WHO grants Emergency Use Listing to COVID-19 vaccine manufactured by Hyderabad-based Bharat Biotech, following additional clarifications by latter
A health worker takes a swab sample from a woman during random testing at a market in Delhi on Tuesday. Pic/AFP
The World Health Organisation (WHO) has granted approval for Emergency Use Listing (EUL) to Covaxin, manufactured by Hyderabad-based Bharat Biotech, for global use of the COVID-19 vaccine. Earlier, the WHO’s Technical Advisory Group (TAG) had sought additional clarifications from Bharat Biotech, in order to conduct a final EUL risk-benefit assessment.
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The approval was done on the recommendation of the TAG, an independent advisory panel that provides recommendations to WHO on whether a COVID-19 vaccine can be listed for emergency use under the EUL procedure.
A medic shows a Covaxin vial, at a government hospital, in Kolkata. File pic/PTI
Covaxin has demonstrated 77.8 per cent effectiveness against symptomatic COVID-19 and 65.2 per cent protection against the new Delta variant. Bharat Biotech said that it concluded the final analysis of Covaxin efficacy from Phase 3 trials.
The WHO has so far approved COVID-19 vaccines of Pfizer-BioNTech, AstraZeneca-Oxford University/Serum Institute of India, Johnson & Johnson, Moderna and Sinopharm for emergency use.
Shelf life increased
Bharat Biotech on Wednesday said the Central Drugs Standard Control Organisation (CDSCO) has approved the extension of shelf life of its COVID-19 vaccine, Covaxin, up to 12 months from the date of manufacture.
A crowded market on the eve of Diwali, in Kolkata, on Wednesday. Pic/PTI
“This approval of shelf life extension is based on the availability of additional stability data, which was submitted to CDSCO,” Bharat Biotech said in a tweet. Covaxin initially had a shelf life of six months.
India’s COVID-19 tally reached 3,43,08,140 with a single-day rise of 11,903 new infections, while the number of active cases declined to 1,51,209, the lowest in 252 days, according to the Union health ministry data updated on Wednesday morning. The COVID-19 death toll has climbed to 4,59,191 with 311 daily fatalities.
April
Month when Bharat Biotech had applied for EUL
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