The Indian Council of Medical Research (ICMR) plans to launch its COVID-19 vaccine Covaxin made in collaboration with Hyderabad-based Bharat Biotech International Limited (BBIL) by August 15 for public use. The ICMR director general Dr. Balrama Bhargava has chosen 12 medical colleges and hospitals across the country to begin clinical trials of the approved vaccine latest by July 7. The ICMR has also requested that all the sites treat this as a high priority.
In its letter written to the medical colleges and hospitals, the ICMR has clearly specified that it plans to launch this indigenous vaccine for public health use by August 15 and plans to complete all its trials in this time period. It also added that even though the company has expedited its process to meet the required targets of the country, the final outcomes will be dependent on all 12 clinical trial sites co-operating with the apex research body as well as the company.
The vaccine is yet to begin Phase I/ Phase II trials and will have to even complete the large scale Phase III trials before August 15 if its effective in the first two.
The ICMR also added that non-compliance and lapses of any kind by these 12 clinical trial sites could have serious consequences as these trials are for bringing the vaccine into the market for public health use as soon as possible. India's fight against COVID-19, with over 6.25 lakh cases and as the fourth worst affected country, will be boosted to protect people who have still not been infected by SARS-CoV-2.
An ICMR official confirmed the authenticity of the letter while Bharat Biotech declined to comment.
The Drugs Controller General of India (DCGI) approved Phase I/II clinical trials for the vaccine only on June 30. This vaccine was developed by Bharat Biotech with the help of a coronavirus strain isolated by the National Institute of Virology (NIV), Pune. NIV sent this strain to the company which later inactivated its replicating genes in its Bio-Safety Level-3 (BSL-3) high containment facility.
India recorded its highest one-day spike with 20,903 new cases on July 3 as the country reported a total of 6,25,544 cases of COVID-19. Maharashtra with 1,86,626 cases has the highest number of cases.
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