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Posted: Jul 03 2020 (19:08)
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Last Updated : Jul 03, 2020 04:07 PM IST @Viswanath Pilla @viswanath_pilla
Explained: How did Bharat Biotech emerge as dark horse in race for COVID-19 vaccine?
ICMR and Bharat Biotech are jointly working on the pre-clinical as well as clinical development of the vaccine.
The India Council of Medical Research (ICMR), the apex medical research body, on July 2 wrote to 12 leading medical...
more...
Explained: How did Bharat Biotech emerge as dark horse in race for COVID-19 vaccine?
ICMR and Bharat Biotech are jointly working on the pre-clinical as well as clinical development of the vaccine.
The India Council of Medical Research (ICMR), the apex medical research body, on July 2 wrote to 12 leading medical...
more...
institutions instructing them to fast-track clinical trials of Bharat Biotech's COVID-19 vaccine. The government has set a deadline of August 15 to launch the vaccine for public health use.
ICMR and Bharat Biotech are jointly working on the preclinical as well as clinical development of this vaccine.
"You have been chosen as clinical trial site of the BBV152 COVID Vaccine. In view of the public health emergency due to COVID-19 pandemic and urgency to launch the vaccine, you are strictly advised to fast track all approvals related to initiation of the clinical trial and ensure that the subject enrollment is initiated not later than July 7, 2020," ICMR Director-General Balram Bhargava said.
Bhargava warned that non-compliance will be viewed very seriously.
"Therefore, you are advised to treat this project on highest priority and meet the given timelines without a lapse," the letter added.
The 12 clinical trial sites include some of India's premier public institutions such as All India Institute of Medical Sciences (AIIMS-New Delhi), AIIMS-Patna, Nizam Institute of Medical Sciences (NIMS) - Hyderabad, Post Graduate Institute of Medical Sciences (PGIMS) - Rohtak, King George Hospital (KGH) - Visakhapatnam, among others.
This is the first indigenous vaccine being developed by India against COVID-19. As one of the top priority projects, the vaccine development programme is being monitored by the topmost level of the government. The vaccine is derived from a strain of SARS-CoV-2 isolated by ICMR-National Institute of Virology in Pune.
What is Bharat Biotech's role in COVID-19 vaccine development?
The National Institute of Virology, which is part of ICMR, had isolated the SARS-CoV-2 strain from a patient and transferred it to Bharat Biotech for developing it into a vaccine.
Bharat Biotech has grown the virus and inactivated it through a chemical process. The company started testing the vaccine on animals for safety and efficacy as part of pre-clinical studies. The company said it was able to accelerate the whole process of pre-clinical studies through expedited regulatory approvals. According to sources, ICMR had closely monitored the pre-clinical work.
The results from these studies have been promising and showed extensive safety and effective immune responses, the company claims. The data hasn't been published yet.
Bharat Biotech also announced early this week that it got the Drug Controller General of India's approval to test the vaccine on humans on Phase I and II human clinical trials. The clinical trial will be the responsibility of principal investigators appointed by the government and the protocols and data will be audited by independent agencies.
The company's primary role is to supply the vaccine for clinical trials and prepare to roll out billions of doses once the vaccine is approved for public use. The company said it has the capacity to supply enough vaccine doses to meet the country's demand.
Why did the government choose Bharat Biotech?
There are several Indian vaccine makers, but what made the government to chose Bharat Biotech as the partner is intriguing. ICMR has been working closely with Bharat Biotech for years. It had earlier partnered with Bharat Biotech for Rotavirus and H1N1 vaccines.
But that's not the only reason; what had prompted ICMR to choose Bharat Biotech could be that the vaccine would be manufactured at the firm's Bio-Safety Level-3 (BSL-3) containment facility located in Genome Valley in Hyderabad, say sources. Bharat Biotech had built India's biggest BSL-3 high-containment facility for manufacturing inactivated polio vaccine, which will now be used for COVID-19 vaccine. BSL-3 is appropriate for work involving microbes that can cause serious and potentially lethal diseases via the inhalation route.
Experts say that an inactivated vaccine involving live SARS-CoV-2 should be produced only in a BSL-3 containment facility due to a high risk of contamination or inadvertent release. Other vaccine companies too can approach ICMR for the strain, if they are interested in developing the vaccine.
Is the August 15 launch plan realistic?
In normal circumstances, it isn't possible. The pre-clinical studies alone take a minimum of six months. But in view of the public health emergency due to COVID-19 pandemic, the government is fast-tracking approvals related to clinical trials. In fact, ICMR's letter says the subject enrollment has to be initiated no later than July 7. But experts told Moneycontrol that it is a difficult deadline despite the government's strong backing.
Why the government is confident that the vaccine will work
Clinical trial data is a critical factor in determining whether a vaccine works or not. Though experts say that inactivated vaccine is the established approach, some doubts were raised in March about the safety and efficacy of inactivated whole virus vaccine. Inactivated vaccines used against SARS (Severe Acute Respiratory Syndrome) and MERS (Middle East Respiratory Syndromme) had led to poorly regulated inflammatory responses or cytokine storms where the immune system overreacts.
Many vaccine companies have been adopting other safer approaches such as live-attenuated vaccine (that uses live but weakened virus), DNA and RNA-based vaccines, recombinant virus subunits (portions) and vaccines based on vectors. An inactivated vaccine requires booster doses because they offer protection for only a limited period.
The data coming from animal and early human studies from Chinese vaccine companies Sinovac Biotech and Sinopharma that developed inactivated vaccines has been promising. Sinovac has tied up with Brazil's Instituto Butantan to run the vaccine’s phase 3. Brazil is the second-worst affected country with 1.5 million reported COVID-19 cases and close to 62,000 deaths. Maybe that data may have given the government confidence to fast-track the vaccine development programme.
ICMR and Bharat Biotech are jointly working on the preclinical as well as clinical development of this vaccine.
"You have been chosen as clinical trial site of the BBV152 COVID Vaccine. In view of the public health emergency due to COVID-19 pandemic and urgency to launch the vaccine, you are strictly advised to fast track all approvals related to initiation of the clinical trial and ensure that the subject enrollment is initiated not later than July 7, 2020," ICMR Director-General Balram Bhargava said.
Bhargava warned that non-compliance will be viewed very seriously.
"Therefore, you are advised to treat this project on highest priority and meet the given timelines without a lapse," the letter added.
The 12 clinical trial sites include some of India's premier public institutions such as All India Institute of Medical Sciences (AIIMS-New Delhi), AIIMS-Patna, Nizam Institute of Medical Sciences (NIMS) - Hyderabad, Post Graduate Institute of Medical Sciences (PGIMS) - Rohtak, King George Hospital (KGH) - Visakhapatnam, among others.
This is the first indigenous vaccine being developed by India against COVID-19. As one of the top priority projects, the vaccine development programme is being monitored by the topmost level of the government. The vaccine is derived from a strain of SARS-CoV-2 isolated by ICMR-National Institute of Virology in Pune.
What is Bharat Biotech's role in COVID-19 vaccine development?
The National Institute of Virology, which is part of ICMR, had isolated the SARS-CoV-2 strain from a patient and transferred it to Bharat Biotech for developing it into a vaccine.
Bharat Biotech has grown the virus and inactivated it through a chemical process. The company started testing the vaccine on animals for safety and efficacy as part of pre-clinical studies. The company said it was able to accelerate the whole process of pre-clinical studies through expedited regulatory approvals. According to sources, ICMR had closely monitored the pre-clinical work.
The results from these studies have been promising and showed extensive safety and effective immune responses, the company claims. The data hasn't been published yet.
Bharat Biotech also announced early this week that it got the Drug Controller General of India's approval to test the vaccine on humans on Phase I and II human clinical trials. The clinical trial will be the responsibility of principal investigators appointed by the government and the protocols and data will be audited by independent agencies.
The company's primary role is to supply the vaccine for clinical trials and prepare to roll out billions of doses once the vaccine is approved for public use. The company said it has the capacity to supply enough vaccine doses to meet the country's demand.
Why did the government choose Bharat Biotech?
There are several Indian vaccine makers, but what made the government to chose Bharat Biotech as the partner is intriguing. ICMR has been working closely with Bharat Biotech for years. It had earlier partnered with Bharat Biotech for Rotavirus and H1N1 vaccines.
But that's not the only reason; what had prompted ICMR to choose Bharat Biotech could be that the vaccine would be manufactured at the firm's Bio-Safety Level-3 (BSL-3) containment facility located in Genome Valley in Hyderabad, say sources. Bharat Biotech had built India's biggest BSL-3 high-containment facility for manufacturing inactivated polio vaccine, which will now be used for COVID-19 vaccine. BSL-3 is appropriate for work involving microbes that can cause serious and potentially lethal diseases via the inhalation route.
Experts say that an inactivated vaccine involving live SARS-CoV-2 should be produced only in a BSL-3 containment facility due to a high risk of contamination or inadvertent release. Other vaccine companies too can approach ICMR for the strain, if they are interested in developing the vaccine.
Is the August 15 launch plan realistic?
In normal circumstances, it isn't possible. The pre-clinical studies alone take a minimum of six months. But in view of the public health emergency due to COVID-19 pandemic, the government is fast-tracking approvals related to clinical trials. In fact, ICMR's letter says the subject enrollment has to be initiated no later than July 7. But experts told Moneycontrol that it is a difficult deadline despite the government's strong backing.
Why the government is confident that the vaccine will work
Clinical trial data is a critical factor in determining whether a vaccine works or not. Though experts say that inactivated vaccine is the established approach, some doubts were raised in March about the safety and efficacy of inactivated whole virus vaccine. Inactivated vaccines used against SARS (Severe Acute Respiratory Syndrome) and MERS (Middle East Respiratory Syndromme) had led to poorly regulated inflammatory responses or cytokine storms where the immune system overreacts.
Many vaccine companies have been adopting other safer approaches such as live-attenuated vaccine (that uses live but weakened virus), DNA and RNA-based vaccines, recombinant virus subunits (portions) and vaccines based on vectors. An inactivated vaccine requires booster doses because they offer protection for only a limited period.
The data coming from animal and early human studies from Chinese vaccine companies Sinovac Biotech and Sinopharma that developed inactivated vaccines has been promising. Sinovac has tied up with Brazil's Instituto Butantan to run the vaccine’s phase 3. Brazil is the second-worst affected country with 1.5 million reported COVID-19 cases and close to 62,000 deaths. Maybe that data may have given the government confidence to fast-track the vaccine development programme.
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