Vaccine Optimism and the Scientific Uncertainty Link

Context: 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.

Features of Indian COVID-19 vaccine development programme:

• Public-private collaboration: the vaccine supply is under the responsibility of Indian pharma companies and the Ministry of Health and Family Welfare to implement the vaccination programme.
  • Two vaccines (Covishield and Covaxin) have been granted restricted use in an emergency, subject to certain regulatory conditions.
• The “adaptive and seamless” approach: As advocated by the World Health Organization (WHO) for public health emergencies and promoted by the Central Drugs Standard Control Organisation.
  • It adds a ‘review-adapt’ feature to the linear ‘design-conduct-analysis sequence’ in traditional clinical trials;
  • An adaptation is referred to a change made to the trial procedure, such as eligibility criteria, study dose, treatment duration or study endpoints, and/or statistical procedures.

Associated concerns with the adaptive seamless approach:

• Defining the level of adaptation that is agreed to by the regulatory agencies.
• Formulating the regulatory standards for the review and approval process of data obtained from adaptive trials with different modifications levels.
• Unique cultural considerations, such as the drawing of blood, may impact the study design, and in turn, the choice of endpoints collected in the study.
• Risk of introducing bias in a trial.

Way forward:

• Adhering to WHO’s guidelines on Good Participatory Practice (GPP): to establish community acceptability of control arms, placebo, and blinding
• Ensure a robust communication strategy:
  • Community engagement: to establish community trust and acceptability of vaccines.
  • Effectively communicate adequacy and appropriateness of the regulatory and authorisation processes.
• Minimise operational bias: by rigorous planning and transparency.
• Build Ensuring Vaccine Confidence: as it encompasses trust in the effectiveness and safety of the vaccine and the system that delivers.
  • Through sharing of the adaptive design protocols in scientific journals for peer guidance, increasing their translational relevance.
  • Need for imaginative social and behavioural research that takes on board the scientific uncertainties.

Conclusion: A climate of transparency and data sharing that allows for public scrutiny and a healthy debate, along with effective communication of the scientific uncertainty is the key to ensuring vaccine confidence and optimism.