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American biotech company Novavax Inc’s Covid-19 vaccine has got its first emergency use authorisation (EUA) in Indonesia. The vaccine will be made by India’s Serum Institute and marketed in Indonesia under the Covovax brandname, the two companies said.
This EUA was for Novavax’s recombinant nanoparticle protein-based Covid-19 vaccine with Matrix-M adjuvant. “Initial shipments into Indonesia are expected to begin imminently,” the companies said, without a timeline. SII has reportedly asked the Indian drug regulator for permission to produce the vaccine. No details are available on when it would be allowed to export, either.
Stanley C. Erck, Novavax President and Chief Executive Officer, said the EUA marked a first for a protein-based Covid-19 vaccine based on Phase 3 clinical data demonstrating efficacy and a favourable safety profile. Many more were expected in the coming weeks and months for the vaccine, he added.
Productivity commitment
The development comes even as reports suggested, the companies had production-related concerns. Novavax had responded stating that it was committed to quality production and had put in place a manufacturing network to produce about 150 million doses per month, by the end of the fourth quarter.
Adar Poonawalla, SII-Chief Executive said, “We continue to work with urgency to ensure the first protein-based Covid-19 vaccine option in Indonesia is available for all awaiting its arrival.” Novavax and SII have a combined commitment of 1.1 billion doses of the vaccine to the WHO-supported Covax.
The two companies have already filed for authorisation of the vaccine in India and the Philippines, besides applying for an Emergency Use Listing (EUL) with the World Health Organization (WHO). The vaccine is stored at 2° to 8° Celsius and can use existing vaccine supply channels with traditional cold chain capabilities, potentially increasing access in hard-to-reach areas and vaccination rates across the nation.
Recently, Novavax also completed rolling submissions for authorisation of the vaccine with regulatory agencies in the UK, European Union, Canada and Australia. The company said it expected to submit additional regulatory filings for its vaccine around the world as well as additional supplemental filings for its vaccine for EUL with the WHO, shortly. Novavax expects to submit its complete package to the US FDA by the year-end, it added.
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