Nearly 140,000 Americans have volunteered for COVID-19 vaccine clinical trials to measure the safety and effectiveness of vaccine candidates, as reported by USA Today in July.
The U.S. Food and Drug Administration, according to The Hill, is prioritizing recruitment of volunteers from especially hard-hit populations such as the elderly, those with pre-existing health conditions, and minorities (in particular Blacks and Latinos according to CNN).
Worldwide, there are eight studies in Phase 3 trials according to The New York Times’ Coronavirus Vaccine Tracker, with two of these studies based in the United States and two more slated for fall. The purpose of a Phase 3 trial is to test thousands of people and see who gets infected — in this case with COVID-19 — compared with those who receive the placebo treatment. Each Phase 3 trial in the U.S. requires about 30,000 volunteers.
The first is a collaboration between the NIH and drug company Moderna who jointly announced in late July that 30,000 volunteers were expected to participate in the first major COVID-19 vaccine trial in the U.S. The hope is for results as early as November according to Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases and a prominent member of the White House Coronavirus Task Force.
In a statement to CNN, National Institutes of Health Director Dr. Francis Collins gave the Moderna trial a “C” grade in terms of recruiting minorities.
“From the first week I saw the numbers, and they were not as encouraging as I would have liked,” he said.
The second Phase 3 trial in the U.S. is conducted by Pfizer and BioNTech. These two reported that their BNT162b1 vaccine candidate has exhibited early positive results where participants mounted an immune response to the vaccine, as reported by Clinical Trials Arena.
“The earlier trial phases have been very encouraging — showing that when injected, the vaccine is tolerated well and generates the appropriate immune response that has the potential to protect humans from COVID-19.” Dr. Onyeme E. Ogbuagu, infectious disease physician, associate professor of Medicine at Yale School of Medicine, and principal investigator for the Pfizer/BioNTech trial, said in a university statement.
AstraZeneca and Inovio, according to USA Today, are planning to launch Phase 3 trials in the fall.
To learn more about volunteering for a COVID-19 Clinical Prevention Study and to complete the Volunteer Screening Registry, please visit the COVID-19 Prevention Network website.
By T.J. La
Ton La, Jr. (T.J.) is a sixth-year MD/JD/LLM candidate at Baylor College of Medicine and the University of Houston Law Center applying to internal medicine residency programs in Fall 2021. He was a 2019–2020 Doximity Op-Med Fellow, a former guest writer for KevinMD.com, and a past Student Editor of The New Physician Magazine from 2017–2019.