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Vaccine-maker Serum Institute of India now has its second in-licensed vaccine ready for roll-out in the country, following the Drug Controller General of India’s (DCGI) restricted approval for Covovax, the Covid-19 vaccine from American biotech company Novavax.
On Tuesday, SII said it had received an emergency use authorisation (EUA)from the DCGI for Novavax’ recombinant nanoparticle protein-based Covid-19 vaccine with Matrix-M™ adjuvant, for those over 18 years. SII already makes and distributes the AstraZeneca-OxfordUniversity vaccine under the name Covishield.
The development comes days after the World Health Organization had issued an Emergency Use Listing to the vaccine, based on details submitted to the DCGI. The vaccine will be manufactured and marketed in India by SII under the brand name Covovax, SII said, though no details are available yet on its production and pricing.
Adar Poonawalla, SII Chief Executive Officer, called the approval “a s ignificant milestone in strengthening our immunization efforts across India and LMICs. (low and middle-income countries)”. He indicated that the protein-based had a more than 90 per cent efficacy rate, based on clinical data demonstrating a favourable safety profile. Novavax expects to submit a complete package of regulatory filings to the United States Food and Drug Administration by the end of the year, the companies said.
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