After sprinting ahead in the race to inoculate its population against the coronavirus, Israel has struck a deal with Pfizer, promising to share vast troves of medical data with the international drug giant in exchange for the continued flow of its vaccine.
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Proponents say the deal could allow Israel to become the first country to vaccinate most of its population while also providing valuable research that could help the rest of the world.
But critics say the deal raises major ethical concerns, including possible privacy violations and a deepening of the global divide that enables wealthy countries to stockpile vaccines as poorer populations.
Sunday saw the Health Ministry publish a redacted copy of a 14-page deal with Pfizer. Titled, "Real-World Epidemiological Evidence Collaboration Agreement," the Jan. 6 agreement lists the logistical workings and legalities of the deal, including the sharing of publicly available and de-anonymized data.
The latter, it said, means to "measure and analyze epidemiological data arising from the product rollout to determine whether herd immunity is achieved after reaching a certain percentage of vaccination coverage in Israel."
"Israel is taking part in research that will serve the entire world. It may be an altruistic thing to do, but Israelis should have been told about it," Dr. Tehilla Shwartz Altshuler of the Israeli Democracy Institute, told Israeli media Monday.
Health Minister Yuli Edelstein stressed that the government will turn over data to "see how it influences, first of all, the level of the disease in Israel, the possibility to open the economy, different aspects of social life, and whether there are any effects of the vaccination."
Israel, home to some 9.3 million people, is considered an ideal place for studying these questions. It provides Israelis with universal healthcare via four publicly funded HMOs, which keep meticulously digitized medical records.
This centralized system has helped Israel administer more than 2 million doses of the vaccine in under a month. Israel has also purchased doses of the Moderna and AstraZeneca vaccines.
Pfizer's vaccine, developed with German partner BioNTech, has received emergency approval from the US Food and Drug Administration and the European Union's regulatory agency and is believed to provide up to 95% protection against COVID-19. But much remains unknown, including its long-term protection and whether it can prevent transmission of the virus.
However, on Monday, Israel's Central Helsinki Committee, which authorizes medical research and clinical trials on humans, said it was investigating whether the transfer of epidemiological data about Israelis to Pfizer constitutes a clinical trial.
A committee insider said that the question of whether the mass vaccination drive constitutes a clinical trial depends on the type of data given to Pfizer.
If the agreement is defined as a clinical trial, the Helsinki Committee would be entitled to intervene and supervise it.
However, details of the deal suggest the pharma giant will have access to general data that is also made public, such as number of confirmed COVID-19 cases, number of fatalities, number people hospitalized, etc., which is not considered clinical trial data.
Helsinki Committee head Professor Eitan Friedman issued a statement saying, "We are currently checking if the agreement complies with the regulations protecting privacy in clinical trials. We are responsible for protecting Israelis' medical privacy and as part of this work we are examining the agreement and if it protects the rights of citizens.
"We have no doubt that the Ministry of Health is behaving with transparency and is planning to protect these rights but still our role is to ensure that the rules are being kept."
Friedman later told financial daily Calcalist that "it is vital to make clear that we support the COVID-19 vaccination effort. We simply seek to ensure that the rights and privacy of Israeli citizens are protected even if clinical research is being conducted."
He stressed that "the vaccination itself has passed all the approvals. The vaccine is not a clinical trial and we call on everyone to get vaccinated.
"The experiment taking place in Israel is not a clinical trial. The vaccine was approved based on clinical trials and the vaccination campaign has nothing to do with clinical trials. The argument is over a single thing – we want to ensure that the committee is doing its job maintaining medical ethics."
The Health Ministry stressed that the vaccination drive "is not a clinical trial and therefore, it does not need approval from the Helsinki Committee."
The Israeli Medical Association also issued a statement saying, "We cannot use a procedural aspect concerning a study into a disinformation tool about the vaccine drive. The immunization campaign in Israel, like in other countries worldwide, has obtained all the necessary permits and it is not, by any means, a clinical trial, certainly not one involving human experimentation."
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