Lok Sabha Question No. 953 (UNSTARRED), answered on 2020-09-18
Subject: Mutation in Spike Protein of SARS-CoV2
Ministry: HEALTH AND FAMILY WELFARE
Asked by: Balak Nath, Sumedhanand Saraswati

## GOVERNMENT OF INDIA MINISTRY OF HEALTH AND FAMILY WELFARE

## DEPARTMENT OF HEALTH RE SEARCH

## LOK SABHA UNSTARRED QUESTION NO. 953 TO BE ANSWERED ON 18 th SEPTEMBER, 2020

## MUTATION IN SPIKE PR OTEIN OF SARS -COV2

## 953. SHRI BALAK NATH: SHRI SUMEDHANAND SARASWATI:

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

- (a) whether the future of the COVID - 19 vaccine is uncertain because of the mutation in spike protein of SARS - CoV2, which hinders the development of COVID -19 vaccine;
- (b) if so, the facts in this regard;
- (c) the present status of research of COVID - 19 vaccine in India; and
- (d)  the  timeline  by  which  it  is  likely  to  be  available in  the  market  as  per  World  Health Organisation estimates?

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

## (SHRI ASHWINI KUMAR CHOUBEY)

- (a) &(b): The Indian Council of Medical Research (ICMR), an autonomous organisation of the Department of Health Research, has informed that all the vaccine or COVID - 19 are under various stages of development. It is difficult as well as premat comment  on  their  effectiveness  and  correlation  with  virus  mutations.  This  data  wil available once full clinical development of vaccine(s) is completed and afte r correlation with the virus strain sequence available at that particular time point.
- (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. Cadila Healthcar e 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 Health Research, has informed that it is facilitating the fol 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 by 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  mac have  been  completed.  The  trial  has revealed  excellent  safety  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 sm all animals: mice, rats, rabbits and guinea 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 clin ical trials have been completed. The trial has revealed excellent safe 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 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  clinica trials in Brazil. Phase II/III bridging studies have been initiated by  ICMR at 14 clinical trial sites. ICMR - National Institute for Research in Tuberculosis (NIRT), Chennai is the lead 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 initiated in second half of October after the vaccine is manufactured by SII. Th 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 development.

(d): 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  ex timelines in view of various complex pathways involved in vaccine development.