Covaxin

Subject: Science and tech

Context:

Indian Council of Medical Research (ICMR) has envisaged launch of a Covid vaccine “Covaxin” for public health use latest by August 15. It sparked debate that whether it is possible to check efficacy and safety of vaccine in short time.

Concept:

• Covaxin has been developed by the company Bharat Biotech India (BBIL) in collaboration with ICMR’s National Institute of Virology (NIV).
• It is an inactivated vaccine that is made by using particles of the Covid-19 virus that were killed, making them unable to infect or replicate.
• Injecting particular doses of these particles serves to build immunity by helping the body create antibodies against the dead virus.

Vaccine development

• The general stages of the development cycle of a vaccine are:
• Exploratory stage
• Pre-clinical stage
• Clinical development
• Regulatory review and approval
• Manufacturing
• Quality control
• Clinical development is a three-phase process.
• During Phase I, small groups of people receive the trial vaccine.
• In Phase II, the clinical study is expanded and vaccine is given to people who have characteristics (such as age and physical health) similar to those for whom the new vaccine is intended.
• In Phase III, the vaccine is given to thousands of people and tested for efficacy and safety.
• In India, Central Drugs Standard Control Organisation gives approvals for clinical trials.

Central Drugs Standard Control Organisation

• CDSCO under Directorate General of Health Services, Ministry of Health & Family Welfare is the National Regulatory Authority (NRA) of India.
• The Drugs & Cosmetics Act,1940 and rules 1945 have entrusted various responsibilities to central & state regulators for regulation of drugs & cosmetics.
• CDSCO is constantly thriving upon to bring out transparency, accountability and uniformity in its services in order to ensure safety, efficacy and quality of the medical product manufactured, imported and distributed in the country.
• Under the Drugs and Cosmetics Act, CDSCO is responsible for approval of Drugs, Conduct of Clinical Trials, laying down the standards for Drugs, control over the quality of imported Drugs in the country and coordination of the activities of State Drug Control Organizations by providing expert advice.
• Drug Controller General of India within CDSCO is responsible for approval of licenses of specified categories of Drugs such as blood and blood products, I. V. Fluids, Vaccine and Sera

Immunogenicity

• Immunogenicity is the ability of a foreign substance to enter a person’s body and cause an immune response.
• A great example of immunogenicity is a vaccination.
• When a person gets vaccinated, they are injected with a very tiny amount of a specific disease. Once a person receives the injection, their immune system will begin to create antibodies, which are special proteins created by the body that help protect us against infectious viruses and bacteria.