Biotechnology firm Novavax Inc and its partner Serum Institute of India on Monday said they have received the first emergency use authorisation (EUA) for Novavax's COVID-19 vaccine, in Indonesia.
The vaccine will be manufactured by Serum Institute of India (SII) in India and marketed by it in Indonesia under the brand name Covovax, Novavax Inc said in a statement.
"The National Agency of Drug and Food Control of the Republic of Indonesia, or Badan Peng was Obat dan Makanan (Badan POM), has granted emergency use authorisation (EUA) for Novavax' recombinant nanoparticle protein-based COVID-19 vaccine with Matrix-M adjuvant," it added.
Initial shipments into Indonesia are expected to begin imminently, the statement said.
"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-III clinical data demonstrating efficacy and a favourable safety profile, he added.
On the development, Serum Institute of India CEO Adar Poonawalla said that 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.
"We continue to work with urgency to ensure that the first protein-based COVID-19 vaccine option in Indonesia is available for all awaiting its arrival," he added.
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 Organization (WHO), the statement said.
Recently, Novavax also completed rolling submissions for authorisation of the Novavax vaccine with regulatory agencies in the UK, European Union, Canada and Australia, it added.
"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. Novavax expects to submit its complete package to the US FDA by the end of the year," the statement said.