US pharma major Novavax may get approval for its vaccine Kovovax in India between July and September. The vaccine, which has shown 90 percent effectiveness against COVID-19, will cost “less a single dollar” per dose, but could cost more than Covishield. While Covovax works against variants of SARS-COV-2, its effectiveness against delta variants is yet to be disclosed.
“We have conducted clinical trials that show the vaccine works exceptionally well in phase 3 trials in the UK. And in the US we are in the final stages of preparing all the clinical data, the safety data, and now the manufacturing data that has to go into the license package. We expect the package to be completed very soon, certainly in the coming quarter,” NDTV quoted Stanley Erk, President and CEO, Novavax as saying.
The delta version has raised concerns around the world as it has led to a surge in COVID-19 cases in several countries including the 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 circulating variants, we had 100 percent protection against moderate and severe disease, and we were 93% protective against circulating variants in our US trial. What we didn’t show is anything that Delta receives because Delta wasn’t transmitting during our testing. So we don’t have that data yet. So time will tell,” Erk said as he insisted testing were walking.
“What we expect, based on the data that we have against different types of variances, is that we will have a significant amount of efficacy against deltas. I just can’t tell you what that number is, Because we have not come across the litigation where Delta has been operated,” he told NDTV.
Meanwhile, Kovovax is also hoping for approval in Europe and the UK around the same time.
Further, explaining the reasons for the delay in regulatory approvals, he said the company started the process a year ago without any manufacturing or process development capabilities. “So when we were running and getting clinical efficacy data, clinical safety data, we were way behind on manufacturing data. So we had to rush to build that capability. Part That’s why we partnered with the Serum Institute — because they have those capabilities,” Erck said.
On the question of approvals in other countries affecting India’s process, he said, “We do not think.” We think it is possible that the DCGI regulatory process is independent of other regulatory processes.”
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