As India approves 2 Covid Vaccines, here's what DCGI spoke on Serum Institute's Covishield

In a massive development, the Drugs Controller General of India (DCGI) on Sunday approved Serum Insititute's 'Covishield' for emergency use, along with Bharat Biotech's 'Covaxin'. Addressing a presser, the DCGI VG Somani said that the Subject Expert Committee of Central Drugs Standard Control Organisation (CDSCO) met on January 1 and 2 and made recommendations in respect of proposal for Restricted Emergency Approval of COVID-19 virus vaccine of Serum Institute of India and Bharat Biotech as well as Phase III clinical trial of Cadila Healthcare Ltd. The nod by India comes days after United Kingdom's approval to Oxford-AstraZeneca's Coronavirus Vaccine which is being manufactured and marketed in India by Serum Institute under the name Covishield.

What DCGI said about Covishield:

About SII's Covishield, the official said, "M/s Serum Institute of India, Pune has presented a Recombinant Chimpanzee Adenovirus vector vaccine (Covishield) encoding the SARS-CoV-2 Spike (S) glycoprotein with technology transfer from AstraZeneca/Oxford University. The firm submitted safety, immunogenicity and efficacy data generated on 23,745 participants aged ≥ 18 years or older from overseas clinical studies. The overall vaccine efficacy was found to be 70.42%. Further, M/s Serum was granted permission to conduct Phase-II/III clinical trial on 1600 participants within the country. The firm also submitted the interim safety and immunogenicity data generated from this trial and the data was found comparable with the data from the overseas clinical studies. After detailed deliberations, Subject Expert Committee has recommended for the grant of permission for restricted use in emergency situation subject to certain regulatory conditions. The clinical trial ongoing within the country by the firm will continue." READ FULL STATEMENT HERE.

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Here's everything you need to know about the Oxford-AstraZeneca-Serum Institute vaccine 'Covishield

• Efficacy: The Oxford-AstraZeneca-SII Covishield vaccine's efficacy in preventing symptomatic infections was 70.4 per cent as 30 of 5,807 people who got the two-dose vaccine developed COVID-19, compared with 101 of 5,829 people who got a placebo, in the clinical trials. 

• For participants who received two full doses at least one month apart, vaccine efficacy was 62%, and in those who received a low dose followed by a full dose, efficacy was 90%.

• Cost: Serum Institute of India CEO Adar Poonawalla has said earlier that for the Government of India, the price of the vaccine will be about USD 3 per dose, so USD 6 [Rs 440] per person, but for the private market it will cost around Rs 700-800. 

• Storage: The vaccine could be kept at normal refrigerator temperatures, between 2 and 8 degrees celsius. In comparison, the Moderna vaccine needs to be stored at -20 degree Celsius and the Pfizer/BioNTech product must be kept at -70 degree Celsius. 

• Technology: The vaccine entails a version of a virus that usually infects chimpanzees and has been modified with a portion of the COVID-19 called the "spike protein" to fire the immune system. Once it enters the human cells, the vaccine would help stimulate the production of antibodies that recognize the virus.

• Safety: According to The Lancet, a medical publication, Oxford's COVID-19 vaccine is safe and efficacious against symptomatic coronavirus disease. The safety was monitored for a median of 3.4 months in all 23,745 participants from the UK, Brazil and South Africa. Out of 23,745 participants, 168 experienced a total of 175 severe adverse events over the period, but 172 events were unrelated to the COVID-19 or control vaccines.

• Doses: The world's biggest producer of vaccines (Serum Institute of India), has already stockpiled about 50 million doses, enough for 25 million people. 

• Approval in UK: On December 30, The Oxford-AstraZeneca vaccine was authorized for emergency use in the United Kingdom (UK). It has been given the go-ahead by the Medicines and Healthcare products Regulatory Agency (MHRA). It is the second vaccine to be approved in the UK after the Pfizer-BioNTech vaccine was given the go-ahead in December. UK Health Secretary Matt Hancock announced on Wednesday that the Oxford-AstraZeneca vaccine will be rolled from January 4 across Britain.

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