×
ADVERTISEMENT
ADVERTISEMENT
ADVERTISEMENT

A coronavirus vaccine in 40 days, ICMR?

When Politics and Pandemics Mix
Last Updated 06 July 2020, 19:01 IST

Misery acquaints us with strange bedfellows. Many years hence, this will perhaps be narrated as an apocryphal story. But for now, the Indian Council of Medical Research (ICMR) appears less the apex body in India for the formulation, coordination and promotion of biomedical research, and more the handmaiden for political populism, diminishing the scientific temper and with it the rigour of the scientific method.

On July 2, 2020, the Director-General of ICMR wrote to a clutch of hospitals and universities -- some reputed, others less so -- that ICMR has partnered with Bharat Biotech International Limited (BBIL) to fast-track clinical trials of an indigenous Covid-19 vaccine. The letter emphasises that it is one of the “top priority projects being monitored at the top-most level of Government”. This is just as well. A project seeking to discover a vaccine that can effectively counter a raging pandemic must receive the highest attention. It goes on to say “it is envisaged to launch the vaccine for public health use latest by 15th August 2020 after completion of all clinical trials”. This is when it begins to tread dangerous ground that is fraught with far-reaching consequences -- for the scientific method, public health and safety, and the ethics of medical research. The letter addressed to institutions that have been selected as clinical trial sites urges them to “ensure that the subject enrolment is initiated no later than July 7, 2020”.

Seriously? The enrolment of subjects begins on July 7, and the vaccine is launched for public health use on August 15 -- the whole process in five weeks? This appears reminiscent of an episode from the classic ‘Yes, Minister’ series.

The stages of the development cycle of a vaccine include: the pre-clinical stage, clinical development, and regulatory review and approval. Clinical development is a three-phase process. During Phase I, small groups of people receive the trial vaccine. In Phase II, the clinical study is expanded, and the vaccine is given to people who have characteristics (such as age and physical health) similar to those for whom the new vaccine is intended. In Phase III, the vaccine is given to thousands of people and tested for efficacy and safety.

The 'International Standard Randomised Controlled Trial Number' (ISRCTN) is perhaps the best database to ascertain the status of the global search for Covid-19 vaccines. The ISRCTN registry is a primary clinical trial registry recognised by the World Health Organisation (WHO) and accepts all clinical research studies, whether proposed, ongoing or completed. The landscape documents prepared by the WHO as on July 2, 2020 listed 18 candidate vaccines in clinical evaluation for Covid-19. No Indian institution is listed. The University of Oxford appears to have made the most progress and is already in phase III of clinical evaluation. What does the study involve? Participants are randomly allocated to receive the investigational vaccine. Volunteers will be followed for 12 months, and they will be tested to see if they develop any symptoms which may represent Covid-19 disease. In addition, blood tests will be done to look at how the volunteers' immune systems have reacted to the virus. At the end of the study, the researchers will look at how many people had Covid-19 disease in each group and this will help them to decide if the vaccine has worked. The University of Oxford anticipates that the study will run from May 2020 to July 2021 -- a full 15 months!

Now, let us look at what stage of the Covid-19 vaccine development cycle Indian institutions are at. The same WHO landscape document lists 129 candidate vaccines in the pre-clinical evaluation stage. Two Indian companies are listed: Hyderabad-based Bharat Biotech and Ahmedabad-based Zydus Cadila -- both shown as being at the pre-clinical stage. The Central Drugs Standard Control Organisation has only in early July given approval to both organisations to move to human clinical trials. Zydus Cadila has stated that it expects to complete the first two phases of human clinical trials for its Covid-19 vaccine candidate, ‘ZyCov-D’, in the next three months. The trials will begin this month in over 1,000 patients across multiple sites. What about Bharat Biotech? Covaxin, the indigenous Covid-19 vaccine by Bharat Biotech, received DCGI approval for Phase I & II Human Clinical Trials and the trials will commence across India from July 2020.

Clearly, neither candidate vaccine is anywhere close to public health use as envisaged by the ICMR.

The institutions selected as clinical trial sites and addressed by the DG, ICMR, represent a curious, motley group, some of which are little-known private hospitals. While the criteria of selection are not known, one can only hope that it has been done by the ICMR through an objective and transparent process, and not by BBIL for that would constitute a serious conflict of interest in a matter that has important public health and safety implications that go beyond the profit motive. So, how might the testing sites, in the midst of considerable lockdown constraints, and without disrupting emergency response treatment of Covid-19 patients, speed up Phase I and Phase II of the clinical trials to complete them for public use of the candidate vaccine by August 15, 2020? Not to speak of the need to complete Phase III of the clinical trials to answer the real question -- whether the immune response the vaccine generates is adequate protection against the disease or not.

There is a sense of disquiet in the scientific community and the credibility of the ICMR stands somewhat eroded. The ICMR has since sought to clarify that the DG’s letter is aimed at cutting red tape, to insulate vaccine development from slow file movement. Clinical trials are not about piles of faceless files. They are about human beings, and introducing a vaccine, about public health and safety. If there is any significance of August 15, 2020 to the search for a Covid-19 vaccine, it is that science must be independent of politics. Never has the need for scientific temper and integrity been greater than now. Politics and pandemics must not mix. ICMR would do well to advance science, rather than political populism.

(The writer is Director, Public Affairs Centre, Bengaluru)

ADVERTISEMENT
(Published 06 July 2020, 18:47 IST)

Follow us on

ADVERTISEMENT
ADVERTISEMENT