Union Health Minister Mansukh Mandaviya on Wednesday congratulated scientists of ICMR and Bharat Biotech after the World Health Organisation today granted emergency use listing (EUL) to COVID-19 vaccine Covaxin.
"WHO today granted for Emergency Use Listing (EUL) of Made-in-India Covaxin. On this occasion, I congratulate scientists of ICMR and Bharat Biotech (the manufacturer of Covaxin)," Union Health Minister Mansukh Mandaviya was quoted as saying by news agency ANI.
The nod of the global health body comes after the Technical Advisory Group (TAG), an independent advisory committee of WHO recommended EUL status for Covaxin.
Dr Poonam Khetarpal Singh, Regional Director of WHO South East Asia, in a tweet, said, "Congratulations India for Emergency Use Listing of its indigenously produced COVID-19 vaccine Covaxin." The WHO said the TAG convened by it and made up of regulatory experts from around the world determined that Covaxin meets its standards for protection against COVID-19, and that the benefit of the vaccine far outweighs risks and thus can be used.
Covaxin was found to have 78 per cent efficacy against COVID-19 of any severity, 14 or more days after the second dose, and is extremely suitable for low- and middle-income countries due to easy storage requirements, it said.
"Covaxin EUL expands the availability of Syringe, the most effective medical tools we have to end #COVID19. It was assessed under the WHO EUL procedure based on the review of data on quality, safety, efficacy, a risk management plan & suitability in low- & middle-income countries," it stated.
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.
The TAG on October 26 had sought "additional clarifications" from the company for Covaxin to conduct a final "risk-benefit assessment" for Emergency Use Listing of the vaccine.
Prime Minister Narendra Modi met WHO Director General Dr Tedros Adhanom Ghebreyesus at the G20 summit recently.
Besides demonstrating 77.8 per cent effectiveness against symptomatic COVID-19, Covaxin has shown 65.2 per cent protection against the new Delta variant.
In June, the company said it concluded the final analysis of Covaxin efficacy from Phase 3 trials.
Bharat Biotech's Covaxin and AstraZeneca and Oxford University's Covishield are the two widely used vaccines in India.