Phase 3 Trial of Potential COVID-19 Vaccine Begins
Phase 3 Trials designed to evaluate if a candidate vaccine “can prevent symptomatic coronavirus disease 2019 (COVID-19) in adults” has begun.
The trial will include “approximately 30,000 adult volunteers who do not have COVID-19”. Trial volunteers will receive two injections “approximately 28 days apart”; Researchers will call participants after each vaccination to discuss any symptoms, which the participants will record in a diary along with daily temperature readings taken by thermometer.
If a test participant is suspected to have COVID-19, the participant will be tested within 72 hours; A participant who then tests positive for a SARS-CoV-2 infection, the virus that causes COVID-19, “will be followed closely and referred for medical care if symptoms worsen”.
After the two doses of vaccine injection, researchers say they’ll be able to “determine if the vaccine can prevent symptomatic COVID-19”.
Development and testing for this vaccine candidate is supported under Operation Warp Speed, a Department of Health and Human Services program which is providing funding for COVID-19 vaccine research and equipment to mobilize a vaccine to millions of Americans upon readiness.