The World Health Organization (WHO) on Wednesday recommended emergency use list (EUL) status for Bharat Biotech’s Covid-19 vaccine, Covaxin.
“WHO has granted an emergency use list (EUL) to COVAXIN (developed by Bharat Biotech), adding to a growing portfolio of vaccines validated by WHO for the prevention of Covid-19”the world health body said in a statement. declaration.
The WHO said Covaxin had also been reviewed by its Strategic Advisory Group of Experts on Immunization (SAGE), which recommended the use of this vaccine in two doses, with a dosing interval of four weeks, in all age groups 18 and over.
“There is insufficient data available on the vaccination of pregnant women with the #Covaxin vaccine to assess the safety or efficacy of the vaccine during pregnancy; studies in pregnant women are planned, including a pregnancy sub-study and a pregnancy registry ”, said the WHO.
Bharat Biotech responded to the news by stating that global organizations can now source Covaxin for distribution.
“With WHO validation, countries can now speed up their regulatory approval processes to import and administer Covaxin. UNICEF, Pan American Health Organization (PAHO), GAVI COVAX facility will be able to purchase Covaxin for distribution in countries around the world“Said the Hyderabad-based company.
Following this, the Union Minister of Health, Mansukh Mandaviya, congratulated the scientists and Bharat Biotech for this feat.
Covaxin has demonstrated 77.8% efficacy against symptomatic Covid-19 and 65.2% protection against the Delta variant.
In June, the company said it had concluded the final analysis of the efficacy of Covaxin from phase 3 trials. Covaxin and AstraZeneca from Bharat Biotech and Covishield from the University of Oxford are the two vaccines widely used in India. .
The emergency use list would allow Bharat to ship the vaccine to countries that rely on WHO guidelines for their regulatory decisions.
Covaxin is seventh to gain WHO support after two injections of mRNA by Pfizer / BioNTech and Moderna, adenovirus vector vaccines developed by AstraZeneca and Johnson & Johnson, and Chinese inactivated vaccines from Sinovac Biotech and Sinopharm .