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Effectiveness of a vaccine is capability to produce desired effect

Wednesday, March 31, 2021, 08:00 Hrs  [IST]

How do efficacy and effectiveness of Covid-19 vaccine differ? 
Mahesh Ramakrishnan

Efficacy of vaccine is the ability of a medicine to provide a beneficial effect when studied in a clinical trial. Effectiveness of vaccine is the capability of a medicine to produce a desired effect in the real-world clinical setting.

In randomized clinical trial, there are restrictions on inclusion criteria, and limitations of sample size and subgroup analysis. Hence, clinical trials cannot provide data on efficacy against clinically important endpoints – prevention of severe disease, hospitalization, mortality, or transmission of infection. Efficacy assessment of such endpoints in clinical trials would require recruitment of large number of young, or elderly participants.
Real-world studies of evaluation of effectiveness of vaccines could be conducted across diverse populations with a wide range of coexisting conditions. Real world studies of effectiveness of Covid-19 vaccines in Israel have provided evidence of (1) direct protective effect of the vaccine at the individual level and (2) real-life impact of vaccination programmes at a population level. In these studies, the Covid-19 vaccines showed high reduction - over 80-90 per cent - in infections and severe disease, symptomatic illness, hospitalization, and mortality. Effectiveness of vaccine in reducing infection and illness was also high amongst subgroups: elderly > 70 years, 3 or more comorbidities, type 2 diabetes mellitus, obesity, and hypertension.

We plan to conduct a retrospective observational clinical study. Do we require consent of patients?
Dr Dinesh Chaturvedi

Ethics committee reviewing a retrospective observational study can consider waiver of informed consent in the following situations:
•    The research involves no more than minimal risk to the study participants
•    The research could not be practicably conducted without waiver of informed consent
•    If the research study plans to use identifiable private information or identifiable biospecimens, the study could not practicably be conducted without using such information or biospecimens in an identifiable format
•    The study design is retrospective, where the participants are de-identified or cannot be contacted
•    The research study is on anonymized biological samples/data
•    The research study is on data available in the public domain

•    The waiver of consent will not adversely affect the rights, safety, and well being of the study participants

How do we ensure protection of privacy and confidentiality of research participants?
Satish Talwalkar

ICMR National Ethical Guidelines for Biomedical and Health Research involving Human Participants, 2017 discuss the issues of privacy and confidentiality.
Protection of privacy and confidentiality of research participants requires understanding following issue:
•    Principle of ensuring privacy and confidentiality requires that to maintain privacy of the potential participant, her/his identity and records are kept confidential and access is limited to only those authorized.
•    Privacy is the right of an individual to control or influence the information that can be collected and stored and by whom and to whom that information may be disclosed or shared.
•    Any publication arising out of research should uphold the privacy of the individuals by ensuring that photographs or other information that may reveal the individual’s identity are not published
•    Confidentiality is the obligation of the researcher/research team/organization to the participant to safeguard the entrusted information. It includes the obligation to protect information from unauthorized access, use, disclosure, modification, loss, or theft.
•    The researcher should safeguard the confidentiality of research related data of participants and the community.
•    Some information may be sensitive and should be protected to avoid stigmatization and/or discrimination.
•    While conducting research with stored biological samples or medical records/data, coding or anonymization of personal information is important and access to both samples and records should be limited.
•    Ethics committee should examine the processes that are put in place to safeguard participants’ privacy and confidentiality.

Dr. Arun Bhatt is a Consultant - Clinical Research & Development,
Mumbai. Readers can send their queries at:arun_dbhatt@hotmail.com


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