Lok Sabha Question No. 2235 (UNSTARRED), answered on 2020-09-23
Subject: Vaccine for COVID-19
Ministry: HEALTH AND FAMILY WELFARE
Asked by: T.N. Prathapan, Y. S. Avinash Reddy

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

LOK SABHA UNSTARRED QUE STION NO. 2235 TO BE ANSWERED ON 23 RD SEPTEMBER, 2020

## VACCINE FOR COVID - 19

## 2235. SHRI T.N. PRATHAPAN: SHRI Y.S. AVINASH RE DDY:

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

- (a) whether the Government has taken note that many organizations are claiming that a vaccine has been invented/developed to control corona virus in the country;
- (b) if so, the details the reof;
- (c) whether the Government has examined their claims, if so, the details thereof;
- (d) if not, the steps being taken by the Government to produce vaccine at the earliest?

## ANSWER

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

(SHRI ASHWINI KUMAR CHOUBEY)

- (a) to (d): Central Drugs Standard Control Organisation (CDSCO) has informed that as on no COVID - 19 vaccine has been approved for manufacture/import and marketing in the country

CDSCO  has  granted  test  license  permission  for  m anufacture  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 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  (ICMR),  an  autonomous  organisation  under  the Department of Hea lth Research, has informed that it is facilitating the following studies 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 viru s 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 safety 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  safety  of  the  candidate  vac Immunogenicity testing is in progress.
- Phase II c linical 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 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 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 clinica l 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  be en  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 vacc ine 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 Biotechnolo gy (DBT)/Department of Science and Technology (DST), more than 30 vaccine candidates have been supported which are in differ stages of development.

While the Govt. and Industry are trying their best to make available a safe and ef vaccine for COV ID-19 at the earliest, it is difficult to comment on the exact timelines in various complex pathways involved in vaccine development.