Serum-Oxford's Covid vaccine gets panel nod for emergency use

New Delhi: As a New Year gift, India is set to get its first vaccine against Covid-19 as the expert panel of the Central Drugs Standard Control Organisation (CDSCO) has given its conditional recommendation for granting emergency use authorisation license to Oxford COVID-19 vaccine Covishield, which is being manufactured by Serum Institute of India.
According to sources, the decision in this regard was taken at a crucial meeting of the Subject Expert Committee (SEC) on Friday wherein the members of the panel recommended granting the license to SII's vaccine with certain conditions. The final clearance would be given by Drugs Controller General of India (DCGI) VG Somani.
However, the decision over granting emergency use authorisation license to other two vaccine candidates — Pfizer and Bharat Biotech's Covaxin — is still awaited.
The Pune-based Serum Institute of India (SII), the world's largest vaccine manufacturer has tied up with AstraZeneca to manufacture Covishield.
Notably, the UK's Medicines and Healthcare products Regulatory Agency (MHRA) had on Wednesday approved the Covid vaccine developed by scientists at Oxford University and produced by AstraZeneca for human use.
The Subject Expert Committee (SEC) on Covid-19 of the CDSCO, which had earlier sought additional safety and immunogenicity data from SII, deliberated on its application seeking emergency use authorisation (EUA) for the shots on Wednesday and met again on Friday to review the matter.
After SII's application, the SEC has started reviewing the EUA application by Bharat Biotech for its Covid-19 vaccine Covaxin but is yet to take a final decision on the matter, sources said.
As per sources, above five crore doses of the AstraZeneca vaccine have already been stockpiled by its local manufacturer Serum Institute of India and the shots could start to be transported from cold storage to all states soon.
"The vaccine will cost about $3 per dose for the government, which means $6 for two doses per person and for the private market, it will cost around Rs 700-800," SIIO CEO Adar Poonawalla said on Friday.
"In terms of safety, Covishield was well tolerated with respect to solicited adverse events... majority of solicited reactions were mild in severity and resolved without any sequelae.
"Therefore, Covishield is safe and can be used effectively for prevention of Covid-19 in the targeted population. Thus, the benefit to risk ratio strongly supports the widespread use of Covishield," the EUA application signed by Prakash Kumar Singh, Additional Director, Government and Regulatory Affairs at Serum Institute of India (SII), had stated.
Meanwhile, the daily new infections in India remained below 30,000 for the 19th consecutive day taking the COVID-19 caseload to 1,02,86,709, while the number of people who have recuperated from the disease surged to 98.83 lakh, according to the Union Health ministry data updated on Friday.
A total of 20,035 new infections were reported in a day, while the death toll increased to 1,48,994 with 256 new fatalities.
Four cases of the highly contagious mutant strain of the Coronavirus were detected in the country on Friday, the ministry has informed. The total of those affected by the strain — first found in the United Kingdom — has reached 29, it added.
Out of the four cases, three were found in a Bengaluru lab, while one was detected in a lab in Hyderabad, sources added.