The Covovax shot developed by American vaccine-maker Novavax, which demonstrated an overall 90.4 per cent efficacy in phase 3 clinical trials, is likely to be cleared for use in India in the next two months, President and CEO of Novavax Stanley Erck told NDTV.
"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," Erck said.
The company has joined hands with the Pune-based Serum Institute of India (SII) for the production of its vaccine as it is "way behind on manufacturing data". Meanwhile, SII has already started the production of the first batch of Novavax (known as Covovax in India). SII CEO Adar Poonawalla in a tweet had said that the Novavax vaccine has "great potential to protect our future generations below the age of 18".
When asked whether India's approval process would depend on the vaccine being cleared elsewhere in the world, Erck said: "We think not. We think it's possible that the DCGI regulatory process will be independent of the other regulatory processes."
When approved in India, it would become the fifth vaccine in the country. Covishield, Covaxin, Sputnik V and Moderna vaccines have already been approved for emergency use in the country.