Lok Sabha Question No. 922 (UNSTARRED), answered on 2020-09-18
Subject: COVID-19 Vaccine by ICMR
Ministry: HEALTH AND FAMILY WELFARE
Asked by: Sougata Ray, Jayadev Galla

## GOVERNMENT OF INDIA MINISTRY OF HEALTH AND FAMILY WELFARE

## DEPARTMENT OF HEALTH RE SEARCH

## LOK SABHA UNSTARRED QUESTION NO. 922 TO BE ANSWERED ON 18 th SEPTEMBER, 2020

## COVID - 19 VACCINE BY ICMR

## 922. PROF. SAUGATA RAY: SHRI JAYADEV GALLA:

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

- (a)  whether  the  Government  has  issued  orders  to the  officials  of  ICMR  for  developing vaccine;
- (b) if so, the details and status of the research programmes announced on 15th August, 2020 to find remedial medicine to check COVID - 19;
- (c) the expected date of the availability of such medicine to common man in the country;
- (d) the details of Government institutions and private agencies approved by ICMR that are undertaking such researches and clinical trials for the purpose in the country; and
- (e) whether the Government has ensured financial assistance to such projects and if so, the details thereof?

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

- (a) to (d):Central Drugs Standard Control Organisation (CDSCO) has informed that in the  light  of  announcements  on  15/08/2020  on  COVID - 19  vaccine,  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., Ahmadabad
3. M/s Bharat Biotech International Ltd., Hyderabad
4. Biological E Ltd., Hyderabad
5. M/s Relian ce 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  (ICMR),  an  autonomous  organisation under the Department of Health Research, has informed that it is facilitating the following studies related to COVID - 19 vaccines:

(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 - 2020770) provided b y 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 follows:

- Phase I clinical trials alongwith parallel studies in hamsters and rhesus macaque been  completed.  The  trial  has  revealed  excellent  safety  of  the  candidate  vac 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 pigs. The vaccine has been found to be safe and immunogenic. Cadila has partnered wi ICMR for conduct of parallel pre - clinical studies in rhesus macaques. Status of clinical trials is as follows:

- Phase I clinical trials have been completed. The trial has revealed excellent s 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 two global vaccine candidates:

- ChAdOx1 - S, which is a non -replicating viral vector vaccine developed by University of Oxford/Astra Zeneca. This vaccine is undergoing phase III clinical trials in Br Phase II/III bridging studies have been initiated by ICMR at 14 clinical tria ICMR - National  Institute  for  Research  in  Tuberculosis  (NIRT),  Chennai  is  the  l institution.
- ICMR and SII have also partnered for clinical development of a glycoprotein sub nanoparticle adjuvanted vaccine developed by Novavax from USA. The trial will b initiated in second half of October after the vaccine is manufactured by SII. T is led by ICMR - National AIDS Research Institute (NARI), Pune.

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

While the Govt. and Industry are trying their best to make available a safe effective vaccine for COVID - 19  at  the  earliest,  it  is  difficult  to  comment  on  the  exa timelines in view of various complex pathways involved in vaccine developmen t.

(e) : ICMR  has  so  far  spent  more  than  Rs.25.00  crore  from  its  intramural  budget  fo undertaking work related to development of vaccine candidate and pre - clinical studies.

The Science and Engineering Research Board (SERB), a statutory body under the Department of Science and Technology, has supported 03 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 by Industry a academia for candidate vaccine development and associated research resources at a tota of Rs. 75 crore.