The response to the COVID-19 pandemic trusted in pharmacovigilance to diminish communication risk

Background

SARS-CoV-2 is one of the most disruptive events in recent history and has become a threat to global health, perhaps the most important one in the world (along with Spanish flu) since the concept of pandemic had been introduced into the public health, approximately a century ¹ ago.

In a globalized world, the COVID-19 pandemic has shown the tremendous differences between world populations, the inequities of global health and the need to balance the opportunities to fight against an infection caused by a virus whose lethality is not the highest, but whose speed of contagion and development of genetic variants have put global health on alert and affected, in an unimaginable way, the economies of poor and middle-income countries, whose response capacity has been challenged. ²

COVID-19 has been handled, in general, with no more resources, until recently, than a non-pharmacological approach based mainly on biosafety measures and lockdowns that allowed health systems, in many parts of the world where this has been possible, to adapt and prepare for the high demand of services and intensive care beds.^3,4

The introduction of vaccines for COVID-19 and the importance of pharmacovigilance

The introduction of COVID-19 vaccines has been a great relief to those at risk of this disease. Vaccines for COVID-19 have been developed in record time (approximately 1 year), successfully overlapping the different phases of preclinical and clinical research. This has allowed them to be used massively through an emergency mechanism that has enabled them to demonstrate their effectiveness in preventing fatal outcomes and reducing demand for intensive care beds. ⁵

Pharmacovigilance has been fundamental to counteract the lack of scientific evidence on the use of vaccines based on new platforms never used before for any type of drugs, such as vaccines based on mRNA. ⁶ Undoubtedly, pharmacovigilance has made it possible to determine that almost all the available vaccines, regardless of their action mechanism, are safe and can even be used in children, and this observation has generated confidence for their widespread use. ⁷

Nevertheless, resistance to the use of vaccines for one reason or another has been evident in many parts of the world. In fact, the anti-vaccine movement, which is not only against SARS-CoV-2 vaccines, has been exacerbated in recent times, causing serious damage to the therapeutic advances against this virus and allowing the emergence of new genetic variants, some of consideration and others that have become dominant in entire countries, regions or continents.^8,9

The pharmacovigilance effort to support the use of vaccines has been worth it given the safety results coming from careful, scientific and ethical observation, but it has encountered an unconscious wall of resistance to the use of vaccines, which has resulted in waves of cases which have pushed this pandemic into peaks and valleys in the last 2 years and will have such a behavior until the infection acquires the status of endemic, perhaps at the end of the year 2022.^10,11

Never before has pharmacovigilance been so close to health systems, nor has its help been so valuable in the absence of conclusive data determined by pharmacological research itself, more so in this case of accelerated development and overlapping research phases. ⁵ Given the need to give free access to the emergency use of these new drugs and vaccines, careful observation of the adverse events reported in massive databases has allowed the safe use of vaccines and, by the end of 2021, some other drugs that are promising for early infection control. ¹²

The challenge of assertive communication in pharmacovigilance during the COVID-19 pandemic

The communication risks, which usually exist under normal circumstances for the use of any new drug, have been even greater with the emergence of SARS-CoV-2 in which many things have not been clear; we have been exposed to tremendous doubts and confusion, to fake news, to the uncertainty and the chaos generated by a disease whose origins are not completely clear and for which there has been a crazy wheel of alternatives that circulates in many countries about doubtful treatments that have only caused more confusion. ¹³ We have even seen irresponsible governments take positions that have echoed this nonsensical therapeutic speculation and that, without a doubt, have influenced the rejection of vaccines among their own nationals. ¹⁴

The worst thing that can exist to handle chaos is to create more chaos, and in a globalized world like the current one in which the flap of a butterfly’s wings in Brazil can set off a Tornado in Texas, this has been evident. The communication risk has been also evident for the pharmacovigilance and control of the COVID-19 pandemic. ¹⁵

Geopolitics has also played a role. Countries have adopted dissimilar mechanisms to control the pandemic, from mitigation to elimination and in this effort, some countries have been very strict with vaccination and others more relaxed due to lack of experience in treating such a virus. When vaccines have arrived, they have also been managed according to the purchasing power of each country and there has been a huge imbalance between low- and middle-income countries versus high-income countries, who, among other things, have monopolized the use of vaccines. ¹⁶

Efforts to manage multilateral mechanisms such as COVAX have not been a panacea ¹⁷ and lead to two questions: what support has been offered to those who manage pharmacovigilance in low-middle income countries (whose needs and limitations are even more numerous)? and how have governments in these countries communicated the risks derived from incomplete observations?

We have seen, with amazement, encouragement to use of substances such as chlorine dioxide, ivermectin, alpha interferon, hydrocortisone and moringa, among many others, supported even by local governments, without any conclusive observation of their usefulness or benefits of their use to control this crisis. ¹⁸ And, again, the communication risk in pharmacovigilance has been due to scarce studies or by misconception of the results or simply by ancestral beliefs.

Conclusions

In conclusion, beyond the immediate public health problem, COVID-19 has also created a greater challenge at global level: the need to effectively share drug and vaccine safety findings, establish regulatory measures to improve the notification of adverse events, highlight the value of scientific data in the community and, ultimately, implement good pharmacovigilance practices that provide the safe use of new interventions as well as addressing the risks derived from them, that must be communicated assertively.