Novavax May Get Approval In 2 Months, Likely To Cost More Than Covishield

The Covovax shot developed by American vaccine-maker Novavax may be cleared for use in India between July and September, which would make it the fifth vaccine in the country. The vaccine would cost a "low single dollar" price per dose but is likely to be costlier than Covishield, the company's CEO said today in an exclusive interview.

Stanley Erck, the president and CEO of Novavax, also said that while Covovax is known to work on Covid variants, the data of its effectiveness against the Delta variant is not known yet.

"We have conducted clinical trials that show that the vaccine works extraordinarily well in phase 3 trials in the UK. And in the US we are in the last stages of preparing all of the clinical data, the safety data, and now the manufacturing data that has to go into a licensing package. Our expectation is that the package will be complete very soon, certainly in the coming quarter," Mr Erck said.

While Novavax has shown 90 per cent effectiveness against Covid, more data is needed on whether it will protect against the Delta variant, a virulent and fast-spreading mutation that was detected in India and is driving fresh cases in parts of the world.

"We have very high rates of efficacy when there are variant circulating, we had a 100 per cent protection against moderate and severe disease, and we were 93% protective against the variants that were circulating in our US trial. What we did not show is anything that gets Delta because Delta was not circulating during our trial. So we don't have those data yet. So time will tell," said the CEO.

But he stressed that tests were on.

"What we hope, based upon the data that we have against a variety of variances, is that we will have a significant amount of efficacy against Delta. I just can't tell you what that number is yet, because we have not been in the trial where Delta has been circulated."

Besides India, approvals are expected around the same time in Europe and UK for the vaccine.

He admitted to a delay in regulatory approvals, blaming it on the fact that the company started the process a year ago without any manufacturing or process development capabilities.

"So while we were running and getting clinical efficacy data, clinical safety data, we were way behind on manufacturing data. So we had to run fast to build that capability. In part that's why we have partnered with Serum Institute - because they have those capabilities," said Mr Erck.

"So we're getting there. It took a bit longer than we had hoped, but in the US and in the UK and in Europe and in India, all of those processes are coming together at roughly the same time."

Asked whether India's approval process would depend on the vaccine being cleared elsewhere in the world, Mr Erck demurred: "We think not. We think it's possible that the DCGI regulatory process will be independent of the other regulatory processes."