Lok Sabha Question No. 852 (UNSTARRED), answered on 2021-02-05
Subject: Parameter to Approve Covishield and Covaxin
Ministry: HEALTH AND FAMILY WELFARE
Asked by: Hibi Eden

## GOVERNMENT OF INDIA MINISTRY OF HEALTH AND FAMILY WELFARE

## DEPARTMENT OF HEALTH AND FAMILY WELFARE

LOK SABHA UNSTARRED QUESTION NO. 852 TO BE ANSWERED ON 5 TH FEBRUARY, 2021

## PARAMETER TO APPROVE COVISHIELD AND COVAX IN

## 852. SHRI HIBI EDEN:

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

(a) the parameters considered to approve the use of the vaccines -Covishield and Covaxin;

- (b) whether the Government has taken any measures to publish the test results of Covishield and C ovaxinfrom Phase II and Phase III trials;
- (c) if so, the details thereof and the action taken thereon?

## ANSWER

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

(a):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.

Covaxin vaccine 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 (SAE) d the  on going  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  this  vaccine  is  In activated 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 trial is a large t rial on 25800 Indian subjects in which all 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 safe 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 infec tion 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  interest  as  an  abundan t  precaution,  in  clinical  trial  mode  with 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 carried out in UK, 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 of restricted  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 reviewed by the committee.

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

Based on the recommendations of SEC, CDSCO granted pe rmission to Serum Institute of India  to  manufacture  COVISHIELD  vaccine  for  restricted  use  in  emergency  situation  wi various conditions/restrictions.

(b) & (c): Under New Drugs and Clinical Trials Rules, 2019, it is not mandatory for publ of resul ts of any clinical trial data by CDSCO. However, Summary of Product Characterist (SmPC) & Prescribing Information for the COVISHIELD and COVAXIN are available in public domain  which  contains  brief  of  clinical  data.  Further,  clinical  trial  data  in  respec t  to  phase  I clinical trial results of COVAXIN of M/s Bharat Biotech & Phase I/II & Phase III clinic results of M/s AstraZeneca who is technical collaborator of COVISHIELD vaccine has  be published in scientific journals and pre prints of Phase II clinical trial reports of COVAXIN of M/s Bharat Biotech are available at MedRxiv.