Amid Looming Uncertainty Over EUA In US, Novavax Eyes India Launch Of Its COVID Jab With Over 90 Per Cent Efficacy

With uncertainty looming over emergency approval to its Covid-19 vaccine in the United States, the US-based Biotech firm Novavax has been eyeing other markets including India, Europe and United Kingdom to launch its jab that the company claimed has shown over 90 per cent efficacy in large phase 3 trials.

Novavax on Monday (14 June) announced that its recombinant nanoparticle protein-based COVID-19 vaccine, NVX-CoV2373, demonstrated 90.4 per cent efficacy overall in the large Phase 3 trials conducted on 29,960 persons in the US and Mexico.

Despite the efficacy of the Novavax jab being closer to Pfizer and Moderna shots and much higher than single-dose Johnson and Johnson vaccine, the firm is unlikely to get regulatory clearance soon in US as the country has already secured enough supplies for domestic use.

Under the US law, there is no need for additional emergency use authorisations (EUAs) once enough doses are secured to cater to domestic needs.

The company expects that the first approvals for its vaccine are likely to be secured from other countries' regulators and has therefore applied in India, European Union, Korea and England for regulatory nod.

The Novavax vaccine has been named Covavax in India and is in advanced stages of Phase 2 and 3 bridging trials with the Serum Institute enrolling 1,600 participants over 18 years across 15 sites, reports Economic Times.

According to the report, the government estimates availability of 20 crore Novavax shots (five crore a month) during September-December in India and the number may rise.

“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 official was quoted in the report as saying.

If the ongoing trials results are positive, India is reportedly looking at an August-September timeline for the first supplies of the Covavax, making it the first country to launch the vaccine.

Further, SII is reportedly also considering applying for expedited authorisation under the Indian government’s revised liberalised norms if Novavax secures EUA in either UK or Europe.