HHS accelerates clinical trials for COVID-19 vaccines
HHS is speeding up the development and manufacturing of COVID-19 vaccines by partnering with Johnson & Johnson-owned Janssen Research and Development and Moderna Therapeutics.
A vaccine trial is already underway, conducted by the National Institute of Allergy and Infectious Diseases at the National Institutes of Health. Moderna collaborated with scientists from NIAID to create the vaccine, SARS-CoV-2 mRNA-1273
The Biomedical Advanced Research and Development Authority (BARDA), which is part of the HHS Office of Assistant Secretary for Preparedness and Response, will support a Phase 1 clinical trial of a vaccine by Janssen, Ad26 SARS-CoV-2, as well as non-clinical studies. Phase 1 of the clinical trial is expected to start no later than the fall of 2020, with the aim to make the vaccine available in 2021.
“Vaccines are essential to saving lives,” BARDA Director Rick Bright, PhD, said in a statement. “Delivering a safe and effective vaccine for a rapidly spreading disease like COVID-19 requires accelerated action with parallel development streams. The rapid progress we are making with industry partners clearly demonstrates a commitment to protecting people at home and abroad.”
Janssen began creating an investigational vaccine in February with BARDA, and the two will work to accelerate advanced clinical trials, regulatory support and large-scale manufacturing to produce 300 million doses in the U.S. annually, according to HHS.
BARDA will also work with Moderna for Phase II of its clinical trial, which requires hundreds or thousands of people to test the vaccine’s safety and effectiveness. BARDA will also work with the FDA to “streamline the development and regulatory processes” to make a safe vaccine available as soon as possible.
Amy joined TriMed Media as a Senior Writer for HealthExec after covering home care for three years. When not writing about all things healthcare, she fulfills her lifelong dream of becoming a pirate by sailing in regattas and enjoying rum. Fun fact: she sailed 333 miles across Lake Michigan in the Chicago Yacht Club "Race to Mackinac."