India's Subject Expert Committee (SEC), which advises the central drug regulatory authority, has recommended upgrading Biological E's COVID-19 vaccine Corbevax from "restricted use in emergency situation" to full "new drug permission" for individuals aged five years and above.
The recommendation follows a comprehensive review of safety and immunogenicity data from phase II/III and phase III clinical trials conducted in India, along with safety data from approximately 100 million doses administered in vaccination programs across India and other countries.
"After detailed deliberation, the committee recommended to update the status of approval of Corbevax SARS-CoV-2 (COVID-19) Vaccine, RBD antigen of SARS-CoV-2 from restricted use in emergency situation to the new drug permission as per rules in individuals aged 5 years and above," stated the committee. The approval comes with conditions that the vaccine will be supplied for programmatic settings, and adverse events following immunization (AEFI) and adverse events of special interest (AESI) will continue to be monitored.
Long-term Efficacy and Safety Profile
A key factor in the committee's decision was the finding that Corbevax induces a persistent humoral response. Data showed binding antibody titers against the RBD protein and neutralizing antibody titers against SARS-CoV-2 or pseudovirus remained effective for up to one year post-vaccination.
The SEC noted that no additional safety concerns have emerged during the vaccine's widespread use. Biological E presented comprehensive data on serious adverse events and safety information from vaccination programs, along with a Risk Management Plan to continue monitoring the vaccine's performance.
Widespread Administration and WHO Recognition
Biological E has supplied more than 85 million doses globally, with 32.5 million individuals in India receiving two doses of Corbevax in the 12-14 years age group alone. The vaccine achieved an important milestone in January 2024 when it was listed by the World Health Organization (WHO) under the Emergency Use Listing (EUL) for use during public health emergencies of international concern.
The company's application to update the approval status specifically requested removing the conditions of permission for restricted use in emergency situations, reflecting confidence in the vaccine's established safety and efficacy profile.
Clinical Development and Technical Specifications
Corbevax is India's first indigenously developed Receptor Binding Domain (RBD) protein sub-unit vaccine for COVID-19. It initially received Emergency Use Authorization (EUA) from the Drugs Controller General of India (DCGI) in December 2021.
The vaccine's development was supported by the Department of Biotechnology (DBT) and its Public Sector Undertaking, Biotechnology Industry Research Assistance Council (BIRAC), from pre-clinical stages through Phase III clinical studies. Financial support was provided under the COVID-19 Research Consortium through the National Biopharma Mission for pre-clinical toxicology studies, with additional support from Mission COVID Suraksha for clinical development.
Comprehensive Phase III clinical trials involved more than 3,000 subjects between the ages of 18 and 80 at 33 study sites across India. These trials demonstrated that the vaccine is safe, well-tolerated, and highly immunogenic.
Corbevax is administered as a 2-dose regimen via intramuscular injection and can be stored at standard refrigeration temperatures of 2°C to 8°C, making it logistically viable for widespread distribution in diverse healthcare settings.
The Translational Health Science and Technology Institute (THSTI), an autonomous institute of DBT, provided key immunogenicity data for the Phase II/III studies, further validating the vaccine's efficacy profile.
Diverse Clinical Studies Supporting Approval
Biological E submitted multiple clinical studies to support the upgrade in approval status, including:
- Phase II and III clinical studies demonstrating protection against COVID-19 disease when administered to COVID-19 negative adults
- Studies evaluating safety, reactogenicity, tolerability, and immunogenicity in children and adolescents
- Research on the immunogenicity and safety of Corbevax as a single booster dose when administered to COVID-19 negative adult volunteers previously vaccinated with two doses of either Covishield or Covaxin
This comprehensive body of evidence has established Corbevax as an important component of India's COVID-19 vaccination strategy, now with full drug approval for individuals aged 5 years and above.
