Tag: Bharat Biotech

Bharat Biotech urges Centre to include its intranasal COVID vaccine in CoWIN portal

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

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Bharat Biotech has requested the central government to include its intranasal COVID-19 vaccine iNCOVACC, in CoWIN portal to enable the recipients of the jab to get vaccination certificates.

The company sources said Bharat Biotech is currently holding discussions with international “potential partners” who have approached the company to manufacture and distribute the intranasal vaccine globally.

“Since iNCOVACC has been approved for “Restricted use under emergency situation” and vaccine recipients will require vaccine certificates, we have requested the government to include iNCOVACC in the COWIN portal. Once this is enabled, India will be one of the few countries to have introduced an intranasal vaccine in its immunization program against COVID,” the sources told PTI.

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Currently Bharat Biotech’s Covaxin, Serum Institute’s Covishield and Covovax, Russian Sputnik V and Biological E Ltd’s Corbevax are listed in the CoWIN portal.

The vaccine maker, on September 6, announced that its iNCOVACC (BBV154), the world’s first intranasal COVID-19 vaccine has received approval from the Drugs Controller General of India under Restricted Use in Emergency Situation for ages 18 and above.

“There have been no requests for procurement from state or central governments,” sources further said.

The city-based vaccine maker also plans to export iNCOVACC to other countries once it gets approvals from the respective nations, sources added.

iNCOVACC (BBV154) has also received approval from the Central Drugs Standard Control Organisation (CDSCO) under Restricted Use in Emergency Situation for ages 18 and above in India, for heterologous booster doses.

Also Read: AstraZeneca’s global chairman reflects on 3 billion COVID shots and what’s next

The vaccine was developed in partnership with Washington University, St Louis, which had designed and developed the recombinant adenoviral vectored construct and evaluated it in pre-clinical studies for efficacy.

The vaccine candidate underwent Phases I, II and III clinical trials with successful results and has been specifically formulated to allow intranasal delivery through nasal drops.

Phase-III trials were conducted for safety, and immunogenicity in approximately 3,100 subjects, at 14 trial sites across India.

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Bharat Biotech’s COVID-19 vaccine iNCOVACC gets CDSCO nod for heterologous booster doses

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

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Bharat Biotech International Limited on Monday announced that its COVID-19 intranasal vaccine iNCOVACC (BBV154) has received approval from the Central Drugs Standard Control Organisation (CDSCO) under Restricted Use in Emergency Situation for ages 18 and above in India, for heterologous booster doses.

A press release from the vaccine maker said iNCOVACC, a recombinant replication deficient adenovirus vectored vaccine with a pre-fusion stabilised SARS-CoV-2 spike protein, is the world’s first intranasal vaccine to receive both primary series and heterologous booster approval.

The vaccine candidate was evaluated in Phases I, II and III clinical trials with successful results and has been specifically formulated to allow intranasal delivery through nasal drops, it said. The nasal delivery system has been designed and developed to be cost-effective in low- and middle-income countries, Bharat Biotech said.

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

The vaccine had earlier received approval under Restricted Use in Emergency Situation for ages 18 and above for primary two-dose schedule. Phase-III trials were conducted for safety, immunogenicity in approximately 3,100 subjects, at 14 trial sites across India.

Krishna Ella, Chairman & Managing Director, Bharat Biotech, said: “Despite the lack of demand for COVID vaccines, we continued product development in intranasal vaccines to ensure that we are well-prepared with platform technologies for future infectious diseases… We have also initiated development of variant-specific vaccines for COVID for future preparedness.”

iNCOVACC was developed in partnership with Washington University, St Louis, which had designed and developed the recombinant adenoviral vectored construct and evaluated in pre-clinical studies for efficacy.

Rajesh S Gokhale, Secretary, DBT, and Chairperson, BIRAC, said, “The DCGI’s approval of Bharat Biotech’s intranasal vaccine iNCOVACC (BBV154) to be used as a heterologous booster dose against currently available COVID-19 vaccines is a moment of great pride for our country. This move will further strengthen our collective fight against the pandemic and broaden vaccine coverage.”

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

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

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

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The Central Drugs Standard Control Organisation (CDSCO) granted emergency use authorisation (EUA) to the booster dose of Bharat Biotech’s COVID-19 nasal vaccine—-iNCOVACC, which was India’s first nasal vaccine developed against Covid-19, sources told CNBC-TV18

EUA was granted for restricted emergency use as the third dose for adults irrespective of having been administered Covaxin or Covishield vaccine doses, the sources added. The vaccination with  the primary dose  of iNCOVACC was aproved in September.

The nasal vaccine can be taken after six months of the second dose. The vaccine administration will begin post-alignment with the Cowin application.

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.

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

CDSCO expert panel to review Bharat Biotech’s intranasal booster jab on November 15

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

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The subject expert committee (SEC) of the Central Drugs Standard Control Organisation (CDSCO) will meet on Tuesday (November 15) to review the application of Bharat Biotech International’s intranasal booster jab, sources privy to the developments told CNBC-TV18.

The CDSCO expert panel will examine the proposal of Hyderabad-based Bharat Biotech seeking market authorisation for the nasal vaccine, according to multiple people familiar with the development.

In September, the Drugs Controller General of India (DCGI) approved Bharat Biotech’s intranasal COVID-19 vaccine for restricted emergency use in those aged above 18 years.

Also Read: What is listeria, the foodborne illness on the rise in the US?

This is India’s first intra-nasal COVID-19 vaccine which will be used for primary immunization against COVID-19 in the 18+ age group for restricted use in an emergency situation.

The company had completed clinical trials of the nasal vaccine with about 4,000 volunteers and there are no side effects or adverse reactions reported so far.

In August, it said its COVID-19 intranasal vaccine (BBV154) has proven to be safe, well-tolerated, and immunogenic in subjects in controlled clinical trials phase -3.

BBV154 is an intranasal replication-deficient chimpanzee adenovirus SARS-CoV-2 vectored vaccine. BBV154 has been specifically formulated to allow intranasal delivery.

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In addition, the nasal delivery system has been designed and developed to be cost-effective in low and middle-income countries, the vaccine maker had said.

Two separate and simultaneous clinical trials were conducted to evaluate BBV154 as a primary dose (2-dose) schedule and a heterologous booster dose for subjects who have previously received 2 doses of the two commonly administered COVID-19 vaccines – Covishield and Covaxin – in India.

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

Bharat Biotech chairman says industrial environment favourable for business in Karnataka, intends to invest

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

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Bharat Biotech chairman Krishna M Ella said on Friday he intends to “invest in Karnataka, where the industrial environment is favourable for business”.

Ella met Karnataka Minister of Large and Medium Industries Murugesh R Nirani in Hyderabad on Friday to discuss the investment opportunities in the state, an official statement said.

The minister assured the Bharata Biotech chairman that “Karnataka is committed to facilitating ease of doing business and shall provide all support and infrastructure facilities to the investors in the state”.

Bharat Biotech already has a vaccine manufacturing unit in Malur in Kolar district of Karnataka.

As per the statement, the minister also invited Ella to the Global Investors Meet scheduled to be held in Bengaluru from November 2 to 4.

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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

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

India’s first intranasal COVID vaccine by Bharat Biotech gets DCGI approval

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

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Bharat Biotech’s intranasal COVID-19 vaccine candidate has been approved by the Drugs Controller General of India (DCGI), Union Health Minister Mansukh Mandaviya said on Tuesday. This is India’s first intra-nasal COVID-19 vaccine Which will be used for primary immunization against COVID-19 in 18+ age group for restricted use in emergency situation.

Big Boost to India’s Fight Against COVID-19!

Bharat Biotech’s ChAd36-SARS-CoV-S COVID-19 (Chimpanzee Adenovirus Vectored) recombinant nasal vaccine approved by @CDSCO_INDIA_INF for primary immunization against COVID-19 in 18+ age group for restricted use in emergency situation.

— Dr Mansukh Mandaviya (@mansukhmandviya) September 6, 2022

The DCGI had earlier given its nod to conduct clinical trials for BBIL’s (Bharat Biotech International Limited) intranasal vaccine as a booster dose. The drug regulator had also permitted the firm to conduct a phase-3 clinical trial to compare the immunogenicity and safety of BBV-154 (intranasal) with Covaxin.

Last week, the Subject Expert Committee (SEC) recommended Emergency Use Authorization (EUA) for Bharat Biotech’s intranasal COVID-19 vaccine, sources said.

Krishna Ella, Chairman and Managing Director of the company, had said earlier that there was no single instance of side effect or adverse reaction reported so far.

Benefits of COVID-19 nasal vaccine

Speaking about the benefit of nasal injection, Ella was earlier quoted by news agency PTI as saying that any injectable vaccine only protects the lower level (of the body). That’s why people vaccinated with injectable vaccines may still get RT-PCR positive, whereas the nasal jab protects the whole body. Bharat Biotech also claimed that the “intranasal vaccine stimulates a broad immune response.”

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

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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

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

Bharat Biotech’s COVID-19 nasal vaccine to be used as heterologous booster — here are the benefits

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

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Bharat Biotech’s COVID-19 intranasal vaccine iNCOVACC (BBV154) received approval from the Central Drugs Standard Control Organisation (CDSCO) in November 2022, under Restricted Use in Emergency Situation for ages 18 and above in India, for heterologous booster doses. Now, government sources said the nasal vaccine will be included in COVID-19 vaccination program from December 23. It will be available first in private hospitals and will be added as an option on CoWin, sources said.

Benefits of COVID-19 nasal vaccine

Speaking about the benefit of nasal injection, Krishna Ella, Chairman and Managing Director of the company, was quoted by news agency PTI as saying that any injectable vaccine only protects the lower level (of the body). That’s why people who were vaccinated with injectable vaccines may still get RT-PCR positive, whereas the nasal jab gives protection to the whole body.

The firm completed clinical trials of the nasal vaccine with about 4,000 volunteers, Ella said. He mentioned that there is no single instance of side effect or adverse reaction reported so far. Bharat Biotech also claims that the “intranasal vaccine stimulates a broad immune response”

Other benefits: 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

The Drug Controller General of India (DCGI) had earlier given its nod to conduct clinical trials for BBIL’s (Bharat Biotech International Limited) intranasal vaccine as a booster dose. The drug regulator had also granted permission to the firm to conduct a phase-3 clinical trial to compare the immunogenicity and safety of BBV-154 (intranasal) with Covaxin.

‘COVID hospitalisation to increase’

Replying to a query, Ella predicted that the country may face higher hospitalisations with the emerging coronavirus variant BA.5 as the new form may evade the vaccine.

“It is totally different from Delta variant. It is totally different from omicron also. They call “deltaomicron”, a combination of both. I think if that attacks then it is going to be an issue. But we keep watching. We are working on that also. Risk mitigation we are trying to do. We are well prepared now… I think hospitalisation will increase if there are BA.5 attacks,” Ella said.’

ALSO READ | Covaxin highly effective in children and adolescents aged 2-18 years: Bharat Biotech

On monkeypox vaccine

In the wake of emerging monkeypox cases in India, Ella said the BBIL’s Gujarat plant is one of the two plants in the world capable of producing a vaccine for monkeypox disease. The other one is in Bavarian Nordic, Germany.

India has so far reported at least seven confirmed cases of monkeypox — two in Delhi and five in Kerala.

(Inputs from PTI)

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Covaxin highly effective in children and adolescents aged 2-18 years: Bharat Biotech

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

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Covaxin — a Covid-19 vaccine manufactured by Bharat Biotech International Limited (BBIL) has proven to be safe, well-tolerated and highly immunogenic in children and adolescents aged 2-18 years, according to the company, whose study was published in the scientific journal Lancet Infectious Diseases.

Bharat Biotech had conducted phase II/III, open-label, and multi-centre study to evaluate the safety, reactogenicity and immunogenicity of Covaxin in healthy children and adolescents in the 2-18 years age group. The clinical trial conducted in the paediatric population between June 2021 to September 2021 has shown safety, less reactogenic, and robust immunogenicity.

The data was submitted to the Central Drugs Standard Control Organisation (CDSCO) in October 2021 and received a nod for emergency use in children aged 6-18 years. Dr Krishna Ella, Chairman and Managing Director, Bharat Biotech, said, “Safety of the vaccine is critical for children and we are glad to share that Covaxin has now proven data for safety and immunogenicity in children. We have now achieved our goal of developing a safe and efficacious COVID-19 vaccine for adults and children, for primary immunisation and booster doses, making Covaxin a universal vaccine.”

It has proven to be a highly safe vaccine based on data from more than 50 million doses administered to children in India. Vaccines are a great preventive tool and the power of vaccines can only be harnessed if used “prophylactically,” he further said.

In the study, no serious adverse event was reported. A total of 374 adverse events were reported, and the majority of adverse events were mild and resolved within one day. Pain at the injection site was the most commonly reported adverse event, the release said.

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If you are travelling to Germany…

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

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Germany will start recognising Bharat Biotech’s COVID-19 vaccine, Covaxin, for travel to the country from June 1. “Entrants will no longer need proof of vaccination as the Federal Cabinet relaxes restrictions,” the pharmaceutical company tweeted on Thursday.

COVAXIN has been approved by Germany. The entrants will no longer need proof of vaccination as the Federal Cabinet relaxes restrictions.#BharatBiotech #COVID19 #COVID19Vaccine #COVAXIN #covaxinapproval #germanytravel #vaccination pic.twitter.com/TMrQUbxK1F

— BharatBiotech (@BharatBiotech) May 26, 2022

Walter J. Lindner, the German Ambassador to India and Bhutan, took to Twitter to share the news and said he was happy that Germany has decided to recognise WHO-listed Covaxin for travels starting June 1.

Very happy that GER government just decided to recognize WHO-listed Covaxin for travels to GER, starting June 1! This Embassy has been pushing very actively for such decision (because of Covid-backlogs visa sections have longer waiting periods than normal, please have patience) pic.twitter.com/LFKqlyYzaW

— Walter J. Lindner (@AmbLindnerIndia) May 26, 2022

Covaxin has so far received emergency use approvals from over 25 countries, including Australia, Japan and Canada. This vaccine was developed in partnership with the Indian Council of Medical Research (ICMR) and the National Institute of Virology (NIV).

Last November, the World Health Organization (WHO) issued an emergency use listing (EUL) for Covaxin. In December 2021, the Drug Controller General of India (DCGI) gave emergency use authorisation to the Bharat Biotech’s vaccine for use on children aged 12-18 years. In April, Covaxin received a nod for the 6-12 age group.

Also Read: ICMR study has shown rise in antibodies post Covaxin booster dose: MoS Health tells Rajya Sabha

Earlier, the US Food and Drug Administration, which had put on hold the phase 2/3 clinical trials of Bharat Biotech’s COVID-19 vaccine Covaxin in the US, lifted the pause.

The WHO had suspended the supply of Covaxin through US procurement agencies after its inspectors identified GMP (good manufacturing practice) deficiencies in Bharat Biotech’s manufacturing plants.

After the WHO inspection, Bharat Biotech had said it was temporarily slowing down the production of Covaxin across its manufacturing units for facility optimisation as it has already completed its supply obligations to procurement agencies and foresees a decrease in demand.

The company had said after the recent WHO post-Emergency Use Listing (EUL) inspection, it is working on further improvements and upgrades to ensure that the production of Covaxin continues to meet ever-increasing global regulatory requirements.

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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

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

FDA lifts hold on Bharat Biotech’s Covaxin clinical trials in US

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

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The US Food and Drug Administration which has put on hold the phase 2/ 3 clinical trials of Bharat Biotech’s COVID-19 vaccine Covaxin, in the USA, has lifted the pause, according to a statement issued by Ocugen Inc, Bharat Biotech’s partner for the jab in USA and Canada.

“We’re extremely pleased that we can proceed with our clinical trials for Covaxin our whole virus inactivated COVID-19 vaccine candidate. The need for delivering an additional, differentiated vaccine option, we believe, remains a priority,” Dr Shankar Musunuri, chairman, CEO and co-founder, Ocugen Inc said.

The FDA’s earlier decision, in April, to put on hold the trials was based on the US firm’s decision to voluntarily implement a temporary pause in dosing participants of the jab, following the World Health Organisation’s observations on Covaxin manufacturing plants in India.

Also Read: Pfizer says 3 COVID-19 shots protect children under 5

“Thank you to our clinical trial partners and site collaborators for their ongoing support. Ocugen will now work with study sites to fully resume this clinical development program immediately,” he further said.

WHO had earlier suspended the supply of Covaxin through US procurement agencies, after its inspectors identified GMP (good manufacturing practice) deficiencies in the Bharat Biotech’s manufacturing plants.

Sources had said the city-based firm, however, had not supplied the Covid vaccine to any UN agency and no impact of the suspension would be felt. OCU-002 is Ocugen’s Phase 3 immuno-bridging study of Covaxin.

Also Read: US CDC urges Pfizer COVID-19 booster for children aged 5 to 11 years

After the WHO inspection, Bharat Biotech had said it is temporarily slowing down the production of Covaxin across its manufacturing units for facility optimisation as it has already completed its supply obligations to procurement agencies and foresees a decrease in demand.

The company further said after the recent WHO post-Emergency Use Listing (EUL) inspection, it is working on further improvements and upgrades to ensure that the production of Covaxin continues to meet ever-increasing global regulatory requirements.

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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

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