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Vaccine pharmacovigilance: Prevention before cure

technology

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02 March 2021

The administration of anti-COVID-19 vaccines is already a fact, but what will be the response to the vaccination plan and the monitoring of its effects? What role will technology play as a facilitator in the entire process, and are we prepared?

Since the first anti-COVID-19 vaccine was approved by the European Medicines Agency on December 27, 2020, many strategic plans have been designed, revised and reworked. Why? Because every drug is indicated for a different type of patient, its active ingredient is different and the focus of the clinical trial that has underpinned its approval has been different.

We can expect that we will continue to see ongoing adjustments and replanning of the Spanish and global vaccination strategy in the coming months until we reach the hoped-for herd immunity that means we can finally turn the page on this chapter.

What is the basis for the vaccination strategy and how does it work?

The speed with which vaccines have been developed has made it impossible to conduct a clinical trial involving the necessary heterogeneity of patients to confirm a vaccine's effectiveness in all groups of people living on this planet. Consequently, the guidelines differ from one type of vaccine to another, from one active ingredient to another and from one laboratory to another. This is the complexity of designing a single, watertight vaccination plan.

But beyond a vaccination plan, we need a roll-out plan. How do we monitor it? How do we measure its effectiveness?

Of course, it is the health authorities who are responsible for identifying priority patients and managing the correct administration of the corresponding doses of vaccines to each. But, as always, information technologies will serve as a cornerstone in the future evolution of the treatment of the SARS-CoV-2 pandemic.

Correct monitoring of potential side effects and reactions caused by the administration of the vaccine will be particularly relevant during the roll-out of the vaccination plan. Ensuring that any adverse reactions to any drug is correctly reported is the main objective of pharmacovigilance. By studying these side effects, the treatment can be fine-tined and new variants of the vaccines can be developed.

Recently, Emer Cooke, Executive Director of the European Medicines Agency, called on the public to actively report any side effects. The information provided by the public will be a particularly relevant input for future PRAC decision-making.

How can technology facilitate active monitoring?

We currently have multiple devices that actively monitor our vital signs: our heart rate, our physical habits, our blood pressure... It seems prudent and highly feasible to go a step further and link the monitoring of these signs to the measurement of the physical reaction of patients in the hours and days after they get the vaccine.

Artificial intelligence and business intelligence will help us identify patterns that can accelerate decision-making. Likewise, can technology help us measure the impact of the vaccination strategy by projecting the immune effect generated by two vaccinated patients in a family of five? My answer is yes.

Technology is ready to meet the need. Are we?

everis has been working with the European Medicines Agency since 2016 on its Pharmacovigilance and Clinical Trials programs, developing the platforms that support both business processes in Europe. Our next challenge will be to design, together with the EMA and other European authorities, the fine-tuning of the monitoring process so that we can shift from the current reactive approach to an active approach and be able to predict adverse events before they occur while accelerating the adaptation of drugs and their guidelines in order to increase their effectiveness.

Prevention before cure, that will be the key.

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