The World Health Organization on Friday, 17 December, issued an emergency use listing (EUL) for COVID-19 vaccine Covovax, making it the 9th coronavirus vaccine to have received the approval.
The vaccine, produced by the Serum Institute of India (SII) under licence from Novavax, and is part of the COVAX facility, a worldwide initiative aimed at providing equitable access to COVID-19 vaccines.
"CovovaxTM 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."World Health Organization
The EUL of Covovax will give a much-needed boost to ongoing efforts to vaccinate more people in lower-income countries, as per the WHO.
"This listing aims to increase access particularly in lower-income countries, 41 of which have still not been able to vaccinate 10 percent of their populations, while 98 countries have not reached 40 percent,” said Dr Mariângela Simão, WHO Assistant-Director General for Access to Medicines and Health Products, in a press release.
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.
Meanwhile, SII chief Adar Poonawalla hailed the emergency use listing as a milestone.