Bharat Biotech’s children’s vaccine is good news. But why has his vaccine for adults not yet obtained authorization from the WHO?



Bharat Biotech is set to become the second Indian vaccine manufacturer to receive emergency domestic use authorization for a Covid vaccine for children. The company’s vaccine, Covaxin, is already in use in the national program. It provided around 111 million doses, or 11.49% of the overall vaccine coverage against Covid. The company’s children’s vaccine has received conditional approval from an expert committee of the drug regulator. The next steps will need to be final approval and authorization from the National Immunization Technical Advisory Group to be included in the national program.

Previously, the Zydus Cadila vaccine had been approved for children over 12 years of age. Covaxin, if approved for emergency use, will cover the age group from 2 to 18 years old. These developments are timely. India’s Covid Vaccination Program has now ensured that around 29.2% of the adult population is fully vaccinated. The deployment of vaccination prioritized the demographic data most at risk. Now there must be a parallel push to immunize children. WHO data showed that between December 30, 2019 and September 6, 2021, children under the age of 15 accounted for 8% of cases worldwide. Therefore, Covid’s containment strategy must place this demographic group under a protective umbrella.

That said, the lack of emergency WHO approval to date for Covaxin is disconcerting. Two vaccines developed by the Chinese Sinovac and Sinopharm using the same inactivated vaccine platform have obtained this approval. WHO approval is a prerequisite for other benefits. This opens the door to vaccine passports and export opportunities. Bharat Biotech needs to overcome this hurdle as soon as possible by meeting WHO data requirements. Until that happens, it bothers millions of Indians who have been vaccinated with Covaxin and may now need to travel for work or study.

India’s cumulative immunization coverage is fast approaching one billion doses. The ramp-up of production, mainly from Covishield, has helped speed up the pace of vaccination in the past two months. If the manufacture of Covaxin is also increased more rapidly, it will contribute to a complete normalization of social interactions in a few months. Indian science has reason to be proud of being one of the few countries to develop its own vaccine against Covid. The point to remember is that further development and regulatory approvals require a much higher level of data recording. Medicines and vaccines is an area in which India is competitive globally. Stakeholders must build on this foundation.


This article was published as an editorial opinion in the print edition of The Times of India.



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