Earlier this hour: “Novavax and Serum Institute of India Receive Emergency Use Authorization for COVID-19 Vaccine in Indonesia.
Novavax, Inc. (Nasdaq: NVAX), a biotechnology company dedicated to developing and commercializing next-generation vaccines for serious infectious diseases, and Serum Institute of India Pvt. Ltd. (SII), the world’s largest vaccine manufacturer by volume, today announced that 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 authorization (EUA) for Novavax’ recombinant nanoparticle protein-based COVID-19 vaccine with Matrix-M™ adjuvant. It will be manufactured by SII in India and marketed by SII in Indonesia under the brand name COVOVAX.
‘The first authorization 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,’ said Stanley C. Erck, President and Chief Executive Officer, Novavax
‘This also marks the first regulatory authorization worldwide of a protein-based COVID-19 vaccine based on Phase 3 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.’
Because the vaccine is stored at 2° to 8° 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.
‘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, Chief Executive Officer, Serum Institute of India. ‘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.’
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 (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. Novavax expects to submit its complete package to the U.S. FDA by the end of the year.
Indonesia is a member of the Pharmaceutical Inspection Co-operation Scheme (PIC/S), a non-binding co-operative arrangement between more than 50 regulatory authorities, including those in the U.S., United Kingdom, European Union, Australia and Canada, in the field of Good Manufacturing Practice (GMP) of medicinal products for human or veterinary use. PIC/S aims at harmonizing inspection procedures worldwide through the development of common standards in the field of GMP and at facilitating cooperation and networking between competent authorities, regional and international organizations, thus increasing mutual confidence.
For additional information on COVOVAX, including the Summary of Product Characteristics, Prescribing Information and Important Safety Information, please visit: Indonesia National Agency of Drug and Food Control (Badan POM). This information will be posted in the coming days ….
Source: PR Newswire
