As Indonesia greenlights Novavax COVID-19 Vaccine, Company Expects More Countries to Follow COVID-19 Science 02/11/2021 • Kerry Cullinan Share this:Click to share on Twitter (Opens in new window)Click to share on LinkedIn (Opens in new window)Click to share on Facebook (Opens in new window)Click to print (Opens in new window) Indonesia has granted emergency use authorization (EUA) for the COVID-19 vaccine developed by Novavax, which will be made by the Serum Institute of India (SII) and sold under the brand name Covovax. “This marks the first regulatory authorization worldwide of a protein-based COVID-19 vaccine based on Phase 3 clinical data demonstrating efficacy and a favourable safety profile,” said Novovax CEO Stanley Erck, adding that it was the first of many authorizations that the company expects in the coming weeks and months. Novavax and SII have also filed for authorization of the vaccine vaccine in India and the Philippines. It has also applied for Emergency Use Listing (EUL) with the World Health Organization (WHO) and will supply the global body with additional supplemental filing “shortly”, it added. Novavax recently also completed rolling submissions for authorization with regulatory agencies in the UK, European Union, Canada and Australia. Novavax expects to submit a full application to the US Food and Drug Administration by the end of the year. “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 Erck. The vaccine is stored at 2° to 8° Celsius (normal refrigeration). “Access to a 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 SII CEO Adar Poonawalla. “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 two Phase 3 trials, the PREVENT-19 trial in the US and Mexico, demonstrated 100% protection against moderate and severe disease and 90.4% efficacy overall, according to the company – although it has not been tested on the Delta variant. It is a protein-based vaccine candidate engineered from the genetic sequence of the first strain of SARS-CoV-2 using “recombinant nanoparticle technology to generate antigen derived from the coronavirus spike (S) protein”, and paired with Novavax’ patented “saponin-based Matrix-M adjuvant to enhance the immune response and stimulate high levels of neutralizing antibodies”, said the company. The US government gave Novovax a contract worth $1.6 billion to develop its vaccine and to provide 100 million doses to the government. Novavax also has committed to supply 1.1 billion doses of its vaccine to COVAX. However, it has been hampered by manufacturing problems. Share this:Click to share on Twitter (Opens in new window)Click to share on LinkedIn (Opens in new window)Click to share on Facebook (Opens in new window)Click to print (Opens in new window) Combat the infodemic in health information and support health policy reporting from the global South. Our growing network of journalists in Africa, Asia, Geneva and New York connect the dots between regional realities and the big global debates, with evidence-based, open access news and analysis. To make a personal or organisational contribution click here on PayPal.