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Bharat Biotech supplying Covaxin to 18 states

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Bharat Biotech has been directly supplying its Covid-19 vaccine Covaxin to 18 states since May 1, the company said on Tuesday.

“Unflinching in our efforts, we will continue the steady supply of our vaccine,” the Hyderabad-based vaccine maker tweeted.

The states are Andhra Pradesh, Assam, Bihar, Chhattisgarh, Delhi, Gujarat, Haryana, Jammu & Kashmir, Jharkhand, Karnataka, Madhya Pradesh, Maharashtra, Odisha, Tamil Nadu, Tripura, Telangana, Uttar Pradesh and West Bengal.

The company, however, has not come out with details of the supplies like the number of doses supplied to the states.

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 24×7,” 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.

Telugu360 is always open for the best and bright journalists. If you are interested in full-time or freelance, email us at Krishna@telugu360.com.

Jagan writes Modi, targets Bharat Biotech

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Andhra Pradesh Chief Minister YS Jaganmohan Reddy wrote a letter to Prime Minister Narendra Modi in the wake of rising criticism on poor vaccination and oxygen deaths in the State. This time, CM Jagan directly targetted Bharat Biotech. He told Modi that there was a need for technology transfer from Bharat Biotech so that some other companies could contribute to the vaccine making to meet the country’s demand.

Already, the YCP Ministers and CM’s Advisor Sajjala Ramakrishna Reddy have commented that Bharat Biotech is not supplying Covaxin to AP. They asked Chandrababu Naidu to use his influence since the vaccine maker belongs to his caste. Whereas, Naidu has been saying that the Centre has given permission to AP to buy vaccines it requires from Bharat Biotech or Serum Institute. However, the AP Government is not buying the vaccines for its own reasons.

Now, CM Jagan Reddy told Modi that Bharat Biotech is the only company in the country which is manufacturing the vaccine. If this technology is transferred to other companies, it would solve the crisis.

The CM has also told Modi that till now, the National Institute of Virology and the Indian Council of Medical Research (ICMR) have extended all help to procure vaccines for the AP needs.

Telugu360 is always open for the best and bright journalists. If you are interested in full-time or freelance, email us at Krishna@telugu360.com.

Bharat Biotech cuts price of Covaxin for states

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Bharat Biotech on Thursday announced that it is slashing the price of its Covid-19 vaccine Covaxin to Rs 400, from Rs 600 earlier, for state governments.

The announcement came a day after the 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.

Bharat Biotech said in a statement on Thursday that it deeply concerned with the critical pandemic circumstances that India is facing at this time.

“Recognising the enormous challenges to the public healthcare system, we have made Covaxin available to state governments at a price of Rs 400 per dose,” the Hyderabad-based company said.

“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 trials,” it added.

The company stated that for the last one 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.

Bharat Biotech had on April 24 announced the prices of Covaxin. It fixed at Rs 1,200 as the price per dose for private hospitals. This is twice the cost fixed by the SII for Covishield.

For exports, it 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 the 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, the SII had hinted at revising this to Rs 400.

Telugu360 is always open for the best and bright journalists. If you are interested in full-time or freelance, email us at Krishna@telugu360.com.

Bharat Biotech scales up manufacturing of Covaxin

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Leading vaccine maker Bharat Biotech on Tuesday announced scaling up of manufacturing capacity to produce about 700 million doses of its Covid-19 vaccine Covaxin annually.

The Hyderabad-based company stated that capacity expansion has been implemented across multiple facilities here and in Bengaluru, to reach 700 million doses a year, one of the largest production capacities for inactivated viral vaccines worldwide.

Inactivated vaccines, while highly safe, are extremely complex and expensive to manufacture, resulting in lower yields when compared to live virus vaccines.

Capacity expansion in vaccines manufacturing is a long and tedious process, requiring investments of several millions of rupees and several years. Bharat Biotech is able to expand Covaxin manufacturing capacity in a short timeline, mainly due to the availability of new specially-designed BSL-3 facilities, first of its kind for manufacturing in India that have been repurposed and preexisting expertise and know-how to manufacture, test and release highly purified inactivated viral vaccines, the company said in a statement.

It said it was also exploring manufacturing partnerships with its partners in other countries, who have prior expertise with commercial scale manufacture of inactivated viral vaccines under biosafety containment.

To further increase capacities, Bharat Biotech has partnered with Indian Immunologicals Ltd (IIL) to manufacture the drug substance for Covaxin. The technology transfer process is underway and IIL has the capabilities and expertise to manufacture inactivated viral vaccines at commercial scale and under biosafety containment.

Covaxin has received Emergency Use Authorisations (EUAs) in several countries across the globe with another 60 in process. EUAs have now been obtained from Mexico, the Philippines, Iran, Paraguay, Guatemala, Nicaragua, Guyana, Venezuela, Botswana, Zimbabwe, among several other countries. EUAs are in process in the USA and several European countries. Pricing for international markets and supplies to governments under EUAs have been established between $15-20/dose.

Bharat Biotech uses a proprietary adjuvant Algel-IMDG, that has now proven to be a safe and effective adjuvant, especially to stimulate memory T cell responses. The synthesis and manufacture of the IMDG component has been successfully indigenised and will be manufactured at commercial scale within the country. This is the first instance where a novel adjuvant has been commercialised in India.

“The protocols for manufacturing, testing and release of inactivated vaccines have been tried, tested and validated across several of our vaccines, these also meet the requirements of WHO, Indian and other regulatory authorities. These protocols have delivered consistent results over a 15-year period with more than 300 million doses supplied globally, with excellent safety and performance record,” it added.

Telugu360 is always open for the best and bright journalists. If you are interested in full-time or freelance, email us at Krishna@telugu360.com.

Death of Covaxin volunteer ‘not related’ to vaccine trials: Bharat Biotech

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After the alleged death of a volunteer enrolled in Bharat Biotech’s Covaxin clinical trial in Bhopal, the Hyderabad-based company clarified on Saturday that the death was unrelated to the vaccine and the probable cause of death was cardio respiratory failure as a result of suspected poisoning.

“As per the post-mortem report issued by the Gandhi Medical College, Bhopal, that the site received from the Bhopal Police, the probable cause of death was due to cardio respiratory failure as a result of suspected poisoning and the case is under police investigation as well,” Bharat Biotech said in a statement.

The firm added, “The volunteer passed away nine days after the dosing and preliminary reviews by the site indicate that the death is unrelated to the study dosing. We cannot confirm if the volunteer received the study vaccine or a placebo as the study is blinded.”

The 42-year-old man died on December 21, 10 days after he participated in the clinical trial for Covaxin held at a private hospital in Bhopal. “Our sympathies are with the family of the deceased,” the company said.

According to Bharat Biotech, the volunteer, at the time of enrolment, had fulfilled all the inclusion and exclusion criteria to be accepted as a participant in the Phase III trial and was reported to be healthy in all the site follow up calls post seven days of his dosing and no adverse events were observed or reported.

“There are several factors that can cause an adverse event during a clinical trial, including the patient’s underlying disease, other pre-existing conditions or any other unrelated occurrence like an accident. We are also continuing to cooperate with the investigation requirements from the Madhya Pradesh Police in Bhopal,” Bharat Biotech added.

On January 3, The Drugs Controller General of India (DCGI) had approved Oxford Covid-19 vaccine Covishield, manufactured by the Serum Institute, and indigenously developed Covaxin of Bharat Biotech for restricted emergency use in the country, paving the way for a massive inoculation drive.

While the efficacy of Bharat Biotech’s Covaxin is yet to be determined, it was given a go-ahead by the DCGI citing ‘public interest’. Covaxin is an indigenously developed vaccine by Bharat Biotech in collaboration with the Indian Council of Medical Research (ICMR).

Telugu360 is always open for the best and bright journalists. If you are interested in full-time or freelance, email us at Krishna@telugu360.com.

Bharat Biotech concludes recruitment for Covaxin’s phase 3 study

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Hyderabad-based vaccine manufacturer Bharat Biotech has concluded the recruitment of volunteers for the phase III trials of its Covid vaccine, Covaxin, on Thursday after achieving the sample size it had promised to the ethics committee. The firm has achieved the targeted number of volunteers, which is 25,800 participants, in total.

The recruitment was supposed to be concluded by December 31 but was extended by a week since it was short of 4,000 volunteers that time.

Dr. Sanjay Kumar Rai, head of community medicine and principal investigator of the trial at All India Institute of All India Institute of Medical Sciences (AIIMS), Delhi told IANS that the recruitment for the phase III study is closed now.

“Around 99 per cent of the promised target was achieved by AIIMS. However, we have finished our enrollment after achieving the target in toto,” he said.

Dr. C Prabhakar Reddy, principal investigator of Covaxin’s phase III clinical trial at Nizam’s Institute of Medical Sciences, Hyderabad, said that a few sites missed their individual target by a few numbers.

“However, the sites which over achieved their target compensated for it,” he added.

While many sites struggled to find volunteers for the phase 3 study, a few sites registered them in abundance. AIIMS Patna, one of the clinical sites for Covaxin undertook around 1,400 subjects despite its individual target set at 1,000.

IANS had earlier reported that AIIMS Delhi and several other clinical sites were facing the dearth of volunteers since people were unwilling to participate in the exercise, hoping that they would receive the vaccine anyway once it is rolled-out by the government.

The phase III study of the Covaxin, which initially spanned at 25 clinical sites across the country, inducted several more sites in the last week of December since many sites were unable to find the volunteers for the study.

Dr. Dhananjay Lad, co-investigator of the trial at Redkar Hospital, Goa, told IANS that the trial was extended to around 30 clinical sites.

“A few sites were also removed in the process because of several reasons. One of the reasons was inability to enroll a bare minimum number of participants,” he said.

The trial was started with three sites each in Uttar Pradesh (Aligarh Muslim University), West Bengal (ICMR-National Institute of Cholera and Enteric Diseases) and Tamil Nadu (Directorate of Public Health and Preventive Medicine) on November 10.

Covaxin has been given approval for restricted emergency use by India’s drug regulator. While the efficacy of the vaccine is yet to be determined, it was given a go-ahead by the Drug Controller General of India (DCGI) citing public interest.

Covaxin is indigenously developed by the Bharat Biotech, in collaboration with the Indian Council of Medical Research (ICMR).

Telugu360 is always open for the best and bright journalists. If you are interested in full-time or freelance, email us at Krishna@telugu360.com.

Giant leap for innovation: Bharat Biotech after DCGI approval to Covaxin

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Bharat Biotech on Sunday said the approval for emergency use of its Covid-19 vaccine –Covaxin — is a giant leap for innovation and novel product development in India.

The Hyderabad-based vaccine maker expressed its delight after Drug Controller General of India (DCGI) granted permission for emergency use of its Covid-19 vaccine.

“The approval of Covaxin for emergency use is a proud moment for the nation and a great milestone in India’s scientific capability, a kickstart to the innovation ecosystem in India. While this vaccine addresses an unmet medical need during this pandemic, our goal is to provide global access to populations that need it the most,” said Bharat Biotech Chairman and Managing Director Dr. Krishna Ella.

He said Covaxin has generated excellent safety data with robust immune responses to multiple viral proteins that persist.

“The development of Covaxin was truly a public private partnership between ICMR, NIV and Bharat Biotech, we sincerely thank the Director General ICMR, Dr. Balram Bhargava for his visionary leadership in this project,” Dr. Ella added.

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.

The Phase III human clinical trials of Covaxin began mid-November, targeted to be done in 26,000 volunteers across India. 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.

India’s indigenous Covid vaccine by Bharat Biotech has been 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.

The product development and clinical trial data thus far has generated 5 publications, which have been submitted to international peer reviewed journals, 4 of which have been accepted and will be published soon. The publication of phase II trial data is undergoing the peer review process. “As a part of our regulatory guidelines, all data has been submitted to the DCGI and CDSCO,” it said.

Telugu360 is always open for the best and bright journalists. If you are interested in full-time or freelance, email us at Krishna@telugu360.com.

DCGI approves Serum, Bharat Biotech vaccine for emergency use (Ld)

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Eleven months after the first case of deadly coronavirus was detected in India, Drug Controller General of India (DCGI) V.G. Somani on Sunday approved Serum Institute of India’s ‘Covishield’ vaccine and Bharat Biotech’s ‘Covaxin’ for emergency use, paving way for its roll-out and administration to millions.

“After adequate examination, the CDSCO has decided to accept the recommendations of the Subject Expert Committee and accordingly, vaccine of Serum and Bharat Biotech are being approved for restricted use in emergency situation,” the Drugs Controller General of India Dr. V.G. Somani said.

Covishield and Covaxin have to be administered in two doses and can be stored at 2-8 degree Celsius. The Drugs Controller General of India has also granted permission to Cadila healthcare for phase 3 clinical trial in India.

This is a major relief for India which has the second highest number of infections in the world after the US. The Central government plans to vaccinate nearly 30 crore people in the first phase of drive in the next six to eight months.

The vaccine will be first offered to one crore healthcare workers, along with two crore frontline and essential workers and 27 crore elderly, mostly above the age of 50 years with co-morbidities.

On Saturday, Union Health Minister Harsh Vardhan had announced that one crore healthcare workers, along with two crore frontline workers will get the vaccine for free.

The Subject Expert Committee, tasked with vetting the vaccine proposals, had recommended Oxford-Astra Zeneca’s ‘Covishield’ and Bharat Biotech’s indigenous ‘Covaxin’ for emergency use approval on January 1 and 2, respectively. The final call was to be taken by the DCGI.

The expert panel recommended granting permission for restricted emergency use of ‘Covaxin’ in “public interest as an abundant precaution, in clinical trial mode, specially in the context of infection by mutant strains.

The Subject Expert Committee consists of domain knowledge experts from the fields of pulmonology, immunology, microbiology, pharmacology, paediatrics, internal medicine, etc.

Pune-based Serum Institute of India has partnered with Oxford-AstraZeneca for conducting clinical trials and manufacturing ‘Covishield’, while Bharat Biotech has collaborated with the Indian Council of Medical Research (ICMR) for ‘Covaxin’.

Serum and Bharat Biotech Pfizer had applied for the accelerated approval on December 6 and 7, respectively.

Serum Institute of India had submitted safety, immunogenicity and efficacy data generated on 23,745 participants aged more or equal to 18 years or older from overseas clinical studies. The overall vaccine efficacy was found to be 70.42 per cent.

Further, Serum was granted permission to conduct Phase-II/III clinical trials on 1,600 participants within the country. The firm also submitted the interim safety and immunogenicity data generated from this trial and the data was found comparable with the data from the overseas clinical studies.

The UK and Argentina have already approved the Oxford-AstraZeneca vaccine. More than five crore doses of the vaccine have already been stockpiled by its manufacturer, Serum Institute of India.

Oxford-AstraZeneca vaccine will play a major role in India’s plan to vaccinate its population against Covid-19 due to several factors — low-cost, ease of storage and transport.

Serum Institute of India this week said that it has a stockpiled 40-50 million doses of its Covid-19 vaccine. India is likely to receive a majority of these 50 million doses.

As far as Bharat Biotech’s Covaxin is concerned, it is India’s first indigenous vaccine for coronavirus. The inactivated virus vaccine is being developed in collaboration with the Indian Council of Medical Research (ICMR) and the National Institute of Virology (NIV).

The firm had generated safety and immunogenicity data in various animal species such as mice, rats, rabbits, Syrian hamster, and also conducted challenge studies on non-human primates (Rhesus macaques) and hamsters.

All this data was shared by the firm with CDSCO. Phase I and Phase II clinical trials were conducted in 800 subjects and the results demonstrated that the vaccine is safe and provides a robust immune response.

The Phase III efficacy trial was initiated in India in 25,800 volunteers and till date, 22,500 participants have been vaccinated across the country and the vaccine has been found to be safe as per the data available till date.

Telugu360 is always open for the best and bright journalists. If you are interested in full-time or freelance, email us at Krishna@telugu360.com.

Bharat Biotech recruits 23,000 volunteers for Phase III trials of Covaxin

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Bharat Biotech on Saturday announced successful recruitment of 23,000 volunteers, and continued progress towards achieving the goal of 26,000 participants for phase-III clinical trial of its coronavirus vaccine ‘Covaxin’ across multiple sites in India.

The phase-III human clinical trials of Covaxin began mid-November, targeting 26,000 volunteers across India. 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, the Hyderabad-based company said.

“We thank every volunteer who has taken the time to participate in this trial. Their volunteering spirit is a great morale boost for India and the world. We thank all the principle investigators, doctors, medical staff and the hospitals for their cooperation and support in taking the phase III trials forward in 26,000 volunteers in India. We continue our progress towards achieving the goal of 26,000 participants for Phase-3 clinical trials of Covaxin,” said Suchitra Ella, Joint Managing Director, Bharat Biotech.

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 product development and clinical trial data thus far has generated five publications, of which four have been accepted by international peer reviewed journals and will be published soon.

“The publication of phase II trial data is undergoing the peer review process. As a part of our regulatory guidelines, all data has been submitted to the Drugs Controller General of India (DCGI) and Central Drugs Standard Control Organisation(CDSCO).”

Covaxin is a highly purified and inactivated 2-dose SARS-CoV-2 vaccine, manufactured in a Vero cell manufacturing platform with an excellent safety track record of more than 300 million doses.

India’s first 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, a one-of-its-kind facility in the world.

Telugu360 is always open for the best and bright journalists. If you are interested in full-time or freelance, email us at Krishna@telugu360.com.

After ‘Covishield’, expert panel recommends Bharat Biotech’s ‘Covaxin’ for emergency use

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The Subject Expert Committee of Central Drug Standard Control Organization on Saturday recommended Bharat Biotech’s ‘Covaxin’ for emergency use in India. The final decision on its approval will, however, be taken by the Drug Controller General of India (DCGI).

The committee of experts assessing Coronavirus vaccines had called Hyderabad-based Bharat Biotech for a meeting in the afternoon today, a day after the firm was asked to present more data to get a nod, a top source said on Saturday.

On Friday, the Subject Expert Committee of the Central Drug Standard Control Organisation (CDSCO) had held that the data provided by Bharat Biotech for its Coronavirus vaccine is not sufficient for grant of emergency use approval and asked for more information.

The expert committee, tasked with vetting Covid-19 vaccine proposals, had convened a meeting to take a call on emergency use authorisation sought by the Serum Institute of India and Bharat Biotech for their respective vaccine candidates.

Notably, the panel recommended emergency licensure for the Serum Institute of India-manufactured ‘Covishield’. It become the first vaccine to secure recommendation for emergency use in India. The nod of the DCGI is, however, awaited on the recommendation.

The Pune-based Serum Institute has partnered with Oxford-AstraZeneca for conducting clinical trials and manufacturing ‘Covishield’ while Bharat Biotech has collaborated with the Indian Council of Medical Research (ICMR) for ‘Covaxin’.

America’s Pfizer was the first one to apply for the accelerated approval on December 4, followed by the Serum Institute and Bharat Biotech on December 6 and 7, respectively.

The Central government plans to vaccinate nearly 30 crore people in the first phase of drive. It will be offered to one crore healthcare workers, along with 2 crore frontline and essential workers and 27 crore elderly above the age of 50 years most of whom have co-morbidities .

Telugu360 is always open for the best and bright journalists. If you are interested in full-time or freelance, email us at Krishna@telugu360.com.

Envoys of 64 countries visit Covid vaccine makers in Hyderabad

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Envoys of 64 countries on Wednesday visited the facilities of Bharat Biotech and Biological E, which are developing vaccines for coronavirus.

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.

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.

Telugu360 is always open for the best and bright journalists. If you are interested in full-time or freelance, email us at Krishna@telugu360.com.

Clinical trials begin for Bharat Biotech’s Covid-19 vaccine

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Hyderabad-based Bharat Biotech on Friday announced that the Phase-I clinical trials of India’s first indigenous Covid-19 vaccine Covaxin began across the country on July 15.

“This is a randomised, double-blind, placebo-controlled clinical trial on 375 volunteers in India,” the company said in a brief statement.

The leading vaccine maker had announced on June 29 that it successfully developed Covaxin in collaboration with the Indian Council of Medical Research (ICMR) and National Institute of Virology (NIV).

The SARS-CoV-2 strain was isolated in NIV, Pune and transferred to Bharat Biotech. The indigenous, inactivated vaccine was developed and manufactured in Bharat Biotech’s BSL-3A (Bio-Safety Level 3) High Containment facility located in Genome Valley, Hyderabad.

The Drug Controller General of India – Central Drugs Standard Control Organisation (CDSCO), Ministry of Health & Family Welfare granted permission to initiate Phase-I and II human clinical trials after the company submitted results generated from pre-clinical studies, demonstrating safety and immune response. The Nizam’s Institute of Medical Science (NIMS), Hyderabad is one of the 12 centres selected by the ICMR for the clinical trials.

The subject enrolment for Phase-I clinical trials at the NIMS began on July 7. There was no clarity on the number of subjects selected at this centre.

The officials had earlier said that for two days after administering the vaccine, the subjects would be monitored in the ICCU at the NIMS by a team of doctors, after which they would be sent home and monitored through video conference or phone.

The Phase-I clinical trial would go on for 28 days, after which the ICMR and Drug Controller General of India would accord permission for Phase-II, which will include more subjects.

Phase-1 would have around 375 subjects across the country and Phase-II, 875.

In a letter to the selected centres early this month, ICMR Director General Balram Bhargava asked them to fast-track all approvals related to initiation of the clinical trial.

“It is envisaged to launch the vaccine for public health use latest by 15th August 2020 after completion of all clinical trials. BBIL is working expeditiously to meet the target, however the final outcome will depend on the cooperation of all clinical trial sites involved in this project,” reads the letter dated July 2.

While experts raised doubts on the August 15 target, the ICMR defended it, saying its process is in accordance with the globally accepted norms to fast-track vaccine development for diseases of pandemic potential.

The research body said Bhargava’s letter was intended to cut red-tape, without bypassing any necessary process, and speed up recruitment of participants for human trials so that these phases can be completed at the earliest.

Bharat Biotech had refused to comment on the ICMR’s August 15 deadline.

Telugu360 is always open for the best and bright journalists. If you are interested in full-time or freelance, email us at Krishna@telugu360.com.

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