The World Health Organisation(WHO) on Friday approved the emergency use for Serum Institute of India’s Covovax, vaccine developed by the Serum Institute of India (SII) in partnership with the US-based Novavax, for showing excellent safety and efficacy. With this approval, Covovax became the 9th Covid-19 vaccine to be permitted for emergency use, providing a boost to ongoing efforts to vaccinate more people in lower-income countries.
“This is yet another milestone in our fight against Covid-19. Covovax is now WHO approved for emergency use, showing excellent safety and efficacy. Thank you all for a great collaboration,” Adar Poonawalla tweeted.
WHO’s EUL procedure 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.
Dr Mariângela Simão, WHO Assistant Director-General for Access to Medicines and Health Products, said with newer variants of the virus emerging, vaccines alone remain the most effective tool to protect people against serious complications and even death. “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%,” Simão said.
“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,” a press release by the WHO said. The health body also added that SII’s vaccine met 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.
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.