Even as the raw material issue for manufacturing Serum Institute of India’s (SII) local version of Novavax vaccine has been sorted out after the United States lifted its export ban on raw materials last month, the launch may still get delayed in India.
The United State-based vaccine maker Novavax, with whom SII has partnered, said that its worldwide launch of the COVID-19 shot will get pushed beyond Q3 2021 (July to September), the Economic Times reported.
SII’s launch of its Novavax version, named Covovax, is likely to happen after the global launch, as its trial is based on comparing immunogenicity and safety data with the Novavax candidate, ET reported quoting officials aware about the matter.
Novavax, one of the first players to make a vaccine against the COVID, said that its highly protective vaccine candidate would not be authorised in the US or Britain until at least July and that it would not reach peak production until the year-end, a report in The New York Times mentioned.
During an earnings call with investors on May 10, the company’s President and Chief Executive, Stanley C Erck, said that the delay was due to the regulatory and manufacturing hurdles, which, however, had been resolved.
Meanwhile, its Indian manufacturer will have to demonstrate that its version of the vaccine is similar to Novavax’s in terms of clinical features.
According to its filings with the clinical trial organisation on May 5, SII started a phase-2/3 observer-blinded, randomised, active-controlled trial this month with 1,600 participants over the age of 18 across 15 centres.
The US government granted up to $1.6 billion to the Maryland company last year for the vaccine which showed robust results in clinical trials.
Earlier, Adar Poonawalla, the Chief Executive Officer of SII, had complained that the manufacturing of the Novavax vaccine was getting delayed in India due to a shortage of raw materials caused by the US export ban.
Earlier, in March Adar Poonawalla, CEO of SII, had announced the company's plans to launch Covovax in India by September 2021.