Bharat Biotech’s Covid vaccine 1st in India to get approval for human trials

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Permission was granted after the firm submitted results from pre-clinical studies of the vaccine that demonstrated its safety and immune response, said Bharat Biotech.
The country’s top drug regulator, Central Drugs Standard Control Organisation, has granted approval to Bharat Biotech India to conduct human clinical trials for ‘Covaxin’, making it the first indigenous Covid-19 vaccine candidate to receive this approval, the firm said Monday. These trials are scheduled to start across India in July.


Drug Controller General of India Dr V G Somani approved Bharat Biotech’s application to conduct phase I and II clinical trials for Covaxin, it stated in a release.


The permission was granted after the company submitted results from pre-clinical studies of the vaccine that demonstrated its safety and immune response, said Bharat Biotech in its release. The vaccine was developed in collaboration with Indian Council of Medical Research’s National Institute of Virology.

“The collaboration with ICMR and NIV was instrumental in the development of this vaccine. The proactive support and guidance from CDSCO have enabled approvals to this project,” stated Bharat Biotech chairman and managing director Dr Krishna Ella.

Other Indian firms engaged in the development of Covid-19 vaccines include Zydus Cadila, Serum Institute of India and, since the beginning of this month, Panacea Biotec. While Panacea is still in the pre-clinical stage, it is not clear whether Zydus and Serum have completed their preclinical studies and have also applied to the Central Drugs Standard Control Organisation for approval to conduct human trials yet. Queries sent on Monday night to Zydus and Serum about the status of their vaccine candidates remained unanswered by press time.


Calls to DCGI Somani remained unanswered as well.
 

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Bharat Biotech has passed mandated protocols, animal testing and is now in clinical development of Covid vaccine, Dr Krishna Ella tells Firstpost
Hyderabad-based Bharat Biotech, one of seven Indian companies involved in the indigenous production of a vaccine for the novel coronavirus, received the green signal from the Central Drugs Standard Control Organisation (CDSCO) to begin human trials of 'Covaxin' last week.

Bharat Biotech chairman and managing director Dr Krishna Ella on Friday said that the company, which is the first Indian firm to have received approval to begin human trials of its COVID-19 vaccine candidate, had developed the first version of the vaccine within 40 days, after which the pre-clinical trials began.


Hyderabad-based Bharat Biotech, which is one of seven Indian companies involved in the indigenous production of a vaccine for the novel coronavirus, received the green signal from the Central Drugs Standard Control Organisation (CDSCO) to begin human trials of 'Covaxin' last week.


Phase 1 and 2 clinical trials of Covaxin in COVID-19 patients will begin this month. The vaccine candidate was developed in collaboration with the Indian Council of Medical Research (ICMR) and the National Institute of Virology (NIV) in Pune.


The ICMR has selected 12 institutes across the country to carry out clinical trials of Covaxin and on Friday, urged the chosen clinical trial sites to expedite approvals and complete recruiting for the trails by 7 July, as per an internal letter from ICMR to the institutions.


The letter also reportedly said that Covaxin should be "launched for public use" by 15 August, however, Bharat Biotech spokespersons refused to comment on the statement.

The letter by ICMR director general Balram Bhargava read, "It is envisaged to launch the vaccine for public health use latest by 15th August 2020 after completion of all clinical trials. BBIL (Bharat Biotech International Limited) is working expeditiously to meet the target, however, final outcome will depend on the cooperation of all clinical trial sites involved in this project."


Covaxin has been expedited through national regulatory protocols, and subjected to "comprehensive pre-clinical studies" according to the company, which reports that the results are "promising" and "show extensive safety and effective immune responses".


In the past, Bharat Biotech has manufactured the H1N1 vaccine during the swine flu outbreak and has over 140 global patents and 16 vaccines in its portfolio. The most significant of their developments is arguably the rotavirus vaccine Rotavac, a next-gen vaccine against viral gastroenteritis that got pre-approval from the WHO after an Oxford laboratory found it safe and efficacious.

Firstpost spoke to Dr Ella about the development of Covaxin, the estimated cost, and the future course of action regarding the vaccine. Edited excerpts follow:


What was the process of development of the vaccine, what were the various stages before Bharat Biotech approached CDSCO for approval for human trials?



The virus strain was first isolated by the National Institute of Virology, Pune after it was collected by ICMR. This isolated strain was then used to develop a vaccine candidate at Bharat Biotech.


Upon receipt of the virus strain from the NIV Pune, Bharat Biotech was able to quickly layout the GMP (good manufacturing practices) protocols for the manufacture of the vaccine candidate. Bharat Biotech took to develop the first set of GMP batches within 40 days and upon completion, the pre-clinical trials commenced.

COVAXIN™ was evaluated in animals on Schedule Y Guidelines (Schedule Y defines the clinical trials as the requirements and guidelines for import and manufacture of new drugs for sale or for clinical trials. It describes the details of the application process for conducting clinical trials; responsibilities of the sponsor, investigators and the guidelines of India's Independent Ethics Committee) and the World Health Organisation.


COVAXIN™ was reported to be safe and immunogenic in all animals. We have now moved forward towards the clinical development of this vaccine.


What does the vaccine contain?


COVAXIN™ is an inactivated vaccine developed on a Vero-cell platform. Inactivated vaccines have a well-proven and accepted track record.

What are you expecting the vaccine to do based on your clinical trials so far? What are some of the key findings of the vaccine from your trials?


Upon receipt of the virus strain from the NIV Pune, Bharat Biotech was able to quickly layout the GMP protocols for the manufacture of the vaccine candidate. Bharat Biotech took to develop the first set of GMP batches within 40 days and upon completion, the pre-clinical trials commenced. COVAXIN™ was evaluated in animals on Schedule Y Guidelines from India and WHO Guidelines. COVAXIN™ was reported to be safe and immunogenic in all animals. We have now moved forward towards the clinical development of this vaccine.


Is it likely to be more effective in some people than others? How long is the vaccine likely to be effective?


Conventionally, inactivated vaccines have been around for decades. Numerous vaccines such as seasonal influenza, polio, pertussis, rabies, and Japanese Encephalitis use the same technology to develop inactivated vaccines. Once the vaccine is injected into a human, it has no potential to infect or replicate, since it is a killed virus. It just serves the immune system as a dead virus and mounts an antibody response towards the virus.

Which authority might be likely to decide the cost of the vaccine? If it's Bharat Biotech, what is the estimated cost?


As a socially inclined organisation and a company that is focussed on public health, we endeavour to deliver world-class vaccines at affordable prices. We have done this earlier and we hope to achieve the same even for COVAXIN™. We must say that it is too early to make any statement regarding the price.

 

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India’s Covid-19 vaccines ready for human trials: All you need to know about Covaxin and ZyCoV-D
Bharat Biotech International Ltd and Zydus Cadila have got an approval from the Drugs Controller General of India (DCGI) for human clinical trials for their indigenously developed vaccine candidates against Sars-Cov-2, the virus which causes the coronavirus disease.

The drug regulator’s approval for Zydus’ ZyCoV-D comes days after Bharat Biotech got a similar nod for human trials for its vaccine candidate as the coronavirus infections continue to surge in the world’s fourth worst-hit country.

Bharat Biotech is among seven Indian firms working on Covid-19 vaccines. It was the first to get the regulatory nod to begin phase 1 and phase 2 human trials.

More than a dozen Covid-19 vaccines from over 100 candidates globally are currently being tested in humans, and some have shown potential in early-stage trials. However, no vaccine has yet been approved for commercial use.

The number of cases of the coronavirus disease in India is more than 625,000 and the country’s death toll is above 18,000.


Here what you need to know about the two vaccine candidates:

* Bharat Biotech had claimed on Monday to have successfully developed India’s first Covid-19 vaccine, Covaxin, and said it has the permission from the drug controller to start human clinical trials.

* The Hyderabad-based biotechnology giant has said that the human clinical trials of its vaccine against the coronavirus disease (Covid-19) will start from July.


* The company said the vaccine was developed in collaboration with the Indian Council of Medical Research (ICMR) and National Institute of Virology (NIV).

The strains of Sars-CoV-2 that causes Covid-19 was isolated by ICMR-NIV and transferred to Bharat Biotech in May. Scientists have managed to isolate and culture 11 strains that can be used to develop vaccines and aid research.

* Bharat Biotech completed comprehensive pre-clinical studies in two months after receiving regulatory approvals. It said results from these studies have been promising and show extensive safety and effective immune responses.


* On Friday, Indian Council of Medical Research (ICMR) said that it is attempting to launch the world’s first Covid-19 vaccine on August 15.

* The plan was disclosed in a letter by the country’s topmost medical research body to 12 institutes where human trials are to be held for Covaxin, ordering them to secure necessary approvals from internal committees by July 7 with a warning that “non-compliance will be viewed very seriously”.

Zydus said on Friday that its potential vaccine showed a “strong immune response” in animal studies and the antibodies produced were able to completely neutralize the wild type virus.


* “In animal studies the vaccine was found to elicit a strong immune response in multiple animal species like mice, rats, guinea pigs and rabbits. The antibodies produced by the vaccine were able to completely neutralize the wild type virus in virus neutralization assay indicating the protective potential of the vaccine candidate,” Zydus, part of Cadila Healthcare Ltd, said in a statement to stock exchanges.

* The company said it will begin human trials this month in more than 1,000 subjects in multiple sites in India. It also plans to ramp up its production capacity for the vaccine contender to serve Indian and global demand, it added.

It said there were no safety concerns for the vaccine candidate in repeat-dose toxicology studies. In rabbits, up to three times the intended human dose was found to be safe, well-tolerated and immunogenic.

* It intends to rapidly ramp up the production capacities of ZyCoV-D at “multiple sites and facilities to cater to Indian and global demand.”
 

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ICMR sets August 15 deadline for world’s 1st Covid-19 vaccine
India’s topmost medical research body ICMR said on Friday that it is attempting to launch the world’s first Covid-19 vaccine on August 15, triggering disbelief among scientists who say the process requires painstaking trials and analysis and cannot reliably be completed in the six weeks that remain for the deadline.

The plan was disclosed in a letter by the Indian Council of Medical Research to 12 institutes where human trials are to be held for the vaccine, Covaxin, ordering them to secure necessary approvals from internal committees by July 7 with a warning that “non-compliance will be viewed very seriously”.

The vaccine has been jointly developed by ICMR and Hyderabad-based Bharat Biotech (BBIL), with the latter itself previously indicating that a vaccine could take more time. In an interview to The New Indian Express on Wednesday, Bharat Biotech chairman and managing director Krishna Ella said that if clinical trials of Covaxin met safety and efficacy standards, the vaccine could be available for mass use by early 2021.

But ICMR has other plans as evident in the do-or-die tone of its letter.

“It is envisaged to launch the vaccine for public health use latest by 15th August 2020 after completion of all clinical trials. BBIL is working expeditiously to meet the target, however final outcome will depend on the cooperation of all clinical trial sites involved in this project,” said the letter signed by Balram Bhargava, the director-general of ICMR.

Clinical trials include a clutch of tightly monitored inoculation among sets of volunteers to test whether a vaccine is safe and works – a process that on average has taken over 10 years. In a pandemic, this timeline can be compressed, but most experts believe that is still likely to take 12-18 months – making India’s plans on Covaxin scientifically implausible.


“I would have understood if the company had made such claims but DG-ICMR making this unscientific claim doesn’t make sense. Anyone who has even basic knowledge of how clinical trials work, would know this is completely unscientific,” said an official at one of the institutes selected for the process, asking not to be named.


Criticised for setting an unreasonable deadline that would affect safety, efficacy and quality, ICMR later suggested that it was only making an effort to put out trial data by August 15. “Request has been made to fast track the vaccine trials,” said Dr Rajnikant Srivastava, spokesperson, ICMR, in a text message. No order was issued.


Experts pointed out that even this objective seemed improbable for the August 15 deadline.

“Developing an effective vaccine is a time-consuming process. Recruitment of participants in itself can take months even if we try to expedite everything like we are doing for Covid-19. Each of the phases — one, two and three — should take at least a few months as it is not just one centre but multiple centres that are involved in conducting trials to determine safety and efficacy of a vaccine,” said Anant Bhan, a researcher in bioethics and global health.

“In one month, it is possible to determine immediate safety, tolerability and immunogenicity of a candidate vaccine. This is sufficient to determine whether the approach has some promise or not. However, promising at this stage means just that, not effectiveness in preventing infections,” said Dr Anurag Agrawal, director, CSIR- Institute of Genomics and Integrative Biology, Delhi.

Covaxin is yet to enter the clinical trials phase, a stage that 18 vaccine candidates across the world have already raced to. The earliest any of these expect to determine safety and efficacy is not until second quarter of next year.

ICMR’s position also surprised experts because data about the vaccine’s preclinical performance has not been made public yet. “It is very ambitious and probably unprecedented. You can’t rush science. It is one thing to do something and another to do it properly. It is not possible to do it properly in such a short span of time,” Bhan said.


One expert said while it usually takes four to five years, human trials can be finished in a year in the case of Covid-19. “Normally for phase 1, 2 and 3 human trials, it takes about four to five years, but this is an unprecedented situation where everyone is talking Covid so the process can be finished in about a year,” said Dr NK Mehra, ICMR chair and former head, transplants immunology and immunogenetics department, All India Institute of Medical Sciences (AIIIMS).

Another doctor at AIIMS, which is one of the institutes were the trials will be held, said: “We are waiting for the ethics committee clearance and unless I get that I cannot comment on that. I don’t know how much time it will takefor the approvals; could be 15 days or probably a month. I can’t say,” said Dr Sanjay Rai, professor, community medicine department, and one of the trial conductors.

Bharat Biotech is among seven Indian firms working on Covid-19 vaccines. It was the first to get the regulatory nod to begin phase 1 and phase 2 human trials on Monday.

A Bharat Biotech spokesperson declined to comment on the letter, but said pre-clinical studies of the vaccine showed “extensive safety and effective immune responses”..

The Sars-CoV-2 strain that causes Covid-19 was isolated in ICMR-National Institute of Virology (NIV), Pune, and transferred to Bharat Biotech on May 9.
 

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All about Bharat Biotech’s Covaxin, India’s first indigenous Covid vaccine candidate

New Delhi: India’s ‘first’ indigenous Covid-19 vaccine Covaxin, developed by Hyderabad-based vaccine manufacturer Bharat Biotech in collaboration with the Indian Council of Medical Research (ICMR), is all set to begin human clinical trials.


The Central Drugs Standard Control Organisation (CDSCO) had granted the company permission to initiate Phase I and II human clinical trials on 29 June, after it submitted results generated from pre-clinical studies, demonstrating the vaccine’s safety and immune response to the infection.


Recently, ICMR Director-General Dr Balram Bhargava also wrote to the principle investigators in the Covaxin trial asking for the vaccine to be launched by 15 August, triggering a massive controversy about how the timeline would be shrunk. Earlier, the company had submitted that the trials will be conducted over 15 months.



As Covaxin gears up for human trials, here are some details about the vaccine and how it works.

An ‘inactivated’ vaccine

Vaccines can broadly be categorised into two types — inactivated and live vaccines.



Bharat Biotech’s Covaxin vaccine falls under the category of inactivated vaccines.


In such vaccines, the pathogen is ‘deactivated’ so that it can no longer cause infection. However, parts of the virus can still be identified by the body’s immune system and can trigger an immune reaction.



Hepatitis A, influenza, and polio vaccines used in India are some examples of inactivated vaccines.


Conversely, live attenuated vaccines carry a live but extremely weakened pathogen which cannot cause the disease, such as the measles or the Bacillus Calmette–Guérin vaccine, used primarily against tuberculosis.


Inactivated vaccines are not as powerful as live ones and typically require booster shots. However, the inactive pathogen cannot replicate in the vaccinated person, making it safer for people with an impaired immune system response.


Once the vaccine is administered, the body produces antibodies that can fight off the novel coronavirus infection.

Influenza vaccine — first successful inactivated vaccine

The first inactivated vaccines were developed by Daniel Elmer Salmon and Theobald Smith in the US and the Pasteur Institute group in France. Inactivation was first applied to pathogens such as typhoid, plague, and cholera bacilli.



The first successful inactivated vaccine was developed for influenza in the 1930s.


An inactivated vaccine, also referred to as killed vaccines, can either carry the entire killed pathogen, such as the rabies or influenza vaccines, or be a subunit vaccine, which contains parts of a pathogen which successfully triggers immune reaction in the body.


Hepatitis B and Human papillomavirus (HPV) vaccines are subunit vaccines.


However, it is unclear which category the Covaxin vaccine falls under.


Furthermore, since most Covid vaccines under development use the spike protein of the virus to trigger the production of antibodies, Covaxin is also expected to do the same.


The spike protein of SARS-CoV-2 helps the virus latch onto and infect human cells.


To develop the vaccine, scientists at Bharat Biotech have used a SARS-CoV-2 strain that was isolated at the National Institute of Virology in Pune.
 

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COVAXIN: Human trials of India’s first coronavirus vaccine on 1,100 people to begin soon
India's first coronavirus vaccine COVAXIN, by Hyderabad-based Bharat Biotech, is expected to begin human trials of its candidate by next week. COVAXIN, which is India’s first indigenous vaccine against the novel coronavirus (COVID-19)

India's first coronavirus vaccine COVAXIN, by Hyderabad-based Bharat Biotech, is expected to begin human trials of its candidate by next week. COVAXIN, which is India’s first indigenous vaccine against the novel coronavirus (COVID-19) and has been developed by Bharat Biotech in collaboration with ICMR and NIV, Pune. COVAXIN will be tested on more than 1,100 people in phase 1 and 2 clinical trials, in which more than 1,100 people are expected to be enrolled


Last week, the inactivated coronavirus vaccine received DCGI approval for phase 1 and 2 clinical trials. COVAXIN is derived from a strain of SARS-CoV-2 virus isolated in NIV, Pune, and transferred to Bharat Biotech to develop into a vaccine candidate.






In phase 1, Bharat Biotech plans to enrol 375 people for the clinical trials scheduled that are scheduled to start next week and 750 people will enrol in the second phase. The company has set July 13 as the final date of enrollment for the trials. The company said COVAXIN has demonstrated safety and immune response in preclinical studies.


In phase 1, they will be split into three groups of 125 and be administered two doses - one each of the candidate and control vaccine - 14 days apart. Pending satisfactory completion of Phase I, a further 750 participants will be registered for Phase II of the clinical trials.


According to the application made by Hyderabad-based Bharat Biotech, the timeframe for Phase I is 28 days, which means the trial must start by July 18 to meet the government's promise of releasing a vaccine by August 15. However, the August 15 target was criticised by experts who said that fast-tracking vaccine trials in four weeks could pose serious health risks.
 

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COVAXIN trial: Can India really get a COVID-19 vaccine by Aug 15? Here’s how vaccines are approved

Key Highlights
  • COVAXIN has become the first vaccine candidate developed in India to receive the DCGI nod to conduct phase 1 and 2 clinical trials

  • The ICMR’s August 15 deadline for the India’s first indigenous coronavirus vaccine has created confusion among experts

  • Can we really have a COVID-19 vaccine by August 15? An expert explains how vaccines are approved
New Delhi: A safe and effective vaccine is the best way to control and finally end the COVID-19 pandemic, caused by the novel coronavirus. With more than 200 candidates being developed across the world, vaccine development is moving at unprecedented speed. Joining the global race to create a safe vaccine against the SARS-CoV-2 virus, Indian researchers will soon start testing the country’s first indigenous coronavirus vaccine candidate, COVAXIN, on 1,100 people in two phases - phase 1 and 2 clinical trials. Developed by Bharat Biotech in partnership with Indian Council Medical Research (ICMR) - National Institute of Virology (NIV), the experimental inactivated vaccine is derived from a strain of SARS-COV-2 virus isolated by ICMR-NIV, Pune. COVAXIN has demonstrated safety and immune response in preclinical studies.


The world urgently needs a COVID-19 vaccine, which will help prevent and reduce the risk of infection, as well as resultant complications. However, there’s also a growing momentum of skeptics raising doubts about future vaccine programmes against other infectious diseases - with safety being a major concern. As COVID-19 continues to spread, pathways of vaccine development are changing in ways as researchers race against time to create a safe jab by shortening process time from the usual 15- to 20-year timeline to one that might be as short as one year. Perhaps, the ICMR’s 40-day target to launch Bharat Biotech’s COVID-19 vaccine by August 15 has caused alarm among scientists and some in the medical fraternity. While the research body has clarified that the date was ‘not a deadline’, several experts have warned against any hasty solution that may compromise standards of scientific rigour.


But, can we really get a vaccine by Independence Day? In this regard, Times Now Digital talked to Dr Inder Maurya, Consultant - Emergency Medicine - CEO and Founder, Foreign OPD, who also tells us how vaccines are approved by regulators if trials succeed, and by when we can expect a vaccine for COVID-19.

Salome Phelamei: On 2nd July 2020, ICMR DG Balram Bhargava had written a letter to 12 institutes chosen for conducting human trials for Covaxin, saying it is envisaged to launch the vaccine for public use latest by 15th August 2020 after completion of all clinical trials. What’s your thought on this?


Dr Inder Maurya:
Ideally, the ICMR should not have jumped the gun and it was quickly panned by scientists. Experts familiar with vaccine trials, including the AIIMS Director, New Delhi, have already said that such deadlines may not be met, given the vaccine is yet to undergo the phase 2/ 3 trials and still there are a few more stages to go through before it could get FDA regulatory approval for production, which in itself is a time-consuming task.


Salome Phelamei: When do you think India will get a vaccine for COVID-19?


Dr Inder Maurya:
Currently, we have almost 254 therapies and 95 vaccines related to Covid-19 being explored globally. Having said that, less than 10 per cent is in the approval rate by the FDA. So, even if clinical trials vaccine is in accelerated mode all the world ( multi-centric trials), the whole process of vaccine approval by FDA to vaccine production and coming to market for effective distribution will not be before August 2021.

Perhaps, I think therapeutic drugs, rather than vaccines, might be the real ‘game changers’. Remdesivir has shown very promising signs in vivo and in vitro, and it is already in phase 3 trials. So if the drugs work at an optimal level, it will bring down the hospital admission rates, thereby reducing the burden on healthcare system. It will also narrow down the window period, so a few people can catch the virus.


Salome Phelamei: How long does it take for a vaccine to be approved, if trials succeed?


Dr Inder Maurya:
The general stages of the development cycle of a new vaccine are as follows:


  • Exploratory stage
  • Pre-clinical stage
  • Clinical development
  • Regulatory review and approval
  • Manufacturing

In Phase 1, normal people of a small sample size receive the vaccine and the failure rate is abut 37 per cent.


In Phase 2, hundreds of healthy volunteers get tested for immunogenic and adverse effects. Here, the failure rate is about 69 per cent.


In Phase 3, the scientists continue to monitor toxicity, immunogenicity, and severe adverse events (SAEs) on a much larger scale, and in here in all probability, the failure rate is 42 per cent.

The vaccine then is sent for approval and licensing. Upon approval by the FDA, the safety, efficacy and production of the vaccine continue to be closely monitored. At this stage, the failure rate could be 15 per cent only. Many vaccines undergo phase 4 ongoing studies after the vaccine is approved and licensed to check for post-marketing adverse effects and complications.


The timeline normally takes about 2 to 10 years till the vaccine is in the market, so we are conventionally looking at 2036! Chickenpox vaccine took 28 years and Rotavirus vaccine which causes millions of pediatric death in Afro- Asian countries particularly India, due to diarrhoeal illness took 15 years for development.


Right now we are in a situation, where desperate time needs desperate measures - and at the fastest speed, it takes 12 to 18 months. Post-approval by the FDA, it should take around 1 - 1.5 years for the massive production of billions of vaccine doses.


Hence, on the safer side, it looks like August 2021 for a viable COVID vaccine to enter the market.
 

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Covaxin trials: Vaccine checks under way, hospitals await nod
Coronavirus (Covid-19) vaccine Covaxin: The Clinical Trials Registry of India on Monday showed that the date of first enrollment for the vaccine is now set at July 13, while the phase I and II trials are estimated to take one year and three months.

While 12 hospitals chosen to conduct clinical trials of Bharat Biotech’s Covaxin prepare to enrol participants this month, samples of the vaccine are still undergoing quality and safety tests at a government facility, The Indian Express has learnt.


The tests, which began last Friday, are expected to be completed by the end of next week and cannot be rushed as they are expected to ensure the vaccines are safe to use in humans, said senior officials.

Meanwhile, at least three of the hospitals – AIIMS in Delhi, SRM Hospital and Research Centre in Kancheepuram and King George Hospital in Vishakhapatnam — are learnt to still be awaiting ethics committee approvals to begin enrolling participants for the study. Other hospitals are awaiting site initiation visits and clearances to ensure their facilities are ready to conduct these trials.

Depending on the hospital, enrollment of participants is expected to begin between this week and the next, but the testing can only start once they receive stock of the vaccine. This will happen once Bharat Biotech receives a clearance from the Central Drugs Laboratory in Kasauli to use its vaccines in the trials.

“We have several volunteers. But paperwork on the government’s end is pending. The sponsor (Bharat Biotech) has not yet sent vaccines,” said Dr Savita Verma from PGIMS, Rohtak, one of the 12 sites.


PGIMS has started the process of short-listing volunteers for trial. Once the site initiation letter (to initiate trial) is received, they will begin collecting blood and urine samples of each prospective participant and send it to a central laboratory to assess whether the candidate is eligible for trial.


The delivery of the vaccine will depend on biosafety and bio sterility tests conducted at CDL Kasauli, said a senior government official. For this specific vaccine, the tests to check whether it is safe to inject in participants will take 14 days as per Indian and international protocols.


Such tests cannot be sped up. They (the tests) are checking for the safety of the vaccine,” said the official. “This is necessary to make sure that no harm is caused to the patients during the trials.”


Following a clearance certificate, it may take a few days to ship the vaccines from Bharat Biotech’s facility to all trial sites. Investigators and officials expect the first phase of the study to begin in two week as a result.


One of the hospitals seeking ethics committee approvals told The Indian Express that the process for these approvals was taking time as the committee was being thorough to ensure no harm to the participants. “This is a stringent process, but it has to be this way. This is a trial on humans,” said the investigator.

The Clinical Trials Registry of India on Monday showed that the date of first enrollment for the vaccine is now set at July 13, while the phase I and II trials are estimated to take one year and three months. According to the protocol on the registry, the first phase alone will at least take a month, after which interim data will have to be submitted to the Drug Controller General of India before proceeding to the next stage.


Some investigators have said they are not under pressure to rush the trials for the sake of a faster launch date. Last week, the Indian Council of Medical Research (ICMR) had faced flak from the scientific community for seeking completion of “all” trials by August 15, adding that it was envisaged to launch the vaccine for public health use no later than that date. However, ICMR had later clarified that it was only seeking to fast-track clearances and cut red-tapism.

“I believe by the middle of the third week of this month, we will be able to start. Everything is going as per our expectations,” said Dr Sanjay Rai of AIIMS in Delhi. “You cannot do phase I and II together. Phase I is the safety trial. First, you have to establish the safety of the vaccine among the human population. We will move as per our protocol, based on the ethics committee’s approval.”


“On Tuesday our advertisement will come in regional newspapers to look for volunteers. But even if we speed up the process, it is not possible to produce results on safety by August 15,” said Dr Chandramani Singh, from AIIMS Patna.


Dr Amit Bhate from Jeevan Rekha hospital in Belgaum, that has been part of other trials for Bharat Biotech, said they would recruit around 50 participants in phase I. “Our job is to enroll, test and give data. But we cannot hurry into it. We cannot work under pressure. Humans are involved in this trial. The results can get delayed if patients don’t show up on assigned date or data collection is slow,” Bhate said.


In Redkar Hospital and Research centre, Goa, Dr Dhananjay Lad also said that enrolment can only begin after a few days. “Each participant has to be tested for Covid-19. We will be able to start enrollment by next week, not before.”

“Initially, we will be putting up 375 patients for phase I (across all sites)… The (results of the) initial 50 across the country will be subjected to a DSMB review–Data Safety and Monitoring Board. They will review and tell us whether it is okay to go ahead. If there are no issues, then we will continue the recruitment,” said Dr E Venkata Rao, who is the principal investigator from Bhubhaneshwar’s Institute of Medical Sciences & SUM Hospital.


In Prakhar hospital, an official said they have started reaching out to social workers to look for eligible candidates. “But unless vaccines come, we cannot proceed,” the official said.


Dr Satyajit Mohapatra from SRM Hospital and Research Centre in Kancheepuram said they are yet to get approval from the ethics committee to start the trial. “It’s a process and it will take time. Once approvals come, we will start the process of shortlisting and screening candidates.”


Dr Prabhakar Reddy from Nizam’s Institute of Medical Sciences said they are fast-tracking the whole process to help the government achieve early results. “Either today or tomorrow ethics committee approval should come. We are trying our best to speed up everything.”

“Whoever does whatever in the race, we should make sure that we always have things of quality in compliance with guidelines and regulations. That is going to be because patient safety is of paramount importance. There is a need for speed, no doubt. But our quality and scrutiny for science should be (upheld) in what we do,” said Dr Chirag Trivedi, president, Indian Society of Clinical Research.
 

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COVID-19 vaccine not possible before 2021: Parliamentary panel informed
A parliamentary panel informed on Friday that a COVID-19 vaccine could be expected by early next year.


The House of Parliamentary Standing Committee on Science and Technology, Environment and Climate heard presentations by the Department of Science and Technology, Department of Biotechnology, Council of Scientific and Industrial Research (CSIR) and the principal scientific adviser to the government on Centre's preparedness for COVID-19.


This was the first meeting of the panel ever since the lockdown was imposed in the country on March 25.



Sources stated that the panel was informed that the coronavirus vaccine could not be produced this year. The vaccine will be made available to the general public by early 2021.


Senior Congress leader Jairam Ramesh chaired the panel. There were six other members present at the meeting.


However, Ramesh argued that these meetings should be held virtually, urging Rajya Sabha Chairman M Venkaiah Naidu to do the same.



Taking to Twitter Ramesh said, "I would still request you Sir to allow virtual meetings given that Parliament is unlikely to meet for the next month at least."

"Our Parliamentary Standing Committee is having a most informative and useful meeting with @DBTIndia @IndiaDST @CSIR_IND & @PrinSciAdvGoI on the issue of Science & Technology & COVID-19. Too bad we are not allowed to have virtual meetings so that more MPs could have participated," he added.


In a bid to put clinical trials of the indigenous COVID-19 vaccine in top gear, the Indian Council of Medical Research (ICMR) had joined hands with Bharat Biotech International Limited (BBIL).



In an official statement, ICMR Director General Balram Bhargava said that ICMR aims to launch the indigenous COVID-19 vaccine by August 15.


Drug Controller General of India CDSCO (The Central Drugs Standard Control Organization) has already given approval for a human clinical trial of two Indian COVID-19 vaccines - COVAXIN and ZyCov-D.


India's COVID-19 case tally crossed the 8 lakh mark with 519 deaths and highest single-day spike of 27,114 new cases in the last 24 hours. Total positive cases stand at 8,20,916 including 2,83,407 active cases, 5,15,386 cured/discharged/migrated, and 22,123 deaths.
 

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COVAXIN: Patna AIIMS to start human trial of coronavirus vaccine from today
The All India Institute of Medical Science (AIIMS), Patna, will start the human trial of coronavirus vaccine-COVAXIN from today (July 13, 2020). COVAXIN, developed by Bharat Biotech in collaboration with ICMR - NIV, is India's first COVID-19 vaccine.The All India Institute of Medical Science (AIIMS), Patna, will start the human trial of coronavirus vaccine-COVAXIN from today (July 13, 2020). COVAXIN, developed by Bharat Biotech in collaboration with ICMR - NIV, is India's first COVID-19 vaccine.

The All India Institute of Medical Science (AIIMS), Patna, will start the human trial of coronavirus vaccine-COVAXIN from today (July 13, 2020). COVAXIN, developed by Bharat Biotech in collaboration with ICMR - NIV, is India's first COVID-19 vaccine.


AIIMS-Patna is among the 12 medical institutes selected by the Indian Council for Medical Research (ICMR) for conducting human trials of the indigenous COVID-19 vaccine (BBV152 COVID vaccine). The trail will be conducted on 18 volunteers selected by the hospital authority.



The selected volunteers will first go through a medical check-up on Monday, and after analysing their reports they will further proceed for the trail. The vaccine, which is derived from a strain of SARS-CoV-2 isolated by ICMR-NIV, Pune, demonstrated safety and immune response in preclinical studies.






Several people contacted the AIIMS hospital to take part in the trail but only 18 people aged between 18 to 55 years were selected for the process.


As per ICMR guidelines, the first dose of the vaccine will be given to only those whose reports will be fine. After the first dose of the vaccine, the patient will be under doctor's supervision for 2 to 3 hours after which they will be sent home.


A total of three dosages of injection will be given to the patients to complete the trial process. The first dose of the vaccine will be given to only those whose reports will be fine.


Till now, Bharat Biotech International Ltd and the Zydus Cadila pharmaceutical companies' indigenously developed vaccine prototypes have got an approval for the human trials from the Drugs Controller General of India. Also, Zydus Caldia's ZyCoV-D received permission.
 

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Bharat Biotech starts human trials for Covaxin, India’s first COVID-19 vaccine
Bharat Biotech has started human trials on its vaccine candidate, ‘Covaxin’. Covaxin, being developed by the Hyderabad-based biotech company and Indian Council of Medical Research (ICMR) is India’s first indigenous COVID-19 vaccine.


Bharat Biotech had stated that it is working to develop an initial capacity of 200 million vials of the vaccine.


The company had earlier received approval from the Drug Controller General of India (DCGI) to conduct phase I and II human clinical trials.


Volunteers from across the nation will first undergo health checks to ensure proper liver function and absence of infection before being cleared for small doses of the COVID-19 vaccine. The sites for the trial includes cities Mumbai, New Delhi, Hyderabad, Rohtak, Chennai, Patna, Vishakhapatnam among others.


COVAXIN is derived from a strain of SARS-CoV-2 virus which had been isolated at National Institute of Virology, Pune, a translational science cells part of ICMR. The strain was then later transferred to Bharat Biotech to produce into a vaccine candidate.
 

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AIIMS Patna starts human trial of COVID-19 vaccine
The first dose has been given to selected people and after 14 days, the second dose will be given

AIIMS Patna in Bihar has started the human trial of coronavirus vaccine on 10 volunteers selected by the hospital authority. Several people offered to take part in the trial, but only 10 people were selected for the process. The first dose has been given to selected people and after 14 days, the second dose will be given. Doctors are keeping strict vigil of those people who have taken a dose of vaccine. For this, a team of doctors has been constituted.



According to a report in The All India Radio, the After completion of the scheduled period, check-up of people will be undertaken for after-effects of the vaccine. The vaccine jointly developed by the National Institute of Virology, Pune and Hyderabad-based Bharat Biotech International in collaboration with the Indian Council of Medical Research. It is the first indigenous vaccine developed in India. AIIMS – Patna is one of the 12 medical institutes in the country to have been shortlisted by ICMR for conducting the human trial of the indigenous vaccine.



Meanwhile, positive cases in the state have risen to 17,421. Patients who have recovered are 12,364 while 4992 patients are undergoing treatment in hospitals. Recovery rate in Bihar stands at 71 per cent. The state recorded 14 deaths during 24 hours including the first Coronavirus death of a doctor, taking the toll to 134.
 

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First phase trial of Covaxin, India’s Covid-19 vaccine, starts on 375 people: Report
Bharat Biotech International Limited (BBIL), which developed India’s first potential indigenous coronavirus disease (Covid-19) vaccine, has said the first phase of testing has begun on 375 people, according to a report on Saturday.

Hindustan, HT’s sister publication, reported that Bharat Biotech has said that human trials of Covaxin started on July 15. The Hyderabad-based pharmaceutical company has jointly developed the vaccine with the Indian Council of Medical Research (ICMR) and National Institute of Virology (NIV).

Twelve hospitals in different parts of the country are carrying out this test.

The vaccine manufacturer has said that these are randomised double-blind clinical trials, Hindustan reported. Some of the people who have volunteered will be vaccinated and some will be given a placebo.


However, neither the volunteers nor the researcher knows who has been given the vaccine. They come to know who was injected with the vaccine only after the test period is over.

During the first phase of the trial, it is checked whether the people who have been vaccinated develop any adverse effect in their body.

Whether the vaccine works against the coronavirus disease will not be known at this stage, which is assessed in the second stage.


The hospitals where the vaccine trials have started include All India Institute of Medical Sciences (AIIMS) Delhi, AIIMS Patna, King George Hospital in Visakhapatnam, Post Graduate Institute of Medical Sciences (PGIMS) in Rohtak, Jeevan Rekha Hospital in Belgaum, Gillurkar Multispeciality Hospital in Nagpur, Rana Hospital in Gorakhpur, SRM Hospital in Chennai, Nizam Institute of Medical Sciences in Hyderabad, Kalinga Hospital in Bhubaneswar, Prakhar Hospital in Kanpur and a hospital in Goa.

ICMR had written to 12 institutes where human trials are to be held for the vaccine, Covaxin, ordering them to secure necessary approvals from internal committees and recruit people for clinical tests by July 7.

Bharat Biotech is among the seven Indian firms working on Covid-19 vaccines. It was the first to get the regulatory nod to begin phase 1 and phase 2 human trials to test the vaccine for efficacy and safety.
 

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Covaxin: Bharat Biotech gets DCGI nod for Phase 3 trial of its coronavirus vaccine
New Delhi: The coronavirus vaccine being developed by Bharat Biotech in collaboration with the Indian Council of Medical Research (ICMR) — Covaxin, has been cleared for the third phase of clinical trials.


The Hyderabad-based vaccine maker had applied to the Drugs Controller General of India (DCGI) on October 2, seeking permission to conduct Phase 3 trials.





As per official reports, the recommendation was given by an expert panel at the Central Drugs Standard Control Organisation (CDSCO) after assessing the safety and immunogenicity data of phase 1 and 2 clinical trials and have been sent to the Drugs Controller General of India (DCGI) for final approval.


The firm in its application said that the study would cover around 28,500 subjects aged 18 years and above and would be conducted in 19 sites - including Delhi, Mumbai, Patna and Lucknow - across 10 states.

On October 2, Bharat Biotech had sought the DCGI’s permission to conduct phase 3 trial of its COVID-19 vaccine, but the vaccine maker was asked to submit the complete safety and immunogenicity data of the phase 2 trial, reported PTI.


The firm had presented data of phase 1 and 2 trials along with animal challenge data in two species including non-human primates (NHP) on the inactivated coronavirus vaccine (BBV152) along with the proposal to conduct event driven phase 3 clinical trial to assess the efficacy of the vaccine, the CDSCO recommendations stated.


In July, the DCGI had given permission to Bharat Biotech to conduct phase 1 and 2 clinical trials of its COVID-19 vaccine.

Besides, Bharat Biotech, an indigenously developed vaccine candidate by Zydus Cadila Ltd is also in Phase 2 of human clinical trials.


The Pune-based Serum Institute of India, which has partnered with AstraZeneca for manufacturing the Oxford COVID-19 vaccine candidate, is also conducting Phase 2 and 3 human clinical trials of the candidate in India.
 

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