Lok Sabha Question No. 970 (UNSTARRED), answered on 2021-12-03
Subject: COVID Vaccine for Children
Ministry: HEALTH AND FAMILY WELFARE
Asked by: Jaskaur Meena, D. Ravikumar, S. Jothimani, Sarmistha Sethi, Mala Roy

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

## LOK SABHA UNSTARRED QUESTION NO. 970

## TO BE ANSWERED ON THE 03 rd  DECEMBER, 2021

## COVID VACCINE FOR CHILDREN

970.     SHRIMATI JASKAUR MEENA SHRI RAVIKUMAR D. MS. S. JOTHIMANI SHRIMATI SARMISTHA SETHI SHRIMATI MALA ROY

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

- (a) whether  the  Government  has  laid  a  roadmap  to  administer  COVID  vaccines  in children between the age group 12 to 18, if so, the details thereof and the number of children in this age group, State/UT-wise;
- (b) the details of clinical trials conducted so far for vaccination in the age group of 12 to 18 years within the country along with the outcome thereof?
- (c) the number of tests required for approval of such vaccination in the country;
- (d) whether any COVID-19 vaccine for children is likely to be developed indeginously in the country, if so, the details thereof;
- (e) whether the Government has any plan to import any COVID-19 vaccine for children, if so, the details thereof; and
- (f) the  time  by  which  the  vaccine  is  likely  to  be  made  available  for  children  to  fully vaccinate them?

## ANSWER

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

(a)  to  (f)  National  Expert  Group  on  vaccine  administration  for  Covid  (NEGVAC)  and National  Technical  Advisory  Group  on  Immunization  (NTAGI)  are  deliberating  and considering scientific evidences related to vaccination of children between the age group 12 to 17 years. The State/UT-wise number of children in the age group 12 to 17 years is given in annexure 1.

As  of  now,  ZyCoV-D  vaccine  manufactured  by  M/s  Cadila  Healthcare  has  received  the approval  for  Restricted  Use  in  Emergency  Setting  by  the  National  Regulator  i.e.  Drug

Controller General of India (DCGI) for the age group of 12 years and above based on the interim clinical data of Phase III clinical trial conducted in the country.

Following COVID-19 vaccines are under clinical trials in the country for age-group of less than 18 years:

- i. M/s  Bharat  Biotech  is  conducting  Phase  II/III  clinical  trial  of  COVAXIN  on  Healthy Volunteers aged 2 to 18 years & firm has submitted interim safety & immunogenicity data to the National Regulator.
- ii. M/s  Serum  institute  of  India  is  conducting  Phase  II/III  clinical  trial  of  Nanoparticle Vaccine (Liquid) (COVOVAX) in 920 subjects of >2 to 17 years age group.
- iii.  M/s Biological E Ltd., is conducting Phase II/III clinical trial of RBD of SARS-CoV-2 gene in 624 subjects of ≥5 to <18years age group.
- iv.  M/s Johnson &  Johnson Pvt. Ltd., is conducting Phase II/III clinical trial of Ad.26COV.2S vaccine in age group of 12-17 years (Global Clinical trial wherein India is one of the clinical trial site).

The  approval  of  aforementioned  COVID-19  vaccines  will  be  dependent  on  the  successful completion of clinical trials and submission of requisite data as per the requirements of New Drugs and Clinical Trials Rules, 2019 under Drugs and Cosmetics Act, 1940.

National  Expert  Group  on  vaccine  administration  for  Covid  (NEGVAC)  and  National Technical Advisory Group on Immunization (NTAGI) is mandated to take decision related to offshore Covid-19 vaccine. At present, no proposal is pending related to import of COVID19 vaccine for use in children & adolescents age group.

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Annexure I

State/UT-wise number of children in the age group of 12-17 years (as per Registrar General of India ( RGI) estimate)

| S. No.   | State/UT               | Children in age group 12-17 years   |
|----------|------------------------|-------------------------------------|
| 1        | A&N Islands            | 44,000                              |
| 2        | Andhra Pradesh         | 47,05,000                           |
| 3        | Arunachal Pradesh      | 2,01,000                            |
| 4        | Assam                  | 40,58,000                           |
| 5        | Bihar                  | 1,67,60,000                         |
| 6        | Chandigarh             | 1,39,000                            |
| 7        | Chhattisgarh           | 32,13,000                           |
| 8        | Dadra and Nagar Haveli | 71,000                              |
| 9        | Daman and Diu          | 45,000                              |
| 10       | Delhi                  | 19,50,000                           |
| 11       | Goa                    | 1,47,000                            |
| 12       | Gujarat                | 69,76,000                           |
| 13       | Haryana                | 30,07,000                           |
| 14       | Himachal Pradesh       | 6,91,000                            |
| 15       | Jammu and Kashmir      | 17,22,000                           |
| 16       | Jharkhand              | 47,88,000                           |
| 17       | Karnataka              | 62,34,000                           |
| 18       | Kerala                 | 30,53,000                           |
| 19       | Ladakh                 | 27,000                              |
| 20       | Lakshadweep            | 8,000                               |
| 21       | Madhya Pradesh         | 93,99,000                           |
| 22       | Maharashtra            | 1,19,69,000                         |
| 23       | Manipur                | 3,55,000                            |
| 24       | Meghalaya              | 4,20,000                            |
| 25       | Mizoram                | 1,33,000                            |
| 26       | Nagaland               | 2,84,000                            |
| 27       | Odisha                 | 46,59,000                           |
| 28       | Puducherry             | 1,64,000                            |
| 29       | Punjab                 | 27,34,000                           |
| 30       | Rajasthan              | 91,54,000                           |
| 31       | Sikkim                 | 80,000                              |
| 32       | Tamil Nadu             | 65,22,000                           |
| 33       | Telangana              | 35,64,000                           |
| 34       | Tripura                | 4,19,000                            |
| 35       | Uttar Pradesh          | 2,68,82,000                         |
| 36       | Uttarakhand            | 12,23,000                           |
| 37       | West Bengal            | 94,14,000                           |
|          | Total                  | 14,52,14,000                        |

Estimated by (RGI)