Hadassah Hospital in Jerusalem has announced that it has signed an agreement with the Russian government to import the Covid-19 vaccine developed by the Russian Government Research Institute. The Russian coronavirus vaccination program has been criticized for being made available for marketing, even though it had only passed Phase I and Phase II human clinical trials, in which only the level of antibodies in volunteers had been tested rather than waiting to see if the vaccine really does protect against infection. Other questions have also been raised regarding the entire development process of the Russian vaccine, which is not considered fit for marketing in Western countries.
However, Hadassah Medical Organization director general Prof. Zeev Rotstein said that he trusts the data from the Phase I and Phase II trials, which have been published in the UK peer-reviewed medical journal "The Lancet." The data only refers to the level of antibodies in the patients and "The Lancet" has also published articles critical of inadequacies in the research in Russia.
Rotstein said, "Hadassah's branch in Moscow has been involved in the trial and if we didn't trust the Russian data, we would not have participated in it. Russia has agreements for this vaccine with many countries around the world, and I don't believe that they can conceal data in such a situation. Meanwhile, to date, no safety problems have been reported regarding the vaccine. It is currently in its Phase III, final phase trials and we are waiting for the results."
In Russia itself they have already begun implementing vaccinations even before the results of the Phase III trial.
You have filed for Ministry of Finance approval even before receiving the Phase III results?
"Correct because we don't want to be delayed by bureaucracy. The results for the final phase should be received during the approval process by the Ministry of Health, and we believe that they will take that into account. It is important for us to file the request for approval to the Ministry of Health, and also that all the other vaccinations will pass this track, so that they will all meet similar criteria.
If the Ministry of Health were to approve the vaccination before Phase III, would you recommend administering it?
"I personally would happily take the vaccination when it has been commercialized, but from my point of view it is only commercialized after Phase III. Like the American vaccine, so this vaccine can suddenly be hit by delays, if there is any suspicion that something has happened to one of the patients."
Will you ask to conduct a trial in Israel?
"We proposed this to the agencies in Russia with whom we signed the agreement, so that there would be support for the results from a country in which is fully open to peer criticism but I'm not yet sure that they will approve that for us."
And if the Ministry of Health won't approve the vaccine?
"Then we will market it to another country that will be interested. Even if it is marketed here alongside other vaccinations, everyone will choose what they prefer."
Published by Globes, Israel business news - en.globes.co.il - on November 8, 2020
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