Novavax set for India launch with Serum Institute as manufacturing 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 destination 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 and 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.

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 the UK regulator but may proceed itself on the 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 the number may rise.

Novavax, named Covavax 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, official sources said. It may well be possible that India becomes the first country for the launch of the vaccine.

“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 Indian official said. Seen as the fourth US vaccine, experts feel it has utility as a booster jab once it is necessary to renew or re-vaccinate people.

Trials found it effective against the Alpha variant first found in Kent, though at a less efficacy of 86%. It reported a much lower 49% efficacy against the variant first found in South Africa. 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 despite the company not having any previous record of developing shots that were marketed. Problems with some of its trials and hitches in manufacturing meant Novavax lost the race to Pfizer and Moderna and though it still remains in the EUA process, the firm may not press its case.

The official said that the government is looking at an August-September timeline for the first lot of supplies of Covavax, if the regulatory processes advance smoothly. SII was considering applying for expedited authorisation under the Indian government’s revised norms if Novavax secures EUA in either UK or Europe.

At a time when the demand for anti-Covid shots has begun to level off in the US with more than 50% of its population inoculated with at least one dose, Novavax vaccine with its high efficacy level is seen as a major breakthrough for developing countries that are vying for more doses to fast vaccinate their population. Experts feel India is strategically placed very well to gain, while it can also be a viable market for the American company to launch its product.

“Like with Covaxin, US FDA has suggested Novavax to apply for full approval, which takes longer than an EUA. This means that a country outside the US may be the first to approve the vaccine. It could be India as well, with the indian version ‘Covavax’ getting fast track approvals,” says Oommen C Kurian, senior fellow, health initiative at ORF.

Novavax is easy to store and transport, an important 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, Canada, Australia, among other countries. In January, the American biotechnology firm had announced that trials in Britain showed 96.4% efficacy against the original strain of SARS-CoV-2 virus and 86.3% efficacy against the B.1.1.7 variant.