Pandemic, vaccine and controversy: Real test begins now

The second is Oxford-AstraZeneca’s, that is being manufactured under a licence by the Serum Institute of India (SII).

The pandemic seems to be on its way out, but not yet gone. The vaccine seems to be on its way in, but has not yet reached households. The one thing that has remained unmoved throughout is controversy!

As I write this on January 9, the numbers are a grim reminder of the havoc wrought by Covid-19. The number of infections is 1,04,31,639 (second place after the United States); the number of deaths is 1,50,798 (third after the US and Brazil); and the number of active cases is 2,24,190. With a population of 138 crore, we can count ourselves lucky but certainly not a shining example of pandemic control and management.

There are six approved vaccines in the world. We know little about the Russian and Chinese vaccines although they are being distributed and administered extensively in the respective countries. As far as I know, no other acknowledged, long-standing regulator has approved for use the Russian or Chinese vaccine.

Four vaccines, great opportunity

That leaves four. The first is Pfizer’s, approved by the US FDA which, in the scientific world and among the medical profession, is the gold standard. The vaccine’s immunogenicity, safety and efficacy have been proven in the mandatory three phases of the trials. The drawback is the conditions of storage (-70 degrees C) and cost in India (undetermined). Pfizer applied for Emergency Use Approval (EUA) to the Drugs Controller General of India (DCGI), but did not appear to present its case to the Expert Committee despite three opportunities. My hunch is Pfizer is not keen on marketing and distributing its vaccine in India because it has assumed that, in India, its cost will be unaffordable and the conditions of storage will not be met. Since Pfizer’s vaccine has been approved by many countries/regulators and the demand is high worldwide, Pfizer may have placed India low in its order of priority.

The second is Oxford-AstraZeneca’s, that is being manufactured under a licence by the Serum Institute of India (SII). We can be proud that an Indian research-cum-manufacturing company has qualified to test, manufacture and distribute a vaccine under the name Covishield.
The third is Moderna’s. It has not yet applied in India for approval.

Needless controversy

The fourth is Bharat Biotech’s Covaxin. While the company may have drawn on the work and knowledge of foreign researchers and scientists, Covaxin is a 100 % Indian product. It is a proud moment for India. The vaccine’s approval was mired in an unnecessary controversy. The DCGI and the government’s spokespersons (especially Dr V K Paul and Dr Balram Bhargava) should have, at the outset, made it clear that Covaxin’s EUA was for distribution-cum-Phase III clinical trials and the results — especially the results on efficacy — will determine its further distribution and use. It is true that reputed scientists, virologists, microbiologists and doctors have questioned the speed (or haste) in granting approval even when Phase III clinical trials are underway. Desperate situations may require desperate remedies. India’s requirement of vaccines (by volume) is so huge that neither the SII’s Covishield nor imports can meet the demand for a quick nationwide roll-out. It is wise to encourage a potential candidate (a life saver) to complete the testing process quickly and also to keep ready a vaccine as a back-up for emergency use. My personal view is that we should be charitable to the DCGI and the government.

There is no evidence that Covaxin is harmful. The trials, so far, have qualified the vaccine on immunogenicity and safety. No adverse reports on efficacy have been received. We should collectively hope that Covaxin will complete Phase III clinical trials by the end of January and the results will be evaluated by March. Thereafter, we can accelerate the roll-out with two vaccines — we may also export reasonable quantities to developing countries — and acquire a place among nations that were able to research, find, manufacture, distribute and use a vaccine in 12 months.

There was, I suspect, a tinge of business between the SII and Bharat Biotech. Happily, both Mr Adar Poonawalla and Mr Krishna Ella buried the hatchet in a couple of days and promised to cooperate and work together. That is the way frontline companies, especially in research and development, should conduct their affairs, with a right mix of public good and private profit.

Real test begins now

The real test begins now. How will the government vaccinate the bulk of the 138 crore population? Here are a few thoughts:

• There must be an order of priority and no breaches of that order should be permitted under any circumstances.
• The vaccine must be administered free of cost in government hospitals and vaccination centres. Levying a charge will encourage people to cut corners and, consequently, lead to corruption.
• When supplies improve, private hospitals should be brought into the roll-out. If they wish to buy the vaccine and charge their customers, the government should fix the price and let those who can afford to pay, pay for the vaccination.
• Just as we have allowed export of India-made vaccines, we should also allow import of approved vaccines. Protectionism is a discredited theory in world trade and has certainly no place when the world is facing a pandemic.
• We must be prepared to face unknown consequences. We must keep faith in our scientists and researchers to find solutions. Ultimately, science will triumph.

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