Home >News >India >Covaxin may get WHO’s EUL this week, says NTAGI official

NEW DELHI : The World Health Organisation (WHO) may take a decision on granting Emergency Use Listing (EUL) to Bharat Biotech’s Covaxin this week, Dr N.K. Arora, National Technical Advisory Group on Immunization (NTAGI) chairperson has said.

 “We should be getting the WHO EUL for Covaxin withing this week. The vaccine should get international recognition with this. Post approval people wanting to travel abroad will not have difficulty," said Arora. 

Union health minister Mansukh Mandaviya met World Health Organization (WHO) chief scientist Soumya Swaminathan on August 12 to discuss the UN agency's approval for Bharat Biotech's covid-19 vaccine Covaxin. Swaminathan in July had said that the WHO may take a decision on granting Emergency Use Listing (EUL) to Covaxin in four-six weeks.  

WHO’s Emergency Use Listing (EUL) is a prerequisite for COVAX Facility vaccine supply to other countries. The EUL assesses the quality, safety, and efficacy of covid-19 vaccines, as well as risk management plans and programmatic suitability, such as cold chain requirements. The assessment is performed by the product evaluation group, composed by regulatory experts from around the world and a Technical Advisory Group (TAG), in charge of performing the risk-benefit assessment for an independent recommendation on whether a vaccine can be listed for emergency use and, if so, under what conditions. So far, the WHO has given EUL to six vaccines. 

Mariangela Simao, WHO assistant director-general for vaccines, according to reports, had said that the UN health agency’s assessment of the Bharat Biotech vaccine was "quite advanced" and officials hoped for a decision by mid-September. 

Covaxin, India's first indigenous covid vaccine, has also received EUAs from 14 countries and another 50 in the process. In June, the drug maker had said that its US partner, Ocugen, has received a recommendation from the US Food and Drug Administration to pursue Biologics License Applications (BLA) path for Covaxin, which is a full approval. Applications have to follow the BLA process, which is the standard for vaccines. 

Bharat Biotech is also exploring manufacturing partnerships with its partners in other countries, who have prior expertise with commercial scale manufacturing of inactivated viral vaccines under biosafety containment for further augmentation.     

According to the union health ministry, more than 72.77 crore vaccine doses (inclusive of all available vaccines (covaxin, covishield and sputnik)) have been provided to States/UTs so far through government of India (free of cost channel) and through direct state procurement category. Further, more than 1.6 Crore doses are in the pipeline. 

More than 4.49 Crores balance and unutilized covid-19 vaccine doses are still available with the States/UTs to be administered. 

India’s covid-19 vaccination coverage has crossed75.81 Crore(75,81,99,331) on Tuesday.  

The recovery of 37,127 patients in the last 24 hours has increased the cumulative tally of recovered patients (since the beginning of the pandemic) to 3,24,84,159. Consequently, India’s recovery rate stands at 97.58%.  

Over 25,404 new coronavirus cases were reported in the last 24 hours. The Active Caseload is presently 3,62,207. Active cases presently constitute 1.09% of the country's total Positive Cases.  India has so far conducted over 54.44 Crores cumulative covid-19 tests.  The Daily Positivity rate was reported to be 1.78% on Tuesday.

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