• UGI USER
  • May 26, 2024
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“STUDY ON COVAXIN’S SAFETY CRITICIZED FOR POOR DESIGN”

Syllabus:

  • GS-3- Advancement in the field of science and technology , Issues related to Vaccine safety and solutions needed

Focus :

  • The focus of the article is on the criticism faced by a study from Banaras Hindu University on Covaxin’s long-term safety. The study, published in the journal Drug Safety, was critiqued by ICMR and experts for its poor design, particularly the lack of a control group and insufficient data, which undermines the validity of its conclusions.
Source-TH

Overview of the Study

Research Objective: Researchers from Banaras Hindu University conducted an observational study to assess the long-term safety of Covaxin, focusing on adverse events of special interest (AESIs) one year after vaccination in adolescents and adults.

Publication: The study’s findings were published in the journal Drug Safety.

Study Criticism: The Indian Council of Medical Research (ICMR) criticized the study for its poor design, highlighting significant limitations.

Criticism by Experts

Vipin M. Vashishtha’s View:

Study’s Acceptance: Dr. Vashishtha argued that the study should have been rejected during the peer-review stage due to its critical limitations.

Purpose Defeated: Simply mentioning limitations, especially those that undermine the study’s purpose, is insufficient.

Gautam Menon’s Perspective:

Inadequate Conclusions: Dr. Menon asserted that the study’s conclusions are not reliable due to its significant limitations.

Need for Control Group: Highlighted the necessity of a control group to draw valid conclusions about the vaccine’s adverse effects.

About ICMR:

1.  Affiliation and Headquarters:

  • Comes under the Department of Health Services (DHS), Ministry of Health and Family Welfare (MoH&FW).
  • Headquarters located in New Delhi.

2.   Status:

  • Not a statutory body.
  • Not a regulatory body.

3.   Clinical Trials Registry – India (CTRI):

  • Hosted by ICMR.
  • Established on 20th July 2007.
  • Free and online public record system for clinical trial registration in India.
  • Initially voluntary until 15th June 2009.
  • Post-2009, registration at CTRI made mandatory by the Drugs Controller General of India (DCGI).

4.   Importance of CTRI:

Encourages registration of clinical trials before enrolling the first participant.

5.  Publications and Research Institutes:

  • Publishing the Indian Journal of Medical Research (IJMR) since 1913.

6.  Governance:

  • The Union Health Minister of India presides over the governing body of ICMR.

Major Limitations of the Study

Lack of Control Group:

Study Design Flaw: The absence of a control group is a major flaw, making it difficult to establish causality between Covaxin and AESIs.

Justification by Researchers: Kishor Patwardhan, a co-author, justified the absence of a control group, arguing that it is not feasible or necessary in a longitudinal observational study.

Absence of Background Rates:

Data Insufficiency: The study lacked data on the background rates of AESIs, making it challenging to associate adverse events solely with the vaccine.

Methodological Concerns

Participant Testing:

Lack of SARS-CoV-2 Testing: The study did not test participants for SARS-CoV-2 infection, attributing all adverse events to the vaccine.

High Infection Rates: Given high infection rates post-Delta wave, some AESIs could be due to prior infections rather than the vaccine.

Deaths and Causality:

Attributing Deaths to Vaccination: The study attributed some deaths to Covaxin without ruling out other causes like pre-existing conditions.

WHO Classification: Used WHO’s AEFI classification, where some deaths might fall under coincidental reactions.

Previous Studies and Comparisons

Covishield Study:

Similar Methodology: The same researchers previously studied Covishield, reporting AESIs in 14% of participants.

Contrasting Findings: Reported AESIs in one-third of Covaxin recipients, which contradicts global perceptions of inactivated vaccines being safer.

Global Perception:

Safety of Inactivated Vaccines: Generally, inactivated vaccines like Covaxin are considered safer than adenovirus vector-based vaccines like Covishield.

Response from Civil Society and Petitioners

Call for Transparency:

Demand for Data Release: Civil society groups and researchers have demanded the release of detailed safety data from ICMR and Bharat Biotech.

Right to Information: The release of voter turnout figures was seen as a victory for transparency, but similar demands for vaccine data persist.

Petition to EC:

Release of Form 17C: Petitioners continue to demand the disclosure of Form 17C, containing booth-level voter turnout data, for greater transparency.

Implications and Future Directions

Need for Robust Studies:

Methodological Rigor: Future studies on vaccine safety must employ rigorous methodologies, including control groups and background rate data.

Transparent Reporting: Clear and transparent reporting of study limitations and data is essential to build public trust.

Policy and Public Health:

Informed Decisions: Reliable data is crucial for policymakers to make informed decisions about vaccine deployment and public health strategies.

Addressing Public Concerns: Addressing public concerns through transparent communication and robust data can enhance vaccine confidence.

Conclusion

  • The BHU study on Covaxin’s long-term safety has faced significant criticism for its methodological flaws, particularly the lack of a control group and absence of background rates for AESIs.
  • Expert opinions underscore the need for robust study designs to draw valid conclusions about vaccine safety.
  • Civil society groups continue to advocate for greater transparency and detailed data release to ensure public trust in vaccination programs.

Source:The Hindu

Associated Article :

https://universalinstitutions.com/celebrating-50-years-of-immunization-progress/

Mains Practice Question :

GS-3

“Discuss the importance of robust study designs in assessing vaccine safety. In light of the criticism faced by the observational study on Covaxin’s safety, outline the key methodological components necessary for reliable vaccine safety studies.?” (250 words)