NIH starts evaluating second COVID-19 booster shots in adults

The NIH recently announced that it has started enrolling adults for a Phase 2 clinical trial evaluating various additional COVID-19 booster shots.

NIH’s National Institute of Allergy and Infectious Diseases (NIAID) is sponsoring the COVID-19 Variant Immunologic Landscape (COVAIL) trial.

“We are looking beyond the Omicron variant to determine the best strategy to protect against future variants,” NIAID Director Dr. Anthony S. Fauci said in a March 31 news release. “This trial will help us understand if we can use prototype and variant vaccines alone or together to shift immune responses to cover existing and emerging COVID-19 variants.”

The COVAIL trial will study immune responses induced by prototype vaccines and variant vaccine candidates — including bivalent vaccines, which target two SARS-CoV-2 variants. The goal is to inform future booster shot recommendations.

Moderna is manufacturing the study vaccines that will be administered. The researchers, led by Dr. Nadine Rouphael of the Hope Clinic at the Emory Vaccine Center in Atlanta, and Dr. Angela Branche of the University of Rochester Medical Center in New York, plan to have initial findings from the 24-clinic, 600-participant study ready by August 2022.

FDA last month authorized a second booster dose of COVID-19 vaccine for individuals who are immunocompromised or 50 and over. The expanded EUA covers vaccines from Pfizer/BioNTech and Moderna.