India's First COVID-19 Vaccine Gets DCGI Approval For Human Trial

Covaxin: India's First Vaccine Against Coronavirus Moves Ahead For Human Trials

While there are multiple vaccine trials ongoing in India, including those of candidates by Zydus Cadila, Serum Institute of India and Panacea Biotec, all of them are in pre-clinical stage as of now.

AstraZeneca could not be reached for comment by press time on the details of the supply agreement, including how Brazil would produce doses of the vaccine.

Phases one and two typically indicate whether the vaccine is safe for use without any unwarranted side effects, although all candidates must complete phase three to obtain and license to go on sale.

J&J has joined hands with the USA government for a $1 billion investment to speed up development and production of its vaccine.

China reported 12 new confirmed Covid-19 cases as ofSunday, down from 17 reported a day earlier, the country's National Health Commission said yesterday.

The SARS-CoV-2 strain was isolated in NIV, Pune and transferred to Bharat Biotech.

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The trials, which will begin in a fortnight, will be conducted in the United States and Belgium on 1,045 healthy adults between the ages of 18 and 55 and adults who are 65 years and older.

At least 10 US-based companies have vaccines in phase 1 or later trials. "After the initial cohort it will be expanded to larger cohorts in a step-wise approach", Stoffels said.

The proactive support and guidance from the Central Drugs Standard Control Organization (CDSCO) had enabled approvals for the project, Mr. Ella said in a statement.The indigenous, inactivated vaccine has been developed and manufactured in Bharat Biotech's Bio-Safety Level 3 (BSL-3) High Containment facility located in Hyderbad's Genome Valley.

There is no clear picture of when a vaccine might be available, or even if one is possible, but top US infectious diseases expert Dr. Anthony Fauci has said there are hopes for a drug by the end of 2020. The company has more than 140 global patents and a portfolio of over 16 vaccines. It helps the immune system mount an antibody response towards virus.

The permission to initiate Phase I & II Human clinical trials came after the company submitted results generated from preclinical studies, demonstrating safety and immune response. Yet, a cure for COVID-19 has not been found.

Interestingly, Bharat Biotech is in collaboration with a University of Wisconsin in the development of another Vaccine too. The shot also won approval for human testing in Canada.

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