A key meeting between Bharat Biotech's Executive Director Dr V Krishna Mohan and other officials of the Hyderabad-based pharma major and senior officials of the Ministry of External Affairs, Ministry of Health, Department of Biotechnology took place on Monday as India pushed for early approval of Covaxin&nbsp;by the World Health Organization (WHO).

Other officials of the Hyderabad-based pharma major were present for the meet as well.

Bharat Biotech has sent an application to the WHO for Emergency Use Listing (EUL) of Covaxin on 19th April and a pre-submission meeting will take place in June.

Officials aware of the development said that the company has "submitted 90% of the documentation required for EUL to WHO", with the remaining to be submitted next month.

They further explained that the company is "confident about obtaining WHO EUL subsequently, given its experience of getting its other vaccines prequalified by WHO."

Bharat Biotech's Covaxin will be the second made-in-India vaccine after Covishield to apply to WHO for approval.

Covishield has already got approval in February. So far, seven vaccines globally have been given approval by WHO for EUL, these are Covid vaccines from Pfizer, AstraZeneca, Janssen, Moderna and Sinopharm.

Covaxin is the first Indian Covid vaccine and is based on inactivated virus vaccines produced in cell culture or Vero cell platform. So far it has received regulatory approval from 11 countries and 11 companies in seven countries have shown interest in the technology transfer and production of Covaxin.

The company is in the final stages of submission of documents required for regulatory approvals for its vaccines in Brazil and Hungary.

In the US, Bharat Biotech is in the "final stages of negotiations" with Food and Drug Administration (FDA) for conducting small-scale Phase-III clinical trials locally.

Officials said, "The company is confident about the robustness of their dossier, as they have data for a much longer duration – for antibody persistence after six&nbsp;months as well as eight months."

The regulatory approvals have both retrospective and prospective effect, and it stands out being few companies that have published papers on all four Covid virus variants. &nbsp;

The company plans to produce 1 billion vaccines via its three facilities in three Indian states.

Hyderabad facility in Telangana will produce 200-250 million vaccines, Bengaluru facility in Karnataka will produce around 500 mn doses and facility in Ankleshwar, Gujarat will produce about 200 mn vaccines.

A key meeting between Bharat Biotech's Executive Director Dr V Krishna Mohan and other officials of the Hyderabad-based pharma major and senior officials of the Ministry of External Affairs, Ministry of Health, Department of Biotechnology took place on Monday as India pushed for early approval of Covaxin by the World Health Organization (WHO).

A key meeting between Bharat Biotech's Executive Director Dr V Krishna Mohan and other officials of the Hyderabad-based pharma major and senior officials of the Ministry of External Affairs, Ministry of Health, Department of Biotechnology took place on Monday as India pushed for early approval of Covaxin by the World Health Organization (WHO). Other officials of the Hyderabad-based pharma major were present for the meet as well. Bharat Biotech has sent an application to the WHO for Emergency Use Listing (EUL) of Covaxin on 19th April and a pre-submission meeting will take place in June. Officials aware of the development said that the company has "submitted 90% of the documentation required for EUL to WHO", with the remaining to be submitted next month. They further explained that the company is "confident about obtaining WHO EUL subsequently, given its experience of getting its other vaccines prequalified by WHO." Bharat Biotech's Covaxin will be the second made-in-India vaccine after Covishield to apply to WHO for approval. Covishield has already got approval in February. So far, seven vaccines globally have been given approval by WHO for EUL, these are Covid vaccines from Pfizer, AstraZeneca, Janssen, Moderna and Sinopharm. Covaxin is the first Indian Covid vaccine and is based on inactivated virus vaccines produced in cell culture or Vero cell platform. So far it has received regulatory approval from 11 countries and 11 companies in seven countries have shown interest in the technology transfer and production of Covaxin. The company is in the final stages of submission of documents required for regulatory approvals for its vaccines in Brazil and Hungary. In the US, Bharat Biotech is in the "final stages of negotiations" with Food and Drug Administration (FDA) for conducting small-scale Phase-III clinical trials locally. Officials said, "The company is confident about the robustness of their dossier, as they have data for a much longer duration – for antibody persistence after six months as well as eight months." The regulatory approvals have both retrospective and prospective effect, and it stands out being few companies that have published papers on all four Covid virus variants. The company plans to produce 1 billion vaccines via its three facilities in three Indian states. Hyderabad facility in Telangana will produce 200-250 million vaccines, Bengaluru facility in Karnataka will produce around 500 mn doses and facility in Ankleshwar, Gujarat will produce about 200 mn vaccines.

Ahead of WHO-Bharat Biotech meet on Covaxin, key stakeholders come together

Hyderabad-based Bharat Biotech has summitted application to the World Health Organization for Emergency Use Listing (EUL) of its Covid vaccine Covaxin, becoming the second India-made vaccine to apply at the global body for authorisation.

Bharat Biotech had summitted its Expression of Interest (EOI) on April 19, with more information required according to documents on WHO website. &nbsp;

It will have to now go through three more stages, pre-submission meeting, dossier accepted for review and final status of assessment. The pre-submission meeting will take place later in May or June. &nbsp;&nbsp;

Last week, speaking to WION exclusively, Suchitra Ella, joint managing director, Bharat Biotech, said, the Covaxin "proved to be neutralising all variants including double mutant, which has been observed in India" and it has an 'edge' given it is inactivated virus vaccines produced in cell culture or vero cell platform.&nbsp;

The company plans to produce one billion vaccines via its three different facilities in three states, 200-250 million from Hyderabad facility, around 500 million doses from Bangalore and 200 million from Ankleshwar, Gujarat.&nbsp;

A benefit of WHO listing will allow Covaxin to get global approval for use, something that has other benefits like easy movement of Indians, who have been vaccinated by it. While when it comes to mutual recognition of vaccines by countries is still under progress, if and when it comes into effect, WHO approved vaccines will give an automatic benefit. &nbsp;

On February 15, WHO gave emergency use approval to Covishield vaccine produced by Serum Institute of India. So far, seven vaccines globally have been given approval by WHO for EUL, these are Pfizer's Comirnaty, Astrazeneca's AZD1222, Janssen's Ad26.COV2.S, Moderna's mRNA-1273 and Sinopharm's SARS-CoV-2 Vaccine. Russia's Sputnik, China's Sinovac and Cuba have also applied for emergency approval.&nbsp;

Hyderabad-based Bharat Biotech has summitted application to the World Health Organization for Emergency Use Listing (EUL) of its Covid vaccine Covaxin, becoming the second India-made vaccine to apply at the global body for authorisation.

Hyderabad-based Bharat Biotech has summitted application to the World Health Organization for Emergency Use Listing (EUL) of its Covid vaccine Covaxin, becoming the second India-made vaccine to apply at the global body for authorisation. Bharat Biotech had summitted its Expression of Interest (EOI) on April 19, with more information required according to documents on WHO website. It will have to now go through three more stages, pre-submission meeting, dossier accepted for review and final status of assessment. The pre-submission meeting will take place later in May or June. Last week, speaking to WION exclusively, Suchitra Ella, joint managing director, Bharat Biotech, said, the Covaxin "proved to be neutralising all variants including double mutant, which has been observed in India" and it has an 'edge' given it is inactivated virus vaccines produced in cell culture or vero cell platform. The company plans to produce one billion vaccines via its three different facilities in three states, 200-250 million from Hyderabad facility, around 500 million doses from Bangalore and 200 million from Ankleshwar, Gujarat. A benefit of WHO listing will allow Covaxin to get global approval for use, something that has other benefits like easy movement of Indians, who have been vaccinated by it. While when it comes to mutual recognition of vaccines by countries is still under progress, if and when it comes into effect, WHO approved vaccines will give an automatic benefit. On February 15, WHO gave emergency use approval to Covishield vaccine produced by Serum Institute of India. So far, seven vaccines globally have been given approval by WHO for EUL, these are Pfizer's Comirnaty, Astrazeneca's AZD1222, Janssen's Ad26.COV2.S, Moderna's mRNA-1273 and Sinopharm's SARS-CoV-2 Vaccine. Russia's Sputnik, China's Sinovac and Cuba have also applied for emergency approval.

Bharat Biotech applies for WHO nod for Covaxin; pre-submission meeting soon

Indian Covid vaccine maker Bharat Biotech's Joint Managing Director Suchitra Ella expressed confidence over meeting commitments that have been made to Government of India. The company aims to produce 1 billion Covid vaccines (Covaxin) doses from facilities located in Hyderabad, Bengaluru&nbsp;and Ankleshwar.

Ella co-founded the company along with Dr Krishna M Ella and the company's&nbsp;Covid vaccine along with Covishield and Sputnik are the only 3 vaccines allowed to be administered&nbsp;in India.

Speaking exclusively to Wion's Principal Diplomatic Correspondent Sidhant Sibal, Ella highlighted the supply chain issues and the Ministry of External Affairs reaching "out to us to take this forward to help ease the supply chain in these areas which are specific to vaccine manufacturers." The company needs chemicals for testing and most of these chemicals come from either Europe or the US.

She assured that "Coovaxin was proved to be neutralizing" the double mutant variant found in India and other variants from South Africa, UK, and Brazil. She pointing out that the vaccine has an "edge" in dealing with Covid variant since it is an "inactivated whole-cell vaccine". Asked about clinical trials for the 2-18 age group, she said, "It is getting started in the month of June" and if all goes well, Bharat Biotech hoped to complete the trial in 3 months timeline.

Wion: According to a recent government announcement, 2 billion vaccines will be manufactured in India by the end of December. Out of this 550 million be Covaxin. Where does the production capacity stand? And how do you plan to meet the growing demand in India, by boosting capacity? 
&nbsp; 
Suchitra Ella: We have conveyed our commitments to the govt of India. We have done it in a phased manner because of the reason that we have 3 different facilities in 3 different states or cities of India.&nbsp;

In Hyderbad, we have a volume of about 200 -250 million does per annum. In the city of Bangalore, Karnataka another facility has been deployed which will be able to produce to the tune of 500 million doses and the 3rd one that got included yesterday in our release was the plant which we already operating in Ankleshwar, Gujarat where we also expect to manufacture to the tune of 200 million doses of Covaxin per annum.&nbsp;

So we are looking at close to a billion doses of Covaxin that could be churned out from 3 different plants physically located in 3 different states of India. India's population is known to everyone, and even going by govt's indication and the requirement for the COVID-19, we stand at least 2 billion-plus in order to get the country vaccinated. I would for sure believe that we at Bharat Biotech will be able to fulfill the commitments that have been given to govt of India already and also as much as possible, to ramp up more volumes. Since its 2 doses of vaccine, everything is double, so there is the challenge.

Wion: Vaccine production is a very complicated and sensitive issue. Give us a sense of supply chain challenges.

Suchitra Ella: The supply chain for us mostly comes in terms of a lot of consumables that are needed for testing. Vaccines involve a tremendous amount of quality testing which is done in-house, which is done out of animal labs, product labs, institutes in Kasauli in Himachal Pradesh, so we consume a lot of chemicals for testing protocols which have to be used day-in and day-out for every batch of the vaccine.&nbsp;

Most of these chemicals come from either Europe or the US, and it will be good to have supplies of these. They are not ingredients but testing chemicals. We also need some equipment in terms of bioprocess areas. They are smaller equipments that go into processing where the bulk of the material is processed.&nbsp;

These again are ordered from companies like the US and Europe. These are the main ingredients used on day to day basis. The equipment, more than 60 to 70% of our equipment which is already been procured and has been installed, they also come from western countries where we have internationally validated vendors.&nbsp;

We already have the equipment not just for Covaxin but also for other vaccines. Certainly, it would help, if the supply chain is eased out. Volumes have gone up, what we normally manufacture on an annual basis, say 200 or 300 million doses of say a polio vaccine, today we looking at a billion doses for the same year of Covaxin. Pressure comes because of the high volume of pandemic vaccines that need to be manufactured in a shorter time frame.

Wion: How much of your supply chain is dependent on external sources? Have you taken this up with the Indian govt and if yes what kind of support you have got from them?

Suchitra Ella: It is very well appraised to the concerned department who almost talk to us frequently and aware of many of the areas of the inputs that have to go into vaccine production. Ministry of health, Ministry of Pharma is aware of it.&nbsp;

We have explained to them that these are some of the areas where things can be eased up. Ministries have been extremely proactive and like to say this very clearly that almost all the ministries we have been like dept of science and tech. The MEA being the bridge between us and other economies of the world, these countries are all friends of India and I'm sure they will understand that India is not just seeking for the sake of manufacturing or supplying vaccine for its own population but also we all know, India is 60 per cent supplier of vaccines to the world at large. So it goes to show India has a very large role to play and the MEA has reached out to us to take this forward to help ease the supply chain in these areas which are specific to vaccine manufacturers.

Wion: if you have to expand capacity, how important is it to ensure external flows and smooth supply chains?

Suchitra Ella: We have made our calculations as to how we have factored in for the first 6 months of the year, for the second 6 months of the year, so certainly in order to reach that one billion doses or volume required by us, the input should come in a regulated, frequent and consistent interval. The quantity of these supplies has to be met in a very consistent manner in order to reach this kind of capacity we are talking about. I am hopeful, this will get done and countries of the world will certainly be talking to India and amongst themselves to ensure a free movement of all these inputs that go into vaccine production.

Wion: Sales of vaccines abroad have been done as commercial commitments and to establish our brand globally. &nbsp;How important are these sales to encourage the global supply chains to keep you supplies?

Suchitra Ella: So we are very much aware of our commitments that we have to keep in mind, serving the country, the children of our country and for sure during the pandemic, we know the requirement of the country.&nbsp;

In addition to that, we also cater to many countries of the world. We have supplied to 125 countries around the world. We also supply to Gavi, Unicef who procure directly from us as manufacturers, very high volumes of vaccines that get distributed to poorer nations of the world.&nbsp;

We also have countries, middle and high-income countries, that have the buying power to place procurement with manufacturers for their countries' requirements of the vaccine. The tremendous role and responsibility Indian manufacturers have to play in being able to get this volume but also to the rest of the world in the right and effective time frame, that is very important right now. We are all racing against time. We normally have 12 months to supply. This is not like that, it's a race against time. Humanity needs it, the world needs us, and it's time for all of us to get together in the best possible manner to save lives.

Wion: Lot of talk about patent transfer. Are you okay with sharing the patent of the vaccine with other companies?

Suchitra Ella: Our vaccine has one of the most difficult process technology vaccines which is developed on an inactivated zero cell platform. It's a classical vaccine process that we deploy...in 3 or 4 vaccines that we already manufacture. This is a very stringent process, it is not about giving the patent or the tech transfer.&nbsp; 
This is about having the infrastructure to manufacture such a vaccine. We have one of the most stringent biosafety levels which is the BSL 3 facility in which we make sure organism should not escape to the environment.&nbsp;

It is the negative pressure environment of the facility that has to be deployed in order to make such vaccines such as the Covaxin. It is very important to keep that in mind, that the quality of the product is important and the safety of the environment where this material will be deployed is very important. People who work in these facilities are also human beings and their lives should be extremely protected and safeguarded by the manufacturer.&nbsp;

So this is a tough process to be deployed or given away to anybody out there unless that particular organization has demonstrated or has a very long record of manufacturing viral vaccine under the guidelines that are required and followed the world over.

Wion: Clinical trial for children. How soon can we expect the results? can it be given Emergency Use Authorization or EUA like in the case of the adults?

Suchitra Ella: Clinical trials are a very time-consuming process, though we have timelines for it...standards, timelines, goals etc are conducted as per the special experts' committee and Drug Controller General of India (DCGI) who gives us the authorization to conduct these trials.&nbsp;

Children's trial has been permitted for Covaxin by the Drug Controller General of India and we hope to start it very soon. It is getting started in the month of June.&nbsp;

Since Covaxin has been studied extensively for 8-9 months, and even some parts of the study are still happening in an adult population where we have deployed 27000 volunteers. We have extensive data on safety and immunogenicity and on efficacy. This has been very well established in adults.&nbsp;

In order to ensure children can also receive the vaccine, the drug controller and the national regulatory authorities of the country will permit us and we will take up this clinical study and will take us 2-3 months.&nbsp; 
If all goes well in the pandemic situation we are in, we hope to complete the trial in a 3-month timeline. So the vaccine will be the same. It is the study that is important so that safety aspect is important in the subject who be children this time. That is very important.

We are normally very well acquainted with the pediatric vaccine trial because most of our vaccines cater to the pediatric segment of the world. We are very well acquainted with trials of this nature. But this time around since Covaxin has come in a reverse manner to children, we will certainly able to do this study for safety in children, especially the age group required. So we will be able to demonstrate that study data, and hopeful and positive that Covaxin can be administrated to children once the data is accepted and approved by DCGI.&nbsp;

Wion: Any timeline when it can be given for it?

Suchitra Ella: Sidhant it's very difficult to give a set timeline. We are in a pandemic and to get volunteers to hospitals, trials are not conducted within 4 walls, on laptops or systems. It is a physical trial in a hospital or medical college and conducted by medical practitioners.&nbsp;

It is a site where volunteers have to physically go and a lot of protocols have to be followed. In spite of all this, we are hoping since we already have a lot of data in Covaxin in adult studies we hope...children are children and there is none of us can go and talk to a parent.&nbsp;

As a company, I cannot go to a parent and convenience them to allow the participation of their children in a trial. It is something they have to do by themselves in a voluntary mode. The hospital will create awareness and will educate the parent and the parent have to be willing.&nbsp;

The parent has to give consent, children have to understand the process. It is a medical process and biological process and need to bear in mind it is very sensitive and at the same time, we do it all the time. We have conducted studies involving more than 500,000 infants and children for many of our pediatric vaccines in about 20 countries of the world. We understand the regulation very well and we only hope we will be able to take it forward especially at a time pandemic. Sensitivities involving children, we have to get all aspects put together well and get it done in best possible time frame.

Wion: Recently, government came out with guidelines for the vaccination gap. Covishield has a gap broadened, where it wasn't the case with Covaxin. Why and how is it different?

Suchitra Ella: Most of the guidelines are by the Ministry of Health and DCGI who permit the doses and the administration and scheduling of vaccines. It comes based on the study, also based on prior experience of getting such vaccines done. With Covid vaccine, technical data, research, and academic research going back and forth is almost changing by the day, if not by the hour.&nbsp;

We have studied our vaccine, within 28 days apart, govt has also gone ahead and said we could extend it to 45 days. It's a zero-day and the second dose is within 45 days. The second dose is always a booster dose.&nbsp;

So in order to ensure booster dose is effective in most of people, a little bit of tweaking of the timeline is not going to be a huge problem, because in many vaccine dosages are done between 0 to 30 and 3rd dose is done within 180 days as well, there is a booster dose which comes after a year. These kinds of things are done for many vaccines. In a Covid situation, our is a whole unit vaccine and the entire inactivated vaccine is deployed and its not spike protein. We have a more uniform way of getting antibodies formed at a level that we have indicated.&nbsp;

If there is information oR data coming from WHO or other agencies from around the world who have a lot of studies and work, then it is upon regulator to advise what should be protocol or dosage for the country.&nbsp;

As a manufacturer, our responsibility ends with dispatching vaccines to govt hospital, govt depots or private hospitals at this point of time. Administration of vaccines and distribution happens at the hospital and the govt intuition. The regulation comes from the ministry itself, this is a multi-pronged collective approach, collective data, collective approach, and best of the practices and information sharing coming from rest of the world is also kept in mind when such decisions are made for certain populations of the world.

Wion: Covaxin and its ability to handle Covid variant...

Suchitra Ella: Our vaccine Covaxin has been studied from the very first strain we received last year in the month of may when initial work started. Covaxin was also tested in variants that emerged in countries like South Africa, Brazil, UK. Covaxin was proved to be neutralizing all these variants including the double mutant, which has been observed in India. All this data has been published in peer-reviewed, international medical journals to show that Covaxin has effectively neutralized (the virus) being an inactivated whole-cell vaccine probably gave it an edge to overcome all the different strains, changes that are happening, the mutation that is happening. As of now, it is working well on all of them and it has been proven clinically and studied, subjected to peer review, internationally.

Wion: How do u feel as a women entrepreneur?

Suchitra Ella: Personally, for me, entrepreneurship is not about gender. Entrepreneurship is not gender-based, it's the mindset with which you come. It is the vision, you have to look at the challenge and turn it into an opportunity or try and see if there is a way to finding a solution for it, which is what we as a company from the days our inception is to innovate. Continuously Develop technology, intellectual property to bring solutions to public health.

We collectively, as an organization have a huge team of more than 2000 people on the Hyderabad campus. We have facilities in Bangalore and Ankleshwar, all put together we are a multi-centric company with multi facilities across the state. Through the pandemic, we have been collectively working in bringing Covaxin which is very important for us as an innovative company because we believe that such innovation can also be brought from India. That was the passion, vision. We worked in mission mode and confidently say, not any employee has gone for vacation. It has been physically and emotionally challenging and we have stood together. I am proud and happy to be where we are for Covaxin.

Indian Covid vaccine maker Bharat Biotech's Joint Managing Director Suchitra Ella expressed confidence over meeting commitments that have been made to Government of India.

Indian Covid vaccine maker Bharat Biotech's Joint Managing Director Suchitra Ella expressed confidence over meeting commitments that have been made to Government of India. The company aims to produce 1 billion Covid vaccines (Covaxin) doses from facilities located in Hyderabad, Bengaluru and Ankleshwar. Ella co-founded the company along with Dr Krishna M Ella and the company's Covid vaccine along with Covishield and Sputnik are the only 3 vaccines allowed to be administered in India. Speaking exclusively to Wion's Principal Diplomatic Correspondent Sidhant Sibal, Ella highlighted the supply chain issues and the Ministry of External Affairs reaching "out to us to take this forward to help ease the supply chain in these areas which are specific to vaccine manufacturers." The company needs chemicals for testing and most of these chemicals come from either Europe or the US. She assured that "Coovaxin was proved to be neutralizing" the double mutant variant found in India and other variants from South Africa, UK, and Brazil. She pointing out that the vaccine has an "edge" in dealing with Covid variant since it is an "inactivated whole-cell vaccine". Asked about clinical trials for the 2-18 age group, she said, "It is getting started in the month of June" and if all goes well, Bharat Biotech hoped to complete the trial in 3 months timeline. Wion: According to a recent government announcement, 2 billion vaccines will be manufactured in India by the end of December. Out of this 550 million be Covaxin. Where does the production capacity stand? And how do you plan to meet the growing demand in India, by boosting capacity? Suchitra Ella: We have conveyed our commitments to the govt of India. We have done it in a phased manner because of the reason that we have 3 different facilities in 3 different states or cities of India. In Hyderbad, we have a volume of about 200 -250 million does per annum. In the city of Bangalore, Karnataka another facility has been deployed which will be able to produce to the tune of 500 million doses and the 3rd one that got included yesterday in our release was the plant which we already operating in Ankleshwar, Gujarat where we also expect to manufacture to the tune of 200 million doses of Covaxin per annum. So we are looking at close to a billion doses of Covaxin that could be churned out from 3 different plants physically located in 3 different states of India. India's population is known to everyone, and even going by govt's indication and the requirement for the COVID-19, we stand at least 2 billion-plus in order to get the country vaccinated. I would for sure believe that we at Bharat Biotech will be able to fulfill the commitments that have been given to govt of India already and also as much as possible, to ramp up more volumes. Since its 2 doses of vaccine, everything is double, so there is the challenge. Wion: Vaccine production is a very complicated and sensitive issue. Give us a sense of supply chain challenges. Suchitra Ella: The supply chain for us mostly comes in terms of a lot of consumables that are needed for testing. Vaccines involve a tremendous amount of quality testing which is done in-house, which is done out of animal labs, product labs, institutes in Kasauli in Himachal Pradesh, so we consume a lot of chemicals for testing protocols which have to be used day-in and day-out for every batch of the vaccine. Most of these chemicals come from either Europe or the US, and it will be good to have supplies of these. They are not ingredients but testing chemicals. We also need some equipment in terms of bioprocess areas. They are smaller equipments that go into processing where the bulk of the material is processed. These again are ordered from companies like the US and Europe. These are the main ingredients used on day to day basis. The equipment, more than 60 to 70% of our equipment which is already been procured and has been installed, they also come from western countries where we have internationally validated vendors. We already have the equipment not just for Covaxin but also for other vaccines. Certainly, it would help, if the supply chain is eased out. Volumes have gone up, what we normally manufacture on an annual basis, say 200 or 300 million doses of say a polio vaccine, today we looking at a billion doses for the same year of Covaxin. Pressure comes because of the high volume of pandemic vaccines that need to be manufactured in a shorter time frame. Wion: How much of your supply chain is dependent on external sources? Have you taken this up with the Indian govt and if yes what kind of support you have got from them? Suchitra Ella: It is very well appraised to the concerned department who almost talk to us frequently and aware of many of the areas of the inputs that have to go into vaccine production. Ministry of health, Ministry of Pharma is aware of it. We have explained to them that these are some of the areas where things can be eased up. Ministries have been extremely proactive and like to say this very clearly that almost all the ministries we have been like dept of science and tech. The MEA being the bridge between us and other economies of the world, these countries are all friends of India and I'm sure they will understand that India is not just seeking for the sake of manufacturing or supplying vaccine for its own population but also we all know, India is 60 per cent supplier of vaccines to the world at large. So it goes to show India has a very large role to play and the MEA has reached out to us to take this forward to help ease the supply chain in these areas which are specific to vaccine manufacturers. Wion: if you have to expand capacity, how important is it to ensure external flows and smooth supply chains? Suchitra Ella: We have made our calculations as to how we have factored in for the first 6 months of the year, for the second 6 months of the year, so certainly in order to reach that one billion doses or volume required by us, the input should come in a regulated, frequent and consistent interval. The quantity of these supplies has to be met in a very consistent manner in order to reach this kind of capacity we are talking about. I am hopeful, this will get done and countries of the world will certainly be talking to India and amongst themselves to ensure a free movement of all these inputs that go into vaccine production. Wion: Sales of vaccines abroad have been done as commercial commitments and to establish our brand globally. How important are these sales to encourage the global supply chains to keep you supplies? Suchitra Ella: So we are very much aware of our commitments that we have to keep in mind, serving the country, the children of our country and for sure during the pandemic, we know the requirement of the country. In addition to that, we also cater to many countries of the world. We have supplied to 125 countries around the world. We also supply to Gavi, Unicef who procure directly from us as manufacturers, very high volumes of vaccines that get distributed to poorer nations of the world. We also have countries, middle and high-income countries, that have the buying power to place procurement with manufacturers for their countries' requirements of the vaccine. The tremendous role and responsibility Indian manufacturers have to play in being able to get this volume but also to the rest of the world in the right and effective time frame, that is very important right now. We are all racing against time. We normally have 12 months to supply. This is not like that, it's a race against time. Humanity needs it, the world needs us, and it's time for all of us to get together in the best possible manner to save lives. Wion: Lot of talk about patent transfer. Are you okay with sharing the patent of the vaccine with other companies? Suchitra Ella: Our vaccine has one of the most difficult process technology vaccines which is developed on an inactivated zero cell platform. It's a classical vaccine process that we deploy...in 3 or 4 vaccines that we already manufacture. This is a very stringent process, it is not about giving the patent or the tech transfer. This is about having the infrastructure to manufacture such a vaccine. We have one of the most stringent biosafety levels which is the BSL 3 facility in which we make sure organism should not escape to the environment. It is the negative pressure environment of the facility that has to be deployed in order to make such vaccines such as the Covaxin. It is very important to keep that in mind, that the quality of the product is important and the safety of the environment where this material will be deployed is very important. People who work in these facilities are also human beings and their lives should be extremely protected and safeguarded by the manufacturer. So this is a tough process to be deployed or given away to anybody out there unless that particular organization has demonstrated or has a very long record of manufacturing viral vaccine under the guidelines that are required and followed the world over. Wion: Clinical trial for children. How soon can we expect the results? can it be given Emergency Use Authorization or EUA like in the case of the adults? Suchitra Ella: Clinical trials are a very time-consuming process, though we have timelines for it...standards, timelines, goals etc are conducted as per the special experts' committee and Drug Controller General of India (DCGI) who gives us the authorization to conduct these trials. Children's trial has been permitted for Covaxin by the Drug Controller General of India and we hope to start it very soon. It is getting started in the month of June. Since Covaxin has been studied extensively for 8-9 months, and even some parts of the study are still happening in an adult population where we have deployed 27000 volunteers. We have extensive data on safety and immunogenicity and on efficacy. This has been very well established in adults. In order to ensure children can also receive the vaccine, the drug controller and the national regulatory authorities of the country will permit us and we will take up this clinical study and will take us 2-3 months. If all goes well in the pandemic situation we are in, we hope to complete the trial in a 3-month timeline. So the vaccine will be the same. It is the study that is important so that safety aspect is important in the subject who be children this time. That is very important. We are normally very well acquainted with the pediatric vaccine trial because most of our vaccines cater to the pediatric segment of the world. We are very well acquainted with trials of this nature. But this time around since Covaxin has come in a reverse manner to children, we will certainly able to do this study for safety in children, especially the age group required. So we will be able to demonstrate that study data, and hopeful and positive that Covaxin can be administrated to children once the data is accepted and approved by DCGI. Wion: Any timeline when it can be given for it? Suchitra Ella: Sidhant it's very difficult to give a set timeline. We are in a pandemic and to get volunteers to hospitals, trials are not conducted within 4 walls, on laptops or systems. It is a physical trial in a hospital or medical college and conducted by medical practitioners. It is a site where volunteers have to physically go and a lot of protocols have to be followed. In spite of all this, we are hoping since we already have a lot of data in Covaxin in adult studies we hope...children are children and there is none of us can go and talk to a parent. As a company, I cannot go to a parent and convenience them to allow the participation of their children in a trial. It is something they have to do by themselves in a voluntary mode. The hospital will create awareness and will educate the parent and the parent have to be willing. The parent has to give consent, children have to understand the process. It is a medical process and biological process and need to bear in mind it is very sensitive and at the same time, we do it all the time. We have conducted studies involving more than 500,000 infants and children for many of our pediatric vaccines in about 20 countries of the world. We understand the regulation very well and we only hope we will be able to take it forward especially at a time pandemic. Sensitivities involving children, we have to get all aspects put together well and get it done in best possible time frame. Wion: Recently, government came out with guidelines for the vaccination gap. Covishield has a gap broadened, where it wasn't the case with Covaxin. Why and how is it different? Suchitra Ella: Most of the guidelines are by the Ministry of Health and DCGI who permit the doses and the administration and scheduling of vaccines. It comes based on the study, also based on prior experience of getting such vaccines done. With Covid vaccine, technical data, research, and academic research going back and forth is almost changing by the day, if not by the hour. We have studied our vaccine, within 28 days apart, govt has also gone ahead and said we could extend it to 45 days. It's a zero-day and the second dose is within 45 days. The second dose is always a booster dose. So in order to ensure booster dose is effective in most of people, a little bit of tweaking of the timeline is not going to be a huge problem, because in many vaccine dosages are done between 0 to 30 and 3rd dose is done within 180 days as well, there is a booster dose which comes after a year. These kinds of things are done for many vaccines. In a Covid situation, our is a whole unit vaccine and the entire inactivated vaccine is deployed and its not spike protein. We have a more uniform way of getting antibodies formed at a level that we have indicated. If there is information oR data coming from WHO or other agencies from around the world who have a lot of studies and work, then it is upon regulator to advise what should be protocol or dosage for the country. As a manufacturer, our responsibility ends with dispatching vaccines to govt hospital, govt depots or private hospitals at this point of time. Administration of vaccines and distribution happens at the hospital and the govt intuition. The regulation comes from the ministry itself, this is a multi-pronged collective approach, collective data, collective approach, and best of the practices and information sharing coming from rest of the world is also kept in mind when such decisions are made for certain populations of the world. Wion: Covaxin and its ability to handle Covid variant... Suchitra Ella: Our vaccine Covaxin has been studied from the very first strain we received last year in the month of may when initial work started. Covaxin was also tested in variants that emerged in countries like South Africa, Brazil, UK. Covaxin was proved to be neutralizing all these variants including the double mutant, which has been observed in India. All this data has been published in peer-reviewed, international medical journals to show that Covaxin has effectively neutralized (the virus) being an inactivated whole-cell vaccine probably gave it an edge to overcome all the different strains, changes that are happening, the mutation that is happening. As of now, it is working well on all of them and it has been proven clinically and studied, subjected to peer review, internationally. Wion: How do u feel as a women entrepreneur? Suchitra Ella: Personally, for me, entrepreneurship is not about gender. Entrepreneurship is not gender-based, it's the mindset with which you come. It is the vision, you have to look at the challenge and turn it into an opportunity or try and see if there is a way to finding a solution for it, which is what we as a company from the days our inception is to innovate. Continuously Develop technology, intellectual property to bring solutions to public health. We collectively, as an organization have a huge team of more than 2000 people on the Hyderabad campus. We have facilities in Bangalore and Ankleshwar, all put together we are a multi-centric company with multi facilities across the state. Through the pandemic, we have been collectively working in bringing Covaxin which is very important for us as an innovative company because we believe that such innovation can also be brought from India. That was the passion, vision. We worked in mission mode and confidently say, not any employee has gone for vacation. It has been physically and emotionally challenging and we have stood together. I am proud and happy to be where we are for Covaxin.

Exclusive: Bharat Biotech's Joint MD Suchitra Ella confident on Covid vaccine production commitments

India's pandemic death toll has crossed 250,000. With the risk of the third wave growing, India has now approved Covaxin trials for children between 2 to 18 years of age. Palki Sharma tells you more.

Gravitas: India to begin Covaxin vaccine trials for kids

As increasing number of state across India complain of vaccine shortage, country's Science and Technology Ministry has said that the production capacity of Covaxin will be doubled in the next one to two months (May-June).

India: Production capacity of Covaxin to be doubled by May-June 2021

India's expert panel of Central Drugs Standard Control Organization(CDSCO) has recommended Bharat Biotech’s <a href="https://www.wionews.com/topics/coronavirus">COVID-19</a> vaccine, Covaxin for second and third phase trials in children aged between two to eighteen years of age.

With 525 participants, the trial is expected to take place at various sites, including AIIMS Delhi, AIIMS Patna, and Meditrina Institute of Medical Sciences, Nagpur.

Also read |&nbsp;<a href="https://www.wionews.com/india-news/003-contracted-covid-19-after-receiving-second-jab-of-covishield-004-post-covaxin-379059">0.03% contracted Covid-19 after receiving second jab of Covishield; 0.04% post Covaxin</a>

On Tuesday, the Subject Expert Committee (SEC) on COVID-19 of the Central Drugs Standard Control Organization deliberated on an application submitted by Hyderabad-based Bharat Biotech. The application sought permission to conduct Phase 2 and 3 trials in children aged 2 to 18 years. &nbsp;

The clinical trials will evaluate the safety, reactogenicity and immunogenicity of Covaxin jabs in children.

"After detailed deliberation, the committee recommended for conduct of proposed phase II/III clinical trial of whole virion inactivated coronavirus vaccine in the 2 to 18 years age group subject to the condition that the firm should submit the interim safety data of phase II clinical trial along with DSMB recommendations to the CDSCO before proceeding to phase III part of the study," a source told PTI.

<div class="videoWrapper trancodeVideo"><iframe allowfullscreen="" autoplay="1" class="includeVideo" frameborder="0" height="350" src="https://www.wionews.com/videos/bharat-biotechs-covaxin-gets-nod-for-phase-23-trials-on-2-18-years-old-384468/embed" style="width:100%;max-width:560px;" width="560"></iframe></div>

The proposal was earlier contemplated over in an SEC meeting on February 24 wherein the firm was asked to submit a revised clinical trial protocol.

Covaxin is an indigenously developed vaccination by Bharat Biotech developed in collaboration with the Indian Council of Medical Research (ICMR), the vaccine is already in use for adults in India's ongoing <a href="https://www.wionews.com/topics/coronavirus">COVID-19</a> vaccination drive.

(With inputs from agencies)

India's expert panel of Central Drugs Standard Control Organization(CDSCO) has recommended Bharat Biotech’s COVID-19 vaccine, Covaxin for second and third phase trials in children aged between two to eighteen years of age.

India's expert panel of Central Drugs Standard Control Organization(CDSCO) has recommended Bharat Biotech’s COVID-19 vaccine, Covaxin for second and third phase trials in children aged between two to eighteen years of age. With 525 participants, the trial is expected to take place at various sites, including AIIMS Delhi, AIIMS Patna, and Meditrina Institute of Medical Sciences, Nagpur. Also read | 0.03% contracted Covid-19 after receiving second jab of Covishield; 0.04% post Covaxin On Tuesday, the Subject Expert Committee (SEC) on COVID-19 of the Central Drugs Standard Control Organization deliberated on an application submitted by Hyderabad-based Bharat Biotech. The application sought permission to conduct Phase 2 and 3 trials in children aged 2 to 18 years. The clinical trials will evaluate the safety, reactogenicity and immunogenicity of Covaxin jabs in children. "After detailed deliberation, the committee recommended for conduct of proposed phase II/III clinical trial of whole virion inactivated coronavirus vaccine in the 2 to 18 years age group subject to the condition that the firm should submit the interim safety data of phase II clinical trial along with DSMB recommendations to the CDSCO before proceeding to phase III part of the study," a source told PTI. The proposal was earlier contemplated over in an SEC meeting on February 24 wherein the firm was asked to submit a revised clinical trial protocol. Covaxin is an indigenously developed vaccination by Bharat Biotech developed in collaboration with the Indian Council of Medical Research (ICMR), the vaccine is already in use for adults in India's ongoing COVID-19 vaccination drive. (With inputs from agencies)

India's expert panel recommends Covaxin trials on 2-18 year-olds

As per the official sources, the trial for the vaccine will take place in 525 subjects at different sites, including AIIMS, Patna, AIIMS, Delhi, and Meditrina Institute of Medical Sciences, Nagpur.

Bharat Biotech’s COVAXIN gets nod for phase 2/3 trials on 2-18 years old

Vaccination centres in Mumbai did not administer Covaxin for the second consecutive day on Monday because of lack of stock, leaving citizens fuming as many of them are due for their second dose of the vaccine against COVID-19.

The Brihanmumbai Municipal Corporation (BMC), through its Twitter handle, released a list of 105 vaccination centres that would be functional on Monday, but informed that these would be administering only the Covishield vaccine.

Watch |&nbsp;

<div class="videoWrapper trancodeVideo"><iframe allowfullscreen="" autoplay="1" class="includeVideo" frameborder="0" height="350" src="https://www.wionews.com/videos/india-to-receive-360-million-sputnik-jabs-by-march-2022-383908/embed" style="width:100%;max-width:560px;" width="560"></iframe></div>

On Sunday also, the BMC had not administered Covaxin to the beneficiaries due to the unavailability of the vaccine.

Several citizens expressed anger and frustration at the state of affairs as many of them are due for their second dose since they had taken the first jab over 42 days back.

As per the government guidelines, the recommended gap between two doses of Covaxin is four-six weeks and for Covishield the suggested interval is four-eight weeks.

Local resident Rupesh Lingayat took to Twitter to express his frustration.

"My father took 1st dose of Covaxin, now it is impossible to get second dose of Covaxin and its been 43 days since took 1st dose. He is 63. Please help," he tweeted.

Another resident Param Sampat also tweeted that his sister had got a booking on Saturday for 3-5 pm slot, but when she reached at 2.45 pm, authorities told her they were out of stock gave her a token for Monday.

"Today when she reached at 8, she was denied a vaccine. This is absolutely irresponsible," he tweeted.

The BMC's executive health officer, Mangala Gomare, did not respond to calls or text messages on the lack of Covaxin doses in the city.

According to a BMC report, a total of 1,76,505 people have been administered Covaxin doses in the city, including 1,20,167 who have received the first dose and 56,338 who have got the second dose as well.

Till Sunday evening, 27,00,431 people were vaccinated in Mumbai against COVID-19. These included 20,52,963 beneficiaries who have taken the first dose and 6,47,468 people who have received their second dose, the report said.

Currently, there are 175 active vaccination centres in Mumbai, included 81 run by the BMC, 20 by the state government and 74 private facilities.&nbsp;

Vaccination centres in Mumbai did not administer Covaxin for the second consecutive day on Monday because of lack of stock, leaving citizens fuming as many of them are due for their second dose of the vaccine against COVID-19.

Vaccination centres in Mumbai did not administer Covaxin for the second consecutive day on Monday because of lack of stock, leaving citizens fuming as many of them are due for their second dose of the vaccine against COVID-19. The Brihanmumbai Municipal Corporation (BMC), through its Twitter handle, released a list of 105 vaccination centres that would be functional on Monday, but informed that these would be administering only the Covishield vaccine. Watch | On Sunday also, the BMC had not administered Covaxin to the beneficiaries due to the unavailability of the vaccine. Several citizens expressed anger and frustration at the state of affairs as many of them are due for their second dose since they had taken the first jab over 42 days back. As per the government guidelines, the recommended gap between two doses of Covaxin is four-six weeks and for Covishield the suggested interval is four-eight weeks. Local resident Rupesh Lingayat took to Twitter to express his frustration. "My father took 1st dose of Covaxin, now it is impossible to get second dose of Covaxin and its been 43 days since took 1st dose. He is 63. Please help," he tweeted. Another resident Param Sampat also tweeted that his sister had got a booking on Saturday for 3-5 pm slot, but when she reached at 2.45 pm, authorities told her they were out of stock gave her a token for Monday. "Today when she reached at 8, she was denied a vaccine. This is absolutely irresponsible," he tweeted. The BMC's executive health officer, Mangala Gomare, did not respond to calls or text messages on the lack of Covaxin doses in the city. According to a BMC report, a total of 1,76,505 people have been administered Covaxin doses in the city, including 1,20,167 who have received the first dose and 56,338 who have got the second dose as well. Till Sunday evening, 27,00,431 people were vaccinated in Mumbai against COVID-19. These included 20,52,963 beneficiaries who have taken the first dose and 6,47,468 people who have received their second dose, the report said. Currently, there are 175 active vaccination centres in Mumbai, included 81 run by the BMC, 20 by the state government and 74 private facilities.

Covid in India: Covaxin doses unavailable for 2nd day in Mumbai; citizens fume

Bharat Biotech on Thursday announced that the price of its <a href="https://www.wionews.com/topics/coronavirus-vaccine">coronavirus vaccine </a>Covaxin will be reduced by Rs 200 (USD 2.7) for Indian states and will be available at Rs 400 (USD 5.4) per dose.

The announcement by the Indian drugmaker comes a day after the Serum Institute of India (SII) also lowered its Covid-19 vaccine Covishield price to Rs 300 (USD 4.05) per dose for state governments in a move it described as a "philanthropic gesture".&nbsp;

Watch |&nbsp;

<div class="videoWrapper trancodeVideo"><iframe allowfullscreen="" autoplay="1" class="includeVideo" frameborder="0" height="350" src="https://www.wionews.com/videos/indian-expats-hire-private-jets-to-escape-covid-19-crisis-381339/embed" style="width:100%;max-width:560px;" width="560"></iframe></div>

Covaxin is the Indian vaccine of Bharat Biotech-ICMR and Covishield is the name of AstraZeneca-Oxford University's drug manufactured in India.&nbsp;

"Recognising the enormous challenges to the public health care system, we have made Covaxin available to state governments at a price of Rs 400/ dose," Bharat Biotech said in a statement.&nbsp;

Also read | <a href="https://www.wionews.com/india-news/private-jets-in-demand-indians-flee-the-country-fly-to-uae-to-escape-covid-surge-381327">Private jets in demand: Indians flee the country, fly to UAE to escape Covid surge</a>

India is currently struggling with the fresh wave of <a href="https://www.wionews.com/topics/coronavirus">Covid-19 </a>and is witnessing record cases on a daily basis.&nbsp;

The country is also facing a shortage of drugs, medical supplies, oxygen and vaccines, but several countries have come forward to solve the crisis.&nbsp;

Meanwhile, India from May 1 will begin its new phase of vaccination drive in which all people over the age of 18 will be permitted to get inoculation. 
&nbsp;

Bharat Biotech on Thursday announced that the price of its coronavirus vaccine Covaxin will be reduced by Rs 200 (USD 2.7) for Indian states and will be available at Rs 400 (USD 5.

Bharat Biotech on Thursday announced that the price of its coronavirus vaccine Covaxin will be reduced by Rs 200 (USD 2.7) for Indian states and will be available at Rs 400 (USD 5.4) per dose. The announcement by the Indian drugmaker comes a day after the Serum Institute of India (SII) also lowered its Covid-19 vaccine Covishield price to Rs 300 (USD 4.05) per dose for state governments in a move it described as a "philanthropic gesture". Watch | Covaxin is the Indian vaccine of Bharat Biotech-ICMR and Covishield is the name of AstraZeneca-Oxford University's drug manufactured in India. "Recognising the enormous challenges to the public health care system, we have made Covaxin available to state governments at a price of Rs 400/ dose," Bharat Biotech said in a statement. Also read | Private jets in demand: Indians flee the country, fly to UAE to escape Covid surge India is currently struggling with the fresh wave of Covid-19 and is witnessing record cases on a daily basis. The country is also facing a shortage of drugs, medical supplies, oxygen and vaccines, but several countries have come forward to solve the crisis. Meanwhile, India from May 1 will begin its new phase of vaccination drive in which all people over the age of 18 will be permitted to get inoculation.

Bharat Biotech reduces price of Covaxin for Indian state governments

A study has found that people who have been vaccinated with Covaxin have protection against the double mutant (B.1.617) variant first found in India.

Covaxin can fight against double mutant variant found in India: study

Covaxin, India's home-grown COVID-19 vaccine, has been found to neutralise the 617 variant of the deadly virus, White House chief medical adviser and America's top pandemic expert Dr Anthony Fauci said here. 
Fauci was speaking to reporters during a conference call on Tuesday. 
 
"This is something where we're still gaining data on a daily basis. But the most recent data, was looking at convalescent Sera of COVID-19 cases and people who received the vaccine used in India, the Covaxin. It was found to neutralise the 617 variant," he said. 
 
"So, despite the real difficulty that we're seeing in India, vaccination could be a very, very important antidote against this," Fauci added. 
 
The New York Times on Tuesday said Covaxin works by teaching the immune system to make antibodies against the SARS-CoV-2 coronavirus. The antibodies attach to viral proteins, such as the so-called spike proteins that stud its surface. 
 
Developed by Bharat Biotech in partnership with National Institute of Virology and the Indian Council of Medical Research, Covaxin was approved for emergency use on January 3. Trial results later showed the vaccine has an efficacy of 78 per cent. 
 
Responding to a question, Dr Andy Slavitt, White House COVID-19 Response Senior Advisor, said that a strike team from the Centers&nbsp;for Disease Control and Prevention is headed over to India to help coordinate this response. 
 
"We are making sure that we are locating some of the raw materials necessary to create more vaccines in India, which I think is going to be an important help there," he said. 
 
"We stand with the country of India during this very trying and tragic surge. We are working to deploy resources and supplies, including therapeutics, rapid testing kits, ventilators, PPE, and raw materials, that are needed to manufacture vaccines in India, and the CDC, which has a long history of working with and in India on public health measures, will be deploying a strike team to the country to support the public health efforts there," Slavitt said. 
 
Given the strong portfolio of approved, highly effective and safe vaccines here in the United States, the administration is looking at options to share AstraZeneca vaccines with other countries as they become available. 
 
This should amount to around 60 million doses or so over the next two months, he added. "The AstraZeneca vaccine is highly safe and effective, and approved in many parts of the world, and since it is not approved for use in the US, we do not need to use the AstraZeneca vaccine here during the next few months," Slavitt said. 
 
"We have sufficient supply of vaccines from Pfizer, Moderna, and Johnson &amp; Johnson to accommodate our needs in the US," he added.

Covaxin, India's home-grown COVID-19 vaccine, has been found to neutralise the 617 variant of the deadly virus, White House chief medical adviser and America's top pandemic expert Dr Anthony Fauci said here.

Covaxin, India's home-grown COVID-19 vaccine, has been found to neutralise the 617 variant of the deadly virus, White House chief medical adviser and America's top pandemic expert Dr Anthony Fauci said here. Fauci was speaking to reporters during a conference call on Tuesday. "This is something where we're still gaining data on a daily basis. But the most recent data, was looking at convalescent Sera of COVID-19 cases and people who received the vaccine used in India, the Covaxin. It was found to neutralise the 617 variant," he said. "So, despite the real difficulty that we're seeing in India, vaccination could be a very, very important antidote against this," Fauci added. The New York Times on Tuesday said Covaxin works by teaching the immune system to make antibodies against the SARS-CoV-2 coronavirus. The antibodies attach to viral proteins, such as the so-called spike proteins that stud its surface. Developed by Bharat Biotech in partnership with National Institute of Virology and the Indian Council of Medical Research, Covaxin was approved for emergency use on January 3. Trial results later showed the vaccine has an efficacy of 78 per cent. Responding to a question, Dr Andy Slavitt, White House COVID-19 Response Senior Advisor, said that a strike team from the Centers for Disease Control and Prevention is headed over to India to help coordinate this response. "We are making sure that we are locating some of the raw materials necessary to create more vaccines in India, which I think is going to be an important help there," he said. "We stand with the country of India during this very trying and tragic surge. We are working to deploy resources and supplies, including therapeutics, rapid testing kits, ventilators, PPE, and raw materials, that are needed to manufacture vaccines in India, and the CDC, which has a long history of working with and in India on public health measures, will be deploying a strike team to the country to support the public health efforts there," Slavitt said. Given the strong portfolio of approved, highly effective and safe vaccines here in the United States, the administration is looking at options to share AstraZeneca vaccines with other countries as they become available. This should amount to around 60 million doses or so over the next two months, he added. "The AstraZeneca vaccine is highly safe and effective, and approved in many parts of the world, and since it is not approved for use in the US, we do not need to use the AstraZeneca vaccine here during the next few months," Slavitt said. "We have sufficient supply of vaccines from Pfizer, Moderna, and Johnson & Johnson to accommodate our needs in the US," he added.

Covaxin found to neutralise the 617 variant of COVID-19: Dr Fauci

Bharat Biotech has fixed the price of its Covid-19 vaccine, Covaxin, at Rs 600 per dose for state governments and at Rs 1,200 per dose for private hospitals, the vaccine maker announced on Saturday.&nbsp;

In a statement, Bharat Biotech Chairman and Managing Director Krishna M Ella said the company is supplying the vaccine to the Central Government at Rs 150 per dosage.&nbsp;

"We would like to state that more than 50 per cent of our capacities have been reserved for Central Government supplies," Ella said.&nbsp;

Recovering cost is essential in the journey of innovation towards other vaccines, such as intranasal Covid-19, Chikungunya, Zika, Cholera and others, he added.&nbsp;

The company has tagged the vaccine between USD 15-20 for export markets.&nbsp;

Earlier this week, Serum Institute of India (SII) had announced a price of Rs 400 per dose for 'Covishield' for state governments and Rs 600 per dose for private hospitals.&nbsp;

The company also said for the next two months, it will address the issue of limited capacity by scaling up vaccine production.&nbsp;

"Going ahead, 50 per cent of our capacities will be served to the Government of India's vaccination programme, and the remaining 50 per cent of the capacity will be for the state governments and private hospitals," Serum Institute of India had said in a statement.&nbsp;

American vaccines in the private market cost more than Rs 1,500 per dose, while Russian and Chinese vaccines cost greater than Rs 750 per dose, it had noted.&nbsp;

Covishield comprises over 90 per cent of the 12.76 crore COVID-19 vaccines administered across the country so far, according to government data on Wednesday.&nbsp;

Of the 127,605,870 COVID-19 vaccination jabs administered till now, 11,60,65,107 are of Covishield, while 1,15,40,763 are Covaxin, according to the government's CO-WIN portal.&nbsp;

Earlier in the day, the government waived customs duty on the import of COVID vaccines as well as medical grade oxygen and related equipment as the nation battled its worst health crisis with a 'tsunami' of infections setting a new world record for cases for the third consecutive day.&nbsp;

The decision to exempt customs duty was taken at a meeting chaired by Prime Minister Narendra Modi to boost oxygen availability in the country.&nbsp;

Customs duty waiver on imported vaccines would help to keep the cost of overseas vaccines low, that are being eyed to supplement domestically made shots ahead of the opening of COVID-19 vaccination to all citizens over 18 years of age.&nbsp;

The government had previously waived customs duty on imported Remdesivir injections and the drug's active pharmaceutical ingredients (API) to boost supplies.&nbsp;

India reported a record 346,786 new infections on Saturday, bringing its total to 1.66 crore. Deaths also rose by a record 2,624 to total 189,544.&nbsp;

Bharat Biotech has fixed the price of its Covid-19 vaccine, Covaxin, at Rs 600 per dose for state governments and at Rs 1,200 per dose for private hospitals, the vaccine maker announced on Saturday.

Bharat Biotech has fixed the price of its Covid-19 vaccine, Covaxin, at Rs 600 per dose for state governments and at Rs 1,200 per dose for private hospitals, the vaccine maker announced on Saturday. In a statement, Bharat Biotech Chairman and Managing Director Krishna M Ella said the company is supplying the vaccine to the Central Government at Rs 150 per dosage. "We would like to state that more than 50 per cent of our capacities have been reserved for Central Government supplies," Ella said. Recovering cost is essential in the journey of innovation towards other vaccines, such as intranasal Covid-19, Chikungunya, Zika, Cholera and others, he added. The company has tagged the vaccine between USD 15-20 for export markets. Earlier this week, Serum Institute of India (SII) had announced a price of Rs 400 per dose for 'Covishield' for state governments and Rs 600 per dose for private hospitals. The company also said for the next two months, it will address the issue of limited capacity by scaling up vaccine production. "Going ahead, 50 per cent of our capacities will be served to the Government of India's vaccination programme, and the remaining 50 per cent of the capacity will be for the state governments and private hospitals," Serum Institute of India had said in a statement. American vaccines in the private market cost more than Rs 1,500 per dose, while Russian and Chinese vaccines cost greater than Rs 750 per dose, it had noted. Covishield comprises over 90 per cent of the 12.76 crore COVID-19 vaccines administered across the country so far, according to government data on Wednesday. Of the 127,605,870 COVID-19 vaccination jabs administered till now, 11,60,65,107 are of Covishield, while 1,15,40,763 are Covaxin, according to the government's CO-WIN portal. Earlier in the day, the government waived customs duty on the import of COVID vaccines as well as medical grade oxygen and related equipment as the nation battled its worst health crisis with a 'tsunami' of infections setting a new world record for cases for the third consecutive day. The decision to exempt customs duty was taken at a meeting chaired by Prime Minister Narendra Modi to boost oxygen availability in the country. Customs duty waiver on imported vaccines would help to keep the cost of overseas vaccines low, that are being eyed to supplement domestically made shots ahead of the opening of COVID-19 vaccination to all citizens over 18 years of age. The government had previously waived customs duty on imported Remdesivir injections and the drug's active pharmaceutical ingredients (API) to boost supplies. India reported a record 346,786 new infections on Saturday, bringing its total to 1.66 crore. Deaths also rose by a record 2,624 to total 189,544.

Bharat Biotech prices Covaxin at Rs 600 for states, Rs 1,200 for pvt hospitals  

The Indian vaccine manufacturer Bharat Biotech has released its amended prices as the country aims to open up vaccination drive to all adults from 1 May.

Bharat Biotech releases Covaxin's price ahead of India's phase 3 of vaccination

The Indian Council of Medical research has found that Bharat biotech COVAXIN is capable of neutralizing the double mutations reported in India.

ICMR says Covaxin effective in neutralising double mutant variant

Can a "Made-in-India" vaccine crush India's deadly second wave? Updated data from Covaxin's final phase of trials shows that the vaccine can "neutralise" deadly mutations - including the double mutant. WION's Palki Sharma tells you more. An interim analysis of the final phase data.

Gravitas: Made-In-India vaccine "neutralises" deadly mutations

The Indian government on Wednesday said 0.03 per cent of people tested positive for coronavirus after taking the second dose of Covishield, while 0.04 per cent contracted the virus after receiving the second jab of Covaxin.&nbsp;

Covishield and Covaxin were the first <a href="https://www.wionews.com/topics/coronavirus-vaccine">coronavirus vaccines </a>that New Delhi approved to begin its nationwide vaccination drive.&nbsp;

Watch |&nbsp;

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While Covishield is AstraZeneca-Oxford University' vaccine prepared by Serum Institute of India, Covaxin has been prepared by India's ICMR and Bharat Biotech.&nbsp;

ICMR Director General Balram Bhargava in a press conference said 0.04 per cent of 17,37,178 individuals, contracted the deadly virus after receiving the second dose of Covaxin.

He added that 0.03 per cent of 1,57,32,754 people who received the second dose of Covishield tested positive.&nbsp;

Over 21,000 people contracted coronavirus after taking the first jab of either Covishield or Covaxin, while 5,500 got infected after taking the second dose.

Also read | <a href="https://www.wionews.com/india-news/serum-institute-fixes-covishield-vaccine-prices-rs-400-for-govt-hospitals-rs-600-for-private-378966">Serum Institute fixes Covishield vaccine prices: Rs 400 for govt hospitals, Rs 600 for private</a>

The official said that so far 100 million people have taken the first jab of Covishield, and 17,145 or 2 per 10,000 people contracted the virus.&nbsp;

As many as 9.3 million people took the first jab of Covaxin and out of that 4,208 (0.04 per cent) contracted Covid-19, the ICMR director-general said.&nbsp;

"This is a very small number and not at all worrisome. Secondly, the highly transmissible second wave also contribute minuscule to the percentage so this could have been even zero per cent," Bhargava said.&nbsp;

 
&nbsp;

The Indian government on Wednesday said 0.03 per cent of people tested positive for coronavirus after taking the second dose of Covishield, while 0.04 per cent contracted the virus after receiving the second jab of Covaxin.

The Indian government on Wednesday said 0.03 per cent of people tested positive for coronavirus after taking the second dose of Covishield, while 0.04 per cent contracted the virus after receiving the second jab of Covaxin. Covishield and Covaxin were the first coronavirus vaccines that New Delhi approved to begin its nationwide vaccination drive. Watch | While Covishield is AstraZeneca-Oxford University' vaccine prepared by Serum Institute of India, Covaxin has been prepared by India's ICMR and Bharat Biotech. ICMR Director General Balram Bhargava in a press conference said 0.04 per cent of 17,37,178 individuals, contracted the deadly virus after receiving the second dose of Covaxin. He added that 0.03 per cent of 1,57,32,754 people who received the second dose of Covishield tested positive. Over 21,000 people contracted coronavirus after taking the first jab of either Covishield or Covaxin, while 5,500 got infected after taking the second dose. Also read | Serum Institute fixes Covishield vaccine prices: Rs 400 for govt hospitals, Rs 600 for private The official said that so far 100 million people have taken the first jab of Covishield, and 17,145 or 2 per 10,000 people contracted the virus. As many as 9.3 million people took the first jab of Covaxin and out of that 4,208 (0.04 per cent) contracted Covid-19, the ICMR director-general said. "This is a very small number and not at all worrisome. Secondly, the highly transmissible second wave also contribute minuscule to the percentage so this could have been even zero per cent," Bhargava said.

0.03% contracted Covid-19 after receiving second jab of Covishield; 0.04% post Covaxin

Bharat BioTech on Wednesday claimed that its <a href="https://www.wionews.com/topics/coronavirus-vaccine">coronavirus vaccine </a>Covaxin has an efficacy of 78 per cent against mild, moderate and severe cases of Covid-19, according to the Phase 3 interim analysis results.&nbsp;

It highlighted that the second interim data of the Phase 3 study showed that the hospitalisation rate due to novel coronavirus reduced by 100 per cent after taking the Covaxin shot.&nbsp;

Watch |&nbsp;

<div class="videoWrapper trancodeVideo"><iframe allowfullscreen="" autoplay="1" class="includeVideo" frameborder="0" height="350" src="https://www.wionews.com/videos/gravitas-indias-covid-surge-china-senses-an-opportunity-378893/embed" style="width:100%;max-width:560px;" width="560"></iframe></div>

The recent spike in Covid-19 infections led to 127 symptomatic cases being recorded after taking the vaccine's shot, leading to an efficacy of 78 per cent against mid, moderate and severe cases, the pharma company said in a statement.&nbsp;

It added that the vaccine has an efficacy of 70 per cent in asymptomatic infection.

Also read | <a href="https://www.wionews.com/india-news/covaxin-is-effective-against-multiple-variants-of-coronavirus-indian-medical-body-378960">Covaxin is effective against multiple variants of coronavirus: Indian medical body</a>

"Efficacy against SARS-Cov-2 has been established. Covaxin has demonstrated an excellent safety record in human clinical trials and in usage under emergency use. Covaxin is now a global innovator vaccine derived from R&amp;D in India," Bharat BioTech Chairman and Managing Director Krishna Ella was quoted as saying by news agency PTI.&nbsp;

Ella also said that the protocols for manufacturing, testing and release of inactivated vaccines meet the requirements of WHO, Indian, and other regulatory authorities.&nbsp;

"These protocols have delivered consistent results over a 15-year period with more than 300 million doses supplied globally, with excellent safety and performance record," the MD said.&nbsp;

The pharma company said final analysis results will be available in June and the final report will then be sent to a peer-reviewed publication.&nbsp;

Covaxin has been jointly prepared by Bharat BioTech and ICMR.&nbsp;

Balram Bhargava, Director General of ICMR and Secretary of Department of Health Research said that Covaxin "works well against" most variants of coronavirus. &nbsp;

 
&nbsp;

Bharat BioTech on Wednesday claimed that its coronavirus vaccine Covaxin has an efficacy of 78 per cent against mild, moderate and severe cases of Covid-19, according to the Phase 3 interim analysis results.

Bharat BioTech on Wednesday claimed that its coronavirus vaccine Covaxin has an efficacy of 78 per cent against mild, moderate and severe cases of Covid-19, according to the Phase 3 interim analysis results. It highlighted that the second interim data of the Phase 3 study showed that the hospitalisation rate due to novel coronavirus reduced by 100 per cent after taking the Covaxin shot. Watch | The recent spike in Covid-19 infections led to 127 symptomatic cases being recorded after taking the vaccine's shot, leading to an efficacy of 78 per cent against mid, moderate and severe cases, the pharma company said in a statement. It added that the vaccine has an efficacy of 70 per cent in asymptomatic infection. Also read | Covaxin is effective against multiple variants of coronavirus: Indian medical body "Efficacy against SARS-Cov-2 has been established. Covaxin has demonstrated an excellent safety record in human clinical trials and in usage under emergency use. Covaxin is now a global innovator vaccine derived from R&D in India," Bharat BioTech Chairman and Managing Director Krishna Ella was quoted as saying by news agency PTI. Ella also said that the protocols for manufacturing, testing and release of inactivated vaccines meet the requirements of WHO, Indian, and other regulatory authorities. "These protocols have delivered consistent results over a 15-year period with more than 300 million doses supplied globally, with excellent safety and performance record," the MD said. The pharma company said final analysis results will be available in June and the final report will then be sent to a peer-reviewed publication. Covaxin has been jointly prepared by Bharat BioTech and ICMR. Balram Bhargava, Director General of ICMR and Secretary of Department of Health Research said that Covaxin "works well against" most variants of coronavirus.

Covaxin has an efficacy of 78% against severe Covid-19 cases: Bharat BioTech

A study by the Indian Council of Medical Research (ICMR) shows that COVAXIN neutralises against multiple variants of SARS-CoV-2 and effectively neutralises the double mutant strain as well, according to news agency ANI.

<div class="ui-state-default" contenteditable="false">
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ICMR study shows <a href="https://twitter.com/hashtag/COVAXIN?src=hash&amp;ref_src=twsrc%5Etfw">#COVAXIN</a> neutralises against multiple variants of SARS-CoV-2 and effectively neutralises the double mutant strain as well. <a href="https://twitter.com/MoHFW_INDIA?ref_src=twsrc%5Etfw">@MoHFW_INDIA</a> <a href="https://twitter.com/DeptHealthRes?ref_src=twsrc%5Etfw">@DeptHealthRes</a> <a href="https://twitter.com/hashtag/IndiaFightsCOVID19?src=hash&amp;ref_src=twsrc%5Etfw">#IndiaFightsCOVID19</a> <a href="https://twitter.com/hashtag/LargestVaccineDrive?src=hash&amp;ref_src=twsrc%5Etfw">#LargestVaccineDrive</a> <a href="https://t.co/syv5T8eHuR">pic.twitter.com/syv5T8eHuR</a>
— ICMR (@ICMRDELHI) <a href="https://twitter.com/ICMRDELHI/status/1384762345314951173?ref_src=twsrc%5Etfw">April 21, 2021</a></blockquote>
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Bharat Biotech's Covaxin has received Emergency Use Authorizations (EUAs) for COVID-19 treatment in India and several countries across the globe with another 60 in the process.

ICMR-National Institute of Virology has successfully isolated and cultured multiple variants of concern of SARS-CoV-2 virus: B.1.1.7 (the UK variant), B.1.1.28 (Brazil variant ) and B.1.351 (South Africa variant).

ICMR-NIV has demonstrated the neutralisation potential of Covaxin against the UK variant and Brazil variant, the apex health research body said.

ICMR-NIV recently has been successful in isolating and culturing the double mutant strain B.1.617 SARS-CoV-2 identified in certain regions of India and several other countries, the ICMR stated.

"Covaxin has been found to effectively neutralise the double mutant strain as well," it said.

(With inputs from agencies)

A study by the Indian Council of Medical Research (ICMR) shows that COVAXIN neutralises against multiple variants of SARS-CoV-2 and effectively neutralises the double mutant strain as well, according to news agency ANI.

A study by the Indian Council of Medical Research (ICMR) shows that COVAXIN neutralises against multiple variants of SARS-CoV-2 and effectively neutralises the double mutant strain as well, according to news agency ANI. ICMR study shows #COVAXIN neutralises against multiple variants of SARS-CoV-2 and effectively neutralises the double mutant strain as well. @MoHFW_INDIA @DeptHealthRes #IndiaFightsCOVID19 #LargestVaccineDrive pic.twitter.com/syv5T8eHuR — ICMR (@ICMRDELHI) April 21, 2021 × Bharat Biotech's Covaxin has received Emergency Use Authorizations (EUAs) for COVID-19 treatment in India and several countries across the globe with another 60 in the process. ICMR-National Institute of Virology has successfully isolated and cultured multiple variants of concern of SARS-CoV-2 virus: B.1.1.7 (the UK variant), B.1.1.28 (Brazil variant ) and B.1.351 (South Africa variant). ICMR-NIV has demonstrated the neutralisation potential of Covaxin against the UK variant and Brazil variant, the apex health research body said. ICMR-NIV recently has been successful in isolating and culturing the double mutant strain B.1.617 SARS-CoV-2 identified in certain regions of India and several other countries, the ICMR stated. "Covaxin has been found to effectively neutralise the double mutant strain as well," it said. (With inputs from agencies)

Covaxin is effective against multiple variants of coronavirus: Indian medical body

Russia's Sputnik V vaccine has been cleared for emergency use in India amid a record spike in COVID-19 cases. An expert committee approved the restricted use of the Russian vaccine.

Russia's Sputnik V vaccine cleared for emergency use in India

Paying "tributes" to India, Vietnam's ambassador the country&nbsp;Pham Sanh Chau recieved&nbsp;the first dose of Indian vaccine Covaxin. Covaxin is made by Bharat Biotech, headquartered in the southern Indian city of Hyderabad. The envoy got vaccinated at Delhi's Dr Ram Manohar Lohia hospital.

Speaking to WION after getting the first jab, Chau said, "I took the decision to come to a government hospital to take my first jab of Covaxin vaccine. Why I decided to take Covaxin, because I believe that Covaxin is a very good vaccine and it will be safer."

He added, "I am here for more than two years, and it's time for me to pay tribute to this great country of India and its people. Also, acknowledge the contribution of Indian scientists to the noble cause of vaccinating the whole world".

The Vietnamese envoy joins other envoys in getting vaccinated. Earlier this month, Australian envoy&nbsp;Barry O’Farrell got vaccinated using Covisheild&nbsp;vaccine.

&nbsp;

In a tweet, the Australian envoy had said, "&nbsp;#FirstDose today of&nbsp;@AstraZeneca ’s #Covishield vaccine, manufactured by Flag of India @SerumInstIndia."&nbsp;

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<a href="https://twitter.com/hashtag/FirstDose?src=hash&amp;ref_src=twsrc%5Etfw">#FirstDose</a> today of <a href="https://twitter.com/AstraZeneca?ref_src=twsrc%5Etfw">@AstraZeneca</a>’s <a href="https://twitter.com/hashtag/Covishield?src=hash&amp;ref_src=twsrc%5Etfw">#Covishield</a> vaccine, manufactured by 🇮🇳 <a href="https://twitter.com/SerumInstIndia?ref_src=twsrc%5Etfw">@SerumInstIndia</a>. Pleased to be a part of the world’s largest <a href="https://twitter.com/hashtag/COVID19?src=hash&amp;ref_src=twsrc%5Etfw">#COVID19</a> vaccination program rolled out in India - 83,110,926 vaccinated since 16 January. <a href="https://twitter.com/hashtag/LargestVaccineDrive?src=hash&amp;ref_src=twsrc%5Etfw">#LargestVaccineDrive</a> <a href="https://twitter.com/hashtag/AstraZenaca?src=hash&amp;ref_src=twsrc%5Etfw">#AstraZenaca</a> <a href="https://t.co/wdw3W6vX7d">pic.twitter.com/wdw3W6vX7d</a>
— Barry O’Farrell AO (@AusHCIndia) <a href="https://twitter.com/AusHCIndia/status/1379304487962087430?ref_src=twsrc%5Etfw">April 6, 2021</a></blockquote>
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&nbsp;

India had earlier this year invited all eligible foreign diplomats and their families based out of Delhi to be vaccinated.

The country began its domestic vaccination drive in January and since then 100 million people have been vaccinated.

New Delhi is also exporting vaccines globally as gift or commercially, and has sent doses to 85 countries so far.

Paying "tributes" to India, Vietnam's ambassador the country Pham Sanh Chau recieved the first dose of Indian vaccine Covaxin. Covaxin is made by Bharat Biotech, headquartered in the southern Indian city of Hyderabad.

Paying "tributes" to India, Vietnam's ambassador the country Pham Sanh Chau recieved the first dose of Indian vaccine Covaxin. Covaxin is made by Bharat Biotech, headquartered in the southern Indian city of Hyderabad. The envoy got vaccinated at Delhi's Dr Ram Manohar Lohia hospital. Speaking to WION after getting the first jab, Chau said, "I took the decision to come to a government hospital to take my first jab of Covaxin vaccine. Why I decided to take Covaxin, because I believe that Covaxin is a very good vaccine and it will be safer." He added, "I am here for more than two years, and it's time for me to pay tribute to this great country of India and its people. Also, acknowledge the contribution of Indian scientists to the noble cause of vaccinating the whole world". The Vietnamese envoy joins other envoys in getting vaccinated. Earlier this month, Australian envoy Barry O’Farrell got vaccinated using Covisheild vaccine. In a tweet, the Australian envoy had said, " #FirstDose today of @AstraZeneca ’s #Covishield vaccine, manufactured by Flag of India @SerumInstIndia." #FirstDose today of @AstraZeneca’s #Covishield vaccine, manufactured by 🇮🇳 @SerumInstIndia. Pleased to be a part of the world’s largest #COVID19 vaccination program rolled out in India - 83,110,926 vaccinated since 16 January. #LargestVaccineDrive #AstraZenaca pic.twitter.com/wdw3W6vX7d — Barry O’Farrell AO (@AusHCIndia) April 6, 2021 × India had earlier this year invited all eligible foreign diplomats and their families based out of Delhi to be vaccinated. The country began its domestic vaccination drive in January and since then 100 million people have been vaccinated. New Delhi is also exporting vaccines globally as gift or commercially, and has sent doses to 85 countries so far.

Vietnamese envoy gets first dose of Indian COVID-19 vaccine Covaxin

India has granted emergency use approval to the Russian Sputnik V against the Coronavirus. After Covishield and Covaxin, Sputnik V became the third vaccine approved by the country against COVID-19.

India gives green signal to Russian vaccine Sputnik V

Paraguay on Monday received a shipment of 1,00,000 doses of India`s indigenously developed Covaxin vaccine.

"Paraguay receives 100,000 doses of Covaxin vaccine from India. We guarantee the continued immunization against COVID-19. Thanks to India for its support," Sputnik reported citing Paraguay Health Ministry.

External Affairs Minister S Jaishankar took to Twitter to announce that `Made in India` vaccines have arrived in the south American country. "Never too far for friendship. Made in India vaccines arrive in Paraguay," Jaishankar tweeted.

Paraguay has reported over 2,09,000 COVID-19 cases. So far, over 4,063 people have died in the country due to the infection.India has been supplying coronavirus vaccines to countries around the world under the Vaccine Maitri initiative.

New Delhi has provided vaccines to over 75 countries. According to the Ministry of External Affairs, over 638.81 lakh doses of vaccines have been provided by India to countries.

Paraguay on Monday received a shipment of 1,00,000 doses of India`s indigenously developed Covaxin vaccine. "Paraguay receives 100,000 doses of Covaxin vaccine from India.

Paraguay on Monday received a shipment of 1,00,000 doses of India`s indigenously developed Covaxin vaccine. "Paraguay receives 100,000 doses of Covaxin vaccine from India. We guarantee the continued immunization against COVID-19. Thanks to India for its support," Sputnik reported citing Paraguay Health Ministry. External Affairs Minister S Jaishankar took to Twitter to announce that `Made in India` vaccines have arrived in the south American country. "Never too far for friendship. Made in India vaccines arrive in Paraguay," Jaishankar tweeted. Paraguay has reported over 2,09,000 COVID-19 cases. So far, over 4,063 people have died in the country due to the infection.India has been supplying coronavirus vaccines to countries around the world under the Vaccine Maitri initiative. New Delhi has provided vaccines to over 75 countries. According to the Ministry of External Affairs, over 638.81 lakh doses of vaccines have been provided by India to countries.

India provides 1,00,000 doses of Covaxin to Paraguay

Nepal gave emergency authorisation to India’s COVID-19 vaccine COVAXIN, becoming the third country to approve the shot.

COVID-19: Nepal gives an emergency nod to India's COVAXIN

Nepal's national drug regulatory authority on Saturday granted emergency use approval to Bharat Biotech's Covaxin.

Nepal has reported 275,750 cases and 3,016 deaths so far. It is now only the third country to approve India's indigenously developed Covid vaccine -- also the third COVID-19 vaccine authorised in the country.

According to The Kathmandu Post, a meeting of the drug advisory committee of the Department of Drug Administration decided to issue a conditional emergency use authorisation to India's homegrown government-backed vaccine Covaxin.

COVAXIN, which demonstrated an interim vaccine efficacy of 81 per cent in the Phase 3 clinical trials India, was approved for emergency use in India in January and Zimbabwe cleared it early this month.

Bharat Biotech had applied for emergency use authorisation for its vaccine in Nepal on January 13. Of the three applications filed on January 13, the department had first granted emergency use authorisation to Oxford-AstraZeneca on January 15.

The AstraZeneca vaccine, manufactured by the Serum Institute of India under the name of Covishiled, was then accordingly brought to the country.

Nepal granted emergency use authorisation to BBIBP-CorV vaccine, developed by China's Sinopharm on February 17.

The country has used one million doses of AstraZeneca vaccines provided by India in January under grant assistance in sync with its Neighbourhood First' policy. It is now also awaiting another consignment of 2 million AstraZeneca vaccines from the Serum Institute of India (SII).'

Nepal's national drug regulatory authority on Saturday granted emergency use approval to Bharat Biotech's Covaxin. Nepal has reported 275,750 cases and 3,016 deaths so far.

Nepal's national drug regulatory authority on Saturday granted emergency use approval to Bharat Biotech's Covaxin. Nepal has reported 275,750 cases and 3,016 deaths so far. It is now only the third country to approve India's indigenously developed Covid vaccine -- also the third COVID-19 vaccine authorised in the country. According to The Kathmandu Post, a meeting of the drug advisory committee of the Department of Drug Administration decided to issue a conditional emergency use authorisation to India's homegrown government-backed vaccine Covaxin. COVAXIN, which demonstrated an interim vaccine efficacy of 81 per cent in the Phase 3 clinical trials India, was approved for emergency use in India in January and Zimbabwe cleared it early this month. Bharat Biotech had applied for emergency use authorisation for its vaccine in Nepal on January 13. Of the three applications filed on January 13, the department had first granted emergency use authorisation to Oxford-AstraZeneca on January 15. The AstraZeneca vaccine, manufactured by the Serum Institute of India under the name of Covishiled, was then accordingly brought to the country. Nepal granted emergency use authorisation to BBIBP-CorV vaccine, developed by China's Sinopharm on February 17. The country has used one million doses of AstraZeneca vaccines provided by India in January under grant assistance in sync with its Neighbourhood First' policy. It is now also awaiting another consignment of 2 million AstraZeneca vaccines from the Serum Institute of India (SII).'

Nepal gives emergency use approval to Bharat Biotech's Covaxin

Ocugen Inc seeks to sell 100 million doses of India's state-backed COVID-19 <a href="https://www.wionews.com/world/australia-to-continue-using-astrazeneca-vaccine-despite-upheaval-in-europe-370761">vaccine</a> COVAXIN in the United States this year, the US firm's chief executive Shankar Musunuri told Reuters on Monday.

Watch:

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The Pennsylvania-based biopharmaceutical firm is partnering with India's Bharat Biotech, a developer of the vaccine, to commercialise the shot in the United States. COVAXIN was shown to be 81 per cent effective in an interim analysis of late-stage trial data on some 26,000 people in India.

Musunuri said Ocugen aimed to launch the two-dose vaccine in the United States in the second quarter of 2021, initially with imported shots before beginning production there.

It is unclear whether the US government is seeking additional <a href="https://www.wionews.com/world/thai-pm-gets-first-shot-of-astrazeneca-vaccine-after-safety-scare-370768">vaccine</a> suppliers. The US Department of Health and Human Services, which runs Operation Warp Speed, declined to comment on potential interest in COVAXIN.

Musunuri said Ocugen had held initial talks with the US Food and Drug Administration&nbsp;(FDA) and planned to seek emergency use authorisation in April. The FDA declined to comment.

The US government's Operation Warp Speed programme to bring <a href="https://www.wionews.com/world/global-covid-19-caseload-tops-120-million-370767">COVID-19 </a>vaccines to market quickly has ordered over 800 million doses from Pfizer-BioNTech, Moderna and Johnson &amp; Johnson, the first three shots to be authorised for emergency use in the country.&nbsp;

Additional supply has been ordered from at least two other drugmakers.

Pfizer, Moderna and J&amp;J are expected to deliver more than enough shots for all adult Americans by the end of May.

Bharat Biotech says as many as 40 countries are interested in COVAXIN and it has sought emergency approvals in Brazil and the Philippines. Cracking the US market would be a significant milestone for the company and India's vaccine industry, the world's largest.

"They're fine with the way the interim analysis is being done," Musunuri said of the FDA, adding that Ocugen had "a regulatory path" to take the process forward.

The FDA has so far required that COVID-19 vaccine makers test their shots in the United States, and the agency must sign off on the manufacturing at each facility that makes the vaccine.

Musunuri said COVAXIN had the potential to work against COVID-19 variants and Ocugen could initially focus on children as it was likely to be safe for those over the age of 12, while shots produced by other drugmakers targeted adults.

Pfizer's vaccine has been authorised for emergency use in the United States for individuals 16 years and older, with the other two given authorisation for emergency use in people 18 years and above.

Pfizer and Moderna are testing their vaccines in trials involving thousands of children. Johnson &amp; Johnson plans to start their trial in children soon.

"Like a polio virus given to babies, this could be safe for all children, high-risk groups, pregnant women and people with comorbidities," Musunuri said of COVAXIN.

He said Ocugen was expecting more data from Bharat Biotech on COVAXIN after a study by the Indian company in January which showed the shot was likely to be effective against the British strain of the coronavirus.

India's drug regulator approved COVAXIN for emergency use in January for people above 12, saying it could act against the whole body of a virus instead of just its "spike-protein" tip, potentially making it more effective in case of mutations.

Musunuri said this could mean it could be used as a booster for people already vaccinated with a first dose of other shots.

He said Bharat Biotech would export "tens of millions of doses" to Ocugen, which is also finalising US contract- manufacturers for the product.

Shares in Ocugen have nearly tripled this year, taking it close to a $2 billion market capitalisation, helped by a spike when Bharat Biotech announced its late-stage trial results.

COVAXIN has been given to more than 2 million prioritised adults in India since the country's vaccination drive began in mid-January. Bharat Biotech says it wants to produce about 700 million doses a year domestically.

Ocugen Inc seeks to sell 100 million doses of India's state-backed COVID-19 vaccine COVAXIN in the United States this year, the US firm's chief executive Shankar Musunuri told Reuters on Monday.

Ocugen Inc seeks to sell 100 million doses of India's state-backed COVID-19 vaccine COVAXIN in the United States this year, the US firm's chief executive Shankar Musunuri told Reuters on Monday. Watch: The Pennsylvania-based biopharmaceutical firm is partnering with India's Bharat Biotech, a developer of the vaccine, to commercialise the shot in the United States. COVAXIN was shown to be 81 per cent effective in an interim analysis of late-stage trial data on some 26,000 people in India. Musunuri said Ocugen aimed to launch the two-dose vaccine in the United States in the second quarter of 2021, initially with imported shots before beginning production there. It is unclear whether the US government is seeking additional vaccine suppliers. The US Department of Health and Human Services, which runs Operation Warp Speed, declined to comment on potential interest in COVAXIN. Musunuri said Ocugen had held initial talks with the US Food and Drug Administration (FDA) and planned to seek emergency use authorisation in April. The FDA declined to comment. The US government's Operation Warp Speed programme to bring COVID-19 vaccines to market quickly has ordered over 800 million doses from Pfizer-BioNTech, Moderna and Johnson & Johnson, the first three shots to be authorised for emergency use in the country. Additional supply has been ordered from at least two other drugmakers. Pfizer, Moderna and J&J are expected to deliver more than enough shots for all adult Americans by the end of May. Bharat Biotech says as many as 40 countries are interested in COVAXIN and it has sought emergency approvals in Brazil and the Philippines. Cracking the US market would be a significant milestone for the company and India's vaccine industry, the world's largest. "They're fine with the way the interim analysis is being done," Musunuri said of the FDA, adding that Ocugen had "a regulatory path" to take the process forward. The FDA has so far required that COVID-19 vaccine makers test their shots in the United States, and the agency must sign off on the manufacturing at each facility that makes the vaccine. Musunuri said COVAXIN had the potential to work against COVID-19 variants and Ocugen could initially focus on children as it was likely to be safe for those over the age of 12, while shots produced by other drugmakers targeted adults. Pfizer's vaccine has been authorised for emergency use in the United States for individuals 16 years and older, with the other two given authorisation for emergency use in people 18 years and above. Pfizer and Moderna are testing their vaccines in trials involving thousands of children. Johnson & Johnson plans to start their trial in children soon. "Like a polio virus given to babies, this could be safe for all children, high-risk groups, pregnant women and people with comorbidities," Musunuri said of COVAXIN. He said Ocugen was expecting more data from Bharat Biotech on COVAXIN after a study by the Indian company in January which showed the shot was likely to be effective against the British strain of the coronavirus. India's drug regulator approved COVAXIN for emergency use in January for people above 12, saying it could act against the whole body of a virus instead of just its "spike-protein" tip, potentially making it more effective in case of mutations. Musunuri said this could mean it could be used as a booster for people already vaccinated with a first dose of other shots. He said Bharat Biotech would export "tens of millions of doses" to Ocugen, which is also finalising US contract- manufacturers for the product. Shares in Ocugen have nearly tripled this year, taking it close to a $2 billion market capitalisation, helped by a spike when Bharat Biotech announced its late-stage trial results. COVAXIN has been given to more than 2 million prioritised adults in India since the country's vaccination drive began in mid-January. Bharat Biotech says it wants to produce about 700 million doses a year domestically.

Pennsylvania-based firm seeks to sell 100 million Indian vaccine doses in United States

India's homemade COVID-19 vaccine known as 'COVAXIN' might soon be available in the United States of America. Ocugen has been seeking to sell 100 mn COVAXIN doses in the USA this year.

Coronavirus Update: US pharma seeks to bring COVAXIN to United States

India becomes the global hub of coronavirus vaccines after the COVAXIN doses reached 65 nations and recently Iran was also added to the list after it got its 125,000 doses of COVAXIN from India.

Coronavirus update: Iran receives its first shipment of COVAXIN from India

The Centre on Thursday said Bharat Biotech's indigenously developed Covaxin is out of the "clinical trial mode" and that it has now been granted the regular restricted emergency use authorisation just like Covishield manufactured by Serum Institute.

Addressing a weekly press conference, NITI Aayog member (Health) Dr V K Paul said Covaxin and Covishield have the same licensure status now.

"The condition of it (Covaxin) being required to be administered under clinical trial mode is no more there," Paul said.

"Both the COVID-19 vaccines Covaxin and Covishield have the same licensure status. It has already being given to around 19 lakh people. Covaxin has stood the test of time in terms of great safety. Only 311 individuals had minimal side effects. It is the triumph for India's research and development enterprise and science and technology enterprise," he said.

India's drug regulator on January 3 had granted permission for the restricted use of Covaxin in emergency situations in the public interest as an abundant precaution, in clinical trial mode, especially in case of infection by mutant strains.

The Subject Expert Panel on COVID-19 of the CDSCO had recommended granting emergency use authorisation to Bharat Biotech's indigenously developed Covaxin while removing the condition for the vaccine to be administered in "clinical trial mode".

The Drugs Controller General of India (DCGI) in a communique to Bharat Biotech said, "Accordingly, based on the recommendations of the SEC, the condition, 'this permission is for restricted use in emergency situation in public interest as an abundant precaution in clinical trial mode' in the permission is amended to read as this permission is for restricted use in emergency situation in public interest."

"However, you are required to continue ongoing phase-3 clinical trial as per approved clinical trial protocol and submit revised summary of product characteristics, prescribing information and fact sheet," it said.

Replying to a question whether the government has a timeline in mind for phase 3 vaccination drive and who gets included in that, Paul said, "We are now focused on the relatively large group of individuals above the age of 60 as well as those aged 45- 60 with comorbidities. We are building a momentum to cover this significantly large group."

"We will see progress and moving forward, yes, further increase in the circle of those who are eligible will be considered," Paul said.

The Centre on Thursday said Bharat Biotech's indigenously developed Covaxin is out of the "clinical trial mode" and that it has now been granted the regular restricted emergency use authorisation just like Covishield manufactured by Serum Institute.

The Centre on Thursday said Bharat Biotech's indigenously developed Covaxin is out of the "clinical trial mode" and that it has now been granted the regular restricted emergency use authorisation just like Covishield manufactured by Serum Institute. Addressing a weekly press conference, NITI Aayog member (Health) Dr V K Paul said Covaxin and Covishield have the same licensure status now. "The condition of it (Covaxin) being required to be administered under clinical trial mode is no more there," Paul said. "Both the COVID-19 vaccines Covaxin and Covishield have the same licensure status. It has already being given to around 19 lakh people. Covaxin has stood the test of time in terms of great safety. Only 311 individuals had minimal side effects. It is the triumph for India's research and development enterprise and science and technology enterprise," he said. India's drug regulator on January 3 had granted permission for the restricted use of Covaxin in emergency situations in the public interest as an abundant precaution, in clinical trial mode, especially in case of infection by mutant strains. The Subject Expert Panel on COVID-19 of the CDSCO had recommended granting emergency use authorisation to Bharat Biotech's indigenously developed Covaxin while removing the condition for the vaccine to be administered in "clinical trial mode". The Drugs Controller General of India (DCGI) in a communique to Bharat Biotech said, "Accordingly, based on the recommendations of the SEC, the condition, 'this permission is for restricted use in emergency situation in public interest as an abundant precaution in clinical trial mode' in the permission is amended to read as this permission is for restricted use in emergency situation in public interest." "However, you are required to continue ongoing phase-3 clinical trial as per approved clinical trial protocol and submit revised summary of product characteristics, prescribing information and fact sheet," it said. Replying to a question whether the government has a timeline in mind for phase 3 vaccination drive and who gets included in that, Paul said, "We are now focused on the relatively large group of individuals above the age of 60 as well as those aged 45- 60 with comorbidities. We are building a momentum to cover this significantly large group." "We will see progress and moving forward, yes, further increase in the circle of those who are eligible will be considered," Paul said.

Covaxin out of clinical trial mode, granted restricted emergency use authorisation

Bharat Biotech has announced the Phase 3 clinical trial results for its Coronavirus vaccine candidate Covaxin. The company said that Covaxin demonstrated an efficacy of 81 per cent in the trials.

Bharat Biotech announces successful Phase-3 trial results of Covaxin

Participants received a vaccine or placebo in a 1:1 ratio, which showed that the vaccine candidate was well tolerated, said the company

Covaxin showed 81% efficacy against UK variant

Indian firm Bharat Biotech's homegrown Covid vaccine has shown an interim efficacy of 81 per cent in late-stage clinical trials, the company has said.

The trials involved 25,800 subjects in partnership with the Indian Council of Medical Research, the Hyderabad-based company said in a statement on Wednesday.

"Today is an important milestone in vaccine discovery, for science and our fight against coronavirus. With today's results from our Phase 3 clinical trials, we have now reported data on our COVID-19 vaccine from Phase 1, 2, and 3 trials involving around 27,000 participants," Bharat Biotech Chairman and Managing Director Krishna Ella said.

Covaxin demonstrates high clinical efficacy trend against Covid-19 but also significant immunogenicity against the rapidly emerging variants.

Covaxin, indigenously developed by Bharat Biotech in collaboration with the Indian Council of Medical Research (ICMR), and Oxford-AstraZeneca's Covishield are the two vaccines that are being administered in the country.

Indian firm Bharat Biotech's homegrown Covid vaccine has shown an interim efficacy of 81 per cent in late-stage clinical trials, the company has said. The trials involved 25,800 subjects in partnership with the Indian Council of Medical Research, the Hyderabad-based company said in a statement on Wednesday.

Indian firm Bharat Biotech's homegrown Covid vaccine has shown an interim efficacy of 81 per cent in late-stage clinical trials, the company has said. The trials involved 25,800 subjects in partnership with the Indian Council of Medical Research, the Hyderabad-based company said in a statement on Wednesday. "Today is an important milestone in vaccine discovery, for science and our fight against coronavirus. With today's results from our Phase 3 clinical trials, we have now reported data on our COVID-19 vaccine from Phase 1, 2, and 3 trials involving around 27,000 participants," Bharat Biotech Chairman and Managing Director Krishna Ella said. Covaxin demonstrates high clinical efficacy trend against Covid-19 but also significant immunogenicity against the rapidly emerging variants. Covaxin, indigenously developed by Bharat Biotech in collaboration with the Indian Council of Medical Research (ICMR), and Oxford-AstraZeneca's Covishield are the two vaccines that are being administered in the country.

Bharat Biotech's Covaxin found 81% efficient in Phase 3 trials

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