Washington – The vaccine developed by the US firm Novavax against COVID-19 has been shown to be safe and totally effective in patients considered “high risk” and with the main new variants of the virus.
According to a statement released today by the Maryland-based company, the vaccine, still in phase 3 study, has been shown to be 93 percent effective against the main variants of the virus that circulate today and to be 91 percent effective in high-risk patients.
NVX-CoV2373, the technical name for the recombinant nanoparticle protein-based vaccine, has met protection expectations in phase 3 trials, which have included a total of 29,960 patients from the United States and Mexico.
“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 moderate and severe COVID-19 infection, ”said Stanley C. Erck, president and CEO of the firm.
“Novavax continues to work with a sense of urgency to complete our regulatory filings and deliver this vaccine, built on a well-known and proven platform, to a world that still has a great need for vaccines,” said the executive.
The company intends to apply for regulatory clearances as the United States Food and Drug Administration (FDA) in the third quarter of this year, once the final stages of qualification of the process are completed. and the assay validation necessary to comply with the chemical, manufacturing and controls requirements in the US agencies.
Novavax could reach a manufacturing capacity of 100 million doses per month by the end of the third quarter of 2021 and 150 million doses per month by the end of the fourth quarter of 2021.
Gregory M. Glenn, President of Research and Development at Novavax said the data “shows consistent and high levels of efficacy and reaffirms the ability of the vaccine to prevent COVID-19 amid the ongoing genetic evolution of the virus.”