STOCK MARKET BSE NSE

Novavax, Serum Institute receive emergency use authorisation for COVID-19 vaccine in Indonesia 

The vaccine will be manufactured by the Serum Institute of India (SII) in India and marketed by it in Indonesia under the brand name Covovax, Novavax Inc said in a statement.

Published: 01st November 2021 09:40 PM  |   Last Updated: 01st November 2021 09:40 PM   |  A+A-

Covid Vaccine, Coronavirus

Image for representation(File Photo | AFP)

By PTI

NEW DELHI: Biotechnology firm Novavax Inc and its partner Serum Institute of India on Monday, November 1, 2021, 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's 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.



Comments

Disclaimer : We respect your thoughts and views! But we need to be judicious while moderating your comments. All the comments will be moderated by the newindianexpress.com editorial. Abstain from posting comments that are obscene, defamatory or inflammatory, and do not indulge in personal attacks. Try to avoid outside hyperlinks inside the comment. Help us delete comments that do not follow these guidelines.

The views expressed in comments published on newindianexpress.com are those of the comment writers alone. They do not represent the views or opinions of newindianexpress.com or its staff, nor do they represent the views or opinions of The New Indian Express Group, or any entity of, or affiliated with, The New Indian Express Group. newindianexpress.com reserves the right to take any or all comments down at any time.

edexworks
flipboard facebook twitter whatsapp