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bharat biotech

IIL to begin production of drug substance for Covaxin under Mission COVID Suraksha

by Medically Speaking Team May 28, 2021

he central government will support Hyderabad based Indian Immunological limited (IIL) with grants under the Mission COVID Suraksha for developing drug substance to make Bharat Biotech’s covid-19 vaccine covaxin.

A technical collaboration agreement has been reached between IIL, a facility under the PSU, National Dairy Development Board and Bharat Biotech, for IIL to supply of the drug substance required the for manufacturing Covaxin Vaccine to Bharat Biotech, the ministry of science and technology said in a statement on Friday.

“The IIL is planning to start the production of drug substance for Covaxin from next month, June 15, and send out the first batch to Bharat Biotech limited by July,” Dr K Anand Kumar, Managing Director of Indian Immunological Limited, said.

Stating that Indian Immunologicals is expected to produce the drug substance for about 10-15 million doses per month, Kumar said it will be initially 2-3 million doses and will be scaled up to 6-7 million per month later in the year.

“We are converting the Karkapatla manufacturing unit of IIL near Hyderabad into a Bio Safety Level -3 (BSL3) facility for the production of the drug substance and is also taking up construction of another block. The IIL is also working on another COVID -19 vaccine and the animal trials are underway currently and is expected to come out by next year for human vaccination,” said Kumar.

Under Atmanirbhar Bharat 3.0 Mission COVID Suraksha was announced by the Government of India, to accelerate the development and production of Indigenous COVID Vaccines. This is being implemented by Department of Biotechnology. The Indian Immunologicals Limited (IIL), Hyderabad has been sanctioned grant of Rs. 60 crore towards enhancing production capabilities.

May 28, 2021 0 comment

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Covaxin manufacturing to vaccination takes 4 months, says Bharat Biotech

by Medically Speaking Team May 28, 2021

written by Medically Speaking Team

Manufacturing to supply of Covid-19 vaccine Covaxin involves four months of lag time depending on technology and regulatory approvals, Bharat Biotech said on Friday.

“The timeline for manufacturing, testing and release for a batch of Covaxin is approximately 120 days, depending on the technology framework and regulatory guidelines to be met. Thus, production batches of Covaxin that were initiated during March this year will be ready for supply only during the month of June,” the vaccine maker said in a press release.

Bharat Biotech’s clarification comes at a time when the country is facing a shortage of Covid-19 vaccines, leading to disruptions in the nationwide inoculation programme.

“There is a four-month lag time for Covaxin to translate into actual vaccination,” it said. The manufacturing, testing, release and distribution of vaccines are complex and multi-factorial processes with hundreds of steps, requiring a diverse pool of human resources, the firm said. For vaccines to result in actual vaccination of people, highly coordinated efforts are required from international supply chains, manufacturers, regulators and State and Central government agencies, it said.

Production scale-up of vaccines is a step-by-step process, involving several regulatory SOPs of GMP (Standard Operating Procedures of Good Manufacturing Practices), Bharat Biotech said. Based on Central Drugs Standard Control Organisation (CDSCO) guidelines, all vaccines supplied in India are mandated by law to be submitted for testing and release to the Central Drugs Laboratory, Government of India.

All batches of vaccines supplied to State and Central Governments are based on the allocation framework received from the Centre, the company said. The timeline forvaccine supplies to reach the depots of the State and Central Governments from Bharat Biotechs facilities is around two days. The vaccines received at these depots have to be further distributed by the State Governments to various districts within their respective states. This requires an additional number of days.

May 28, 2021 0 comment

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ICMR to examine effectiveness of AstraZeneca’s Covishield and Bharat Biotech’s Covaxin

by Medically Speaking Team May 26, 2021

written by Medically Speaking Team

In the first of its kind study since the launch of the AstraZeneca’s Covishield and Bharat Biotech’s Covaxin in the country, the Indian Council of Medical Research (ICMR) will conduct a survey from next week to examine the effectiveness of these vaccines in preventing the progression of COVID into a severe form.

Around 4,000 people above the age of 45 years who have taken either one or both doses of any of these two vaccines will be reviewed, according to Dr Tarun Bhatnagar, senior scientist at ICMR’s National Institute of Epidemiology (NIE) in Chennai.

“As a part of the study we will take people who are COVID-19 positive and hospitalised and compare their vaccination status with those who have tested COVID negative,” Bhatnagar told PTI.

“The aim is to assess how effective vaccination is in preventing the progression of the disease into a severe form,” he said.

Noting that this is the first of its kind study since the launch of these vaccines in the country and used in India’s inoculation drive, Bhatnagar said the survey is expected to be undertaken from next week.

The study will also compare the effects of one dose of Covishield and Covaxin against two doses, he added.

The cumulative vaccine doses administered in the country have crossed 20 crores so far.

The central government has been urging people to get vaccinated, maintaining that the vaccine will not protect one from contracting the coronavirus infection but will prevent its progression to a severe form and thereby reduce mortality.

The government has also been stressing the need to wear a mask and adherence to other COVID protocols.

As of date, India is using three vaccines against COVID-19 in its immunization drive. These include Covishield manufactured by the Pune-based Serum Institute and Covaxin of Bharat Biotech in Hyderabad.

The Russian Sputnik V is the third vaccine to get approval from the Drug Controller General of India (DCGI) for Emergency Use Authorisation and has been used in a few private hospitals so far

May 26, 2021 0 comment

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WHO seeks more info for emergency use listing of Covaxin

by Medically Speaking Team May 25, 2021

written by Medically Speaking Team

The World Health Organisation (WHO) has said more information is required from Bharat Biotech, which is seeking emergency use listing (EUL) for its Covaxin vaccine for COVID-19.

The latest Status of COVID-19 Vaccines within WHO EUL/PQ evaluation process’ guidance document dated May 18 on the WHO website said Bharat Biotech submitted EOI (Expression of Interest) on April 19 and that more information required . A pre-submission meeting is expected to be planned May-June 2021, the guidance document said.

According to the WHO, submissions to it for prequalification or listing under the emergency use procedure are confidential.

If a product submitted for assessment is found to meet the criteria for listing, WHO will publish the results widely. Duration of the emergency use listing process depends on the quality of the data submitted by the vaccine manufacturer and on those data meeting WHO criteria, according to the agency.

Meanwhile, Hyderabad-based Bharat Biotech International Limited (BBIL) has conveyed to the government that it has already submitted 90 per cent of documents to WHO for obtaining emergency use listing (EUL) for the Covaxin vaccine, sources said in New Delhi on Monday.

The remaining documents are expected to be submitted by June, the Hyderabad-based Bharat Biotech Ltd told the Central government during a discussion on obtaining the World Health Organisation’s authorisation for emergency use listing for Covaxin, sources said.

“BBIL is confident about obtaining WHO’s emergency use listing,” said a source. Noting that Covaxin has already received regulatory approval from 11 countries, sources said there was also interest from other 11 companies in seven nations for technology transfer and production of Covaxin.

The company is in the final stages of negotiations with the Food and Drug Administration of the US for conducting small-scale phase-III clinical trials of Covaxin in the United States, sources said.

Sources said the meeting with BBIL on the EUL was attended by the company’s managing director V Krishna Mohan and his colleagues besides senior officers of the Ministry of Health, Department of Biotechnology and Ministry of External Affairs.

Foreign Secretary Harsh Vardhan Shringla was among those who attended the meeting.

May 25, 2021 0 comment

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Covaxin trials on children expected to start in June: Bharat Biotech

by Medically Speaking Team May 24, 2021

written by Medically Speaking Team

Bharat Biotech, the maker of coronavirus disease vaccine Covaxin, is expected to start paediatric trials from June, the company’s Business Development and International Advocacy Head Dr Raches Ella on Sunday.

“We focused on developing the product last year. Now our focus is on ramping up our manufacturing capacity. Kids vaccine trials of Bharath Biotech may get the license in the third quarter of this year,” Dr Ella said during a virtual conversation with members of FICCI Ladies Organisation (FLO), Hyderabad.

Responding to a question from one of the participants, Dr Ella said that Bharat Biotech will be ramping up the 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 ₹1,500 crore. This will help us to increase our risk appetite. That is why we are expanding to Bangalore and Gujarat,” he added.

May 24, 2021 0 comment

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Bharat Biotech is ramping up its manufacturing capacity to 700 million doses which is likely to be achieved by the end of this year: Dr. Raches Ella

by Medically Speaking Team May 23, 2021

written by Medically Speaking Team

Few side effects of vaccination are common and that shouldn’t deter anyone from taking it said Dr. Raches Ella, Head-Business Development & International Advocacy of Bharat Biotech while on a virtual conversation with members of FICCI Ladies Organisation (FLO) Hyderabad on & All About Vaccines

Welcoming the gathering Uma Chigurupati, Chairperson of FLO Hyderabad described the COVID-19 as a global health crisis. India is the worst hit and we surpassed Brazil. And many of us have many concerns and vaccine seems to be the only hope. Let’s find answers to our doubts and dilemmas, she said.

FLO also paid homage to the members including founder member Indu Jain and FLO Hyderabad member Nafisa Ali who lost their lives to the pandemic

The talk on the most topical topic, All About Vaccines was well attended by over 160 members. It was a very informative and enlightening session and participants heard the speaker with the utmost attention.

Interacting with Dr. Pragnya Chigurupati, Consultant–Breast Oncology & Oncoplastic Surgeon who moderated the talk, Dr. Raches said if you inject the purest form of water into anybody it is likely to generate few reactions. It is the biological nature of the body. If it doesn’t then there is a problem with your body.

Whenever any foreign body enters our body a good body should react. Same is the case with vaccine. That is why we side effects. He dispelled various myths about vaccine hesitancy. And he said COVID Vaccines are safe and everyone should take vaccines.

Bharat Biotech has received permission to carry out pediatric trials of the vaccine and it may commence trails from June 1st. It will be a trial on children aged 2-18 years he said. Kids vaccine trials of Bharat Biotech may get the license in the third quarter of this year he gave his confidence.

I am happy that our hard work is paying off well as the vaccine is working well and saving lives. We have this good feeling when we go back home from work each day. We will be soon ramping up our manufacturing capacity to 700 million doses by the end of this year informed Dr. Raches Ella as a response to a question from a participant.

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 rupees 1500 crore. This will help us to increase our risk appetite. That is why we are expanding to Bangalore and Gujarat, informed the young executive of Bharat Biotech.

We focused on developing the product last year, now our focus is on ramping up our manufacturing capacity he added.

Dr. Raches answered many questions of the moderator Dr. Pragnya. She asked what the majority of Indian population likes to know.

When she asked him about challenges he said the success probability of a vaccine is just 6% from discovery to development. That is why we see fewer vaccines, he said. And we took that biggest and the calculated risk, he added.

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 Dr. Raches explained.

When 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 good antibody response can be developed. Talking about a booster

dosage he said the current vaccines are doing good enough but that will depend on future variants of the virus if any booster dosages needs to be taken or not.

No vaccines offer 100% protection. The vaccine efficacy can be improved up to 100% protection by your COVID Appropriate Behaviour and following other safety protocols he said.

When asked why we still get Corona even after taking the first dose, he replied that the first dose gives you

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, Dr. Raches explained.

Right now pregnant and lactating mothers, special population and kids are not allowed to be given vaccines.

Once separate clinical trials are done on these groups and proved effective those groups may be allowed to give a JAB he said women in Menstruation and couple conceiving are most welcome to take jabs. Dr. Raches ridiculed half-knowledge and misinformation spreading on WhatsApp. Please cut down your time on WhatsApp as it is spreading a lot of misleading information and trust only such information comes out from a trusted source, he said.

Speaking about contra indication, he said it is doctors call whether or not to suggest inoculation to HIV and immunocompromised people. Though the vaccine is safe, the doctors are the ultimate authority to decide on it he said.

Speaking about heard immunity Dr. Raches said if the majority of the population are inoculated the virus spread breaks and that is when we will achieve heard immunity. When asked 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.

Speaking on distribution he said right now we are allowed to sell vaccines to the Union Government, The State Governments, and Private Hospitals in the ratio of 70:20 and 10. If any corporates planning to inoculate their staff, they may collaborate with private hospitals explained Dr. Raches.

About WHO approval he said we have initiated the process and may get its approval soon. A few of our products in the past got their approval. We expect approval for Covaxin by the end of Q(quarter)3 or Q 4.

The virtual talk held on Zoom Platform.

Credit: Solus Media, D. Ramchandram

May 23, 2021 0 comment

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Bharat Biotech to ramp up Covaxin production via new plant

by Medically Speaking Team May 20, 2021

written by Medically Speaking Team

Bharat Biotech on Thursday said it has ramped up additional manufacturing capacities for the Covaxin covid-19 jabs as the country faces a severe shortage of vaccines. Chiron Behring, a subsidy of Bharat Biotech in Ankleshwar, Gujarat, plans to produce 200 million doses of Covaxin per annum in the GMP facilities that are already operational for the production of vaccines based on Inactivated Vero Cell Platform Technology, under stringent levels of GMP and biosafety, the company said in a statement.

The addition in manufacturing capabilities takes the volume of covaxin doses to up to 1 billion doses per annum, the company said. The company ramped up capacities at its own established campuses specialised for manufacturing inactivated viral vaccines under the highest biosafety levels.

Product availability at Ankleshwar to commence from Q4 2021, it added.

May 20, 2021 0 comment

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DCGI nod to Phase II/III clinical trial of Bharat Biotech’s Covaxin among 2-18 yr olds

by Medically Speaking Team May 19, 2021

written by Medically Speaking Team

The Phase 2-3 clinical trials of Covid-19 vaccine, Covaxin, which has been approved by the Drugs Controller General of India (DCGI), for in the age group of 2 to 18 years, will begin in the coming 10 to 12 days, Dr VK Paul, Member, NITI Aayog said.

“I have been told that trials will begin in the next 10-12 days,” Dr VK Paul said on Tuesday during a press briefing on Covid-19.

This is the first time in India that a Covid-19 vaccine will be tested on children.

The clinical trials involve two Covid-19 vaccine shots injected on day 0 and day 28.

The trials will take place at several sites, including AIIMS, Delhi, AIIMS, Patna and Meditrina Institute of Medical Sciences, Nagpur.

India’s drug regulator has accepted the recommendation of the Subject Expert Committee (SEC) and given a nod to the Hyderabad-based Bharat Biotech to conduct Phase II/III clinical trial of Covid-19 vaccine Covaxin in the age group 2 to 18 years.

Covaxin maker Bharat Biotech had proposed to carry out a Phase-II/III clinical trial of Covaxin in the age group of 2 to 18 years. The trial will be conducted in 525 healthy volunteers.

Apart from Covaxin, vaccine maker Serum Institute’s Covishield is being used to vaccinate people in the country. Meanwhile, Russia’s Covid-19 vaccine Sputnik V is also available at Apollo Hospital at Hyderabad’s Jubilee Hills and is being administered only to the beneficiaries who are 45 years or older.

May 19, 2021 0 comment

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Govt planning to ramp up Covaxin production to 10 crore doses per month: VK Paul

by Medically Speaking Team May 15, 2021

written by Medically Speaking Team

With several states complaining of vaccine shortage, the Centre on Saturday stated that the plan is to ramp up the production of Bharat Biotech’s Covaxin in coming months. Currently, 1.5 crore doses are being produced every month and the intent is to increase the production to 10 crore doses monthly, the news agency ANI reported.

Dr. VK Paul, Member-Health, Niti Aayog, “Around 1.5 crore doses of Covaxin are being produced per month. The plan is to ramp up the production to 10 crore doses per month.”

Meanwhile, the Ministry of Science and Technology, earlier today, announced to provide a grant to increase the production of the indigenous vaccine.

In an official statement, the ministry said, “To augment the capacity of Indigenous production of Covaxin under the Mission, the Department of Biotechnology, Government of India in April, 2021 provided financial support as Grant to vaccine manufacturing facilities for enhanced production capacities, which is expected to reach more than 10 crore doses per month by September, 2021.”

“As a part of this augmentation plan, capacities of Bharat Biotech Limited, Hyderabad as well as other public sector manufactures are being upgraded with required infrastructure and technology. Financial support is being provided as grant from GoI to the tune of approx. ₹65 crore to Bharat Biotech’s new Bangalore facility which is being repurposed to increase the capacity of vaccine production,” it added.

Earlier this week, Paul informed that Bharat Biotech is ready to share its technology with other manufacturers to ramp up the production amid the cry of vaccine shortage. Paul noted, “People say that Covaxin be given to other companies for manufacturing. I am happy to say that Covaxin manufacturing company (Bharat Biotech) has welcomed this when we discussed it with them. Under this vaccine live virus is inactivated & this is done only in BSL3 labs.”

“Not every company has this. We give an open invitation to companies who want to do this. Companies that want to manufacture Covaxin, should do it together. Govt will assist so that capacity is increased,” he said.

Taking the cue, Paul today said, “Tie-ups and technology transfer are complex process. Government is exploring areas or ways to scale up vaccine production.”

May 15, 2021 0 comment

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Will explore if Covaxin can be made by private institutions too: Centre

by Medically Speaking Team May 15, 2021

written by Medically Speaking Team

As Bharat Biotech’s Covaxin will now be manufactured by two public sector undertakings, the Centre on Saturday said that private firms can also come forward to give a leg up in India’s vaccine production. Talks are on with others, Niti Aayog (health) member Dr VK Paul said adding that such decision of technology and knowledge transfer entails a long process.

Bharat Biotech’s Covaxin will now be produced by Hyderabad’s Indian Immunologicals Limited, Uttar Pradesh’s Bharat Immunologicals and Biologicals Corporation and Mumbai’s Haffkine Institute for Training, Research and Testing. Once they start production, 13 crore doses of Covaxin will be produced in a month, according to the government’s estimate. Out of these 13 crore doses, Bharat Biotech will produce 10 crore, while the three firms will produce one crore doses each.

“These tie-ups are not done over a week. That’s not how complex technologies are transferred. There was an assessment of whether the vaccine can be made there. Following that there was training, fund allocation and then there was an agreement to formalise the entire arrangement,” Dr Paul said.

Covaxin can’t be made anywhere, Dr Paul said explaining that the vaccine-making process deals with live virus. “This can be done only in very sophisticated, biological safety level 3 labs so that the virus can not affect the scientists. A garment factory can not start producing the vaccine from tomorrow,” Dr Paul said.

Any narrative that discourages the country’s scientific institutions should not be indulged, Dr Paul said asserting that the Central government shares a partnership with all institutions engaged in vaccine making. “The two vaccine makers consider us as partners. They have honoured their contracts and made vaccines for the country.”

May 15, 2021 0 comment

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