COVID-19 vaccine safety efforts to feature app tracking of vulnerable groups

New tools, along with existing ones, are expected to help track serious adverse side effects associated with COVID-19 vaccines once approved and widely distributed. Monitoring is critical, public health officials say, given the celerity of vaccine development and anticipated scope of distribution. Researchers normally follow clinical trial enrollees at least 6 months before a vaccine is approved, but FDA is accepting 2 months of follow-up in 50% of the study sample as sufficient, considering the urgency of the pandemic. While some safety nets already exist, none is an effective stand-alone solution. One CDC system, for example, captures information primarily from West Coast health care networks, with limited data from other parts of the country; while a Medicare initiative offers safety insight on older adults but not young people. In response, CDC will use a smartphone app called V-SAFE to survey Americans about their symptoms after vaccination; ask hospitals to report how staffers fare after vaccination; and monitor the safety of vaccine recipients at long-term care facilities in 25 states. Vaccine developers also will do their part, through continued follow-up of trial participants who received the vaccine. There is also interest in targeted monitoring for special populations, including pregnant women.