Novavax has received the first emergency use authorisation (EUA) for its COVID-19 vaccine in Indonesia, with the company adding it is expecting further authorisations in the coming weeks and months.
Novavax’s jab is a recombinant protein-based COVID-19 vaccine with its Matrix-M adjuvant.
The vaccine will be manufactured by the Serum Institute of India (SII) and marketed in Indonesia under the brand name Covovax.
Novavax, alongside SII, has already filed for authorisation of the vaccine in India and the Philippines, as well as for an emergency use listing (EUL) with the World Health Organization (WHO).
Recently, Novavax also completed rolling submission for authorisation of its vaccine with regulatory agencies in the UK, EU, Canada and Australia.
Further regulatory filings for Novavax’s vaccine are expected to be submitted to additional global regulatory authorities, the company added in a statement.
This includes an expected completed package submission for the vaccine to the US Food and Drug Administration by the end of the year.
“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,” said Stanley C. Erck, president and chief executive officer, Novavax.
“This also marks the first regulatory authorization worldwide of a protein-based COVID-19 vaccine based on Phase III 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 authorszations that Novavax expects in the coming weeks and months for our vaccine globally,” he added.