SII, Bharat Biotech get DCGI approval for Covishield, Covaxin respectively

Hyderabad: Bharat Biotech on Sunday said the approval for emergency use of its Covid-19 vaccine --Covaxin -- is a giant leap for innovation and novel product development in India.

The Hyderabad-based vaccine maker expressed its delight after Drug Controller General of India (DCGI) granted permission for emergency use of its Covid-19 vaccine. The move came corresponding to the body giving its nod to the Serum Institute of India's 'Covishield' vaccine

"The approval of Covaxin for emergency use is a proud moment for the nation and a great milestone in India's scientific capability, a kickstart to the innovation ecosystem in India. While this vaccine addresses an unmet medical need during this pandemic, our goal is to provide global access to populations that need it the most," said Bharat Biotech Chairman and Managing Director Dr. Krishna Ella.

He said Covaxin has generated excellent safety data with robust immune responses to multiple viral proteins that persist.

"The development of Covaxin was truly a public private partnership between ICMR, NIV and Bharat Biotech, we sincerely thank the Director General ICMR, Dr. Balram Bhargava for his visionary leadership in this project," Dr. Ella added.

Covaxin is a highly purified and inactivated 2 dose SARS-CoV2 vaccine, manufactured in a Vero cell manufacturing platform with an excellent safety track record of more than 300 million doses.

The Phase III human clinical trials of Covaxin began mid-November, targeted to be done in 26,000 volunteers across India. This is India's first and only Phase III efficacy study for a Covid-19 vaccine, and the largest phase III efficacy trial ever conducted for any vaccine in India.

Covaxin has been evaluated in approximately 1,000 subjects in Phase I and Phase II clinical trials, with promising safety and immunogenicity results, with acceptance in international peer reviewed scientific journals.

India's indigenous Covid vaccine by Bharat Biotech has been developed in collaboration with the Indian Council of Medical Research (ICMR) -- National Institute of Virology (NIV). This indigenous, inactivated vaccine is developed and manufactured in Bharat Biotech's BSL-3 (Bio-Safety Level 3) bio-containment facility, one of its kind in the world.

The product development and clinical trial data thus far has generated 5 publications, which have been submitted to international peer reviewed journals, 4 of which have been accepted and will be published soon. The publication of phase II trial data is undergoing the peer review process. "As a part of our regulatory guidelines, all data has been submitted to the DCGI and CDSCO," it said.

Prime minister took to Twitter to call this a historic moment.

"A decisive turning point to strengthen a spirited fight! DCGI granting approval to vaccines of @SerumInstIndia and @BharatBiotech accelerates the road to a healthier and COVID-free nation. Congratulations India. Congratulations to our hardworking scientists and innovators," the Prime Minister said in a series of tweets.

He further said it would make every Indian proud that the two vaccines that have been given emergency use approval are made in India.

"This shows the eagerness of our scientific community to fulfil the dream of an Aatmanirbhar Bharat, at the root of which is care and compassion. We reiterate our gratitude to doctors, medical staff, scientists, police personnel, sanitation workers and all Corona warriors for the outstanding work done, that too in adverse circumstances. We will remain eternally grateful to them for saving many lives."

Covishield and Covaxin have to be administered in two doses and can be stored at 2-8 degree Celsius. The Drugs Controller General of India has also granted permission to Cadila healthcare for phase 3 clinical trial in India.

"A watershed moment in India's famed battle against COVID19 under the charismatic leadership of Hon'ble PM Narendra Modi Ji," Vardhan wrote in a series of tweets, adding that these vaccines are a fitting tribute to the corona warriors.

The Union Minister further said, "It's now time to reap the benefits of the robust supply chain infrastructure we've put in place for quick and equitable distribution of the vaccine."

He also urged the citizens to entrust the stringent protocols followed for ensuring safety, efficacy and immunogenicity of the approved vaccines. He had earlier asked people not to believe in rumours against the vaccine.

K. Vijayaraghavan, the Principal Scientific Advisor (PSA) to the Union government said that the vaccination will begin soon.

"Vaccination will begin soon. This is a result of focused work by scientists, national laboratories, government agencies, regulators, health care workers, and most importantly, all our people who have waited patiently following all COVID appropriate behaviour," he said.