Rolling out vaccines in the time of a raging pandemic in a nation as populous as India was bound to be accompanied by attendant challenges. But the lack of transparency and public anxiety regarding the effectivity of these medicines were not expected to be among the obstacles. Yet, that is exactly the situation that India is dealing with after the Drugs Controller General of India, which is responsible for approving drug licences, gave its nod to ‘Covishield’ and ‘Covaxin’, the two drugs that have been developed by the Serum Institute of India — the manufacturer of the AstraZeneca-Oxford vaccine — and Bharat Biotech, respectively. It must be noted that the DCGI approval pertains to ‘restricted use in emergency situations’. Additionally, both companies have been asked to submit information related to safety, efficiency and immunogenicity from ongoing trials. These stipulations are not unwarranted. The SII has furnished Phase III trial data from Brazil and the United Kingdom, but the results of tests on Indian respondents are still awaited; as for Bharat Biotech, it has received the DCGI’s nod in spite of not finishing its Phase III trial data. The absence of this information is worrying for two — one medical, the other ethical — reasons. First, science’s triumph over Covid-19 is not complete yet. Already, there are signs of the emergence of at least two highly contagious strains. Expediting vaccination — India’s Covid load notwithstanding — without adequate knowledge of their impact on indigenous recipients warrants caution. Second, this is not the first time that medications have been pushed through in India; influenza vaccines had received the green signal during the H1N1 outbreak sans efficacy data. This only goes to show that democratic India is yet to learn to demand accountability from manufacturers and regulatory institutions even in the arena of public health.
A bit of the blame must lie with the prevailing populist model of politics. The ruling Bharatiya Janata Party is already making suitable noises in a bid to gain political mileage out of the vaccination exercise. Characteristically, it has targeted those who are raising legitimate concern about the relaxation of standard protocols — Phase III trial data, for instance — as part of the initiative. The prime minister has described the vaccine roll out as a shot in the arm for the nation. His admirers would be hoping that it would be a boost for his party too.