Serum’s launch of Novavax shot in India may face delay

The launch of Serum Institute of India’s (SII) Novavax vaccine may get delayed in India after its partner organisation Novavax said on Monday that the company’s worldwide launch of the Covid-19 shot will get pushed beyond Q3 2021 (July to September).

Consequently, Serum’s launch of its version of the Novavax vaccine is likely to happen sometime after that as the company’s vaccine trial is based on comparing immunogenicity and safety data with the Novavax candidate, officials aware of the development told ET. The Pune-based vaccine maker will have to demonstrate that its vaccine is similiar in clinical features to that of Novavax.

According to its filings with the clinical trial organization on May 5, SII is conducting a phase-2/3 observer-blinded, randomised, active controlled study with 1,600 participants involving adults over the age of 18 to “evaluate the safety of its vaccine Covovax in comparison with Novavax SARS-CoV-2 rS with Matrix-M1™ (adjuvant) and placebo.”

The trials, which will run across 15 centers in India, were started in May.

Adar Poonawalla, CEO of SII, had complained in the past that the manufacturing of the Novavax vaccine was getting delayed due to a shortage of raw materials caused by the US export ban.