SII has a tie-up with US biotech company Novavax for the manufacture and supply of Covovax. The WHO approval for Covovax would significantly expand Covid-19 vaccine supply to COVAX countries. SII has a commitment to supply 1.1 billion doses of Covovax under COVAX.
WHO chief scientist Dr Sowmya Swaminathan said on Monday the Strategic Advisory Group of Experts on Immunization (SAGE) was slated to meet on December 16 to take up emergency use approval for SII’s Covovax. SAGE advises WHO and recommends vaccine approval.
Swaminathan said the Covovax trials had shown it was safe and efficacious. She did not commit on a date for the approval, but indicated it could be expected in December.
Speaking to CNBV-TV18, Swaminathan said they were looking forward to some visibility and transparency from all vaccine makers regarding Covid-19 vaccine supplies. There was lack of clarity on when and how much they would supply as manufacturers suddenly prioritised other orders as many countries were struggling to increase vaccine coverage, she said.
The European Medicines Agency is also evaluating the company’s application for conditional marketing authorisation for Novavax’s vaccine, which will be marketed in the European Union under the brand name Nuvaxovid.
The Novavax-SII vaccine has recently received emergency use authorisation in Indonesia and Philippines. It has also filed for emergency use authorisation in India. Novavax also announced regulatory filings for its vaccine in the United Kingdom, Australia, New Zealand, Canada and with the WHO.