Phase 1 clinical trials of two indigenous Covid vaccines reveal ‘excellent safety’

Status of development of Covid-19 Vaccine in India

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Photo - Arek Socha from Pixabay

While the Government and Industry are trying their best to make available a safe and effective vaccine for Covid-19 at the earliest, it is difficult to comment on the exact timelines given various complex pathways involved in vaccine development.

The Government has constituted a high-level National Expert Group on vaccine administration for Covid-19, chaired by member Niti Aayog and co-chaired by the secretary, Ministry of Health and Family Welfare, among other representatives. The committee addresses vaccine delivery issues, selection of suitable vaccines, procurement, prioritization of groups, logistics — cold chain requirements, finance, and national and International equity.

Central Drugs Standard Control Organisation (CDSCO) has granted test license permission to manufacture Covid-19 Vaccine for preclinical tests, examination, and analysis to several Indian manufacturers. These include Serum Institute of India, Pune; Cadila Healthcare, Ahmadabad; Bharat Biotech International, Hyderabad; Biological E, Hyderabad; Reliance Life Sciences, Mumbai; AurbindoPharma, Hyderabad; and Gennova Biopharmaceuticals, Pune.

The Indian Council of Medical Research (ICMR), an autonomous organization under the Department of Health Research, has informed that the following companies are conducting clinical trials for Covid-19 vaccines in India:

  • An inactivated whole virion candidate vaccine (BBV152) for SARS-CoV-2 has been developed by Bharat Biotech International (BBIL) using the virus isolate (NIV-2020-770) provided by ICMR-National Institute of Virology (NIV), Pune. Characterization of the vaccine candidate has been undertaken at ICMR-NIV, followed by safety and tolerability studies in small animals like rats, mice, and rabbits. Status of clinical trials in — Phase I clinical trials and parallel studies in large animals have been completed. The trial has revealed the ‘excellent safety’ of the candidate vaccine. Immunogenicity testing is in progress. Phase II clinical trials are ongoing.
  • A DNA vaccine (ZyCov-D) has been developed by Cadila Healthcare. Preclinical toxicity studies were conducted in small animals — mice, rats, rabbits, and guinea pigs. The vaccine has been found to be safe and immunogenic. Cadila has partnered with ICMR for the conduct of parallel preclinical studies in large animals. Status of clinical trials is — Phase I clinical trials have been completed. The trial has revealed the ‘excellent safety’ of the candidate vaccine. Immunogenicity testing is in progress. Phase II clinical trials are ongoing.
  • Serum Institute of India (SII) and ICMR have partnered for clinical development of two global vaccine candidates — ChAdOx1-S, a non- replicating viral vector vaccine developed by the University of Oxford or AstraZeneca. This vaccine is undergoing phase III clinical trials in Brazil. ICMR has initiated phase II and III bridging studies at 14 clinical trial sites. ICMR-National Institute for Research in Tuberculosis (NIRT), Chennai, is the lead institution.

    ICMR and SII have also partnered for clinical development of a glycoprotein subunit nanoparticle adjuvanted vaccine developed by Novavax from the USA. The trial will be initiated in the second half of October after SII manufactures the vaccine. The trial is led by ICMR-National AIDS Research Institute (NARI), Pune.

As per details provided by the Department of Biotechnology (DBT)/Department of Science and Technology (DST), more than 30 vaccine candidates have been supported, which are in different development stages.

The ICMR has allocated Rs 25 crore for various studies and other research activities about 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 expenditure is Rs 22,27,579, and the committed expenditure is Rs 3,20,78,161.

The Department of Biotechnology supports 8 proposals by Industry and academia for candidate vaccine development and associated research resources at a total cost of Rs 75 crore.

The Minister of State (Health and Family Welfare), Ashwini Kumar Choubey, stated this in a written reply in the Rajya Sabha on 15 September 2020.


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