This vaccine was scheduled for a September 2021 launch in India. The Indian government expects to get 20 crore doses of this vaccine from SII.
US Vaccine maker Novavax on Monday said that its Covid dose demonstrated 90% overall efficacy and 100% protection against moderate and severe disease in Phase 3 trials. Novavax has a tie-up with Serum Institute of India to manufacture these vaccines for India and other low-income countries.
The company said the vaccine had 93% efficacy against predominantly circulating variants of concern and variants of interest. There was an 11% efficacy in high-risk populations and 100% efficacy against variants not considered variants of concern or interest.
“These clinical results reinforce that NVX-CoV2373 is extremely effective and offers complete protection against both moderate and severe Covid-19 infection,” Stanley C. Erck, president and CEO, Novavax, said. Novavax was working with a sense of urgency to complete regulatory submissions and deliver the vaccine, he said.
The company intends to file for regulatory authorisations in the third quarter, upon completion of the final phases of process qualification. Upon regulatory approvals, Novavax said they were on track 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.
As per the new vaccine approval regulations, SII will be able to launch the vaccine in India if Novavax gets Emergency Use Authorisation in the US. SII has tied up with Novavax to manufacture Covid vaccines in India. This vaccine was scheduled for a September 2021 launch in India. The Indian government expects to get 20 crore doses of this vaccine from SII.
The Novavax trial was carried out on 29,960 participants of 18 years and above in 119 locations in the US and Mexico. The vaccine candidate, NVX-CoV2373, is a protein-based vaccine candidate engineered from the genetic sequence of the first strain of SARS-CoV-2, the virus that causes Covid-19 disease.
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