On 03 Jan 2020, India’s National Drug Regulator, Drugs Controller General of India (DCGI) gave marketing approval to both Covishield and Covaxin vaccines for emergency usage after the government-appointed Subject Expert Committee (SEC) panel of the Central Drugs Standard Control Organisation (CDSCO) recommended the grant of Emergency Use Authorisation (EUA). The Committee has recommended for 2 doses for both the vaccines. Both the vaccines are recommended to be stored at 2-8 degree Celsius.
About Covishield
Covishield is developed by Swedish drugmaker AstraZeneca and Oxford University. Pune-based Serum Institute of India (SII), the world’s largest vaccine manufacturer has been given the responsibility to manufacture and distribute the vaccine in India.
About Covaxin
Covaxin is developed by Hyderabad-based Bharat Biotech in collaboration with the Indian Council of Medical Research (ICMR).
Emergency Use Authorisation means that Regulatory authorities need to approve vaccines, medicines, diagnostic tests and medical devices before these can be used on the general public or used by medical professionals.
Complete approval vs authorisation?
The vaccine has only been granted an emergency use authorisation and not complete approval. Final approval would be granted only after completion of the trials and analysis of full data.
India’s Strategy for Vaccination
The vaccination program would be on a voluntary basis and no mass vaccination would occur. Initially, India would be vaccinating a priority group of 300 million people to include 10 million healthcare providers and 20 million frontline workers followed by people older than 50 years. Healthcare workers would include doctors, paramedics, nurses, and hospital staff. Second rung of priority would be persons younger than 50 years of age with associated comorbidities based on evolving pandemic situation. The third rung includes remaining population based on the disease epidemiology and vaccine availability.
Preparations for Vaccination
India is the world's biggest vaccine producer and supplier. It also runs the world's largest vaccination programme. Two rounds of mock drills have already been held- the first in four states on December 28-29, and the second on January 2, covering 285 session sites in 125 districts in all states around the country. Around 96,000 vaccinators have been trained by India so far for the entire drive. The country’s cold chain infrastructure has been sufficiently upgraded to ensure last-mile delivery, and adequate supplies of syringes and other logistics have been arranged.
Proposed Registration Model
The COVID-19 Vaccine Intelligence Network (Co-WIN) system, a digital platform will be used to track the enlisted beneficiaries for vaccination and COVID-19 vaccines on a real-time basis. At the vaccination site, only pre-registered beneficiaries will be vaccinated per the prioritization, and there will be no provision for on-the-spot registrations.
Cost Models of Vaccination
SII has offered a price of ₹225-₹250 per dose for the first tranche. As per SII CEO, Adar Poonawalla Covishield vaccine would be costing around cost ₹440 per individual if purchased from government stores and around ₹700-₹800 if bought from private markets.
Reference
- https://www.opindia.com/2021/01/india-grants-emergency-use-approval-for-usage-to-oxford-astrazeneca-vaccine-serum-institute/
- https://timesofindia.indiatimes.com/india/happy-new-year-expert-panel-clears-oxford-vaccine-for-india/articleshow/80066219.cms