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 hub 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 & 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.
‘SII planning Covovax trials for kids’
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 UK regulator but may proceed itself on 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 number may rise
Novavax, named Covovax 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, sources said. It may well be possible that India becomes the first country for vaccine launch.
“The results are very encouraging and we’re looking forward to the vaccine. We are 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 official said.
