Serum Institute Of India Applies For Emergency Approval For COVID Vaccine
The development comes hours after the US-based Pfizer has filed for the emergency use approval for its vaccine in India
The Serum Institute of India (SII) has become the first Indian company to seek emergency use approval for Covidshield vaccine. Adar Poonawalla, the chief executive officer of SII—the world’s largest vaccine maker—on Monday took to Twitter to announce it.
As promised, before the end of 2020, @SerumInstIndia has applied for emergency use authorisation for the first made-in-India vaccine, COVISHIELD. This will save countless lives, and I thank the Government of India and Sri @narendramodi ji for their invaluable support.— Adar Poonawalla (@adarpoonawalla) December 7, 2020
This announcement has come as a ray of hope after the Haryana minister tested positive for the contagious virus after being inoculated with the country’s indigenious vaccine Covaxin from Hyderabad-based Bharat Biotech pharmaceutical firm.
Covidshield—prepared by the University of Oxford and British drugmaker Astra-Zeneca in participation with SII—is the second vaccine to have sought the emergency use approval from the Drugs Controller General of India (DGCI) in the backdrop of the ongoing pandemic. The first company to have sought approval in the country was the American-based Pfizer for its vaccine, according to multiple news reports
The phase-three clinical trial of Covishield, co-sponsored by Indian Council of Medical Research (ICMR), is being conducted by SII. Additional clinical studies on the vaccine are also being carried out in the UK and Brazil.
According to the ICMR, the Pune-based firm has already manufactured 40 million doses of the vaccine under the at-risk manufacturing and stockpiling license it obtained from the DGCI, reported PTI.
Preliminary data indicate that the Oxford vaccine is 70.4 per cent effective, with tests on two different dose regimens showing that the vaccine was 90 per cent effective if administered at a half dose and then at a full dose, or 62 per cent effective if administered in two full doses.
While its true that the efficacy is lower compared with Pfizer or Moderna, experts suggest that the Covidshield vaccine is to be best suited for Indian conditions in terms of storage and deployment. The vaccine requires a temperature of 2-8 degree celsius for storage, which is quite viable in India as against the Pfizer’s which needs to be stored at -70 degree celsius, a technology capability that India lacks in.
Needless to say Covidshield will also be cheaper. Poonawala has earlier suggested the two dosages of the vaccine will cost around INR 1,000 in India and the price for the government will be much lower.
While the UK is preparing for the deployment of Pfizer-BioNTech after it received emergency US approval, Russia has already started inoculating its Sputnik V through 70 clinics in Moscow.