Lok Sabha Question No. 177 (STARRED), answered on 2021-02-12
Subject: Claims for New Corona Vaccines
Ministry: HEALTH AND FAMILY WELFARE
Asked by: Y. S. Avinash Reddy

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

## LOK SABHA STARRED QUESTION NO. 177 TO BE ANSWERED ON THE 12 TH FEBRUARY , 2021 CLAIMS FOR NEW CORON A VACCINES

## *177. SHRI Y.S. AVIN ASH REDDY:

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

- (a)  whether  the  Government  has  taken  note  that  many  organizations  a claiming  that  vaccines  have  been  developed  to  control  Corona  Virus  in country;
- (b) if so, the details thereof; and
- (c)  whether  the  Government  has  examined  their  claims,  if  so,  the  de thereof?

## ANSWER THE MINISTER OF HEALTH AND FAMILY WELFARE (DR. HARSH VARDHAN)

- (a)to ( c)A Statement is laid on the Table of the House.

## STATEME NT REFERRED TO IN REPLY TO LOK SABHA STARRED QUESTION NO. 177* FOR 12 TH FEBRUARY , 2021

(a) to (c) Various COVID - 19 vaccines are under development in India.  A s per New Drugs and Clinical Trials Rules, 2019 ( ND & CT Rules 2019 ) formulated under  Drugs  and  Cosmetics  Act,  1940  and  in  light  of  urgent  need  due COVID pandemic in the country, Central Drugs Standard Control Organisation ( CDSCO) in consultation with its Subject Expert Committee (SEC) has grante permission to manufacture the following COVID - 19 vaccines:

Covaxin vaccine is being manufactured by M/s Bharat Biotech International Limited.  The  firm  had  submitted  interim  safety  and  immunogenicity  data Phase I and II clinical trials carried o ut in the country along with safety data including Serious Adverse Event (SAE) data of the ongoing Phase III clin trial in the country. The data was reviewed by Central Drugs Standard Co Organisation (CDSCO) in consultation with Subject Expert Com mittee (SEC) comprising domain knowledge experts. The committee noted that this vaccine Inactivated  Whole  Virion  Corona  Virus  Vaccine  having  potential  to  tar mutated corona virus strains. The data demonstrated a strong immune respo (both antibody as well as T cell) and in - vitro viral neutralization. The ongoing clinical trial is a large trial on 25800 Indian subjects in which all 2580 have already been enrolled. The firm also presented the safety and efficac from Non-human primate c hallenge study to CDSCO, where the vaccine has been found to be safe and effective.

After detailed deliberations, the SEC recommended grant of permission restricted  use  in  emergency  situation  in  public  interest  as  an  ab precaution, in clin ical trial mode to this vaccine.CDSCO has granted permissio to  M/s  Bharat  Biotech  International  Limited,  Hyderabad  to  manufactu Covaxin vaccine for restricted use in emergency situation in public inte an abundant precaution, in clinical trial mod e.

M/s  Serum  Institute  of  India  Pvt.,  Ltd.  Pune has  submitted  safety immunogenicity & efficacy data of phase II/III clinical trials of Astra vaccine  carried  out  in  UK,  Brazil  and  South  Africa  along  with  the  safe immunogenicity data from t he ongoing Phase II/III clinical trial in India. Subject Expert Committee (SEC) of CDSCO reviewed the proposal of restricte emergency use along with above details and the data received. The Medicines and Healthcare products Regulatory Agency ( MHRA) approval for AstraZeneca vaccine on 30.12.2020 along with its conditions/restrictions was also rev by the SEC .

The SEC noted  that  the  safety  &  immunogenicity  data  presented  by  th firm from the Indian study is comparable with that of the overseas clinical trial data.

Based  on  the  recommendations  of  SEC,  CDSCO  granted  permission  to Serum  Institute  of  India  to  manufacture  COVISHIELD  vaccine  for  restrict use in emergency situation .

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