American biotech company Novavax has said that its Covid-19 vaccine has shown 100 per cent protection against moderate and severe disease, and 93 per cent efficacy against “predominantly circulating” virus variants.

The findings from their late-stage Phase III clinical trial inject a spot of optimism into the basket of vaccines that will become available to India, as Serum Institute has an alliance with Novavax. It is presently undertaking bridging trails on this vaccine in India, which is expected to be completed by September. Explaining Novavax’s efficacy against the virus variants, a person familiar with the development told BusinessLine that it is also effective against the Delta variant that originated in India and as classified by the World Health Organisation.

Other variants include those that originated in the UK, South Africa and Brazil.

Evaluation

The Novavax product is a recombinant nanoparticle protein-based vaccine, and was studied on 29,960 participants across 119 sites in the US and Mexico to evaluate efficacy, safety and immunogenicity. Stanley C Erck, Novavax President and Chief Executive Officer said, they were working with “a sense of urgency” to complete regulatory submissions. In a conference call following the latest findings, the management said they would file for regulatory authorisations in the third quarter in the US, UK, and other geographies, including India. Upon regulatory approvals, Novavax remains 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, said the company.

‘High levels of efficacy’

Gregory M Glenn, Novavax President of Research and Development, said the data showed consistent, high levels of efficacy and reaffirmed “the ability of the vaccine to prevent Covid-19 amid ongoing genetic evolution of the virus”.

High-risk population

Further, the company said its vaccine showed success among “high-risk” population (over age 65, under age 65 with certain comorbidities or having life circumstances with frequent Covid-19 exposure). Novavax said that fatigue, headache and muscle pain were the most common symptoms recorded and it lasted less than two days.

The company was also undertaking trials in adolescents from 12 to less than 18 years of age, it added.

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