Chennai

The approval granted by the Drugs Controller General of India (DCGI) for the emergency use of two vaccines Covishield (an Indian variant of the one developed by Oxford University and Astra Zeneca) and Covaxin (the indigenously-developed Bharat Biotech product) are the first steps in what promises to be a game-changer in tackling the coronavirus. Of the two, Covishield will roll out first, given that the Serum Institute of India has already stockpiled more than 50 million doses. Covaxin will take a little longer. Either way, the country should witness the launch of mass vaccination programmes this month.

Some have argued that the DCGI’s approval has come much too quickly and that it should have waited until the data from the Phase III efficacy trials were available and made public. The charge here is that the government has been less than transparent and circumvented regular procedure. The government’s counter consists of arguing that the vaccines are “110 per cent” safe, implying that its critics want to create a climate of mistrust about the vaccines by linking safety with efficacy. As for efficacy, it suggests there is enough evidence that there is a robust response to the administration of the vaccines. However, this will once again be put to the test when the rollout begins as there have been quite a few cases in the US where people have had different reactions to the vaccine ranging from relapses to allergies.

Be that as it may, there is still a lack of clarity about the nature of the rollout. For instance, it is not clear whether Covaxin will remain for now only as a back-up. This seems like the case given the nuanced approval for the vaccine, which will be administered in the public interest “as an abundant precaution” to have more options for vaccination, “especially in case of infection by mutant strains.” But there is no evidence whatsoever that Covaxin is efficacious against mutant strains

The fine print of the rollout is also awaited, although it is clear that health workers will receive top priority, followed by frontline workers and those in higher-risk categories. There is also some lack of clarity whether the vaccine will be free for all or whether this will be limited to around 30 crore people, as the COVID-task force head Dr Vinod Paul has suggested. It is likely though that the criticism about approval will now abate, with the WHO welcoming the approval of the two vaccines and those relating to lack of transparency will get settled with the efflux of time.

There are other kids on the block. India has cleared a third vaccine, another indigenous one manufactured by Zydus Cadila. More vaccines are in different stages of development in the country and China’s Sinovac and Russia’s Sputnik are in the process of undergoing trials. The challenges going forward are to ensure that there the cold chain network is adequate and administration of the vaccines take place with stringent protocols to ensure safety. If all goes well, and COVID-19 and its mutants do not spring any more surprises, India and the world will be in a far better place in the next six months or so. It is important to keep in mind that while health is the principal goal, defeating the virus has far more implications that relate to employment, livelihoods, and economic growth.

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