Herald View: The curious case of Covaxin and WHO

External Affairs Minister S. Jaishankar on March 1 was among the first Indians to receive the Covid-19 vaccine. While it is not clear whether this was his first or the second dose, he did tweet, ‘Got my jab. For the curious, it was Covaxin. Felt secure, will travel safely’. It was immensely reassuring to see the public display of faith by a union minister in the Indian vaccine. The Indian middle class then were either looking for Serum Institute’s Covishield, developed by Oxford and licensed by AstraZeneca, or were waiting to be administered the US vaccines manufactured by Pfizer or Moderna. The Indian vaccine was widely believed to be less effective at the time. But when both Prime Minister Narendra Modi, who did not specifically say he received the Covaxin, and other union ministers like the EAM who did, took Covaxin, it was both good public relations and was also reassuring to the people. But curiously, six months after S. Jaishankar took the jab, Covaxin is yet to be approved by the World Health Organisation (WHO) and by most major countries. There are indeed reports in the media about the impending approval of the vaccine from WHO.

Some reports say that the approval will come by the middle of September. But there is little clarity on why the approval has taken so long. Questions on how the EAM and other Union Ministers, who have all presumably received the Covaxin, have been travelling abroad without the approval is another question that has been asked but not answered. While SII belatedly woke up to the fact that even Covishield had not been approved by the European Union or the United States, while its original variant Oxford-AstraZeneca was, international travellers from India, mostly students, faced enormous inconvenience and cost of being quarantined on arrival at their destination. Even more curiously, the approval, if it does come by the middle of September, will coincide with Prime Minister Narendra Modi’s first visit abroad after the pandemic when he is expected to visit the US and address the UN General Assembly in New York.

Bharat Biotech’s application for emergency use approval had been turned down by the US Food and Drug Administration (FDA) in June. WHO’s chief scientist Soumya Swaminathan was quoted in July as saying that it would take four to six more weeks for including Covaxin in WHO’s Emergency Use Listing (EUL), which is granted after an international panel examines and approves the quality, safety and efficacy besides cold chain requirements and risk management etc. It is a prerequisite for supplying the vaccine to other countries. In mid-August Union Health Minister Mansukh Mandaviya also met Swaminathan to discuss the delay in listing.

While WHO’s approval is awaited, Covaxin is said to have been approved by at least 14 countries so far, among them Iran, Nepal and Zimbabwe, thus adding to the mystery. While it is now known that Bharat Biotech had not even submitted its Expression of Interest (EIO), the first step for approval, till April this year, the Indian Council of Medical Research (ICMR) has consistently claimed that Covaxin is equally effective against the Beta and Delta variants. It is also not known if the delay by the WHO is connected in any way to the ongoing investigation in Brazil, which had first raised quality and safety issues about the Indian vaccine. Reasons for keeping people in the dark, a feature of this government otherwise known for both effective and fake and excessive communication, remains a mystery.