Serum Institute of India (SII) announced that clinical trials of COVID-19 vaccine Covovax have begun in India and the company hopes to launch it by September 2021. In August 2020, US-based vaccine maker Novavax, Inc. had announced a license agreement with SII for the development and commercialization of NVX-CoV2373, its COVID-19 vaccine candidate for manufacturing and supply of the vaccine to low and middle-income countries and India.
Novavax’s vaccine, NVX-CoV2373, is a protein-based vaccine candidate engineered from the genetic sequence of SARS-CoV-2. This vaccine will be branded as ‘Covovax‘ in India. The vaccine has been tested against African and UK variants of COVID-19 and has indicated an overall efficacy of 89.7%. However, data from a phase 3 trial conducted in the UK indicated a 96.4% efficacy for NVX-CoV2373, the highest efficacy achieved so far for any COVID-19 vaccine against the original virus strain. NVX-CoV2373 is also being tested in two ongoing Phase 2 studies, a Phase 2b trial in South Africa that demonstrated 48.65% efficacy against a newly emerging escape variant, and a Phase 1/2 continuation in the U.S. and Australia.
Novovax also indicated that the vaccine has shown an efficacy of 55.4% efficacy from phase 2 trials in South Africa. The trial included HIV-negative trial participants and conducted in a region where the vast majority of strains are B1.351 escape variants. Across both trials, the vaccine showed 100 per cent protection against severe disease, including all hospitalisation and death.
India currently has two vaccines approved against COVID-19 which are Covishield, manufactured by the SII and Covaxin by Bharat Biotech (for restricted emergency use in the country). If approved before any of the other pipeline vaccines, this will be the third Covid-19 vaccine for use in India. Novavax with Serum will provide 1.1 billion cumulative doses of NVX-CoV2373 for the COVAX Facility.