Covovax vaccine, produced and manufactured by Serum Institute of India (SII) has been approved for emergency use listing (EUL) by the World Health Organization (WHO). It is the ninth Covid-19 vaccine to get WHO’s approval.
"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," SII CEO Adar Poonawalla said.
In an official statement, the WHO said, “Today, the World Health Organization issued an emergency use listing (EUL) for NVX-CoV2373, expanding the basket of WHO-validated vaccines against the SARS-CoV-2 virus. The vaccine, named Covovax, is produced by the Serum Institute of India under license 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."
"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," the world health body said in a tweet.
The WHO Emergency Use Listing Procedure (EUL) is a risk-based procedure for assessing and listing unlicensed vaccines, therapeutics and in vitro diagnostics with the ultimate aim of expediting the availability of these products to people affected by a public health emergency. This will assist interested UN procurement agencies and Member States in determining the acceptability of using specific products, based on an essential set of available quality, safety, and efficacy and performance data.
“Today’s decision from the WHO is vital to ensuring global access to a protein-based COVID-19 vaccine for hundreds of millions of people around the world,” said Stanley C Erck, President and Chief Executive Officer, Novavax.
The vaccine will help overcome barriers to vaccine access in many regions of the world by leveraging the traditional refrigeration used in existing vaccine supply channels, while also offering an option based on a familiar and well-understood technology, he added.
SII already manufactures Covishield in collaboration with AstraZeneca. Currently, Covishield and other COVID-19 vaccines are approved for people above the age of 18, and Bharat Biotech's Covaxin is being used for vaccinating children between the age 15 to 18.
SII’s Covovax Vaccine bags WHO’s approval for emergency use.