Lok Sabha Question No. 4089 (UNSTARRED), answered on 2021-03-19
Subject: Regulatory Process for Clearing Vaccines
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 QUESTI ON NO. 4089 TO BE ANSWERED ON 19 TH MARCH, 2021

## REGULATORY PROCESS F OR CLEARING VACCINES

## 4089. SHRI MANISH TE WARI:

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

- (a) the regulatory processes/steps involved in clearing a vaccine for mass inoculation;
- (b) whether the regulatory processes were followed while granting approvals to both Covishield and Covaxinrespectively, if so, the details thereof;

(c) the details of the recommendation of the Subjects Experts Committee on Covaxin;

- (d)  whether  the  SEC  did  a  U  turn  on  it's recommendations  with  regard  to  Covaxin  between December 30th 2020 and January 2nd 021, if so, the details thereof; and
- (e) whether the approvals to Covaxin were granted without completion of Phase - 3 Trials and overlooking the unfavourable trial results and if so, the details ther of?

## ANSWER

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

(a)  to  (e):  The  approval  of  COVID - 19  vaccine  for  manufacturing/marketing  is  based  on  the submission  of  adequate  data  including  Chemistry,  Manufacturing  and  Control  (CMC),  non -clinical (animal studies) data, clinical trial data as per provisions of New Drugs and Clinical Trials (ND  & CT) Rules, 2019 and outcomes of evaluation of the same in consultation with Subject Expert Committee (SEC).

A s per New Drugs and Clinical Trials Rules, 2019 ( ND & CT Rules 2019 ) under Drugs and Cosmetics Act, 1940 and in light of urgent need due to COVID pandemic in the count Central  Drugs  Standard  Control  Organisation  ( CDSCO)  in  consultation  with  Subject  Expert Committee (SEC) has granted 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  of  Phase  I  and  II  clinical carried out in the country along with safety data including Serious Adverse Event (SAE) d the  ongoing  Phase  III clinical  trial  in  the  country.  The  data  was  reviewed  by  Central  Dr Standard Control Organisation (CDSCO) in consultation with Subject Expert Committee (SEC comprising  domain  knowledge  experts.  The  committee  noted  that  this  vaccine  is  Inactiv 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  trial  on  25800 Indian  subjects  including subjects with co - morbid conditions as well which has demonstrated safety till date. Moreover, the firm presented the safety and efficacy data from Non - human primate challenge study also to CDSCO, where the vaccine has been found t o 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, es pecially 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  pu blic  interest  as  an  abundant  precaution,  in  clinical  trial  mode various conditions/restrictions.

Subsequently,  CDSCO  in  consultation  with  Subject  Expert  Committee  (SEC)  had approved the implementation protocol for rolling out the Whole Virion Inactivated Corona Virus Vaccine  (BBV152)  in  clinical  trial  mode  along  with  factsheet,  informed  consent  form adverse event form. Thereafter, the firm submitted the interim safety and efficacy data III clinical trial of Whole Virion, Inactivat ed Corona Virus Vaccine (BBV152) to CDSCO which was reviewed in consultation with SEC (COVID -19) meetings held on 08.03.2021 & 10.03.2021 respectively, wherein after detailed deliberation the committee recommended for omission condition  of  the  use  o f  the  vaccine  in  clinical  trial  mode.  However,  the  vaccine  should continued to be used under restricted use in emergency situation condition.

Further,  the  ongoing  phase  III  clinical  trial  should  be  continued  as  per  the  a protocol. The firm s hould update the prescribing information and factsheet accordingly (und restricted  use  in  emergency  situation  condition).  All  other  conditions  of  the  ma authorisation  shall  continue  to  remain  the  same.  Based  on  the  recommendations  of  SEC, condition of permission of the vaccine under clinical trial mode has been removed providi the permission is for restricted use in emergency situation.

M/s Serum Institute of India Pvt., Ltd. Pune has submitted safety immunogenicity & efficacy dat a of phase II/III clinical trials of AstraZeneca vaccine carried out in UK, Br 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 reviewe d 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 reviewe d 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 permission to Serum Institute of India  to  manufacture  COVISHIELD  vaccine  for  restricted  use  in  emergency  situation  wi various conditions/restrictions.