Helsinki C'ttee probes Israel-Pfizer vaccine data deal

Vaccination

Israel's Health Ministry is infuriated by suggestions that the agreement might constitute a clinical trial and stresses that the vaccine is FDA approved.

Israel's Central Helsinki Committee is investigating whether the transfer of epidemiological data about Israeli citizens to pharmaceutical company Pfizer constitutes a clinical trial. The Helsinki Committee is subject to Israel's Ministry of Health and is responsible for the clinical trials conducted in Israel.

The question of whether it is a clinical trial depends on the type of data given to Pfizer. If for example there is data that allows extracting information about specific people being vaccinated then there will be need to receive their consent. The agreement between the Ministry of Health and Pfizer that was published yesterday suggests that the pharmaceutical company will not be receiving such specific data and that that was not the aim of the agreement. The type of data stipulated in the agreement such as number of confirmed Covid-19 cases, (number of fatalities, the number of people hospitalized and more) is not considered a clinical trial.

However, the Ministry of Health's agreement with Pfizer does have a clause allowing an expansion of the data to be provided with the agreement of both sides and the concern is that use will be made of this clause to transfer data that could be interpreted as trial data. If the agreement is defined as a clinical trial then the Helsinki Committee would be entitled to intervene to supervise matters and examine whether data can be transferred.

Helsinki Committee Israel head Prof. Eitan Friedman said, "We are currently checking if the agreement is according to regulations protecting privacy in clinical trials and we will issue an official announcement on our conclusions. We are responsible for protecting medical privacy of Israel's citizens 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.

He added, "The vaccination itself has passed all the approvals. The vaccine is not a clinical trial and we call on everyone that doesn't have a contraindication to go and get vaccinated. We want to make sure as the Helsinki Committee that that the rights and privacy of the State of Israel are being protected even if clinical research is being conducted then it should be appropriate research."

Each of Israel's health funds and hospitals has its own independent Helsinki Committee, which can stop the body is oversees from transferring detailed data to the Ministry of Health, if there is any concern that data will be used for an unethical clinical trial.

While Prof. Friedman expresses himself cautiously regarding the Ministry of Health, the Ministry of Health when contacted by "Globes" responded very harshly about the need for the Helsinki Committee to investigate the matter. "Does the information received about the number of positive tests in a certain city, for example, before we make it a red (high infection) city require the Helsinki Committee? We completely dismiss this."

"We are talking about a vaccine that has been approved by the US Food and Drug Administration (FDA) and the EU's EMS and from that point of view there is no clinical trial here, which requires the Helsinki Committee. The trial ended after Phase III by Pfizer and the results were published."

Published by Globes, Israel business news - en.globes.co.il - on January 18, 2021

© Copyright of Globes Publisher Itonut (1983) Ltd. 2021

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