After beginning clinical trials in May, Gaithersburg, Maryland-based Novavax has moved its COVID-19 vaccine candidate into phase three of testing.
The clinical-stage biotech company that develops vaccines to prevent serious infectious diseases gained hundreds of millions of dollars to advance its vaccine candidate this year. Back in May, Novavax conducted phase one and two clinical trials of its coronavirus vaccine on 130 healthy participants ages 18 to 59 in Australia, and shared the positive results of those trials in August.
This phase-three clinical trial will focus on evaluating the candidate’s safety, efficacy and ability to provoke an immune response. The trial is being conducted over the next four to six weeks in the United Kingdom in partnership with the British government’s Vaccines Taskforce.
“The data from this trial is expected to support regulatory submissions for licensure in the UK, EU and other countries,” said Novavax’s president of research and development, Gregory M. Glenn, M.D., in a statement. “We are grateful for the support of the UK Government, including from its Department of Health and Social Care and National Institute for Health Research, to advance this important research.”
Novavax is conducting the phase three trial of its coronavirus vaccine on on up to 10,000 participants ages 18 to 84. Half of the trial participants will receive two muscle injections administered 21 days apart while the other participants will receive placebos. At least 25% of the trial will target participants over the age of 65 and other specific groups most affected by the coronavirus, like racial minorities. Up to 400 participants total will also receive a flu shot as part of a sub-study.
For transparency, Novavax plans to share its U.K. study protocol publicly soon. A preliminary analysis of the trial’s results will be conducted when at least 67% of participants who show any coronavirus symptoms have received the vaccine.
The company is one of 11 worldwide to reach this third phase of testing, per The New York Times.