Covid Vaccine DeliveryApprox Read Time: 3 min
- Prime Minister Narendra Modi recently reviewed the pandemic situation and the preparedness of vaccine delivery, distribution and administration at a meeting.
- The meeting noted that three vaccines are at advanced stages of development in India, of which two are in Phase II and one is in Phase-III.
Highlights of the meeting:
- The PM directed that every step in the logistics, delivery and administration of the vaccine should be developed rigorously.
- It must include advanced planning of cold storage chains, distribution network, monitoring mechanism and advance assessment and preparation of ancillary equipment such as vials and syringes.
- The PM said that India should make use of experience of successful conduct of elections and disaster management in vaccine administration and delivery.
- This should involve the participation of States/UTs/district level functionaries, civil society organisations, volunteers, citizens and experts from all necessary domains.
- Further, the entire process should have a strong IT backbone and the system should be designed in such a manner so that it has a significant and long lasting impact on the country’s healthcare system.
- It was pointed that Indian scientists and research teams are collaborating and strengthening the research capacities in neighbouring countries viz., Afghanistan, Bhutan, Bangladesh, Maldives, Mauritius, Nepal and Sri Lanka.
- To help the global community, the PM further directed that the country should not limit its efforts to the immediate neighbourhood but also reach out to the entire world in providing vaccines, medicines and IT platforms for the vaccine delivery system.
Approval for clinical trial of Sputnik V vaccine:
- Reddy’s Laboratories and Russia’s sovereign wealth fund Russian Direct Investment Fund (RDIF) have received approval from the Drugs Controller General of India (DCGI) to conduct a phase 2/3 human clinical trial for Sputnik V vaccine in India.
- The approval was given by the subject expert committee (SEC), that advises the drug regulator on clinical trials as well as drug and vaccine approvals.
- The Sputnik V vaccine uses two adenovirus vectors against SARS-CoV-2 virus.
- Adenoviruses are common viruses that cause a range of illness. They can cause cold-like symptoms, fever, sore throat, bronchitis, pneumonia, diarrhea, and pink eye (conjunctivitis).
- Earlier in September 2020, Dr. Reddy’s and RDIF entered into a partnership to conduct clinical trials of Sputnik V vaccine and its distribution in India.
- As part of the partnership, RDIF shall supply 100 million doses of the vaccine to Dr.Reddy’s after regulatory approval in India.
- Dr Reddy’s and RDIF had initially planned to conduct only a phase 3 trial of the vaccine, but the subject expert committee (SEC) denied permission for it.
- The SEC asked Dr Reddy’s to conduct a Phase 2 and 3 clinical trial in India, instead of just a phase 3 study, because the safety and immunogenicity data in overseas phase I/II studies was small and there was no data available on Indians.
- Immunogenicity is defined as the ability of a substance to produce an immune response. It is the key to a successful and safe vaccine development program.
Clinical trials of Sputnik V vaccine:
- India will now carry out a phase II and III human clinical trial involving 1,500 participants. The trial will be a multi-centre study, which will include safety and immunogenicity study.
- A Phase III trial involving 40,000 participants is currently going on in Russia. Additionally, a phase 3 clinical trial of the vaccine recently commenced in the UAE.
- In addition to Indian clinical trials data, RDIF will provide safety and immunogenicity data from the Russian Phase-3 clinical trial as well.
- This data will further strengthen the clinical development of Sputnik V vaccine in India.
About: Drugs Controller General of India (DCGI)
- Drugs Controller General of India, an office under the Ministry of Health & Family Welfare is responsible for approval of licences of specified categories of drugs, intravenous fluids and vaccines in India.
- It also sets standards for manufacturing, sales, import, and distribution of drugs in India.