Real-world data critical to study of COVID vaccine in pregnant women

Researchers at the US Centers for Disease Control and Prevention (CDC) have used patient data stored in the Oracle-developed v-safe system to understand the impact of COVID-19 vaccinations on pregnant women. Preliminary findings have not shown obvious safety signals among pregnant women who received mRNA COVID-19 vaccines, the researchers said.

In the study — published in The New England Journal of Medicine — expectant mothers provided information to the CDC using the v-safe after vaccination health checker.

“The Oracle-developed v-safe system enables millions of patients to voluntarily share their vaccination experience and data without compromising their privacy,” explained Oracle Chairman and CTO Larry Ellison. “Healthcare professionals can then immediately access, analyse and act on the millions of up-to-the-minute health records in the database.

“Access to this massive amount of real-world health data will improve the quality of decision-making critical to the practice of medicine and formulation of public health policy. We needed to get this data in the hands of researchers and medical practitioners immediately, and American citizens rose to the challenge by volunteering their data to help others,” Ellison said.

“Oracle is proud to play a role in this program and mark a new era of medicine using real-world evidence to guide decisions.”

Oracle has provided cloud technology and services to the US government throughout the pandemic, to ensure that public health officials have access to up-to-the-minute data to better understand and combat the virus. This includes developing the v-safe system and making it easy for every person who receives a COVID-19 vaccination to report side effects and other data in just seconds using their smartphone or computer.

More than one hundred million records are currently in the system, enabling the global medical community to see the impact of the vaccine on various segments of the population, including pregnant women — where no data or intelligence was collected before. An ongoing CDC study is enabling pregnant women to voluntarily opt-in to provide continued updates throughout their pregnancy and birth, providing invaluable insight on any potential long-term effects of the vaccines.

The Oracle v-safe system, in addition to other public health systems, is being used to manage the distribution of vaccines throughout the world. To provide high levels of security and privacy, these systems are built on the Oracle Cloud.

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