Israel National News Reports “Vaccine Troubles” in Israel

Helsinki Committee to declare Pfizer performing unauthorized human experiment in Israel

Committee in charge of supervising human trials expected to state vaccine campaign is clinical study and needed pre-approval.

Tags:ExperimentVaccineHuman RightsCoronavirusMordechai Sones , Jan 18 , 2021 4:14 PM
Pfizer vaccine campaignPfizer vaccine campaignFlash 90

Calcalist reports the Helsinki Committee for Human Rights is expected to announce that Pfizer is conducting unauthorized human experiments in Israel.

The committee in charge of supervising human trials is expected to submit an opinion to the Health Ministry stating that the immunization process led by the state with Pfizer is a clinical study, and therefore needed to be approved in advance.

The Supreme Helsinki Commission – in charge of supervising human trials in Israel – is expected to submit an opinion to the Health Ministry stating that the vaccine campaign led by the Israeli government together with Pfizer is fundamentally clinical research, a code name for human trials, and thus, needed to receive explicit Committee authorization. The opinion has already been formulated and in coming days is expected to be handed over to Health Ministry Director Hezi Levy, possibly even today.

“Reading the contract signed between the Israeli government and Pfizer, it is clear, unequivocal and unambiguous that this is a clinical study for all intents and purposes, and thus, it needed to be approved by the Helsinki Committee,” a senior official explained to Calcalist, adding: “And that’s what will be written in the Committee’s opinion: ‘There’s nothing wrong with clinical trials, on the contrary, but clinical trials (human trials) must get committee approval, and of course, from the people on whom the trial is being conducted, while giving the right to refuse to be part of the trial. These are very basic matters,” he concluded.

Helsinki Committee Chairman Prof. Eitan Friedman refused to comment on the publication and told Calcalist that the Committee would present its position in an orderly manner and in the usual way, not through the media. Since the Committee is a statutory committee (established by virtue of the law), the practical implication is that it will determine that the experiment on humans that Pfizer is currently conducting in Israel is illegal.

The expected letter from the Helsinki Committee is of far-reaching significance. First, the Committee can determine that the Israeli government must stop transmitting information to Pfizer, something that could cause Israel to be in breach of contract. If the government decides to ignore the Committee’s directive, every Israeli citizen will be able to appeal to the Supreme Court on the matter.

The Committee can also demand that all Israeli citizens be informed that the results of the vaccine will be passed on to a third party, and also oblige the Health Ministry to request approval of those vaccinated to be an experiment subject.

In addition, neither the Committee nor the citizens of Israel have any need to use legal tools: A short letter from the Committee announcing that it does not approve the experiment could greatly complicate matters for Pfizer and the Israeli government because in consequence of that letter, Pfizer may not contact the FDA and request final approval for the vaccine. “It is inconceivable that the FDA would grant final approval to a vaccine based on a clinical study rejected by the Israeli Helsinki Committee,” the paper said.

Health Communication Lecturer at IDC Herzliya International School Dr. Yaffa Shir Raz responded to the Helsinki development, saying: “The question of questions: Where does this scandal put the Green Passport? Can the government even continue to promote the compulsion of the experiment on us? The road to court has never looked more paved, and this time, it’s hard to see how they’ll ignore it.”

Update: After publication of the Calcalist report, Helsinki Committee Chairman Prof. Eitan Friedman issued a denial, saying that he and the entire Helsinki Committee continues to recommend the vaccine in those not contraindicated, continuing that “the vaccine is not a clinical trial. It is based on clinical study, it is based on experimentation. There is no connection between the vaccine and a clinical test.”

He says the “commotion” centers around one issue alone, and that is that “as a Supreme Committee, some of its members are jurists, and they read parts of the agreement between the Health Ministry and Pfizer, and we as an ethics committee want to assure that the rights and privacy of Israeli citizens are guarded.”

He continued: “Also when a clinical trial, which is a worthy trial, is performed, we do want to know from a scientific standpoint what happens, what the effects are of the vaccine, what are the adverse effects; yes, we very much want to know and lend a shoulder. But, we want to know if, in the framework of the contract with Pfizer, those rights are being protected.”

Senior Israel Democracy Institute attorney Dr. Tehila Schwartz-Altshuler told Calcalist: “Anyone who might claim this is not a clinical study is simply a liar. This is the most extensive study of human beings in the 21st century. Israel is becoming the experimental field, not to mention the backyard for the whole world. It may be a beautiful and altruistic thing, but this should have been shared with the citizens of Israel.”

She says: “There’s no clearer research hypothesis than in section 2.1 of the contract between the State of Israel and Pfizer, which states that the purpose of the ‘experiment’ is ‘to measure and analyze’. To say it isn’t research is a lie. In section 2.2 the word ‘data’ appears again and again, and the idea is that it is information from which you want to learn something other than transfer it to the medical file of the patient you have treated. This is a collaboration for research and therefore there are also ‘Principles of collaboration’.

Moreover, Schwartz-Altschuler explains that “Article 4 – as with any medical research agreement – has terms and terminations and there are agreements regarding the safety of the project. This further reinforces the fact that this is a study. For example, under the clause, the agreement will be revoked if one of the parties decides that it is ‘scientifically insignificant’.

Fierce Pharma Show There is Gold in Them Thar Hills in COVID Vaccine Gold Rush

First-to-market Pfizer expects a whopping $15B from its COVID-19 shot in 2021

by Eric Sagonowsky | Feb 2, 2021 11:54am

Pfizer building

Pfizer laid out its 2021 financial expectations on Tuesday.(Tracy Staton)ShareFacebookTwitterLinkedInEmailPrint

More and more COVID-19 vaccines are nearing the market, but mRNA shots from Pfizer and Moderna are still working off a head start in the global rollout. Now, Pfizer has revealed just what that head start could be worth this year.

Short answer: $15 billion. And it could be more.

The company said Tuesday that it’s expecting that much in sales from its BioNTech-partnered mRNA shot this year. In last year’s fourth quarter, the vaccine chipped in $154 million. 

E-BOOK

Industry insights for pharmaceutical marketers

To build trusted relationships and drive successful outcomes for customers and partners, marketers in the pharmaceutical industry must leverage tools and technologies to innovate, better inform and overcome challenges. Get the e-book and learn how to deliver better customer-centered experiences.DOWNLOAD NOW

The estimate, unveiled as part of Pfizer’s 2021 guidance, is primarily based on doses set to be delivered in 2021 under existing contracts, the company said. The estimate “could change if additional contracts are signed,” according to the company’s investor presentation.

To put $15 billion into context, Pfizer also markets the bestselling vaccine outside of COVID-19, pneumococcal shot Prevnar 13. That product generated $5.85 billion last year. Pfizer’s entire vaccine franchise pulled in $6.56 billion in 2020. The company is one of the four leading vaccine players worldwide.

RELATED: While Pfizer and Moderna hold the lead, new data from J&J, Novavax show there’s ‘room for everyone’ in the market: analysts 

Pfizer and its partner BioNTech were the first to score COVID-19 vaccine authorizations in developed countries, and Pfizer says it’s shipped 65 million vaccine doses worldwide as of Sunday. The company expects to deliver 200 million vaccines to the U.S. by the end of May. 

Based on the new six-dose-per-vial label, expansions at current sites and an expectation by the companies to bring on more manufacturing partners, Pfizer and BioNTech say they can produce 2 billion shots worldwide in 2021. 

Meanwhile, mRNA rival Moderna is also eying megabillions from its COVID-19 vaccine, mRNA-1273. As of mid-January, Moderna had secured $11.7 billion in advance purchase orders from various governments and organizations for the vaccine, and the company was in the process of negotiating more deals. Moderna CEO Stephane Bancel said in an interview the company could join the ranks of the largest vaccine players by revenue this year. A year ago, Moderna didn’t have any approved products. 

RELATED:  The $38B pie: Pfizer, Moderna COVID-19 vaccines set for lion’s share of 2021 sales 

The Pfizer guidance comes as the list of coronavirus vaccines with efficacy data has grown longer in recent days. Novavax and Johnson & Johnson posted efficacy results late last week, and Russia’s Sputnik V shot demonstrated strong protection in a phase 3 study analysis published Tuesday in The Lancet. 

While there were caveats to the J&J and Novavax data, ODDO BHF analysts wrote to clients that the results show there’s “room for everyone” in the COVID-19 vaccine market. Still, recent data readouts have outlined the “superior efficacy” profiles for the mRNA shots.  

The ODDO BHF analysts project $13.7 billion in COVID-19 vaccine sales for Moderna’s vaccine this year, while a separate team of analysts at SVB Leerink predicts $9.5 billion. 

Another vaccine, from AstraZeneca, is being rolled out in Europe and elsewhere. SVB Leerink analyst Andrew Berens projected $1.9 billion in revenues for the shot in 2021 and $3 billion in 2022. AstraZeneca has pledged to sell the vaccine on a not-for-profit basis during the pandemic. 

Previously, Bernstein analysts predicted multibillion-dollar opportunities for the five leading vaccine players—Pfizer, Moderna, AstraZeneca, Johnson & Johnson and Novavax—in 2021. But they predicted Pfizer and Moderna would be way out ahead of the rest of the pack in coronavirus vaccine revenues.

Greek Cypriot Comedy “Committed”: Romantic Comedy with a Twist

You think you know in what direction this film is heading in but be prepared for a twist that gives an extra meaning to “Committed”.

George (Orestes Sophocleous) is a Cypriot Greek educated as an engineer in London. As many engineers can be he is technical and scientific. Love is nothing but an infatuation caused by a series of chemical reactions.

Well ordered George is teetering with a break-up with his girlfriend Christina who has given him an ultimatum which would be let’s get married or else. George is not ready for commitment, family and falling out of love. So in his beloved vintage Mercedes convertible he takes  a long drive in the countryside and well then his life goes topsy turvy as he passes by Greek-American Eva (Melia Kreiling), a drama and film teacher, who is in a bridal outfit wandering down the road.

She is passionate and full of wonder with the power of love but freaking out with her wedding day unable to settle down to a boring and predictable life.

George and Eva are diametrically different so it seems.

Well through a long drive and discussions and a bit of a sappy roadside pick up of a puppy (Mo) left in a cardboard box on the road. It would seem George’s rigidity melts as does Eva’s fear of commitment.

So you are in a Harry and Sally moment until at a stop at a gas bar and mini-mart George sees an “interesting” newspaper article that will flip you on your head.

George and Eva part under strange circumstances and I think fair to say they have rediscovered love and be prepared to see a different aspect of what “committed” means and why on earth Eva’s attitude to love is still so expansive.

It will be playing through to March 6th for a fee.

Clever writing and who can’t be impressed with the sassy performance of Kreiling and Mr. Serious Sophocleous.

You can catch the trailer here and marvel at the beautiful Cypriot scenery https://www.youtube.com/watch?v=6C1BQeFHE-U&feature=emb_logo

This 2013 film is in English and just over an hour and a half. It is available on the Hellenic Film Society’s USA’s website here https://hellenicfilmusa.org/

COVID-19 and Mental Health: What are they saying in Quebec?

The Quebec Magazine L’actualité had as its feature in the December edition “Comment Aller Mieux: Conseils d’experts Pour tenir le coup durant cette 77^^%%@@ pandémie” meaning “How to feel better: expert advice in coping with a difficult situation during this (expletive) pandemic”.

Part of the article dealt how are the guys doing?

Phillipe Roy a professor of male health at the University of Sherbrooke noted , “ To be a real man you have to show that health issues don’t bother you”. According to a recent study of that University 24.3% of women confirmed they were suffering from COVID induced depression or anxiety but men were behind that at 19%.

As Gilles Tremblay, professor of social studies and criminality at the University of Laval discovered men are taught to be tough. He said, “To endure pain and suffering in silence in their mind is a sign of virility yet as studies have shown men live with greater anxiety”. In Quebec the suicide rate for men is three times greater than that for women. Tremblay continues, “Men 35 and younger find it easier to express their emotion but all men express a reluctance to consult a professional particularly in mental health.” As Roy noted mean seek help at one second prior to midnight. He says that men have had the access to their workplaces, commercial centres all of which have a role in increasing social isolation.

Tremblay remarked men tend to have a very short fuses and one should closely survey if they show signs of irritability and aggressiveness and some may even show violence.

For Tremblay it is the granting of access for men facing mental health issues which is key. When it is easy for men to access mental health resources men will respond to the call.

Tara Brach’s “Radical Acceptance Theory: Embracing your life with the heart of a Buddha”

“The message of original sin is unequivocal. Because of our basically flawed nature, we do not deserve to be happy, loved by others, at ease with life. We are outcasts, and if we are to re-enter the garden we must redeem our sinful selves. We must overcome our flaws by controlling our bodies, controlling our emotion, controlling our natural surroundings, controlling other people. And we must strive tirelessly-working, acquiring, consuming, achieving, e-mailing, over-committing and rushing- in a never ending quest to prove ourselves”

Virus # 26:Chapter 54 “the post pandemic world: The University for Global Pandemic Management”

Chapter 54 “the post pandemic world: The University for Global Pandemic Management”

The United Nations was fired up with creativity and purpose after the toll of COVIDs and Virus # 26 were tallied. To my delight a new University was established and funded by U.N. member states and located in Toronto. Students would be selected by governments in numbers proportionate to the fatality rates exacted by the viruses in their countries.

The goal was to synthesize all the lessons learnt by the different countries in battling the viruses and creating a curriculum to assist countries in managing the viruses which included both successes and failures.

The university students were to include physicians, naturopaths, sociologists, first line hospital responders and hospital administrators. Big Pharma was excluded due to the carnage caused by botched clinical trials and horrendous side effects for COVID-19 and Virus # 26 vaccines. It should be noted that initially the COVID-19 vaccine was effective but within 5 years its negative effects became known. The worst one was rapid cognitive decline eventually leading to Alzheimer’s. And then there were other vaccines that caused ALS which we know as Lou Gehrig’s disease on the cruelest of cruel diseases. You recall most of these vaccinations had been trialed amongst healthy adults which in the United States was estimated to be only 30% of the population and there was such urgency to get the jabs going no long-term study was ever done. But it became apparent years after vaccination there were debilitating side effects to most of them. Look at Russia today with their Sputnik vaccine. 40% of Russians now have Alzheimer’s.

Much to my surprise I was to be a lecturer on cardiology and pandemics perhaps attributable to the couple of research studies I had lead dealing with the COVIDs and Virus # 26. I was the first director of Pandemic Research for the University for a two-year period which I accepted on the understanding most of my duties could be completed remotely from my compound in Sunridge, Ontario.

Virus # 26 made me feel useless as a physician as all I could do was watch patients die but perhaps here was a second chance to strike back and the next virus which would come certainly but when?

Tara Brach’s “Radical Acceptance Embracing your life with the heart of a Buddha”

“The trance of unworthiness intensifies when our lives feel painful and out of control. We may assume that our physical sickness or emotional depression is our fault-the result of bad genes or our lack of discipline and willpower. We may feel that the loss of a job or a painful divorce is a reflection of our personal flaws. If we had only done better, if we were somewhere different, things would have gone right. While me might place the blame on someone else we still tacitly blame ourselves for getting into the situation in the first place.”

From Tara Brach’s “Radical Acceptance Embracing your life with the heart of a Buddha

“Inherent in the trance of unworthiness is the belief that no matter how hard we try, we are always, in some way falling short. Feeling unworthy goes hand in hand with feeling separate from others, separate from life. If we are defective, how can we possibly belong? It’s a vicious cycle. The more deficient we feel, the more separate and vulnerable we feel. Underneath our fear of being flawed is a more primal fear that something is wrong with life, that something bad is going to happen. Our reaction to this fear is to feel blame, even hatred, toward whatever we consider the source of the problem: ourselves, others, life itself.”

Poetry Corner: “Creeping October (aka Homecoming Week in North America)”

Creeping October (aka Homecoming Week in North America)

Guess who is in town
for the big college football game
goon jocks with their war cries
purple painted face engineering students
initiation rights
into what?
last binge?
and the roar after the big play
fat assed frat girls as caramel sundaes
for their boys
and we all know the topping I’m talking about

but back home everything is so decent when the turkey is carved

Robert K. Stephen

Virus # 26:Chapter 53 “the post pandemic world: time for global consistency”

Chapter 53 “the post pandemic world: time for global consistency”

One noticed as a physician or lay person the many different approaches taken by countries to control and limit the spread of viruses. There was anything but a concise and uniform approach. Masks were useless at one point then they became essential depending in what political entity you were living in. There were shortages of personal protective equipment and of treatment pharmaceuticals. The World Health Organization was lambasted continually often for good reason for being inconsistent and subject to political pressure.

So similar to the United Nations, a global approach to outlaw biological warfare research another convention was signed by all United Nations’ members called “A Uniform Global Approach to Treatment of Pandemics”. I will not bore you with its contents other than saying it was an operating manual to managing a pandemic on a consistent basis.

The WHO was totally reorganized and for the next pandemic there would be a member appointed “Pandemic Response Committee”. Their first piece of business was to ensure each country had stockpiled all the weapons necessary to contain a pandemic such as PPE, ventilators and pharmaceuticals generically required to deal with seriously ill people. It did not cover all eventualities but set up general guidelines of pandemic management particularly obligating swift reporting of outbreaks to the WHO and established penalties for fudging numbers. It was at least a start in the right direction to try and create order from the past pandemic mayhem.

One sorely needed approach was how to manage long term care facilities where it was estimated for the COVIDs 50-80% of all fatalities occurred.

So the end result of all this murdering in the name of science came to an end with a United Nations treaty “A Convention to Outlaw Biological Warfare and its Research”. All countries signed this treaty, even North Korea. This time all countries had suffered under biological warfare research gone wrong so it looked as if this treaty was not a treaty made to be broken.

So many scientists had become whores for close to a century and we all hoped this would end their murderous inclinations.