Biotechnology company Novavax, Inc. (NVAX) and Serum Institute of India Pvt. Ltd. or SII, the world’s largest vaccine manufacturer by volume, announced Monday that NVX-CoV2373 COVID-19 Vaccine has received emergency use authorization or EUA in Indonesia.
In pre-market activity on Nasdaq, Novavax shares were gaining around 12.1 percent to trade at $167.
NVX-CoV2373 is Novavax’ recombinant nanoparticle protein-based COVID-19 vaccine with Matrix-M adjuvant.
The National Agency of Drug and Food Control of the Republic of Indonesia has granted the EUA for Novavax’ COVID-19 vaccine, which will be manufactured by SII in India and marketed by SII in Indonesia under the brand name COVOVAX.
Initial shipments into Indonesia are expected to begin imminently.
The vaccine is stored at 2° to 8° Celsius, due to which the existing vaccine supply channels with more traditional cold chain capabilities will be enough to store it. This will potentially increase access in hard-to-reach areas and vaccination rates across the country.
Novavax and SII have already filed for authorization of Novavax’ COVID-19 vaccine in India and the Philippines, as well as for Emergency Use Listing or EUL with the World Health Organization (WHO).
Novavax recently also completed rolling submissions for authorization of the Novavax vaccine with regulatory agencies in the United Kingdom, European Union, Canada and Australia. 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.
The company expects to submit its complete package to the U.S. FDA by the end of the year.
Separately, the company announced the completion of its rolling submission to Health Canada for authorization of its COVID-19 vaccine candidate NVX-CoV2373. In addition, the company has completed the submission of all data and modules to the European Medicines Agency or EMA to support the final regulatory review of its dossier.
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