COVAXIN, India’s indigenous vaccine candidate for the coronavirus, is slated to be launched on August 15, according to the ICMR. Human clinical trials for the vaccine—which is being jointly developed by Bharat Biotech and ICMR-NIV—are set to begin this month, after the drug regulator gave approval for phase one and two human trials.
“This is the first indigenous vaccine being developed by lndia, and is one of the top priority projects which is being monitored at the topmost level of the government," according to the ICMR. "It is envisaged that the vaccine will be launched for public health use latest by August 15, 2020, after completion of all clinical trials. BBIL is working expeditiously to meet the target. However, the final outcome will depend on the cooperation of all clinical trial sites involved in this project,“ ICMR DG wrote in a letter to the 12 hospitals chosen as sites for a clinical trial for the vaccine.
“ln view of the public health emergency due to COVID-19 pandemic and urgency to launch the vaccine, you are strictly advised to fast-track all approvals related to initiation of the clinical trial and ensure that the subiect enrollment is initiated no later than July 7, 2020,” the letter reads. “Kindly note that non-compliance will be viewed very seriously. Therefore, you are advised to treat this project on highest priority and meet the given timelines without any lapse,” it states.
Confirming the development, Rajnikant Srivastava said that the ICMR has indeed made a request to “fast-track” the vaccine trials. Speaking to Malayala Manorama, Bharat Biotech co-founder and joint managing director Suchitra Ella had, on Thursday, said that the initial phases of the human trials will commence mid-July and will take at least three months for completion. Ella had given a timeline of early 2021 for the vaccine to be rolled out.
Vaccine development is a long-drawn and time-consuming process, and it sometimes takes up to a decade to develop a safe and effective vaccine. Researchers have to test the vaccine for safety and efficacy. To test the efficacy, however, requires doing human challenge studies, and recruiting subjects for it can be a challenge. With an August 15 launch date, the Centre is setting an extremely ambitious target, say experts.
On June 30, Prime Minister Narendra Modi had chaired a high-level meeting to review the planning and preparations for vaccination against COVID-19. The PM had said that plans for large-scale vaccination should be undertaken “immediately”.
A four-pronged strategy had been discussed for a large scale vaccination programme. Issue such as management of medical supply chains, prioritisation of at-risk populations, coordination between different agencies involved in the process, as well as the role of private sector and civil society were also discussed.
Identification of vulnerable groups such as doctors, nurses, healthcare workers, non-medical frontline coronavirus warriors, and vulnerable people among the general population would form the first lot. PM had promised vaccination of “anyone, anywhere” in the second phase, and had emphasised that the vaccine must be affordable and universal. Technology to ensure the smooth functioning of the process was also highlighted.