While scientists and researchers have been calling for transparency in COVID-19 vaccine-related research data, the Centre, ironically, released the draft version of the Science, Technology, and Innovation Policy (STIP) in December 2020 based on the ethos of “Open Science”.
Open Science has emerged as a global movement amidst a growing crisis in science that has affected India as well, and includes issues such as fabrication and falsification of data, plagiarism, unethical authorship, failure to disclose funding sources and gender disparity in research institutions. An interesting example to understand the crisis is the “10,000 steps a day to remain healthy” goal, which most of us are aware of. How many, however, know that this goal is based on bad science and there is no evidence for the 10,000 steps figure?
Open Science draws attention to some core values such as transparency, accessibility, collaboration, and “constant and continuous transfer of knowledge between producers and users of knowledge.” It’s also an essential part of the draft STIP 2020, which states that an “all-encompassing Open Science Framework will be built to provide access to scientific data, information, knowledge, and resources to everyone” and “all data used in and generated from publicly funded research will be available to everyone under FAIR (findable, accessible, interoperable and reusable) terms”. However, the news on the “Emergency Use Authorisation” (EUA) to the two COVID-19 vaccine candidates, whose efficacy data is either currently unavailable or disputable in the Indian context, leads one to wonder if there is an inconsistency between policy and practice.
The first vaccine candidate to receive the EUA, Covishield, has been developed by AstraZeneca and Oxford University and is manufactured in India by the Pune-based Serum Institute. The Central Drugs Standards Control Organisation (CDSCO), the country’s drug regulatory authority, states that the overall efficacy of the vaccine, based on studies in Brazil, South Africa and UK (23,745 participants aged 18 or above) is 70.42 per cent. In India, based on the Phase II/III clinical trials on 1,600 participants, this is “comparable with those from the overseas clinical studies” according to the regulatory body. Scientists have, however, raised two major concerns — there is “limited ethnicity data” in the current trials and there is also an absence of results on older people, the ones at the highest risk, because most trial participants were under the age of 55. This concern is especially relevant in the Indian context because people above 50 years are amongst the priority groups in the vaccination drive. Also, as some researchers have pointed out, as per the latest CDSCO Guidelines, a “bridging study” needs to be carried out to understand immune response in the Indian population. This is, however, the “first full peer-reviewed efficacy result” to be published for a COVID-19 vaccine, so it can arguably be said to be within the norms of “good science”.
The second approved vaccine candidate, “Covaxin”, developed by Hyderabad-based Bharat Biotech in collaboration with the Indian Council of Medical Research (ICMR) is still undergoing Phase III trials. It is widely acknowledged in the scientific community that these trials are important to understand the ability of the vaccine to prevent clinical disease. The development of both the vaccine candidates is part of public-funded research — ICMR funded the clinical trial site fees for Covishield and collaborated in the development of Covaxin. These would, therefore, fall within the scope of the draft STIP 2020 — so all research data on the vaccines must be made available in the public domain for collective scrutiny and peer-review.
When data is not openly available, especially in cases of publicly-funded research and research which have wider public safety concerns, the vaccine for instance, not only is public trust in science and scientists damaged, the self-critical and self-correcting nature of science is severely hampered as well. The government’s intention to prioritise research and innovation in the fight against the COVID-19 pandemic is laudable. A vaccine, however, cannot come at the cost of transparency, an indispensable element in the fight against the virus. While CDSCO guidelines clearly mention that “adequate data should be generated” to ensure safety and effectiveness of any vaccine whose development is expedited for unmet medical needs of the country, this data should also be made public.
Going ahead, data across the different stages of COVID-19 vaccine research (including but not limited to research methodology, research tools, negative results, efficacy data, and other limitations) should be made public on ICMR’s open access repository, the central repository of the Department of Science and Technology or other open access repositories identified by the CSIR. This must be done on a priority basis to ensure that bad science does not compromise peoples’ health and the trust in science remains intact.
This article first appeared in the print edition on January 25, 2021 under the title ‘Open, only on paper’. The writer is a researcher with the government of Punjab