Novavax claims its coronavirus vaccine produced immune response in small study – National


Novavax Inc said on Tuesday that its investigational COVID-19 vaccine produced antibodies to the novel coronavirus and appeared to be safe, according to initial data from a small, early-stage clinical trial.The Maryland-based biotech company said its vaccine candidate, NVX-CoV2373, produced higher levels of antibodies in healthy volunteers after two doses than those found in recovered COVID-19 patients, eliciting the hope for its eventual success.

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The addition of its adjuvant Matrix-M, a substance designed to stimulate the body’s immune response, enhanced the effect of the vaccine in the study, the company said.

the Novavax vaccine is one of the first of a handful of programs selected for U.S. funding as part of Operation Warp Speed, the White House program to accelerate access to vaccines and treatments capable of combating the disease. virus.

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Effective vaccines and treatments are seen as key to ending a pandemic that has claimed more than 695,000 lives worldwide.

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Novavax Research chief Gregory Glenn told Reuters the company will soon begin much larger late-stage clinical trials and could potentially glean enough data to get regulatory approvals as early as December.

The US government agreed in July to pay Novavax $ 1.6 billion to help cover the costs of testing and manufacturing the vaccine, with the goal of purchasing 100 million doses by January 2021.

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The trial, which began in late May, tested the vaccine in 106 subjects aged 18 to 59 against a placebo. Phase I of the study examined the safety of the vaccine and its ability to induce immune responses.

He tested 5 microgram and 25 microgram doses of the vaccine, with and without adjuvant.

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The company said the second vaccination induced higher levels of side effects such as swelling and pain at the injection site, which are not considered serious, with only one participant having a fever.

The phase II portion of the study will be conducted in several countries, including the United States. It will assess the vaccine’s ability to prevent infections or reduce the severity of COVID-19, in addition to safety and immune response, in a wider range of volunteers.

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