Kate Feldman New York Daily News (TNS)
Novavax, a Maryland-based biotech company, announced Monday that its COVID-19 vaccine is 90.4% effective at preventing people from getting sick and 100% effective at preventing moderate or severe disease, hopefully laying the groundwork for a fourth vaccine in the fight against the coronavirus.
Almost 30,000 participants across 119 sites in the U.S. and Mexico took part in the Phase 3 study, which evaluated “efficacy, safety and immunogenicity, with an emphasis on recruiting a representative population of communities and demographic groups most impacted by the disease.”
Of those who got the two-shot inoculation, only 77 people tested positive for COVID-19, and all cases were “mild.” No hospitalizations or deaths were reported.
Among high-risk populations — those over age 65, under age 65 with certain comorbidities or having life circumstances with frequent COVID-19 exposure — the Novavax vaccine was 91% effective, the company said.
“Today, Novavax is one step closer to addressing the critical and persistent global public health need for additional COVID-19 vaccines,” Novavax President and CEO Stanley Erck 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.”
The company also bragged about how “well-tolerated” its vaccine is, with only mild to moderate injection site pain and tenderness. Symptoms like fatigue, headache and muscle pain typically only lasted up to two days.
Novavax plans to apply for emergency authorization from the Food and Drug Administration in the fall and, if granted, promised 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, which has been unsuccessfully developing vaccines for almost 30 years, received a $1.6 billion contract for 100 million future doses from the Trump administration’s Operation Warp Speed last year, but its trials were slowed down due to manufacturing delays.
Novavax previously pledged 1.1 billion doses of its vaccine to COVAX, the World Health Organization’s initiative to increase distribution globally.
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