New Delhi: Novavax’s nanoparticle protein-based Covid-19 vaccine, set to be manufactured by the Serum Institute of India (SII), has been authorised by Indonesia for emergency use.
SII, the world’s largest vaccine manufacturer, will be marketing the vaccine in Indonesia under the brand name Covovax. The approval was given by Indonesia’s National Agency of Drug and Food Control, known as the BPOM.
“The first authorisation 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 vaccines for its population,” Stanley C. Erck, president and chief executive officer of Novavax, said in a statement.
“This also marks the first regulatory authorisation worldwide of a protein-based Covid-19 vaccine based on Phase 3 clinical data demonstrating efficacy and a favorable safety profile,” Erck added.
SII ‘working with urgency to make it available’
The vaccine needs to be stored at 2 to 8 degrees Celsius, which means it can make use of the existing vaccine supply channels. Initial shipments into Indonesia are “expected to begin imminently”, Novavax said in a statement.
Adar Poonawalla, CEO of the SII, added, “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. 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 also filed for authorisation of the vaccine in India, the Philippines, United Kingdom, European Union, Canada and Australia, as well as for emergency use listing with the World Health Organization (WHO).
Science behind the vaccine
NVX-CoV2373, Novavax‘s Covid vaccine, is a protein-based vaccine candidate engineered from the genetic sequence of the first strain of SARS-CoV-2. The vaccine also contains Novavax‘s patented adjuvant known as Matrix-M to enhance the immune response.
NVX-CoV2373 contains purified protein antigen and can neither replicate nor can it cause Covid-19.
The vaccine is packaged as a ready-to-use liquid formulation in a vial containing ten doses. The vaccination regimen calls for two 0.5 ml doses (5 microgram antigen and 50 microgram Matrix-M adjuvant) given intramuscularly, 21 days apart.
(Edited by Paramita Ghosh)