What is the status of development of COVID Vaccine in India?

At a time when the whole world is waiting for a vaccine against COVID, the Indian government along with its research bodies and biotech companies are also trying to develop a safe and effective serum.

The Minister of State (Health and Family Welfare), Ashwini Kumar Choubey in a written reply in the Rajya Sabha said that though the Government and the 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 in view of various complex pathways involved in vaccine development.

He informed that the Government has constituted a high-level National Expert Group on vaccine administration for COVID-19 which is chaired by Member, Niti Aayog, and co-chaired by Secretary, Ministry of Health & Family Welfare.

The committee is addressing issues related to vaccine delivery, selection of suitable vaccines, procurement, prioritization of groups, logistics: Cold chain requirements, finance, and national/international equity.

Choubey said that the Central Drugs Standard Control Organisation (CDSCO) has granted test license permission for the manufacture of COVID-19 Vaccine for a preclinical test, examination, and analysis to the following manufacturers in India:-

Serum Institute of India, Pune
Cadila Healthcare Ltd, Ahmadabad
Bharat Biotech International Ltd, Hyderabad
Biological E Ltd, Hyderabad
Reliance Life Sciences Pvt Ltd, Mumbai
AurbindoPharma Limited, Hyderabad
Gennova Biopharmaceuticals Limited, Pune

He further said that 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:

(i) An inactivated whole virion candidate vaccine (BBV152) for SARS-CoV-2 has been developed by Bharat Biotech International Ltd (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. The status of clinical trials is as follows:

Phase I clinical trials along with 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.

(ii) A DNA vaccine (ZyCov-D) has been developed by Cadila Healthcare Ltd 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. The status of clinical trials is as follows:

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.

(iii) Serum Institute of India (SII) and ICMR have partnered for clinical development of two global vaccine candidates:

(a) ChAdOx1-S, which is a non- replicating viral vector vaccine developed by the University of Oxford/AstraZeneca. This vaccine is undergoing phase III clinical trials in Brazil. Phase II/III bridging studies have been initiated by ICMR at 14 clinical trial sites. ICMR-National Institute for Research in Tuberculosis (NIRT), Chennai is the lead institution.

(b) 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 the vaccine is manufactured by SII. 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 stages of development.