more damage from the vaccine than from omikron and vaccination also does not help against spread and against lung covid probably does not help either. All for the turnover? Van der Leyen has ordered about 10 injections per European from her boyfriend Bourla (by secret text message), should they perhaps be delivered at all costs? It's not just them to do the turnover, explains Robert F. Kennedy.
Robert F. Kennedy Jr. is an attorney, specialized in damages cases against the pharmaceutical industry and author of The Real Anthony Fauci. (On sale as an e-book for € 3,34. It has also been translated into Dutch under the flat title "The most dangerous doctor on earth" € 24,95)
What Robert Kennedy Jr. says comes down to this: the pharmaceutical companies enjoy when using emergency vaccines temporary liability protection. They are therefore exempt from responsibility in the event of side effects: as long as they are emergency vaccines, pharmaceutical companies cannot be charged. However, a permanent safeguard applies to vaccines approved for children. Once that approval for children has been passed, there is never again a possibility for adults to sue pharmaceutical companies for causing side effects.
Kennedy: “That is why the pharmaceutical companies are now going after the children. They know this will kill and harm a large number of children, but they must do it to maintain liability protection, should the vaccines ever be fully "authorized."“
The underlying idea speaks for itself: vaccines for children have been tested for safety in such a way that adults cannot possibly get complaints from them. That saves a lot of lawsuits from people who want to make a profit out of it. Also in tests on eight mice.
Here is the video in which he explains it, December last year. (dangerous)
Robert Kennedy may be a fighter against malpractices by pharmaceutical companies, but he has been conducting lawsuits in that area for 40 years and generally has his facts more than in order. In his book, he accuses Fauci of the worst crimes. Yet no complaint has yet been filed against him, which only makes his allegations more credible. Fauci's strategy is that he can only get away with his practices if he manages to downplay and ignore everything.
Insight into state science takes its place
I summarize again in shorthand what the reactions of the external FDA vaccine advisory panel were in approving the booster. Everything they already knew a year ago has now been confirmed from several sides. There is now more substantiation for the objections of that time. Yet state science does not show any progressive insight. On the contrary: they shield more, even pay fines for it, obscure decision-making processes, minutes and communication and cancel unwelcome voices from outside. The external advisory panel has now also been cancelled. FDA and pharmaceutical companies have their hands a bit freer again.
Shudder first at the arguments of the proponents and then at those of the opponents. And realize that these are arguments that are now a year old.
Arguments in favour of admission
Ben Newton– Approval requires 50% effectiveness, so boosters are desperately needed to stay above 50% given the decreasing effectiveness! He speaks of "The right to be vaccinated" and "Every unvaccinated person has the same R0 value as an anti-vaxxer".
Kermit Kubitz– Mentions benefits: "Boosters" are wrong naming, normal vaccination protocols sometimes also require months between administration. Boosters protect against variants and getting sick. Boosters protect against infection, including those who are unvaccinated. Worldwide supply will come from cheaper, more conventional vaccinations and Organic E vaccines are coming [I have taken these points almost literally because I do not understand everything but what I do understand is not true]. But in any case: vote for the boosters.
Kathleen Cameron– Very pro-vax, wants rapid vaccines for the elderly and communities of color. Asks for an informed decision because vaccines are important and the impact of Covid-19 is terrible so we want to do everything we can.
Brian Hujdich– Concerned about decreasing effectiveness, especially in connection with his own foundation that deals with HIV patients. Would like extra protection for HIV patients and others with a malfunctioning immune system. Before, to inoculate everyone aged 16 years and older so that HIV patients are protected.
So much for the medical-scientific considerations of the proponents. I shall refrain from commenting.
Arguments against admission
Rajesh Gupta Ph.D.: Strongly advises against. Presence of antibodies are not a reliable target (cdc itself also says). Trials have not investigated contagiousness infection. Vaccination makes little sense except for the very vulnerable. Against vaccination of 16+.
Professional.Retset Levi(URL MIT)– Not satisfied with monitoring for side effects in Israel [despite the fact that research is being done, as will be added a little later]. Herd immunity not possible. Still high infection rate and mortality is increasing despite the vaccines. First determine research and strategy. Until then: don't!
Dr.Jessica Rose: Viral immunologist. Points to the sheer amount of side effects in VAERS: more than all vaccines combined in the past 10 years. Especially unacceptable for children. Variants only become more dangerous because of the booster shots. So don't do it.
Dr.Joseph Fraiman– Need for larger trials. Gain experience with Covid and with the vaccines. For people in their twenties, it is not possible to prove that covid is more harmful than vaccines. Too little evidence to be able to give the boosters to everyone! Also look at other medications.
Steve Kirsch– Trial showed that there were 4x as many heart attacks in vaccinated people. 20 deaths in vaccinated persons; 14 in the placebo group. Vaccines cost more life than they save. Myocarditis occurred in about 1:1000 boys. After vaccination at 1:317. After the booster, he expects 1:25. Points to fraud in the trials. Very strong against.
Dr.David Wiseman– Politicized topic. No studies, no proper effectiveness and certainly not about the boosters. In Israel, excess mortality increases with Booster roll-out. Menstrual problems. Gene therapy should be investigated for carcinogenicity for 5-10 years. In short: too little data, too many side effects, no insight into long-term effects, especially relevant for young people. Look at existing drugs! Against.
Dr.Peter Doshi– If there is a Pandemic of Unvaccinated, why a Booster? There is no study of side effects of the third dose. Furthermore, all warning sounds from doctors and scientists are dismissed as "spreading misinformation". Worrisome situation, what is the FDA doing about it? Under these circumstances: Clearly against. Too many unknowns.
Dr.Michael Carome– No risk/benefit profile for the boosters. Unclear to what extent side effects increase. Protection against serious illness unclear. Quotes Lancet. More important to vaccinate poor countries. Speaks of 'highly effective'.
Kim Witczak– Goalposts continue to be moved. Trials are severely insufficient, involve several hundred people. Absurd as a basis for a global roll-out. mRNA vaccines are never designed to stop infection or eradicate the virus. False pretenses: vaccines would be better than natural immunity, people were 'bribed' to get vaccinated, demonizing unvaccinated people. Again accusation of obstruction of free speech and certainly of doctors and scientists. Side effects are huge. The biggest medical experiment ever. So against.
Lynda Dee– There is no scientific basis. Discusses approval protocols. Too little data to approve.
Dr.Meg Seymour– Safety research is far too small and also not representative. Only 12 patients over 65, while that is the main group. Ages 16-17 are modeled based on the results of 18+. Three months is also too short to signal effects. Methodological objections, not scientifically justifiable. Very disappointing.
Dr.Paul Alexander– Strong criticism of the evaluation and monitoring. Scientific substantiation is insufficient, too short-term. "We currently do not have the safety data". Too many red flags in animal testing! So strongly against. Under no circumstances vaccinate children! Don't!
Beth Battaglino– Promo talk for the activities of her foundation. I couldn't distill an opinion from it.
What a state of affairs. I'll say it again: don't get your kids vaccinated, there's too much evidence that it's just not necessary. There are also many signs that it can indeed do harm. The approval process is rattling and the stakes are astronomical. A life-threatening combination.
You can read more about the interweaving of the FDA with their sector on the site of the Eucalyptic Society, including the text of this article, also as a Dutch version.
Meanwhile, Steve Kirsch also posted an article about this statement by Offit on his Substack. In the comments, Offit is seen as one of the first rats to leave the sinking ship, he would like to save his skin in this way.
Maarten Keulemans tweeted that he had written something about it, but I cancelled all my subscriptions to the state newspapers. So I'm absolved of that. We read VK, AD, NRC. The occasionally inferior pieces and incorrect information I forgave them (they are just journalists). I now see that as systematic indoctrination. I hope more people take that step. Out with those Belgians. I don't believe everything about the Other Newspaper and blckbx, but at least there is thought and I sometimes estimate them to be a bit wandering but always with integrity.