New Delhi: SII (The Serum Institute of India), along with its partner Novavax, on Wednesday said that they received the emergency use authorisation (EUA) for their recombinant nanoparticle protein-based Covid-19 vaccine, Novavax, in Indonesia.
The SII will manufacture the vaccine in India and will market it in Indonesia under the brand name Covovax.
“The first authorisation of Novavax’ Covid-19 vaccine exemplifies our commitment to equitable global access and will fill a vital need for Indonesia, which despite being the fourth-most populous nation on earth, continues to work to procure sufficient vaccine for its population,” Novavax President and Chief Executive Officer, Stanley C. Erck, said.
“This also marks the first regulatory authorisation worldwide of a protein-based Covid-19 vaccine based on Phase 3 clinical data demonstrating efficacy and a favourable safety profile. This is a landmark moment for Novavax and our partner, Serum Institute of India, and it is the first of many authorisations that Novavax expects in the coming weeks and months for our vaccine globally,” he added.
SII CEO Adar Poonawalla said: “Access to supply of a safe and highly effective vaccine, coupled with the ease of its distribution, should be a critical enabler to help Indonesia control the current coronavirus outbreak.”
He said that they continue to work with urgency to ensure the first protein-based Covid-19 vaccine option in Indonesia is available for all awaiting its arrival.
Because the vaccine is stored at 2 to 8 degrees Celsius, the use of existing vaccine supply channels with more traditional cold chain capabilities is possible, potentially increasing access in hard-to-reach areas and vaccination rates across the nation. Initial shipments into Indonesia are expected to begin imminently.
Novavax and SII have already filed for authorisation of Novavax’ Covid-19 vaccine in India and the Philippines, as well as for Emergency Use Listing (EUL) with the World Health Organisation (WHO). Novavax recently also completed rolling submissions for authorisation of the Novavax vaccine with regulatory agencies in the UK, the European Union, Canada, and Australia.
Novavax expects to submit additional regulatory filings for its vaccine around the world as well as an additional supplemental filing for its vaccine for EUL with the WHO, shortly. It expects to submit its complete package to the US’ FDA by the end of the year.