Coronavirus vaccine under development (illustrative)
(photo credit: DADO RUVIC/REUTERS)
Israel could soon have access to a proven coronavirus vaccine, after Russia announced on Wednesday that its Sputnik V vaccine is 92% effective at protecting against COVID-19, according to interim trial results.
Hadassah-University Medical Center has already signed a memorandum of understanding with the country’s sovereign wealth fund, Russian Direct Investment Fund, and the Gamaleya Research Institute of Epidemiology, who are collaborating on the production of the vaccine, according to Hadassah head Prof. Zeev Rotstein.
He told The Jerusalem Post that the hospital had submitted the dossier to the Health Ministry to register the vaccine and has signed an MOU for 1.5 million doses of the vaccine candidate.
“We know that the chances of Israel enjoying vaccines from different countries are unclear,” Rotstein said. “Different governments could decide to vaccinate their people first and only then send vaccines to other countries. We came to the agency early so we could get on the list.”
He said the MOU includes an option to double the number of doses to 3 million.
Russia’s results are only the second from a late-stage human trial, following on swiftly from data released on Monday by Pfizer Inc and BioNTech, which said their shot was also more than 90% effective.
While experts said the Russian data was encouraging and reinforced the idea the pandemic could be halted by vaccines, they warned that the results were only based on a small number of trial volunteers who had contracted COVID-19.
Specifically, the analysis was conducted after 20 participants developed the virus and examined how many had received the vaccine versus a placebo.
The results are based on data from the first 16,000 trial participants to receive both shots of the two-dose vaccine.
The Phase III trial of the shot is taking place in 29 clinics across Moscow and will involve 40,000 volunteers in total, with a quarter receiving a placebo shot.
Hadassah’s branch in Moscow’s Skolkovo Innovation Center has been collaborating on the trial.
The chances of contracting COVID-19 were 92% lower among people vaccinated with Sputnik V than those who received the placebo, the RDIF said. That’s well above the 50% effectiveness threshold for COVID-19 vaccines set by the US Food and Drug Administration.
“We are showing, based on the data, that we have a very effective vaccine,” said RDIF head Kirill Dmitriev, adding that it was the sort of news that the vaccine’s developers would talk about one day with their grandchildren.
The RDIF said data from the study would be published in a leading medical journal following a peer review. The results of the early-stage Russian trials were peer reviewed and published in September in The Lancet medical journal.
Rotstein said that the Israeli government has not formally considered purchasing the Russian vaccine, but “as usual, we are serving as a pilot to show the Health Ministry the right way and we are hoping that, over time, the government of Israel will realize that this vaccine is safe and efficient. Then, we will be ready to pass everything necessary over to the government so that people can get vaccinated through the health funds and not Hadassah.”
But he added that if the government in the end decided it did not need the Russian vaccine, then Hadassah would take it upon itself to vaccinate those who want to receive it through a commercial initiative.
Rotstein said that the 1.5 million doses would not cover the needs of the country, “but at least it is something positive and, if you take into consideration that some of the other vaccines are also quite close, the people of Israel could enjoy more than one vaccine.”
He spoke to The Jerusalem Post an hour before Prime Minister Benjamin Netanyahu released a video informing the public that he had spoken to Pfizer chairman and CEO Albert Bourla on Wednesday about obtaining the candidate for Israel.
“I am constantly working to bring vaccines to Israel and today I have important news,” Netanyahu said. “The day before yesterday, Pfizer announced that it has developed a vaccine against the coronavirus with 90% efficacy. The entire world wants to receive its drugs. We are conducting negotiations with them.
“I asked to speak with him and he responded immediately,” the prime minister continued. “It seems that Albert Bourla is proud of his Greek and Jewish heritage from Thessaloniki and he told me he holds the development of relations between Greece and Israel, which I have been leading in recent years, in high regard.”
Netanyahu said that following the conversation he was convinced that “we will complete the contract with Pfizer. This is very important news vis-à-vis bringing many vaccines to you, citizens of Israel. I hope we succeed.”
But as Israel races to obtain early rights to these vaccine candidates, experts said it was not yet clear how long immunity would last, nor how efficient they would be for different age groups.
The Coronavirus National Information and Knowledge Center released a report on Wednesday explaining that the Pfizer announcement raises the likelihood of the effectiveness of other vaccines developed using the same technology, such as that of Moderna Inc., which is also in the midst of a Phase III clinical trial.
The company announced Wednesday that it is expected to report on the results of its trial in the coming month.
Israel has signed an agreement with Moderna to be among the first to receive four million doses of the vaccine.
“If Moderna’s results are similar to those of Pfizer, it is likely that by the end of 2020, there will be at least two vaccines approved for use against the coronavirus,” the center’s report said.
But it added that there are a number of “complex obstacles” facing these vaccines before they can be widely used.
With regards to the Pfizer vaccine: “The clinical trial is still ongoing and approval of the vaccine for use by the general public is expected to take several months,” the report stated. “During this period, the vaccine safety test will continue for the entire vaccinated population.”
It said the vaccine is intended for the adult population and there is a gap in information on its effectiveness among children and older adults.
In addition, there are also logistical complications of delivering and storing the vaccine, which needs to be kept at minus 70 degrees Celsius.
“In general, there are significant gaps in our understanding of the disease itself, the immune response that develops during it, and in particular that which is induced by the vaccine over time,” the report concluded. “Therefore, at this time, it is difficult to assess.”
Back to the Russian vaccine: It is named Sputnik V after the Soviet-era satellite that triggered the space race, a nod to the project’s geopolitical importance for Russian President Vladimir Putin.
Russia registered the vaccine for public use in August, the first country to do so, ahead of the start of the large-scale trial in September.
So far, in addition to the clinical trial, the country has inoculated 10,000 members of the public considered at high risk of contracting COVID-19 such as doctors and teachers.
The vaccine is designed to trigger a response from two shots administered 21 days apart, each based on different viral vectors that normally cause the common cold: human adenoviruses Ad5 and Ad26.
The Pfizer and BioNTech vaccine uses messenger RNA (mRNA) technology and is designed to trigger an immune response without using pathogens, such as actual virus particles.
RDIF said as of Nov. 11 no serious side effects had been reported during the Sputnik V Phase III trial. Some volunteers had short-term minor adverse events such as pain at the injection site, flu-like syndrome including fever, weakness, fatigue, and headache, it said.
“The publication of the interim results of the post-registration clinical trials that convincingly demonstrate Sputnik V vaccine’s efficacy gives way to mass vaccination in Russia against COVID-19 in the coming weeks,” said Alexander Gintsburg, Gamaleya Center director.
“Thanks to the production scale up at new manufacturing sites, Sputnik V vaccine will soon be available for a wider population. This will break the current trend and lead to an eventual decrease in COVID-19 infection rates, first in Russia, then globally.”
Prof. Polina Stepensky, chairman of the Department of Bone Marrow Transplantation & Cancer Immunotherapy of Adults and Children at Hadassah, told the Post that she was personally aware of several of several people who had been vaccinated in Russia and that they have thus far been protected and “are feeling OK.”
However, like the coronavirus center’s report about the Pfizer vaccine, she cautioned that Russia’s announcement on Wednesday “is only a declaration for journalists. It is not scientific. We have to see the data from Pfizer and from the Russians and we cannot say anything for sure without a scientific, peer-reviewed paper.”
In general, experts said knowledge about the Russian trial’s design was sparse, making it hard to interpret the data. In the past, some Western experts, including some scientists in Israel, have warned against the use of the vaccine until all internationally approved testing and regulatory steps have been taken. They have also questioned Russia’s ability to develop the vaccine so quickly.
But Rotstein said it was “not right to be skeptical. There are a lot of accusations regarding Russian technology and science. But if you remember, the fact that they called it Sputnik V is to say to the world, ‘Remember who was first in space.’ Russia could be very advanced.”
The hesitation in Israel over the Russian vaccine has more to do with the US-Russia struggle over the primacy of finding the vaccine and not its quality, Rotstein said. Whether the vaccine is safe and effective will not be known until the Phase III trial is completed, he said.
“Vaccines should be above politics,” said Dmitriev. “The world needs a diversified portfolio of high-quality vaccines with Sputnik V, based on the well-tested human adenoviral vector platform, being an important element of it.”