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Bharat Biotech ties up with Serum Institute subsidiary for production and supply of polio vaccines

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

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Summary

The two biotech companies have signed a requisite agreement wherein Bharat Biotech will procure drug substances for the production of oral polio vaccines to be supplied within India and globally. Both companies will jointly obtain the regulatory approvals and licenses required to commercially manufacture OPVs in India for global supplies from drug substances manufactured in the Netherlands at Bilthoven Biologicals.

Vaccines and bio-therapeutics manufacturer Bharat Biotech, on April 2, announced a collaboration with the country’s largest vaccine maker Serum Institute of India’s Netherlands-based wholly-owned subsidiary Bilthoven Biologicals B.V. This collaboration is “to further strengthen the production and supply security of oral polio vaccines (OPV)”, Bharat Biotech said in a statement.

Polio or Poliomyelitis is a disability and a life-threatening disease caused by the poliovirus. This virus is contagious as it can spread from one person to another and can also lead to permanent paralysis.

The two biotech companies have signed the requisite agreement with which Bharat Biotech will procure drug substances for the production of oral polio vaccines from Bilthovan for supply within India and globally. Both companies will jointly obtain the regulatory approvals and licenses required to commercially manufacture OPVs in India using drug substances manufactured at Bilthoven Biologicals in the Netherlands.

Also Read: India is ceding ground to its Asian peers in biopharma innovation and manufacturing, warns an open letter to the PM

On the collaboration, Adar Poonawalla, CEO of Serum Institute of India, said, “Our vision is to eradicate Polio worldwide, taking a crucial step towards reducing the impact of this deadly disease on vulnerable populations.” Dr Krishna Ella, Executive Chairman of Bharat Biotech, said, “This collaboration between BBIL and BBio exemplifies cooperation between vaccine companies, ensuring a secure supply of oral polio vaccines and fortifies the nation’s mission to eradicate polio”.

India began administering the polio vaccines in 1978 and joined the global effort to eradicate the disease. UNICEF worked along with the Indian government since the beginning of the vaccination programme. Until the 1990s, polio was a hyper-endemic disease in the country and the government launched the Universal Immunisation Programme to combat the disease. This programme was named as ‘Pulse Polio’ campaign, which was initiated in 1995.

Following the massive polio eradication effort, in January 2011, the last case of polio was reported in West Bengal. Three years after the report of the last case, India was declared to be polio-free by the World Health Organisation (WHO) in March 2014.

Also Read: Understanding Digestive Health: Insights from gastroenterology expert Dr Amit Maydeo

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

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

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index Price Change
nifty 50 ₹16,986.00 -72.15
sensex ₹1,882.60 +28.30
nifty IT ₹2,206.80 +30.85
nifty bank ₹1,318.95 -14.95
index Price Change
nifty 50 ₹16,986.00 -7.15
sensex ₹1,882.60 +8.30
nifty IT ₹2,206.80 +3.85
nifty bank ₹1,318.95 -1.95
index Price Change
nifty 50 ₹16,986.00 -72.15
sensex ₹1,882.60 +28.30
nifty IT ₹2,206.80 +30.85
nifty bank ₹1,318.95 -14.95
index Price Change
nifty 50 ₹16,986.00 -7.15
sensex ₹1,882.60 +8.30
nifty IT ₹2,206.80 +3.85
nifty bank ₹1,318.95 -1.95
index Price Change
nifty 50 ₹16,986.00 -7.15
sensex ₹1,882.60 +8.30
nifty IT ₹2,206.80 +3.85
nifty bank ₹1,318.95 -1.95

Currency

Company Price Chng %Chng
Dollar-Rupee 73.3500 0.0000 0.00
Euro-Rupee 89.0980 0.0100 0.01
Pound-Rupee 103.6360 -0.0750 -0.07
Rupee-100 Yen 0.6734 -0.0003 -0.05
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Bharat Biotech initiates TB vaccine clinical trials on adults in India

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

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Summary

Krishna Ella, Executive Chairman Bharat Biotech said “Our quest for a more effective vaccine against Tuberculosis received a big boost today, with clinical trials in India. Our goal to develop TB vaccines to prevent disease in adults and adolescents has taken a big step today.”

Bharat Biotech International Ltd on Sunday said it started clinical trials of the Tuberculosis vaccine Mtbvac on adults in India. This is the first vaccine against Tuberculosis derived from a human source by the Spanish biopharmaceutical company, Biofabri, a press release from Bharat Biotech said.

The release said that Mtbvac is being developed for two purposes; firstly, as a more effective and potentially longer-lasting vaccine than BCG ( Bacillus Calmette Guérin) for newborns and secondly, for the prevention of TB in adults and adolescents, for whom there is currently no effective vaccine.

The trials are carried out by Bharat Biotech in close collaboration with Biofabri.

Trials to evaluate the safety and immunogenicity of Mtbvac have started with a pivotal safety, immunogenicity and efficacy trial which has been planned to start in 2025, the release said.

It is a giant step to test in adults and adolescents in the country where 28% of the world’s TB cases accumulate. TB remains one of the world’s leading infectious causes of death, especially in India, Esteban Rodriguez, CEO of Biofabri said.

Krishna Ella, Executive Chairman Bharat Biotech said “Our quest for a more effective vaccine against Tuberculosis received a big boost today, with clinical trials in India. Our goal to develop TB vaccines to prevent disease in adults and adolescents has taken a big step today.”

The Mtbvac vaccine has passed several milestones before entering clinical trials in India. After the recent completion of a Phase-2 dose finding trial, a double-blind controlled Phase-3 clinical trial in newborns has been started in 2023 to compare the vaccine with the current BCG vaccine.

As many as 7,000 newborns from South Africa, 60 from Madagascar and 60 from Senegal will be vaccinated. To date, more than 1,900 babies have been vaccinated, the release added.

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index Price Change
nifty 50 ₹16,986.00 -72.15
sensex ₹1,882.60 +28.30
nifty IT ₹2,206.80 +30.85
nifty bank ₹1,318.95 -14.95
index Price Change
nifty 50 ₹16,986.00 -7.15
sensex ₹1,882.60 +8.30
nifty IT ₹2,206.80 +3.85
nifty bank ₹1,318.95 -1.95
index Price Change
nifty 50 ₹16,986.00 -72.15
sensex ₹1,882.60 +28.30
nifty IT ₹2,206.80 +30.85
nifty bank ₹1,318.95 -14.95
index Price Change
nifty 50 ₹16,986.00 -7.15
sensex ₹1,882.60 +8.30
nifty IT ₹2,206.80 +3.85
nifty bank ₹1,318.95 -1.95
index Price Change
nifty 50 ₹16,986.00 -7.15
sensex ₹1,882.60 +8.30
nifty IT ₹2,206.80 +3.85
nifty bank ₹1,318.95 -1.95

Currency

Company Price Chng %Chng
Dollar-Rupee 73.3500 0.0000 0.00
Euro-Rupee 89.0980 0.0100 0.01
Pound-Rupee 103.6360 -0.0750 -0.07
Rupee-100 Yen 0.6734 -0.0003 -0.05
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Bharat Biotech, Sydney ID announce MoU to advance vaccine research initiative

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

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Summary

The agreement aims to build strong sectoral and cross-organisational collaborations to design novel methodologies to tackle future epidemics and infectious diseases, Bharat Biotech said in a statement.

Bharat Biotech and the University of Sydney Infectious Diseases Institute Tuesday announced a memorandum of understanding between them to advance vaccine research initiatives, strengthen academic-industry partnerships and augment global efforts to combat infectious diseases.

The agreement aims to build strong sectoral and cross-organisational collaborations to design novel methodologies to tackle future epidemics and infectious diseases, Bharat Biotech said in a statement. It also aims at leveraging academia-industry strengths to advance the science of vaccines and biotherapeutics, it added.

Dr Krishna Ella, the executive chairman at Bharat Biotech, said, “This agreement reflects our ethos to facilitate collaborative research, foster innovation, and further advance the science vaccine technology.”

“Mutually, we are excited about the new opportunities to strengthen our shared vision, leverage the prowess of education, and research capabilities to help build a healthier universe and improve people’s lives by developing safer vaccine platforms. Most importantly, build the talent of young scientists with a passion to innovate,” he said.

Also Read: US FDA approves updated COVID-19 vaccines for enhanced protection

Professor Jamie Triccas, the deputy director at Sydney ID said, “Positioning Sydney ID on a global scale to drive innovation and highlight our expertise in the development of new vaccines and biotherapeutics is paramount.”

“The reputational and societal impacts of developing novel vaccines to eradicate human and animal diseases that are safe, affordable, and effective cannot be overstated. Together with Bharat Biotech International Ltd, we aim to make a lasting impact on global health,” he said.

Vaccines are the most effective and cost-effective way to protect billions of people worldwide, with vaccine development potentially transforming health by removing the burden of life-threatening infectious diseases from the population, Triccas said.

India’s capabilities in manufacturing vaccines came to the fore during the COVID-19 pandemic where companies such as Bharat Biotech were able to provide vaccines that met over 60% of the world’s demand and supplied over 2.4 billion doses of COVID-19 vaccines, the statement said.

Also Read: WHO authorizes emergency use of Novavax’s updated COVID vaccine

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

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

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index Price Change
nifty 50 ₹16,986.00 -72.15
sensex ₹1,882.60 +28.30
nifty IT ₹2,206.80 +30.85
nifty bank ₹1,318.95 -14.95
index Price Change
nifty 50 ₹16,986.00 -7.15
sensex ₹1,882.60 +8.30
nifty IT ₹2,206.80 +3.85
nifty bank ₹1,318.95 -1.95
index Price Change
nifty 50 ₹16,986.00 -72.15
sensex ₹1,882.60 +28.30
nifty IT ₹2,206.80 +30.85
nifty bank ₹1,318.95 -14.95
index Price Change
nifty 50 ₹16,986.00 -7.15
sensex ₹1,882.60 +8.30
nifty IT ₹2,206.80 +3.85
nifty bank ₹1,318.95 -1.95
index Price Change
nifty 50 ₹16,986.00 -7.15
sensex ₹1,882.60 +8.30
nifty IT ₹2,206.80 +3.85
nifty bank ₹1,318.95 -1.95

Currency

Company Price Chng %Chng
Dollar-Rupee 73.3500 0.0000 0.00
Euro-Rupee 89.0980 0.0100 0.01
Pound-Rupee 103.6360 -0.0750 -0.07
Rupee-100 Yen 0.6734 -0.0003 -0.05
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Bharat Biotech’s Krishna Ella suggests merging state drugs regulators with central body

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

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Summary

The whole of Indian pharmaceutical industries cannot be sullied for a handful of cases, he said. “Even in Western countries, some of the companies are penalised on quality issues.”

All state drug regulatory bodies should be merged with the Central Drugs Standard Control Organisation(CDSCO) to ensure “one quality one standard” for Indian drugs, Bharat Biotech’s Executive Chairman Dr Krishna Ella has suggested.

His comments came on Sunday in the backdrop of questions being raised about the quality of Indian drugs over the past few months. The latest instance was on Friday, when the Tamil Nadu-based Global Pharma Healthcare recalled its entire lot of eye drop linked allegedly to vision loss in the US.

Before that, India-made cough syrups were allegedly linked to children deaths in the Gambia and Uzbekistan last year.

The whole of Indian pharmaceutical industries cannot be sullied for a handful of cases, he said. “Even in Western countries, some of the companies are penalised on quality issues.”

Also Read: Economic Survey 2023 | Domestic pharmaceutical market to reach $130 billion by 2030

“There should be a single regulatory framework in India. All state drug regulatory bodies should be merged with the Central Drugs Standard Control Organisation(CDSCO) and that will solve the problem,” Ella said.

“But somewhere a political decision and commitment is required for this,” he said on the sidelines of an event in which an agreement was signed between the University of Wisconsin (UW)-Madison Global Health Institute (GHI) and the Ella Foundationin Delhi for establishment of the first ever “UW-Madison One Health Centre” in Bengaluru.

It is important to centralise the system, he said. “The licences for the cough syrups that were under question in the recent cases were given by state regulatory bodies, not by the Central (body”.  “We have extremely good companies but because of some local agencies we are getting into trouble,” he said.

Also Read: Sun Pharma acquires three brands to strengthen its anti-inflammatory portfolio

A day after its plant was inspected by Indian drug regulatory bodies over allegations that its eye drop was linked to vision loss in the US, Tamil Nadu-based Global Pharma Healthcare on Saturday was asked to stop manufacturing all ophthalmic products till the inquiry is completed.

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

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index Price Change
nifty 50 ₹16,986.00 -72.15
sensex ₹1,882.60 +28.30
nifty IT ₹2,206.80 +30.85
nifty bank ₹1,318.95 -14.95
index Price Change
nifty 50 ₹16,986.00 -7.15
sensex ₹1,882.60 +8.30
nifty IT ₹2,206.80 +3.85
nifty bank ₹1,318.95 -1.95
index Price Change
nifty 50 ₹16,986.00 -72.15
sensex ₹1,882.60 +28.30
nifty IT ₹2,206.80 +30.85
nifty bank ₹1,318.95 -14.95
index Price Change
nifty 50 ₹16,986.00 -7.15
sensex ₹1,882.60 +8.30
nifty IT ₹2,206.80 +3.85
nifty bank ₹1,318.95 -1.95
index Price Change
nifty 50 ₹16,986.00 -7.15
sensex ₹1,882.60 +8.30
nifty IT ₹2,206.80 +3.85
nifty bank ₹1,318.95 -1.95

Currency

Company Price Chng %Chng
Dollar-Rupee 73.3500 0.0000 0.00
Euro-Rupee 89.0980 0.0100 0.01
Pound-Rupee 103.6360 -0.0750 -0.07
Rupee-100 Yen 0.6734 -0.0003 -0.05
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Bharat Biotech launches iNCOVACC — world’s first nasal COVID vaccine

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

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Summary

According to a statement issued by Bharat Biotech, ‘iNCOVACC’ is priced at Rs 800 for private markets and Rs 325 for supplies to the government of India and state governments. For patients, who have already got Covaxin and Covishield, the nasal vaccine can also be used as a heterologous booster dose.

Union Health Minister Mansukh Mandaviya and Union Science and Technology Minister Jitendra Singh, on the occasion of Republic Day, launched Bharat Biotech International Limited ‘s first India-made nasal COVID-19 vaccine, iNCOVACC. Bharat Biotech also claims that iNCOVACC is also the world’s first COVID intranasal vaccine for primary series and heterologous booster.

Mandaviya, during the launch event, said that over 65 percent of vaccines supplied in the world are from India. He also congratulated the Bharat Biotech team for bringing about the world’s first nasal vaccine. He said, “…being the world’s first intra-nasal COVID-19 vaccine, this marks a glorious tribute to the call for Atmanirbhar Bharat.”

This new nasal vaccine, BBV154, received the Drugs Controller General of India (DCGI) approval in November for restricted emergency use among adults as a heterologous booster dose.

Singh also congratulated the company for developing another vaccine and said that “India has taken a lead in developing vaccines and medicines for diseases common in the developing world”. He credited Prime Minister Narendra Modi’s intervention and regular monitoring for inspiring and enabling the launching of “Mission Covid Suraksha”, which has not only strengthened Aatmanirbhar Bharat but also bolstered India’s status as a worldwide vaccine development and manufacturing centre, thus showcasing the strength of India’s Science and Technology capabilities. “Next step would be to develop vaccines for non-communicable diseases,” he added.

Rajesh Gokhale, Secretary, Department of Biotechnology; Rajesh Kumar Pathak, Secretary of Technology Development Board; and other senior officials of the Ministry were also present on the occasion. Krishna Ella, Co-Founder & Executive Chairman of Bharat Biotech, and Suchitra Ella, Co-Founder and MD, were also present.

Last week, Ella revealed that iNCOVACC will be launched on January 26 as the nasal COVID vaccination had already received official approval for use among people older than 18 years, and it will also be given as a heterologous booster dose.

According to a statement issued by Bharat Biotech, iNCOVACC is priced at Rs 800 for private markets and Rs 325 for supplies to the Government of India and state governments. For patients who have already got Covaxin and Covishield, the nasal vaccine can also be used as a heterologous booster dose. Interestingly, iNCOVACC is also the first intranasal vaccine in the world to get approval for both primary series and heterologous booster.

iNCOVACC is a recombinant replication-deficient adenovirus vectored vaccine with a pre-fusion stabilised spike protein. This vaccine candidate was evaluated in phase I, II and III clinical trials with successful results, the Hyderabad-based vaccine maker had said.

Phase III trials of the vaccine were conducted on 3,100 participants at 14 trial sites across India to evaluate immunogenicity and safety. Hyderabad-based companies also intend to export iNCOVACC overseas once it gets licensed.

Bharat Biotech is currently in discussions with overseas “potential partners”, who have contacted the company about producing and distributing the intranasal vaccine internationally, according to corporate sources. The vaccine was partnered with Washington University in St. Louis, which created the recombinant adenoviral vectored construct and tested its efficacy in pre-clinical investigations.

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

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

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index Price Change
nifty 50 ₹16,986.00 -72.15
sensex ₹1,882.60 +28.30
nifty IT ₹2,206.80 +30.85
nifty bank ₹1,318.95 -14.95
index Price Change
nifty 50 ₹16,986.00 -7.15
sensex ₹1,882.60 +8.30
nifty IT ₹2,206.80 +3.85
nifty bank ₹1,318.95 -1.95
index Price Change
nifty 50 ₹16,986.00 -72.15
sensex ₹1,882.60 +28.30
nifty IT ₹2,206.80 +30.85
nifty bank ₹1,318.95 -14.95
index Price Change
nifty 50 ₹16,986.00 -7.15
sensex ₹1,882.60 +8.30
nifty IT ₹2,206.80 +3.85
nifty bank ₹1,318.95 -1.95
index Price Change
nifty 50 ₹16,986.00 -7.15
sensex ₹1,882.60 +8.30
nifty IT ₹2,206.80 +3.85
nifty bank ₹1,318.95 -1.95

Currency

Company Price Chng %Chng
Dollar-Rupee 73.3500 0.0000 0.00
Euro-Rupee 89.0980 0.0100 0.01
Pound-Rupee 103.6360 -0.0750 -0.07
Rupee-100 Yen 0.6734 -0.0003 -0.05
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Bharat Biotech founder bats for incentives, tax breaks for patented products, innovation

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

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Summary

Bharat Biotech founder Dr Krishna Ella on Friday batted for “research linked incentives” and tax breaks for new products based on breakthrough and patented innovation done within the country.

Bharat Biotech founder Dr Krishna Ella on Friday batted for “research linked incentives” and tax breaks for new products based on breakthrough and patented innovation done within the country. He was speaking to reporters on the sidelines of the 72nd Indian Pharmaceutical Conference underway here.

“Research linked incentive for Indian companies is very important. I would request the ministry to give tax breaks to any product that is created from patent filed in India. It will inspire entrepreneurs to go for innovation,” he said.

Speaking at the 72nd IPC here earlier in the day, Drugs Controller General of India Dr V G Somani had said the Centre was all set to introduce a research linked incentive programme shaped on the lines of the production linked incentive (PLI) scheme to boost research and development of biotech products in the country.

Queried about the need for three doses of the COVID-19 vaccine instead of just one, Ella said his company was working on the issue.

The three-day Indian Pharmaceutical Congress will cover various issues related to the sector, academia and community pharmacy and will be attended by delegates from India and abroad.

Also read: Davos 2023 | Adar Poonawalla says multilateral organisations must cooperate to tackle future disease outbreaks

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

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

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

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index Price Change
nifty 50 ₹16,986.00 -72.15
sensex ₹1,882.60 +28.30
nifty IT ₹2,206.80 +30.85
nifty bank ₹1,318.95 -14.95
index Price Change
nifty 50 ₹16,986.00 -7.15
sensex ₹1,882.60 +8.30
nifty IT ₹2,206.80 +3.85
nifty bank ₹1,318.95 -1.95
index Price Change
nifty 50 ₹16,986.00 -72.15
sensex ₹1,882.60 +28.30
nifty IT ₹2,206.80 +30.85
nifty bank ₹1,318.95 -14.95
index Price Change
nifty 50 ₹16,986.00 -7.15
sensex ₹1,882.60 +8.30
nifty IT ₹2,206.80 +3.85
nifty bank ₹1,318.95 -1.95
index Price Change
nifty 50 ₹16,986.00 -7.15
sensex ₹1,882.60 +8.30
nifty IT ₹2,206.80 +3.85
nifty bank ₹1,318.95 -1.95

Currency

Company Price Chng %Chng
Dollar-Rupee 73.3500 0.0000 0.00
Euro-Rupee 89.0980 0.0100 0.01
Pound-Rupee 103.6360 -0.0750 -0.07
Rupee-100 Yen 0.6734 -0.0003 -0.05
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Who can’t receive COVID-19 nasal vaccine — From benefits to side effects, here’s your one-stop guide

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

 Listen to the Article (6 Minutes)

Summary

COVID-19 in India: The government has approved Bharat Biotech’s COVID-19 nasal vaccine — BBV154 or iNCOVACC — as a “heterologous booster dose” and it is recommended to be taken as the “first booster dose” only, according to reports.

India’s first COVID-19 nasal vaccine — BBV154 or iNCOVACC — will soon be available in the country and will be used as a booster dose. It will be available at government, as well as, private hospitals and people can book the precautionary dose at CoWin. Bharat Biotech’s nasal vaccine could prove to be a big boost to India’s vaccination programme as it eliminates needle-associated risks and could even “cut into vaccine hesitancy“.

What are the other benefits of this nasal vaccine? When will it be available in the market? How much will it cost? And who can use it? Here’s your one-stop guide:

What is Bharat Biotech’s BBV154 or iNCOVACC?’

iNCOVACC is an intranasal vaccine for “active immunization” against SARS-CoV-2 virus infection.

How many doses of iNCOVACC can be taken and how is it administered?

iNCOVACC® is administered through the nose, as a two-dose series, four weeks apart. The vaccination course iNCOVACC consists of two separate doses of 0.5 mL of eight drops with four drops indicated for each nostril.

Recently, the government has approved it as a “heterologous booster dose” and it is recommended to be taken as the “first booster dose” only.

Who can receive the naval vaccine?

As of now, the intranasal vaccine is recommended as one of the options for precautionary doses for those aged 18 years and above in India. Those who have been vaccinated with two doses of either Covishield or Covaxin can opt for iNCOVACC as a precautionary dose.

But, if a person has already taken a precautionary or booster dose, iNCOVACC is not recommended for them as the next vaccine shot. In an exclusive interview with NDTV, Dr NK Arora, the head of the country’s vaccine task force, said, “It (nasal vaccine) is recommended as the first booster… It is for those who have not yet taken a precautionary dose.”

ALSO READ | Decision on nasal vaccine for children only after Phase 2, 3 trial on adults: Bharat Biotech CMD

One must not get vaccinated with iNCOVACC if:

  • You had a severe allergic reaction to any ingredients of the vaccine
  • You had a severe allergic reaction after a previous dose of this vaccine
  • You currently have an acute infection or fever

What should you mention before taking your vaccination?

One must inform the vaccinator or the supervising officer about all of your medical conditions, including if you:

  • Are on regular medication for any illness, for how long and for which condition
  • Have any allergies
  • Have fever
  • Have a coagulation/bleeding disorder or are on a blood thinner
  • Are immunocompromised or are on a medicine that affects your immune system
  • Are pregnant
  • Have received another COVID-19 vaccine

When will COVID-19 nasal vaccine be available and how to opt for it?

iNCOVACC has been already been introduced on CoWin. However, the doses are likely to be rolled out in the fourth week of January 2023.

Once they are available, one can log in on CoWin and select iNCOVACC to be their precautionary dose. Here’s a step-by-step process to do so:

  • Visit CoWIN website
  • Login using your registered mobile number
  • Enter One Time Password (OTP) to verify
  • Afer logging in, click on your vaccine status and tap on the available booster dose
  • Search for your nearest vaccination centre by entering the pin code or district name
  • Select your preferred centre
  • Select your preferred date and time to get the nasal vaccine booster dose
  • Confirm your slot

What is the cost of one dose of the COVID-19 nasal vaccine?

Bharat Biotech International Limited said its COVID-19 intranasal vaccine iNCOVACC is priced at Rs 800 (excluding 5 percent Goods and Services Tax (GST)) for private markets and Rs 325 (excluding GST) for government supplies.

Provided that private hospitals are permitted to charge up to Rs 150 as an administrative charge for every dose of the COVID-19 vaccine, one dose of this vaccine developed on a technology licensed by the Washington University in St Louis may cost about Rs 1,000 for every recipient, Moneycontrol reported.

What are the benefits of COVID-19 nasal vaccine?

While any injectable vaccine only protects the lower level (of the body), the nasal jab gives protection to the whole body, Krishna Ella, Executive Chairman of Bharat Biotech, had said earlier. It is also designed for efficient distribution and easy pain-free administration, the pharma company said.

As mentioned by Bharat Biotech, the nasal vaccine is:

  • Likely to block both infection and transmission of COVID-19
  • Non-invasive and needle-free
  • Easy to administer as it does not require trained healthcare workers
  • Eliminates needle-associated risks (injuries and infections)
  • High compliance — ideally suits children and adults
  • Scalable manufacturing — able to meet global demand

What are the side effects of the iNCOVACC vaccine?

Side effects that have been reported include:

  • Headache
  • Fever
  • Running nose
  • Sneezing

“A severe allergic reaction may very rarely occur after getting a dose of iNCOVACC®. However no such event was reported in the clinical trial with iNCOVACC®,” the Bharat Biotech factsheet says.

What if you have side effects after getting vaccinated with iNCOVACC?

One must contact or visit their health provider/vaccinator/officer supervising their vaccination. They can also immediately go to the nearest hospital.

Moreover, Bharat Biotech says one must report vaccination side effects to the company on toll-free Number: +1 800 102 2245 or email at pvg@bharotbiotech.com .

How successful were trials of iNCOVACC?

Emphasising the success of trials of iNCOVACC vaccine, Krishna Ella had earlier said there is no single instance of side effect or adverse reaction reported so far. Bharat Biotech also claimed that the “intranasal vaccine stimulates a broad immune response”.

“Phase III clinical trial done in 3000 participants, iNCOVACC® has been shown to generate good immunity following two doses given four weeks apart,” the Bharat Biotech factsheet says. “…there is no chance of getting COVID-19 post immunisation with iNCOVACC®,” it adds.

Meanwhile, “there is no scientific information yet available on the appropriateness of use of iNCOVACC® along with other vaccines,” it says. The factsheet also mentions that “individuals with immunosuppression may not generate a full immune response to COVID-19”, adding that “data is not currently available to establish vaccine safety and efficacy in these (immunocompromised) groups.”

iNCOVACC vaccine candidate was evaluated in phase I, II and III clinical trials with successful results, Bharat Biotech, the Hyderabad-based vaccine maker, said in a statement. Clinical trials were conducted to evaluate iNCOVACC as a primary dose schedule as well as a heterologous booster dose for subjects who have previously received two doses of either Covishield or Covaxin.

Phase-III trials of iNCOVACC (as a two-dose regimen) were conducted for safety, immunogenicity in approximately 3100 subjects, in 14 trial sites across India while Heterologous booster dose studies were conducted for safety and immunogenicity in 875 subjects, the release further said.

When did this vaccine get approval from the government?

iNCOVACC is “the world’s first intranasal vaccine” to receive approval for the primary two-dose schedule, and as a heterologous booster dose, Bharat Biotech said in a press release.

It had received approval of the Drugs Controller General of India (DCGI) in November for restricted use in an emergency situation for those above 18 years as a heterologous booster dose.

Earlier this month, Bharat Biotech received approval from the Central Drugs Standard Control Organisation (CDSCO) for the use of heterologous booster doses of iNCOVACC.

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index Price Change
nifty 50 ₹16,986.00 -72.15
sensex ₹1,882.60 +28.30
nifty IT ₹2,206.80 +30.85
nifty bank ₹1,318.95 -14.95
index Price Change
nifty 50 ₹16,986.00 -7.15
sensex ₹1,882.60 +8.30
nifty IT ₹2,206.80 +3.85
nifty bank ₹1,318.95 -1.95
index Price Change
nifty 50 ₹16,986.00 -7.15
sensex ₹1,882.60 +8.30
nifty IT ₹2,206.80 +3.85
nifty bank ₹1,318.95 -1.95

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Nasal vaccine can be an effective weapon against Covid

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

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Summary

The main advantage of this vaccine is that it will provide a broad spectrum of immunity. The nasal route has an advantage for delivery as they do not require injections.

Intranasal vaccine, though not much data on its clinical efficacy yet available in the public domain, could prove to be an easy and effective tool to enhance the immunity against Coronavirus infection that is again on the surge globally.  For India, it could also help lift the much lagged immune booster programme.  

The vaccine is new in terms of technology and use in terms of real world experience. So there is limited data available to compare and qualify the   product on the basis of clinical experience in a large and vivid population. However, considering its ease of use and the price point (in India), the vaccine can go a long way in the fight against Covid pandemic.    

Since the vaccine does not require an injection, it can cut into vaccine hesitancy that had come into place after the Covid curve became almost flat. The vaccine, to be launched in India by Bharat Biotech as it has been approved  by the drug control authority, is priced at Rs 800 for private markets and Rs 325 for the government.

According to Bharat Biotech, the vaccine will be rolled out in the fourth week of January and will serve as a booster dose for those above 18 years of age.

 Easy delivery, Needle free

Several mucosal COVID-19 vaccines are in development globally. The nasally inhaled vaccine is designed to induce immunity in the airways and block virus transmission. The main advantage of this vaccine is that it will provide a broad spectrum of immunity. The nasal route has an advantage for delivery as they do not require injections. All the other risks of injection like infection and soreness are also eliminated. The health care workers also need not be as skilled in this case as the administration is easy.

Bharat Biotech’s nasal vaccine is a recombinant replication deficient adenovirus vectored vaccine with a pre-fusion stabilised SARS-CoV-2 spike protein. This vaccine candidate was evaluated in phases I, II and III clinical trials with successful results. It has been specifically formulated to allow intranasal delivery through nasal drops. The nasal delivery system has been designed and developed to be cost-effective in low- and middle-income countries.

The vaccine that is stable at 2-8C for easy storage and distribution also has the benefit of enabling faster development of variant specific vaccines and easy nasal delivery that enables mass immunisation to protect from emerging virus variants of concern.

Challenging canvas, No data

Delivering vaccines to the nose is one of the most efficient and easy ways to achieve immunity. It can be easily administered and is especially helpful for those who have a fear of needles. Old people who have difficulties in getting an injection will benefit from them.

But despite the several merits there are many challenges. Experts are not sure on how well they will work and how long they will work. There is no available data in the public domain that shows their efficiency and durability. There has to be a robust clinical study on these vaccines to establish their efficacy. In the absence of proper data, their durability cannot be known.

Researchers from the University of Oxford recently published new findings from a Phase 1 clinical trial studying the safety and immune response of an intranasally-administered vaccine against COVID-19. The study was performed in collaboration with AstraZeneca.

The researchers reported mucosal antibody responses were seen in a ‘minority’ of participants. Systemic immune responses to intranasal vaccination were also weaker compared with intramuscular vaccination. The researchers said that the vaccine did not generate a consistent mucosal antibody nor a strong systemic immune response.

Apart from the data constraints, manufacturing of the nasal vaccine needs to be spruced urgently to meet the growing demand. It is not sure whether the current production will be able to meet the demand. The government must help in whatever way possible to ensure that there is no gap in production and demand.

The supply chains that had weakened after the dip in case numbers needed to be activated. The cold storage systems should also be re-looked at to plug any loopholes that have developed.  There is also a need to establish a strong pharmacovigilance system to identify any safety concerns.

But despite the challenges, the new vaccine platform can act as a powerful tool in reducing the transmission. The government must ensure that the programme does not lose its steam.

The author Dr Vanita Srivastava is an independent science and health writer
Read her previous articles here

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nifty 50 ₹16,986.00 -7.15
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index Price Change
nifty 50 ₹16,986.00 -72.15
sensex ₹1,882.60 +28.30
nifty IT ₹2,206.80 +30.85
nifty bank ₹1,318.95 -14.95
index Price Change
nifty 50 ₹16,986.00 -7.15
sensex ₹1,882.60 +8.30
nifty IT ₹2,206.80 +3.85
nifty bank ₹1,318.95 -1.95
index Price Change
nifty 50 ₹16,986.00 -7.15
sensex ₹1,882.60 +8.30
nifty IT ₹2,206.80 +3.85
nifty bank ₹1,318.95 -1.95

Currency

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Dollar-Rupee 73.3500 0.0000 0.00
Euro-Rupee 89.0980 0.0100 0.01
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Bharat Biotech’s intranasal COVID-19 vaccine will cost Rs 800 plus 5% GST per dose to private hospitals

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

 Listen to the Article (6 Minutes)

Summary

The vaccine is likely to be available in private hospitals around January 26 and may cost about Rs 1,000 to a recipient including an administrative charge.

A single dose of Bharat Biotech’s intranasal vaccine iNCOVACC, which was approved for inclusion into India’s COVID-19 immunisation programme last week, will cost Rs 800 each, apart from 5 percent Goods and Services Tax (GST) in private hospitals, top government sources told Moneycontrol.

Provided that private hospitals are permitted to charge up to Rs 150 as an administrative charge for every dose of the COVID-19 vaccine, one dose of this vaccine developed on a technology licensed by the Washington University in St Louis may cost about Rs 1,000 for every recipient.

The intranasal vaccine, which has been earlier approved both as a booster shot for those fully vaccinated with Covaxin or Covishield, as well as a primary vaccine for a full two-dose course against COVID-19, would be available at private vaccination centres by the end of January.

“Bharat Biotech had reached out to us for price fixation of its intranasal and it has been approved now; the vaccine is going to be available in less than a month in private hospitals,” a senior government official said.

The government has urged all adults, especially the vulnerable population groups, to receive precautionary doses against coronavirus amid concerns of a fresh wave of COVID-19 in the country as neighbouring China, which recently lifted all coronavirus-related restrictions, is facing a massive surge in infections.

Also Read: What China should have learnt from previous COVID-19 waves

Vaccination status

As of now, the government is not planning to procure iNCOVACC for vaccination at government hospitals, which is provided free of cost to the eligible beneficiaries.

At present, government hospitals offer Covishield and Covaxin as a booster or precautionary dose for all above 60 years provided they have completed their primary vaccination schedule at least six months earlier.

Those in the 18-59-year age group, however, are entitled to receive booster doses only in private hospitals by paying predetermined rates.

Private hospitals meanwhile said they expect demand for booster doses, especially the intranasal vaccine, to rise in the wake of the COVID-19 situation in China.

“But the booster uptake may still stay low, given that India’s COVID-19 situation seems stable, if the intranasal vaccine is prohibitively expensive,” Girdhar J Gyani, director general of the Association of Private Healthcare Providers of India, said.

Also Read: Insurance regulator reaches out to life and general insurers on COVID-19 preparedness

Bharat Biotech has not responded to a query by this publication on the launch of this vaccine but sources in the company said the quantity of supply will depend on the demand raised by private vaccination centres.

This copy will be updated when the vaccine maker responds to our query.

So far in India, less than 30 percent of those eligible for precautionary doses have received it and experts say that those aged 60 and above, people with multiple co-morbidities and immunocompromised should make it a point to receive booster COVID-19 vaccine.

Potential game-changer?

iNCOVACC is an adenoviral vector-based SARS CoV-2 vaccine for nasal administration only and its vaccination course consists of two separate doses of 0.5 mL of eight drops with four drops indicated for each nostril.

Once called a “game-changer” for its potential role in preventing transmission of the virus and not just severity of the disease, the vaccine has been studied in phases 1 and 2 and an ongoing phase 3 clinical studies for safety and immunogenicity and found to be safe and immunogenic, as per data submitted to the Drug Controller General of India.

Also Read: COVID alert: Health Minister Mansukh Mandaviya warns against ‘infodemic’

“As the vaccine is administered through the nose, where the virus enters humans, it has the potential to block infection and disrupt the cycle of transmission, apart from preventing lung damage,” said a virologist working with a research institution run by the department of science and biotechnology.

A package insert on the vaccine, accessed by Moneycontrol, showed the company claiming that the vaccine has been evaluated and shown satisfactory immune response against several variants of such as Delta, Beta and Omicron including the recent variant BA.5.

“Cell mediated immune response, both T and B cell phenotype distribution is evaluated against SARS-CoV-2 variants including omicron variants found the response is persistent across variants,” says the insert.

Senior government officials are also upbeat about the ease with which the vaccine can be stored and administered.

“Once opened, multi-dose vials should be used within 6 hours and stored at 2 to 8ºC between administrations,” the insert says.

Also Read: COVID-19 mock drills across India today — Here’s what to expect

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

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index Price Change
nifty 50 ₹16,986.00 -72.15
sensex ₹1,882.60 +28.30
nifty IT ₹2,206.80 +30.85
nifty bank ₹1,318.95 -14.95
index Price Change
nifty 50 ₹16,986.00 -7.15
sensex ₹1,882.60 +8.30
nifty IT ₹2,206.80 +3.85
nifty bank ₹1,318.95 -1.95
index Price Change
nifty 50 ₹16,986.00 -72.15
sensex ₹1,882.60 +28.30
nifty IT ₹2,206.80 +30.85
nifty bank ₹1,318.95 -14.95
index Price Change
nifty 50 ₹16,986.00 -7.15
sensex ₹1,882.60 +8.30
nifty IT ₹2,206.80 +3.85
nifty bank ₹1,318.95 -1.95
index Price Change
nifty 50 ₹16,986.00 -7.15
sensex ₹1,882.60 +8.30
nifty IT ₹2,206.80 +3.85
nifty bank ₹1,318.95 -1.95

Currency

Company Price Chng %Chng
Dollar-Rupee 73.3500 0.0000 0.00
Euro-Rupee 89.0980 0.0100 0.01
Pound-Rupee 103.6360 -0.0750 -0.07
Rupee-100 Yen 0.6734 -0.0003 -0.05
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Bharat Biotech intranasal vaccine to launch on Co-WIN app today

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

 Listen to the Article (6 Minutes)

Summary

The approval for the vaccine comes amid a surge of COVID cases in China. India, on Friday, reported 163 new cases and three new deaths.

The Union Ministry of Health and Family Welfare on Friday approved Bharat Biotech’s nasal vaccine, a needleless COVID vaccine. It can be provided as a booster dose for those above 18 years of age, official sources said on Thursday.

The vaccine will be used as a “heterologous booster” and will be first be made available in private hospitals, official sources say. The vaccine, called iNCOVACC, got emergency use authorisation on November 25, 2022. It is India’s first nasal vaccine developed against COVID-19.

Also read: Bharat Biotech’s COVID-19 nasal vaccine booster gets emergency use authorisation

Bharat Biotech had claimed that the “intranasal vaccine stimulates a broad immune response.” It is likely to block both infection and transmission of COVID-19. It is non-invasive and needle-free which makes it easy to administer as it does not require trained healthcare workers.

The approval for the vaccine comes amid a surge of COVID cases in China. India, on Friday, reported 163 new cases and three new deaths. It accounts for 0.03 percent of global COVID cases.

Prime Minister Narendra Modi had on Thursday cautioned people against complacency and urged them to wear masks in crowded places, while also directing officials to strengthen surveillance measures, especially at international airports.

Union Health Minister Mansukh Mandaviya on Thursday briefed the Parliament on the COVID surge and advised states and individuals to be vigilants. Several Members of the Parliament, including PM Modi, were seen wearing a mask on Thursday.

“We haven’t done any politics on COVID,” Mandaviya told the Rajya Sabha yesterday.

Mandaviya will meet representatives of the Indian Medical Association (IMA) and other stakeholders on Monday, December 26, 2022. The IMA is currently looking at a study investigating the link between COVID vaccinations and death due to cardiac arrests.

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

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

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index Price Change
nifty 50 ₹16,986.00 -72.15
sensex ₹1,882.60 +28.30
nifty IT ₹2,206.80 +30.85
nifty bank ₹1,318.95 -14.95
index Price Change
nifty 50 ₹16,986.00 -7.15
sensex ₹1,882.60 +8.30
nifty IT ₹2,206.80 +3.85
nifty bank ₹1,318.95 -1.95
index Price Change
nifty 50 ₹16,986.00 -72.15
sensex ₹1,882.60 +28.30
nifty IT ₹2,206.80 +30.85
nifty bank ₹1,318.95 -14.95
index Price Change
nifty 50 ₹16,986.00 -7.15
sensex ₹1,882.60 +8.30
nifty IT ₹2,206.80 +3.85
nifty bank ₹1,318.95 -1.95
index Price Change
nifty 50 ₹16,986.00 -7.15
sensex ₹1,882.60 +8.30
nifty IT ₹2,206.80 +3.85
nifty bank ₹1,318.95 -1.95

Currency

Company Price Chng %Chng
Dollar-Rupee 73.3500 0.0000 0.00
Euro-Rupee 89.0980 0.0100 0.01
Pound-Rupee 103.6360 -0.0750 -0.07
Rupee-100 Yen 0.6734 -0.0003 -0.05
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