Novavax announced on June 14 that its COVID-19 vaccine candidate has been found to be highly effective in phase-3 clinical trials conducted in the United States and Mexico, including against the various strains of the novel coronavirus.
The NVX-CoV2373, Novavax's recombinant nanoparticle protein-based COVID-19 vaccine showed 90 percent effectiveness in preventing symptomatic COVID-19 and 100 percent effectiveness at preventing moderate-to-severe infections, the American biotechnology company said.
Gregory M Glenn, MD, President of Research and Development, Novavax, said: “These data show consistent, high levels of efficacy and reaffirm the ability of the vaccine to prevent COVID-19 amid ongoing genetic evolution of the virus. Our vaccine will be a critical part of the solution to COVID-19, and we are grateful to the study participants and trial staff who made this study possible, as well as our supporters, including the US Government.”
The vaccine candidate, developed along with the Coalition for Epidemic Preparedness Innovations (CEPI), demonstrated 93 percent effectiveness against variants of concern and variants of interest.
It also showed success among the high-risk populations -- defined as over age 65, under age 65 with certain comorbidities or having life circumstances with frequent COVID-19 exposure.
Doses for the two-shot regimen need to be stored between two to eight degrees Celsius. Thus, the vaccine, which is easy to store and transport, is expected to play an important role in boosting vaccine supplies, especially in developing countries.
Stanley C Erck, President, and Chief Executive Officer, Novavax, said: “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.”
"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 is looking to file for regulatory authorisations in the third quarter, upon completion of the final phases of process qualification and assay validation needed to meet chemistry, manufacturing, and controls (CMC) requirements.
As such, the vaccine's rollout is expected to take more time. The company has said it plans to seek authorisation for the shots in the US, Europe and elsewhere by September-end, and will be able to produce up to 100 million doses per month by then and 150 million doses a month by December.
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The company has committed to supplying 110 million doses to the US over the next year and a total of 1.1 billion doses to developing countries.
In September 2020, Novavax had announced that the Serum Institute of India (SII) would manufacture 1 billion doses of its jab in 2021. It has similar manufacturing partnerships in other countries including Japan.
However, it was reported in May that the launch of the Novavax shot in India may face delay.
Vaccine alliance Gavi had announced in May that it had signed an agreement to buy 350 million doses of Novavax’s vaccine, with deliveries estimated to begin in the third quarter.
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