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Novavax COVID Vaccine Hits 90% Efficacy in Late-Stage Trial; Shares Leap

'Clinical results reinforce that NVX-CoV2373 is extremely effective and offers complete protection against both moderate and severe COVID-19 infection,' says CEO Stanley Erck.

Novavax  (NVAX) - Get Report said Monday that its developing coronavirus vaccine passed a 90% efficacy rate in late-stage trials and said it plans to seek regulatory approval in the coming months. 

Novavax said its NVX-CoV2373 coronavirus vaccine candidate hit a 90.4% efficacy rate in a trial of nearly 30,000 participants, with a 100% protection rate against moderate and severe forms of the disease. Its efficacy rate against 'predominantly circulating' variants, Novavax said, was around 93%.

The Gaithersburg, Maryland-based drugmaker said it expects to seek regulatory approval for the vaccine in the third quarter, and remains on track to reach manufacturing capacity of 100 million doses per month by October and 150 million does per month by the end of the year. 

"Today, Novavax is one step closer to addressing the critical and persistent global public health need for additional COVID-19 vaccines. These clinical results reinforce that NVX-CoV2373 is extremely effective and offers complete protection against both moderate and severe COVID-19 infection," said CEO Stanley Erck. "Novavax continues to work with a sense of urgency to complete our regulatory submissions and deliver this vaccine, built on a well understood and proven platform, to a world that is still in great need of vaccines."  

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Novavax shares were marked 11.1% higher in pre-market trading Monday following news of the trial to indicate an opening bell price of $233.00 each.

Last week, Moderna MRNA formally asked the U.S. Food & Drug Administration for emergency approval to use allow its coronavirus vaccine to be administered to teenagers over the coming months.

Moderna, which filed a similar request with European health authorities earlier this week, said late-stage data from its TeenCOVE study "met its primary immunogenicity endpoint, successfully bridging immune responses to the adult vaccination' with a vaccination efficacy of 100% among the 2,500 participants. A 93% efficacy rate was also noted 14 days after the first of the vaccine's two dose regiment, Moderna said.