After India’s Central Drugs Standard Control Organisation (CDSCO) approved the emergence use of Covishield (developed by Oxford University and AstraZeneca) vaccine on Friday, plans are underway by the Modi government to roll-out the immunisation programme.
As per reports, while the subject expert committee (SEC) of the drug regulator recommended the emergency-use authorisation (EUA) of the vaccine, it stated that two full doses of the vaccine must be administered to an individual with a gap of 4-6 weeks. Moreover, the individual will be provided information about the vaccine in the form of a factsheet, prior to inoculation. SEC also recommended that the manufacturing company will have to submit reports of ‘adverse incidents’ every 15 days.
Happy New Year: Expert panel clears Oxford vaccine for India
— The Times Of India (@timesofindia) January 2, 2021
The approval is on the cards and the first shots are expected to be given in 7-10 days.https://t.co/uqWM2hc2CX pic.twitter.com/tPn2sWTsI9
Reportedly, the Modi government is planning to immunise 30 crore people, classified under the priority population, within the month of July. As such, a dry run has been scheduled today in at least three ‘session sites’ in every state capital and districts with poor logistical support.
The objective of the government, behind this exercise, is to assess the on-field situation of the vaccination process. At the same time, a total of 96000 vaccinators have been trained to execute the inoculation programme. The government has directed all states to be ready with the list of health workers, who would be vaccinated first.
Covishield vaccine awaiting DCGI approval
It must be pointed out that the Covishield vaccine is yet to receive the final approval for marketing from the Drugs Controller General of India (DCGI). It falls under the Central Drugs Standard Control Organisation (CDSCO) and regulates pharmaceuticals, medical devices.
A source informed, “DCGI approval will take another day or two”. The approval is on the cards and the first shots are expected to be given in 7-10 days.” Moreover, DCGI will also be responsible for approving the labels, to be printed on the vaccine vials. Once the labels are printed and stuck to the vials, they will be dispatched to roll out the vaccination programme.
An official also emphasised, “Preparations are in full swing. As soon as DCGI approves the EVA, the government will place a formal contract or supply order with the manufacturer along with details of supply schedule and locations.”
Who gets the vaccine first?
Earlier, the Modi government decided to provide Coronavirus vaccine shots to the healthcare workers on priority, including doctors, paramedics, nurses and hospital staff. After the healthcare workers, the frontline workers would be next in the line. Following that, people above the age of 50 years and those with co-morbidities but below the age of 50 will be inoculated. Once the priority population is vaccinated, the other categories will be included in the programme.
Manufacture and Pricing of Oxford-AstraZeneca vaccine
It must be pointed out that the world’s largest vaccine manufacturer, Serum Institute of India (SII), has been entrusted with the responsibility to manufacture the vaccine in India. Reportedly, SII has stockpiled over 5 crore doses of Covishield vaccine and can begin transporting the vaccines from cold storage to the Indian States, starting this Saturday.
Moreover, SII CEO Adar Poonawalla had reportedly informed India Today that Covishield vaccine (2 doses) will cost $6 (₹440) per individual if purchased from government stores. However, the vaccine will be priced higher (₹700-₹800) if bought from private markets. Each dose of the vaccine, as targeted by WHO and most international aid organisations, is to cost around 3 dollars.
