Lok Sabha Question No. 1995 (UNSTARRED), answered on 2021-07-30
Subject: Clinical Traial of 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 UNSTARR ED QUESTION NO. 1995 TO BE ANSWERED ON 30 TH JULY, 2021

## CLINICAL TRAIAL OF C OVAXIN

## 1995. SHRI MANISH TE WARI:

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

- (a)  whether  the  Government  has  taken  into  cognizance  that  Covaxin  was  allowed  to administered before the publishing of the third phase data, if so, the details thereof;
- (b) whether the Government is aware that 26 sites in the third phase trial for Covaxin follow the New Drug and Clinical Trial Rules 2019, like refusing to provide free medical participants in the trial, if so, the details thereof;
- (c) whet her the members of the Subject Expert Committee of the Drugs Controller General India (DCGI), changed their minds about Covaxin over the course of meetings on three d between December 30, 2020 to January 2, 2021 and permitted its use in clinical tria l mode, if so, the details thereof; and
- (d) whether this implies that Covaxin was rolled out for mass inoculation in clinical t and if so, the details thereof?

## ANSWER THE MINISTER OF STATE IN THE MINISTRY OF HEALTH AND FAMILY WELFARE ( DR. BHARATI PRAVIN PAWAR )

(a) to (d): 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) of the Central Drugs Standard Control Organisation (CDSCO).

CDSCO, in consultation with SEC, has g ranted permission to manufacture the COVID -19 vaccine of M/s Bharat Biotech International Limited, Hyderabad in light of the urgen due to COVID pandemic in the country, as per the provisions of New Drugs and Clinical Tr Rules, 2019 (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) data of the  ongoing  Phase  III  clinical  trial  in  the  country.  The  data  was  reviewed  by  CDSC consultation with SEC comprising domain knowledge experts. The committee noted that th vaccine is 'an Inactivated Whole Virion Corona Virus Vaccine', having potential to also target mutated corona virus strains. The ongoing clinical trial is a large trial on 25800 Indian subj including subjects with co - morbid conditions as well, which has demonstrated s afety till date. Moreover, the firm presented the safety and efficacy data from Non - human primate challenge study also to CDSCO, wherein the vaccine has been found to be safe and effective.

After detailed deliberations, the SEC recommended grant of permis sion for restricted use in emergency situation in public interest, as an abundant precaution in clinical trial m to have more options for vaccinations, especially in case of infection by mutant strains.

Accordingly, based on the recommendations of SEC, CDSCO has granted permission to M/s  Bharat  Biotech  International  Limited,  Hyderabad  to  manufacture  Covaxin  vaccine  f restricted use in emergency situation with various conditions/restrictions.

Subsequently,  CDSCO  in  consultation  with  SEC  also  ap proved  the  implementation protocol  for  rolling  out  the  Whole  Virion  Inactivated  Corona  Virus  Vaccine  (BBV152) clinical  trial  mode  along  with  factsheet,  informed  consent  form  and  adverse  event Thereafter, the firm submitted the interim safety and e fficacy data of phase III clinical trial of Whole Virion, Inactivated 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 t he committee recommended for omission of the condition of the use of the vaccine in clinical trial mode.

Subsequently, Based on the recommendations of SEC, the condition of permission of t vaccine under clinical trial mode has been removed providing tha t the permission is for rest icted use in emergency situation.