The Vaccine Conundrum

A vaccine developed and ready to be injected in less than one year is a miracle that no research laboratory or pharmaceutical company would have dreamed of before 2020 began. Their track record has been that Jonas Salk’s lightning-fast development of polio vaccine in less than 4 years, and Ebola vaccine was approved in December 2019 after the first Ebola incidence was found in 1976, i.e. more than 40 years after.

From discovery to approved vaccination is a 10-year long process involving 2-5 years of discovery research, 2 years of pre-clinical period, 5 years of clinical development at its very best, 1-2 years of regulatory approval, and then of course comes in the manufacturer. The clinical development period has its 3 phases that is creating the buzz we hear day in and day out these days. Phase I is when researchers concentrate on the question, “Is it safe?” Phase II tries to establish whether the vaccine is activating an immune response or not. Then comes Phase III when they answer the all-important question whether it protects against the disease. The process is not over yet, because regulatory review and approval is going to take its own time. Finally then is the ball thrown into the Manufacturer’s court who has to produce it and despatch it to the user ends.

The million dollar predicament before the denouement is whether it is ethical to deploy the Covid-19 vaccine(s) based on safety and immunogenicity data generated by phase-I and II clinical trials alone, without waiting for the crucial phase-III trials? Common adverse effects may not be missed by the phase I/II trials, but these trials are not sufficient to detect less common adverse effects. And the cases with less common adverse effects shall be large because a huge population is to be vaccinated.

The answer is not straightforward, as many complexities are involved, say Vipin Vashishtha and Puneet Kumar in Indian Journal of Medical Ethics, published online on November 26, 2020.

Besides, the safety confidence data from the young and healthy people cannot be extrapolated to the elderly population, pregnant mothers, and lactating mothers who have unique situations of their own.

The WHO says vaccination currently saves 2-3 million lives every year, but another 1.5 million deaths could be avoided if more people were vaccinated. The barriers to universal immunization are formidable, especially in less developed areas. In India, if we can achieve 25% of our population vaccinated in 3 to 5 years, it shall be a wonder.

I leave you with sobering thought. How many shall die because of the vaccine-instigated health issues in short term and in long term? Is that number likely to be a lot smaller than what Covid19 is doing to us today?

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