Lok Sabha Question No. 899 (UNSTARRED), answered on 2021-02-05
Subject: Development of Vaccine for Coronavirus
Ministry: HEALTH AND FAMILY WELFARE
Asked by: Omprakash Bhupalsinh alias Pawan Rajenimbalkar, Rahul Ramesh Shewale

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

## LOK SABHA UNSTARRED QUESTION NO. 899 TO BE ANSWERED ON 5 TH FEBRUARY, 2021

## DEVELOPMENT OF VACCI NE FOR CORONAVIRUS

## 899. SHRI OMPRAKASH BHUPA LSINH ALIAS PAWAN RAJENIMBALKAR: SHRI RAHUL RAMESH SH EWALE:

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

- (a)  whether  any  deviation  has  been  reported  in research  and  development  of  vaccine  for Coronavirus from the standard established procedure;
- (b)  if  so,  the  details  thereof  and  the  reasons  therefor along  with  the  standard  established procedure for research and development of a vaccine for any virus/ bacteria in the country;
- (c)  whether  the  Institutes/Companies  developing vacc e  for  Coronavirus have  shared  the outcome of human trials conducted by them with the Government;
- (d) if so, the details thereof along with the number of cases of adverse reactions reported in such trials; and
- (e)  the  time  by  which  vaccine  for  Coronavirus  is l kely  to  be provided  to  all  citizens  in  the country?

## ANSWER

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

(a) to (d) :Central Drugs Standards Control Organization (CDSCO) has granted permission to manufacture both Covishield and Covaxin as per New Drugs and Clinical Trials 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) 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 In dian 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 de tailed deliberations, the SEC recommended grant of permission for restricted 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 s trains.

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  abundant  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  from 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 w various conditions/restrictions.

Furthermore,  CDSCO  has  granted  permission  to  conduct  clinical  trials  of  COVID - 19 vaccines either manufact ured in the country/outside the country.

Common adverse events which have been reported from COVID - 19 vaccines which are approved  for  restricted  use  in  emergency  situation  includes  headache,  rash,  chills, fatigue,  fever,  dizziness,  inflammation and  pain,  swelling  or  redness  at  the  site  of  injectio vaccination site, erythema, pruritus etc.   So far as Serious Adverse Events (SAE) are co 51 SAEs have been received by CDSCO from various clinical trials of COVID - 19 vaccine.

(e):The priority groups for vaccination have been recommended by the National Experts Grou on Vaccine Administration for Covid - 19 (NEGVAC). The recommendations of NEGVAC in this regard have been accepted by the Central Government. The vaccine administration acros s the country is being done following the recommendations of NEGVAC.