Vaccine Optimism and the Scientific Uncertainty Link

The Hindu     16th January 2021     Save    
QEP Pocket Notes

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.

QEP Pocket Notes