The Centers for Disease Control and Prevention (CDC) is planning to release V-SAFE, a new smartphone-based application to track side effects of vaccines aimed at preventing the coronavirus disease 2019 (COVID). The goal is to detect whether COVID-19 vaccines cause any serious side effects once they are approved for widespread use.
V-SAFE facilitates daily symptom surveys as well as text messages to check in with vaccine recipients about how they are feeling. It will provide telephone follow up to anyone who reports medically significant adverse events. The surveys will be sent to anyone who provides contact information daily for the first week post-vaccination and then weekly for six weeks.
Normally, after the Food and Drug Administration (FDA) clears a vaccine for use, it requires researchers to track side effects for at least six months among those vaccinated in clinical studies. However, due to the urgency of the COVID-19 pandemic, the FDA will require only two months of safety follow-up for about half of those vaccinated during clinical trials. The CDC developed V-SAFE to provide the additional surveillance. For COVID-19 vaccines, the CDC also intends to ask hospitals to report on their workers’ health conditions after being vaccinated.
A CDC presentation about V-SAFE is posted at https://www.cdc.gov/vaccines/acip/meetings/downloads/slides-2020-09/COVID-03-Shimabukuro.pdf (accessed November 22, 2020).
This was reported by the CDC on October 14, 2020.
Contact information: Coronavirus Disease 2019, Centers for Disease Control and Prevention, 1600 Clifton Road, Atlanta, Georgia 30329; 800-232-4636; Email: firstname.lastname@example.org; Website: https://www.cdc.gov/coronavirus/2019-ncov/vaccines/safety.html