The World Health Organisation (WHO) has approved Covid-19 vaccine Covovax for emergency use, expanding the basket of WHO-validated vaccines against the SARS-CoV-2 virus to nine. The vaccine is produced by the Serum Institute of India (SII) under licence from the U.S.-based Novavax. Covovax is part of WHO's COVAX facility portfolio, established to ensure adequate supply of Covid-19 vaccines to people in lower-income countries.
WHO chief scientist Soumya Swaminathan congratulated Serum Institute, its CEO Adar Poonawalla and Novavax for offering one more highly effective and safe vaccine for COVAX and the world.
WHO’s emergency use listing (EUL) assesses the quality, safety and efficacy of Covid-19 vaccines and is a prerequisite for COVAX vaccine supply. It also allows countries to expedite their own regulatory approval to import and administer Covid-19 vaccines. ‘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%,” said Dr Mariângela Simão, WHO's assistant director general for access to medicines and health products.
Covovax is a sub-unit 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 degrees Celsius 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, a WHO statement said.
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.
The 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.