Lok Sabha Question No. 532 (UNSTARRED), answered on 2022-02-04
Subject: COVID-19 Vaccines for Emergency Use
Ministry: HEALTH AND FAMILY WELFARE
Asked by: Sangamlal Kadedin Gupta, Locket Chatterjee, Rajendra Agrawal, P.P. Chaudhary, Srinivas Kesineni

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

## LOK SABHA UNSTARRED QUESTION NO. 532

## TO BE ANSWERED ON 04 th  FEBRUARY 2022

## COVID-19 VACCINES FOR EMERGENCY USE

## 532. SHRI SANGAM LAL GUPTA:

MS. LOCKET CHATTERJEE:

SHRI RAJENDRA AGRAWAL:

SHRI P.P. CHAUDHARY:

SHRI KESINENI SRINIVAS:

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

- (a) The details of the COVID-19 vaccination available for emergency use in India, and the vaccines in the pipeline along with the expenditure incurred on procurement of these vaccines;
- (b) the reasons for the delay in approving more vaccines for use in India;
- (c) whether the Government is undertaking trails to understand the effects on immunological response of administering disparate vaccine doses to individuals, if so, the details thereof and if not, reasons therefor;
- (d) whether the Government is reviewing the latest research for vaccinating children below the age of 15 years, if so, the details thereof; and
- (e) whether the Government has formulated any action plan for administering the booster dose to individuals who have earlier been vaccinated with both the doses and if so, the details thereof?

## ANSWER THE MINISTER OF STATE IN THE MINISTRY OF HEALTH AND FAMILY WELFARE (DR. BHARATI PRAVIN PAWAR)

- (a)  to  (e)  National  Regulator  i.e.  Central  Drugs  Standard  Control  Organization  (CDSCO)  has granted permissions to following vaccines for restricted use in emergency  situation  as per the New Drugs and Clinical Trials (NDCT) Rules, 2019:
1. COVISHIELD of M/s Serum Institute of India Pvt. Ltd. for ≥ 18 years age
2. COVAXIN of M/s Bharat Biotech ≥ 12 years age
3. ZyCovD of Cadila Healthcare Limited for ≥ 12 years age
4. SPUTNIK-V imported  by  Dr.  Reddy's  Lab.  Ltd.  and  manufactured  by  M/s  Panacea Biotec and M/s Hetero Biopharma, for ≥ 18 years age
5. Moderna imported by M/s Cipla Ltd., for ≥ 18 years age
6. Janssen Vaccine imported by M/s Johnson & Johnson Pvt. Ltd and  manufactured by M/s Biological E Limited, for ≥ 18 years age
7. CORBEVAX of M/s Biological E Ltd., for ≥ 18 years age
8. COVOVAX of M/s Serum Institute of India Pvt. Ltd., for ≥ 18 years age

The following COVID-19 vaccines are under various phases of clinical development:

1. SPUTNIK-LIGHT of M/s Dr. Reddy's Lab. Ltd (Phase III).
2. Lyophilized mRNA based COVID-19 vaccine of M/s Gennova Biopharma. Ltd. (Phase II/III).
3. Nasal vaccine of M/s Bharat Biotech (Phase III).
4. Multiple Protein/ Peptide-Based SARS-CoV-2 Vaccine of M/s Aurobindo (Phase II/III).
5. Inactivated Whole-virion virus (Intra-dermal route) of M/s Bharat Biotech (Phase I/II).
6. Inactivated  Rabies  vector  platform  Corona  Virus  Vaccine  (rDNA-BBV151)  of  M/s Bharat Biotech (Phase I).
7. SARS-CoV-2 Recombinant protein subunit vaccine of M/s Reliance (Phase I).

The  approval  of  COVID-19  vaccine  by  the  national  regulator  is  dependent  on  the  safety, immunogenicity  and  efficacy  profile  of  vaccine  through  non-clinical  and  clinical  trial  data generated and there is no delay in approval of the COVID-19 vaccines.

National  Regulator  i.e.  Central  Drugs  Standard  Control  Organization  (CDSCO)  has  granted permissions to following entities for conduct of clinical trials for administration of mixed vaccine regimen:

1. M/s Christian Medical College, Vellore to conduct Phase IV study with COVISHIELD and COVAXIN to compare immunogenicity of mixed vaccine regimen.
2. M/s Bharat Biotech for Phase II clinical trial to evaluate the immunogenicity and safety of BBV152 (COVAXIN) with BBV154 (Adenoviral Intranasal COVID-19 vaccine).

As  per  the  recommendation  of  the  National  Technical  Advisory  Group  on  Immunization (NTAGI), administration of precaution dose has started from 10th January 2022 to those Health Care Workers (HCWs), Front Line Workers (FLWs) and persons aged 60 years & above with comorbidities who have received two doses of Covid-19 vaccines.

Any  decision  on  extension  of  eligible  beneficiaries  for  precaution  dose  and  vaccination  of children  below  15  years  of  age  is  as  per  the  recommendations  of  The  National  Technical Advisory  Group  on  Immunization  (NTAGI)  on  the  basis  of  review  of  available  scientific evidences.

In the current financial year i.e. 2021-22, INR  35,000 crore has been budgeted for implementation of COVID-19 Vaccination Programme. As on 31 st January 2022, an expenditure of  INR  27,945.14  crore  has  been  incurred  against  this  allocation  which  has  been  utilized  for procurement of COVID-19 vaccine for free of cost supply to State/UTs.

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