The Subject Experts Committee (SEC) has recommended Covishield to Drugs Controller General of India (DCGI) for use against COVID-19 virus in India. It was confirmed that 1.7 Lakh frontline workers will get the COVID-19 vaccine. Healthcare workers will be vaccinated in phase 1.
The 10-member Subject Expert Committee of India's Central Drug Standard Control Organisation on Friday (January 1) approved emergency use authorisation of the Oxford-AstraZeneca coronavirus vaccine 'Covishield'. The expert panel had convened a meeting to take a call on the emergency use authorisation sought by the Serum Institute of India, the manufacturer of Covishield, and Bharat Biotech for its Covaxin.
Once the vaccines are cleared by the committee, the application will be sent to Drugs Controller General of India (DCGI) V.G. Somani for final approval.
Britain and Argentina have already authorised the vaccine for urgent public use. India wants to start administering the shots soon.
It is also considering emergency-use authorisation applications for vaccines made by Pfizer Inc with Germany's BioNTech, and by India's Bharat Biotech. At more than 10 million, India has reported the second highest number of coronavirus cases after the United States, though its rate of infection has come down significantly from a mid-September peak.
The UK Medicines and Healthcare products Regulatory Agency (MHRA) had earlier this week given an emergency authorisation to AstraZeneca’s covid-19 vaccine for immunising people that are 18 years or older. The authorisation recommends two full doses administered with an interval of between four and 12 weeks.
SII had submitted its proposal for emergency licensure for the vaccine in early December, but the SEC had asked the company to return with updated data and after an approval was given by the UK MHRA to AstraZeneca for the original version. The original version was co-developed by AstraZeneca and the University of Oxford, with AstraZeneca having the commercial rights.
Unlike vaccines from other candidates like Pfizer and Moderna, Covishield does not have to be stored in freezing conditions and requires storage at domestic fridge temperatures (2 to 8 degrees Celsius). The vaccine also holds a cost advantage over others and is likely to be priced well under Rs 1,000 for two mandatory dosages.
