Union Health Minister Mansukh Mandaviya commended ICMR and Bharat Biotech scientists on the World Health Organization’s (WHO) decision to issue COVID-19 vaccine Covaxin emergency use listing (EUL) today.
“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.
The EUL process, developed by the World Health Organization, evaluates the quality, safety, and effectiveness of COVID-19 vaccines and is a requirement for COVAX vaccine delivery. It also permits nations to speed their own regulatory clearance for COVID-19 vaccine import and administration.
The TAG had requested “additional clarifications” from the firm on October 26 in order for Covaxin to undertake a final “risk-benefit assessment” for the vaccine’s Emergency Use Listing.
At the recent G20 conference, Prime Minister Narendra Modi met with WHO Director General Dr Tedros Adhanom Ghebreyesus.
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.