India to get Covid Vaccine today? DCGI presser after Covishield & Covaxin recommendations

A day after DCGI's expert panel recommended that Oxford-AstraZeneca and Bharat Biotech vaccines against COVID-19 be allowed for emergency use in country, drug regulator DCGI will brief media at 11 am on Sunday at National Media Centre regarding vaccine.

SEC's recommendations to DCGI

On Saturday, Subject Expert Committee (SEC) of Central Drugs Standards Control Organisation (CDSCO) me recommendations to Drugs Controller General of India to grant permission for restricted emergency use of Serum Institute of India (SII) and Bharat Biotech's vaccines. As per an official release, SEC met on Friday and Saturday and me its recommendations in respect of accelerated approval process request of SII, Bharat Biotech International Ltd as well as about phase-III trials of Cila Healthcare Ltd.

Subject Expert Committee recommended a grant of permission for restricted emergency use of vaccine, subject to multiple regulatory conditionalities, to Serum Institute of India, Pune. It also recommended grant of permission for restricted use in an emergency situation in public interest as an abundant precaution, in clinical trial mode, especially in context of infection by mutant strains, to Bharat Biotech International Ltd Hyderab. recommendations were me for consideration and final decision of Drugs Controller General of India.

Two vaccines in forefront of getting approval

Covaxin is an indigeusly developed Coronavirus vaccine developed by Bharat Biotech in collaboration with Indian Council of Medical Research (ICMR). Meanwhile, Bharat Biotech on Saturday said it is moving towards achieving target of having 26,000 volunteers across country for Phase-3 trials of its Covid-19 vaccine.  company has alrey roped in 23,000 volunteers for trials, it said.

Bharat Biotech, Serum Institute and Pfizer h applied with Drug Controller General of India (DCGI) for emergency use authorisation for ir respective vaccines.

According to PTI, while granting restricted emergency use approval for Oxford COVID-19 vaccine on Friday, expert panel h imposed certain regulatory provisions, including that shot is indicated for active immunisation in individuals of 18 years or more to prevent disease and that SII should submit safety, efficacy and immugenicity data from ongoing clinical trials in country and across globe for review at earliest. 

RE | Bharat Biotech's Covaxin gets SEC's d, DCGI decision on vaccine likely tomorrow: Sources

RE | ICMR isolates strain of UK-variant COVID-19; says 'Índia first country to do so'

Serum Institute of India, world's largest vaccine manufacturer, has tied up with AstraZeneca to manufacture Covishield. Pfizer h applied for regulatory approval for its vaccine on December 4 has t yet turned for deliberation.

Union Health Minister Harsh Vardhan appealed to people on Saturday t to be misguided by "rumours" regarding safety and efficacy of Coronavirus vaccine, and said, "We will t compromise on any protocol before approving a vaccine." He also said that in first phase of COVID-19 vaccination, free vaccine shall be provided across nation to most prioritised beneficiaries that include one crore healthcare and two crore frontline workers.

RE | Sourav Ganguly Health Updates LIVE: 'BCCI Prez stable haemodynamically,' updates hospital

RE | Rohit Sharma, Pant & 3 or Team India players isolated for breaching bubble in Australia

(With ncy inputs)