We Need Challenge Studies for COVID-19 Vaccines

Combined with standard testing protocols, challenge studies could accelerate development of a safe and effective vaccine.

Challenge studies involve giving a developmental vaccine to volunteers followed by infecting those volunteers with the SARS-CoV-2 virus. Challenge studies are rare but the National Institutes of Health has been doing them for a few years for a mild strain of influenza.

From 1954-1973, during The Cold War, the U. S. Army conducted a series of challenge studies on more than 2000 Seventh-day Adventist volunteers. Operation Whitecoat was created to protect against the threat of Soviet bioweapons. The studies were conducted at Ft Detrick MD and set the gold standard for the use of human volunteers in medical experiments. In 2018, I directed & produced a documentary film about these incredibly patriotic young men.

Looking forward, after a COVID-19 vaccine completes Phase I safety testing, volunteers for a challenge study would be vaccinated and later infected with the COV-SARS-2 virus. Initially, only young, healthy volunteers would be selected. They would be closely monitored in a medical facility.

Donna Shalala (D-FL), a former secretary of Health and Human Services, along with 33 other members of Congress from both parties, have expressed support for the use of human challenge trials. The World Health Organization and National Institutes of Health are currently examining the issue.

This is not a common procedure for vaccine development.

These are not common times.