If approved by the FDA, Novavax plans to manufacture 100 million doses per month

Covid vaccine
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Novavax has announced that they plan to file for regulatory authorization for their COVID-19 vaccine, which has been found to be about 90% effective in clinical trials.

On Monday, the American biotechnology company announced in a press release that its vaccine is 90.4% effective overall and offers 100% protection against moderate and severe disease. Their Phase 3 PREVENT-19 study, which launched in December, included 29,960 participants aged 18 or older, across 119 sites in the U.S. and Mexico. 

Throughout the course of the study, there were 77 cases of COVID-19, according to the company. Among those cases, 63 occurred in the placebo group while the remaining 14 individuals, all of whom had mild cases, were in the vaccine group.

According to Novavax, preliminary data showed that the vaccine was "generally well-tolerated" and that "no single adverse event term was reported by more than 1% of participants." The most common symptoms were fatigue, headache and muscle pain, which lasted for less than 2 days.

"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 Stanley C. Erck, Novavax President and CEO, in a statement.

"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," Erck added.

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Novavax's vaccine uses recombinant nanoparticle technology in order to "enhance the immune response and stimulate high levels of neutralizing antibodies," according to the company.

If approved by the FDA for emergency-use authorization, Novavax is planning to manufacture "100 million doses per month by the end of the third quarter and 150 million doses per month by the end of the fourth quarter of 2021."

The company is currently undergoing an additional study to determine vaccine effectiveness on adolescents aged 12-17.

As of June 14, more than 64% of American adults have received at least one dose of a COVID-19 vaccine, and 54% are now fully vaccinated against the virus, the CDC reports.

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