WHO lists Novavax-Serum Institute’s COVID-19 vaccine to boost vaccination in lower-income countries
The World Health Organization on Friday issued an emergency use listing to Serum Institute of India’s version of Novavax Inc’s NVX-CoV2373 COVID-19 vaccine. The recombinant nanoparticle protein-based vaccine with Matrix-M™ adjuvant is active for immunization of individuals 18 years of age and older for the prevention of coronavirus disease 2019 caused by SARS-CoV-2. WHO certified the vaccine as meeting the established standards for quality, safety, and efficacy thus paving way for shipping of their doses to the COVAX Facility, which was established to allocate and distribute vaccines equitably to participating countries and economies.
“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,” said Stanley C. Erck, President, and Chief Executive Officer, Novavax.
“We thank the World Health Organization for its thorough assessment. 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 familiar and well-understood technology.”
On his side, Adar Poonawalla, Chief Executive Officer, Serum Institute of India said the EUL by the World Health Organization is a great encouragement towards making COVID-19 vaccines more accessible and noted that their partnership with Novavax has been successful in providing global public health leadership and ensuring that all countries have broad access to a viable vaccine.
“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,” said Adar.
The emergency use listing (EUL) procedure assesses the suitability of novel health products during public health emergencies. The objective is to make medicines, vaccines, and diagnostics available as rapidly as possible to address the emergency while adhering to stringent criteria of safety, efficacy, and quality. The assessment weighs the threat posed by the emergency as well as the benefit that would accrue from the use of the product against any potential risks.
The grant of EUL to the vaccine was based on the totality of preclinical, manufacturing, and clinical trial data submitted for review. This includes two pivotal Phase 3 clinical trials: PREVENT-19, which enrolled approximately 30,000 participants in the U.S. and Mexico, the results of which were published December 15, 2021, in the New England Journal of Medicine (NEJM); and a trial that evaluated the vaccine in more than 14,000 participants in the U.K., the results of which were published June 30, 2021, in NEJM. In both trials, NVX-CoV2373 demonstrated high efficacy and reassuring safety and tolerability profile. Novavax will continue to collect and analyze real-world data, including the monitoring of safety and the evaluation of variants, as the vaccine is distributed.
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 U.S. FDA by the end of the year.