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WHO grants emergency use listing to Bharat Biotech's Covaxin

WHO grants emergency use listing to Bharat Biotech's Covaxin

The global body's Technical Advisory Group has determined that Covaxin meets WHO standards for protection against COVID-19, the benefit of the vaccine far outweighs risks and the vaccine can be used, WHO said.

Covaxin has demonstrated 77.8 per cent effectiveness against symptomatic COVID-19 and 65.2 per cent protection against the new Delta variant. Covaxin has demonstrated 77.8 per cent effectiveness against symptomatic COVID-19 and 65.2 per cent protection against the new Delta variant.

The World Health Organization (WHO) on Wednesday granted emergency use listing (EUL) to Bharat Biotech's COVID-19 vaccine Covaxin.
 
The global body's Technical Advisory Group, made up of regulatory experts from around the world, has determined that Covaxin meets WHO standards for protection against COVID-19, the benefit of the vaccine far outweighs risks and the vaccine can be used, WHO said in a series of tweets.
 

Covaxin was assessed under the WHO EUL procedure based on the review of data on quality, safety, efficacy, a risk management plan and programmatic suitability, a statement said. 

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Covaxin had demonstrated 77.8 per cent effectiveness against symptomatic COVID-19 and 65.2 per cent protection against the new Delta variant.
 

"Available data on vaccination of pregnant women with the vaccine are insufficient to assess vaccine safety or efficacy in pregnancy; studies in pregnant women are planned, including a pregnancy sub-study and a pregnancy registry," the statement added. 

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.
 
"This emergency use listing expands the availability of vaccines, the most effective medical tools we have to end the pandemic," said Dr Mariângela Simão, WHO Assistant-Director General for Access to Medicines and Health Products. "But we must keep up the pressure to meet the needs of all populations, giving priority to the at-risk groups who are still waiting for their first dose, before we can start declaring victory."
 
Covaxin and Serum Institute of India's Covishield are the two widely used vaccines in India.

Bharat Biotech, in a tweet, said the EUL by WHO validates the international safety and quality standards of the vaccine.

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