CDC to Roll out Cell Phone-Based Surveillance System for Monitoring COVID-19 Vaccine Recipients

The US Centers for Disease Control and Prevention (CDC Atlanta, GA, USA) has added a new safety monitoring system to evaluate the safety of COVID-19 vaccines in real time and ensure that they are as safe as possible after they are authorized or approved for use.

Currently, clinical trials are evaluating investigational COVID-19 vaccines in many thousands of study participants to generate scientific data and other information for the Food and Drug Administration (FDA) to determine their safety and effectiveness. After a vaccine is authorized or approved for use, many vaccine safety monitoring systems watch for adverse events (possible side effects). This continued monitoring can pick up on adverse events that may not have been seen in clinical trials. If an unexpected adverse event is seen, experts quickly study it further to assess whether it is a true safety concern. Experts then decide whether changes are needed in vaccine recommendations. This monitoring is critical to help ensure that the benefits continue to outweigh the risks for people who receive vaccines.

As people get vaccinated, CDC, FDA, and other federal partners will use robust systems and data sources to conduct ongoing safety monitoring. Among its various safety monitoring systems, the CDC plans to use a new smartphone-based, after-vaccination health checker named V-SAFE for people who receive COVID-19 vaccines. V-SAFE is a smartphone-based text, text-to-web survey, and email-to-web survey active surveillance program for early vaccine recipients. V-SAFE uses contact information (phone numbers) from the registration process for COVID-19 vaccination of essential workers - up to 20+ million people during the first few months of a vaccination program.

V-SAFE will use text messaging and web surveys from CDC to check in with vaccine recipients for health problems following COVID-19 vaccination. V-SAFE will conduct health checks on vaccine recipients via text messages and email daily for the first week post-vaccination and weekly thereafter for six weeks post-vaccination. The system also will provide telephone follow up to anyone who reports medically significant (important) adverse events.

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Centers for Disease Control and Prevention (CDC)