Phase I clinical trials have demonstrated “excellent safety” of two candidate vaccines developed through Bharat Biotech in collaboration with ICMR and Cadila Healthcare Ltd and their immunogenicity tests are being conducted recently, the Minister of State reported. at Ashwini Choubey Health in Rajya Sabha on Tuesday.
His Phase II clinical trials are underway, Choubey said in reaction to the existing prestige of the COVID-19 vaccination/clinical trial program conducted through the Indian Medical Research Council (ICMR) and other personal studies centers in the country.
Choubey reported that discussions on collaborations on the recombinant vaccine developed through Russia are ongoing, however, no formal studies have been launched.
The Serum Institute of India (SII) and ICMR have teamed up for the clinical progression of two candidate vaccines.
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The first is ChAdOx1-S, a non-replicative viral vector vaccine developed through Oxford University/AstraZeneca. This vaccine is recently found in Phase III trials in Brazil.
Phase II/III transition studies have been introduced through ICMR at 14 test sites, Choubey said. The ICMR-National Institute for Tuberculosis Research in Chennai is the leading institution.
Choubey reported that ICMR and IBS have also been associated for the clinical progression of an adjuvant nanoparticle adjuvant subunit glucoprotein vaccine developed through Novavax in the United States.
The trial will be introduced in October, after the vaccine is manufactured through the ISS. The trial is being led by the ICMR-National AIDS Research Institute (NARI), Pune, he said.
Developing the two locally evolved candidate vaccines, Choubey stated that an inactivated total virion candidate vaccine for SARS-CoV-2 was developed through Bharat Biotech International Ltd, the isolated virus provided through the ICMR-National Institute of Virology (NIV), Pune.
Characterization of the candidate vaccine performed in ICMR-NVNI, followed by studies of protection and tolerability in small animals such as rats, mice and rabbits.
Phase I clinical trials and parallel animal studies have been completed.
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“The trial revealed the protection of the candidate vaccine. Immunogenicity tests are ongoing. Phase II clinical trials are underway,” he said.
In addition, a DNA vaccine (ZyCov-D) was developed through Cadila Healthcare Ltd, whose preclinical toxicity studies were conducted in small animals: mice, rats, rabbits and guinea pigs.
The vaccine was found to be immunogenic. Cadila has partnered with ICMR to conduct parallel preclinical studies in giant animals.
“While the government and industry are doing everything they can to have a safe and effective COVID-19 vaccine as soon as possible, it is difficult to pinpoint the precise deadlines given the complex pathways involved in vaccine development,” he said. Said.
Other Indian corporations in the progression of the COVID-19 vaccine are Premas Biotech, Gennova, Mynvax, Epygen Biotech, Luxmatra Innovations, Biological Evans. All applicants are in the preclynic progression phase, the minister said.
According to data from the Department of Biotechnology (DBT) / Department of Science and Technology (DST), “more than 30 candidate vaccines have received support at other levels of progression, 03 applicants are at a complex level of Phase I / Trials II / III and more than 04 are in complex prec transit progression phase”.
The ICMR has allocated Rs 25 million for studies and other activities of studies similar to vaccine development. The Scientific and Technical Research Council (SERB), a legal framework under the Science and Technology Decomposer, has supported 3 projects under COVID-19 on vaccine studies as a component of intensified studies in priority areas (IRHPA)
The expenses sanctioned are 22,27,579 rupees and the expenses incurred are 3,20,78,161 rupees in detail.
The Ministry of Biotechnology is also supporting 8 industry and education proposals for the progression of candidate vaccines and study resources related to a total burden of 75 million rupees, the minister said in response to the question.
According to the World Health Organization, 35 vaccine applicants are being clinically evaluated and 145 applicants are on the preclynic assessment as of September 9, Choubey said.
The government has formed a high-level national panel of vaccine management experts opposed to COVID-19, which is chaired through niTI member Aayog and co-chaired through the Secretary of the Ministry of Health.
Representatives are: Secretary, Ministry of Foreign Affairs, Secretary, Department of Biotechnology, Secretary, Department of Health Research, Director General of Health Services, Ministry of Health and Family Welfare, Director, Indian Institute of Medical Sciences, Head of ECD, India Medical Research Council, Director of the Jawaharlal Institute for Postgraduate Medical Education and Research (Member of NTAGI) and Representatives of State and Expenses.
The committee addresses problems similar to vaccine delivery, the right range of vaccines, procurement, organization prioritization, logistics, the addition of bloodless chain requirements, finance and national/international equity, Choubey said.
The Coronavirus Essential Serum Institute will produce 10 million rupees of vaccine doses for the poorest countries; COVID-19 tests will soon be implemented