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CORBEVAXTM

Posted on December 31, 2021 by admin1  27

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Recently, CORBEVAXTM received approval for Emergency Use Authorization (EUA)

by Drug Controller General of India (DCGI).

Drugs Controller General of India

  • It is the apex department of the Central Drugs Standard Control Organization (CDSCO) of the Government of India.
    • CDSCO is a regulatory body for Indian pharmaceuticals and medical devices.
    • It comes under the Ministry of Health and Family Welfare.
  • Functions:
    • Approval of licences of specified categories of drugs such as blood and blood products, IV fluids, vaccines and sera in India.
    • Sets standards for the manufacturing, sales, import, and distribution of drugs in India.

Emergency Use Authorization (EUA)

  • It is an authorization issued for unregistered drugs and vaccines in a public health emergency.

About CORBEVAXTM

  • It is India’s first indigenously developed Receptor Binding Domain (RBD) protein subunit vaccine for COVID-19.
  • It is a 2-dose vaccine administered intramuscularly and can be stored at 2ºC to 8ºC.
  • It is developed by Biological E Limited.
    • 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 the preclinical stage through Phase III clinical studies. 
  • Financial Support: The vaccine candidate was provided financial support under COVID-19 Research Consortium, through the National Biopharma Mission, for preclinical toxicology studies. 
    • Later support was provided under Mission COVID Suraksha for clinical development. 
  • The recombinant protein subunit vaccine developed from the Receptor Binding Domain (RBD) of the spike protein on the viral surface is adjuvanted with Dynavax’s CpG 1018 and alum. 
  • Result of Phase III clinical trials 
    • 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. 
  • Significance 
    • This vaccine will sharpen the country’s efforts in ending the pandemic. The development of indigenous vaccines to fight the pandemic will also inspire the country’s scientists and manufacturers to resolve the problems of the country.

Mission COVID Suraksha Program

  • The Department of Biotechnology (DBT), Ministry of Science & Technology, Government of India (GoI) has taken myriads of initiatives to increase investments in research & development (R&D) and manufacturing of COVID-19 Vaccines. 
  • The establishment of the Mission COVID Suraksha Program is one such endeavour for COVID-19 vaccine development to reinforce and streamline available resources towards a warpath for accelerated vaccine development, leading to bringing in a safe, efficacious, affordable and accessible COVID-19 Vaccine for the citizens at the earliest with a target of Atmanirbhar Bharat.
  • COVID Suraksha Program’s endeavour to accelerate vaccine development played a crucial role in the initial development, the mechanism that was set up with the support of the Department of Biotechnology and DBT-Biotechnology Industry Research Assistance Council (BIRAC) allowed us to scale up to a capacity of about 1.2 billion doses per annum making the dream of accessibility – affordability and supply – a reality.”

The National Biopharma Mission (NBM)

  • It is an Academia-Industry Collaborative Mission for Accelerating Discovery Research to Early Development for Biopharmaceuticals. 
  • The objective of the Mission is to enable and nurture an ecosystem for preparing India’s technological and product development capabilities in biopharmaceuticals including vaccines, biologics, medical devices and diagnostics to a level that will be globally competitive over the next decade.
  • The dedicated Program Management Unit (PMU) at Biotechnology Industry Research Assistance Council (BIRAC) under the aegis of the Department of Biotechnology is the Implementing Agency for the Mission. 
  • Under the National Biopharma Mission, skill development training programmes shall be facilitated for young professionals to build next-generation inter-disciplinary skills for product innovation, knowledge of navigating regulatory policies, business development capabilities, better management of IPR systems and practices for building effective workforce and next-generation leaders through close engagement and collaboration of industry and academic training partners.

Source: PIB

 
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