CAA’s Articulate – VPM1002: Recombinant BCG vaccine


Context:

  • Serum Institute of India Pvt. Ltd. (SIIPL) has conducted a clinical trial of a recombinant BCG vaccine candidate, VPM1002.

More on the news:

  • The clinical trial has been supported under the Department of Biotechnology’s (DBT) National Biopharma Mission.
  • SIIPL has partnered with DBT – Biotechnology Industry Research Assistance Council (BIRAC) for this study.
  • The objective of this trial is to evaluate the ability of VPM1002 in reducing infection incidence and severe disease outcomes of COVID-19 among high-risk persons.
  • About 6,000 health workers and high-risk individuals have been enrolled in a clinical trial to determine if the recombinant Bacillus Calmette-Guerian (rBCG) can boost immunity to fight against the virus.

Recombinant DNA Technology

  • Recombinant DNA technology is the joining together of DNA molecules from two different species.
  • The recombinant DNA molecule or artificial DNA is inserted into a host organism to produce new genetic combinations that are of value to science, medicine, agriculture, and industry.
  • This technology is popularly known as genetic engineering.

About the BCG (or Bacillus Calmette-Guerin) vaccine:

  • As a part of the National childhood immunization programme to prevent tuberculosis (TB) (an infection caused by bacteria that mainly affects the lungs), it is administered routinely to all newborn babies .
  • It has beneficial heterologous effects and proven antiviral and immune modulatory properties that protect against infectious diseases through induction of trained innate immunity and heterologous adaptive immunity.
  • BCG vaccine is a proven platform and utilizing its off-target effects for diseases other than TB is a very pragmatic approach to take.

Significance:

  • This is an important milestone, in the quest for preventing the spread of Covid-19 disease.
  • Will ensure safety and health of workers who are on the forefront fighting the epidemic, household contacts of COVID positive patients and all other people residing or working in COVID-19 hotspots/outbreak areas.
  • Elsewhere: Paul Ehrlich Institute (PEI) and Health Canada also approved similar trials with rBCG.

About DBT:

  • The Department of Biotechnology (DBT), Ministry of Science & Technology, promotes and accelerates the development of biotechnology in India, including growth and application of biotechnology in the areas of agriculture, healthcare, animal sciences, environment and industry.

About BIRAC:

  • Biotechnology Industry Research Assistance Council (BIRAC) is a not-for-profit Section 8, Public Sector Enterprise, set up by the Department of Biotechnology (DBT), Government of India.
  • It is an Interface Agency to strengthen and empower the emerging Biotech enterprise to undertake strategic research and innovation, addressing nationally relevant product development needs.

About National Biopharma Mission:

  • The Industry-Academia Collaborative Mission of the Department of Biotechnology (DBT), Government of India, launched in 2017.
  • The mission works towards accelerating discovery research to early development for Biopharmaceuticals.
    • This program is dedicated to deliver affordable products to the nation with an aim to improve the health standards of India’s population.
    • Vaccines, medical devices and diagnostics and biotherapeutics are few of its most important domains.
    • It also works towards strengthening the clinical trial capacity and building technology transfer capabilities in the country.
  • Funding and implementation: With a total cost US$ 250 million, 50% co-funded by the World Bank, the mission is being implemented at Biotechnology Research Assistance Council (BIRAC).

About SIIPL:

  • It is the world’s largest vaccine manufacturer by number of doses produced and sold globally which includes Polio vaccine as well as Diphtheria, Tetanus, Pertussis, Hib, BCG, r-Hepatitis B, Measles, Mumps and Rubella vaccines.
  • Vaccines manufactured by the Serum Institute are accredited by the World Health Organization, Geneva and are being used in around 170 countries across the globe in their national immunization programs, saving millions of lives throughout the world.