As Israel’s government begins discussions with Russia about buying its coronavirus vaccine, Jerusalem’s Hadassah Medical Center has already secured an order for 1.5 million doses of “Sputnik V” — and said it is considering becoming a regional distributor for the shots.
The plan could also help with some of the financial woes faced by the institution, which is owned by Hadassah, the Women’s Zionist Organization of America. It faced financial collapse in 2014 and was rescued by the US-based organization and Israel’s government.
Hospital director Zeev Rotstein has become a major enthusiast for the as-yet unproven inoculation — raising some eyebrows in the healthcare community.
“We signed a memorandum of understanding, and now a contract, which means we will be a distribution center for the vaccine — possibly not only in Israel, but also in the area,” Rotstein told The Times of Israel, saying he was talking about the Palestinian Authority and “some other countries.”
Rotstein is also keen to launch an unusual initiative: Having Israel approve the vaccine without waiting for the international bodies that Jerusalem normally follows, particularly the US Food and Drug Administration.
His hunch is that the FDA will give priority to local vaccines without licensing Sputnik V, and he “definitely” hopes Israel will independently approve the vaccine.
Rotstein has already begun applications with the Health Ministry. “Time is life,” he said of the need to act quickly.
A Russian hospital that operates under Hadassah’s supervision, and with its branding, has been involved in clinical trials in Russia. Rotstein said this inspired confidence.
“Hadassah is represented in Moscow. We participated in the Phase 3 trial, and our team saw with their own eyes that people didn’t grow horns,” he said.
He foresees his hospital, which is privately-owned but whose patients are mostly financed from the public purse, supplying vaccines to Israel’s health maintenance organizations, and possibly health providers abroad. And in a plan that is likely to generate controversy among medical ethicists, he said that while the “first priority” will be to vaccinate those in most urgent need, including high-risk Israelis and hospital staff, after this some of the vaccine might be made available to the public on a pay-per-shot basis.
The hospital insists the planned purchase, which will be funded by investors and won’t affect operating costs, was motivated by health considerations.
“We live in a capitalist country. We have to finance what we are doing, and the vaccine is going to be another medical activity,” said Rotstein.
Prime Minister Benjamin Netanyahu spoke to Russian President Vladimir Putin on Monday regarding the possibility of the government securing shots, five days after the release of initial data suggesting that the vaccine is 92 percent effective at protecting people from COVID-19.
“Before now, nobody in Israel wanted to hear about the Russian vaccine,” Rotstein said, adding that some time ago he “anticipated a situation where Russia would be first,” and decided that as the government wasn’t negotiating for shots, it would be beneficial to make a private arrangement. He said that, should the government now want to take over the contract, he will happily step aside.
Part of Rotstein’s drive for Israel to acquire the Russian shot stems from the fact it is a “vector” vaccine, meaning it uses traditional technology to piggy-back the genetic instructions on a harmless animal virus, in order to deliver them to human cells. The two other current leading vaccine candidates, from Pfizer and Moderna, use groundbreaking — but hitherto untried — mRNA technology. Rotstein believes that Israel should have a diverse stock of vaccines which includes both familiar and pioneering tech.
Assuming Hadassah retains the contract, he said it will wait on authorization from the Health Ministry before distributing Sputnik V shots.
Rotstein said his motivations are pure, and that the hospital was under no pressure from any direction to make the deal. “There are accusations we’re making money or making publicity but the reality is we are caring for the people,” he said.
But vaccines expert Manfred Green said the arrangement sounds inappropriate.
Green is the director of the University of Haifa’s international master’s program in public health, and previously headed the Public Health Branch for the Israel Defense Forces. He is the founding director of the Israel Center for Disease Control.
He told The Times of Israel: “I’d be unhappy knowing a hospital in Israel is promoting a vaccine and making a profit. A hospital should be pretty much neutral [on vaccine preference]. I’ve not heard of something like this happening before.”
Moscow said last week that its vaccine is 92 percent effective. The result was generated from tests overseen by Crocus Medical, a clinical trials company with headquarters in the Netherlands. The announcement came on the heels of Pfizer’s announcement indicating 90% effectiveness for its vaccine — since updated to 95% — and just before Moderna reported a 94.5% figure.
Russia’s result was based on a snapshot of the trial, with 20 cases of COVID-19, while the Pfizer and Moderna results came at a more advanced stage, with 94 and 95 cases respectively, sparking some criticism for Russia’s report.
“I worry that these data have been rushed out on the back of the Pfizer/BioNTech announcement,” said immunologist Eleanor Riley, who sits on a board that advises the UK government on vaccines. “This is not a competition. We need all trials to be carried out to the highest possible standards and it is particularly important that the pre-set criteria for unblinding the trial data are adhered to, to avoid cherry-picking the data.”
Her comments followed the ringing of alarm bells two months ago when the Russian team published earlier results on the vaccine in the medical journal, The Lancet. This led to an open letter signed by dozens of experts saying that the reporting raised “several concerns which require access to the original data to fully investigate.”
Russia’s decision in August to approve the vaccine for widespread use before trials were completed was widely derided, including by Houston vaccine scientist Peter Hotez, who called it “unethical” as well as “reckless and foolish.”
Russian scientists had hoped that the announcement of the vaccine’s efficacy last week would lay skepticism to rest, but criticism continues.
“I don’t think the scientific community looks up to this vaccine so much, as the data have been sparse and not thorough,” said Prof. Tomer Hertz, who runs a systems immunology lab at Ben Gurion University of the Negev. “They don’t run things the way other countries do.”
“The data published so far has not illustrated they are standing on solid ground,” Hertz said. “There’s lots of really good Russian science, but also a tradition of a lack of transparency that would make you more cautious about relying on current data.”
But Hertz stressed his doubts shouldn’t exclude Sputnik V as a vaccine candidate, saying it can still prove itself, and that the scientific processes of scrutiny, peer review and other hurdles before approval will bring everything into the open.
“If they have convincing data I do not see a reason upfront to discard this vaccine just because it was made in Russia,” he said, arguing there is nothing wrong with Hadassah’s plan, since it is a privately-owned hospital.
Gabi Barbash, former director-general of Israel’s Health Ministry, took a similar view. He said the Russian vaccine hasn’t met Western criteria, but if Hadassah wants to invest in it and hopes its results will pass with Israeli regulators, this is acceptable.
“It’s their own commercial decision,” he said. “If they want to risk their money it’s their decision.”
Hertz said: “In the state we’re in, and considering that Israel is unlikely to have lots of vaccine doses coming any time soon, despite what [Netanyahu] says, if there’s a way to bring a safe, efficacious vaccine that’s been peer-reviewed and regulated by the Health Ministry, that’s a good idea.”
Vaccine expert Green, who has tested vaccines for the Health Ministry, disagreed. “We don’t need another vaccine,” he said. “There are enough on the market now. I see no reason to take a vaccine that hasn’t been on the same process.”
He is concerned by the possible scenario of Israel authorizing the vaccine independent of approval by the FDA or a European body. “I would want a Phase 3 trial that goes through an EU or US regulator,” he said, adding that Israel doesn’t have the necessary experience for the task.
“It’s not enough for Israel to send one or two people. You need top experts on vaccines and we don’t have the people or the experience.”
Green warned early on in the pandemic against rushing vaccines. He predicted in March that a shot would take 18 months and said: “If a vaccine is developed in the next few months, you can imagine if there were a one in 1,000 or one in 10,000 adverse reaction — that could be very problematic if you’re giving it to millions of people.”
Discussing Sputnik V on Tuesday, Green said: “Russia produces good vaccines and I’m not concerned about their ability, but I’m concerned about rapid process and I’m concerned we don’t have good data.”
Prof. Jonathan Gershoni, a vaccine expert from Tel Aviv University, said the Russian vaccine may have distinct advantages over others, decrying the “arrogance and snobbery” of people who dismiss Sputnik V because it is Russian.
Gershoni said a line needed to be drawn between the posturing and politics of the Russian regime and the science from its labs.
“Of course it’s entirely political that they said they have the first vaccine and called it Sputnik, but that shouldn’t imply concern about the quality of the vaccine, and we shouldn’t assume it is being developed without proper oversight,” he said.
”Everybody and his uncle loves conspiracy, so we accuse others of being less thorough and less smart, but we should be more humble and give credit to others,” he said.
The first advantage, in Gershoni’s view, is its use of the more well-established technology than that employed by Pfizer and Moderna. “RNA vaccines are unknown as yet, while the Russian technology is a little more proven, and so [Rotstein’s] trying to get access to this vaccine which is admirable.”
And Gershoni argued that by the time Sputnik V reaches Israel, it may be more tried and tested than any other vaccine on the market — as Russia is expected to vaccinate large numbers of people in a limited roll-out even before trials are completed.
“This shouldn’t be regarded as sloppy or cutting corners, but rather, a different approach,” he argued, saying authorities in Russia have decided that the benefits of advancing the vaccine’s use outweigh possible problems. “The Chinese are doing the same. With Moderna and Pfizer, side effects are being tested on a total of 74,000 people, while in Russia, the vaccine will soon be used on hundreds of thousands of people and we’ll have good insights we wouldn’t otherwise get.”
Moscow’s decision is “not abusive — it’s a different culture.” And it can only benefit people outside Russia, he said. “We certainly should not view ourselves as ‘guinea pigs,’ but rather understand that by the time the vaccine becomes available to us, it will have been given to many people in Russia and other countries.”
Hertz, meanwhile, believes that as mRNA vaccines appear to be performing well, there is no advantage in opting for the more conventional vaccine. He rejects the notion that widespread use of the vaccine in Russia will benefit Israelis, since there are no guarantees that adverse reactions would be discovered and recorded and wouldn’t be hushed up.
“If the people given the vaccine are not subject to a study, their vaccination is not relevant,” he said.
Gershoni, the Tel Aviv University vaccine expert, believes that one of the current main concerns when it comes to vaccine supply isn’t which specific vaccine Israel embraces and which it rejects. Rather, he thinks it needs to be sufficiently focused on securing foreign vaccines for the foreseeable future and not relying on the Israeli vaccine, which has just started trials.
He worries that the promotion of an Israeli vaccine for global use may distract leaders from the main task in hand, which is to keep the Israeli population safe.
“Our problem is how to protect 10 million people, not how to be a beacon for the world,” he said. “All we need is 20 million doses.”
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