Hyderabad-based Bharat Biotech is yet to secure approval from the World Health Organisation for emergency use listing of its COVID-19 vaccine ‘Covaxin’. While the WHO has said it requires more information from the Covaxin maker, Bharat Biotech has said that it has already submitted 90 per cent of the documents required by the WHO.
The company is confident of getting EUL for Covaxin and has assured the Union government that it will submit the remaining documents to the WHO by June. Notably, Covaxin has been already approved for emergency use in 11 countries. Also, 11 companies in seven countries have shown interest in technology transfer and production of Covaxin.
With countries recovering from the COVID-19 pandemic, global trade is once again picking up requiring people to travel. Since Covaxin is not approved by the regulators in the US, the UK, Canada, Australia and Ireland among others as well as the WHO, people who have been administered Covaxin might not be able to travel to these countries.
The WHO has so far approved Pfizer, Moderna, Covishield, J&J and China’s Sinopharm. However, Covaxin has not made it to the list.
The importance of getting the WHO nod is that the middle and poor-income countries that do not have a robust system to evaluate a vaccine for safety and efficacy depend on the WHO’s assessment. Once WHO clears a vaccine, these countries can use the approved vaccines without having to worry about its safety. Also, approval by the WHO makes a vaccine eligible for the global vaccination programme.
Only three vaccines approved in India
So far, the Indian drug regulator has approved only three vaccines—Covishield, Covaxin and Sputnik V. India’s vaccination drive is running at a relatively slower rate as compared to its huge population. Many states have discontinued the vaccination of people in the 18-44 year age group due to acute shortage of the jabs and to prioritise the vaccination of people above 45 who had already taken the first dose of the two-dose vaccines.
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