“We want to have early eyes on safety as soon as possible,” Grace Lee, MD, who leads a COVID-19 vaccine safety group on the CDC’s Advisory Committee on Immunization Practices, told the publication.
Five details:
1. The CDC plans to roll out a smartphone-based system, called V-SAFE, which will send daily surveys through text message to people who get vaccinated. The surveys will be sent to anyone who provides contact information daily for the first week post-vaccination and then weekly for six weeks.
2. With V-SAFE, individuals will self-report chills and other potential symptoms following vaccination.
3. While there is no approved COVID-19 vaccine in the U.S., several are being tested in studies of thousands of people run by companies including Pfizer and Moderna. When a vaccine is typically cleared for use, researchers follow people vaccinated in clinical studies for at least six months to ensure no serious safety concerns arise.
4. Because of the urgency of the pandemic, the FDA said it would require only two months of safety follow-up for at least half of the people in clinical trials before it authorizes emergency use of a vaccine, prompting the adoption of new surveillance tools.
5. In addition to the smartphone app, the CDC will ask hospitals to report their workers’ health conditions after getting the COVID-19 vaccine.
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