COVAXIN (Syllabus: GS Paper 3 – Sci and Tech)

Context: Researchers at Banaras Hindu University (BHU) recently found that nearly one-third of individuals who received Bharat Biotech's Covaxin reported 'adverse events of special interest' (AESI).

Adverse Events of Special Interest

• About: It is one of scientific and medical concern specific to the sponsor’s product or program.
• Monitoring and Communication: Ongoing monitoring and rapid communication by the investigator to the sponsor may be appropriate for an AESI.
• Need for Further Investigation: Such an event might warrant further investigation to characterize and understand it.
• Rapid Communication to Regulators: Depending on the nature of the event, rapid communication by the trial sponsor to other parties, such as regulators, might also be warranted.

Key Findings of Report

• Approximately 33% of participants reported AESI, with skin and subcutaneous disorders (10.5%) being the most common in adolescents.
• General disorders (10.2%) and nervous system disorders (4.7%) were also common AESIs among adolescent participants.
• In adults, common AESIs included general disorders (8.9%), musculoskeletal disorders (5.8%), and nervous system disorders (5.5%).
• Serious AESIs, such as stroke and Guillain-Barre syndrome, were reported by 1% of participants.
• Nearly 50% of the 926 participants experienced infections, primarily viral upper respiratory tract infections, during the follow-up period.
• The study emphasized the need for extended surveillance to understand AESIs' long-term outcomes and called for larger studies on immune-mediated phenomena post-COVID-19 vaccination.

Covaxin

• About: It is produced by Bharat Biotech, Hyderabad, in collaboration with the Indian Council of Medical Research’s National Institute of Virology, Pune.
• Constituents and Action:

o It is an inactivated vaccine developed by inactivating (killing) the live microorganisms responsible for the disease.

o This process destroys the pathogen's ability to replicate while preserving its structure, enabling the immune system to recognize it and mount an immune response.