Last year, a study participant sent Serum Institute of India a legal notice after experiencing neurological impairment following administration of Covishield, the COVID-19 vaccine being produced by the company in partnership with AstraZeneca. In response, the company, the largest producer of vaccines in the world, hit back with a threat to counter-sue the study participant in excess of ₹100 crore, calling the allegations “malicious and misconceived”.
While the recent results of successful vaccine trials are a cause for celebration, these successes ought to be coupled with transparency in information and communication for vaccine production to translate into vaccination. The legal counterclaim and lack of transparency by Serum Institute coupled with silence from AstraZeneca and other stakeholders in this deal fuels the notion that facts are being suppressed. Considering the difficulty of implementing effective non-pharmaceutical interventions, primarily physical distancing and mask use, finding a silver bullet remains the most attractive option to combat COVID-19. However, despite the major contribution of vaccines in eliminating the infectious scourge of our age, the anti-vaccine undercurrent still runs strong. This particular incident only furthers these sentiments.
What clinical trials do
Clinical trials employ various scientific methodologies to test novel drugs and vaccines on human participants and ascertain whether such drugs are safe and effective against a particular disease. They are probably the most important inventions that help us develop drugs and vaccines against diseases. Furthermore, it is the human subjects who are at the heart of these trials more than the trial investigators or sponsors. It is because of clinical trials that we know now that hydroxychloroquine and convalescent plasma do not reduce mortality due to COVID-19, and that steroids save the lives of COVID-19 patients.
More than being a scientific methodology, clinical trials are a method of human cooperation. The sanctity of this cooperation rests on a tacit understanding of trust; integrity; agreed upon ethical and moral norms; and, most importantly, care and respect for, consent of, and fair compensation to the participants. It is this cooperation that allows trials across countries and ensures that the results of a study in one part of the world can be reasonably applied to other countries. The coercive attempt to falsify a study participant’s claims and intimidate him or her violates the agreed upon rules of clinical trials, jeopardises the whole process, and puts a question mark on the validity of the particular trial.
In order to protect human subjects from harm in clinical trials, multiple checks and balances are put in place such as the formation of a data and safety monitoring board, institutional ethics committees, and regulatory bodies for clinical trials such as the Central Drugs Standard Control Organisation in India. These same regulatory bodies had failed to protect the rights of HPV vaccine study participants in India in 2007, leading to the death of seven girls in the HPV vaccine study.
Maintaining silence
While the study sponsor, Serum Institute, which has financial interest in the COVID-19 vaccine, has made multiple statements about the neurological injury to the study participant, these regulatory bodies and committees have remained silent. By doing so, they give the impression that they are not independent and are failing in their duty of ensuring the safety of research participants. It is not only the bodies in India which have maintained a silence, but also other important international stakeholders. AstraZeneca, which has promised not to profit from the vaccine during the pandemic, is the original developer of the vaccine in association with Oxford University. The Bill and Melinda Gates Foundation, leading advocates for all major vaccines across the globe, which had the vision of increasing both accessibility and availability of Covishield by funding and encouraging the U.K. group to set up an advance collaboration with Serum Institute, failed to make a statement. Likewise, it seems Gavi, the vaccine alliance, and the World Health Organization have also chosen to remain silent publicly.
The science of vaccines
Vaccination as a science has come a long way. We have been able to eradicate smallpox and we are close to eradicating polio simply due to the effective use of vaccines. Millions of lives are saved by the simple act of timely vaccination. However, vaccine hesitancy is on the rise, and diseases like measles and whooping cough are coming back in epidemic proportions as vaccination rates drop. The claims and counterclaims and lack of transparency around Covishield threaten public faith in a life-saving, simple, cost-effective intervention. The reputation or fiscal health of one institution is not worth a setback to the idea of immunisation even if the institution in question is one of the largest suppliers of vaccines across the globe.
The very act of developing and testing a vaccine in less than a year since the emergence of COVID-19, a novel viral pathogen, is revolutionary. This has changed the way we look at vaccine science, timelines, and policies. As responsible healthcare providers, we want a vaccine, we want this pandemic to end, and we want to return to a normal life but not at the cost of the safety of study participants. We want a vaccine which is rooted in integrity, transparency, respect for study participants, and agreed upon ethical standards.
We urge the regulatory bodies, ethics committees and international stakeholders to not overlook this as a singular event. Ignoring this one event is a slippery slope which may set us back in our fight against COVID-19.
Anup Agarwal is a physician at Rehoboth Mckinley Christian healthcare Services, Gallup, New Mexico, U.S.