FDA is set to issue requirements for approving COVID-19 vaccines

Cheryl Sanders
July 1, 2020

The SARS-CoV-2 strain was isolated at National Institute of Virology (Pune), an institute under the ICMR, and transferred to Bharat Biotech. The potential vaccine was developed and manufactured at Bharat Biotech's BSL-3 (Bio-Safety Level 3) High Containment facility located in Genome Valley, Hyderabad, India.

The trials will begin across the country in July.

Expedited through national regulatory protocols, the company said it accelerated its objective in completing the comprehensive pre-clinical studies and added results from these studies have been promising and show extensive safety and effective immune responses. Apart from Covaxin, Bharat Biotech is partnering with US-based vaccine maker FluGen and virologists at the University of Wisconsin-Madison to develop an intranasal vaccine - CoroFlu.

The company in a statement said it is the first indigenous COVID-19 vaccine to receive the approval.

Experts have suggested that it could take a minimum of 12 to 18 months to guarantee a safe and effective vaccine through clinical trials.

Shots will not be able to get approval if studies only show that they lead to the development of antibodies in the bloodstream, which is not proof that the vaccine can actually prevent coronavirus infection.

For comparison purposes with the FDA's goal for a coronavirus vaccine, the effectiveness of the seasonal flu vaccine ranges from 40 to 60 percent when the vaccine is similar to circulating flu viruses, according to the Centers for Disease Control and Prevention.

But CanSino said that it can not guarantee that the vaccine, which has undergone both phase one and two clinical trials in China, will ultimately be commercialised.

Pune-based Serum Institute of India, the world's largest vaccine maker by number of doses produced and sold globally, has also partnered to mass produce a vaccine being developed by the University of Oxford and backed by the United Kingdom government.

"The guidelines are pretty standard, they look pretty much like influenza vaccine guidelines", Gregory Poland, director of Mayo Vaccine Research Group said. The country is slated to initially produce 30 million doses of the vaccine - half by December and half by January of next year, according to a Reuters report.

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