ICMR should fast track coronavirus vaccine, not for 15 August but for science

Clinical trials of coronavirus vaccine simply cannot be completed by 15 August. The job of authorities includes the moral duty to say ‘no’ to political leaders.

Representational image | A magnified coronavirus illustration in a lab inside the Pasteur Institute | Photo: Adrienne Surprenant | Bloomberg

There is absolutely no doubt that the world needs a vaccine for the novel coronavirus or SARS-nCOV-2 fast and the country that acquires one first will not only secure health and economic benefits, but gain a geopolitical window of opportunity that it can exploit. For strategic reasons, therefore, I have previously argued that “India must accelerate efforts to develop an indigenous vaccine” and that “We should be prepared to manufacture sufficient doses for our own population and export large volumes to the rest of the world.”

To the extent that Indian Council of Medical Research’s (ICMR) controversial letter to certain hospitals to “launch a vaccine for public health use latest by 15th August 2020 after completion of all clinical trials” indicates that the Narendra Modi government is serious about running the vaccine race, it is a good sign. However, as Warren Buffett once said, “No matter how great the talent or efforts, some things just take time. You can’t produce a baby in one month by getting nine women pregnant.” In fact, ICMR’s hope, demand or injunction — whatever it was — is logically impossible to satisfy: all clinical trials simply cannot be completed by 15 August. It seems to have acknowledged this in its subsequent clarification.

The Modi government must not damage India’s competitive advantage in vaccines and pharmaceuticals through absurd benchmarks that will not be trusted by other countries.

The need for an indigenous vaccine does not necessarily mean India should win the race. We need not have the first vaccine, but we must have a valuable one: safe and effective enough, affordable and available in quantity.

Policy over science?

As Hindustan Times’ pseudonymous Chanakya writes “The symbolism of the August 15 (it is India’s Independence Day) deadline shouldn’t be lost on anyone — but it is a symbolism that should matter to politicians, not scientists. And when it comes to vaccines, a matter of life and death really, symbolism and politics should give way to science.” That we have allowed politics to prevail over good science in the middle of a deadly, unprecedented pandemic tells us a lot about Indian society.

Whether this politically-driven vaccine timeline, or a Tamil Nadu minister claiming that a Siddha preparation has a 100 per cent success rate without empirical verification, or Ramdev getting away with a misleading formulation in the name of Ayurveda, it is the lack of public outcry that is more damning than the claim. This calls for political leaders and public officials to be even more respectful of science, at least during such a pandemic. To the extent politics substitutes science, we are doomed.

The trial models 

It is entirely possible to reconcile politics and good science. Politics can drive priorities. It can allocate resources and align organisational priorities. And it can allow science to inform policymaking.

In the case of vaccines and treatments, there is a compelling case to shorten the clinical trials framework. The World Health Organization’s (WHO) four-phase clinical trial framework only clears a drug after being tested on tens of thousands of participants over several years. The idea is to ensure that the drug is safe, in that it doesn’t harm the subject, and is effective, in that it works better than mere placebo. To clear a coronavirus vaccine, the US FDA requires large scale clinical trials (called Phase 3 trials) to prove that “people who have received the vaccine are at least 50% less likely to become infected”. This is a prudent approach and employs abundant caution to protect people from coming into harm due to the effects or side-effects of medication.

With the Covid-19 pandemic, we don’t have the luxury of being able to wait for years as we would have done in normal times. The ethical dilemma is different — societies have to trade off the health and economic costs of the pandemic against the risk of fast-tracked vaccine or treatment. There is a general consensus that in these extraordinary times, there is merit in accelerating vaccines and treatments to the extent possible. While a lot of the drug development timeline can be shortened by increasing the computing power, what cannot be speeded up, in the literal sense of what Buffett says, is the human biological system.

Saying No

Now there is nothing sacrosanct about the WHO four-phase framework, and you do things differently in emergencies. So, instead of commanding a vaccine by an arbitrary date, ICMR’s intellectual capabilities ought to be directed at working out ways to shorten the clinical trial timelines. It is not an insuperable problem, but one that requires experts in science, mathematics, process engineering, logistics, public administration and communication to collaborate and give options to “the topmost level of government”. In any event, squeezing timelines does not absolve ICMR of the need to ensure safety, efficacy and offer public reasoning as to why deviation from the norm is called for.

It should make the trade-offs explicit, anticipate the risks involved and explain what plans the government has to manage the unintended consequences. The greater the official transparency, the greater the credibility of the vaccines and treatments developed in India.

Indeed, the credibility of India’s medical and pharmaceutical regulatory authorities is of strategic importance. Beyond protecting Indians, indigenously developed vaccines and treatments have global potential. Everyone on the planet will need this vaccine, at least once.

And yes, the job description of apex authorities of all professions — from military to medicine — includes the moral duty, after careful consideration, to say “no, it can’t be done” to the political leadership.

The author is the director of the Takshashila Institution, an independent centre for research and education in public policy. Views are personal