Novavax, a US-based vaccine manufacturer, filed regulatory submissions before Drugs Controller General of India (DCGI), through its partner Serum Institute of India (SII), for emergency use of its vaccine in India, reports NDTV. SII manufactures the Covishield vaccine, which is currently administered in the country.
The company said in a statement that they and SII have now completed the submission of all modules required by regulatory agencies in India for the initiation of review of preclinical, clinical, and chemistry, manufacturing and control data.
The Novavax CEO, Stanley Erck, said that the submissions are an important step toward access to millions of doses of a safe and effective vaccine for countries with an urgent need to control the pandemic.
The company has partnered with SII to manufacture, develop and sell their vaccine. The duo has a cumulative aim to provide more than 1.1 billion doses to the COVAX Facility.
Novavax has also asked for the approval of regulators in Indonesia and the Philippines for the emergency use of its pandemic vaccine. It also has plans, later in August, to request the World Health Organisation's (WHO) review to be part of the COVAX global vaccine programme. WHO's grant of emergency use listing (EUL) is required to exports vaccines to many countries participating in the COVAX Facility, which is putting effort into the equitable distribution of doses to all participating countries.
In June, Stanley Erck had told NDTV that their vaccine, branded Covovax, might be costlier than Covishield. He also had said that though the vaccine was found 90% against some covid variants, the data regarding its effectiveness against Delta is not out yet.