Novavax set for India launch with SII as mfg partner

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.

Sushmi Dey
  • Updated On Jun 15, 2021 at 05:20 AM IST
Read by: 100 Industry Professionals
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New Delhi: 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’

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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.

Trials found it effective against the Alpha variant first found in Kent, though at a less efficacy of 86%. The shots were found to have milder after-effects. The sub-protein two-shot vaccine received a massive $1.6 billion assistance from the US government. The official said the government is looking at an August-September timeline for the first lot of supplies of Covovax, if the regulatory processes advance smoothly. SII was considering applying for expedited authorisation under the government’s revised norms if Novavax secures EUA in either UK or Europe.

Novavax vaccine with its high efficacy level is seen as a major breakthrough for developing nations that are vying for more doses to fast vaccinate their population. Experts feel India is strategically placed well to gain, while it can also be a viable market for the American company to launch its product. “Like with Covovax, US FDA has suggested Novavax to apply for full approval. This means that a country outside the US may be the first to approve the vaccine. It could be India as well,” says Oommen C Kurian, senior fellow, health initiative at ORF.

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Novavax is easy to store and transport, a key 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 rolling review of its data with regulators in Europe, UK, Australia, among other countries.





  • Published On Jun 15, 2021 at 04:33 AM IST
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