Clinical Pharmacology and COVID-19 Vaccine Development

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Table of Contents

Introduction
Role of Clinical Pharmacology
COVID-19 Vaccines
Breakthroughs
Controversies
Conclusion
References

Introduction

The unprecedented medical concerns associated with coronavirus disease of 2019 (COVID-19) compelled the World Health Organization (WHO), research institutions, and governments to consider a multiagency approach to develop and test vaccines. Within the first three months after the emergence of this condition, many countries experimented with various strategies that were primarily intended to protect lives. Some of them included quarantine measures, preventing movements, and contact tracing, and improving research in the area of ventilation. These approaches led to numerous social and economic implications, including the loss of livelihoods, economic stagnation, and inability to pursue global logistical operations. These threats meant that the global community was staring at an unavoidable recession. The expedited process of vaccine development characterized by the key aspects of clinical pharmacology remained a priority for WHO and other agencies at the time.

Role of Clinical Pharmacology

In the wider healthcare sector, clinical pharmacology remains a useful practice intended to support medical practice. According to Miller et al. (2019), the concept describes the overall process of completing research, teaching practitioners, developing policy mechanisms, and providing timely guidelines regarding medicines. Upon the development of drugs intended to treat specific conditions, the approach results in the implementation of the acquired knowledge and ideas in clinics. Due to the complexities associated with COVID-19, clinical pharmacology offered an opportunity for researchers to rely on physiologically-based pharmacokinetic (PBPK) approach to confirm, learn, and even apply emerging scientific ideas to the continuous development of safe vaccines (Miller et al., 2019). The multiagency model led to the creation of resource centers that collaborated to pursue clinical analyses, share research findings, and provide timely outputs (Miller et al., 2019). Emerging findings from different private corporations and government-sponsored institutions were shared to support the goals of the vaccine development projects.

Throughout the vaccine development and implementation phases, the roles of clinical pharmacology led to desirable outcomes. First, the field presented timely guidelines for promoting safe process of the development and trials for the developed drugs. Second, the processes led to efficient, timely, and economical vaccines capable of empowering more patients. Following the successful development of approved vaccines, medical professionals relied on pharmacological practices to apply the vaccines in clinical settings (Wagner et al., 2021). The approach made it possible to identify people at risk of COVID-19 and prioritize their health needs. Fourth, the stakeholders collaborated to share information regarding the outcomes of such health practices. This approach made it possible for the involved teams to improve emerging vaccines and customizing them for every new virus strain of COVID-19.

COVID-19 Vaccines

Method of Action

In terms of action, the developed vaccine stimulates the human immune system to respond accordingly to the developed product. The body is able to create a unique memory of the specific COVID-19 virus, thereby being able to recall it whenever the individual is infected. The subsequent outcome is that the immune system will protect the entire body against the identified virus (Wagner et al., 2021). This process will result in a biological defense mechanism, thereby increasing chances of preventing the development of the disease.

Interactions

Through the power of clinical pharmacology, experts have relied on trials to monitor the manner in which the developed vaccines interact with other drugs in the human body. According to a report by WHO, the COVID-19 vaccines developed in the recent past were not observed to interfere with most of the available over-the-counter and other prescriptions medicines (Wagner et al., 2021). Consequently, patients could rely on them since they were effective, safe, and capable of meeting the needs of more people. However, the presented guidelines revealed that there was a need for clients to collaborate with their respective medical professionals to maximize their overall heath experiences.

Indications

The concept of indication refers to the specific reason why a specified medical process, surgery, test, or drug is appropriate. WHO and other agencies, such as CDC, recommended the use of the developed vaccines in people aged six months and above (Bollyky et al., 2020). To be specific, mRNA vaccines were preferable due to their higher efficacy rates, such as Novavax and Pfizer (Wagner et al., 2021). However, additional studies and trials were being conducted in an effort to deal with the pandemic and meet the health outcomes of more people in different parts of the world.

Contraindications

WHO presents a number of guidelines encouraging administers and users of COVID-19 vaccines to be aware of the contraindications associated with them. For example, Moderna vaccines were associated with anaphylaxis in the event of previous doses from Pfizer (Bollyky et al., 2020). The same concern was observed for AstraZeneca and Nuvaxovid vaccines (Bollyky et al., 2020). Physicians had to reassess individuals who reported allergic reactions, anaphylaxis, and mastacytosis before vaccinating them with these products (Doan et al., 2022). These outcomes should inform the next dosage of COVID-19 vaccine to the affected patients.

Side Effects

Through the completed clinical pharmacological processes, different agencies managed to develop and implement several vaccines that have proved to be useful in the ongoing fight against COVID-19. However, some of these vaccines were found to trigger a number of side effects capable of disorienting the overall health outcomes of most of the individuals. For example, Doan et al. (2022) observed that a large percentage of the immunized persons reported prolonged pain at the spot where the vaccine was administered. Some individuals reported cases of swollen lymph nodes associated with mild pain (Bollyky et al., 2020). Additional side effects associated with COVID-19 included loss of appetite, sleepiness, crying, unexplained headaches, and irritability (Bollyky et al., 2020). These observations have been necessary to guide more people to manage the emerging issue efficiently.

Breakthroughs

The problems and threats associated with COVID-19 led to numerous efforts that supported the development of new vaccines. The multiagency approach was instrumental since it made it possible for different institutions to fund the ongoing vaccine discovery efforts. The implemented clinical pharmacology exercises allowed different stakeholders to develop the much-needed vaccines in a record time of less than two years (Doan et al., 2022). The expedited process and the subsequent discovery of such products was a major breakthrough that would help slowdown the spread of the disease. With such outcomes, the global community was able to benefit from a new evidence-based medical practice capable of tackling the challenge of COVID-19 directly.

With the ongoing research efforts, different agencies and institutions have produced several vaccines that are effective and capable of meeting the health demands of more people across the globe. The subsequent introduction of booster shots has become a significant breakthrough in the fight against COVID-19 (Bollyky et al., 2020). With the ongoing efforts, it has become possible for hospitals and community health departments to continue providing vaccines to people who at risk, thereby maximizing the overall level of protection against COVID-19. Consequently, the rate of hospitalization due to COVID-19 complications has reduced significantly.

Controversies

While the completed clinical pharmacology exercises have led to a coordinated, scientific, and timely response to the COVID-19 pandemic, a number of controversies emerged throughout the processes. First, the move to include human subjects in most of the vaccine and drug trials seemed problematic since it led to ethical questions. Second, the global community remained concerned that some of the vaccines were associated with additional complications, such poor health outcomes and hospitalization (Doan et al., 2022). Third, the expedited processes in the development of such vaccines bypassed some of the key requirements involved in most of the processes. These controversies, therefore, explain why the acceptability of these vaccines has remained quite low in different parts of the world.

Conclusion

The economic and medical predicaments associated with COVID-19 compelled different agencies and organizations across the globe to collaborate and develop healthy vaccines. The concept of clinical pharmacology was critical since it supported the development and subsequent administration of the developed vaccines. Such a process ensured that the final medical products were safe and informed by evidence-based ideas in the field of healthcare. A proper understanding of the method of action, indications, interactions, contraindications, and side effects associated with COVID-19 vaccines is essential to ensure that more people benefit from them. These attributes show conclusively that clinical pharmacology is a timely practice that has the potential to address a wide range of health problems affecting the global community.

References

Bollyky, T. J., Gostin, L. O., & Hamburg, M. A. (2020). The equitable distribution of COVID-19 therapeutics and vaccines. JAMA, 323(24), 2462-2463. Web.

Doan, T., Lievano, F., Scarazzini, L., Liebelt, K., Jaradeh, M., Kantarcioglu, B., Fareed, J., & Jones, K. (2022). Development and implementation of an online global pharmacovigilance certificate program during the COVID-19 pandemic. Clinical and Applied Thrombosis/Hemostasis, 28, 1-8. Web.

Miller, N. A., Reddy, M. B., Heikkinen, A. T., Lukacova, V., & Parrott, N. (2019). Physiologically based pharmacokinetic modelling for first-in-human predictions: An updated model building strategy illustrated with challenging industry case studies. Clinical Pharmacokinetics, 58(6), 727-746. Web.

Wagner, R., Hildt, E., Grabski, E., Sun, Y., Meyer, H., Lommel, A., Keller-Stanislawski, B., Müller-Berghaus, J., & Cichutek, K. (2021). Accelerated development of COVID-19 vaccines: Technology platforms, benefits, and associated risks. Vaccines, 9(7), 747-757. Web.

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