Phase 3 clinical trials for investigational COVID-19 vaccine underway
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Baylor College of Medicine’s Vaccine and Treatment Evaluation Unit is one of approximately 90 sites selected to participate in the Phase 3 clinical trial for Moderna’s investigational mRNA-1273 vaccine to evaluate the efficacy of the vaccine at preventing COVID-19 disease. Dr. Hana El Sahly, associate professor of molecular virology and microbiology and medicine at Baylor, serves as a national co-principal investigator of the trial.
Baylor’s Vaccine and Treatment Evaluation Unit is part of the National Institutes of Health’s newly established COVID-19 Prevention Network, formed by the National Institute of Allergy and Infectious Diseases to respond to the global pandemic and enroll thousands of volunteers to conduct Phase 3 efficacy trials for COVID-19 vaccines and monoclonal antibodies. The network is a part of “Operation Warp Speed,” a partnership led by the U.S. Department of Health and Human Services to invest in and coordinate the development, manufacturing and distribution of COVID-19 diagnostics, therapeutics and vaccines.
“This is an important next step in determining the safety and efficacy of the vaccine in a diverse group of persons of different ages, background and exposures,” said El Sahly, who also is the principal investigator for the Vaccine and Treatment Evaluation Unit at Baylor.
Volunteers will be given two doses of either the vaccine or a placebo separated by one month. Researchers will follow volunteers every week to determine whether the vaccine is preventing COVID-19. If a volunteer experiences any symptoms of COVID-19, they will be tested as a part of the trial.
If the vaccine is successful in preventing the disease, the next step will be to share the information with regulatory authorities, who will then weigh in on approving the vaccine for use.
For more information on the trial at Baylor or to volunteer, call 713-798-4912 or email CoVID-vax@bcm.edu.
Baylor’s Vaccine and Treatment Evaluation Unit is funded by the National Institutes of Health (grant number 1 UM1 AI148575-01).