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Coronavirus Vaccine: Restricted emergency use approval for Serum's Covishield and Bharat Biotech's Covaxin
Mirror Online | Jan 03, 2021, 11:47 IST
In a two minute statement read out to the media on Sunday morning, India's drug regulatory body announced it has granted emergency restricted use approval to two Covid-19 vaccines.
In a two minute statement read out to the media on Sunday morning, India's drug regulatory body announced it has granted emergency restricted use approval to two Covid-19 vaccines. These two are Serum Institute's Covishield and Bharat Biotech's Covaxin. The Drug Controller also announced that it has granted permission to Cadila to conduct phase 3 clinical trials. No questions were taken and the briefing was wrapped up after the brief announcement.
What we know so far:
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 an emergency situation and permission is being granted to M/s Cadila Healthcare for the conduct of Phase III clinical trial.
CDSCO made recommendations in respect of a proposal for Restricted Emergency Approval of COVID-19 virus vaccine of Serum Institute of India and Bharat Biotech as well as Phase III clinical trial of M/s Cadila Healthcare Ltd.
How the vaccine will reach its first recipient in Mumbai
Serum Institute of India
Serum 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%.
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.
The ongoing clinical trial by the firm continues. Serum has been granted emergency permission for restricted use in emergency situation subject to certain regulatory conditions.
Bharat Biotech
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.
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.
After review and recommendations of the expert committee, vaccines of Serum and Bharat Biotech are being approved for restricted use in emergency situation.
Cadila Healthcare Ltd
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 suggest that the vaccine is safe and immunogenic with three doses when administered intradermally. Accordingly, the firm has sought permission to conduct Phase-III clinical trial in 26000 Indian participants, which has been recommended by the Subject Expert Committee.
Cadila Healthcare has been granted permission to conduct the Phase III clinical trial.
What we know so far:
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 an emergency situation and permission is being granted to M/s Cadila Healthcare for the conduct of Phase III clinical trial.
CDSCO made recommendations in respect of a proposal for Restricted Emergency Approval of COVID-19 virus vaccine of Serum Institute of India and Bharat Biotech as well as Phase III clinical trial of M/s Cadila Healthcare Ltd.
How the vaccine will reach its first recipient in Mumbai
Serum Institute of India
Serum 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%.
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.
The ongoing clinical trial by the firm continues. Serum has been granted emergency permission for restricted use in emergency situation subject to certain regulatory conditions.
Happy new year, everyone! All the risks @SerumInstIndia took with stockpiling the vaccine, have finally paid off. C… https://t.co/huBUaYsVpv
— Adar Poonawalla (@adarpoonawalla) 1609652416000Bharat Biotech
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.
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.
After review and recommendations of the expert committee, vaccines of Serum and Bharat Biotech are being approved for restricted use in emergency situation.
Cadila Healthcare Ltd
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 suggest that the vaccine is safe and immunogenic with three doses when administered intradermally. Accordingly, the firm has sought permission to conduct Phase-III clinical trial in 26000 Indian participants, which has been recommended by the Subject Expert Committee.
Cadila Healthcare has been granted permission to conduct the Phase III clinical trial.
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