IASbhai Daily Editorial Hunt | 16th Jan
“No one can make you feel inferior without your consent.” —Eleanor Roosevelt
EDITORIAL HUNT #318 :“Vaccine Optimism and the Scientific Uncertainty | UPSC ”
Rajib Dasgupta and Rama V. Baru
Vaccine Optimism and the Scientific Uncertainty | UPSC
Rajib Dasgupta and Rama V. Baru are professors at the Centre of Social Medicine and Community Health, Jawaharlal Nehru University, New Delhi.
Vaccine optimism and the scientific uncertainty link
Amidst the vaccine rollout, there is a critical need for a climate of transparency and data sharing for scrutiny and debate
SYLLABUS COVERED: GS 3 : Health : Vaccine : Diseases
Are we, as a community of researchers and policymakers, making adequate and appropriate efforts to communicate the vaccine uncertainties. Discuss the loopholes in mass immunisation programme. -(GS 3)
- Present Status of Vaccines
- Clinical trials
- Need for more Caution in trials
- Adequacy of process
- Way forward
- MASS IMMUNISATION : With its robust domestic vaccine industry and strong fundamentals of the Universal Immunisation Programme, India is now embarking on the world’s largest COVID-19 vaccination programme, on January 16, 2021.
- PUBLIC PRIVATE PARTNERSHIP : This represents the forging of a novel public-private collaboration wherein the vaccine supply is under Indian pharma companies and the GOI for the implementation of the vaccination programme.
- PRESENT STATUS : The clinical trial ongoing within the country by the firms will continue.These vaccines are thus deemed to be market ready while regulatory processes and logistic requirements are being laid out.
- CLINICAL TRIALS : Traditional clinical trials follow a straightforward but mandatory three-step approach: designing, conducting and analysing the collected data, according to a pre-specified analysis plan.
- TRAIL PROCEDURE : Seamless adaptive designs add a ‘review-adapt’ loop to the linear design-conduct-analysis sequence, with a pre-defined one primary endpoint and several secondary endpoints.
IMPACT OF MODIFICATIONS
- GOOD PARTICIPATORY PRACTICE : Community engagement is critical to establish community acceptability of control arms, placebo, and blinding and should adhere to WHO’s guidelines on good participatory practice (GPP).
NEED FOR MORE CAUTION
- CAUTIOUS APPROACH : The European Medicines Agency cautions that while the increased flexibility of this option may well fit the needs in early phases of drug development.Phase III trials deserves a more cautionary approach.
- PHARMACOLOGY EXPERTS OPINION : “not every trial can be rescued by adaptation and adaptive designs… these should not be a cure for poor planning”.
- The challenge is to minimise operational bias by rigorous planning and transparency.
- MUST NEEDED PROTOCOLS : There is also a need to build and sustain trust through clear and comprehensive sharing of the adaptive design protocols in scientific journals for peer guidance, particularly in projects with major translational relevance.
- TRANSPARENCY : These challenges are as critical to the regulators as to those designing communication strategies and messages, with obvious implications for vaccine confidence.
- DIFFERENT OPINIONS: Among these diverse constituencies, there are optimists and sceptics about the effectiveness and safety of the vaccines.
ADEQUACY OF PROCESSES
- DECISION MAKING : An important aspect is also the perceived motivations of policymakers making decisions about the vaccine.
- EFFICACY : Given the fact that data are still awaited on the effectiveness and safety of the vaccine, the rollout decisions may well add to the scepticism.
- BEHAVIOURAL RESEARCH : There is a need for imaginative social and behavioural research that takes on board the scientific uncertainties and helps to build trust in the health service system and the community.
- COMMUNICATION : Trust-building in the vaccine and its rollout is important for a robust communication strategy.
- INFORMATION OUTREACH PROGRAMMES : It is critical at this stage for the government and establishment scientists to communicate how the regulatory processes and authorisation are adequate and appropriate.
- COMMUNICATING UNCERTAINTIES : It entails identifying facts that are specifically relevant to potential vaccinees, characterising the relevant uncertainties, assessing their magnitude, drafting possible messages and evaluating their success.
- VACCINE OPTIMISM : Underlying the vaccine optimism is the search for a strong signal that the evidence is certain enough and how far the predictions of valued outcomes can be relied upon.
- SCIENTIFIC CONSTRAINTS : Scientists are trained and professionalised in dealing with doubt and uncertainty, given that all scientific knowledge is uncertain.
- LEVEL OF UNCERTAINTY : The task, particularly in the current context, is to be able to communicate scientific uncertainty — both to policymakers and the public at large.
- ACCOUNTABILITY : This requires a climate of transparency and data sharing that allows for public scrutiny and a healthy debate.
To solve any problem that has never been solved before, you have to leave the door open.Otherwise, if you have made up your mind already, you might not solve it.-Richard Feynman