 The Subject Expert Committee (SEC), which advises the central drug regulatory authority on new drugs and clinical trials, has recommended to upgrade the status of approval for Biological E's Covid-19 vaccine Corbevax from restricted use in emergency situation to the new drug permission in individuals aged five years and above.
The SEC, which looks into the approvals related to Covid-19 medicines, made the recommendation after reviewing safety and immunogenicity data of phase II/III and phase III clinical trials conducted in the country and safety data of around 10 crore doses of the vaccine administered in the vaccination programme in India and other parts of the world.
After the review, the Committee noted that there have been no additional safety concerns till now.
"After detailed deliberation, the committee recommended to update the status of approval of Corbevax SARS-CoV-2 (Covid19) Vaccine, RBD antigen of SARS-CoV-2 (Covid-19) from restricted use in emergency situation to the new drug permission as per rules in individuals aged 5 years and above with conditions that the vaccine to be supplied for programmatic settings & AEFI, AESI shall be continued to be monitored," said the Committee.
It noted that the company has presented safety and immunogenicity data of phase II/III and phase III clinical trials along with information of serious adverse events and safety data from the vaccination programme. A Risk Management Plan has also been submitted.
Besides, a humoral response was found persistent in terms of binding antibody titers against the RBD protein and neutralizing antibody titers against SARS-CoV-2 or Pseudo virus till one year post vaccination.
The company has supplied more than 85 million doses, out of which 32.5 million received two doses of Corbevax in India for vaccination in the age group of 12-14 years. The vaccine was listed by the World Health Organisation (WHO) under the Emergency Use Listing (EUL) in January 2024 for use during public health emergencies of international concern (PHEICs), or in other public health emergencies.
The SEC's recommendation follows the company's request to update the status of approval for the vaccine by excluding the conditions of permission for restricted use in emergency situations.
The company submitted various studies including various phase II and III clinical studies for protection against Covid-19 disease when administered to Covid-19 negative adults; to evaluate safety, reactogenicity, tolerability and immunogenicity of Corbevax vaccine in children and adolescents; and to evaluate the immunogenicity and safety of single booster when administered to Covid-19 negative adult volunteers previous vaccinated with two doses of either Covishield or Covaxin.
Corbevax, India's first indigenously developed Receptor Binding Domain (RBD) protein sub-unit vaccine for Covid-19, received Emergency Use Authorisation (EUA) from the Drugs Controller General of India (DCGI) in December, 2021.
The Department of Biotechnology (DBT) and its Public Sector Undertaking (PSU), Biotechnology Industry Research Assistance Council (BIRAC), have supported Biological E’s Covid-19 vaccine candidate from pre-clinical stage through phase III clinical studies.
The vaccine candidate was provided financial support under Covid-19 Research Consortium, through the National Biopharma Mission, for pre-clinical toxicology studies. Later support was provided under Mission Covid Suraksha for clinical development. Corbevax is a 2-dose vaccine administered intramuscularly and can be stored at 2ºC to 8ºC.
Comprehensive phase III clinical trials involving more than 3000 subjects between the ages of 18 and 80 at 33 study sites across India, demonstrated the vaccine to be safe, well tolerated and highly immunogenic, said the Ministry of Science and Technology in 2021. The Translational Health Science and Technology Institute (THSTI), an Autonmous Institute of DBT, provided key immunogenicity data for the phase II/ III studies.
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