Serum institute could begin US Covovax vaccine trial on children in India next month

The uncertain path to authorisation in the US for Novavax despite passing the efficacy test with an impressive score of 90.4% might see India emerge as a major destination for the shots with the Serum Institute of India as manufacturing partner. 

The large Novavax trials conducted on 29,960 persons in the US and Mexico have delivered results that equal the Pfizer and Moderna jabs and do better than Johnson and Johnson, but regulatory clearance appears distant as an overflowing vault of vaccines has diminished the need for emergency use approvals. Under the US law, there is no need for additional EUAs once there are enough doses to cater to domestic needs.

A report in NYT quotes Novavax chief executive Stanley Erck acknowledging that the first approvals for the vaccine are likely to be accorded abroad and that the company has applied in UK, EU, Korea and India. India can take a cue from the UK regulator but may precede itself on the basis of strong interim data, Indian sources said. As per Indian government estimates, 20 crore Novavax shots (five crore a month) can be available during September-December and the number may rise.

Novavax, named Covavax in India, is in advanced stages of Phase 2/3 “observer-blinded, randomised, active-controlled” bridging trials with SII enrolling 1,600 participants over 18 years across 15 centres. SII has also indicated an interest in conducting trials in children, official sources said. It may well be possible that India becomes the first country for the launch of the vaccine.

“The results are very encouraging and we are looking forward to the vaccine. We are already engaged with SII for supplies and the company is doing trials with ICMR. It is a very promising vaccine candidate and we are hopeful that they will be able to submit data in India for regulatory approvals very soon,” an Indian official said. 

“What we’re learning from data available in the public domain is that this vaccine is very safe and highly effective. It’ll be produced in India,“ Dr VK Paul, Member-Health, Niti Aayog said in a routine briefing by the Union Health Ministry on Covid-19 situation in India.

He also added that there will be some gap in production (of Novavax vaccine) for a while. “I am also hoping they (US company Novavax) would also start trials on children too,” Paul said.

To be sure, Novavax’s vaccine candidate has partnered with Pune-based vaccine manufacturer Serum Institute of India to produce 1.1 billion doses in India

Novavax is easy to store and transport, an important factor that may make it a good fit for India which is not only trying to ramp up its Covid-19 vaccination programme but is also faced with the challenge of taking it to remote corners.

Novavax has initiated a rolling review of its data with regulators in Europe, UK, Canada, Australia, among other countries. In January, the American biotechnology firm had announced that trials in Britain showed 96.4% efficacy against the original strain of SARS-CoV-2 virus and 86.3% efficacy against the B.1.1.7 variant

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