Covovax receives WHO approval for emergency use

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.

Covovax receives WHO approval for emergency use

Mumbai: In a step to strengthen the fight against COVID-19 pandemic, the World Health Organization (WHO) has issued an emergency use listing (EUL) for NVX-CoV2373 manufactured by Serum Institute of India (SII), expanding the basket of WHO-validated vaccines against the coronavirus. 

The vaccine, named CovovaxTM, is produced by the SII under licence from Novavax and is part of the COVAX facility portfolio, giving a much-needed boost to ongoing efforts to vaccinate more people in lower-income countries.

Adar Poonawalla said in a tweet, "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."

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. ‘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%.”

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.