The Minister of State (Health and Family Welfare), Ashwini Kumar Choubey, declared the report in a written response in today’s Rajya Sabha, during the second day of the Monsoon session in Parliament.
Choubey also said that the lockdown from March 25 to May 31 successfully controlled the aggressive progression of COVID-19 in India, but there has been a steady increase in the number of cases in the post-lockdown phase.
He also said that phase I clinical trials have revealed “excellent safety” of the two candidate vaccines developed indigenously by Bharat Biotech in collaboration with ICMR and Cadila Healthcare Ltd and that their immunogenicity tests are now ongoing.
Mentioning the development progress of Covid-19 vaccines, he said that the Central Medicines Standard Control Organization (CDSCO) has granted trial license permission for the manufacture of vaccines for preclinical testing, examination and analysis to the following manufacturers in India:
1) Serum Institute of India Pvt., Ltd., Pune
2) Cadila Healthcare Ltd., Ahmadabad
3) Bharat Biotech International Ltd., Hyderabad
4) Biological E Ltd., Hyderabad
5) Reliance Life Sciences Pvt Ltd., Mumbai
6) AurbindoPharma Limited, Hyderabad
7) Gennova Biopharmaceuticals Limited, Pune
Additionally, the Indian Council for Medical Research (ICMR) has reported that the following companies are conducting clinical trials for COVID-19 vaccines in India:
1) Bharat Biotech International Ltd (BBIL) has developed an inactivated whole virion vaccine candidate (BBV152) for SARS-CoV-2 using the virus isolate (NIV-2020-770) provided by ICMR-National Institute of Virology (NIV ), Pune.
Characterization of the candidate vaccine was carried out at ICMR-NIV, followed by safety and tolerability studies in small animals such as rats, mice, and rabbits. The status of clinical trials is as follows:
Phase I clinical trials have been completed along with parallel studies in large animals. “The trial has revealed excellent safety of the candidate vaccine. Immunogenicity testing is ongoing,” Choubey said.
Phase II clinical trials are ongoing.
2) Cadila Healthcare Ltd. has developed a DNA vaccine (ZyCov-D). Preclinical toxicity studies were performed in small animals: mice, rats, rabbits, and guinea pigs. The vaccine has been found to be safe and immunogenic. Cadila has partnered with ICMR to conduct parallel preclinical studies in large animals. The status of clinical trials is as follows:
Phase I clinical trials have been completed. “The trial has revealed excellent safety of the candidate vaccine,” he said. Immunogenicity tests are underway.
Phase II clinical trials are ongoing.
3) Serum Institute of India (SII) and ICMR have partnered for the clinical development of two candidate vaccines worldwide:
ChAdOx1-S, which is a non-replicating viral vector vaccine developed by the University of Oxford / AstraZeneca. This vaccine is in phase III clinical trials in Brazil. The ICMR has initiated phase II / III bridging studies at 14 clinical trial centers. ICMR-National Institute for Tuberculosis Research (NIRT), Chennai is the leading institution.
ICMR and IBS have also partnered for the clinical development of an adjuvanted nanoparticle glycoprotein subunit vaccine developed by Novavax of the US The trial will begin in the second half of October after IBS manufactures the vaccine. The trial is led by ICMR-National AIDS Research Institute (NARI), Pune.
According to details provided by the Department of Biotechnology (DBT) / Department of Science and Technology (DST), more than 30 vaccine candidates that are at different stages of development have been endorsed, the statement added.
The ICMR has assigned ₹Rs 25 million for various studies and other research activities related to vaccine development.
The Science and Engineering Research Board (SERB), a statutory body under the Department of Science and Technology, has supported three projects under Covid-19 on vaccine research under Intensified Research in High Priority Areas (IRHPA) The sanctioned spending is of Rs 22, 27,579 and the committed expenditure is ₹3,20,78,161.
The Department of Biotechnology is also supporting 08 proposals from industry and academia for candidate vaccine development and associated research resources at a total cost of ₹75 crore.
According to the World Health Organization, 35 vaccine candidates are in clinical evaluation and 145 candidates are in the preclinical evaluation stage as of Sept. 9, Choubey said.
The Center has formed a “National Group of High-Level Experts on the Administration of Vaccines for Covid-19, which is chaired by member Niti Aayog and co-chaired by the Secretary of the Ministry of Health and Family Welfare,” a statement read .
The committee is addressing issues related to vaccine delivery, selection of suitable vaccines, procurement, group prioritization, logistics – cold chain requirements, finance, and national / international equity.
.
