Novavax Inc and its partner Serum Insitute of India (SII) on Monday received the emergency use authorisation (EUA) for its COVID-19 vaccine from Indonesia. The National Agency of Drug and Food Control of Indonesia granted emergency use authorization for Novavax' recombinant nanoparticle protein-based Covid-19 vaccine with Matrix-M adjuvant.
The biotech firm in an official statement confirmed that the vaccine will be manufactured by SII in India and marketed by SII in Indonesia under the brand name Covovax.
The biotech firm also went on to add that because the vaccine is stored at 2 degree to 8 degree Celsius, the use of existing vaccine supply channels with more traditional cold chain capabilities is possible, potentially increasing access in hard-to-reach areas and vaccination rates across the nation.
Initial shipments into Indonesia are expected to begin imminently, announced Novavax.
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 biotech company 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. It also expects to submit its complete package to the US FDA by the end of the year.
Meanwhile, earlier in the day, Australia recognised India's Covaxin for the purpose of travel to the nation as it eased some restrictions on international travel. After over 18 months of some of the world's most stringent COVID-19 border policies, millions of Aussies are now allowed to travel freely without a permit from authorities or the need to quarantine while arriving in the country.
ALSO READNovavax, COVID-19 vaccine which demonstrated 90% efficacy, likely to be cleared for use in India in...
(To receive our E-paper on whatsapp daily, please click here. We permit sharing of the paper's PDF on WhatsApp and other social media platforms.)