Lok Sabha Question No. 2142 (UNSTARRED), answered on 2020-09-23
Subject: Vaccines being Developed to Combat Coronavirus
Ministry: HEALTH AND FAMILY WELFARE
Asked by: Preneet Kaur, Manish Tewari

## GOVERNMENT OF INDIA MINISTRY OF HEALTH AND FAMILY WELFARE

## DEPARTMENT OF HEALTH RESEARCH

## LOK SABHA UNSTARRED QUESTION NO. 2142 TO BE ANSWERED ON 23 RD SEPTEMBER, 2020

## VACCINES BEING DEVEL OPED TO COMBAT CORON AVIRUS

## 2142. SHRIMATI PRENEET KAU R:

## SHRI MANISH TEWARI:

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

- (a) the number of vaccines being developed in the country to combat Corona virus, along with the progress of trials, stage - wis ;
- (b) the vaccines that have graduated to th e stage of clinical/human trials;
- (c) the details of the places where such trials are taking place and the success rate of these trials conducted on human beings so far; and
- (d) whether a triage or vaccination schedule to inoculate the 130 crore people of India has been conceptualized by the Government, if so, the details thereof and action taken thereon?

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

(a)  to  (c):  Central  Drugs  Standard  Control Organisation  (CDSCO)  has  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. Cadi la Healthcare Ltd., Ahmadabad
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  o f  Medical  Research  (ICMR),  an  autonomous  organisation  under  the Department of Health Research, has informed that it is facilitating the following studie to COVID - 19 vaccines:

- (i) An  inactivated  whole  virion  candidate  vaccine  (BBV152)  for  SARS - Co V - 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 vacc

candidate has been undertaken at ICMR -NIV followed by safe ty and tolerability studies in small animals like rats, mice and rabbits. Status of clinical trials is as follows:

- Phase I clinical trials alongwith parallel studies in hamsters and rhesus macaque been  completed.  The  trial  has  revealed  excellent  safe ty  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.  Pre - clincial 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 conduct parallel pre - clinical studies in rhesus macaques. Status of clinical trials is as follows:

- PhaseI clinical trials have been completed. The trial has revealed excellent safet candidate vaccine. Immunogenicity testing is in progress.
- Phase II clinical trials are ongoing.

(iii) Serum Institute of India (SII) and ICMR have partnered for clinic al development of two 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 Brazil II/III  bridging  studies  have  b een  initiated  by  ICMR  at  14  clinical  trial  sites.  ICMR -National Institute for Research in Tuberculosis (NIRT), Chennai is the lead institut

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

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

CDSCO has informed that it has granted permission to conduct clinical trials in vario clinical tria l sites such as New Delhi,Chennai, Chandigarh, Jaipur, Kanpur, Surat, Hyderabad, Pune, Mumbai, Ahmadabad, Bhubaneswar, Patna, Gorakhpur etc. and the trials are  on going.

(d)  Presently,  under  Universal  Immunization  Program  (UIP)  vaccine  distribution  is  b ased  on Electronic  Vaccine  Intelligence  Network  (eVIN)  system.  eVIN  is  an  internet  based  dig system  to  track  routine  immunization,  vaccine  stocks,  storage  temperature  in  about  2 dedicated  cold  chain  storage  points  across  the  country  as  well  as  mov ement  of  vaccine.  The vaccine is distributed to health facilities and outreach station sites, so as to reach eVIN system is regularly monitored by health authorities at state and district level. eVI

is being enhanced to address the ne eds for distribution and tracking of COVID 19 vaccine, when it becomes available.

Further, a National Expert Group on COVID 19 vaccine has been constituted to guide Government on: -

- Prioritization of population groups for vaccination.
- Selection of COVID 19 vaccine candidates.
- Inventory  management  and  delivery  mechanism  of  the  vaccine  including  making  of vaccination process.
- Selection of delivery platforms.
- Cold chain and associated infrastructure for roll - out of COVID 19 vaccination etc.