Covovax gets WHO's approval for emergency use
New Delhi, Dec 17: Serum Institute of India's Covid vaccine Covovax has been approved for emergency use by the World Health Organisation, for showing excellent safety and efficacy.
"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.
This is yet another milestone in our fight against COVID-19, Covovax is now W.H.O. approved for emergency use, showing excellent safety and efficacy. Thank you all for a great collaboration, @Novavax @WHO @GaviSeth @Gavi @gatesfoundation https://t.co/7C8RVZa3Y4— Adar Poonawalla (@adarpoonawalla) December 17, 2021
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.
"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.
"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," said a press release from WHO.
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.