COVID-19: India gets vaccine as DCGI approves Serum, Bharat Biotech vaccines for emergency use

▴ COVID-19: India gets vaccine as DCGI approves Serum, Bharat Biotech vaccines for emergency use
DGCI on Sunday (January 3) formally approved Serum Institute's Covishield and Bharat Biotech's Covaxin for use in India.

In a significant development, Drugs Controller General of India (DCGI) on Sunday (January 3) formally approved Serum Institute's Covishield and Bharat Biotech's Covaxin for restricted use in India.

"Serum Institute and Bharat Biotech vaccines have to be administered in two doses. All the three vaccines have to be stored at 2-8° C. After adequate examination, CDSCO has decided to accept the recommendations of the Expert Committee and accordingly, vaccines of M/s Serum and M/s Bharat Biotech are being approved for restricted use in emergency situation and permission is being granted to M/s Cadila Healthcare for the conduct of the Phase III clinical trial," DCGI said in a press statement.

"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%," the DCGI said about Covishield.

"Bharat Biotech has developed a Whole Virion Inactivated Corona Virus Vaccine (Covaxin) in collaboration with ICMR and NIV (Pune), from where they received the virus seed strains. This vaccine is developed on Vero cell platform, which has well established track record of safety and efficacy in the country & globally. he firm has generated safety and immunogenicity data in various animal species such as mice, rats, rabbits, Syrian hamster, and also conducted challenge studies on non-human primates (Rhesus macaques) and hamsters. All these data has been shared by the firm with CDSCO. Phase I and Phase II clinical trials were conducted in approx 800 subjects and the results have demonstrated that the vaccine is safe and provides a robust immune response," the DCGI said about Bharat Biotech's Covaxin.

"We'll never approve anything if there's slightest of safety concern. Vaccines are 110 % safe. Some side effects like mild fever, pain & allergy are common for every vaccine. It (that people may get impotent) is absolute rubbish," said Dr VG Somani, Drug Controller General of India.

The DGCI granted the approval after a Subject Expert Committee of Central Drugs Standard Control Organisation (CDSCO) recommended these two vaccines for emergency use in India. It may be recalled that Covishield was recommended for emergency use on January 1, whereas Covaxin was recommended for restricted use on January 2. On Saturday, Union Health Minister Harsh Vardhan had said the vaccines would be given free of cost to priority groups in the first phase.

Tags : #DCGI #SerumInstitute #BharatBiotech #Covaxin #Covishield #AdenovirusVectorVaccine #InactivedCoronaVirusVacine #CDSCO

About the Author


Team Medicircle

Related Stories

Loading Please wait...

-Advertisements-




Trending Now

Sanmarg Auto++: Revolutionizing Mobility at Kolkata’s Biggest Auto FairMarch 22, 2025
39th Prof. M. Viswanathan Oration Highlights Strategies to Prevent Diabetic Foot AmputationsMarch 22, 2025
Catapulting funding crisis into opportunity by getting on track to end TB and tobacco useMarch 22, 2025
University of Leeds Opens Applications for MSc in Sustainable Agriculture & Food Production for Indian StudentsMarch 21, 2025
Crompton Reimagines Lighting with Launch of INFINIA - 20% Extra Brightness & SlimO - Ultra-Sleek Appeal!March 21, 2025
March 21, 2025
World Down Syndrome Day: Why India is Still Failing Its Special ChildrenMarch 21, 2025
The Digital Delusion: How Social Media Is Rewiring Your RealityMarch 21, 2025
Can Giving Blood Lower Your Risk of Heart Disease and Diabetes? Find OutMarch 21, 2025
Embracing Extra Chromosomes: Individuals with Down Syndrome face health challenges, stigma, and limited care, but early intervention and inclusion can transform their livesMarch 20, 2025
Why Doctors May Soon Prescribe Walks in the Park Instead of PillsMarch 20, 2025
Today some of the LIC agents met the Hon’ble Leader of Opposition and raised certain issues.March 20, 2025
Sarvodaya Healthcare, in partnership with Oncidium Foundation, becomes India’s first to offer Nuclear Therapy for cancer patientsMarch 20, 2025
Sarvodaya Healthcare, in partnership with Oncidium Foundation, becomes India’s first to offer Nuclear Therapy for cancer patientsMarch 20, 2025
Think Alcohol Is Bad for You? New Research Might Prove You WrongMarch 20, 2025
Lilly Launches Mounjaro® (tirzepatide), offering a new option for the treatment of obesity and type 2 diabetesMarch 20, 2025
How can we leave those behind who are at higher TB risk?March 20, 2025
The Global Tuberculosis Fight: Why Prevention Holds Key to EradicationMarch 20, 2025
Chew Your Way to a Sharper Mind: The Surprising Brain Hack No One Told You AboutMarch 20, 2025
Danger of substandard and falsified medical products is real and growingMarch 19, 2025