SEC Endorses Corbevax for Transition to New Drug Status

The Subject Expert Committee (SEC), which advises India’s central drug regulatory authority on new drugs and clinical trials, has recommended that Biological E's COVID-19 vaccine, Corbevax, be upgraded from its current restricted emergency use to full drug permission for individuals aged five years and older.

The recommendation comes after the SEC reviewed extensive data from Phase II/III clinical trials conducted in India, along with safety data from approximately 10 crore doses managed globally. According to the committee, there are no additional safety measures to be found, and it concluded that the vaccine demonstrated strong immunogenicity.

Key Takeaways:

• WHO listed Corbevax for emergency global use in January 2024.
• The vaccine shows strong immunity lasting up to one year post-vaccination.
• India’s first RBD protein subunit COVID-19 vaccine is safe and effective.

The SEC's updated approval for Corbevax depends on its continued use in programmatic settings, and ongoing monitoring of Adverse Events Following Immunization (AEFI) and Adverse Events of Special Interest (AESI). The vaccine has already shown persistent humoral responses, including lasting neutralizing antibody levels for up to a year after vaccination.

In India, Corbevax has been directed to over 85 million doses, including 32.5 million doses given to children aged 12–14 years. In January 2024, the vaccine was Emergency Use Listed (EUL) by the World Health Organization (WHO) and made available for global public health.

The company presented results from various clinical trials, which discovered safety, immunogenicity, and the response to activate doses in adults previously vaccinated with Covishield or Covaxin.

Also read: FDA Review of Novavax COVID Vaccine Raises Doubts about Broader Shot Approval

Corbevax is India’s first original RBD protein subunit vaccine for COVID-19. It received Emergency Use Authorization (EUA) from the Drugs Controller General of India (DCGI) in December 2021.

The vaccine is a 2-dose regime, controlled intramuscularly, and is stable at 2 to 8 degrees Celsius, making it easier to stock up and issue. Clinical trials involving over 3,000 participants showed that Corbevax is safe, well-tolerated, and highly immunogenic.