The Serum Institute-AstraZeneca vaccine episode and the questions it has raised

By E Kumar Sharma,    

In the journey of a vaccine development, the phase 3 trials cover the crucial aspect of studying the efficacy of the vaccine with the trials conducted in different cohorts. However, this phase of the Serum Institute of India and AstraZeneca COVID-19 vaccine has been in the spotlight for some rather unpleasant developments.

Since October 11th, there have been series of news reports on the law suits involving high sums of money between a corporate and a litigant – a 40-year volunteer alleging adverse reaction.

Experts within the field say the debate around safety and efficacy is for the regulator to look into and for the company, that has had a long history of vaccine-making to consider and review. However, what is hard to miss are some deeper issues that are hard to ignore. Answers to these could have long-term implications on the way India deals with clinical trials, reviews it and the message it sends out on trust, the only answer to infodemic – or the rapidly spreading unreliable information – which is emerging as a bigger problem than the pandemic.

Consider this: The development happened on October 11th and FE.com learns that the Drug Controller General of India (DCGI), the highest authority of the Indian drug regulatory ecosystem was informed within the stipulated seven days. However, as this article gets to print, the drug regulator is still investigating into the matter.

Scientists and technical experts who understand the disclosure and examination process say, if the regulator was informed in time and the investigation is still on then what has guided the decisions on the continuance of the trials. Speaking to FE.com on condition of anonymity, they point to the West, where any adverse event has led companies to pause the trials, even if temporarily. What role is the Drug Safety Monitoring Board playing and what say it has had on this matter, they ask? Has the Indian drug regulator missed taking timely action or is the matter too small and quickly reviewable and therefore not necessitating any pause in the trial process? Will suit and counter suit be the way forward in the Indian drug trials?

Since the trials are being allowed to continue and presuming the issue is not serious then it boils down to questions around need for more transparency and rigour in the review process? FE.com learns that the lead investigator for the Chennai arm of the trials (the trials were conducted at Sri Ramachandra Institute of Higher Education and Research in Chennai) had informed as per norms and that both the hospital’s Institutional Ethics Committee (IEC) and the drug controller were communicated. Apparently, there was no immediate response or restraint imposed by the drug controller.

Also, there is very little clarity on whether the alleged adverse reaction is related to trials at all? And what was the arrangement with respect to trials till some basic info was gathered? Be it whether the volunteer was administered the vaccine or a placebo or if the person had any pre-existing conditions? Finally, is the initial assessment by the hospital’s institutional ethics committee enough to decide on the future course of the trials? After all, it is for the DCGI to decide and it is still examining the matter in consultation with experts.

Samiran Panda, a senior scientist with the Indian Council of Medical Research (ICMR) reminds, “the DCGI is a reputed institution and is very watchful and the initial assessment by the institutional ethics committee did not find any causal link between the investigational product (read: vaccine) and the serious event reported.”

He says, typically, both the institution which is conducting the trials and its partner are bound by the law of the land to report any adverse event within 24 hours to the IEC and within seven days to the DCGI. “This is good clinical practice and it was communicated by both the sponsor (Serum Institute) and the executor (the partner hospital in Chennai).”

On the conduct of the trials, he says, it is for the DCGI to decide and “it has not indicated any stoppage of trials.” Sources close to the company also add that it is a rigorous process and is all “video-taped and consent forms signed and volunteers made aware of the downsides.” But then, despite this, questions remain with hopes for convincing answers.