Is it true that India's Bharat Biotech is not too far away from finding a vaccine for COVID-19 as they have now been approved for human trials?
Is it true that India's Bharat Biotech is not too far away from finding a vaccine for COVID-19 as they have now been approved for human trials?
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At this time, it is unlikely that a vaccine for COVID-19 will be produced before 2021. The Indian Council of Medical Research, the primary body overseeing clinical research for COVID-19 in India, has pushed to fast-track clinical trials for the Bharat Biotech-developed drug COVAXIN, which is currently in Phase II trials. ICMR had initially announced an ambitious deadline of August 15th 2020 to launch the vaccine, which had been criticized by doctors and researchers as a rushed and impractical timeline that carries substantial risks. ICMR has clarified that the intention is to complete the trials as fast as possible and speed up recruitment of participants, but everything will depend on the results of the clinical trials. The timeline to develop a safe and effective vaccine is lengthy and requires several stages of clinical trials, as well as plenty of regulatory oversight. This process usually takes several months and can continue for more than a year. Even if pre-clinical data is promising, human clinical trials that are necessary to deploy a vaccine take place in stages that take a very long time, in order to assess efficacy and safety. The process typically takes well over 12 months to complete. Lots of testing happens in animals before a vaccine begins phased testing in humans. During the first stage of vaccine testing on humans (Phase I), a new vaccine is provided to small groups of people—which is the first time the vaccine is tested in humans. The second stage (Phase II) involves testing the vaccine on people who have similar characteristics (such as age and physical health) to the target population, which means the group for which the vaccine is intended. The goal of this stage is to identify the most effective dosages and schedule for Phase III trials. The final stage (Phase III) provides the vaccine to hundreds of people across several different healthcare settings from the target population to see how safe and effective it is. Once the vaccine clears this last stage, the manufacturer can apply for a license from regulatory authorities to market for human use.
At this time, it is unlikely that a vaccine for COVID-19 will be produced before 2021. The Indian Council of Medical Research, the primary body overseeing clinical research for COVID-19 in India, has pushed to fast-track clinical trials for the Bharat Biotech-developed drug COVAXIN, which is currently in Phase II trials. ICMR had initially announced an ambitious deadline of August 15th 2020 to launch the vaccine, which had been criticized by doctors and researchers as a rushed and impractical timeline that carries substantial risks. ICMR has clarified that the intention is to complete the trials as fast as possible and speed up recruitment of participants, but everything will depend on the results of the clinical trials. The timeline to develop a safe and effective vaccine is lengthy and requires several stages of clinical trials, as well as plenty of regulatory oversight. This process usually takes several months and can continue for more than a year. Even if pre-clinical data is promising, human clinical trials that are necessary to deploy a vaccine take place in stages that take a very long time, in order to assess efficacy and safety. The process typically takes well over 12 months to complete. Lots of testing happens in animals before a vaccine begins phased testing in humans. During the first stage of vaccine testing on humans (Phase I), a new vaccine is provided to small groups of people—which is the first time the vaccine is tested in humans. The second stage (Phase II) involves testing the vaccine on people who have similar characteristics (such as age and physical health) to the target population, which means the group for which the vaccine is intended. The goal of this stage is to identify the most effective dosages and schedule for Phase III trials. The final stage (Phase III) provides the vaccine to hundreds of people across several different healthcare settings from the target population to see how safe and effective it is. Once the vaccine clears this last stage, the manufacturer can apply for a license from regulatory authorities to market for human use.
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What our experts say
At this time, it is unlikely that a vaccine for COVID-19 will be produced before 2021. The Indian Council of Medical Research, the primary body overseeing clinical research for COVID-19 in India, has pushed to fast-track clinical trials for the Bharat Biotech-developed drug COVAXIN, which is currently in Phase II trials. ICMR had initially announced an ambitious deadline of August 15th 2020 to launch the vaccine, which had been criticized by doctors and researchers as a rushed and impractical timeline that carries substantial risks. ICMR has clarified that the intention is to complete the trials as fast as possible and speed up recruitment of participants, but everything will depend on the results of the clinical trials.
The timeline to develop a safe and effective vaccine is lengthy and requires several stages of clinical trials, as well as plenty of regulatory oversight. This process usually takes several months and can continue for more than a year.
Even if pre-clinical data is promising, human clinical trials that are necessary to deploy a vaccine take place in stages that take a very long time, in order to assess efficacy and safety. The process typically takes well over 12 months to complete.
Lots of testing happens in animals before a vaccine begins phased testing in humans. During the first stage of vaccine testing on humans (Phase I), a new vaccine is provided to small groups of people—which is the first time the vaccine is tested in humans. The second stage (Phase II) involves testing the vaccine on people who have similar characteristics (such as age and physical health) to the target population, which means the group for which the vaccine is intended. The goal of this stage is to identify the most effective dosages and schedule for Phase III trials. The final stage (Phase III) provides the vaccine to hundreds of people across several different healthcare settings from the target population to see how safe and effective it is. Once the vaccine clears this last stage, the manufacturer can apply for a license from regulatory authorities to market for human use.
At this time, it is unlikely that a vaccine for COVID-19 will be produced before 2021. The Indian Council of Medical Research, the primary body overseeing clinical research for COVID-19 in India, has pushed to fast-track clinical trials for the Bharat Biotech-developed drug COVAXIN, which is currently in Phase II trials. ICMR had initially announced an ambitious deadline of August 15th 2020 to launch the vaccine, which had been criticized by doctors and researchers as a rushed and impractical timeline that carries substantial risks. ICMR has clarified that the intention is to complete the trials as fast as possible and speed up recruitment of participants, but everything will depend on the results of the clinical trials.
The timeline to develop a safe and effective vaccine is lengthy and requires several stages of clinical trials, as well as plenty of regulatory oversight. This process usually takes several months and can continue for more than a year.
Even if pre-clinical data is promising, human clinical trials that are necessary to deploy a vaccine take place in stages that take a very long time, in order to assess efficacy and safety. The process typically takes well over 12 months to complete.
Lots of testing happens in animals before a vaccine begins phased testing in humans. During the first stage of vaccine testing on humans (Phase I), a new vaccine is provided to small groups of people—which is the first time the vaccine is tested in humans. The second stage (Phase II) involves testing the vaccine on people who have similar characteristics (such as age and physical health) to the target population, which means the group for which the vaccine is intended. The goal of this stage is to identify the most effective dosages and schedule for Phase III trials. The final stage (Phase III) provides the vaccine to hundreds of people across several different healthcare settings from the target population to see how safe and effective it is. Once the vaccine clears this last stage, the manufacturer can apply for a license from regulatory authorities to market for human use.
Context and background
Bharat Biotech International Limited is a Hyderabad-based pharmaceutical company that focuses primarily on manufacturing vaccines and bio-therapeutics. It has produced over 160 patents since starting operations in 1996. On June 29, 2020, Bharat Biotech announced that it received regulatory approval for Phase 1 and Phase 2 human clinical trials for COVAXIN, India’s first homegrown vaccine for SARS-CoV-2, from the Drug Controller General of India (DCGI) after submitting data from preclinical studies. The vaccine was developed in collaboration with the Indian Council of Medical Research (ICMR) and the National Institute of Virology (NIV). ICMR had initially announced an ambitious deadline of August 15th 2020 to launch the vaccine, which was criticized by doctors and researchers as a rushed and impractical timeline that carried substantial risks. The vaccine is currently in Phase II trials.
Bharat Biotech International Limited is a Hyderabad-based pharmaceutical company that focuses primarily on manufacturing vaccines and bio-therapeutics. It has produced over 160 patents since starting operations in 1996. On June 29, 2020, Bharat Biotech announced that it received regulatory approval for Phase 1 and Phase 2 human clinical trials for COVAXIN, India’s first homegrown vaccine for SARS-CoV-2, from the Drug Controller General of India (DCGI) after submitting data from preclinical studies. The vaccine was developed in collaboration with the Indian Council of Medical Research (ICMR) and the National Institute of Virology (NIV). ICMR had initially announced an ambitious deadline of August 15th 2020 to launch the vaccine, which was criticized by doctors and researchers as a rushed and impractical timeline that carried substantial risks. The vaccine is currently in Phase II trials.
Resources
- ICMR process to develop vaccine to fight Covid 19 pandemic as per globally accepted norms of fast tracking (ICMR)
- ICMR's Rush to Produce 'Indian Vaccine' for COVID-19 Suggests Politics is Driving Science (The Wire)
- 'We are working day and night': India races to have coronavirus vaccine by 15th August (Live Mint)
- ICMR process to develop vaccine to fight Covid 19 pandemic as per globally accepted norms of fast tracking (ICMR)
- ICMR's Rush to Produce 'Indian Vaccine' for COVID-19 Suggests Politics is Driving Science (The Wire)
- 'We are working day and night': India races to have coronavirus vaccine by 15th August (Live Mint)
