Adar Poonawalla said he was hopeful that Covovax, the Novavax vaccine made by SII, will be launched around October this year for adults and for children by the first quarter of next year, depending on DCGI approvals, Reddit reports.
Covid vaccine from US major Novavax may get a nod from the Indian drug regulator even before the vaccine is approved in the US.
The company and its partner Serum Institute of India (SII) had, on August 5, applied for an emergency use authorisation with the Drugs Controller General of India (DCGI) and regulatory bodies in Indonesia and the Philippines.
India has said any vaccine, which has approval from stringent regulatory bodies like the US Food and Drug Administration (USFDA) and the Medicines and Healthcare products Regulatory Agency (MHRA) in the UK, among others, would be approved for use in India.
Novavax’s protein nano-particle two-dose Covid vaccine is not yet approved in the US or the UK. This raised concerns around its approval timelines in India.
However, a senior government official clarified: “Indian regulator can review the global data from phase 3 trials, as well as the bridging trial data from the 1,600 volunteers in India to consider granting an approval. Whether or not it is approved in the US does not matter. The Indian regulator can conduct an independent review.”
SII and Novavax have now completed submission of all modules required by regulatory agencies in India, Indonesia and the Philippines for the initiation of review of the vaccine, including preclinical, clinical, and chemistry, manufacturing and controls data, Novavax said.