Lok Sabha Question No. 1063 (UNSTARRED), answered on 2020-09-18
Subject: Distrubution of Vaccines for COVID-19
Ministry: HEALTH AND FAMILY WELFARE
Asked by: Rahul Gandhi, Talari Rangaiah

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

LOK SABHA UNSTARRED QUESTION NO. 1063 TO BE ANSWERED ON 18 TH SEPTEMBER, 2020

## DISTRUBUTION OF VACC INES FOR COVID - 19

## 1063. SHRI RAHUL GAN DHI: SHRI TALARI RANGAIAH:

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

- (a)  whether  the  Government  has  formulated  a  vaccine  strategy  to  facilitate  the  develo manufacture and distribution of vaccines for COVID - 19 in India, if so, the details thereof ;
- (b) the details of the COVID - 19 vaccine candidates currently being developed or manufactured in India;
- (c) whether India has joined international efforts to ensure equitable and fair access t for COVID-19, if so, the details thereof;
- (d)  whether  India  is  planning  to  enter  into  advance  purchase  agreement(s)  with  va manufacturers, if so, the details thereof?

## ANSWER THE MINISTER OF STATE IN THE MINISTRY OF HEALTH AND FAMILY WELFARE

## (SHRI ASHWINI KUMAR CHOUBEY)

- (a) to (d) Government of India has formed a National Expert Group on Vaccine Administration for Covid - 19 chaired by Member(health), Niti Aayog.

They Expert Group has deliberated on broad parameters guiding the selection of Cov -19 vaccine candidates for the countr y and working in close coordination with Standing Technical Sub-Committee  of  National  Technical  Advisory  Group  on  Immunization  (NTAGI).  It  is  also creating  strategy  on  the  procurement  mechanisms  for  COVID - 19  vaccine,  including  both indigenous and internati onal manufacturing along with guiding principles for prioritization population groups for vaccination.

Central Drugs Standard Control Organisation (CDSCO) has granted test license permissi for  manufacture  of  COVID - 19  Vaccine  for  preclinical  test,  exa mination  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 Reliance Life Sciences Pvt Ltd., Mumbai
6. M/s Aurbindo Pharma Limited, Hyderabad
7. M/s Gennova Biopharmaceuticals Limited, Pune

Indian Council of Medical Research (ICMR) is facilitating the following studies relat COVID - 19 vaccines:

(i)An  inactivated  whole  virion  candidate  vacc ine  (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. Phase I clinical trials al with parallel studies in hamsters an d rhesus macaques have been completed & have revealed excellent  safety  of  the  candidate  vaccine.  Immunogenicity  testing  is  in  progress.  Ph clinical trials are ongoing.

(ii) A DNA vaccine (ZyCov - D) has been developed by Cadila Healthcare Ltd. Pre - cli ncial toxicity studies were  conducted in small animals: mice, rats, rabbits and guinea pig vaccine has been found to be safe and immunogenic. Cadila has partnered with ICMR for conduct of parallel pre -clinical studies in rhesus macaques. Phase I clin ical trials have been completed. The trial has revealed excellent safety of the candidate vaccine. Immunogeni testing is in progress. Phase II clinical trials are ongoing.

(iii) Serum Institute of India (SII) and ICMR have partnered for clinical devel opment 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 been init iated by ICMR at 14 clinical trial sites.
- 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 initiated in second half of October after the va ccine is m nufactured by SII. The trial is led by ICMR - National AIDS Research Institute (NARI), Pune.

Department  of  Biotechnology  (DBT)/Department  of  Science  and  Technology  (DST)  are also supporting more than 30 vaccine candidates which are in different stages of development.

The Government of India conveyed its intent to be part of the  Vaccine Pillar of the to  COVID - 19  Tools  (ACT)  Accelerator,  which  may  be  beneficial  in  providing  access  to  t global vaccine candidates in advanced stages, for the ir further utilization in the country. Under this  pillar,  COVAX  facility  has  been  created  which  is  led  by  GAVI  and  WHO,  for  fair equitable distribution of Covid - 19 vaccine across the world.

The  Department  of  Biotechnology  through  the  IND - CEPI  Mission  i s  involved  in  key partnerships  with  'Coalition  for  Epidemic  Preparedness  Innovations  (CEPI)'  for  supporting Indian researchers for development of clinical immune assays to advance vaccine research.

No advance purchase agreement with any vaccine manufactur ers have been entered into.