SII had applied for emergency use authorisation (EUA) to the drug regulator in August.
“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,” said a senior government official.
According to the official, SII 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,” added the official.
An email sent to SII did not elicit any response.
In August SII CEO Adar Poonawalla had said, “We are hoping that Covovax will be launched in October. For children, it will be the first quarter of 2022”.
SII has already manufactured the first batch of Covovax.
Poonawalla had earlier said that the vaccine has the potential to protect future generations below the age of 18.
The phase-2 and 3 trials among adults in India are likely to conclude only by October. SII has applied for licensure for Covovax on the strength of global data.
According to Novavax, the vaccine has demonstrated 93% efficacy against predominantly circulating variants of concern and variants of interest.