August 4th: Novavax Inc. said Tuesday that its experimental COVID-19 vaccine produces antibodies opposed to the new coronavirus and appears to be safe, according to initial knowledge of a small early-stage clinical trial.
Maryland-based biotechnology firm said its vaccine candidate, NVX-CoV2373, produced higher degrees of antibody in healthy volunteers after two doses than those discovered in patients recovered with COVID-19, increasing hopes for their eventual success.
The addition of its Matrix-M adjuvant, a substance designed to boost the body’s immune response, did enhance the effect of the vaccine in the study, the company said.
The Novavax vaccine is among the first of a handful of programs singled out for U.S. funding under Operation Warp Speed, the White House program to accelerate access to vaccines and treatments that can fight the virus.
Effective vaccines and remedies are essential to end a pandemic that has killed more than 695,000 people worldwide.
Novavax research chief Gregory Glenn told Reuters the company will start much larger late-stage clinical trials soon and could potentially glean enough data to obtain regulatory approvals as early as December.
In July, the U.S. government agreed to provide Novavax with $1.6 billion to cover the prices of testing and vaccine production, in order to buy one hundred million doses through January 2021.
The trial, which started in late May, tested the vaccine in 106 subjects aged 18 to 59 versus a placebo. Phase I of the study looked at the vaccine’s safety and ability to induce immune responses.
Tested doses of five micrograms and 2 five micrograms of the vaccine, with and adjuvant.
The corporate said that by the time the vaccination had induced higher degrees of side effects such as swelling and pain at the injection site, which are not serious, only one player has a fever.
The Phase II component of the review will be conducted in several countries, adding the United States. It will assess the vaccine’s ability to save infections or the severity of COVID-19, as well as protection and immune response, in a wider diversity of volunteers. (Reporting through Julie Steenhuysen in Chicago, Carl O’Donnell in New York and Manas Mishra in Bangalore; edited through Bill Berkrot)
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