Tag: Bharat Biotech

Dr Reddy’s partners with BIRAC for Sputnik V vaccine clinical trials in India

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

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Drug major Dr Reddy’s Laboratories on Thursday announced its partnership with the Biotechnology Industry Research Assistance Council (BIRAC), set up by the Department of Biotechnology, for advisory support on clinical trials of Russian COVID-19 vaccine, Sputnik V, in India.

”The partnership will allow Dr Reddy’s to identify and use some of BIRAC’s clinical trial centres for the vaccine, which are funded under the National Biopharma Mission (NBM), implemented by Project Management Unit-NBM at BIRAC. Further, the company will have access to good clinical laboratory practice (GCLP) labs to conduct immunogenicity assay testing of the vaccine,” Dr Reddy’s Laboratories said in a regulatory filing.

Earlier this month, Dr Reddy’s and Russia Direct Investment Fund (RDIF) received approval from the Drugs Controller General of India (DCGI) to conduct an adaptive phase 2/3 human clinical trial for Sputnik V vaccine in India. On August 11, 2020, the Sputnik V vaccine developed by the Gamaleya National Research Institute of Epidemiology and Microbiology was registered by the Ministry of Health of Russia and became the world’s first registered vaccine against COVID-19 based on the human adenoviral vector platform.

Currently, two indigenously developed vaccine candidates for COVID-19, one by Bharat Biotech in collaboration with ICMR and another one by Zydus Cadila, are undergoing phase 2 of human clinical trials. Pune-based Serum Institute of India, which has partnered with AstraZeneca for manufacturing the Oxford COVID-19 vaccine is also conducting phase 2 and phase 3 human clinical trials in India.

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Covaxin: Expert committee approves phase 3 trials of Bharat Biotech COVID-19 vaccine candidate

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

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Bharat Biotech has received expert committee approval to conduct phase 3 trials for its COVID-19 vaccine candidate Covaxin. The drug regulator’s expert committee recommended granting approval after assessing data submitted following phase 1 and 2 trials, along with animal challenge study, suggesting “minor amendments” in the protocol.

In its meeting on October 20 to approve third phase of trials, SEC said, “After detailed deliberation and based on the available evidences, the committee recommended for grant of permission to conduct Phase III clinical trial subject to the condition that the Primary efficacy endpoint for symptomatic cases should be amended.”

SEC has suggested amending the criteria on how a suspect case be clinically evaluated and classified as a symptomatic case. Bharat Biotech now needs to submit a completed protocol to the drug regulator Drug Controller General of India (DCGI) for final approval.

The phase 3 trials are pivotal studies that will assess the efficacy of Covaxin in a large participant population while also studying the safety profile. Bharat Biotech intends to cover 28,500 subjects aged 18 years and above in phase 3 trials that would be conducted in 19 sites across 10 states in India.

Covaxin is a two-dose vaccine to be administered at a gap of 14 days.

The subject expert committee had earlier rejected the proposal on October 5 seeking full phase 1 and 2 trial data and doses fixed based on safety and efficacy data.

Bharat Biotech had reduced the size of phase 2 trials to expedite the process. Instead of testing the vaccine candidate on 750 healthy volunteers, as per the earlier approved protocol, the company dosed just 380 volunteers. The number of sites conducting the trials were also reduced accordingly. Experts said it is possible that a good immune response seen in phase 1, even if measured as a secondary goal, could be the reason a larger phase 2 trial was thought to be not required. Experts said the company might have combined immunogenicity (immune response generated in the body as an effect of the vaccine) data of phase 1 and abbreviated phase 2 to move rapidly to phase 3.

Covaxin, which is an inactivated Sars-Cov-2 vaccine completed phase 1 trials on 375 healthy volunteers. The interim data for phase 1 or 2 has yet not been published in peer reviewed journal or made public.

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Bharat Biotech cuts Covaxin Phase 2 trial size by half

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

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In an unprecedented move, vaccine maker Bharat Biotech has cut the size of Phase-2 clinical trial of its COVID-19 vaccine Covaxin by half. Instead of testing the vaccine candidate on 750 healthy volunteers, as per the earlier approved protocol, the company will now be dosing just 380 volunteers, sources told CNBC-TV18. The number of sites conducting the trials has also been reduced accordingly.

While confirming the development, two lead trial investigators told CNBC-TV18 that the decision was based on good seroconversion or immunogenicity seen in volunteers in Phase 1.

Covaxin, which is an inactivated Sars-Cov-2 vaccine, has completed Phase 1 trials on 375 healthy volunteers. The active trial sites in Phase 2 are currently in the process of administering the second dose of Covaxin to participants. Apart from minor side effects like mild fever and body aches, trial investigators say no major adverse reactions have been noted so far.

Covaxin is a 2-dose vaccine to be administered in a gap of 14 days between doses. The interim data for Phase 1 or 2 has yet not been published or made public.

Sources indicate the move to trim could expedite Phase 2 trials, lead to early initiation of Phase 3 trials and could shorten the overall clinical trial duration for Covaxin. For the 3 vaccines under clinical trials in India, preliminary findings are expected only by January and final results by March, according to trial investigators. A trimmed timeline could mean the pace of development for Covaxin may be faster. It is being developed by Bharat Biotech in collaboration with the Indian Council of Medical Research and the National Institute of Virology.

Bharat Biotech has however yet not responded to CNBC-TV18 queries to detail the reasons behind shortening trials. A company source however confirmed the development.

On October 5, the Drugs Controller General of India’s (DCGI) subject expert committee (SEC) denied approval for starting Covaxin Phase 3 trials based only on the interim data of early-stage trials. The SEC opined that while the design of the Phase 3 study “is in principle satisfactory”, clarification is needed on the definition of “asymptomatic” participants, and “the study should be initiated with appropriate dose identified from the phase 2 safety and immunogenicity data.” Hence data from the second phase of its trial must be submitted “for consideration”.

Bharat Biotech is said to have submitted a plan to test 28000 volunteers in late-stage Phase 3 trials.

There are 42 candidate COVID-19 vaccines in clinical evaluation and nearly 9 experimental vaccines are in late-stage clinical trials globally, as per data from the World Health Organisation. While many of these vaccine trials have seen minor amendments in the process, Bharat Biotech’s Covaxin is the only one to see a major alteration as cutting Phase 2 size by half.

Experts say it is possible that a good immune response in Phase 1, even if measured as a secondary goal, could be the reason a larger Phase 2 trial was thought to be not required.

In a vaccine trial, Phase 1 tests the vaccine primarily for safety. Studying immunogenicity (meaning antibody response after vaccination) is a secondary goal post in Phase 1 trials. Phase 2 trials on the other hand look to study immune response primarily and appropriate doses, while also assessing the safety of the vaccine in a larger number of volunteers. Phase 3 trials test the vaccines in thousands of volunteers to provide pivotal evidence that a vaccine both works by reducing the rate of infection and is safe.

Dr Gagandeep Kang, Professor at Christian Medical College Vellore and one of India’s leading medical scientists, says there could be a way to explain reducing the size of the Phase 2 study from what was proposed.

“A good immunogenicity readout from Phase 1, would encourage the company to combine immunogenicity data from Phase 1 and the abbreviated Phase 2 and move rapidly to Phase 3. Of course, approval from the regulator would be required, and a way to get that would be to nest an immunogenicity cohort in the Phase 3 study. This could shorten the overall timeline for all phases of testing with no compromise,” she said.

These modifications however were still not reflected in the Clinical Trials Registry of India.

Vaccine expert Dr Davinder Gill however questioned the rationale. “It is puzzling. Many other leading vaccine candidates like the ones from Cansino and Sino Pharma got good immunogenicity data in Phase 1 studies, but they continued their full course of planned trials. My apprehension is why shorten Phase 2 trials and not study safety in a complete manner.”

A large Phase 1 trial and similar goalposts in the two rolling early-stage trials could be another reason to combine and shorten, say experts. Most Phase 1 studies recruit less than 100 volunteers, Phase 2 tests vaccines on a few hundreds and typically late-stage Phase 3 trials test in thousands in various parts of the world. Bharat Biotech’s Phase 1 trial itself was on 375 participants.

India’s second indigenous vaccine maker Zydus Cadila is currently testing its 3-dose vaccine in 1000 volunteers in Phase 2 trials. Dosing is expected to be completed by the end of November and results for Phase 1/2 are expected by 2020 end, say investigators.

University of Oxford’s vaccine candidate, being developed by Serum Institute of India, has completed the first dosing in 100 participants in Phase 2 trials. Screening & recruitments of volunteers for Phase 3 trials are ongoing in several sites. Serum Institute will test the vaccine in 1500 volunteers in Phase 3.

A detailed query sent to Bharat Biotech remained unanswered.

The copy will be updated as and when company comments are received.​

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Bharat Biotech asked to submit complete phase 2 data of its COVID-19 vaccine before phase 3 trial

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

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Bharat Biotech, which had sought DCGI’s nod for conducting phase-3 clinical trials of its COVID-19 vaccine candidate, has been asked to submit complete safety and immunogenicity data of the ongoing phase-2 trial, besides providing some clarifications, before proceeding for the next stage.

The vaccine candidate — ‘Covaxin’ — is being indigenously developed by the Bharat Biotech in collaboration with the Indian Council of Medical Research (ICMR).

According to officials, the Hyderabad-based vaccine maker applied to the Drugs Controller General of India (DCGI) on October 2, seeking its permission to conduct the phase-3 randomised double-blind placebo-controlled multicentre trial of its COVID-19 vaccine candidate.

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

According to sources, the phase-2 trial of the Covaxin is going on and the second dose is yet to be given to volunteers at some sites.

“The company presented phase-3 clinical trial protocol along with interim data of phase 1 and 2 clinical trials,” an official said. The subject expert committee (SEC) at the Central Drugs Standard Control Organisation(CDSCO) deliberated on the application on October 5.

“After detailed deliberation, the committee opined that the design of the phase-3 study is in principle satisfactory except for clarification on the definition of asymptomatic, etc.

“However, the study should be initiated with an appropriate dose identified from the phase-2 safety and immunogenicity data. Accordingly, the firm should submit safety and immunogenicity data from the phase-2 trial for consideration,” the panel said in its recommendations.

The SEC during its discussion also observed that the vaccine was well-tolerated in all dose groups and no serious adverse events have been reported so far, a source said. The most common adverse event was pain at the injection site, which resolved transiently, the source said.

The phase-3 clinical trial application proposed a dose of 0.5 ml on day 0 and 28, sources said. Besides, Bharat Biotech, an indigenously developed vaccine candidate by Zydus Cadila Ltd is in phase 2 of the 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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COVID-19 vaccine: Covaxin to use ViroVax’s adjuvant Alhydroxiquim-II to boost immune response

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

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Vaccine maker Bharat Biotech on Monday announced its novel coronavirus vaccine (under development) Covaxin, which was approved for human trials, will use adjuvant Alhydroxiquim-II to boost immune response and longer-lasting immunity. According to a press release issued by the city-based vaccine innovator, the technology is being used under a licensing agreement with Kansas-based ViroVax LLC.

Covaxin is an inactivated vaccine derived from a strain of SARS-CoV-2 virus, isolated at the National Institute of Virology (NIV), Pune, an Indian virology research institute. The inactivated virus is formulated with ViroVax’s adjuvant to produce the vaccine candidate, it said.

Bharat Biotech is currently conducting Phase II human trials of Covaxin after receiving approval from the Drug Controller General of India (DCGI). ”There is critical need for development and availability of adjuvants that elucidate mechanisms of action inducing greater antibody responses to vaccine antigens, thus resulting in long-term protection against pathogens. Adjuvants also enhance the sustainability of the global vaccine supply on account of their antigen-sparing effect,” Krishna Ella, Chairman and Managing Director of Bharat Biotech,said.

”Our partnership with ViroVax resonates with Bharat Biotech’s relentless efforts towards developing safe and effective vaccines coupled with long term immunity,” he added. ”ViroVax is delighted to partner with Bharat Biotech. This has been possible because of support from the National Institutes of Health,” Sunil David, Founder of ViroVax said.

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

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Bharat Biotech inks pact with WU’s School of Medicine for COVID-19 intranasal vaccine

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

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Bharat Biotech On Wednesday signed a licensing agreement with Washington University School of Medicine in St Louis for a novel ”chimp-adenovirus” (Chimpanzee adenovirus), single-dose intranasal vaccine for COVID-19. According to a press release issued by the city-based vaccine maker, Bharat Biotech owns the rights to distribute the vaccine in all markets except the US, Japan and Europe.

While the Phase I trials will take place in St Louis University’s Vaccine and Treatment Evaluation Unit, Bharat Biotech, upon obtaining the required regulatory approval, will pursue further stages of clinical trials in India and undertake large scale manufacture of the vaccine at its GMP facility located in Genome Valley here, it said. ”Our experience in viral vaccines, manufacturing capabilities, and distribution continue to be our strong suit in ensuring safe, efficacious, and affordable vaccines.

It is prudent for Bharat to be involved in diverse but tenable projects to provide a much-needed vaccine against COVID-19 reaches all citizens of the world,” Chairman and Managing Director of Bharat Biotech, Dr Krishna Ella said. The company envisions to scale this vaccine to one billion doses, translating to an equal number of individuals vaccinated receiving a single-dose regimen.

An intranasal vaccine will not only be simple to administer but reduce the use of medical consumables such as needles, syringes, etc., significantly impacting the overall cost of a vaccination drive, it said. Director of Biologic Therapeutics Center and Professor of Radiation Oncology at Washington University School of Medicine and Precision Virologics Interim CEO, Dr David T Curiel said,”The ability to accomplish effective immunization with a single nasal dose is a major advantage, offering broader reach and easier administration.

An effective nasal dose not only protect against COVID- 19, but it also prevents the spread of the disease by offering another kind of immunity that occurs primarily in the cells that line the nose and throat. Most other vaccine candidates currently under development cant do that.” This vaccine expands BBs portfolio of vaccines that are currently being developed and are in various stages of clinical development including Covaxin which is currently in Phase II human clinical trials in India, it said.

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Bharat Biotech’s COVID-19 vaccine Covaxin gets robust immune responses in animal trial

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

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Hyderabad-based Bharat Biotech on Friday released animal study results of COVID-19 vaccine candidate Covaxin. Covaxin is currently in Phase I/II human trials. The results show a reduction in replication of the virus in the nasal cavity, throat and lung tissues of monkeys.

It said the results demonstrated the protective efficacy of the vaccine in a live viral challenge model.

“Bharat Biotech proudly announces the animal study results of COVAXIN – These results demonstrate the protective efficacy in a live viral challenge model,” tweeted the Hyderabad-based firm.

It said the data from the study on primates substantiate the immunogenicity of the vaccine candidate.

According to a detailed statement attached to the tweet, Bharat Biotech developed and assessed the protective efficacy and immunogenicity of an inactivated SARS-CoV-2 vaccine (BBV152) or Covaxin in rhesus macaques (Macaca mulata). Twenty macaques were divided into four groups of five animals each.

“To summarize, the vaccine candidate was found to generate robust immune responses. Thus, preventing infection and disease in the primates upon high amounts of exposure to live SARS-CoV-2 virus,” it added.

The vaccine is being evaluated in Phase-I clinical trials in India.

The vaccine maker early this month received approval from the Central Drugs Standard Control Organisation to conduct the Phase-II trials.

Bharat Biotech had announced on June 29 that it successfully developed Covaxin 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 candidate has been developed and manufactured in Bharat Biotech’s high containment facility located in Genome Valley, Hyderabad.

(with inputs from agencies)

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Race for a COVID-19 vaccine intensifies: Here are the top candidates

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

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The world is keeping its fingers crossed as pharma majors across the globe are working overtime on over dozens of clinical trials to deliver an anti-COVID-19 vaccine.

Needless to say the successful restoration of normalcy in the world — socially and economically — depends on the success of these vaccine development ventures.

The testing for a vaccine is a four-stage process—pre-clinical testing on animals, phase I clinical testing on a small group of people to determine its safety and to learn more about the immune response it provokes, phase II trials are expanded safety trials, and phase III testing is done by administering it to thousands of people to confirm its efficacy.

Globally, the World Health Organisation (WHO) is tracking around 140 candidates vaccines, of which 23 are in various phases of human clinical trials, including from Moderna and AstraZeneca Plc.

In India, multiple companies are working on the coronavirus vaccine on their own or with global partners. In fact, Bharat Biotech and Indian Council of Medical Research (ICMR) are conducting the first phase of human trials of Covaxin at a dozen centres.

Zydus Cadila started its first phase trials last week. Additionally, the Serum Institute of India has partnered with the University of Oxford and its partner AstraZeneca on their potential coronavirus vaccine seeks to undertake human trials in India.

Here’s a list of various coronavirus vaccines at the different stages of the trial in India and abroad:

Covaxin: The Covaxin trial will take place in at least three stages, AIIMS director Randeep Guleria said in a briefing on Monday. The first phase will study the samples of 375 healthy people aged 18-55 years without any co-morbidities over a trial period of 4-6 weeks. The stage two of the trial phase will cover samples from 750 healthy people aged 12-65 years. The third stage will focus on the efficacy of the vaccine with samples of around 1800 people. On fulfilling trial criteria, the vaccine could be ready by end of 2020 or early next year, Guleria said.

Oxford-AstraZeneca vaccine: Sharing the results of the potential vaccine during early-stage clinical trials, the developers/scientists said on Monday it has shown positive results, generating both antibodies and cell-mediated immune responses. They expressed hope that a vaccine could be rolled out by the end of the year but there is no certainty. The Serum Institute has said it will be able to produce about 300-400 million doses of the vaccine by December and half of its production will be for India. SII CEO Adar Poonawalla has said the company will apply for a license from the Indian regulator to start clinical trials of the Oxford vaccine in a week’s time.

BioNTech-Pfizer: The German and US firms on Monday reported that additional data from their experimental Covid-19 vaccine conducted in Gerrmany on 60 healthy adults showed it was safe and induced an immune response in patients. The results were similar to tests conducted in the US. The pharma majors said the data also demonstrated an induction of high level of T-cell responses against the novel coronavirus.

ZyCoV-D: Apart from the Bharat Biotech-ICMR vaccine, the Drugs Controller General of India (DGCI) has allowed Zydus Cadila Healthcare Ltd to go in for phase 1 and 2 human trials. The company aims to complete clinical trials of its coronavirus vaccine ZyCoV-D in seven months after starting the first phase of trials last week.

Panacea Biotec: The New Delhi-headquartered generic pharma firm in June had said that it was setting up a joint venture firm in Ireland with US-based Refana Inc to develop a vaccine for COVID-19. It aims to make over 500 million doses of the potential COVID-19 vaccine, with over 40 million doses expected to be available for delivery early next year, PTI quoted Panacea Biotec statement.

Other Indian firms: Indian Immunologicals, a subsidiary of National Dairy Development Board (NDDB), has inked an agreement with Australia’s Griffith University to develop a vaccine for coronavirus, PTI said in a report. Others like Mynvax and Biological E are also working to develop vaccines for COVID-19, the news agency added.

Sinovac Biotech’s CoronaVac: The Nasdaq-listed Chinese pharma major has reportedly moved into the third phase of trials in Brazil with two doses of ‘CoronaVac’ inducing neutralising antibodies after 14 days. It has penned a deal with Brazilian immunobiologic producer Instituto Bhutantan to run the stage 3 trial in Brazil. Bangladesh Medical Research Council (BMRC) has also approved the last stage trial of coronavirus vaccine by Chinese firm Sinovac Biotech Ltd.

CanSino Biologics: Among five China-developed COVID-19 vaccine candidates including Sinovac’s CoronaVac, the one by CanSino is leading the race. The adenovirus-based recombinant vaccine, which was the first in the world to enter a phase 2 trial and the first to report first-in-human data in a peer-reviewed journal, according to a blog on fiercepharma.com.

Other Chinese firms: Apart from above two, Sinopharm and the Chinese Academy of Medical Sciences’ Institute of Medical Biology are also working on an inactivated version of COVID-19 vaccines.

In fact, global brokerage Jefferies recently shared a research note on the ongoing developments efforts on the COVID-19 vaccine front. Here’s an illustration that shows various stages of some of the top candidates for coronavirus vaccine:

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