Plan to track COVID-19 vaccine side effects unites old and new strategies

(Image by Sam Moqadam on Unsplash)

In pharmacovigilance, detecting risks linked to new medicine can be a slow process. The typical procedures for doing so, known as signal detection and assessment, involves probing hypothetical risks tied to a medicine based on at least some degree of supporting evidence.

The U.S. government aims to speed the process by combining routine signal detection and assessment strategies with new techniques.

The most recent CDC Advisory Committee on Immunization Practices (ACIP) panel meeting discussed the approaches.

One of the new programs designed to evaluate COVID-19 vaccine safety in real time is known as Vaccine Safety Assessment for Essential Workers (V-SAFE). The program uses smartphone-based text messaging and web surveys to determine whether people receiving COVID-19 vaccines develop adverse reactions to them. The system will also rely on telephone conversations for patients reporting medically significant adverse events.

“The V-SAFE program is not an app. It’s actually a text messaging program where you get a text message and there’s a link to a survey in there,” said Tom Shimabukuro, deputy director of the Immunization Safety Office at CDC in the ACIP meeting.

Vaccine recipients will receive daily texts for the first week following a vaccine dose. Afterward, they will receive weekly text messages for a time period before switching to a quarterly cadence.

People who don’t want to receive text messages from the program can opt out.

The V-SAFE program will be available in several languages in addition to English.

(Adverse event tracking strategies overview courtesy of CDC)

A more traditional strategy for monitoring patient health is known as Vaccine Adverse Event Reporting System (VAERS), an FDA and CDC program launched in 1990. VAERS combines clinical review of individual reports with aggregate report review. VAERS also supports statistical data mining methods to uncover specific vaccine-linked adverse events.

Critics have faulted VAERS for its uneven data quality. Notably, the autism activist Dr. Jim Laidler submitted a report to VAERS in 2005 that a flu vaccine had turned him into the Incredible Hulk from the Marvel Comics series, which was initially accepted into the database.

Other established systems CDC uses to monitor adverse events include Vaccine Safety Datalink (VSD) and Clinical Immunization Safety Assessment (CISA).