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Novavax and Serum Institute of India’s COVID-19 vaccine, Covavax, received an Emergency Use Authorization from the Indonesian government.
Novavax, a biotechnology company specializing in vaccines, and Serum Institute of India (SII), a vaccine manufacturer, announced on Nov. 1, 2021, that the National Agency of Drug and Food Control of the Republic of Indonesia granted Emergency Use Authorization (EUA) for Novavax’s COVID-19 vaccine. Shipments of Novavax's recombinant nanoparticle protein-based vaccine (which will be marketed as Covavax in Indonesia) are expected to begin immediately.
"The first authorization 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," said Stanley C. Erck, president and CEO, Novavax, in a company press release. "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 favorable safety profile. This is a landmark moment for Novavax and our partner, Serum Institute of India, and it is the first of many authorizations that Novavax expects in the coming weeks and months for our vaccine globally."
According to the press release, because the vaccine is stored at 2° to 8° C, it can be safely placed in traditional vaccine storage facilities. Novavax believes that this can potentially help increase vaccine rates in hard-to-reach areas.
"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," said Adar Poonawalla, CEO, SII, in the press release. "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."
In addition to this authorization, Novavax and SII have filed for vaccine authorization in India and the Philippines. They have applied for an Emergency Use Listing with the World Health Organization, and completed rolling submission for authorization with the United Kingdom, European Union, Canada, and Australia.