Tag: Bharat Biotech

Phase I human trials for COVAXIN begin; 10 things to know

KV Prasad Jun 13, 2022, 06:35 AM IST (Published)

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Human trials of India’s first indigenous COVID-19 vaccine, Covaxin, commenced at AIIMS Delhi on July 20,  with as many as 100 healthy people volunteering between 18 and 55 years of age. The development comes at a time when the world is desperately looking for a solution to the raging COVID-19 virus that has claimed over 6 lakh lives so far.

Here are 10 key things you should know about the vaccine:

1. According to Bharat Biotech, the Phase 1 clinical trial for Covaxin was initiated across the country from July 15 and this is a randomised, double-blind, placebo-controlled clinical trial of 375 volunteers across the country.

2. The indigenous, inactivated vaccine is being developed and manufactured at Bharat Biotech’s BSL-3A (Bio-Safety Level 3) High Containment facility located in Genome Valley, Hyderabad.

3. The SARS-CoV-2 strain was isolated at NIV, Pune, and transferred to Bharat Biotech.

4. The Drug Controller General of India, Central Drugs Standard Control Organisation (CDSCO) and the Ministry of Health and Family Welfare granted permission to initiate Phase-I and II human clinical trials after the company submitted results generated from pre-clinical studies, demonstrating safety and immune response.

5. Several drugs have been tested for their effectiveness against COVID-19, the disease resulting from coronavirus, but they have fallen short. Gilead Sciences’ remdesivir has been found to be effective in reducing the time spent in hospital by infected patients, but a cure is yet to be found.

6. Earlier, the Indian Council of Medical Research had written to clinical trial sites to fast track all approvals and initiate enrolment for clinical trials of the indigenous COVID-19 vaccine, Covaxin, by July 7, so that “results of the clinical trials can be launched by August 15”.

7. Covaxin is an “inactivated” vaccine that was made using particles of the Covid-19 virus that were killed.

8. As per Bharat Biotech, injecting particular doses of these particles build immunity by helping the body create antibodies against the deadly virus.

9. The first phase of the trials for Covaxin are expected to take over a month to complete.

10. Around 15 months are required to complete both phases of the trial.

-With agency inputs.

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Covaxin’s phase-1 clinical trials launched on July 15: Bharat Biotech

KV Prasad Jun 13, 2022, 06:35 AM IST (Published)

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Bharat Biotech on Friday said that it has initiated phase-1 clinical trials for the country’s first indigenous Covid-19 vaccine Covaxin across the country on July 15.

This is a randomised, double-blind, placebo-controlled clinical trial on 375 volunteers across India, the company said.

Last month, Covaxin had received approval of drug regulator DCGI for phase I and II of human clinical trials. It had also said that the human clinical trials will start across India in July 2020.

Bharat Biotech is developing the vaccine in collaboration with the Indian Council of Medical Research (ICMR) and the National Institute of Virology (NIV).

ICMR had earlier claimed that an indigenous Indian vaccine could be ready as early as August 15.

Last week, Dr TV Venkateswaran, senior scientist at Vigyan Prasar (New Delhi), had claimed that “none of these vaccines were likely to be ready for mass use before 2021.

Experts had opined that the timeline to develop a vaccine and complete three crucial phases of clinical trials in six weeks was “scientifically impossible” and “unrealistic”.

ICMR, in its clarification, said: “ICMR’s process is exactly in accordance with the globally accepted norms to fast-track the vaccine development for diseases of pandemic potential wherein human and animal trials can continue in parallel.”

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Science Ministry retracts statement after saying COVID-19 vaccine unlikely before 2021

KV Prasad Jun 13, 2022, 06:35 AM IST (Published)

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With Drug Controller General of India giving pharma companies the go ahead to conduct human trials for coronavirus vaccines — to Bharat Biotech for COVAXIN and Zydus Cadila for ZyCov-D — senior scientist at Vigyan Prasar (New Delhi) Dr TV Venkateswaran claimed that “none of these vaccines is [are] unlikely to be ready for mass use before 2021”. ICMR had recently claimed that an indigenous Indian vaccine could be ready as early as August 15.

Dr Venkateswaran’s article, which was released by the Press Information Bureau on July 5, spoke about how indigenous Indian COVID19 vaccines are in the global race to end the pandemic. However, the Ministry of Science and Technology was quick to retract the statement and issued the same note, without mentioning that none of them would be ready by at least 2021.

On July 3, Indian Council of Medical Research (ICMR) said that India was aiming to launch the world’s first COVID-19 vaccine by August 15. It sent a letter to 12 hospitals selected for conducting clinical trials on the indigenously developed candidate COVAXIN and had asked for clinical trials to be fast-tracked and volunteers be enroled, by July 7. Experts soon commented that the timeline to develop a vaccine and complete three crucial phases of clinical trials in six weeks was “scientifically impossible” and “unrealistic”.

A day later, in a clarification the premier medical research institute said: “ICMR’s process is exactly in accordance with the globally accepted norms to fast-track the vaccine development for diseases of pandemic potential wherein human and animal trials can continue in parallel.” However, ICMR has not said anything about how it intends to launch the vaccine by August 15.

Six Indian companies are working on COVID-19 vaccines, with inputs from ICMR and Pune-based National Institute of Virology (NIV) and Hyderabad-based Center for Cellular and Molecular Biology (CSIR).

Meanwhile, Dr Venkateswaran mentioned in his article that a vaccine for the novel coronavirus can be developed anywhere in the world, but without the involvement of Indian manufacturers, it would not be feasible to achieve the required production quantity. India is responsible for manufacturing 60 percent of vaccines globally.

The article also spoke about leading candidates AZD1222 developed by Jenner Institute of University of Oxford and licenced to AstraZeneca and MRNA-1273 vaccine which is being developed by Kaiser Permanente Washington Health Research Institute, which will be manufactured by US-based Moderna pharmaceutical. “Both these firms have already inked an agreement with Indian manufacturers for production of the COVID vaccines,” the article noted.

Parallelly, Indian institutions have engaged in R&D for the development of vaccines in India. With the primary scientific inputs coming from institutions like NIV and CSIR, six Indian companies are working on a vaccine for COVID-19. Along with the two Indian vaccines — COVAXIN and ZyCov-D — 11 out of 140 vaccine candidates have entered the human trials across the world.

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ICMR issues clarification regarding August 15 target, says move to fast-track vaccine follows global norms

KV Prasad Jun 13, 2022, 06:35 AM IST (Published)

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The Indian Council of Medical Research (ICMR) on Saturday issued a clarification regarding the launch a COVID-19 vaccine by August 15 and said the process to develop an indigenous vaccine to fight the coronavirus pandemic is as per globally accepted norms of fast tracking.

The ICMR earlier announced an indigenous vaccine, developed with Bharat Biotech and has asked clinical trials to be completed in time for a launch before August 15.

Also read: Coronavirus vaccine: ICMR fast-tracks COVAXIN procedure, aims at August 15 launch

“In the larger public health interest, it is important for ICMR to expedite clinical trials with a promising indigenous vaccine. Faced with the unprecedented nature of the Covid 19 pandemic, all other vaccine candidates across the globe have been similarly fast-tracked,” ICMR said in an official press release.

Further, it said, “The letter by DG-ICMR to investigators of the clinical trial sites was meant to cut unnecessary red tape, without bypassing any necessary process, and speed up recruitment of participants.”

“Just as red tape was not allowed to become a hindrance in the fast track approval of new indigenous testing kits or for introducing in the Indian market potential COVID-19 related drugs, the indigenous vaccine development process has also been sought to be insulated from slow file movement. The aim is to complete these phases at the earliest, so that population-based trials for efficacy could be initiated without delay,” it said.

Also read: ICMR recommends allowing private doctors to prescribe COVID-19 tests

“ICMR’s process is exactly in accordance with the globally accepted norms to fast-track the vaccine development for diseases of pandemic potential wherein human and animal trials can continue in parallel,” the agency said.

The vaccine trials will be done following the best practices and rigour, and will be reviewed, as required, by a Data Safety Monitoring Board (DSMB), ICMR said.

“While issues raised in public domain from time-to-time by commentators are welcome, as they form an important part of feedback loop, the best of India’s medical professionals and research scientists should not be second guessed for their professionalism or adherence to the highest scientific rigour. ICMR is committed to treat the safety and interest of people of India as a topmost priority,” it added.

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Coronavirus vaccine: ICMR fast-tracks COVAXIN procedure, aims at August 15 launch

KV Prasad Jun 13, 2022, 06:35 AM IST (Published)

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The Indian Council of Medical Research has written to clinical trial sites to fast track all approvals and initiate enrolment for clinical trials of the indigenous COVID-19 vaccine, Covaxin, by July 7, so that “results of the clinical trials can be launched by August 15.”

ICMR and Bharat Biotech International Limited are jointly working for the preclinical as well as clinical development of the vaccine.

ICMR has written to all clinical trial partners to fast track the enrollment process.

“It is envisaged to launch the vaccine for public use latest by August 15 after completion of all clinical trials. BBIL is working expeditiously to meet the target however the final outcome will depend on the cooperation of all clinical sites involved in this project,” the ICMR letter said, adding that non-compliance would be “viewed seriously.”

ICMR and Bharat Biotech declined to comment on the letter.

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India’s first COVID-19 vaccine candidate COVAXIN gets DCGI approval; human trials to begin in July

KV Prasad Jun 13, 2022, 06:35 AM IST (Published)

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India’s first COVID-19 vaccine candidate COVAXIN has received the approval of drug regulator DCGI for phase I and II of human clinical trials. The drug has been developed by Bharat Biotech.

Human clinical trials are scheduled to start across India in July 2020.

It has been developed in collaboration with the Indian Council of Medical Research (ICMR) and the National Institute of Virology (NIV). The SARS-CoV-2 strain was isolated in NIV, Pune and transferred to Bharat Biotech.

The indigenous, inactivated vaccine has been developed and manufactured by Bharat Biotech.

A number of drug manufacturers across the globe are working to find a cure for coronavirus, but no pharmaceutical firm has won the race yet.

Earlier Monday Reuters reported that China’s military has received the greenlight to use a COVID-19 vaccine candidate developed by its research unit and CanSino Biologics after clinical trials proved it was safe and showed some efficacy.

Several drugs have been tested for their effectiveness against COVID-19, the disease resulting from coronavirus, but they have fallen short. Gilead Sciences’ remdesivir has been found to be effective in reducing the time spent in hospital  by infected patients, but a cure is yet to find.

COVID-19 has infected more than 10 million people globally and has killed half a million.

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Thursday’s filing dispelled some doubts, though Musk still has work to do. He and his advisers will spend the coming days vetting potential investors for the equity portion of his offer, according to people familiar with the matter

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CEPI grants $14.1 million to Bharat Biotech consortium for Chikungunya vaccine

KV Prasad Jun 13, 2022, 06:35 AM IST (Published)

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The Coalition for Epidemic Preparedness Innovations (CEPI) will provide a fund of USD 14.1 million to a consortium, comprising Bharat Biotech and International Vaccine Institute (IVI), for vaccine manufacturing and clinical development of a two-dose live-inactivated vaccine (BBV87) against Chikungunya.

CEPI is an innovative partnership between public, private, philanthropic, and civil organisations, launched at Davos in 2017, to develop vaccines to stop future epidemics.

This grant is supported by the European Unions (EU) Horizon 2020 programmethrough an existing framework partnership agreement with CEPI, a press release from the city-based vaccine manufacturer said on Wednesday.

The consortium will be further supported with a grant of up to USD 2 million from the centre’s Ind-CEPI initiative which will fund the set-up of GMP (Good Manufacturing Practice) manufacturing facilities for the vaccine in India, and the subsequent manufacture of clinical trial materials, it said.

In addition to manufacturing, the partnering agreement will finance a multi-centre Phase 2/3 adaptive clinical trial to be conducted by IVI in Colombia, Panama and Thailand which will provide crucial data about the safety and immunogenicity of the vaccine candidate.

“The partnership will build on Bharat Biotech’s experience of developing and supplying affordable vaccines, and WHO prequalification procedures, to ensure affordable access to the vaccine in countries where Chikungunya is endemic, in line with CEPI’s core commitment to equitable access,” it said.

The investment is part of CEPI’s third call for proposals which was launched in January 2019.

Since the launch of this call, over USD 80 million of CEPI core funding has been committed to three Chikungunya vaccine candidates and two Rift Valley Fever vaccine candidates.

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Thursday’s filing dispelled some doubts, though Musk still has work to do. He and his advisers will spend the coming days vetting potential investors for the equity portion of his offer, according to people familiar with the matter

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Bharat Biotech to lead project to develop human antibodies for COVID-19

KV Prasad Jun 13, 2022, 06:35 AM IST (Published)

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Leading vaccine maker Bharat Biotech on Friday said it will lead CSIR-NMITLI supported project to develop human antibodies for COVID-19 therapy.

The Council of Scientific and Industrial Research (CSIR) under its New Millennium Indian Technology Leadership Initiative (NMITLI) has sanctioned a project to develop human monoclonal antibodies as therapy for COVID-19 infections.

The project will be led by Bharat Biotech, a Hyderabad-based manufacturer of vaccines and bio-therapeutics which exports its products to over 65 countries.

“We are fast-tracking the development process, to make the antibodies available within the next 6 months and thus improve the treatment efficacy,” said Dr Krishna Ella, Chairman and Managing Director, Bharat Biotech.

He said while both Israel and Netherlands recently announced the development of virus-neutralizing antibodies, their approach would be to develop a powerful cocktail of neutralizing antibodies that can also simultaneously block mutational variants of the virus.

This programme brings together National Centre for Cell Science (NCCS), Pune, Indian Institute of Technology, Indore, PredOmix Technologies and Bharat Biotech in a collaborative mode for a public health emergency.

Although efforts are underway for the development of drugs and vaccines for controlling the COVID-19 pandemic, these are slow and expensive processes with uncertainties. Therefore, an alternate therapeutic regimen for early deployment is critical, Bharat Biotech said.

“The purpose of vaccination is to protect the healthy against future infections and it alone may not provide the complete solution. We feel the monoclonal antibody therapy will provide a viable option,” said Dr. Ella.

“The question is of how to treat those individuals who are already infected? plus, we do not yet know how effective an anti-SARS-CoV2 vaccine will be in the elderly people and those with co-morbidities. Given the large number of Indians suffering from hypertension, diabetes, and heart diseases, this becomes an important issue,” he added.

Also, catch all the latest updates and trends on the novel coronavirus with CNBCTV18’s blog

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Thursday’s filing dispelled some doubts, though Musk still has work to do. He and his advisers will spend the coming days vetting potential investors for the equity portion of his offer, according to people familiar with the matter

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Coronavirus cure: Human trials on Bharat Biotech’s COVID-19 nasal-drop vaccine to begin in 4 months

KV Prasad Jun 13, 2022, 06:35 AM IST (Published)

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As countries struggle to contain the conronavirus pandemic, scientists and pharma companies across the world are racing against time to develop a vaccine to beat the deadly virus. The Wall Street Journal reported that over 140 experimental drug treatments and vaccines for COVID-19 are in the development stage and 11 of these are already in various stages of clinical trials.

Pulitzer winning author, scientist and oncologist Dr Siddhartha Mukherjee on Monday said that a vaccine is still a long way to come. However, he stressed that there has been some progress on anti-viral therapies based on anti-bodies that may prove effective against the virus.

In India, Pune-based Serum Institute last week said that it hopes to begin human trials for its vaccine by the end of the year. And now, another Indian vaccine manufacturer is throwing its hat into the ring.

Hyderabad-based Bharat Biotech, which has been working on developing a intra-nasal drop vaccine for COVID-19, has initiated testing in the US in collaboration with the University of Wisconsin-Madison and vaccine developer FluGen. The company is hoping that its CoroFlu vaccine is ready for human trials by end-2020.

Speaking to CNBC-TV18, Dr Krishna Ella, Chairman and MD of Bharat Biotech said, “We are working with one of the COVID-19 nasal-flu vaccines in collaboration with University of Wisconsin. We have completed R&D experiments and now it is going through animal trials. We are looking at animals because as the vaccine has some problems similar to that of dengue. So, you need to be cautious in animal testing to ensure the safety of people.”

“We chose a nasal strategy because the flu and COVID-19 or any other respiratory pathogen enters through the nose and gets into the lungs. So, it it best to enhance mucosal immunity, which is one of the best immunity the human body can produce against any infectious disease. Hence, the nasal dose is the best option for mucosal immunity and that will last longer and protect against any infections,” he added.

Speaking about bottlenecks in terms of R&D in India, Ella said, “Animal testing will take another two-three months to check if everything is alright, the immunogenosity is alright and the efficacy – it protects against the challenge of the virus. We need to establish the above thee points and that is happening at the moment at Madison-Wisconsin. The reason we have to do this abroad is because we do not have animals in the country [India]. If we want to import animals, then it takes about a year. So, I do not think we can do a lot of R&D in the country, that is one of the bottlenecks we face as Indian manufacturers.”

According to Ella, the vaccine platform they are working on has already been proven in phase-two human trials. “FluGen has completed using the vaccine. We are already working on cell culture, vector and have established the safety profile of the product. We have easier ways to fast track a lot of things. We expect that in the next four months human clinical trials would begin.”

“We have already established the dose required for humans. This gives a lot of confidence to move forward faster,” he pointed out.

Elon Musk forms several ‘X Holdings’ companies to fund potential Twitter buyout

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Thursday’s filing dispelled some doubts, though Musk still has work to do. He and his advisers will spend the coming days vetting potential investors for the equity portion of his offer, according to people familiar with the matter

KV Prasad Journo follow politics, process in Parliament and US Congress. Former Congressional APSA-Fulbright Fellow