Author Archives: Katherine Freitas

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Vaccine Bartering: Israel’s real-world evidence exchange with Pfizer

In the global race to secure COVID-19 vaccines, Israel, the 100th most populous country behind Papua New Guinea and Serbia, is the world leader in COVID-19 vaccine doses administered per capita. In a span of just 7 weeks, Israel, to date, has administered a total of 5.3 million doses, inoculated nearly approximately 30% of its total population, and 80% of citizens 60 years of age and older. In context, Israel has administered 58.9 doses per 100 residents, far exceeding the UK’s 16.5 doses and the US’s 10.6 doses. Which begs the question, how exactly has Israel beat out these bigger countries in the race to secure the coveted COVID-19 vaccine supply?

Israel struck a unique deal with Pfizer – vaccines for health data. On January 7, 2021, it was announced that Israel made an agreement with Pfizer to expedite deliveries of its COVID-19 vaccines so that all citizens over 16 years of age can be inoculated by the end of March 2021 in return for the health data of citizens taking part in the vaccination program. Formally named the “Real-World Epidemiological Evidence Collaboration Agreement,” the deal describes that the Project’s objective is to “measure and analyze epidemiological data arising from the Product [Pfizer-manufactured vaccines] rollout, to determine whether herd immunity is achieved after reaching a certain percentage of vaccination coverage in Israel.” As part of this collaboration, the agreement stipulates that Israel’s Ministry of Health will “use its best efforts to ensure timely reporting [of Project Data] to Pfizer” and “will assure rapid distribution, deployment, and use of the Product.”  In exchange, the Ministry is “relying on receipt of Product doses […] and on the product delivery rate by Pfizer to allow maintaining vaccination rate sufficient to achieving herd immunity and enough data as soon as possible.” Beyond this, however, the exact bargain between Israel and Pfizer is unclear.

As one can imagine, this agreement has instigated fierce debate in Israel among data privacy experts, researchers, and citizens weighing the potential benefits of having highly valuable real-world evidence on vaccination efficacy against the potential abuse of millions of personal medical records. The only solace the agreement offers is in its limited definition of “Project Data” (defined as any de-identified data provided by the Ministry of Health to Pfizer in the framework of the Project) and a 7 item list of the governing regulations concerning data use. Understandably, critics question why the agreement made no mention of what measures Pfizer is taking to keep the data secure or that Pfizer’s use of the data is limited to studying the effects of the COVID-19 vaccine.

Despite engaging in this novel arrangement, Israel is not new to the big data scene. Israeli health plans utilize a universal electronic medical record system and cover about 98% of the population. Although operating independently, Israel’s four HMOs and their affiliated hospitals have for the past two decades used the same electronic medical records platform, with access to patient records available at each point of care as needed. To Pfizer’s delight, this has resulted in a wealth of data about patients, conditions, and treatments. But Israel’s privacy and data protection laws, the same named in the agreement, fall behind those of the surrounding EU, allowing for much more latitude in the use and disclosure of its citizens’ data.

Although we cannot predict if and how Israeli’s health data will be used by Pfizer, or if a precedent has been set encouraging less-wealthy countries to trade citizen privacy for pharmaceuticals, we do know that Israel’s rapid vaccination roll-out (as a result of this agreement) appears to be working – Cases and hospital admissions in Israel are falling steeply among vaccinated age groups. Data collected by Israel’s Ministry of Health show that there was a 41% drop in confirmed COVID-19 infections in that age group and a 31% drop in hospitalizations from mid-January to early February.

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“Elective” Medical Services: Abortion during a Pandemic

Since the COVID-19 outbreak emerged in the U.S., federal guidance and state orders have been released in waves over the last several months having an especially drastic effect on healthcare that extends beyond the care of patients infected with the virus. Many states have now mandated the suspension of elective medical services. When response efforts are locally executed and state managed, however, disparities emerge over what governments consider to be “elective”. As a result, while many healthcare services have remained uninterrupted, surgical abortions are being called into question as to whether they should be considered “elective,” and therefore suspended during this time.

What is an essential business?

On March 16, 2020, the President and the Coronavirus Task Force recommended that civilians work from home while calling for those who work in critical infrastructure industries to remain in operation. The “Essential Critical Infrastructure Workforce” advisory list was developed to help state officials determine which businesses and services should remain operational during this period.

State interpretations

To create capacity and meet the increases in resource demands, many states have chosen to follow CDC guidelines stating that “healthcare facilities and clinicians should prioritize urgent and emergency visits and procedures…”

In states where surgical abortion procedures were previously facing challenges, the term “elective” in these materials has given states significant latitude in determining what patients need, under what terms, and when. The argument for restricting elective or non-urgent medical procedures is not without merit. The U.S. is experiencing a shortage of personal protective equipment and medical supplies leaving states to ration existing provisions. Most states have required providers to suspend non-urgent services such as annual physicals, dental check-ups, cosmetic procedures, and routine screenings such as colonoscopies and mammograms.

Although a patient may choose to receive an abortion, relying on this choice to classify surgical abortions as elective results in unique issues unfaced by other elective-designated medical procedures. Abortions are time sensitive. Most acutely in states that have reduced the window of time a patient may obtain an abortion, requiring a patient to wait until after the outbreak jeopardizes the opportunity they have to access this service. This is especially challenging when states are consistently moving back the date upon which elective or nonessential medical services can be resumed as new information emerges on the severity of state outbreaks. Historically, we know that restricting access to surgical abortions does not decrease the need for their services. Women who are unable to obtain an abortion will either require complex surgical procedures for later-term abortions, remain pregnant and require prenatal care and delivery services, or may use dangerous methods to induce an abortion on their own (UCSF Bixby Center). The side effects of suspending surgical abortions would result in more frequent clinical visits (i.e. prenatal care) or longer admissions (i.e. later-term abortions, self-induction, delivery) in the hardest hit clinical settings these restrictions are trying to protect. If suspending elective medical procedures is also a tactic to reduce social contact among patients and with medical providers, restricting abortions will likely result in women traveling to other states where the service is preserved, increasing the chance for viral mobility and exposure.

Below is a summary of the states that have classified abortions as “elective” during the pandemic and states that are facing challenges to these determinations in court.

Additional information on state-specific mandates/guidance can be found here. Challenges to these designations in court have been summarized here.

Post-pandemic

The COVID-19 outbreak has illuminated many vulnerabilities in our healthcare system. Prior to the pandemic, abortion services were facing renewed challenges in courts. Classifying abortions as “elective”, however, perpetuates the rhetoric that abortions are chosen luxuries when women often face little choice in the nonmedical reasons they have to obtain an abortion. It is difficult to see through the thicket of disparate recommendations and orders made by state and local governments, but it is clear that the end of the pandemic will not eliminate the challenges raised by these regulations nor the discretion states may take in the future in deeming what is and is not essential medical care.

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