Icon to conduct US government trial of next-gen COVID-19 vaccines

CRO giant Icon has been tapped by the U.S. Department of Health and Human Services’ Biomedical Advanced Research and Development Authority (BARDA) to conduct a clinical trial to evaluate next-generation vaccines for COVID-19.

The trial, which will involve 10,000 patients, are to study the effectiveness of the candidates against future variants of the virus as well as extend long-term protection, the company said in a Sept. 13 press release. Enrollment is expected to be conducted over six months with BARDA selecting the vaccine to be tested in the phase 2b clinical trial.

Financial details were not disclosed.

“As new variants emerge, timely clinical research has a pivotal role to play in helping ensure the development of medicines is accelerating as quickly as possible in line with the virus,” Edward Wright, president of Icon’s government and public health solutions division, said in the release.

The trial is part of Project NextGen, which connects the U.S. government and the private sector to advance vaccines and therapeutics from clinical trials to regulatory review, and potential commercialization.

On Monday, the FDA approved retooled mRNA shots against COVID-19 from Pfizer-BioNTech and Moderna. Those separate vaccine formulations are more closely targeted to current variants of the disease, the FDA said. Each company’s shot is approved for people ages 12 and up and emergency authorized for patients 6 months old to 11 years old.

Novavax’s revised COVID-19 vaccine is still pending regulatory approval.