New Delhi: Putting an end to India’s desperate wait for a vaccine against the Coronavirus, the Drugs Controller General of India (DCGI) on Sunday gave approval to Covishield by Oxford-AstraZeneca which is manufactured by Serum Institute of India (SII), and indigenous Covaxin by ICMR-Bharat Biotech for emergency use.
The approvals came at breakneck speed after the Subject Expert Committee (SEC) of Central Drugs Standards Control Organisation (CDSCO) recommended the two vaccines for accelerated approval process on Saturday.
Besides, the DCGI approved the Phase 3 trials of the country's first DNA vaccine candidate being developed by Zydus Cadila. It is supported by the National Biopharma Mission (NBM) under the aegis of the Biotechnology Industry Research Assistance Council (BIRAC), a public sector unit under the department of biotechnology.
The vaccination schedule is likely to be announced by the Centre next week. Vaccination will be in three phases. Health minister Dr Harsh Vardhan has said healthcare, frontline workers and security forces will be inoculated in the first round, the second people will cover those above 50 years of age and those with co-morbidity conditions and serious illness and the rest of the population will be covered in the third phase.
According to one timeline, the government intends to complete immunisation of the population by June 2021.
As questions were raised on the efficacy and safety of the vaccines, and the speed of the approvals, DCGI V.G. Somani said that the SII submitted safety, immunogenicity, and efficacy data generated on 23,745 participants aged 18 and above, from overseas clinical studies. The overall vaccine efficacy was found to be 70.42 per cent.
Somani said Bharat Biotech had developed Covaxin, a whole virion inactivated coronavirus vaccine, in collaboration with the Indian Council for Medical Research in Delhi and the National Institute of Virology in Pune. This vaccine is developed on the Vero Cell platform, which has a well-established track record of safety and efficacy.
The vaccination programme has been divided into three phases.
Phase 1: Health, frontline workers, security forces
Phase 2: People above 50 years or those under 50 but with co-morbidity and serious illness
Phase 3: Rest of the population that is under 50 years.
Vaccination is voluntary and those who have been already infected by Covid-19 too can take the jab that will be given in two rounds after a gap of 28 days.
Active and symptomatic patients need to defer vaccination for at least 14 days after symptoms have resolved.
Registration of beneficiaries is mandatory. A photo ID card given by government agencies including passport, driving licence, PAN Card, health insurance card, service identity card, voter ID card is needed for registration.
Only registered beneficiaries will be called for vaccination at the designated site with the same photo ID card submitted earlier. Beneficiaries will be alerted through SMS on due date and time for vaccination.
Complete schedule of vaccination — two doses, 28 days apart — has to be taken by all.
Protected level of antibodies will develop two weeks after the second dose of the vaccine.
Patients will need to wait for 30 minutes after vaccination at site to check for adverse effects.
After both doses are administered, the beneficiary will get a QR Code enabled certificate of vaccination.