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Monday, October 26, 2020

CDC Will Monitor COVID-19 Vaccine Recipients

Once a coronavirus vaccine is approved and being distributed, the CDC will look for health issues by staying in touch with vaccine recipients through text messages and surveys, according to CNN.

The smartphone-based program, called V-SAFE, will allow CDC officials to monitor real-time trends in adverse events following vaccination. Anyone who reports a significant adverse event will receive a follow-up phone call.

"Clinically important adverse events include missing work, unable to do normal daily activities and receiving medical care," Tom Shimabukuro, deputy director of the CDC's Immunization Safety Office, said Thursday during a virtual meeting of the FDA’s Vaccines and Related Biological Products Advisory Committee.

Health checks will go out by text and email each day during the first week, and then weekly for about six weeks, he said. The CDC will be able to analyze data and publish reports about vaccine responses, including regarding specific groups such as pregnant women and children.

The CDC and FDA have similar surveillance systems for other diseases, including the flu, but the texting program is new, CNN reported.

"I don’t think there’s anything quite like this, but I think there’s been clearly a trend towards this type of program," Amesh Adalja, MD, a senior scholar at the Johns Hopkins University Center for Health Security, told CNN.

The CDC will have other monitoring systems as well, including the agency’s existing National Healthcare Safety Network and the Vaccine Adverse Event Reporting System.

"It’d be important to have alternative methods for reporting adverse reactions as well and not just rely on the mobile cell reporting," Claire Standley, a researcher at the Georgetown University Center for Global Health Science and Security, told CNN.

Even still, "there are definitely advantages [to the texting program] as well, particularly since in the context of COVID-19 we really do need to get a lot of data quite quickly," she said.

Sources:

CNN, "For Covid-19 vaccine recipients, CDC to roll out cell phone-based monitoring system."

CDC, "Ensuring the Safety of COVID-19 Vaccines in the United States."

FDA," Vaccines and Related Biological Products Advisory Committee, October 22, 2020."

https://www.medscape.com/viewarticle/939765

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