Time to Exempt Sputnik V, J&J, Pfizer Vaccines from Bridging Trials to Win War Against COVID-19

To see the end of the pandemic, current wisdom suggests that 60-70 per cent of the population should be vaccinated, or have immunity as a result of previous infection. That is what the society ‘needs’. With that logic, all adults ‘need’ the vaccine. However, that is not feasible due to limited vaccine stocks and manufacturing capacity.

The next best policy would be to vaccinate all those who are either at high risk of acquiring COVID-19 infection or developing severe disease. While the former group includes those living and working in clusters and hotspots (think teachers, journalists, delivery agents, supply chain staff), the latter includes all adults with co-morbidities. These are people with diabetes, hypertension, chronic diseases of the liver, kidney, heart or lungs, or those who have undergone organ transplants.

The current eligibility criteria for those with co-morbidities regrettably leaves out adults under-45. For instance, thousands of my patients between 18-45 years of age who have liver disease or have had liver transplants most definitely ‘need’ vaccines to stay safe from COVID-19.

In the face of limited vaccine stocks and manufacturing capacity, risk-stratification of the population and sequential opening of vaccines from the highest to the lowest-risk category is undeniably logical. However, restricting vaccination to a vulnerable but small proportion of the population is all but fire-fighting, with herd immunity nowhere in sight.

At the cost of reiterating, the herd immunity threshold we are aiming for is 60-70 per cent. That’s the daunting range where the elimination of this virus and subsequent return to normalcy can be within plain sight. For context, however, at India’s current pace, it will take another 16 months to cover 70 per cent of our population (assuming supply sustains).

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And, to achieve our targets, we need to enhance the vaccine supply to enhance coverage. The approval of the next lot of vaccines in the pipeline—Sputnik V, J&J, Pfizer and Novavax vaccines—must be expedited. Insistence on bridging trials data for the first three is hardly relevant anymore, given the desperate and dire situation. Millions (including Indians and others of Asian origin) have had these all over the world, and enough scientific data is available to justify their use in India.

What We Must Do Now

Over the next few weeks, there ought to be a rapid expansion of the vaccination drive. India does not have the luxury of the vaccine stock or capacity to vaccinate 60-70 per cent of its people any time soon. So, unlike the US and the UK, we can’t hope to bring down the COVID-19 numbers just by vaccination.

It is time to forget vaccine politics and embrace COVID unity. All states along with the Center must make a concerted effort to test, track, treat and prevent COVID-19. The policy makers can make policy, but the onus is on us to follow it. We have to preach as well as practice the lessons learnt over the past year—masking, distancing and hand hygiene. While we can treat COVID-19 better than ever, all we ask as doctors is that everyone should adhere to COVID-appropriate behaviour for their own safety, for the society, and to avoid the breakdown of the healthcare system.

Crowding must be avoided at all costs, in every sphere of activity. I am afraid that also means that school and college education must remain online for the moment. That said, we must endeavour to craft solutions to bring our students back to their classrooms safely, with physical distancing. Ongoing pediatric vaccine trials also offer some hope here.

Night and weekend curfews are needed. The logic is simple: they can substantially curb social gatherings like weddings, parties, dinners that would otherwise morph into super-spreader events. Day-time clusters, on the other hand, are more linked to livelihood, and allowing controlled activity sans social gatherings during the day would avoid complete economic paralysis.

As appropriate, no more than 50 per cent capacity should be allowed in places with natural clusters and/or no more than 10-20 people, and that too with physical distancing. There is a need to enforce stricter measures in hotspots and containment zones too.

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