"Big Boost to India's Fight Against COVID-19! Bharat Biotech's ChAd36-SARS-CoV-S COVID-19 (Chimpanzee Adenovirus Vectored) recombinant nasal vaccine approved by @CDSCO_INDIA_INF for primary immunization against COVID-19 in 18+ age group for restricted use in emergency situation," Union Health Minister Mansukh Mandaviya tweeted.
This step will further strengthen our collective fight against the pandemic.
— Dr Mansukh Mandaviya (@mansukhmandviya) September 6, 2022
India has harnessed its science, R&D, and human resources in the fight against COVID-19 under PM @NarendraModi Ji's leadership.
With the science-driven approach & Sabka Prayas, we will defeat COVID-19.
He said this step will further strengthen "our collective fight" against the pandemic.
India has harnessed its science, research and development (R&D), and human resources in the fight against COVID-19 under Prime Minister Narendra Modi's leadership, he said.
"With the science-driven approach & Sabka Prayas, we will defeat COVID-19," Mandaviya also said.
The Hyderabad-based firm completed clinical trials of the nasal vaccine with about 4,000 volunteers and there is no side effect or adverse reaction reported so far, company sources had said.
The vaccine candidate was evaluated earlier in phase I and II clinical trials with successful results. BBV154 has been specifically formulated to allow intranasal delivery. In addition, the nasal delivery system has been designed and developed to be cost-effective in low and middle-income countries, a press release from the vaccine maker said.
BBV154 was developed in partnership with Washington University St Louis, which had designed and developed the recombinant adenoviral vectored constructs and evaluated them in preclinical studies for efficacy.
Product development related to pre-clinical safety evaluation, large-scale manufacturing scale-up, formulation, and delivery device development, including human clinical trials, was conducted by Bharat Biotech.
The Centre partially funded product development and clinical trials through the Department of Biotechnology's, COVID Suraksha programme.
Two separate and simultaneous clinical trials were conducted to evaluate BBV154 as a primary dose (2-dose) schedule and a heterologous booster dose for subjects who have previously received 2 doses of the two commonly administered Covid vaccines in India.
Suchitra K Ella, Joint Managing Director, Bharat Biotech, said, "On this Independence Day, we are proud to announce successful completion of clinical trials for BBV154 intranasal vaccine. We stay committed and focused on innovation and product development; this is yet another achievement for the multidisciplinary teams at Bharat Biotech."
If approved, the intranasal vaccine will make it easier to deploy in mass immunisation campaigns with an easy to administer formulation and delivery device, she further said.
Primary dose schedule phase III trials were conducted for safety, and immunogenicity in approximately 3,100 subjects, and compared with Covaxin. The trials were conducted in 14 trial sites across India.
Heterologous booster dose studies were conducted for safety and immunogenicity in approximately 875 subjects, where a booster dose (3rd dose) of BBV154 intranasal vaccine was administered to study participants who were previously vaccinated with licensed COVID vaccines. The trials were conducted in 9 trial sites across India.
The CEPI will provide funding of up to $19.3 million to support the development of a "variant-proof" SARS-CoV-2 vaccine candidate to an international multidisciplinary consortium comprising Bharat Biotech International Ltd (BBIL), India, the University of Sydney, Australia, and ExcellGene SA, Switzerland.
According to a joint statement released here, the CEPI's funding will support the consortium as it seeks to establish preclinical and clinical proof of concept for an adjuvanted subunit vaccine designed to provide broad protection against all known SARS-CoV-2 variants of concern, as well as future variants of the virus which have not yet emerged.
The CEPI will fund the researchers to conduct activities including immunogen design, preclinical studies, manufacturing process development, and a Phase 1 clinical trial.
In this new vaccine design, modified trimeric spike immunogens will be produced in a robust and scalable process with high purity and yield at low cost, based on a biomanufacturing approach that has provided significant quantities of protein therapeutics to the world.
This strategy could also be used to enable rapid development of broadly protective vaccines against other beta coronaviruses, as well as vaccines against 'Disease X' -unknown pathogens with pandemic potential that may emerge in the future.
Under the terms of the funding agreement, the consortium partners have committed to achieving equitable access to the outputs of this project, in line with the CEPI's equitable access policy.
"As repeated waves of Covid-19 infection remind us, we will be living alongside the virus for many years to come. The threat of a new variant emerging that might evade the protection of our current vaccines is real, so investing in R&D for variant-proof SARS-CoV-2 vaccines is a global health security imperative. Our partnership with Bharat Biotech, University of Sydney, and ExcellGene will advance the development of a vaccine candidate to protect against future variants of COVID-19, potentially contributing to the long-term control of the virus," said Dr Richard Hatchett, CEO of the CEPI.
"BBIL has successfully commercialised a universal Covid-19 vaccine for adults and children. While current generations of vaccines are safe and effective, against currently known variants, it is imperative that we focus on innovation for multi-epitope vaccines, where a single vaccine can protect against all future variants. Our expertise in product development and innovation, especially with novel adjuvants and platform technologies will add to the strong partnership with CEPI, ExcellGene, and the University of Sydney," said Dr Krishna Ella, Chairman and Managing Director, BBIL said.
"Our mission is to deliver safe, affordable and highly effective vaccines to combat existing and future SARS-CoV-2 variants, and our international consortium is well placed to achieve this goal. The University of Sydney will provide a framework for pre-clinical assessment of vaccine candidates, together with access to Australia's world-class early phase clinical trial community," said Prof James Triccas, Sydney Institute for Infectious Diseases, The University of Sydney.
"Our technological platform for innovative protein designs was used in the past to identify and manufacture an antigen for an Ebola candidate vaccine, resulting in sterilizing immunity in pre-clinical challenge models. For the current Covid-19 project we are using similar approaches to generate numerous antigen preparations derived from spike protein variants of SARS-CoV-2, focussing eventually on the most promising antigen for vaccine purposes. Obtaining funding and scientific advice from CEPI to further our ongoing collaborations with the University of Sydney and Bharat Biotech is an exciting and most gratifying perspective and will, we hope, contribute towards the science for this and other novel protein-based vaccines," said Dr Maria J. Wurm, CEO, ExcellGene.
The WHO said in a statement late on on Saturday that the Covaxin suspension was in response to the outcomes of its post EUL (emergency use authorisation) inspection, held between March 14-22, and the need to conduct process and facility upgrades to address recently identified GMP (good manufacturing practice) deficiencies.
"The World Health Organisation (WHO) is today confirming the suspension of supply of Covaxin produced by Bharat (Biotech) through UN procurement agencies and recommending to countries that received the vaccine to take actions as appropriate," the global health agency said.
Bharat Biotech on Sunday said it had nothing else to add to an earlier statement where it said it is working on further improvements and upgrades to ensure that the production of Covaxin continues to meet ever increasing global regulatory requirements.
"During the recent WHO post EUL inspection, Bharat Biotech agreed with the WHO team on the scope of the planned improvement activities and indicated that they will be executed as soon as practical," it had said in a statement on April 1.
Hyderabad-based vaccine manufacturer Bharat Biotech then announced the temporary slowing down of its Covid vaccine Covaxin's production across its manufacturing facilities.
"Bharat Biotech announces the temporary slowing down of production of Covaxin across its manufacturing facilities, having completed its supply obligations to procurement agencies and foreseeing the decrease in demand," it said.
The company will focus on pending facility maintenance, process and facility optimisation activities for the coming period, it said.
A statement issued by WHO on Saturday said the suspension is in response to the outcomes of its post EUL (emergency use authorisation) inspection held between March 14 22, 2022 and the need to conduct process and facility upgrade to address recently identified GMP (good manufacturing practice) deficiencies.
There will be interruption of supply of Covaxin due to suspension of production for export, WHO said. The risk assessment to date does not indicate change in the risk-benefit ratio. The data, available to WHO, indicate the vaccine is effective and no safety concern exists, WHO said.
Company officials could not be reached immediately for a response.
Bharat Biotech on April 1 announced the temporary slowing down of production of its covid-19 vaccine Covaxin across its manufacturing facilities, having completed its supply obligations to procurement agencies and foreseeing the decrease in demand.
During the recent WHO inspection, Bharat Biotech agreed with the former's team on the scope of the planned improvement activities and indicated that they will be executed as soon as possible.
The company has committed to comply by addressing the GMP deficiencies and is developing a corrective and preventive action plan, for submission to the Drugs Controller General of India (DCGI) and WHO.
In the interim and as a precautionary measure, the company has indicated its commitment to suspend its production of Covaxin for export, WHO said.
Stating that it has received feedback that certain immunisation centres are recommending taking three paracetamol 500mg tablets along with Covaxin for children, the company clarified that such a step was not required.
"No paracetamol or painkillers are recommended after being vaccinated with Covaxin," Bharat Biotech said in a tweet.
Paracetamol was recommended along with certain other COVID-19 vaccines and is not recommended for Covaxin, it asserted.
"Through our clinical trials spanning 30,000 individuals, approximately 10-20 per cent individuals report side effects. Most of these are mild, resolve within 1-2 days, and do not require medication. Medication is only recommended only after you consult a physician," the company said.
Last month, the Drugs Controller General of India (DCGI) had granted emergency use authorisation to indigenously-developed Bharat Biotech's Covaxin for children above 12 years with certain conditions.
Prime Minister Narendra Modi had announced that vaccination against COVID-19 for children between 15-18 years would start from January 3.
Subsequently, India opened up vaccination for the 15-18 years age-group on Monday and so far over 85 lakh beneficiaries in the category have received the first shot.
The approval was sought by the vaccine manufacturer last week.
The SEC has asked the company to submit the protocol for booster study.
On Tuesday, the Committee held a meeting to discuss the vaccine manufacturer Bharat Biotech's application for clinical trials of its intranasal Covid vaccine as a booster.
The Hyderabad-based manufacturer had proposed the booster dose for those who have been already been innoculated with Covishield and Covaxin vaccines.
According to a source, Bharat Biotech aims to conduct clinical trials on 5,000 healthy subjects: half or 2,500 individuals who have received Covishield and another 2,500 who have been administered Covaxin.
There will be a gap of around six months between the second and the intranasal booster dose. The source said that the nasal booster vaccine is likely to be launched in India by March following clinical trials.
In his address to the nation on December 25, Prime Minister Narendra Modi had assured that soon the country will develop a nasal vaccine.
The vaccine manufacturer had conducted phase II/III, open-label, and multicentre studies to evaluate the safety, reactogenicity, and immunogenicity in healthy children and adolescents in the 2-18 age group. The clinical trials conducted in the paediatric population between June 2021 to September 2021 have shown robust safety, reactogenicity, and immunogenicity. The data was submitted to the Central Drugs Standard Control Organisation (CDSCO) during October 2021 and received emergency use nod for children aged 12-18 from DCGI recently.
Dr Krishna Ella, Chairman and Managing Director, Bharat Biotech, said, "Covaxin's clinical trial data from the paediatric population is very encouraging. Safety of the vaccine is critical for children, and we are glad to share that COVAXIN has now proven data for safety and immunogenicity in children. We have now achieved our goal of developing a safe and efficacious COVID-19 vaccine for adults and children. Vaccines are a great preventive tool; the power of vaccines can only be harnessed if used prophylactically."
In the study, no serious adverse event was reported. 374 subjects reported either mild or moderate severity symptoms with 78.6 per cent getting resolved within one day. Pain at the injection site was the most commonly reported adverse event, claimed Bharat Biotech in the statement.
For the trial, 976 subjects were screened for SARS-CoV-2 by RT-PCR and ELISA testing. Out of these, 525 eligible participants were enrolled. Based on the age, participants were distinguished into three groups in an age de-escalatory manner. Group I consisted of children of age 12-18 years (n175), group II consisted of children of age 6-12 years (n175), and group III consisted of children of age 2-6 years (n175). Seroconversion was documented at 95-98%, in all three groups four weeks after the second dose, indicating superior antibody responses in children when compared to adults and also displayed Th1 bias, said vaccine manufacturer.
According to The New York Times, the company added the games in an over-the-air software update that was sent to most of its cars this summer.
The games can be played by a driver or by a passenger in full view of the driver, raising fresh questions about whether Tesla is compromising safety as it rushes to add new technologies and features in its cars, the report said.
"It is a big concern if it plays in view of the driver, for sure," Jonathan Adkins, executive director of the Governors Highway Safety Association, which coordinates state efforts to promote safe driving, was quoted as saying.
Previously, video games were only playable while the vehicle was in park.
Tesla's Autopilot system has for several years faced criticism from safety experts because it allows drivers to take their hands off the steering wheel for extended periods, even though they are not supposed to.
As per the National Highway Traffic Safety Administration (NHTSA), the combination of hands-free driving and drivers' looking away from the road has been connected to at least 12 traffic deaths since 2016 in Tesla cars that were operating in Autopilot mode.
Adkins said the addition of video games "is crying out for NHTSA to provide some guidance and regulation".
Tesla was yet to comment on the report.
The efficacy data which was peer reviewed also said the vaccine demonstrated 63.6 per cent protection against asymptomatic Covid-19 and 65.2 per cent safety against the Delta variant besides showing 70.8 per cent guard against all variants of SARS-CoV-2 virus.
The efficacy analysis demonstrated that Covaxin to be 93.4 per cent effective against severe symptomatic Covid-19.
"The peer-review of Covaxin phase III clinical trial data in The Lancet, an authoritative voice in global medicine validates our commitment to data transparency and meeting the stringent peer-review standards of world leading medical journals."
"The data from our product development and clinical trials have been published in 10 peer-reviewed journals, making Covaxin one of the most highly published COVID-19 vaccines in the world. This accomplishment reflects the undeterred commitment by my team members at Bharat Biotech, our public partners, Indian Council of Medical Research, National Institute of Virology, and the trust imposed by our trial participants who made this happen," Bharat Biotech Chairman Krishna Ella said in a statement.
The phase 3 trial Efficacy and Safety Study involving 25,800 volunteers across 25 sites in India is India's largest ever clinical trial conducted for a Covid-19 vaccine.
Balram Bhargava, Director General, Indian Council of Medical Research (ICMR) said, following successful isolation of the SARS-CoV-2 virus at NIV, ICMR and Bharat Biotech embarked upon one of the most successful public-private partnerships to develop the virus isolate into an effective COVID-19 vaccine.
"I am delighted to see that the phase III efficacy data has also been published in The Lancet, one of the most reputed journals worldwide. This itself speaks high about the strong position of Covaxin amongst other global front-runners COVID-19 vaccines," Bhargava said.
The bench to bedside journey of Covaxin in less than 10 months showcases the immense strength of "Atmanirbhar Bharat" along with the Indian academia and industry in fighting against the odds and carving a niche in the global community, he added.
Recently, the World Health Organisation granted emergency use listing to Covaxin, enabling countries to expedite their regulatory approval to import and administer doses.
The jab has also received emergency use authorisations in several countries with applications in process in more than 50 countries worldwide.
Bharat Biotech has partnered with Ocugen to obtain approvals for Covaxin in the United States and Canada.
With more than 150 million doses manufactured, supplied, and with an excellent safety and efficacy profile, Covaxin is a major contributor to the global fight against the COVID-19 pandemic, the statement said.
Covaxin is currently being evaluated in controlled clinical trials in children 2-18 years of age, with results available during Q4 2021.
Bharat Biotech is poised to achieve its goal of an annualised capacity of about 1.0 billion doses of the jab by the end of 2021.
"The submission is based on results of a Phase 2/3 pediatric clinical trial conducted by Bharat Biotech in India with 526 children two-18 years of age, which bridged immunogenicity data to a large, Phase 3 safety and efficacy clinical trial in nearly 25,800 adults in India," it said in a statement.
Covaxin uses the same Vero Cell manufacturing platform as other childhood vaccines, including the inactivated polio vaccine.
A Phase 2/3, open-label, multicentre study was conducted in India from May 2021 to July 2021, to evaluate the safety, reactogenicity and immunogenicity, of the whole-virion inactivated SARS-CoV-2 Vaccine in healthy volunteers in the above mentioned age group.
Covaxin was evaluated in three age groups: two-six years, six-12 years and 12-18 years. All participants received two doses of the whole virion inactivated SARS-CoV-2 virus vaccine 28 days apart, added the statement from Ocugen.
The neutralising antibody responses against wild-type strain in the paediatric age group of two-18 years were equivalent to those seen in adults, aged 18 and above, in Bharat Biotech's large Phase 3 efficacy and safety trial.
"Filing for EUA in the US for pediatric use is a significant step toward our hope to make our vaccine candidate available here and help combat the Covid-19 pandemic," said Shankar Musunuri, Chairman of the Board, Chief Executive Officer, and Co-Founder of Ocugen.
Among the 526 study subjects in the pediatric clinical trial, no serious adverse effects, such as deaths, hospitalisations, myocarditis, pericarditis, Guillain-Barre syndrome, vaccine-induced thrombotic thrombocytopenia or anaphylactic reactions were reported in the study, the statement added.
Bharat Biotech's Covaxin and AstraZeneca and Oxford University's Covishield are the two widely used vaccines in India.
Australia has already recognised Covishield.
"Today, the Therapeutic Goods Administration (TGA) determined that Covaxin (manufactured by Bharat Biotech, India) and BBIBP-CorV (manufactured by Sinopharm, China) vaccines would be 'recognised' for the purpose of establishing a traveller's vaccination status, Australia's medicines and medical devices regulator TGA said in a tweet.
This recognition is for travellers aged 12 and over who have been vaccinated with Covaxin, and those 18 to 60 who have been vaccinated with BBIBP-CorV.
In recent weeks, the TGA has obtained additional information demonstrating these vaccines provide protection and potentially reduce the likelihood that an incoming traveller would transmit COVID-19 infection to others while in Australia or become acutely unwell due to COVID-19.
The supporting information has been provided to the TGA from the vaccine sponsor and/or the World Health Organisation.
Today, the @TGAgovau determined that Covaxin (manufactured by @BharatBiotech,) vaccine would be 'recognised' for the purpose of establishing a traveller's vaccination status, Australia's High Commissioner to India Barry O'Farrell AO said on Twitter,
Importantly, recognition of #Covaxin, along with the previously announced recognition of #Covishield (manufactured by @AstraZenecaIn), means many citizens, as well as other countries, will now be considered fully vaccinated on entry to Australia, he said in another tweet.
"Vaccination is the most important thing to strengthen the country's fight against coronavirus. Released the first commercial batch of #COVAXIN from Bharat Biotech's plant at Ankleshwar, Gujarat today. This will increase the supply of vaccine in the country and will help the vaccine reach every Indian," Mandaviya said on social media.
In May, Bharat Biotech had announced that it planned to produce an additional 200 million doses of Covaxin at its subsidiary Ankleshwar-based facility.
India's vaccination coverage against coronavirus under the mass vaccination drive has crossed the landmark of 63 crore. Over 73 lakh doses have been administered in the last 24 hours.
However, India reported a total of 45,083 new Covid-19 cases and 460 deaths in the last 24 hours, according to the health ministry's data. The active caseload in the country stands at 3,68,558. The surge in daily Covid cases has been driven by a recent spike in Kerala, which accounts for more than half of all the active Covid-19 cases in the country, followed closely by Maharashtra.
(IANS)
"Bharat Biotech's intranasal vaccine is the first nasal vaccine that has received the regulatory approval for Phase 2/3 trials. This is the first of its kind Covid-19 jab to undergo human clinical trials in India. BBV154 is an intranasal replication-deficient chimpanzee adenovirus SARS-CoV-2 vectored vaccine.BBIL has in-licensed technology from Washington University in St Louis, USA," a Ministry of Science & Technology statement said.
Phase 1 clinical trial has been completed in age groups ranging from 18 to 60 years. The company reports that the doses of the vaccine administered to healthy volunteers in the Phase I trial have been well-tolerated, and no serious adverse events were reported. Previously, the vaccine was found to be safe, immunogenic, and well-tolerated in the pre-clinical toxicity studies. The vaccine was able to elicit a high level of neutralising antibodies in animal studies.
The regulatory approval has been received for conducting "Phase 2 randomised, multi-centric, clinical trial of the heterologous prime-boost combination of SARS-CoV-2 vaccines to evaluate the immunogenicity and safety of BBV152 (Covaxin) with BBV154 (Adenoviral Intranasal Covid-19 vaccine) in healthy volunteers.
Secretary, Biotechnology and BIRAC Chairperson, Dr Renu Swarup, said that "the department, through mission Covid Suraksha, is committed to the development of safe and efficacious Covid-19 vaccines. Bharat Biotech's BBV154 Covid vaccine is the first intranasal vaccine being developed in the country entering into late-stage clinical trials."
The union health minister said in a tweet that following PM Midi's vision, it will increase vaccine availability and accelerate the world's largest vaccine drive.
"Govt of India approves vaccine manufacturing facility for production of @BharatBiotech's Covaxin in Ankleshwar, Gujarat. Following PM NarendraModi ji's vision of #SabkoVaccineMuftVaccine, this will increase vaccine availability & accelerate the world's largest vaccine drive", the minister tweeted on Tuesday.
Meanwhile, India on Tuesday recorded the lowest fresh daily Covid cases in the last 147 days as a total of 28,204 new cases of Covid-19 were detected across the nation in the last 24 hrs. With 373 deaths in the same time span, the death toll due to Covid-19 has climbed to 4,88,682, said the Covid bulletin released by the Ministry of Health and Family Welfare.
India's Covid vaccination coverage has crossed 51 crores cumulatively. A total of 54,91,647 doses of vaccines were administered in the last 24 hrs, pushing the total vaccination so far at 51,45,00,268, said the bulletin released by the ministry.
Bharat Biotech Chairman and Managing Director Krishna Ella said all documents required for EUL of Covaxin have been submitted to WHO as of July 9.
"The review process has now commenced with the expectation that we will receive EUL from WHO at the earliest," he said.
The Hyderabad-based company had said in May that that application for EUL was submitted to WHO-Geneva and regulatory approvals are expected by July-September 2021.
On June 30, the vaccine maker announced that it is working closely with the WHO for inclusion of Covaxin in its EUL.
"Approval from WHO is not expected to be a long-drawn process as the cell line and majority of our facilities have already been audited and approved by WHO for our other vaccines in the past," it had said.
"We are a step closer to the final decision on Covaxin's global acceptance, as the rolling data is slated to begin in July 2021," it added.
The company claims that with 10 scientific publications in 12 months, Covaxin is one of the very few vaccines to have extensive data published in globally-renowned peer-reviewed journals.
SII is likely to introduce the Novavax vaccine, to be known as Covavax in the country, by September.
This week Novavax Inc announced that its vaccine has turned out to be more than 90 per cent effective in clinical trials conducted in the US.
Bharat Biotech has already begun clinical trials of Covaxin for children in the 6-12 age group.
Novavax Inc had announced that NVX-CoV2373, its recombinant nanoparticle protein-based Covid-19 vaccine, demonstrated 100 per cent protection against moderate and severe disease, 90.4 per cent efficacy overall, and met the primary endpoint in its PREVENT-19 pivotal Phase 3 trial.
The study enrolled 29,960 participants across 119 sites in the US and Mexico to evaluate efficacy, safety and immunogenicity, with an emphasis on recruiting a representative population of communities and demographic groups most impacted by Covid-19.
The company intends to file for regulatory authorisations in the third quarter, upon completion of the final phases of process qualification and assay validation needed to meet chemistry, manufacturing and controls (CMC) requirements.
Upon regulatory approvals, Novavax remains on track to reach a manufacturing capacity of 100 million doses per month by the end of the third quarter and 150 million doses per month by the end of the fourth quarter of 2021.
"PREVENT-19 confirms that NVX-CoV2373 offers a reassuring tolerability and safety profile," said Gregory M. Glenn, President of Research and Development, Novavax.
"These data show consistent, high levels of efficacy and reaffirm the ability of the vaccine to prevent Covid-19 amid ongoing genetic evolution of the virus," Glenn added.
The company's co-founder and joint managing director Suchitra Ella on Wednesday tweeted that Andhra Pradesh, Assam, Delhi, Gujarat, Karnataka, Madhya Pradesh, Maharashtra, Tamil Nadu, and Telangana were supplied the vaccines through government of India from June 8 to 14.
The Hyderabad-based vaccine maker also made supplies to 16 states during the same period. The states are Assam, Bihar, Chhattisgarh, Delhi, Haryana, Jharkhand, Karnataka, Madhya Pradesh, Odisha, Punjab, Rajasthan, Tamil Nadu, Telangana, Tripura, Uttarakhand, and West Bengal.
She also tweeted that vaccine doses were also dispatched to private hospitals in 27 cities across the country from June 8 to 14.
These include Delhi, Mumbai, Chennai, Kolkata, Bangalore and Hyderabad. A total of seven cities in Telangana and Andhra have dispatched the vaccine under this category.
She, however, has not provided details like the number of doses dispatched under the three categories.
"Our mission is to deliver Covaxin to your towns-cities & states. Pls register & vaccinate @ govt or pvt hospitals near you," tweeted Suchitra Ella.
The company had Monday defended differential pricing policy for the central and state governments and private sector.
It said that the supply price of Covaxin to the government of India at Rs 150 per dose, is a non-competitive price and clearly not sustainable in the long run. Hence a higher price in private markets is required to offset part of the costs, it said in a statement.
The company clarified that Covaxin is more expensive for the private sector is due to fundamental business reasons, ranging from low procurement volumes, high distribution costs, and retail margins.
At Rs 1,200 per dose for private hospitals, Covaxin is reported to be the third costly vaccine globally.
Bharat Biotech had fixed the price of Covaxin for state governments at Rs 600 per dose but later slashed it to Rs 400.
The process will extend Covaxin timelines for seeking US approvals, the company said in a statement.
The FDA had on Thursday recommended Ocugen, the US partner of the Indian vaccine maker, to "pursue a Biologics Licence Application (BLA) submission instead of an EUA application" and "requested additional information and data".
"Our US partner, Ocugen, has received a recommendation from the FDA to pursue Biologics License Applications (BLA) path for COVAXIN which is full approval instead of EUA. All applications have to follow the BLA process, which is the standard process for vaccines," Bharat Biotech said in a statement.
"Therefore, for BLA, data from an additional clinical trial will be required to support the marketing application submission for COVAXIN This process will extend our timelines," it added.
The company said that no vaccine manufactured or developed from India has ever received EUA or full licensure from USFDA.
"Thus, it will be a Great Leap Forward for vaccine innovation and manufacturing from India when approved."
"With good herd immunity and a significant percentage of the population vaccinated, the pandemic is reducing in the United States (US). On the sidelines of this, the USFDA had earlier communicated that no new emergency use authorization (EUA) would be approved for new Covid-19 vaccines," the statement noted.
Covaxin has received approval for emergency use from 14 countries with more than 50 countries in the process. More than 30 million doses of the vaccine have been supplied in India and other countries.
"Although we were close to finalising our EUA application for submission, we received a recommendation from the FDA to pursue a BLA path. While this will extend our timelines, we are committed to bringing Covaxin to the US," said Shankar Musunuri, Chairman of the Board, Chief Executive Officer, and Co-founder of Ocugen, in a statement on Thursday.
"This differentiated vaccine is a critical tool to include in our national arsenal given its potential to address the SARS-CoV-2 variants, including the delta variant, and given the unknowns about what will be needed to protect US population in the long term," Musunuri added.
Ocugen recently announced that it secured exclusive rights to commercialise Covaxin in Canada and has initiated discussions with Health Canada for regulatory approval.
"The Company will pursue expedited authorisation for Covaxin under the Interim Order Respecting the Importation, Sale and Advertising of Drugs for Use in Relation to Covid-19 in Canada," the statement said.
Covaxin has so far emerged safe in clinical trials to date, said Bruce Forrest, Acting Chief Medical Officer and member of the vaccine scientific advisory board of Ocugen.
The "Ministry of Health and Family Welfare of Republic of India reported no potential thromboembolic events following the administration of over 6.7 million doses of Covaxin," Forrest added.
Bharat Biotech developed Covaxin in collaboration with the Indian Council of Medical Research (ICMR) - National Institute of Virology (NIV).
It is an inactivated vaccine that is manufactured using a vero cell manufacturing platform. Covaxin has showed strong results in all the studies conducted to date including a vaccine efficacy rate of 78 per cent overall efficacy and 100 per cent in severe Covid-19 disease, including hospitalisations, in second interim results of Bharat Biotech's Phase 3 clinical trial.
Covaxin studies show that it effectively neutralised the Brazil variant of SARS-CoV-2, B11282, the alpha variant, B117, which was first identified in the UK, as well as the delta variant, B1617, which was first identified in India.
The company earlier said it started the supplies based on the allocations received by the Government of India.
"Requests have been received from other states, & will be processed for distribution based on availability of stocks 24x7," Bharat Biotech co-founder and Joint Managing Director Suchitra Ella had tweeted earlier.
Bharat Biotech had on April 24 announced pricing for Covaxin. It fixed the price of Covaxin at Rs.600 per dose for state governments.
However, it later slashed the price to Rs.400. This came after Serum Institute of India (SII) cut the price of Covishield to Rs.300 from Rs.400 earlier.
The two vaccine makers slashed the prices after the central government reportedly made a request to them amid the row over different pricing for the central and state governments.
For private hospitals, Bharat Biotech fixed the price at Rs.1,200 per dose. This is twice the cost fixed for Covishield.
For exports, Bharat Biotech has priced India's first indigenous Covid vaccine at $15-$20 (Rs 1,125-1,500).
Ever since the launch of Covid vaccination programme in India, Bharat Biotech and SII have been supplying their vaccines to the Centre at Rs.150 per dose.
While Bharat Biotech is likely to continue the supplies to the Centre at the same price, SII is seeking to revise this to Rs.400.
Both Bharat Biotech and SII have announced that they are reserving 50 per cent of their production capacities for supplies to the central government.
The states are Andhra Pradesh, Assam, Chhattisgarh, Delhi, Gujarat, Jammu & Kashmir, Jharkhand, Madhya Pradesh, Maharashtra, Odisha, Tamil Nadu, Telangana, Uttar Pradesh and West Bengal.
The Hyderabad-based company said it started the supplies based on the allocations received by the Government of India.
"Requests have been received from other states, & will be processed for distribution based on availability of stocks 24x7," tweeted Bharat Biotech co-founder and Joint Managing Director Suchitra Ella.
The company, however, has not come out with details of the supplies like the number of doses supplied to the states.
Bharat Biotech on April 24 announced pricing for Covaxin. It fixed the price of Covaxin at Rs 600 per dose for state governments.
However, it later slashed the price to Rs 400. This came after Serum Institute of India (SII) cut the price of Covishield to Rs 300 from Rs 400 earlier.
The two vaccine makers slashed the prices after the central government reportedly made a request to them amid the row over different pricing for the central and state governments.
For private hospitals, Bharat Biotech fixed the price at Rs 1,200 per dose. This is twice the cost fixed for Covishield.
For exports, Bharat Biotech has priced India's first indigenous Covid vaccine at $15-$20 (Rs 1,125-1,500).
Ever since the launch of Covid vaccination programme in India, Bharat Biotech and SII have been supplying their vaccines to the Centre at Rs.150 per dose.
While Bharat Biotech is likely to continue the supplies to the Centre at the same price, SII is seeking to revise this to Rs 400.
Both Bharat Biotech and SII have announced that they are reserving 50 per cent of their production capacities for supplies to the central government.
“Bharat Biotech is deeply concerned with the critical pandemic circumstances that India is facing at this time. Recognising the enormous challenges to the public health care system, we have made Covaxin available to State Governments at a price of Rs.400/dose,” the vaccine maker said in a statement.
“We wish to be transparent in our approach to pricing which was determined by internally funded product development, several operationally-intensive BSL-3 manufacturing facilities the first of its kind in our country) and clinical Viols,” it added.
The vaccine manufacturer further said, “We wish to champion “Innovation in India” and our commitment to public health is absolute.”
For the last year Team Bharat Biotech has been fearlessly handling Live SARS-CoV-2 virus strains, tirelessly working round-the-clock while overcoming many challenges given the uncertainty of the pandemic.
With the greater part of the organization’s facilities and resources being diverted to COVID-19 vaccines, we continue to work towards offering superior COVID-1 9 vaccines and sincerely wish that this gesture enables our country towards a foster recovery.
We offer our prayers to all the citizens of India and wish them safety and health!
#BREAKING | Bharat Biotech announces price for #Covaxin.
State Govt: 600 INR
Pvt Hospitals: 1200 INR pic.twitter.com/JXSaf2zwXe— OTV (@otvnews) April 24, 2021
In a statement, Bharat Biotech Chairman and Managing Director Krishna M Ella said the company is supplying the vaccine to the central government at Rs 150 per dosage and the government on its part is distributing it free of cost.
“We would like to state that more than 50 per cent of our capacities have been reserved for central government supplies,” Ella said.
Recovering the cost is essential in the journey of innovation towards other vaccines such as intranasal Covid-19, Chikungunya, Zika, Cholera and others, he added.
India has administered 14 crore doses of COVID-19 vaccine in just 99 days, the fastest in the world, the Health Ministry said on Saturday.
More than 24 lakh vaccine doses were administered on Saturday till 8 pm, the ministry said.
The cumulative number of COVID-19 vaccine doses administered in the country stands at 14,08,02,794, according to a provisional report at 8 pm.
“India became the fastest country to administer 14 crore doses of COVID-19 vaccine in just 99 days,” the ministry said.
The beneficiaries include 92,89,621 healthcare workers (HCWs) who have taken the 1st dose and 59,94,401 HCWs who have taken the 2nd dose, 1,19,42,233 frontline workers (FLWs) who have got the first dose, and 62,77,797 FLWs the second dose.
As many as 4,76,41,992 people aged between 45-plus and 60 have got the first dose and 23,22,480 in the age group received the second dose.
As many as 4,96,32,245 beneficiaries aged above 60 years have got the first dose and 77,02,025 the second dose, the ministry said.
On Saturday, the 99th day of the nationwide vaccination drive, a total of 24,22,989 vaccine doses were given till 8 pm — 15,69,631 beneficiaries for the first dose and 8,53,358 for the second dose.
Phase-I of the nationwide COVID-19 vaccination drive was launched on January 16, prioritizing protection for healthcare workers and frontline workers.
The phase-II was initiated from March 1, focusing on protecting most vulnerable i.e. all people above 45 years of age.
Everyone above 18 years of age will be eligible to get vaccinated against COVID-19 from May 1, the central government said on Monday as it liberalised the vaccination drive to allow states, private hospitals and industrial establishments to procure the doses directly from manufacturers.
The B1617 variant, first detected in Maharashtra, contains mutations from two separate virus variants — E484Q and L452R. The third mutation evolved from the double mutation where three different Covid strains combined to form a new variant.
Two of these triple-mutant varieties have been found in samples collected from Maharashtra, Delhi, West Bengal and Chhattisgarh.
The RNA virus has the potential to acquire mutations as it replicates and spreads. These mutations can, sometimes, result in virus variants with better adaptability to its environment.
“As the virus spreads, it gets more opportunities to acquire mutations and evolve at a faster rate. This is a natural aspect of virus life-cycle but it is very important that we track these changes (virus surveillance) and follow the important viral characteristics associated with these mutations,” Dr Veena P. Menon, Faculty-In-Charge, Clinical Virology Laboratory, Amrita Institute of Medical Sciences, Kochi, told IANS.
While the SARS-CoV2, causing the Covid-19 infections, has evolved at a much slower rate compared to Influenza or HIV viruses but as the number of infections rises, we are observing a rapid emergence of numerous viral variants.
With the increase in the number of infections and spread, there are more opportunities for the virus to mutate.
“As the infections are increasing at an alarming rate, there is a very high likelihood that we will encounter more virus variants in our population. Some of these variants get selected for faster transmissibility (spread) or ‘increased severity’ (more pathogenic) and also “immune (vaccine) escape”, Menon explained.
The evidence so far suggests that none of the important virus variants are associated with increased severity. However, an increased transmissibility is associated with the UK variant (lineage B1.1.7) while the Brazilian and South African variants exhibit ability to escape vaccine-induced immunity.
“Mutation in the respiratory virus is a natural process. This process is augmented in situations of high spread and presence of vaccinated people in the community. We will see more variants in India in future too,” Dr Harshal R. Salve, Associate Professor at Centre for Community Medicine, AIIMS New Delhi, told IANS.
Stricter implementation of public health infection control measures like usage of masks, social distancing and vaccinations are all key to prevent the spread. Besides, the need is to continue monitoring the virus evolution, the experts said.
“Combining genetic surveillance methods with evaluation of the biological and clinical characteristics of these virus variants will aid in better understanding virus variants and its clinical and public health impact,” Menon added.
Vaccinations can play a great role in curbing the spread of Covid.
Covaxin, developed by Bharat Biotech, is able to “effectively neutralise” the double mutant strains, including the UK variant and the Brazil variant of the coronavirus, the Indian Council of Medical Research (ICMR) said in a report.
SII will supply 200 million doses and Bharat Biotech is to supply another 90 million doses to the government by July at a pre-agreed rate of Rs 150 per dose.
Sources said the finance ministry has relaxed rules to allow advance payment without bank guarantee to help the vaccine makers ramp up production.
SII will get Rs 3,000 crore in advance and Bharat Biotech about Rs 1,500 crore.
Earlier this month, SII CEO Adar Poonawalla had said that the company would require around Rs 3,000 crore to ramp up production capacity for making vaccines for COVID-19.
Meanwhile, the government on Monday allowed citizens over the age of 18 years to receive Covid-19 vaccination from May 1 as it seeks to control the rapid spread of the virus.
Under the third phase of its vaccination strategy, manufacturers will be required to supply 50 per cent of their monthly doses to the government and the rest to state governments or the open market.
Vaccination will continue as before in the government of India vaccination centres free of cost for the eligible population — healthcare and frontline workers and all people above 45 years of age.
Latest data showed that over 2.59 lakh coronavirus infections pushed overall cases in India to more than 1.53 crore, making the country the second-worst affected nation after the US, which has reported more than 3.1 crore infections. India’s deaths from COVID-19 rose by a record 1,761 to over 1.8 lakh.
According to a statement issued by the ICMR, the team will use the virus strain isolated at ICMR's National Institute of Virology (NIV) in Pune.
"The strain has been successfully transferred from NIV to Bharat Biotech International Ltd (BBIL). Work on vaccine development has been initiated between the two partners. ICMR-NIV will provide continuous support to BBIL for vaccine development. ICMR and BBIL will seek fast-track approvals to expedite vaccine development, subsequent animal studies and clinical evaluation of the candidate vaccine," read the statement.
.@ICMRDELHI has transferred the #Covid_19 strain isolated at @icmr_niv to @bharatbiotech. We will be partnering with them to develop an indigenous #Covid_19 vaccine!#icmrfightscovid19 #IndiaFightsCoronavirus @MoHFW_INDIA #MakeInIndia pic.twitter.com/Q73JZsU30f
— ICMR (@ICMRDELHI) May 9, 2020
According to the Union Health Ministry data, India has so far reported 59,662 Covid-19 cases of which 17,847 persons have been cured while 1,981 people have succumbed to the dreaded virus.
Leading vaccine maker Bharat Biotech 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.
(IANS)
The Drug Controller General of India - CDSCO, Ministry of Health & Family Welfare granted permission to initiate Phase I & II Human clinical trials after the company submitted results generated from preclinical studies, demonstrating safety and immune response. Human clinical trials are scheduled to start across India in July 2020.
Announcing the vaccine development milestone, Dr. Krishna Ella, Chairman, and Managing Director said: “We are proud to announce COVAXIN, India’s first indigenous vaccine against COVID-19. 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. Our R&D and Manufacturing teams worked tirelessly to deploy our proprietary technologies towards this platform.”
Expedited through national regulatory protocols, the company accelerated its objective in completing the comprehensive pre-clinical studies. Results from these studies have been promising and show extensive safety and effective immune responses.
Speaking about Bharat Biotech’s prowess, Mrs. Suchitra Ella, Joint Managing Director said, “Our ongoing research and expertise in forecasting epidemics has enabled us to successfully manufacture a vaccine for the H1N1 pandemic. Continuing our focus on creating the only BSL-3 containment facilities for manufacturing and testing in India, Bharat Biotech is committed to advancing vaccine development as a matter of national importance to demonstrate India’s strength in handling future pandemics.”
Bharat Biotech’s track record in developing vero cell culture platform technologies has been proven in several vaccines for Polio, Rabies, Rotavirus, Japanese Encephalitis, Chikungunya, and Zika.
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In his tweet, the minister also said the vaccine has been administered to three persons who have shown no adverse effect to it.
"Human trial with Corona vaccine (COVAXIN) of Bharat Biotech started at PGI Rohtak today, said Vij, who is also the Home and Science & Technology minister.
Three subjects were enrolled today. All have tolerated the vaccine very well. There were no adverse effects, Vij further said in his tweet.
The minister later told reporters in Ambala that more vaccine candidates will be enrolled for the trial in coming days .
Bharat Biotech got the country's drug regulator's approval to start clinical trials of its anti-Corona vaccine Covaxin recently.
There are over seven anti-corona vaccines at various stages of development in the country with two of them having received the drug regulator's go-ahead to start the human clinical trials of their vaccines.
Earlier on Wednesday, Drug firm Zydus Cadila had said it has started human clinical trials of its COVID-19 vaccine candidate ZyCoV-D.
In the phase of trials, the company will be enrolling over 1,000 subjects across multiple clinical study sites in India, it had said in a regulatory filing.
Zydus had earlier this month said it it has received approval from authorities to start human trials for its anti-COVID-19 vaccine.
Zydus had got the approval a few days after India's first indigenous COVID-19 vaccine candidate COVAXIN, developed by Bharat Biotech in collaboration with Indian Council of Medical Research and National Institute of Virology, got the nod for human clinical trials from the Drug Controller General of India.
(PTI)
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Bharat Biotech, Serum Institute, Zydus Cadila, Panacea Biotec, Indian Immunologicals, Mynvax and Biological E are among the domestic pharma firms working on the coronavirus vaccines in India.
Vaccines normally require years of testing and additional time to produce at scale, but scientists are hoping to develop a coronavirus vaccine within months because of the pandemic.
Bharat Biotech has received approval to conduct phase I and II clinical trial for its vaccine candidate Covaxin, that has been developed and manufactured in the company's facility in Hyderabad. It last week started human clinical trials.
Leading vaccine major Serum Institute of India has said that it is hoping to develop a COVID-19 vaccine by the year-end.
"At present, we are working on the AstraZeneca Oxford vaccine which is undergoing phase III clinical trials. In addition to this, we will also start human trials in India in August 2020. Based on the current situation and most recent updates on the clinical trials, we are hoping that the AstraZeneca Oxford vaccine will be available towards the end of this year," Serum Institute of India CEO Adar Poonawalla told PTI.
The company is also developing a live attenuated vaccine with US-based biotech firm Codagenix, which is undergoing pre-clinical trials, he added.
"Apart from AstraZeneca Oxford vaccine and Codagenix, we have associated with multiple institutions worldwide as manufacturing partners for vaccine candidates that are being developed. These include Austria's Themis along with two others," Poonawalla said.
On the partnership with AstraZeneca, Poonawalla said: "Serum Institute of India has entered a manufacturing partnership with AstraZeneca to produce and supply 1 billion doses of the COVID-19 vaccine being developed by Oxford University."
These vaccines will be for India and middle and low-income countries across the world (GAVI countries), he added.
Pharma major Zydus Cadila has said that it is looking to complete clinical trials of its COVID-19 vaccine candidate ZyCoV-D in seven months.
The company had last week started clinical trials of its COVID-19 vaccine candidate with the first human dosing.
Depending on the study outcomes and if the data is encouraging and the vaccine is found to be effective during the trials, it could take a total of seven months for the trials to be completed and for the vaccine to be launched, Zydus Cadila Chairman Pankaj R Patel said in a statement.
Hyderabad-based Bharat Biotech last week started human trials of its vaccine Covaxin at Rohtak's Post-Graduate Institute of Medical Sciences.
The phase I and II clinical trials of the vaccine for SARS-CoV-2 by Bharat Biotech have been approved by the Indian drug regulator after pre-clinical studies demonstrated safety and immune response.
The company has developed the vaccine in collaboration with the Indian Council of Medical Research (ICMR) and the National Institute of Virology (NIV).
Panacea Biotec in June said that it was setting up a joint venture firm in Ireland with US-based Refana Inc to develop a vaccine for COVID-19.
The company in partnership with Refana aims to manufacture over 500 million doses of COVID-19 candidate vaccine, with over 40 million doses expected to be available for delivery early next year, Panacea Biotec had said.
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.
Others like Mynvax and Biological E are also working to develop vaccines for COVID-19.
Vaccines typically provide the immune system with harmless copies of an antigen: a portion of the surface of a bacterium or virus that the immune system recognises as foreign. A vaccine may also provide a non-active version of a toxin a poison produced by a bacterium so that the body can devise a defence against it. They must follow higher safety standards than other drugs because they are given to millions of healthy people.
Vaccine testing 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 around two dozen are in various phases of human clinical trials.
Chinese company Sinovac Biotech is moving into phase III trials in Brazil while University of Oxford/AstraZeneca is in a combine phase II/III trial in the UK and has recently gone into phase III trials in South Africa and Brazil.
US-based Moderna expects to start phase III trials of its vaccine candidate this month.
Among other leading players, German firm BioNTech is collaborating with pharma major Pfizer to develop a vaccine for COVID-19.
The companies have received fast track designation from the US Food and Drug Administration (USFDA) for two investigational vaccine candidates being developed to help protect against SARS-CoV-2.
(PTI)
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COVAXIN-India’s 1st COVID-19 Vaccine Candidate Gets DCGI Nod For Human Trials
The Hyderabad-based vaccine maker received the approval from Central Drugs Standard Control Organisation under the Directorate General of Health Services to conduct the phase II trials of indigenous vaccine candidate Covaxin.
Joint Drugs Controller Dr S. Eswara Reddy wrote a letter to Bharat Biotech International, conveying the organisation's nod for conducting the phase II trials.
These trials of the BBV152 coronavirus vaccine or Covaxin will be conducted on 380 participants, who will have to be screened for four days after they receive the vaccine shots.
Through the letter, which IANS has seen, the Joint Drugs Controller said that the directorate had no objection to conducting the trial titled 'An adaptive, seamless Phase I, followed by Phase II randomized, double-blind, multicentre study to evaluate the safety, reactogenicity, tolerability and immunogenicity of the whole-virion inactivated SARS-CoV-2 vaccine (BBV152) in healthy volunteers'.
The letter mentions that Bharat Biotech's request for approval to initiate phase II clinical trials was examined in consultation with Subject Expert Committee (COVID-19) experts held through virtual meeting on September 3.
"This is to inform you that the subject proposal was examined in consultation with SEC (COVID-19) experts held through virtual meeting on 03-09-2020, wherein the committee recommended for the conduct of Phase II part of clinical trials with 380 participants subject to the condition that time for screening the participants should be revised to 4 days," reads the letter dated September 3.
Phase I clinical trials of the vaccine began on July 15 at 12 centres across the country where healthy volunteers were administered two doses of vaccination shots with a gap of 14 days. These trials on 375 volunteers are still continuing.
The subjects were monitored at the respective centres for two days after they were administered the vaccine shots. In the phase II clinical trials, this period has been revised to four days.
Bharat Biotech had announced on June 29 that it had 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.
Last month, SEC also approved Bharat Biotech's proposal to conduct trials using the intradermal (ID) vaccine delivery route.
Under this route, the vaccine shot is given in the dermis, one of the layers of the skin. Experts say the shot is less invasive, requires lesser dosage and sometimes, helps the vaccine show better immune response.
At the SEC meeting held on August 13, Bharat Biotech presented its proposal for the conduct of Phase I and II clinical trials of Covaxin by ID route.
The SEC, while recommending approval, laid down the conditions that the trial sites should be different from the sites where the present clinical trials are going on for the vaccine through the intramuscular route and that the subject should be followed up for six months for clinical and antibody assessments.
(IANS)
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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.
Bharat Biotech proudly announces the animal study results of COVAXIN™ - These results demonstrate the protective efficacy in a live viral challenge model.
Read more about the results here - https://t.co/f81JUSfWpD@icmr_niv #BharatBiotech #COVAXIN #Safety #Vaccine #SARSCoV2 pic.twitter.com/fva1SOcLOr
— BharatBiotech (@BharatBiotech) September 11, 2020
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.
"One group was administered a placebo while three groups were immunised with three different vaccine candidates at 0 and 14 days. All the macaques were challenged with SARS-CoV-2 14 days after the second dose. The protective response was observed with increasing SARS-CoV-2 specific IgG and neutralising antibody titres from third week post-immunisation," it said.
"Viral clearance was observed from bronchoalveolar lavage fluid, nasal swab, throat swab, and lung tissues at 7 days post-infection in the vaccinated groups. No evidence of pneumonia was observed by histopathological examination in vaccinated groups, unlike the placebo group which showed features of interstitial pneumonia and localisation of viral antigen in the alveolar epithelium and macrophages by immunohistochemistry."
"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.
(IANS)
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The Hyderabad-based company owns the rights to distribute the vaccine in all markets except USA, Japan and Europe.
While the Phase I trials will take place in Saint Louis University's Vaccine & 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, Hyderabad.
According to Bharat Biotech, this intranasal vaccine candidate has shown unprecedented levels of protection in mice studies; the technology and data having been recently published in the prestigious scientific journal ‘Cell' and in an editorial in ‘Nature'.
"We are proud to collaborate on this innovative vaccine. We envision that we will scale this vaccine to 1 billion doses, translating to 1 billion 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," said Krishna Ella, Chairman and Managing Director of Bharat Biotech.
"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," he added.
David T. Curiel, Director of Biologic Therapeutics Center and Professor of Radiation Oncology at Washington University School of Medicine in St. Louis and Precision Virologics Interim CEO said that 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 protects 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 can't do that," he said.
This vaccine expands Bharat's 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, the company said.
(IANS)
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The minister said that the Hyderabad-based drugs and vaccine research and manufacturing company has entered into an agreement with Washington University and St. Louis University for the trials of the nasal vaccine candidate.
"It (Bharat Biotech) has entered into an agreement with Washington University's School of Medicine under which the company will conduct trials, produce and market an intranasal vaccine for the COVID-19," Vardhan told his social media audience at his weekly webinar, Sunday Samvaad.
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The minister also informed that the Phase 1 trials of the vaccine candidate will take place in St Louis University's vaccine and treatment evaluation unit while further stages of the trials will be conducted in India.
"Bharat Biotech on receipt of regulatory approval will pursue further stages of clinical trials in India," he added.
Vardhan also informed about the development of another intranasal vaccine by the US-based biotech company Codagenix along with Serum Institute of India.
"Codagenix is collaborating with the Serum Institute of India to develop CDX-005, which is the company's intranasal, live-attenuated vaccine candidate for SARS-CoV-2. The preclinical animal studies have been successfully completed, and Codagenix expects to initiate a Phase 1 first-in-human clinical trial in the UK by the end of 2020," he said.
CDX-005 is a single dose intranasal vaccine made with a live attenuated version of the virus.
The World Health Organization (WHO) has cataloged 169 candidate vaccines for the COVID-19.
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The vast majority of these use a dead virus, genetic material from the virus, or components of the virus, such as the spike protein. Only Codagenix and two other developers have used a live attenuated version of the virus.
(IANS)
The Phase III trials of Covaxin will be conducted at 21 centres across India and at SUM hospital in Odisha (Bhubaneswar). The vaccine will be administered to nearly 2,000 volunteers in Odisha, informed Dr. E Venkata Rao, Principal Investigator of the trial at Institute of Medical Sciences and SUM Hospital.
Recently, the Drug Controller General of India (DCGI) granted permission to Bharat Biotech to start the Phase III trials of Covaxin.
The permission for the Phase III trials is subject to minor changes in the primary efficacy endpoint for the symptomatic cases.
The permission was granted to the vaccine maker to start Phase-III trials after it assessed data from the Phase-I and II trials along with the animal challenge study, sources said.
Around 28,500 people are expected to enroll for the Phase-III trials in the country who would be given two doses of the investigational vaccine.
(Edited By Suryakant Jena)
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Sai Prasad, Executive Director, Bharat Biotech International Limited (BBIL), told IANS that Phase I data for neutralising antibodies has shown good immunogenicity.
"Covaxin was found to be safe without any major adverse events in the first two stages of the trials involving about 1,000 participants. Having received the approval from DCGI after assessing data from Phase I and II as well as the results of animal challenge study, we have moved into the last phase of trials," he said.
"Our goal is to develop and deliver to the world a safe and effective vaccine. Phase I data for neutralising antibodies had shown good immunogenicity. Analysis of Phase II data is on," he said when asked to comment on the view by some experts that early vaccines may not be fully effective.
"We have tested four different strains (clades) in India and done work on functional immunological assays, which will show us if this generates T-cell response, memory response," he added.
The indigenous vaccine developed in collaboration with the Indian Council of Medical Research (ICMR) and the National Institute of Virology (NIV) is an inactivated intramuscular vaccine that works by injecting the inactivated version of SARS-CoV-2, the virus which causes Covid-19, into the body to develop an immune response.
"We follow a well-designed vaccine development protocol, and ensure each stage of our vaccine development is driven with a sole goal to attain a strong immune response rate in our clinical trials. When we do a trial design, we take into account the attack rates, the disease type, the ability of us to detect the disease and then the recruitment timelines," the official said when asked about the comparison with vaccines being developed by several companies around the world.
The Hyderabad-based vaccine maker hopes to apply for regulatory approval for the vaccine in the second quarter of 2021.
"The Phase III efficacy data will be available approximately at the end of Q1 in 2021, after which we will apply for regulatory approval for release of the vaccine. We will continue on to phase IV which routinely follows up the participants for a few years," said Prasad.
BBIL has initiated site preparatory exercises for Phase III clinical trials. Recruitment of volunteers and dosage plan will begin this month.
"Phase III trials will be conducted across 25 sites in about 10-12 states. Two doses will be administered to each of the vaccine and placebo recipients, respectively. We plan to test 25,000-26,000 volunteers in the third phase of trials for Covaxin, involving about 1,000 participants enrolled per hospital," Prasad said.
When asked about the timeline the company is looking at for the vaccine launch, Prasad merely said they were looking to apply for approval in 2021.
"Although speed is the need of the hour, we are committed to conduct our research in the most ethical and scientific manner. We are focussed on safety and efficacy and we look to apply for approval in 2021," he said.
The company is looking for vaccine supply to both the government and private markets. It is also in preliminary discussions with other countries for probable supply.
"Currently, we have built capacities to manufacture 200 million doses of vaccine. We plan to further enhance our capacities to 500 million doses," Prasad said.
It is investing about Rs 350-400 crore for the development of the vaccine and the new manufacturing facilities, which includes investments for conducting the Phase III clinical trials, in the next six months.
Bharat Biotech had announced on June 29 that it had successfully developed Covaxin in collaboration with ICMR and NIV.
The SARS-CoV-2 strain was isolated in NIV, Pune, and transferred to Bharat Biotech. The vaccine candidate has been developed and manufactured in Bharat Biotech's high containment facility located in Genome Valley, Hyderabad.
The Phase I trials began in July while Phase II trials started in September.
(IANS)
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Speculations became rife after Bharat Biotech’s Covid-19 vaccine candidate showed safety and efficacy during the phase 1 and 2 trials as well as animal studies. And if everything goes well in phase 3 trials, the country could see an early start for mass vaccination drives against coronavirus.
“As per our projection, we hope the vaccine will be manufactured by December end as 10 types of vaccines are under various stages of trial at present. As some of the vaccine candidates are now in phase 3 trials, it is certainly going to help,” said health expert, Dr Subrat Jena.
At present, there are three vaccine candidates undergoing human trials in India. Of these, the Oxford-AstraZeneca candidate is in the most advanced stage in Phase 3 and Pune-based Serum Institute is conducting the trials. The phase 3 data are expected to be released by November end or December this year.
Bharat Biotech’s Covaxin is now in phase 3 trials on nearly 25000 people across the country. The third phase human trial of indigenously developed COVID-19 vaccine will be carried at the Institute of Medical Sciences (IMS) and SUM Hospital in Odisha for which 2000 volunteers have enrolled so far.
Meanwhile, the Odisha government on Friday decided to fast track the setting up of an advanced vaccine manufacturing unit with an investment of Rs 300 crore at Andharua on the outskirts of Bhubaneswar.
Hyderabad-based Bharat Biotech International Limited (BBIL) has been roped in as the anchor developer and it will produce 10 types of vaccines including that of COVID-19 and malaria.
Bharat Biotech International Limited (BBIL) Chairman and Managing Director Krishna Ella said the company's Bio-Safety Level 3 (BSL-3) facility currently has limited capacity but hoped to reach one billion (100 crore) doses by next year.
"We have partnered with ICMR (Indian Council of Medical Research) for Covaxin and as we speak, we are entering phase III trials but I am not happy because it is a two-dose injectable vaccine. If we have to vaccinate 1.3 billion population with two dose vaccine, we need 2.6 billion (260 crore) syringes and needles," he said.
Ella was addressing Deccan Dialogue organised by the Indian School of Business (ISB) and supported by the Ministry of External Affairs (MEA) on 'Crisis and cooperation: Imperative in the times of pandemic'.
"We are working on another vaccine, a single dose nasal drop. We have experience of making Rotavirus and Polio nasal drop vaccines. We can scale up to 1 billion doses and my feeling is that by next year we will reach there," he said.
"The challenge is to vaccinate 1.3 billion population. Six billion (600 crore) people in the developing world have to be vaccinated but the opportunity is if 20 per cent of them are vaccinated, I have done my job as a scientist. You partly need vaccine because there will be herd immunity," he added.
The Hyderabad-headquartered vaccine maker announced in September that it is collaborating with the Washington University School of Medicine in St Louis, Missouri to manufacture a billion doses of a single-dose intranasal vaccine.
Ella also pointed out that 40,000 unknown viruses are existing. "10,000 viruses can hop from animal to animal and to human. What we are seeing today is only a sample. Because of its impact on economy it got more attention. We are yet to see lot many things."
Indian Institute of Technology (IIT), Hyderabad's Prof M. Vidyasagar, who is also the chairman of the 'COVID-19 Indian National Supermodel Committee', however, said for this pandemic 30 to 40 per cent people needed to be vaccinated to achieve herd immunity.
"The challenge is whether the cold weather especially in north India exacerbate this pandemic and whether we can predict this by observing the course of the pandemic," he said.
He noted that India had more success in controlling the pandemic unlike other countries like the US, the UK and France who have death rate per million 7 to 8 times higher than that of India.
"These countries have gone back to second lockdown because they see so-called second wave. This raises the question could proper modeling have helped these countries to foresee that there will be second wave, whether it could have helped the countries to assess effectiveness of the first lockdown, would the second lockdown be more effective this time when it was apparently not successful the last time," said Prof Vidyasagar.
Arti Ahuja, Additional Secretary, Ministry of Health and Family Welfare, said India should be proud of what it has done to deal with the pandemic.
She said from just one public health institute conducting COVID-19 test, the country now has 2,000 laboratories. According to her, it was not just the government but the participation of all stakeholders, including the private sector which helped the country deal with the pandemic.
(Nitesh Kumar Sahoo With IANS Inputs)
This is India's first Phase-3 efficacy study for a Covid-19 vaccine, and the largest Phase-3 efficacy trial ever conducted in India, the Hyderabad-based company said.
Trial volunteers will receive two intramuscular injections approximately 28 days apart. Participants will be randomly assigned to receive Covaxin or a placebo. The trial is double blinded, such that the investigators, the participants and the company will not be aware of who is assigned to which group.
The trials are being conducted at 22 institutes in India including the All India Institute of Medical Sciences (AIIMS), the Guru Tegh Bahadur Hospital (both New Delhi), the Aligarh Muslim University, the Grant Government Medical College and Sir J.J. Group of Hospitals, Lokmanya Tilak Municipal General Hospital and Medical College (Sion Hospital) (all three Mumbai), the ICMR-National Institute of Cholera and Enteric Diseases, Kolkata, the Directorate of Public Health and Preventive Medicine, Chennai and King George Hospital, Vizag.
Participating volunteers, who undergo vaccination in the Phase-3 trials, will be monitored to detect occurrence of Covid-19.
Covaxin has been evaluated in about 1,000 subjects in Phase-1 and Phase-2 clinical trials, with promising safety and immunogenicity data. Volunteers who wish to participate in this trial should be adults over 18 years of age.
Covaxin by Bharat Biotech is developed in collaboration with the ICMR - National Institute of Virology (NIV). This indigenous, inactivated vaccine is developed and manufactured in Bharat Biotech's BSL-3 (Bio-Safety Level 3) bio containment facility.
Covaxin is a highly purified and inactivated vaccine, manufactured in a vero cell manufacturing platform with an excellent safety track record of more than 300 million doses supplied.
"The development and clinical evaluation of Covaxin marks a significant milestone for vaccinology in India, for a novel vaccine. It is important for Indian companies to innovate and develop indigenous vaccines, especially during a pandemic. Covaxin has garnered interest from several countries worldwide for supplies and introduction," said Suchitra Ella, Joint Managing Director of Bharat Biotech.
(With IANS Inputs)
He made the announcement while reviewing the Coronavirus scenario in the State.
The Odisha government had already commenced process for the preparation of a comprehensive database of frontline workers including the health activists, Anganwadi workers and ASHA for seamless initiation of the vaccination programme.
The State wing of Indian Medical Association, AYUSH Association, Nursing Association, Paramedic Workers Association and Private Hospital Owners Association have been asked to submit details of their members to their respective district Collector, municipal commissioner or chief district medical officer for enrollment in the database.
Similarly, the government has also instructed officials of Women and Child Development (WCD) department and Mission Shakti to come up with the individual details of anganwadi workers, helpers, supervisors and child development project officers.
The Odisha government had earlier announced to establish an advanced vaccine manufacturing unit at Andharua on the outskirts of Bhubaneswar. The government will spend Rs 300 crore for the unit.
The unit will produce 10 types of vaccines including that of COVID-19 and malaria. Hyderabad-based Bharat Biotech International Limited (BBIL) will be the anchor developer.
According to sources, the Centre has planned to procure the vaccine and distribute to the States, which would utilise them on the priority groups. The Centre has requested the States not to go for separate procurement of the vaccine. The vaccine will be administered on priority basis free of cost under a special immunisation programme, sources added.
The money would go through the Covid-19 Vaccine Global Access (COVAX) Advance Market Commitment (AMC) mechanism, which will help support 92 low- and lower-middle-income countries' access through the COVAX Facility, said the statement.
The COVAX Facility is a global risk-sharing mechanism which seeks to procure, equitably allocate and deliver 2 billion doses of COVID-19 vaccines by the end of 2021.
Singapore is one of 97 self-financing participants in the Facility.
The contribution is part of "our consistent support for vaccine multilateralism, and the fair and equitable access and allocation of vaccines", said the statement.
The AMC eligible countries include several ASEAN countries as well as small states globally, it added.
The Covid-19 virus "does not respect borders, and no one is safe until everyone is safe", said the statement, adding that the successful development of safe and efficacious vaccines is a critical step towards overcoming the pandemic.
Ambassadors and High Commissioners of around 80 countries will be landing in the city on December 9 to visit Bharat Biotech and BE limited which are working on the COVID-19 vaccine.
An official release said on Friday Chief Secretary Somesh Kumar held a meeting with an advance team, including Chief of Protocol Nagesh Singh and other senior officials of the state government and discussed the arrangements to be made in connection with the high profile visit,.
"Chief Secretary informed that the dignitaries will be visiting Bharat Biotech Limited and Biological E limited the industrial units which are working on the COVID-19 vaccine in the country.
He asked the officials to make foolproof arrangements duly following all the COVID-19 protocols during the visit of the dignitaries," the release said.
As many as five well equipped buses and a special medical team, should be put in place for the envoys.
A presentation should also be made to showcase the states potential in the production and supply of vaccine and should also include the Pharma City and Genome Valley, he added.
The Ministry of External Affairs is organising the visit of Ambassadors and High Commissioners to familiarise the foreign envoys about some key research and development activities being done by the country, according to the release.
(With IANS Inputs)
The application was filed before the apex drug regulator on Monday evening, a company source told IANS on the condition of anonymity. Covaxin, India's indigenous Covid-19 vaccine by Bharat Biotech, is developed in collaboration with the Indian Council of Medical Research (ICMR) and the National Institute of Virology (NIV).
Emergency use authorisation is a mechanism to facilitate the availability and use of medical countermeasures, including vaccines, during public health emergencies.
The development comes a day after the Serum Institute of India, the world's largest vaccine maker by number of doses produced, sought government approval for emergency use authorisation of its coronavirus vaccine that it is being developed in collaboration with the University of Oxford and British drugmaker AstraZeneca.
The Pune-based pharmaceutical firm was the second to do so after American firm Pfizer sought approval from the drug regulator for its vaccine, which has been cleared by the UK and Bahrain.
Covaxin is an indigenous, inactivated vaccine being developed and manufactured at Bharat Biotech's Bio-Safety Level 3 bio containment facility. It is a highly purified and inactivated vaccine, manufactured in a vero cell manufacturing platform.
On November 16, Bharat Biotech had announced commencement of Phase III trials of the vaccine. The trials involved 26,000 volunteers across India, conducted in partnership with ICMR. It is the largest clinical trial conducted for a Covid-19 vaccine in India.
Covaxin has been evaluated in 1,000 subjects in Phase I and Phase II clinical trials, with promising safety and immunogenicity data.
On November 28, Prime Minister Narendra Modi had visited the Bharat Biotech facility in Hyderabad to review vaccine development. "At the Bharat Biotech facility in Hyderabad, was briefed about their indigenous Covid-19 vaccine. Congratulated the scientists for their progress in the trials so far. Their team is closely working with ICMR to facilitate speedy progress," the PM had tweeted.
On Saturday, a controversy had erupted around Covaxin after Haryana Health Minister Anil Vij, who was administered the first dose of Covaxin last month, tested positive for Covid-19.
This prompted the company to clarify, "Covaxin clinical trials are based on a 2-dose schedule, given 28 days apart. The vaccine efficacy will be determined 14 days post the 2nd dose. Covaxin has been designed to be efficacious when subjects receive both doses and post the 14 days period after the 2nd dose."
(With IANS Inputs)
After landing in Hyderabad by a special Air India flight, the Ambassadors and High Commissioners from the countries in Asia, Africa, Europe, North America, South America, and Oceania reached Genome Valley on the city outskirts to visit the two companies.
The visit by the heads of foreign missions was organised by the Ministry of External Affairs (MEA) and was part of India's efforts to develop partnerships for the manufacture and delivery of vaccines.
Telangana: Foreign envoys take a tour of Bharat Biotech facility in Hyderabad where #COVID19Vaccine, Covaxin is being developed. pic.twitter.com/dGtktEMV8v
— ANI (@ANI) December 9, 2020
Last month, the diplomats were briefed on trials of vaccines underway in the country and efforts to manufacture and deliver the doses.
Officials said the diplomats were divided into two batches and they went around the two companies to see for themselves the facilities developed for research and manufacturing of vaccines.
Top officials of both the companies briefed the envoys about the progress made so far in the development of the vaccines and the rollout plans by both the companies after their vaccines get the approval from regulators.
At Bharat Biotech, the delegation was briefed about company's vaccine development programme by Dr. Krishna Ella, Chairman and Managing Director, spearheading Covaxin research, development, clinical trials and production teams.
The delegates were explained about Bharat Biotech's research process, manufacturing capabilities, expertise through virtual and physical tours of the facilities.
The envoys voiced their appreciation of the company's work of national and global public health significance.
Covaxin, India's indigenous Covid-19 vaccine, is developed by Bharat Biotech in collaboration with the Indian Council of Medical Research (ICMR) - National Institute of Virology (NIV). This indigenous, inactivated vaccine is developed and manufactured in Bharat Biotech's BSL-3 (Bio-Safety Level 3) bio-containment facility.
Covaxin is a highly purified and inactivated 2 dose SARS-CoV2 vaccine, manufactured in a vero cell manufacturing platform with an excellent safety track record of more than 300 million doses.
According to Bharat Biotech, Covaxin has been evaluated in approximately 1000 subjects in Phase 1 and Phase 2 clinical trials, with promising safety and immunogenicity results.
The Phase 3 human clinical trials of the vaccine began in November, involving 26,000 volunteers across India. This is India's first and only Phase 3 efficacy study for a Covid-19 vaccine, and the largest phase 3 efficacy trial ever conducted for any vaccine in India.
"The development and clinical evaluation of COVAXIN marks a significant milestone for novel vaccinology in India. Covaxin has garnered interest from several countries worldwide for supplies and introduction," said Suchitra Ella, Joint Managing Director of Bharat Biotech while addressing the foreign envoys.
Biological E last month initiated clinical trial of its Covid-19 subunit vaccine candidate in India following approval from the Drugs Controller General of India (DGCI).
It is making the vaccine in collaboration with Dynavax Technologies Corporation (Dynavax), a US-based vaccine focused biopharmaceutical company, and Baylor College of Medicine, a health sciences university in Houston.
Telangana Chief Secretary Somesh Kumar also addressed the diplomats and showcased the potential of the state. He said though being the youngest state in the country, Teangana achieved tremendous progress under the dynamic leadership of Chief Minister K. Chandrasekhar Rao.
He also informed that the combined value of the pharma sector in the state is around $50 billion. Hyderabad is the vaccine hub of not only India but the entire world with 33 percent of the entire vaccine production being done in Hyderabad.
During the last six years, the state has been a front ranker in the ease of doing business in the country. The state is home to some of the top valued companies such as Google, Apple, Facebook, Amazon, Microsoft etc. Most of these companies have their largest establishments outside the US in Hyderabad.
The Chief Secretary told the diplomats that the state has formulated a new TSiPASS policy for speedy approvals to the industries. Industries who do not get permission within 15 days are deemed to have been approved. This policy has proved to be a game changer and during the last six years around 14,000 units have been grounded in the state.
Principal Secretary Industries and IT, Jayesh Ranjan, also made a power point presentation and showcased the investment potential of the state to the visiting dignitaries. He said that Hyderabad Pharma city will be operational in a couple of months. Similarly a medical devices park is being set up near Outer Ring Road in 500 acres.
(With IANS Inputs)
The Phase III human clinical trials of Covaxin began mid-November, targeted to be done in 26,000 volunteers across India.
Suchitra Ella, Joint Managing Director of Bharat Biotech termed this as an unprecedented vaccine trial ever in India. She said they were overwhelmed with the steady rise in participation. "We sincerely thank all the 13,000 volunteers across the country for their support in enabling us to bring out a safe and efficacious Indian vaccine for COVID-19. This pro-vaccine public health volunteerism is a morale booster for us to achieve our milestone target of 26,000 soon."
This is India's first and only Phase III efficacy study for a COVID-19 vaccine, and the largest phase III efficacy trial ever conducted for any vaccine in India.
Covaxin has been evaluated in approximately 1,000 subjects in Phase I and Phase II clinical trials, with promising safety and immunogenicity results, with acceptance in international peer reviewed scientific journals, the Hyderabad-based company said.
Covaxin, India's indigenous Covid-19 vaccine by Bharat Biotech is developed in collaboration with the Indian Council of Medical Research (ICMR) -- National Institute of Virology (NIV).
This indigenous, inactivated vaccine is developed and manufactured in Bharat Biotech's BSL-3 (Bio-Safety Level 3) bio-containment facility, one of its kind in the world.
Covaxin is a highly purified and inactivated 2 dose SARS-CoV2 vaccine, manufactured in a Vero cell manufacturing platform with an excellent safety track record of more than 300 million doses.
(With IANS Inputs)