Novavax Vaccine’s Nearly 90% Efficacy Sparks Hope in India as Serum Institute Seeks Local Trial Nod

·3-min read

US-based Novavax’s Covid-19 vaccine candidate has shown nearly 90 per cent efficacy and the ability to work against the UK and South African variants of the virus. The company, in a statement, said its Covid-19 vaccine demonstrated 89.3 per cent efficacy in UK Phase-3 trial.

The vaccine, a more conventional protein-based vaccine, had higher efficacy against the original coronavirus strain, 95.6 per cent, and 85.6 per cent against the more deadly and easily transmissible UK variant – so 89.3 per cent overall.

Results of the trials also showed that the vaccine gives some protection, at 50 per cent, against the variant causing even more concern in South Africa. Novavax said the trials involved 15,000 people. Almost 4,000 people in the study (27 per cent) were in the over-65 age group, who are most at risk from the virus.

“Nvx-cov2373, the protein-based Covid-19 vaccine candidate, met the primary endpoint, with a vaccine efficacy of 89.3%, in the Phase-3 clinical trial conducted in the UK. The study assessed efficacy during a period with high transmission and with a new UK variant strain of the virus emerging and circulating widely. It was conducted in partnership with the UK government’s vaccine taskforce,” the company said in a statement.

Pune-based Serum institute of India, the world's largest vaccine manufacturer, has sought the Drugs Controller General of India's (DCGI) permission to conduct a small domestic trial of the Novavax vaccine. The SII and the Indian Council of Medical Research have a tie-up with the company and bridging studies will be done once the regulators give the approval.

SII's application with the DCGI is being examined. A bridging trial is a supplementary trial performed in a new region or country to get more clinical data on efficacy, safety and dose regimen.

Earlier, Dr Umesh Shaligram, executive director of SII, told News18 that the company is keen on starting the bridging trials in the country and that SII would be in a position to start the trials by February once the approvals come through. “Data of protection against the new variants is promising. The good thing is that the new strain in South Africa emerged as the trials of the vaccine were going on in the country,” he said.

In September 2020, Novavax had announced its deal with Serum Institute to produce 2 billion doses of the Covid-19 vaccines. In India, the vaccine will be called Covovax, developed by Novavax and upscaled by the SII.

Florian Krammer, a professor at the department of microbiology at the Icahn School of Medicine at Mount Sinai, New York, said the data was reassuring in many ways as it the vaccine worked very well against the 'old' variant and the UK variant. “The low efficacy against the b.1.351 (South African variant) is concerning,” he tweeted.

British Prime Minister Boris Johnson said the news was good. “Our medicines regulator will now assess the vaccine, which will be made in Teesside. If approved, we have 60m (million) doses on order,” Johnson said on twitter.