In a welcome development for Indians wanting to travel overseas, the WHO on Wednesday said it has granted emergency use listing (EUL) to Hyderabad-based Bharat Biotech's vaccine Covaxin.
This essentially means the 'made-in-India' vaccine will finally find acceptance in other countries; Indians who have received the jab need not self-quarantine or face restrictions when travelling abroad.
The nod has come after an exhaustive review; Bharat Biotech had provided the first batch of data way back in July which included assurances about the vaccine's safety, efficacy and stability, as well as details of production facilities. The excessive delay left many in the lurch, especially students bound for studies in Canada, the US, the UK, and Australia.
Last week, at the G-20 summit, PM Modi had given a sly nudge to WHO chief Tedros Adhanom Ghebreyesus by saying that India is ready to produce over 5 billion Covid vaccine doses next year to help the world in the fight against the pandemic. That possibly expedited the clearance.
The vaccine is also extremely suitable for low- and middle-income countries due to easy logistics and storage requirements; the WHO nod will help Bharat Biotech secure bulk export orders, sources said.
"A Technical Advisory Group has determined that Covaxin meets standards for protection against COVID-19... the benefit of the vaccine far outweighs risks (and) the vaccine can be used," the global health body said.
‘‘Covaxin was also reviewed by a Strategic Advisory Group of Experts on Immunization, which recommended its use in two doses, with an interval of four weeks, in all age groups 18+.
According to WHO, the vaccine has demonstrated 77.8% effectiveness in symptomatic cases and provided 65.2% protection against the new Delta variant.
However, the available data on pregnant women vaccinated with Covaxin was insufficient to assess its safety or efficacy in pregnancy; so, more studies on pregnant women are planned, including a pregnancy sub-study and a pregnancy registry.
Most important, the WHO approval has validated the trust in Indian vaccine industry. Significantly, Covaxin is one of the few 'made-in-India' vaccines and an instance of PM Modi’s flagship ‘Atmanirbhar Bharat’ programme. It can now be bracketed with Covishield and other WHO approved vaccines produced by American pharma giants Pfizer, Johnson & Johnson and Moderna, and China's Sinopharm.
Dr Krishna Ella, Chairman and Managing Director, Bharat Biotech, termed it a ‘significant step’. “The EUL authorisation for Covaxin will enable us to contribute to accelerating the equitable access of Covid-19 vaccine, and the access to our vaccine globally, thereby addressing the current public health emergency,” a company statement quoted him as saying.
WHO Regional Director for South-East Asia Dr Poonam Singh also congratulated India for the approval. Union Health Minister Mansukh Mandaviya called it a ‘win for Atmanirbhar Bharat’ and PM Modi’s goodwill and determination.
