US-based vaccine maker Novavax has filed regulatory submissions for emergency use authorization in India. The submission was made to the Drugs Controller General of India (DCGI) through its partner, Serum Institute of India (SII), which also manufactures the Covishield vaccine which is being administered in the country.
Apart from India, Novavax has also asked regulators in Indonesia and the Philippines to allow emergency use of its COVID-19 vaccine. Later this month, the US vaccine maker plans to seek the World Health Organization review to be part of the COVAX global vaccine programme.
Novavax CEO Stanley Erck called the submissions 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.”
In India, the US pharma giant has partnered with Serum Institute of India to manufacture, develop and sell the vaccine. Novavax and SII have cumulative commitments to provide more than 1.1 billion doses to the COVAX Facility.
“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,” the vaccine maker said in a statement.
“A submission to the World Health Organization (WHO) for emergency use listing (EUL) based on the DCGI submission is expected to be filed in August. The grant of EUL by the WHO is a prerequisite for exports to numerous countries participating in the COVAX Facility, which was established to allocate and distribute vaccines equitably to participating countries and economies,” it said.
The Novavax two-dose vaccine, branded Covovax, is likely to be costlier than Covishield, the company’s CEO had told NDTV during an exclusive interview in June.
Mr Erck had also said that while Covovax is known to work on Covid variants, the data of its effectiveness against the Delta variant is not known yet.
While Novavax has shown 90 per cent effectiveness against Covid, more data is needed on whether it will protect against the Delta variant, a virulent and fast-spreading mutation that was detected in India and is driving fresh cases in parts of the world.