Lok Sabha Question No. 1026 (UNSTARRED), answered on 2020-09-18
Subject: Procedure for Research on Vaccine
Ministry: HEALTH AND FAMILY WELFARE
Asked by: Bhartruhari Mahtab

## GOVERNMENT OF INDIA MINISTRY OF HEALTH AND FAMILY WELFARE DEPARTMENT OF HEALTH RESEARCH

## LOK SABHA UNSTARRED QUESTION NO. 1026 TO BE ANSWERED ON 18 TH SEPTEMBER, 2020

## PROCEDURE FOR RESEAR CH ON VACCINE

## 1026. SHRI BHARTRUHA RI MAHTAB:

Will the Minister of HEALTH AND FAMILY WELFARE be pleased to state:

- (a) the details of the standard established procedure for research and development of a for any  virus/ bacteria in the country;
- (b) whether any deviation from the said standard procedure in research  and development of vaccine for Corona Virus has come to the notice of the Government in the country, if so details thereof and the reasons therefor;
- (c) whether the Government has conducted human trial of any vaccine for coron a virus so far;
- (d) if so, the details and outcome thereof; and
- (e) the steps taken/being taken by the Government for development of corona vaccine in country along   with achievements thereof?

## ANSWER THE MINISTER OF STATE IN THE MINISTRY OF HEALTH AND FAMILY WELFARE (SHRI ASHWINI KUMAR CHOUBEY)

- (a) The  Central  Drugs  Standard  Control  Organisation  (CDSCO)  has  informed  that  the requirements and guidelines to conduct clinical trial or grant of permission for marketing of new drugs including vaccines are prescribed under New Drugs and Clinical Trials Rules, 201

Further, the Indian Council of Medical Research (ICMR), an autonomous organisation of t Department of Health Research, has informed that the sta ges of vaccine development include the following steps:

- i.  Identification  and  development  of  an  appropriate  vaccine  strain  which  may  be  safe immunogenic.
- ii. Full characterization of the vaccine strain by in -vitro experiments.
- iii. Pre - clinical studies in small animals like rats, mice, rabbits, guinea pigs, hamsters e are safety and dose determination studies.
- iv.  Preclinical  studies  in  large  animals  (depending  upon  feasibility  and  availabil determine safety, pr otective efficacy and potential dose and formulation.

v.  Phase  I  human  clinical  trials  which  establish  the  safety  of  the  product.  The  numbe usually < 100.

vi. Phase II human clinical trials to determine the immunogenicity or immune protection. numbers are usually < 1000.

vii.  Phase  III  human  clinical  trials  to  determine  the  efficacy.  The  numbers  range  in thousands. After successful completion of phase III studies, regulatory approval is accord viii. Phase IV or post marketing surveillance studies.

(b) CDSCO has informed that it has not received any report regarding such deviation fro standard procedures in research and development of vaccine for Coronavirus.

(c)  to  (e)  Central  Drugs  Standard  Control  Organisation  (CDSCO)  h as  informed  that  it  has granted  test  license  permission  for  manufacture  of  COVID - 19 Vaccine  for  preclinical  test, examination and analysis to the following manufacturers in India:

1. M/s Serum Institute of India Pvt., Ltd., Pune
2. Ms. Cadila Healthcare Ltd., Ah madabad
3. M/s Bharat Biotech International Ltd., Hyderabad
4. Biological E Ltd., Hyderabad
5. M/s Reliance Life Sciences Pvt Ltd., Mumbai
6. M/s Aurbindo Pharma Limited, Hyderabad
7. M/s Gennova Biopharmaceuticals Limited, Pune

The Indian Council of Medical Research (IC MR), an autonomous organisation under the Department  of  Health  Research,  has  informed  that  it  is  facilitating  the  following  s related to COVID - 19 vaccines:

(i)An  inactivated  whole  virion  candidate  vaccine  (BBV152)  for  SARS - CoV - 2  has  been developedby Bharat Biotech International Ltd (BBIL) using the virus isolate (NIV - 2020- 770) provided  by  ICMR - National  Institute  of  Virology  (NIV),  Pune.  Characterization  of  th vaccine  candidate  has  been  undertaken  at  ICMR - NIV  followed  by  safety  and  tolerability st udies in small animals like rats, mice and rabbits. Status of clinical trials is as fol

- Phase I clinical trials alongwith parallel studies in hamsters and rhesus macaques been  completed.  The  trial  has  revealed  excellent  safety  of  the  candidate  v accine. Immunogenicity testing is in progress.
- Phase II clinical trials are ongoing.

(ii) A DNA vaccine (ZyCov - D) has been developed by Cadila Healthcare Ltd. Pre - clincial toxicity studies were  conducted in small animals: mice, rats, rabbits and guinea pi gs. The vaccine has been found to be safe and immunogenic. Cadila has partnered with ICMR for conduct  of  parallel  pre -clinical  studies  in  rhesus  macaques.  Status  of  clinical  trials  i follows:

- Phase I clinical trials have been completed. The trial has r evealed 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 global vaccine candidates:

- ChAdOx1 - S, which is a non - replicating viral vector vaccine developed by University of Oxford/AstraZeneca. This vaccine is undergoing phase III clinical trials in B Phase  II/III  bridging  studies  have  been  initiated  by  ICMR  at  14  clinical  trial ICMR - N ational  Institute  for  Research  in  Tuberculosis  (NIRT),  Chennai  is  the  le institution.
- ICMR and SII have also partnered for clinical development of a glycoprotein subun nanoparticle adjuvanted vaccine developed by Novavax from USA. The trial will be ini tiated in second half of October after the vaccine is manufactured by SII. The t led by ICMR - National AIDS Research Institute (NARI), Pune.

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