Biological E VaccineBiological E has received approval from the Drugs Controller General of India (DCGI) for two clinical trials of its Covid-19 vaccine candidate Corbevax.
- The Indian FDA approved the Hyderabad-based pharmaceutical firm’s Phase 2 and 3 clinical trials for its anti-Covid injections, known as Corbevax, on children aged 5 to 18 with specified circumstances
- The trial will take place in ten different places.
- Biological E was granted approval following a recommendation from the Subject Expert Committee.
Working of Corbevax
- Corbevax is a “recombinant protein sub-unit” vaccine
- It is made up of a specific component of SARS-CoV-2, the virus’s surface spike protein.
- The spike protein allows the virus to invade the body’s cells, letting it multiply and cause illness. However, because the rest of the virus is missing, when this protein is delivered to the body alone, it is unlikely to cause harm.
- The injected spike protein is expected to cause a body-wide immune response. As a result, when a real virus tries to invade the body, the body will already be prepared with an immune response, making it unlikely that the person will become very ill.
How it is different from others
- Other Covid-19 vaccines that have been approved include mRNA vaccines (Pfizer and Moderna), viral vector vaccines (AstraZeneca-Oxford/Covishield, Johnson & Johnson, and Sputnik V), and inactivated vaccines (Covaxin, Sinovac-CoronaVac, and Sinopharm’s SARS-CoV-2 Vaccine–Vero Cell).
- Inactivated vaccines, which include dead particles of the complete SARS-CoV-2 virus, aim to attack the virus’s entire structure. Corbevax, on the other hand, works in a similar fashion to the mRNA and viral vector Covid-19 vaccines in that it solely targets the spike protein.
- Viruses, mRNA, and vaccines all employ a code to get our cells to manufacture the spike proteins that the body needs to build immunity against.
The Central Drugs Standard Control Organization (CDSCO)
- The National Regulatory Authority (NRA) of India is the Central Drugs Standard Control Organisation (CDSCO), which is part of the Directorate General of Health Services, Ministry of Health & Family Welfare, Government of India.
- CDSCO is responsible for approving drugs, conducting clinical trials, establishing drug standards, monitoring the quality of drugs imported into the country, and coordinating the activities of State Drug Control Organizations by providing expert advice in order to achieve uniformity in the enforcement of the Drugs and Cosmetics Act.