If advanced clinical trials of the Covid-19 vaccine are successful, an effective vaccine will likely be available by the end of the first quarter of 2021, State Health Minister Ashwini Choubey informed Lok Sabha on Friday.
I was answering a question about when an effective Covid-19 vaccine is likely to be released commercially.
The minister further said that no advance purchase agreement has been signed with any vaccine manufacturer.
Responding to another question, Choubey said that phase I clinical trials have revealed excellent safety of the two candidate vaccines developed indigenously by Bharat Biotech in collaboration with the Indian Council for Medical Research (ICMR) and Cadila Healthcare Ltd, and now your immunogenicity tests. It is in process. Its phase II clinical trials are ongoing. The Government of India has formed a National Covid-19 Vaccine Administration Expert Group chaired by Niti Aayog Member (Health), which is creating a strategy on vaccine procurement mechanisms, including domestic and international manufacturing along with the principles for prioritizing population groups for vaccination, Choubey said.
The Group of Experts has deliberated on the general parameters that guide the selection of Covid-19 vaccine candidates for the country and working in close coordination with the Permanent Technical Subcommittee of the National Technical Advisory Group on Immunization (NTAGI), it said in a response. written to Lok Sabha.
The Central Medicines Standard Control Organization (CDSCO) has granted trial license permission for the manufacture of Covid-19 vaccine for preclinical testing, examination and analysis to the seven manufacturers in India.
These are Serum Institute of India in Pune, Cadila Healthcare Ltd. in Ahmedabad, Bharat Biotech International Ltd in Hyderabad, Biological E Ltd. in Hyderabad, Reliance Life Sciences Pvt Ltd in Mumbai, Aurbindo Pharma Limited in Hyderabad and Gennova Biopharmaceuticals Limited, Pune.
The ICMR is facilitating studies related to Covid-19 vaccines.
Bharat Biotech International Ltd has developed an inactivated whole virion candidate vaccine (BBV152) for SARS-CoV-2 using the virus isolate provided by ICMR-National Institute of Virology (NIV), Pune. “Phase I clinical trials have been completed along with parallel studies in hamsters and rhesus macaques and have revealed excellent safety of the candidate vaccine. Immunogenicity tests are underway. Phase II of the clinical trials is ongoing, ”Choubey said. Cadila Healthcare Ltd. has developed a DNA vaccine. 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 rhesus macaques. Phase I clinical trials have been completed. The trial has revealed excellent safety of the candidate vaccine. Immunogenicity tests are underway. Phase II clinical trials are ongoing, ”he said.
The Serum Institute of India (SII) and the ICMR have partnered for the clinical development of two candidate vaccines globally, including ChAdOx1-S, which is a non-replicating viral vector vaccine developed by the University of Oxford / AstraZeneca.
This vaccine is in phase III of clinical trials in Brazil. The ICMR has started phase II and III bridging studies at 14 clinical trial sites, the minister said.
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 start in the second half of October after IBS manufactures the vaccine . The trial is led by ICMR-National AIDS Research Institute (NARI), Pune. The Department of Biotechnology (DBT) and the Department of Science and Technology (DST) are also supporting more than 30 candidate vaccines that are in different stages of development. The government of India conveyed its intention to be part of the Covid-19 Tool Access Accelerator (ACT) Vaccine Pillar, which may be beneficial in providing access to global candidate vaccines in advanced stages, for further use in the country. . .
Under this pillar, the COVAX facility, led by GAVI and the World Health Organization (WHO), has been created for the fair and equitable distribution of the Covid-19 vaccine around the world, Choubey reported.
DBT, through the IND-CEPI mission, participates in key partnerships with the ‘Coalition for Epidemic Preparedness Innovations (CEPI)’ to support Indian researchers in the development of clinical immunological trials to advance the research of vaccinations “No advance purchase agreement has been signed with any vaccine manufacturer,” said the minister. The ICMR has so far spent more than 25 billion rupees of its intramural budget to carry out work related to vaccine candidate development and preclinical studies, Choubey said.
The Science and Engineering Research Board (SERB), a statutory body under the DST, has supported three projects under Covid-19 on vaccine research under Intensified Research in High Priority Areas (IRHPA).
The sanctioned expenditure is Rs 22.27,579 and the committed expenditure is Rs 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 Rs 75 million.
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