Bharat Biotech Phase 3 Trials

Dr Krishna Ella, Chairman and Managing Director of Bharat Biotech said that the clinical phase III trials of the COVID-19 nasal vaccine have been completed and the company will submit its data with Drugs Controller General of India next month.

The US Food and Drug Administration which has put on hold phase 2/ 3 clinical trials of Bharat Biotech's COVID-19 vaccine Covaxin, in USA, has lifted pause, according to a statement issued by Ocugen Inc, Bharat Biotech's partner for jab in US, Canada

Bharat Biotech has sought the Drug Controller General of India's approval to conduct phase-3 trials of its intranasal vaccine (BBV154) against Covid to be used as a booster dose, sources said on Monday.

Hyderabad-based Bharat Biotech has said that the results compare well with 65.2 per cent efficacy against Delta variant obtained during controlled phase 3 clinical trials of COVAXIN conducted among the general population.

Bharat Biotech has completed the Phase 2/3 trials of COVID-19 vaccine, Covaxin for use in children under 18 years of age and is expected to submit the data by next week to the DCGI, Chairman and Managing Director of Bharat Biotech, Krishna Ella said.

BBV154, developed by Bharat Biotech, is India's first intranasal vaccine to receive regulatory nod for late-stage clinical trials from the Biotechnology Industry Research Assistance Council's (BIRAC) under the Department of Biotechnology.

Bharat Biotech's Covaxin is overall 77.8 per cent effective "against symptomatic COVID-19", the vaccine maker said today in a statement, citing the data from the third phase of clinical trials. The data, however, is yet to be peer-reviewed.

Coronavirus: Bharat Biotech's Covaxin is 77.8 per cent effective in protecting against COVID-19 - according to results of Phase III trial data approved by the DCGI's Subject Expert Committee - sources said on Tuesday afternoon.

Bharat Biotech has submitted Phase III trial data for the Covaxin coronavirus vaccine to the DCGI (Drug Controller General of India), whose SEC (subject expert committee) is expected to meet later today - likely around noon.

Once the results of Covaxin's phase 3 trials are out in July, its manufacturers have scheduled a phase 4 trial to test the vaccines real-world effectiveness, Bharat Biotech said today.

Covaxin trials on children from two to 18 years were cleared by the Drugs Controller General of India (DCGI) today. This is the first time in India that a Covid vaccine will be tested on children.

Covaxin, India's first indigenous vaccine against COVID-19, showed enhanced immune response without any serious side effects in the Phase 1 trials, according to the results published in well-respected Lancet Infectious Disease journal on Friday.

Bharat Biotech has enrolled 25,800 volunteers for phase 3 clinical trials of its COVID-19 vaccine, the company said today. The maker of Covaxin is one of the two firms cleared by the government to deploy their product for mass inoculation in the country. The other is Oxford-AstraZeneca's Covishield manufactured by the Serum Institute of India.

Bharat Biotech has recruited 23,000 volunteers so far for the Phase III clinical trials of its COVID-19 vaccine candidate, ''Covaxin''.

The people of Mumbai have not shown the expected enthusiasm in participating in the phase 3 trials of Covaxin, a homegrown anti-Covid vaccine being developed by Bharat Biotech in collaboration with the Indian Council For Medical Research or ICMR, sources say.

Dr Krishna Ella, Chairman and Managing Director of Bharat Biotech said that the clinical phase III trials of the COVID-19 nasal vaccine have been completed and the company will submit its data with Drugs Controller General of India next month.

The US Food and Drug Administration which has put on hold phase 2/ 3 clinical trials of Bharat Biotech's COVID-19 vaccine Covaxin, in USA, has lifted pause, according to a statement issued by Ocugen Inc, Bharat Biotech's partner for jab in US, Canada

Bharat Biotech has sought the Drug Controller General of India's approval to conduct phase-3 trials of its intranasal vaccine (BBV154) against Covid to be used as a booster dose, sources said on Monday.

Hyderabad-based Bharat Biotech has said that the results compare well with 65.2 per cent efficacy against Delta variant obtained during controlled phase 3 clinical trials of COVAXIN conducted among the general population.

Bharat Biotech has completed the Phase 2/3 trials of COVID-19 vaccine, Covaxin for use in children under 18 years of age and is expected to submit the data by next week to the DCGI, Chairman and Managing Director of Bharat Biotech, Krishna Ella said.

BBV154, developed by Bharat Biotech, is India's first intranasal vaccine to receive regulatory nod for late-stage clinical trials from the Biotechnology Industry Research Assistance Council's (BIRAC) under the Department of Biotechnology.

Bharat Biotech's Covaxin is overall 77.8 per cent effective "against symptomatic COVID-19", the vaccine maker said today in a statement, citing the data from the third phase of clinical trials. The data, however, is yet to be peer-reviewed.

Coronavirus: Bharat Biotech's Covaxin is 77.8 per cent effective in protecting against COVID-19 - according to results of Phase III trial data approved by the DCGI's Subject Expert Committee - sources said on Tuesday afternoon.

Bharat Biotech has submitted Phase III trial data for the Covaxin coronavirus vaccine to the DCGI (Drug Controller General of India), whose SEC (subject expert committee) is expected to meet later today - likely around noon.

Once the results of Covaxin's phase 3 trials are out in July, its manufacturers have scheduled a phase 4 trial to test the vaccines real-world effectiveness, Bharat Biotech said today.

Covaxin trials on children from two to 18 years were cleared by the Drugs Controller General of India (DCGI) today. This is the first time in India that a Covid vaccine will be tested on children.

Covaxin, India's first indigenous vaccine against COVID-19, showed enhanced immune response without any serious side effects in the Phase 1 trials, according to the results published in well-respected Lancet Infectious Disease journal on Friday.

Bharat Biotech has enrolled 25,800 volunteers for phase 3 clinical trials of its COVID-19 vaccine, the company said today. The maker of Covaxin is one of the two firms cleared by the government to deploy their product for mass inoculation in the country. The other is Oxford-AstraZeneca's Covishield manufactured by the Serum Institute of India.

Bharat Biotech has recruited 23,000 volunteers so far for the Phase III clinical trials of its COVID-19 vaccine candidate, ''Covaxin''.

The people of Mumbai have not shown the expected enthusiasm in participating in the phase 3 trials of Covaxin, a homegrown anti-Covid vaccine being developed by Bharat Biotech in collaboration with the Indian Council For Medical Research or ICMR, sources say.