Lok Sabha Question No. 912 (UNSTARRED), answered on 2021-02-05
Subject: Covishield and Covaxin
Ministry: HEALTH AND FAMILY WELFARE
Asked by: Manish Tewari

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

LOK SABHA UNSTARRED QUESTION NO. 912 TO BE ANSWERED ON 5 TH FEBRUARY, 2021

## COVISHIELD AND COVAX IN

## 912. SHRI MANISH TEW ARI:

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

(a) the details of the regulatory approval that has been given to both Covishield and Covaxin;

(b) whether Phase 3 trials of these vaccines have been completed, if so, the details thereof and if not, the reasons for using these vaccines for mass immunization programme;

(c) whether approval of these vaccines certified for restricted use in emergency situation qualify for mass immunization, if so, the details thereof;

(d) whether a large number of people in Bhopal were made to participate in the trials of Covaxin without taking their informed consent, if so, the details thereof; and

(e) whether many of them have reported adverse effects after participating in the Covaxin trials and this was taken into account by the Sub jects' Experts Committee and other concerned bodies beforerecommending  Covisheild  and  Covaxin  for  the immunisation  drive,  if  so,  the  details thereof?

## ANSWER

## THE MINISTER OF STATE IN THE MINISTRY OF HEALTH AND FAMILY WELFARE (SHRI ASHWINI KUMAR CHOUBEY)

(a) to (c): Central Drugs Standards Control Organization (CDSCO) has granted permission to manufacture both Covishield and Covaxin as per New Drugs and Clinical Trials Rules, 20 (ND & CT Rules 2019) under Drugs and Cosmetics Act, 1940.

Covaxinvaccine is being manufactured by M/s Bharat Biotech International Limited. The firm  had  submitted  interim  safety  and  immunogenicity  data  of  Phase  I  and  II  clinical carried out in the country along with safety data including Serious Adverse Event (SA E) data of the  ongoing  Phase  III  clinical  trial  in  the  country.  The  data  was  reviewed  by  Central Standard Control Organisation (CDSCO) in consultation with Subject Expert Committee (SEC comprising  domain  knowledge  experts.  The  committee  noted  that  t his  vaccine  is  Inactivated Whole Virion Corona Virus Vaccine having potential to target mutated corona virus strains data demonstrated a strong immune response (both antibody as well as T cell) and in - vitro viral neutralization. The ongoing clinical t rial is a large trial on 25800 Indian subjects in which

25800 subjects have already been enrolled. Moreover, the firm presented the safety and ef data  from  Non - human  primate  challenge  study  also  to  CDSCO,  where  the  vaccine  has  been found to be sa fe and effective.

After detailed deliberations, the SEC recommended grant of permission for restricte in emergency situation in public interest as an abundant precaution, in clinical trial mod more options for vaccinations, especially in case of infection by mutant strains.

Based on the recommendations of SEC, CDSCO has granted permission to M/s Bharat Biotech International Limited, Hyderabad to manufacture Covaxin vaccine for restricted u emergency  situation  in  public  inter est  as  an  abundant  precaution,  in  clinical  trial  mode  wit various conditions/restrictions.

M/s Serum Institute of India Pvt., Ltd. Pune has submitted safety immunogenicity & efficacy data of phase II/III clinical trials of AstraZeneca vaccine carr i d out in UK, Brazil and South Africa along with the safety & immunogenicity data from the ongoing Phase II/III cl trial in the country. The Subject Expert Committee (SEC) of CDSCO reviewed the proposal restricted  emergency  use  along  with  above  d etails  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 reviewed by the committee.

The  committee  noted  that  the  safety  & immunogenicity  data  presented  by  the  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 restricted use in emergency situation with various conditions/restrictions.

(d) & (e): As per the provisions under New Drugs and Clinical Trials Rules, 2019, in all freely given, informed, written consent is required to be obtained from subj ects of each  study before their inclusion in clinical trial.  As per available information, none of the pa the Covaxin clinical trial have been enrolled without taking an informed consent.

Common adverse events which have been reporte d from COVID-19 vaccines approved for restricted use in emergency situation include headache, rash, chills, myalgia, fatig dizziness, inflammation and pain, swelling or redness at the site of injection, erythema etc.  The data from phas e 1 safety trials of Covaxin have been recently published in The Lanc Infectious Diseases.