Novavax along with its partner SII intend to obtain World Health Organization (WHO) emergency use listing (EUL) this month, based on the DCGI submission
Novavax along with its partner Serum Institute of India (SII) has filed regulatory submissions with the Drugs Controller General of India (DCGI) and regulatory agencies in Indonesia and the Philippines for the emergency use authorisation of its Covid-19 vaccine candidate NVX-CoV2373.
The companies have submitted all modules required by regulators in respective countries, including preclinical, clinical, and chemistry, manufacturing and controls data, to start the review.
SII has teamed up with Novavax to manufacture and develop and commercialise the Covid-19 vaccine in India.
In May this year, Indian regulatory agency DCGI has completed a Good Manufacturing Practice joint site inspection at SII.
SII and Novavax are expected to file an application with the World Health Organization (WHO) for emergency use listing (EUL) this month, based on the DCGI submission.
The WHO EUL allows the export of the vaccine to various countries under the COVAX Facility, where the companies are jointly committed to supplying more than 1.1 billion doses.
Novavax president and CEO Stanley Erck said: “Today’s submission of our recombinant nanoparticle Covid-19 vaccine, the first protein-based option filed with any regulatory agency, represents a major milestone in Novavax’ transformation into a commercial global vaccine company.
“This important step toward access to millions of doses of a safe and effective vaccine for countries with an urgent need to control the pandemic was made possible through our strategic partnership with Serum Institute of India, and it demonstrates the power of global collaboration.”
NVX-CoV2373 is a recombinant nanoparticle protein-based Covid-19 vaccine candidate that leverages saponin-based Matrix-M adjuvant for enhanced antigen presentation.
The vaccine is stored at 2° to 8°C, to support the vaccine supply and cold chain channels, and is administered as two 0.5 ml doses, given intramuscularly 21 days apart.
In preclinical studies, the vaccine protected from infection and disease by triggering immune responses and was generally well-tolerated.
NVX-CoV2373 was evaluated in two pivotal Phase 3 trials, one in the UK that showed 89.7% overall efficacy, and the other, PREVENT-19 trial in the US and Mexico showed 90.4%.
Novavax has recently reached an agreement with the European Commission (EC) to supply up to 200 million doses of NVX-CoV2373, through 2023.