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Novavax Begins Clinical Study for Coronavirus Vaccine

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Novavax, Inc. NVAX announced that it has initiated a phase I/II clinical study on its coronavirus vaccine candidate, NVX-CoV2373, which has been made using the company’s proprietary nanoparticle technology. Preliminary immunogenicity and safety data from the study is expected in July.

Notably, NVX-CoV2373 includes Novavax’s proprietary Matrix-M adjuvant to improve immune responses and stimulate high levels of neutralizing antibodies.

The study is being conducted in two parts. The phase I portion will evaluate the candidate in approximately 130 healthy volunteers aged from 18 to 59 years at two sites in Australia.

If the results of the phase I part show positive outcomes, then the company will quickly begin the phase II portion of the study, which will be conducted across multiple countries and assess immunity, safety and COVID-19 disease reduction in a broader age bracket of patient population.

Earlier this month, the Coalition for Epidemic Preparedness (CEPI) provided an additional funding of up to $388 million to Novavax for the clinical development of NVX-CoV2373. The above-mentioned study is being supported by this aid.

In March, the CEPI awarded an initial funding of $4 million to back Novavax’s efforts for developing the vaccine candidate.

NVX-CoV2373 showed high immunogenicity in pre-clinical studies after a single immunization. Moreover, microneutralization titers, which were already high after the first dose, increased eight-fold with the second dose. Higher the microneutralization titers, more likely is the vaccine to be effective in humans.

Shares of Novavax were up 16.7% in pre-market trading on Tuesday following the announcement of the news. In fact, the stock has skyrocketed 1058.6% so far this year compared with the industry’s increase of 7.9%.

We remind investors that in April 2020, Novavax identified its potential coronavirus vaccine candidate, NVX-CoV2373.

Significantly, the company has an agreement with Emergent BioSolutions EBS to manufacture and supply GMP vaccine product for use in its clinical studies.

The CEPI is financing several biotechs for developing a coronavirus vaccine including Moderna MRNA and Inovio Pharmaceuticals. Several big players including Sanofi, Pfizer PFE and J&J joined the mission to develop a vaccine against COVID-19.

Meanwhile, global leaders and the World Health Organization are committed to work together to fight against the COVID-19 pandemic, which already infected more than 5 million people across the globe and the number is growing by the day.

Zacks Rank

Novavax is a Zacks Rank #3 (Hold) stock, currently. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

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