At a time when the whole world is looking forward to the COVID vaccine, the million-dollar question is obviously how billions of people will get immunized. At the same, time, the billion-dollar question is, how are Pharmacovigilance activities going to be managed if the Vaccine hopes really materialize?

In a country like India, where Pharmacovigilance is still evolving, we need to be quite considerate. If we even assume an incidence rate of 0.1% (being extremely conservative), we can anticipate 1.35 million Adverse event reports, if the entire 1.35 billion population gets vaccinated. We can more or less generalize this issue to other countries.

• Are we prepared for this?
• Are the companies coming up with the vaccine equipped to handle these many adverse event reports?
• Are the regulatory agencies equipped?
• Are we geared to evaluate the long term side-effects of vaccine administration?
• How are we going to ensure traceability of vaccine administration? Can we maintain registries or electronic data records of everyone who has been administered the vaccine?

Clinical Trials generally exclude the high-risk population, that includes the pediatric population, the elderly, and the patients with pre-existing morbidities. Hence, it is not clear if the vaccine can be administered to this population. If not, can we safely ignore this population, as the elderly population is anyways the most affected, in the current scenario, with higher mortality rates? Vaccine-Drug Interaction is another grey area. One cannot predict if the vaccine can interact with other medicines that the individual is already consuming.

Distribution of vaccine vials is another big challenge, as one needs a controlled environment (cold chain) for transporting these. Any temperature change can have a bearing on the safety and efficacy of the vaccine. Besides, counterfeit medications are quite rampant, so one needs to be extra cautious, as we are considering exorbitant volumes. However, this can be minimized to a great extent, if the manufacturing is done locally, with effective governance processes for transportation and administration.

The average life-cycle for clinical trials (all phases) is 5-7 years. In the case of COVID-19 vaccine, this lifecycle has been shortened to 5-7 months. It may be prudent to assume that the companies that are working on Vaccine trials may not have considered most of the above factors, as the priority ‘is’ to come out with the vaccine first. It is no doubt the right time to start considering these factors and make adequate provisions to welcome the vaccine.

Rest assured, the COVID-19 vaccine is expected to be a game-changer for Pharmacovigilance.

The policymakers need to capitalize on this opportunity and use this as a channel for creating awareness among healthcare professionals, and even the consumers.