A biotech company in Gaithersburg, Maryland, says it has fully enrolled two of its three planned late-stage trials for its experimental coronavirus vaccine and has administered doses to more than 20,000 participants.
Novavax on Monday said it has enrolled 15,000 participants in a phase three clinical trial in the United Kingdom and recruited 4,422 volunteers for a phase two trial in South Africa.
More than 25% of enrollees in the U.K. trial are over the age of 65, and a large proportion of them have underlying medical conditions. The trial in South Africa is expected to increase knowledge of the coronavirus vaccine’s effectiveness in racially and geographically diverse populations and older adults.
Data from both trials could be available as soon as the first quarter of 2021.
In the coming weeks, the company anticipates starting its phase three clinical trial in the U.S. and Mexico. More than 100 trial sites have been selected along with some alternative sites.
The vaccine, NVX-CoV2373, is a protein-based vaccine candidate made from the genetic sequence of SARS-CoV-2, the virus that causes COVID-19 disease.
“We continue to make meaningful progress as we work to test, manufacture and ultimately deliver NVX-CoV2373 with unprecedented speed, as well as put partnerships in place that would ensure widespread and equitable access worldwide,” said Stanley C. Erck, president of Novavax.
Novavax was awarded $1.6 billion in federal funds to develop a COVID-19 vaccine as part of Operation Warp Speed. The deal requires the company to produce 100 million doses to be distributed by the federal government. The Department of Defense also gave Novavax an additional $70 million to deliver 10 million vaccine doses for the armed forces.