American pharma major Novavax may receive approval for its vaccine Covovax in India between July and September. The vaccine, which has shown 90 per cent effectiveness against COVID-19, would cost a “low single dollar” price per dose but may be priced higher than Covishield. While Covovax works against the variants of SARS-COV-2, its effectiveness against Delta variant is yet to be revealed.
“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,” NDTV quoted Stanley Erck, the president and CEO of Novavax.
The Delta variant has raised concerns across the world as it has led to spike in COVID-19 cases in several countries, including US, UK, and Australia, which was a COVID success story till a few days back.
“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 Erck as he emphasised 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,” he told NDTV.
Meanwhile, Covovax is also expecting approvals around the same time in Europe and UK.
Further, explaining the reason behind a delay in regulatory approvals he said 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 Erck.
On the question of approvals in other countries affecting India’s process, he said, “We think not. We think it’s possible that the DCGI regulatory process will be independent of the other regulatory processes.”
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