The WHO on Friday issued an emergency use listing (EUL) for NVX-CoV2373, or Covovax, the anti-Covid vaccine being produced by the Pune-based Serum Institute of India (SII) under licence from Novavax.
“The EUL by the World Health Organization (WHO) is a great encouragement towards making Covid-19 vaccines more accessible. Our partnership with Novavax has been successful in providing global public health leadership and ensuring that all countries have broad access to a viable vaccine,” said Adar Poonawalla, Chief Executive Officer, SII. “Covovax is the first protein-based Covid-19 vaccine option with demonstrated efficacy and a well-tolerated safety profile to be made available through the COVAX Facility. We thank the WHO and seek to help the world control the spread of the pandemic,” Poonawalla said in a statement on Friday.
The EUL prequalifies Novavax’s Covid-19 vaccine as meeting the established WHO standards for quality, safety and efficacy. EUL is a prerequisite for exports to numerous countries, including those participating in the COVAX facility, which was established to allocate and distribute vaccines equitably to participating countries and economies.
Covovax is a subunit of the vaccine developed by Novavax and the Coalition for Epidemic Preparedness Innovations (CEPI). It requires two doses and is stable at 2 to 8°C refrigerated temperatures. The vaccine uses a novel platform and is produced by creating an engineered baculovirus containing a gene for a modified SARS-CoV-2 spike protein.
The grant of EUL was based on the totality of preclinical, manufacturing and clinical trial data submitted for review. This included two pivotal Phase 3 clinical trials: PREVENT-19, which enrolled approximately 30,000 participants in the US and Mexico, the results of which were published on December 15 in the New England Journal of Medicine (NEJM), and a trial that evaluated the vaccine in more than 14,000 participants in the UK, the results of which were published in NEJM on June 30.
Novavax and SII recently received emergency use authorization (EUA) for Covovax in Indonesia and The Philippines. The vaccine is also currently under review by multiple regulatory agencies worldwide. The company expects to submit its complete chemistry, manufacturing and controls (CMC) data package to the US FDA by the end of the year.
“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,” said Dr Mariângela Simão, WHO Assistant-Director General for Access to Medicines and Health Products. “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…”
Covovax was assessed under the WHO EUL procedure based on the review of data on quality, safety and efficacy, a risk-management plan, programmatic suitability, and manufacturing site inspections carried out by the Drugs Controller General of India. The Technical Advisory Group for Emergency Use Listing (TAG-EUL), convened by WHO and made up of experts from around the world, has determined that the vaccine meets WHO standards for protection against Covid-19, that the benefit of the vaccine far outweighs any risks, and that the vaccine can be used globally.
The originator product produced by Novavax, named Nuvaxovid, is currently under assessment by the European Medicines Agency (EMA). WHO will complete its own assessment of this vaccine once the EMA has issued its recommendation. A meeting of WHO’s Strategic Advisory Group of Experts on Immunization (SAGE) this week also reviewed the vaccine. SAGE, which formulates specific policies and recommendations for vaccine use in populations, will issue recommendations for Nuvaxovid/Covovax in the coming days.
“Today’s (Friday’s) decision from the WHO is vital to ensuring global access to a protein-based Covid-19 vaccine for hundreds of millions of people around the world,” said Stanley C Erck, President and Chief Executive Officer, Novavax. “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,” Erck added.