Israeli Government Sharing COVID-19 Vaccine Data With Pfizer

JERUSALEM — This capital city’s largest convention center has been transformed into a coronavirus vaccination clinic, inoculating thousands of people a day.

“We are defeating corona,” read signs from Meuhedet, the Israeli HMO running this vaccination station, one of hundreds around the country as Israel remains far ahead of any other nation in shots administered per capita.

More than 20% of Israel‘s population of about 9 million has received the first dose of vaccine, compared with 3.7% in the United States. Nearly all 2 million Israelis who have been vaccinated have received the Pfizer shot, with a tiny fraction getting shots made by Moderna Inc., another company whose two-dose vaccine regimen has been approved by the U.S. Food and Drug Administration and many other countries for emergency use.

Now, Pfizer is hoping that Israel’s aggressive vaccination campaign, occurring as new coronavirus cases here also rise to record-high levels, can help it learn more about the real-world efficiency of the vaccine.

This week, Israel’s health ministry made public an agreement with Pfizer, partially outlining how in return for expedited vaccine deliveries, Israel will share aggregated health data with the New York-based pharmaceutical company. It is the first of what Pfizer hopes will be similar agreements with other health systems and other countries, according to a company spokeswoman.

“This project will gather critical real-world epidemiological information that will enable real-time monitoring of the evolution of the epidemic in Israel and evaluate the potential of a vaccination program using the Pfizer-BioNTech COVID-19 vaccine to trigger indirect protection and interrupt viral transmission,” says Dervila Keane, a spokeswoman for Pfizer. “While this project is conducted in Israel, the insights gained will be applicable around the world and, we anticipate, will allow governments to maximize the public health impact of their vaccination campaigns, determine potential immunization rates needed to interrupt transmission and ultimately help bring an end to the global COVID-19 pandemic.”

[MORE: Pandemic Boosting Anti-Virus Research Around the World]

The data could help track adverse effects tied to the vaccine, such as allergic reactions, in a pool of people much bigger than the approximately 40,000 who have been part of Pfizer’s ongoing clinical study. It could also help shed light on big unknowns, including if the vaccine prevents transmission of the virus in addition to infection, and how effective a single dose could be. It could also begin giving clues about what percentage of people need to be vaccinated to see an overall reduction in the number of cases. Israel’s highly digitized health system, in which all citizens belong to one of four health maintenance organizations, also means a comprehensive system is already in place for tracking vaccinations, case numbers and other information.

“Any data on the vaccine and how the population responds is valuable,” says Nadav Davidovitch, an epidemiologist and chairman of the Department of Health Systems Management at Ben-Gurion University of the Negev. “In a situation like this, it’s unethical to have control groups, so you need to look at what’s happening on the ground.”

Israeli Prime Minister Benjamin Netanyahu, running for reelection in March, has touted the agreement as a sign of the government’s success in fighting the coronavirus. He says that Israel, where everyone above the age of 40 is now eligible for a vaccine, will have fully inoculated its entire eligible population by March. Those under 16 are not eligible for the vaccine, as Pfizer has not completed clinical trials on children.

“This is how we will be first in the world to emerge from the coronavirus,” Netanyahu said in a recent statement. “This is how we will open our economy and this is how we will get back to living.” Netanyahu met the expedited delivery of Pfizer doses at the airport last week, and those doses have now ended a temporary lull in the administration of first shots earlier this month when supply had dropped.

Legal and public health experts, however, say they have concerns about patient privacy, and the ethics of sharing health data. Pfizer and the Israeli government say the shared data will be aggregated and anonymous.

“But we don’t really know what’s being shared,” says Jonathan Klinger, a cyberlaw attorney and legal adviser for the Israeli Digital Rights Movement, a nonprofit group. “Even if aggregated or anonymous data is transferred, it could be re-identified. This is still a concern.”

[MORE: In Israel, an Attempt to Create Virus-Free Zones]

Israelis receiving the vaccine also have not been asked for permission, or given a choice to opt out of their data being included in any information shared with Pfizer. Privacy concerns aside, Tehilla Shwartz Altshuler, a senior fellow at the Israel Democracy Institute think tank, says there needs to be consent, and those whose information is included in any aggregated data should have some understanding of what, if anything, Pfizer will reveal to them, including the possible emergence of safety or other health concerns based on the data.

“There is a medical experiment going on here,” she says. “There should be consent, and this should be happening in a framework of a registered medical experiment.”

When she received her vaccine last week, Shwartz Altshuler had mixed feelings. “I am very happy for this wonderful vaccination operation. But on the other hand, the government ownership over our health data is wrong.”

Data from Israel so far shows that one dose of vaccine reduces infection rates by about 50%, the health ministry said earlier this month. At the same time, about 17% of those hospitalized for COVID-19 had received the first dose, the ministry said.

And Israel remains far from beating back the virus: Even as the number of serious cases has dropped slightly of late, the number of positive tests continues to rise, and the government has extended a national lockdown until the end of January. Officials are considering further measures, including closing the airport.

Last Saturday night, an outdoor testing station near the temporary vaccination facility at the Jerusalem convention center was packed with people trying to get swabbed for the virus, as there were not enough available appointments left for the day.

“Stand back,” an employee yelled at the restless group waiting in hopes of getting a test. “We need order here.”

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Israeli Government Sharing COVID-19 Vaccine Data With Pfizer originally appeared on usnews.com

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