US-based biotech company Novavax has approached the Drugs Controller General of India (DCGI) seeking Emergency Use Authorisation (EUA) for its COVID-19 vaccine.
The submission has been made through the Serum Institute of India (SII), which is its partner in manufacturing its vaccine in the country. The SII presently manufactures Covishield in India.
As per Novavax CEO Stanley Erck, the regulatory submission is and "important step toward access to millions of doses of a safe and effective vaccine for countries with an urgent need to control the pandemic," NDTV quoted.
Besides India, Novavax has also applied for emergency use of its vaccine in Indonesia and the Philippines.
Further, Novavax and SII have cumulative commitments to provide over 1.1 billion doses to the COVAX Facility, NDTV reported.
In a statement, the vaccine maker said, "SII and Novavax have now completed the 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."
(With inputs from NDTV)
(At The Quint, we question everything. Play an active role in shaping our journalism by becoming a member today.)