NEW DELHI: With the Modi government giving top priority to the indigenous development of Covid-19 vaccine amid the rising cases, Hyderabad-based vaccine major Bharat Biotech will start the phase 1 and 2 of human trials of its vaccine candidate Covaxin “this month across the country” in collaboration with ICMR and NIV, Pune.
While, pharma major Zydus Cadila became the second Indian company to get the Drug Controller General of India (DCGI) approval for human clinical trials of its vaccine ZyCoV-D.
Covaxin, which is the first vaccine in India to get the DCGI nod for human trials as reported by TOI, has successfully being tested on rats, mice and rabbits by Bharat Biotech in its BSL-3 (Bio-Safety Level 3) high containment facility in Hyderabads Genome Valley.
The “inactivated” vaccine candidate, which Bharat Biotech owns 100% unlike other two vaccines where it is working in international collaboration, will reportedly be in “two doses and delivered to patients in a fortnight interval this month” during the human trial phase. On being asked by TOI, Bharat Biotech has refused to comment on the ICMRs letter to the company “to complete the trial procedure in a fast-track method so that results can be launched by August 15”.
PM Narendra Modi is personally reviewing vaccine development efforts and recently chaired a high-level meeting to review the planning and preparations for vaccination. In fact, in his Mann ki Baat Twitter handle, he recently wrote, “Work being done in our labs on Corona vaccine is being keenly observed by the world and we are hopeful too.”
On getting the DCGI nod, Bharat Biotech CMD Krishna Ella told TOI, “Upon receiving the virus strain from the NIV Pune, Bharat Biotech was able to quickly layout GMP (good manufacturing practice) protocols for the manufacture of the vaccine candidate. Covaxin was evaluated in animals on Schedule Y as per Indian and WHO guidelines. It was reported to be safe and immunogenic in all animals.”
Besides Covaxin, Bharat Biotech, which had also developed vaccines against swine flu (H1N1), Zika, rotavirus and over a dozen viral diseases, is simultaneously working on two other Covid vaccines —one nasal vaccine CoroFlu in collaboration with the University of Wisconsin-Madison and another with Thomas Jefferson University but both the candidates are in pre-clinical stage. Krishna Ella had told TOI that “CoroFlu could be in human clinical trials by the fall of 2020 and will hit the market in 12 to 18 montRead More – Source
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