Another COVID-19 vaccine is all set to debut in India as the Pune based Serum Institute of India is gearing itself for the production of Novavax’s COVID-19 vaccine candidate ‘Covovax’, which has demonstrated an overall 90.4 per cent efficacy in phase 3 clinical trials. SII CEO Adar Poonawalla hopes to launch ‘Covavax’ in India by September as its trials are in advanced stages of completion.
Earlier last year, Novavax signed a manufacturing agreement with SII for its COVID-19 vaccine NVX-CoV2373. Poonawalla said the trials of the vaccine will likely conclude by November this year. However, he mentioned the pharmaceutical giant can apply for a vaccine license even before the trial in the country concludes based on the data from global trials.
The availability of Novavax’s vaccine will help the central government’s ambitious goal of jabbing the entire country by December 2021. The Centre expects the availability of 200 mn doses of Covovax between August and December. It is assumed that India will allow entry of this vaccine here once the USFDA approves it. The company is also planning to start the trials of Covovax for children in July.
Novavax’s partner Serum Institute of India is focusing to manufacture 50 mn doses of Covovax a month at its Pune facility. The company has not disclosed the volume of vaccines it is producing now, but it is surmised that the current production capacity is less than 50 mn monthly doses currently.
Novavax claims 100 per cent protection against moderate and severe COVID-19, overall 90.4 per cent efficacy
According to the global trial data, Novavax’s COVID-19 vaccine candidate provides 100 per cent protection against moderate and severe disease, 90.4 per cent efficacy overall, and also met the primary endpoint in the PREVENT-19 phase 3 trial, the company said in a statement issued on June 14.
Novavax claimed that preliminary safety data showed that the vaccine was generally well-tolerated, and serious adverse events were low in number. No single adverse event term was reported by more than one per cent of the participants, it claimed.
The company said it will file regulatory authorisations in the third quarter. The company also mentioned that if regulatory hurdles are cleared, it is well poised to reach a manufacturing capacity of 100 mn doses a month by the end of the third quarter and 150 mn doses per month by the fourth quarter of 2021.
“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,” said Stanley C. Erck, President and Chief Executive Officer, Novavax.
The statement further mentioned that the study enrolled 29,960 volunteers across 119 cities in the US and Mexico to evaluate the efficacy, safety and immunogenicity of the company’s vaccine candidate. It added that the emphasis was placed on recruiting a representative population of communities and demographic groups most affected by the disease.