New Delhi: The Subject Expert Committee of Central Drugs Standard Control Organisation (CDSCO) met on
1st and 2nd January, 2021 and made recommendations in respect of proposal for Restricted
Emergency Approval of COVID-19 virus vaccine of M/s Serum Institute of India and M/s Bharat
Biotech as well as Phase III clinical trial of M/s Cadila Healthcare Ltd.

The Subject Expert Committee consists of domain knowledge experts from the fields of
pulmonology, immunology, microbiology, pharmacology, paediatrics, internal medicine, etc.
M/s Serum Institute of India, Pune has presented a Recombinant Chimpanzee Adenovirus vector
vaccine (Covishield) encoding the SARS-CoV-2 Spike (S) glycoprotein with technology transfer
from AstraZeneca/Oxford University. The firm submitted safety, immunogenicity and efficacy
data generated on 23,745 participants aged ≥ 18 years or older from overseas clinical studies. The
overall vaccine efficacy was found to be 70.42%. Further, M/s Serum was granted permission to
conduct Phase-II/III clinical trial on 1600 participants within the country. The firm also submitted
the interim safety and immunogenicity data generated from this trial and the data was found
comparable with the data from the overseas clinical studies. After detailed deliberations Subject
Expert Committee has recommended for the grant of permission for restricted use in emergency
situation subject to certain regulatory conditions. The clinical trial ongoing within the country by
the firm will continue.

M/s Bharat Biotech has developed a Whole Virion Inactivated Corona Virus Vaccine (Covaxin)
in collaboration with ICMR and NIV (Pune), from where they received the virus seed strains. This
vaccine is developed on Vero cell platform, which has well established track record of safety and
efficacy in the country & globally.

The firm has generated safety and immunogenicity data in various animal species such as mice,
rats, rabbits, Syrian hamster, and also conducted challenge studies on non-human primates (Rhesus
macaques) and hamsters. All these data has been shared by the firm with CDSCO. Phase I and
Phase II clinical trials were conducted in approx.800 subjects and the results have demonstrated
that the vaccine is safe and provides a robust immune response. The Phase III efficacy trial was
initiated in India in 25,800 volunteers and till date, ~22,500 participants have been vaccinated
across the country and the vaccine has been found to be safe as per the data available till date.

The Subject Expert Committee (SEC) has reviewed the data on safety and immunogenicity of the
vaccine and recommended for grant of permission for restricted use in emergency situation in
public interest as an abundant precaution, in clinical trial mode, to have more options for
vaccinations, especially in case of infection by mutant strains. The clinical trial ongoing within the
country by the firm will continue.

M/s Cadila Healthcare Ltd., has developed a Novel Corona Virus-2019-nCov-Vaccine using DNA
platform technology. The firm initiated Phase-I/II clinical trial in India in more than 1000
participants which is ongoing. The interim data suggests that the vaccine is safe and immunogenic
with three doses when administered intradermally. Accordingly, firm has sought permission to
conduct Phase-III clinical trial in 26000 Indian participants, which has been recommended by the
Subject Expert Committee.

M/s Serum and M/s Bharat Biotech vaccines have to be administered in two doses. All the three
vaccines have to be stored at 2-8° C.

After adequate examination, CDSCO has decided to accept the recommendations of the Expert
Committee and accordingly, vaccines of M/s Serum and M/s Bharat Biotech are being approved
for restricted use in emergency situation and permission is being granted to M/s Cadila Healthcare
for conduct of the Phase III clinical trial.

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