Vaccines are one of the most useful and cost-effective disease preventive methods available, helping to improve long-term health and eradicate disease across the globe. There has been an upsurge in the number of vaccination clinical trials undertaken in resource-constrained nations over the last decade. Vaccine studies for diseases like malaria and dengue fever, which are endemic in many low- and lower-middle-income countries, are among them. Majority of these vaccine trials are being conducted in Asia and Africa as the burden of infectious diseases are high in these continents.
Figure 1: Analysis of top 10 geographical locations for vaccine clinical trials in 2005 and 2016
The COVID-19 pandemic is considered as a catalyst for this significant rise in vaccine trials as it jeopardized millions of lives within few months. Though the signs and symptoms were common to the knowledge of mankind but there was no specific drug/treatment that could battle this condition. This forced the physicians to provide symptomatic treatment for the time being and it simultaneously questioned the advancement of technology and medicines. Thus every researcher in world turned towards the conduct of trials on vaccine for COVID-19 in search of that ‘one medicine’ which everyone is in dire need of. This dire need of the population may be exploited by researchers which may expose vulnerable subjects. Thus regulatory authorities have to very keenly monitor these trials and have to protect the rights, safety and well-being of its trial subjects.
Though the trials on vaccine have increased drastically but it has its own challenges. Setting up and successfully conducting international standard GCP vaccine studies across trial centres in resource-constrained contexts is difficult. Trial site location and its infrastructure also plays a key role in developing countries.
As the pandemic started nearly 65% of clinical trials around the world came to a halt which affected the R & D sector drastically. But we could not let this pandemic affect us and thus ‘Decentralized Clinical Trials’ came into picture where e-consent will be taken from the trial participants, visits with principle investigator will be done virtually and investigational drug will be delivered at home.
Challenges do not end with the release of vaccine in the market. There has to be continuous vigilance to ensure proper efficacy of vaccine and its safety in the population. Thus, Vaccine Adverse Event Reporting System (VAERS) should be maintained and practiced. this will help in identifying rare type of ADRs. According to Our World Data, 56% (77.3 Cr) population of India has been fully vaccinated against COVID. Is this number really correct? We are not sure because all this data has not been properly validated and documented.
The concept of decentralization is the new future and it has made clinical trial procedures more patient oriented. Strict vaccine trial regulations have to be followed with proper documentation to prevent exploitation of subjects and post market release Adverse Event Following Immunization (AEFI) should be monitored.
Who knows, in the future we might face another pandemic. So clinical and vaccine trials will always be conducted to meet the never-ending needs of human and to uncover the secrets of science.
Grenham, Amy, and Tonya Villafana. “Vaccine development and trials in low and lower-middle income countries: Key issues, advances and future opportunities.” Human vaccines & immunotherapeutics vol. 13,9 (2017): 2192-2199. doi:10.1080/21645515.2017.1356495 WRITTEN BY:
Author: Afshan Mahweesh, Pharm.D