The WHO EUL for Novavax’s Covid-19 vaccine is currently under assessment; will be completed following European Medicines Agency (EMA) review
WHO Headquarters in Geneva. (Credit: Yann Forget/Wikipedia.)
Novavax and Serum Institute of India (SII) announced that the World Health Organisation (WHO) has granted Emergency Use Listing (EUL) for Novavax’s Covid-19 vaccine NVX-CoV2373.
NVX-CoV2373 is a protein-based vaccine engineered from the genetic sequence of the initial SARS-CoV-2 strain and uses Matrix-M adjuvant.
The United Nations (UN) agency granted EUL for active immunisation of individuals aged 18 years and above, to prevent Covid-19.
The EUL relates to COVOVAX, a novel recombinant, adjuvanted SARS-CoV-2 rS vaccine manufactured and marketed by SII in India and other licensed territories.
WHO is currently reviewing an additional EUL filing by Novavax, seeking approval for marketing the vaccine under the brand name Nuvaxovid.
With the EUL, Novavax’s Covid-19 vaccine is prequalified to meet the established WHO standards for quality, safety and efficacy.
Novavax president and chief executive officer Stanley Erck said: “Today’s decision from the World Health Organization is vital to ensuring global access to a protein-based Covid-19 vaccine for hundreds of millions of people around the world.
“We believe this vaccine will help overcome barriers to vaccine access in many regions of the world by leveraging the traditional refrigeration used in existing vaccine supply channels, while also offering an option based on a familiar and well-understood technology.”
The WHO EUL was based on totality of preclinical, manufacturing and clinical trial data, including two Phase 3 trials, PREVENT-19, and a study conducted in the UK.
Phase 3 PREVENT-19 enrolled around 30,000 participants in the US and Mexico, while the UK study more than 14,000 participants.
In both trials, NVX-CoV2373 showed high efficacy and superior safety and tolerability profile.
COVOVAX was recently granted emergency use authorisation (EUA) in Indonesia and the Philippines and is currently under review in various other regulatory agencies.
Novavax is planning to submit complete chemistry, manufacturing and controls (CMC) data package to the US FDA by the end of this year.
WHO access to medicines and health products assistant-director general Mariângela Simão said: “Even with new variants emerging, vaccines remain one of the most effective tools to protect people against serious illness and death from SARS-COV-2.
“This listing aims to increase access particularly in lower-income countries, 41 of which have still not been able to vaccinate 10% of their populations, while 98 countries have not reached 40%.”