Lok Sabha Question No. 2152 (UNSTARRED), answered on 2021-12-10
Subject: Nasal Vaccine for Children
Ministry: HEALTH AND FAMILY WELFARE
Asked by: Jaskaur Meena

## GOVERNMENT OF INDIA MINISTRY OF HEALTH AND FAMILY WELFARE

## DEPARTMENT OF HEALTH AND FAMILY WELFARE

## LOK SABHA UNSTARRED QUESTION NO. 2152 TO BE ANSWERED ON THE 10 TH  DECEMBER, 2021

## NASAL VACCINE FOR CHILDEN

## 2152.   SHRIMATI JASKAUR MEENA:

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

- (a) whether the Government proposes to introduce nasal vaccine for children across the country;
- (b) if so, the details thereof;
- (c) the details of the tests conducted so far along with the outcome thereof;
- (d) the time by which the nasal vaccine is likely to be launched; and
- (e) the other steps taken by the Government to protect the children from the third wave of COVID19?

## ANSWER

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

(DR. BHARATI PRAVIN PAWAR)

- (a)  to  (d)  No  Nasal  vaccine  trial  for  children  is  ongoing  across  the  country.  However,  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 depends 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.

(e)The guiding principle to minimize and avert the risk of future resurgence of Covid-19 cases is the 5fold strategy of Test-Track-Treat-Vaccinate and COVID Appropriate Behaviour. Besides this States are also being provided requisite technical and financial support by the Government of India to prepare for and respond to any exigencies arising out of surge in Covid-19.

A  new  scheme  'India  COVID-19  Emergency  Response  &  Health  System  Preparedness  Package: (ERCP-II)' amounting to Rs 23,123 crore has been approved for Financial year 2021-22 that aims to prevent, detect and respond to the continuing threat posed by COVID-19 and strengthen national health systems for preparedness in India for all.

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