The launch of the Covovax Covid-19 vaccine in India may take longer than expected since the shot has not yet received approval in the US and the Drug Controller General of India (DCGI) has sought immunogenicity data from the Serum Institute of India, The Economic Times reported.
Serum Institute is manufacturing the Indian version of US firm Novovax's vaccine candidate. While the trials in the country are going on, the data is likely to be submitted by next month, sources told the publication.
SII had applied for emergency use authorisation or EUA in August.
A government official said the approval of Covovax is tricky as the vaccine is not yet approved in the US.
"So, either we will have to wait for the approval in the US or take a decision based on immunogenicity data. The company has been asked to submit additional data,” they told ET.
Serum Institute has so far submitted international data. "The phase-3 trials are ongoing. The data is likely to be submitted by next month and hence no immediate decision can be taken as of now," the official said.
SII CEO Adar Poonawalla had said they were hoping Covovax would be launched in October. Children, he said, will likely receive the vaccine in the first quarter of 2022.
Novovax says its vaccine has shown 93 per cent efficacy against variants of concern and variants of interest.
Check out latest DH videos
Published 09 September 2021, 10:32 IST