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Review process begins for WHO listing of Covaxin: Bharat Biotech

Bharat Biotech on Monday said that it has submitted all documents to the World Health Organisation (WHO) for Emergency Use Listing (EUL) of its Covid-19 vaccine Covaxin and the review process has commenced.

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.

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Supply of Covaxin to govt at Rs 150/dose not sustainable: Bharat Biotech

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The supply price of Covaxin to the government of India at Rs 150 a 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, Bharat Biotech said on Tuesday.

It said there are live examples of such pricing policies where Human Papilloma virus vaccine is priced for GAVI supplies at $4.5/dose (Rs 320), but is also available in the private market at Rs 3,500.

Rotavirus vaccines are supplied to the Govt of India at Rs 60/dose, but is also available in the private market at Rs 1,700/dose. The prices for COVID-19 vaccines internationally have varied between $10 to $37/dose, (Rs 730 – Rs 2,700/dose).

On why Coaxin is more expensive for the private sector, Bharat Biotech said another key point of discussion has been about pricing our vaccines for private sector players which is significantly higher than that given to governments and large procurement agencies. This is purely due to fundamental business reasons, ranging from low procurement volumes, high distribution costs and retail margins among few others.

As directed by the Govt of India, less than 10% of our total production of Covaxin to date has been supplied to private hospitals, while most of the remaining quantity was supplied to State and Central Governments. In such a scenario the weighted average price of Covaxin for all supplies realized by Bharat Biotech is less than Rs 250/dose. Going forward, 75% of the capacity will be supplied to State and Central Governments with only 25% going to private hospitals.

Unlike most medicines and therapeutics, vaccines are provided free of cost by the Govt of India to all eligible Indian citizens. “Thus, the procurement of vaccines by private hospitals is optional and not mandatory, albeit it gives a choice to citizens who are willing to pay for better convenience. In our view, the question of product pricing is only of extraneous interest to all concerned, especially when the same vaccine is made available free of cost”, Bharat Biotech said that for the private sector it is optional.

Bharat Biotech has so far invested over Rs 500 crores at risk from its own resources for product development, clinical trials and setting up of manufacturing facilities for Covaxin. The support from The Indian Council of Medical Research (ICMR) was with respect to provision of the SARS CoV2 virus, animal studies, virus characterization, test kits and partial funding for clinical trial sites. In return for this valuable support, Bharat Biotech will pay royalties to ICMR and the National Institute of Virology (NIV), based on product sales. Royalties are also payable to Virovax towards the licensure of IMDG agonist molecules, it said.

Bharat Biotech is investing in new facilities and repurposing existing ones across several states in India for enhancing the production of Covaxin.

It is pertinent to mention here that the urgent need to set up a significant number of manufacturing facilities and to divert existing ones for Covaxin has resulted in reduced production of other vaccines at our facilities, leading to loss in revenues.

It added that low product price realization dispirits domestic R&D. Companies such as Bharat Biotech, which are innovators with specialized expertise in product development, and large scale manufacturing, should be allowed to maintain a differential pricing strategy for Governments and private hospitals. It is distressing to see that a large country like India has a very basic level of innovation in vaccines and pharmaceutical products, it added.

It may well be argued that the low-price realization for home-grown innovators constraints innovation and product development in India. In the absence of a dual pricing system, Indian vaccine and pharmaceutical companies risk being reduced to mere contract manufacturers with intellectual property licensed from other nations, the company said.

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Covaxin trials on children likely from next month

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Bharat Biotech may commence paediatric trials of its Covid-19 vaccine Covaxin from June, a senior company official said.

The vaccine maker has already received permission to carry out trials on children aged 2-18 years.

Bharat Biotech’s Business Development & International Advocacy Head, Dr Raches Ella, exuded confidence that vaccine for kids may get the license in the third quarter of this year.

Holding a virtual conversation with members of FICCI Ladies Organisation (FLO) Hyderabad on “All About Vaccines, he said that the company expected approval from the World Health Organisation (WHO) for Covaxin by the end of third or fourth quarter.

Ella also said Bharat Biotech will be ramping up manufacturing capacity of Covaxin to 700 million doses by the end of this year.

“We are happy to have the full support of the government because of which we are able to stand where we are today in this journey. The vaccine is co-developed by us and ICMR. The Government placed an advanced purchase order of Rs 1,500 crore. This will help us to increase our risk appetite. That is why we are expanding to Bangalore and Gujarat,” he said.

Also seeking to dispel various myths about vaccines, he said that they are safe and everyone should take vaccines.

Replying to a query by Consultant, Breast Oncology & Oncoplastic Surgeon, Dr Pragnya Chigurupati, who moderated the talk, Ella said the success probability of a vaccine is just 6 per cent from discovery to development.

“”In normal circumstances, the development of a vaccine takes anywhere between 7 to 10 years, which we have done in the least possible time. This was never taught in books. This is something I learned practically. The journey was challenging, promising, and fulfilling,” he said.

Asked about dosing intervals he said ideally the gap should be between two weeks and can go up to six weeks. “If for some reason you miss that schedule, you need not get panicked. You can go and take the second dose anytime possible but at the earliest possible time.”

Three months after the second dose, a good antibody response can be developed. Talking about a booster dosage he said the current vaccines are doing good enough but it will depend on future variants of the virus if any booster doses needs to be taken or not.

About herd immunity, he said if the majority of the population are inoculated, that is when herd immunity can be achieved. About cross-matching of different vaccines he said: “As of now, no mix and match. The studies are on, if proved well, then we can take a call in the future”.

Stressing that no vaccines offer 100 per cent protection, he said that the vaccine efficacy can be improved up to 100 per cent protection by Covid appropriate behaviour and following other safety protocols.

Asked why people still get Corona even after taking the first dose, he replied that the first dose gives only partial efficacy. “That is because your immune system takes time to develop. It is a biological process and the system needs some time. The severity of the Covid effect will be a lot less after the second dose,” he said.

On distribution, he said right now they are allowed to sell vaccines to the Union government, the state governments, and private hospitals in the ratio of 70:20:10. If any corporates plan to inoculate their staff, they may collaborate with private hospitals, he said.

FLO Hyderabad Chairperson, Uma Chigurupati described Covid-19 as a global health crisis. She pointed out that India is the worst hit and has surpassed Brazil.

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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.

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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.

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‘Covaxin demonstrates overall interim clinical efficacy of 78%’

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Leading vaccine maker Bharat Biotech and the Indian Council of Medical Research (ICMR) on Wednesday announced interim results from phase 3 clinical trials of Covaxin, which show 78 per cent overall clinical efficacy and 100 per cent efficacy against severe Covid-19.

The second interim analysis is based on accruing more than 87 symptomatic cases of Covid-19. Due to the recent surge in cases, 127 symptomatic cases were recorded, resulting in a point estimate of vaccine efficacy of 78 per cent against mild, moderate, and severe Covid-19 disease.

The efficacy against severe Covid-19 disease was 100 per cent, with an impact on reduction in hospitalizations. The efficacy against asymptomatic Covid-19 infection was 70 per cent, suggesting decreased transmission in Covaxin recipients.

Safety and efficacy results from the final analysis will be available in June, and the final report will be submitted to a peer-reviewed publication, Hyderabad based Bharat Biotech said.

Based on the achievement of the success criteria, placebo recipients have now become eligible to receive two doses of Covaxin.

The phase 3 study enrolled 25,800 participants between 18-98 years of age, including 10 per cent over the age of 60, with the analysis conducted 14 days post the 2nd dose.

Covaxin was developed with seed strains received from the National Institute of Virology, and the phase 3 clinical trial was co-funded by the ICMR.

“Efficacy against SARS-Cov-2 has been established. Covaxin has demonstrated an excellent safety record in human clinical trials and in usage under emergency use. Covaxin is now a global innovator vaccine derived from research and development from India. The efficacy data against severe Covid-19 and asymptomatic infections is highly significant, as this helps reduce hospitalizations and disease transmission, respectively,” said Dr Krishna Ella, Chairman & Managing Director, Bharat Biotech.

“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,” he added.

“I am very pleased to state that Covaxin, the first indigenous COVID-19 vaccine developed by ICMR and BBIL, has shown the efficacy of 78% in the second interim analysis. The tireless efforts of our scientists at ICMR and BBIL have resulted in a truly effective international vaccine of the highest standards and efficacy. I am also happy to note that Covaxin works well against most variants of SARS-CoV-2. These findings together consolidate the position of our indigenous vaccine in the global vaccine landscape,” said Prof Balram Bhargava, Secretary Dept. of Health Research & Director General, Indian Council of Medical Research.

Several million doses of Covaxin have been supplied and administered in India and several other countries with an excellent safety record, evident by the minimal or lack of adverse events post-immunization. It was approved and introduced initially through Emergency Use Authorization under the clinical trial mode, resulting in robust safety data in real-life conditions.

The company said its efforts to further develop Covaxin continue with clinical trials planned in India and globally to evaluate its safety and immunogenicity in younger age groups, the impact of booster doses, and protection against SARS-CoV-2 variants.

Suchitra Ella, Joint Managing Director, Bharat Biotech, said Covaxin’s’s evidence-based development has proved its suitability for global access, with excellent efficacy results against symptomatic, asymptomatic, and severe disease. “The interest from countries worldwide has quietly validated our efforts. We thank our volunteers, principal investigators, partners and team Bharat Biotech for their contribution to this project towards improving global public health,” she said.

Bharat Biotech said more than 60 countries globally have expressed their interest in Covaxin. These countries are highly satisfied with the safe, inactivated vaccine technology and robust data package for safety and immunogenicity across the whole SARS-CoV-2 virus. Emergency Use Authorizations have been received from several countries.

The company’s development efforts have been transparent and published in 6 peer-reviewed journals, with additional publications in process.

The capacity expansion has been implemented across multiple facilities in Hyderabad and Bengaluru to reach approximately 700 million doses per year, one of the largest production capacities for inactivated viral vaccines worldwide.

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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.

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PM’s gesture may give boost to Covaxin

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Covaxin, India’s first indigenous vaccine for Covid-19, received a shot in the arm with Prime Minister Narendra Modi and Odisha Chief Minister Naveen Patnaik, among other senior politicians, choosing to take the jab on Monday.

As the leaders opted for Covaxin on the first day of the third phase of vaccination, the number of its takers is now likely to go up. The vaccine developed by Hyderabad-based Bharat Biotech so far had few takers in the country though many countries are evincing interest in procuring Covaxin.

Though the vaccination for healthcare workers began on January 16 and subsequently other frontline workers were also vaccinated, there were few takers for Covaxin compared to Covishield, the other vaccine which is part of the national immunisation programme for Covid-19.

Bharat Biotech was obviously upbeat over Monday’s development. “Inspired and humbled by PM’s remarkable commitment to build an ‘Aatmanirbhar Bharat’. Yes, we all shall fight Covid-19 together and emerge victorious,” the company said.

Bharat Biotech’s Co-founder and Joint Managing Director, Suchitra Ella, also hailed Odisha Chief Minister’s gesture.

“Hon CM of Orissa Sri Naveen Patnaik ji, leading by example of getting vaccinated today. Covaxin’s Team & Bharat Biotech is thankful & honoured by the gesture,” she tweeted.

When the Drugs Controller General of India (DCGI) cleared Covaxin for emergency use along with Covishield, developed by Oxford University and pharmaceuticals company AstraZeneca and manufactured by Serum Institute of India, Pune, questions were raised on the indigenous vaccine’s efficacy.

The move to include Covaxin for national rollout even before publication of data from its Phase 3 trials came under criticism from some quarters. However, the regulator defended the decision, saying both the vaccines are totally safe.

Bharat Biotech has developed Covaxin in collaboration with the Indian Council of Medical Research (ICMR) – National Institute of Virology (NIV).

Doctors and other healthcare workers at various places, including Bharat Biotech’s home Hyderabad, were reluctant to take the vaccine as the DCGI had authorised restricted use of Covaxin under the clinical trial mode.

Bharat Biotech also released a factsheet advising people not to take Covaxin if they have allergies, fever, bleeding disorder or are on blood thinners, if they are immune-comrpomised or are on a medicine that affects immune system. It also said that pregnant and breastfeeding women should not take the vaccine.

“As with any new medicine, this vaccine will be closely monitored to allow quick identification of any new safety information,” Bharat Biotech had said.

The company said in case of any Serious Adverse Events (SAV), vaccine recipients will be provided medically recognised standards of care in the government designated and authorised centres/hospitals.

The compensation for Serious Adverse Events will be paid by Bharat Biotech International Limited and if SAV is proven to be casually related to the vaccine. The compensation will be determined by the ICMR Central Ethics Committee, as appropriate.

In Phase 1 and Phase 2 clinical trials, Covaxin demonstrated the ability to produce antibodies against Covid-19. However, the clinical efficacy of Covaxin is yet to be established and it is still being studied in phase 3 clinical trial.

In ongoing clinical trial, Covaxin has been shown to generate immunity following two doses given four weeks apart, the firm said.

According to data provided by the government in reply to a question in the Lok Sabha last month, only 16 of the 37 states and Union Territories had started to administer Covaxin as on February 9.

Telangana had received 1,72,960 doses of Covaxin, second highest consignment among all states but it had the third lowest administration rate of the vaccine.

Telangana’s Director of Public Health Dr G. Srinivasa Rao was the first person in the state to take Covaxin shot on February 8. However, not many frontline workers came forward to take the vaccine.

Experts also tried to dismiss talks of vaccine hesitancy. “Both vaccines are equally effective. There should not be any doubts in the minds of people,” eminent breast cancer surgeon Dr P. Raghu Ram told IANS

“AIIMS director who is the main force leading the drive against the pandemic and all the staff in AIIMS have taken Covaxin. This speaks volumes,” added Dr Raghu Ram.

Riyaz M. Khan, CEO, Continental Hospitals believes that misinformation may be creating reluctance among some people.

“Both the vaccines have gone through a robust testing programme and these are stable technologies. The inactivated technology used for Covaxin is the same technology used for almost all other vaccines. Covishield is based on vector-based technology. These technologies have gone through trials. To say that one is safe over the other may not be safe comparison,” he said.

The reluctance at home is in contrast to the orders Bharat Biotech is receiving from various countries. Last week it announced that the Brazilian government has signed a deal to procure 20 million doses of Covaxin. Several other countries have evinced interest in buying covaxin.

Ukraine’s health minister Dr Maksym Stepanov last week visited Bharat Biotech’s facility in Hyderabad’s Genome Valley and discussed with the company officials the plans to procure Covaxin.

The Indian government has so far procured 5.5 million doses of Covaxin and issued a letter of comfort to company for another 4.5 million doses.

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NITI Aayog propose vax price between Rs 300-500

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The NITI Aayog has promulgated a price range of Rs 300-500 for two Covid vaccines that would be available for the priority group at private facilities in the third phase of vaccination set to begin from March 1, sources privy to the development told IANS, adding that the Bharat Biotech’s Covaxin would cost a bit higher.

However, the union health ministry would take a final call on the proposition.

The proposed price has been floated after a five-hour long meeting held between the Dr VK Paul, member (health), NITI Aayog and officials from Serum Institute of India and Bharat Biotech on Friday evening, which was concluded around 11 p.m., sources added.

“This would be the price end-user would pay for a dose. It includes the service charge the private facilities can take from the beneficiaries,” a top official said.

IANS had reported earlier that private facilities will be able to collect a “service charge” of up to Rs 100 from the beneficiaries to meet the operational expenses they will be incurring during the vaccination drive against Covid-19. This will be in addition to the cost of the vaccines.

As per reports, the government has been procuring SII’s Covishield for around Rs 210 per dose while the cost of Covaxin is around Rs 290 for a shot.

The third phase of vaccination will begin from March 1 and will cover 27 crore people above 60 years of age and those above 45 years of age with comorbidities at 10,000 government and over 20,000 private vaccination centres.

The government has decided that the people will be vaccinated free of cost at the government hospitals, while those taking the shots at private hospitals will have to pay.

The vaccines will be stored at public health facilities having cold chain points. The private facilities will be able to receive the desired doses from public hospitals in their vicinity.

Akin to the previous priority groups, healthcare and frontline workers, the general public as well will not be given a choice among the two vaccines. However, the people can make a choice between the centres where they are willing to take the jab, officials told IANS.

“One would not be allowed to choose among the two vaccines. However, they can indirectly go for their preference by selecting the centre they wish to be inoculated since the information of centres along with the vaccines they use will be available to the public,” the official informed.

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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).

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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.

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AIDAN asks DCGI to withdraw approval for Bharat Biotech’s Covaxin

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The All India Drug Action Network (AIDAN) said it is shocked to learn of the SEC’s recommendation to grant REU approval to Bharat Biotech’s COVAXIN in “clinical trial mode” and “specially in the context of infection by mutant strains”.

“In light of the intense concerns arising from the absence of efficacy data and hence the limited regulatory review of the vaccine candidate, the implications of public rollout of an untested product, and lack of transparency we urge the DCGI to reconsider the recommendations of the SEC in granting the REU approval to COVAXIN,” it said.

Disturbingly, it appears that no efficacy data for the vaccine candidate were submitted from the Phase 3 trials that are ongoing and being conducted by Bharat Biotech and ICMR.

The only data for humans, available through publication pre-prints, are for safety and immunogenicity from Phase 1 and Phase 2 trials, across a total of 755 participants. In the interest of transparency it will be in the fitness of things that the trial data on the basis of which decisions have been taken by the SEC are immediately made public. It is also not clear under which provisions of the extant law the SEC has recommended for grant of REU approval and in “clinical trial mode” at that, AIDAN said.

“It is not clear if there is any scientific basis to claim that COVAXIN will be effective in the “context of infection by mutant strains” when its efficacy has not been established and is currently unknown against any strain of the virus”, it said.

“The hypothesis being propagated that the whole virion inactivated vaccine is likely to be effective against mutations of the virus is not being supported by any efficacy from the trial because no data have as yet been generated in the Phase 3 trial. Yet this appears to have been used to justify the totally non-sequitur decision which has no basis in the science of rational vaccine development”, it said.

“We are baffled to understand what scientific logic has motivated the top experts in the SEC to approve this vaccine posthaste. Moreover this is a violation of the criteria in the draft regulatory guidelines for development of Covid-19 vaccines published by CDSCO on September 21, 2020. The decision to approve an incompletely studied vaccine, even under accelerated process, raises more questions than answers and likely will not reinforce faith in our scientific decision making bodies.

On the Covishield vaccine, AIDAN said it wants to know the efficacy estimates for the dosing regimen and dosing schedule that will be followed in India as concluded by the SEC, the specific data and analysis of the foreign trials of the AstraZeneca/Oxford vaccine that was the basis of the SEC’s decision, the extent of the data for safety and immunogenicity from the Phase 2/3 bridging study in India that was submitted and reviewed by the SEC, the “multiple regulatory conditionalities” proposed by the SEC.

Any REU granted by the DCGI on the recommendation of the SEC must be accompanied by the legal provisions under which the approval is granted, the specific approved use of the vaccine candidate and details of restrictions/conditions, it said.

“In the interest of transparency and public welfare, we ask that the regulator share the detailed rationale for the decision along with disclosure of the data, evidence and information that was reviewed by the SEC and the data and analysis on the basis of which the REU approval is granted. This is particularly important given the lack of adequate information regarding the UK MHRA’s review of the AstraZeneca/Oxford vaccine and the fact that interim data for safety and immunogenicity from the Serum Institute/ICMR Phase 2/3 study have not been made publicy available”, it said.

“Bear in mind that the objective of a bridging study to assess the vaccine candidate in an Indian population would be undermined if the data generated from the trial is not reviewed in the process of regulatory approval”, 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.

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.

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