Bharat Biotech' s COVAXIN explained by smartpharmainfo.blogspot.com

Covaxin

It was the India's first COVID-19 Vaccine candidate. COVAXIN is inactivated vaccine is being developed by the Barat Biotechnology in collaboration with Indian Council of Medical Research and National Institute of Virology (NIV), Pune. Bharat Biotechnology is the Hyderabad based vaccine manufacturer .The company had also received permission from the Drug Controller General of India (DCGI) to begin human trials, expected to commence in August.

On Thursday, the ICMR’s Balram Bhargava said in a letter to Bharat Biotech, “It is envisaged to launch the vaccine for public health use latest by 15th August 2020 after completion of all clinical trials.”

According to Bharat Biotech, Covaxin is an inactivated vaccine developed from an Indian strain of the novel coronavirus isolated by NIV(National Institute of Virology).  No further information has been provided, especially about the nature of the vaccine or how it was developed. There have been no prior announcements either about when the process of developing such a vaccine was begun.

ICMR transferred the strain NIV had isolated to Biotech Bharat on May 9. The company published its press release on June 29. So there were only 50 days in between, during which time the company should have developed the inactivated vaccine, conducted preclinical animal trials (with mice and hamsters, according to the company), and sent its reports to be evaluated and approved by DCGI.

Collaboration with US company

Bharat Biotech  has currently invested in two other vaccines: 

CoroFlu in collaboration with FluGen Inc. and the University of Wisconsin-Madison, and an inactivated rabies vaccine vehicle for coronavirus proteins developed along with Matthis Schnell, director of the Jefferson Vaccine Centre (JVC), Pennsylvania.

FluGen’s vaccine candidate M2SR will act as the backbone for developing CoroFlu.

M2SR is a self-limiting version of the influenza virus that induces an immune response against the flu, invented by FluGen co-founders Yoshihiro Kawaoka and Gabriele Neumann and UW–Madison virologists.

Kawaoka’s lab is planning to insert M2SR with the genetic sequences from the novel coronavirus SARS-CoV-2 so that the new vaccine can induce an immune response against   COVID-19 also.

The refinement and testing of the CoroFlu vaccine in animal models could take three to six months to complete. Bharat Biotech will then scale up the production of the vaccine for human trials that would probably begin by the fall of 2020.

By adding the coding region of coronavirus spike protein to the M2SR, the immune response against both the coronavirus and influenza can be achieved through the vaccine. M2SR is a unique form of flu virus that lacks the M2 gene necessary for the virus to replicate in cells.