Novavax says its COVID-19 vaccine is 90% effective overall

Photo (c) Xavier Lorenzo - Getty Images

The company plans to file for regulatory authorizations later this year

Novavax said today that its COVID-19 vaccine is 90% effective in preventing the virus. 

In a trial involving 29,960 people across the U.S. and Mexico, the company said there were 77 cases of COVID-19: 14 in people who had received its two-shot vaccine and 63 in the group that got a placebo. In the placebo group, ten cases were moderate and four were severe, which meant that the shots were effective in preventing serious cases of the illness. 

Novavax’s vaccines work by delivering parts of the coronavirus spike protein, prompting the body to generate antibodies against them. The company said preliminary safety data from the study showed that the vaccine was “generally well-tolerated.” 

“Serious and severe adverse events were low in number and balanced between vaccine and placebo groups,” the biotechnology company said in a statement. 

The most common “local” symptoms after the second shot were injection site pain and tenderness, and those symptoms were generally mild to moderate in severity. Fatigue, headache, and muscle pain were the most common symptoms, and Novavax said they lasted less than two days. 

Seeking regulatory approval

Three COVID-19 vaccines are already available in the United States, and supply levels are comfortable enough that the Biden administration has started sending doses to other countries. Still, Novavax says it plans to submit its vaccine to regulators in the U.S. and around the world in the third quarter of this year. 

Upon receiving regulatory approval, the company said it’s aiming to reach manufacturing capacity of 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.

"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," Stanley Erck, the company’s CEO, said 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."

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