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

According to reports, Chinese hacking groups are targeting Indian vaccine makers Serum Institute of India (SII) and Bharat Biotech. Both SII and Bharat Biotech are involved in producing the COVID-19 vaccine.

Report: Hackers target Indian vaccine makers SII, Bharat Biotech

Brazil's health ministry on Thursday signed a deal with India's Bharat Biotech to purchase 20 million doses of Covaxin, a <a href="https://www.wionews.com/topics/coronavirus-vaccine">coronavirus vaccine</a>.&nbsp;

The news came a day before Brazil marks one year since the first case of Covid-19 was confirmed in the country after a Sao Paulo businessman returning from a trip to Italy tested positive.

Watch |&nbsp;

<div class="videoWrapper trancodeVideo"><iframe allowfullscreen="" autoplay="1" class="includeVideo" frameborder="0" height="350" src="https://www.wionews.com/videos/uk-south-africa-brazil-mutated-covid-strains-reached-india-364176/embed" style="width:100%;max-width:560px;" width="560"></iframe></div>

The health ministry in a statement said the 1.6 billion reais ($290,000) contract will assure the country 20 million shots, with the first eight million expected to arrive in March.

Also read | <a href="&lt;div class=&quot;videoWrapper trancodeVideo&quot;&gt;&lt;iframe src=&quot;https://www.wionews.com/world/how-pfizer-tried-to-bully-argentina-and-brazil-in-exchange-for-vaccines-366037/embed&quot; width=&quot;560&quot; height=&quot;350&quot; style=&quot;width:100%;max-width:560px;&quot; class=&quot;includeVideo&quot; frameborder=&quot;0&quot; autoplay=1 allowfullscreen&gt;&lt;/iframe&gt;&lt;/div&gt;">How Pfizer tried to bully Argentina and Brazil in exchange for vaccines</a>

The next batch of another eight million will likely reach Brazil in April and May.

The deal comes as Brazil on Thursday crossed the grim milestone of 250,000 deaths due to novel coronavirus with 1,541 fatalities in the last 24 hours, the second-highest daily death toll.&nbsp;

This has been the deadliest week so far in the country with a daily average of 1,149 deaths over the last seven days, according to the official data.&nbsp;

So far, Brazil has vaccinated less than four cent of its population of 210 people and certain cities have also stopped immunisation campaigns due to the unavailability of vaccine supplies.&nbsp;

The South American country has seen 10,390,461 Covid-19 infections, the third-highest globally after the United States and India.&nbsp;

 
&nbsp;

Brazil's health ministry on Thursday signed a deal with India's Bharat Biotech to purchase 20 million doses of Covaxin, a coronavirus vaccine. The news came a day before Brazil marks one year since the first case of Covid-19 was confirmed in the country after a Sao Paulo businessman returning from a trip to Italy tested positive.

Brazil's health ministry on Thursday signed a deal with India's Bharat Biotech to purchase 20 million doses of Covaxin, a coronavirus vaccine. The news came a day before Brazil marks one year since the first case of Covid-19 was confirmed in the country after a Sao Paulo businessman returning from a trip to Italy tested positive. Watch | The health ministry in a statement said the 1.6 billion reais ($290,000) contract will assure the country 20 million shots, with the first eight million expected to arrive in March. Also read | How Pfizer tried to bully Argentina and Brazil in exchange for vaccines The next batch of another eight million will likely reach Brazil in April and May. The deal comes as Brazil on Thursday crossed the grim milestone of 250,000 deaths due to novel coronavirus with 1,541 fatalities in the last 24 hours, the second-highest daily death toll. This has been the deadliest week so far in the country with a daily average of 1,149 deaths over the last seven days, according to the official data. So far, Brazil has vaccinated less than four cent of its population of 210 people and certain cities have also stopped immunisation campaigns due to the unavailability of vaccine supplies. The South American country has seen 10,390,461 Covid-19 infections, the third-highest globally after the United States and India.

Brazil signs deal with India's Bharat Biotech for 20 million Covid-19 vaccine doses

India's exports of the COVID-19 vaccine stood at around Rs 338 crore till February 8, Commerce and Industry Minister Piyush Goyal said in the Rajya Sabha on Friday.

The exports include grant of the vaccine doses to friendly countries and commercial shipments. Replying to supplementary questions in the House, Goyal said exports of the vaccine started in January.

India is taking care of the domestic vaccine requirement first and based on that "giving vaccines to friendly countries," he said.

"Total export is about Rs 338 crore worth of COVID vaccine," the minister said.

Giving details, Goyal said the export of Covishield vaccine manufactured by the Serum Insitute of India, Pune as Government of India grant stood at 62.7 lakh doses with FoB (free on board) value of about Rs 125.4 crore.

Paid exports of 1.05 crore doses were valued at about Rs 213.32 crore.

Goyal said the government has granted permission to the Serum Institute and Bharat Biotech International Limited, Hyderabad for manufacture of COVID-19 vaccines.

Close coordination is being maintained through regular interaction between relevant departments of the Government of India and vaccine manufacturers to ensure adequate availability of COVID-19 vaccines for the national vaccination program, he added.

The minister further said the health ministry is working along with all states, and the Prime Minister is also interacting with all states. Highest priority for vaccination has been given to healthcare and frontline workers by the government, Goyal said.&nbsp;

India's exports of the COVID-19 vaccine stood at around Rs 338 crore till February 8, Commerce and Industry Minister Piyush Goyal said in the Rajya Sabha on Friday.

India's exports of the COVID-19 vaccine stood at around Rs 338 crore till February 8, Commerce and Industry Minister Piyush Goyal said in the Rajya Sabha on Friday. The exports include grant of the vaccine doses to friendly countries and commercial shipments. Replying to supplementary questions in the House, Goyal said exports of the vaccine started in January. India is taking care of the domestic vaccine requirement first and based on that "giving vaccines to friendly countries," he said. "Total export is about Rs 338 crore worth of COVID vaccine," the minister said. Giving details, Goyal said the export of Covishield vaccine manufactured by the Serum Insitute of India, Pune as Government of India grant stood at 62.7 lakh doses with FoB (free on board) value of about Rs 125.4 crore. Paid exports of 1.05 crore doses were valued at about Rs 213.32 crore. Goyal said the government has granted permission to the Serum Institute and Bharat Biotech International Limited, Hyderabad for manufacture of COVID-19 vaccines. Close coordination is being maintained through regular interaction between relevant departments of the Government of India and vaccine manufacturers to ensure adequate availability of COVID-19 vaccines for the national vaccination program, he added. The minister further said the health ministry is working along with all states, and the Prime Minister is also interacting with all states. Highest priority for vaccination has been given to healthcare and frontline workers by the government, Goyal said.

India has exported vaccines worth Rs 338 crore: Government declares in Parliament

According to a new study, India's homegrown jab Covaxin is likely to be effective against the UK variant of the Coronavirus. Covaxin is developed by Bharat Biotech, it has been approved for emergency use by India's drug regulators.

Study: Covaxin developed by Indian Pharma firm Bharat Biotech neutralizes UK variant

Britain`s GSK will shift production of the world`s first effective malaria vaccine to Indian COVID-19 vaccine developer Bharat Biotech, as part of global efforts to battle the deadly fever, the drugmakers said on Wednesday.

The agreement includes transfer of manufacturing of the protein part of the vaccine, RTS,S/AS01, while GSK will continue to supply Bharat Biotech with the adjuvant or vaccine booster for the shot, the joint statement said.

The vaccine, developed by GSK for over three decades and with nonprofit group PATH since 2001, is currently being administered under a special World Health Organization-backed scheme in Ghana, Kenya, and Malawi.

Malaria is caused in humans by five types of parasites transmitted through the bite of a certain variety of infected female mosquitoes.

Two of these parasite variants, including Plasmodium falciparum, against which the GSK vaccine was developed, pose the greatest threat.

"Helping secure the long-term future of the only vaccine available by working with an established leader like Bharat

Biotech is vital for the continued fight against this devastating disease," said Thomas Breuer, the chief medical officer for vaccines at GSK.

There were 229 million cases of the disease worldwide in 2019, with 94% of the malaria cases and deaths occurring in Africa, according to the WHO.

London-listed GSK has committed to donate up to 10 million doses of the vaccine to WHO`s pilot program, and supply up to 15 million doses annually until 2028 if recommended for wider use by the U.N. agency.

Hyderabad, India-based Bharat Biotech has been supplying vaccines to the Indian region, vaccine alliance GAVI and UNICEF, and currently manufactures 17 licensed vaccines including those for typhoid and polio.

It is expected that Bharat Biotech will be the sole supplier of the malaria vaccine by 2029 at the latest, with GSK continuing to supply the adjuvant to them, the companies said.

Britain`s GSK will shift production of the world`s first effective malaria vaccine to Indian COVID-19 vaccine developer Bharat Biotech, as part of global efforts to battle the deadly fever, the drugmakers said on Wednesday.

Britain`s GSK will shift production of the world`s first effective malaria vaccine to Indian COVID-19 vaccine developer Bharat Biotech, as part of global efforts to battle the deadly fever, the drugmakers said on Wednesday. The agreement includes transfer of manufacturing of the protein part of the vaccine, RTS,S/AS01, while GSK will continue to supply Bharat Biotech with the adjuvant or vaccine booster for the shot, the joint statement said. The vaccine, developed by GSK for over three decades and with nonprofit group PATH since 2001, is currently being administered under a special World Health Organization-backed scheme in Ghana, Kenya, and Malawi. Malaria is caused in humans by five types of parasites transmitted through the bite of a certain variety of infected female mosquitoes. Two of these parasite variants, including Plasmodium falciparum, against which the GSK vaccine was developed, pose the greatest threat. "Helping secure the long-term future of the only vaccine available by working with an established leader like Bharat Biotech is vital for the continued fight against this devastating disease," said Thomas Breuer, the chief medical officer for vaccines at GSK. There were 229 million cases of the disease worldwide in 2019, with 94% of the malaria cases and deaths occurring in Africa, according to the WHO. London-listed GSK has committed to donate up to 10 million doses of the vaccine to WHO`s pilot program, and supply up to 15 million doses annually until 2028 if recommended for wider use by the U.N. agency. Hyderabad, India-based Bharat Biotech has been supplying vaccines to the Indian region, vaccine alliance GAVI and UNICEF, and currently manufactures 17 licensed vaccines including those for typhoid and polio. It is expected that Bharat Biotech will be the sole supplier of the malaria vaccine by 2029 at the latest, with GSK continuing to supply the adjuvant to them, the companies said.

GSK to move malaria vaccine production to India's Bharat Biotech

Indian drugmaker Bharat Biotech's coronavirus vaccine, which has been authorized for use in the country, proved safe and produced an immune response in a small group of adults aged 18 to 55, according to a study published in The Lancet medical journal.

The vaccine, developed with the&nbsp;Indian Council of Medical Research (ICMR), is being evaluated in a separate 25,800 person trial, which started in November.

Bharat Biotech said on Friday 13,000 people participating in the late-stage trial had been given the second dose.

The interim data published in the journal included three different vaccine formulations and a placebo group among 375 adults.

Two formulations of the vaccine, called COVAXIN, have been selected for more advanced stages of testing and further efficacy trials are warranted, the report said.

COVAXIN is an inactivated vaccine that introduces dead virus into the body to trigger an immune response.

This is the first peer-reviewed data for the vaccine that has come under scrutiny after widespread criticism over the lack of transparency on the approval process for the shot.

The vaccine was granted emergency approval by the drugs controller general of&nbsp;India&nbsp;this month along with another vaccine, Covishield, developed by AstraZeneca and Oxford University.

India, which has reported the highest number of coronavirus infections after the United States, kicked off its own vaccination drive on Saturday in what the government called the "world's largest vaccination program."

Indian drugmaker Bharat Biotech's coronavirus vaccine, which has been authorized for use in the country, proved safe and produced an immune response in a small group of adults aged 18 to 55, according to a study published in The Lancet medical journal.

Indian drugmaker Bharat Biotech's coronavirus vaccine, which has been authorized for use in the country, proved safe and produced an immune response in a small group of adults aged 18 to 55, according to a study published in The Lancet medical journal. The vaccine, developed with the Indian Council of Medical Research (ICMR), is being evaluated in a separate 25,800 person trial, which started in November. Bharat Biotech said on Friday 13,000 people participating in the late-stage trial had been given the second dose. The interim data published in the journal included three different vaccine formulations and a placebo group among 375 adults. Two formulations of the vaccine, called COVAXIN, have been selected for more advanced stages of testing and further efficacy trials are warranted, the report said. COVAXIN is an inactivated vaccine that introduces dead virus into the body to trigger an immune response. This is the first peer-reviewed data for the vaccine that has come under scrutiny after widespread criticism over the lack of transparency on the approval process for the shot. The vaccine was granted emergency approval by the drugs controller general of India this month along with another vaccine, Covishield, developed by AstraZeneca and Oxford University. India, which has reported the highest number of coronavirus infections after the United States, kicked off its own vaccination drive on Saturday in what the government called the "world's largest vaccination program."

Bharat Biotech's COVID-19 shot safe, produced immune response in early human trial: Study

India's Bharat Biotech submitted on Thursday an application for the emergency use of its COVID-19 vaccines in the Philippines, Food and Drug Administration chief Rolando Enrique Domingo said.

If allowed to go ahead, this would be the first trial of any coronavirus vaccine in Bangladesh and could give the densely-populated country of more than 160 million faster access to the shot for mass use.

The vaccine, developed with the Indian Council of Medical Research, was given the green light for restricted use in India this month without any efficacy data.

"We have received their proposal. The committee will review it," Mahmood-uz-Jahan, a director at the state-run Bangladesh Medical Research Council, told Reuters, declining to give details.

The Dhaka-based International Centre for Diarrhoeal Disease Research, Bangladesh (ICDDR,B), has applied to run the trial on behalf of Bharat Biotech, said a source with direct knowledge of the matter who declined to be named citing internal rules.

ICDDR,B declined to comment. Spokespeople for Bharat Biotech had no immediate comment.

Sinovac Biotech's late-stage trial of a potential vaccine in Bangladesh has become uncertain after Dhaka refused to meet the Chinese company’s demand for co-funding.

Bharat Biotech started a late-stage trial for COVAXIN at home in November and a top Indian government vaccine official, Vinod Kumar Paul, has told Reuters that a smaller study involving 1,000-2,000 people could also be done in Bangladesh.

Bangladesh will from Thursday start receiving millions of India-made doses of another vaccine licensed from Oxford University and AstraZeneca. It is being mass produced by the Serum Institute of India, the world's largest vaccine maker.

Bangladesh, however, has no immediate plans to buy COVAXIN whose efficacy data from the late India trial are expected by March.

"Our vaccine procurement is in good shape. We are going to start the vaccination in the first week of February," Bangladesh Health Secretary Abdul Mannan told Reuters.

"No plan to buy from Bharat Biotech at present."

Brazil is the only country that has publicly announced plans to buy COVAXIN doses from India.

India's Bharat Biotech submitted on Thursday an application for the emergency use of its COVID-19 vaccines in the Philippines, Food and Drug Administration chief Rolando Enrique Domingo said.

India's Bharat Biotech submitted on Thursday an application for the emergency use of its COVID-19 vaccines in the Philippines, Food and Drug Administration chief Rolando Enrique Domingo said. If allowed to go ahead, this would be the first trial of any coronavirus vaccine in Bangladesh and could give the densely-populated country of more than 160 million faster access to the shot for mass use. The vaccine, developed with the Indian Council of Medical Research, was given the green light for restricted use in India this month without any efficacy data. "We have received their proposal. The committee will review it," Mahmood-uz-Jahan, a director at the state-run Bangladesh Medical Research Council, told Reuters, declining to give details. The Dhaka-based International Centre for Diarrhoeal Disease Research, Bangladesh (ICDDR,B), has applied to run the trial on behalf of Bharat Biotech, said a source with direct knowledge of the matter who declined to be named citing internal rules. ICDDR,B declined to comment. Spokespeople for Bharat Biotech had no immediate comment. Sinovac Biotech's late-stage trial of a potential vaccine in Bangladesh has become uncertain after Dhaka refused to meet the Chinese company’s demand for co-funding. Bharat Biotech started a late-stage trial for COVAXIN at home in November and a top Indian government vaccine official, Vinod Kumar Paul, has told Reuters that a smaller study involving 1,000-2,000 people could also be done in Bangladesh. Bangladesh will from Thursday start receiving millions of India-made doses of another vaccine licensed from Oxford University and AstraZeneca. It is being mass produced by the Serum Institute of India, the world's largest vaccine maker. Bangladesh, however, has no immediate plans to buy COVAXIN whose efficacy data from the late India trial are expected by March. "Our vaccine procurement is in good shape. We are going to start the vaccination in the first week of February," Bangladesh Health Secretary Abdul Mannan told Reuters. "No plan to buy from Bharat Biotech at present." Brazil is the only country that has publicly announced plans to buy COVAXIN doses from India.

India's Bharat Biotech seeks emergency use approval for vaccine in Philippines

There will be a gap of 28 days between two doses of COVID-19 vaccine and its effectiveness will begin 14 days after the second dose, the Health Ministry said on Tuesday.

Addressing a press briefing, Union Health Secretary Rajesh Bhushan said vaccine effectiveness will be seen only after 14 days.

"So we urge people to keep following COVID appropriate behavior," he said.

Bhushan said there will be a gap of 28 days between two doses of the COVID-19 vaccine.

India will launch its COVID-19 vaccination drive from January 16 with priority to be given to nearly three crore healthcare and frontline workers. India had recently granted emergency use authorisation to two vaccines, Oxford's Covishield being manufactured by Serum Institute of India and Bharat Biotech's Covaxin.

Both vaccines, the statement from the Health Ministry said, have established safety and immunogenicity.

Dr V K Paul member, NITI Aayog member, said these two vaccines have been tested in thousands of people, they are the safest and there is no risk of any significance.

"We should have no doubt that the two vaccines approved are the safest of the vaccines. Both the vaccines have been tested on thousands of people and side-effects are negligible. There is no risk of any significance," he said.

Bhushan said that as said earlier, there will be a sequential rollout of COVID-19 vaccination.

"Healthcare workers (approximately one crore) will be on the top priority, followed by frontline workers (approximately 2 crore) and prioritized age groups (approximately 27 crore). The cost of healthcare workers and frontline workers will be borne by the central government," Bhushan said.

There will be a gap of 28 days between two doses of COVID-19 vaccine and its effectiveness will begin 14 days after the second dose, the Health Ministry said on Tuesday.

There will be a gap of 28 days between two doses of COVID-19 vaccine and its effectiveness will begin 14 days after the second dose, the Health Ministry said on Tuesday. Addressing a press briefing, Union Health Secretary Rajesh Bhushan said vaccine effectiveness will be seen only after 14 days. "So we urge people to keep following COVID appropriate behavior," he said. Bhushan said there will be a gap of 28 days between two doses of the COVID-19 vaccine. India will launch its COVID-19 vaccination drive from January 16 with priority to be given to nearly three crore healthcare and frontline workers. India had recently granted emergency use authorisation to two vaccines, Oxford's Covishield being manufactured by Serum Institute of India and Bharat Biotech's Covaxin. Both vaccines, the statement from the Health Ministry said, have established safety and immunogenicity. Dr V K Paul member, NITI Aayog member, said these two vaccines have been tested in thousands of people, they are the safest and there is no risk of any significance. "We should have no doubt that the two vaccines approved are the safest of the vaccines. Both the vaccines have been tested on thousands of people and side-effects are negligible. There is no risk of any significance," he said. Bhushan said that as said earlier, there will be a sequential rollout of COVID-19 vaccination. "Healthcare workers (approximately one crore) will be on the top priority, followed by frontline workers (approximately 2 crore) and prioritized age groups (approximately 27 crore). The cost of healthcare workers and frontline workers will be borne by the central government," Bhushan said.

Gap of 28 days between two Covid vaccine doses, effectiveness to begin after 14 days: Government

After Delhi, the first consignment of India's Serum Insitute's coronavirus <a href="https://www.wionews.com/india-news/centre-to-bear-vaccination-cost-of-3-crore-health-frontline-workers-pm-modi-356105">vaccine</a> arrived in Hyderabad airport.

<a href="https://www.wionews.com/india-news/first-flight-of-coronavirus-vaccine-covishield-flown-to-delhi-356150">Also Read:&nbsp;First flight of coronavirus vaccine Covishield flown to Delhi</a>

"The first consignment of the <a href="https://www.wionews.com/india-news/centre-to-bear-vaccination-cost-of-3-crore-health-frontline-workers-pm-modi-356105">vaccine</a> will be going to 11 destinations outside the state by this evening," Hyderbad airport CEO Pradeep Panicker said.

Chennai also received the first batch of coronavirus vaccine&nbsp;"Covishield".

Tamil Nadu health secretary J Radhakrishnan said that 5.56 lakh vaccine doses have been dispatched from Pune.

Radhakrishnan said that the vaccine will be distributed to regional centres and 51 walk-in coolers at the district level by Tuesday evening and later it will go to the actual vaccination site in cold boxes.

"The dispatch details of remaining 20,000 doses of <a href="https://www.wionews.com/india-news/oxford-astrazeneca-vaccine-to-cost-rs200-a-vial-in-india-purchase-order-placed-with-sii-reports-356029">Covaxin</a> are yet to be received," the Tamil Nadu health secretary said.

The first consignment of 2.76 lakh doses of the COVID-19 vaccine is also due to arrive in Ahmedabad today with the vaccine being distributed to Ahmedabad, Gandhinagar and Bhavnagar zones.

As the vaccines are being transported to various centres across the country, India on Tuesday reported 12,584 new COVID-19 case with 167 fatalities in the last 24 hours.

The total number of coronavirus cases in the country has now shot up to 1,04,79,179 with 1,51,327 deaths. There are 2,16,558 active cases nationwide, according to India's health ministry.

After Delhi, the first consignment of India's Serum Insitute's coronavirus vaccine arrived in Hyderabad airport. Also Read: First flight of coronavirus vaccine Covishield flown to Delhi "The first consignment of the vaccine will be going to 11 destinations outside the state by this evening," Hyderbad airport CEO Pradeep Panicker said.

After Delhi, the first consignment of India's Serum Insitute's coronavirus vaccine arrived in Hyderabad airport. Also Read: First flight of coronavirus vaccine Covishield flown to Delhi "The first consignment of the vaccine will be going to 11 destinations outside the state by this evening," Hyderbad airport CEO Pradeep Panicker said. Chennai also received the first batch of coronavirus vaccine "Covishield". Tamil Nadu health secretary J Radhakrishnan said that 5.56 lakh vaccine doses have been dispatched from Pune. Radhakrishnan said that the vaccine will be distributed to regional centres and 51 walk-in coolers at the district level by Tuesday evening and later it will go to the actual vaccination site in cold boxes. "The dispatch details of remaining 20,000 doses of Covaxin are yet to be received," the Tamil Nadu health secretary said. The first consignment of 2.76 lakh doses of the COVID-19 vaccine is also due to arrive in Ahmedabad today with the vaccine being distributed to Ahmedabad, Gandhinagar and Bhavnagar zones. As the vaccines are being transported to various centres across the country, India on Tuesday reported 12,584 new COVID-19 case with 167 fatalities in the last 24 hours. The total number of coronavirus cases in the country has now shot up to 1,04,79,179 with 1,51,327 deaths. There are 2,16,558 active cases nationwide, according to India's health ministry.

Coronavirus vaccine arrives in Hyderabad; Gujarat, Tamil Nadu set to receive consignment

Various global leaders such as tech genius Bill Gates and the&nbsp;Director-General of the World Health Organization Tedros Adhanom Ghebreyesus have congratulated India for its quick and decisive actions regarding the coronavirus vaccine.

"It’s great to see India’s leadership in scientific innovation and vaccine manufacturing capability as the world works to end the COVID-19 pandemic," Bill Gates tweeted on Tuesday while tagging the Prime Minister's official Twitter account.

Also read|&nbsp;<a href="https://www.wionews.com/india-news/india-to-begin-coronavirus-vaccine-roll-out-in-10-days-government-354599" hreflang="en">India to begin coronavirus vaccine roll out in 10 days: Government</a>

<div class="ui-state-default" contenteditable="false">
<div class="twitter-block" draggable="false">
<blockquote class="twitter-tweet">
It’s great to see India’s leadership in scientific innovation and vaccine manufacturing capability as the world works to end the COVID-19 pandemic <a href="https://twitter.com/PMOIndia?ref_src=twsrc%5Etfw">@PMOIndia</a> <a href="https://t.co/Ds4f3tmrm3">https://t.co/Ds4f3tmrm3</a>
— Bill Gates (@BillGates) <a href="https://twitter.com/BillGates/status/1346184604827279360?ref_src=twsrc%5Etfw">January 4, 2021</a></blockquote>
<script async src="https://platform.twitter.com/widgets.js" charset="utf-8"></script></div>
<a class="close-mark close-div" href="#" id="jqclosemark">×</a></div>

The message has come two days after the&nbsp;Drug Controller General of India approved AstraZeneca/Oxford's vaccine Covishield — which is being&nbsp;manufactured by the Serum Institute of India — and&nbsp;Bharat Biotech's&nbsp;indigenously developed vaccine Covaxin.

Director-General of the World Health Organization Tedros Adhanom Ghebreyesus also took to Twitter to congratulate India for this achievement. "India continues to take decisive action &amp; demonstrate its resolve to end COVID19 pandemic. As the Earth globe europe-africa’s largest vaccine producer it’s well placed to do so," he said. "If we #ACTogether, we can ensure effective &amp; safe vaccines are used to protect the most vulnerable everywhere."

<div class="ui-state-default" contenteditable="false">
<div class="twitter-block" draggable="false">
<blockquote class="twitter-tweet">
<a href="https://twitter.com/hashtag/India?src=hash&amp;ref_src=twsrc%5Etfw">#India</a> continues to take decisive action &amp; demonstrate its resolve to end <a href="https://twitter.com/hashtag/COVID19?src=hash&amp;ref_src=twsrc%5Etfw">#COVID19</a> pandemic. As the 🌍’s largest vaccine producer it’s well placed to do so. 
If we <a href="https://twitter.com/hashtag/ACTogether?src=hash&amp;ref_src=twsrc%5Etfw">#ACTogether</a>, we can ensure effective &amp; safe vaccines are used to protect the most vulnerable everywhere <a href="https://twitter.com/narendramodi?ref_src=twsrc%5Etfw">@narendramodi</a>
— Tedros Adhanom Ghebreyesus (@DrTedros) <a href="https://twitter.com/DrTedros/status/1346203046959865860?ref_src=twsrc%5Etfw">January 4, 2021</a></blockquote>
<script async src="https://platform.twitter.com/widgets.js" charset="utf-8"></script></div>
<a class="close-mark close-div" href="#" id="jqclosemark">×</a></div>

<a href="https://www.wionews.com/videos/gravitas-indias-vaccine-rollout-354478">WATCH|</a>

<div class="ui-state-default" contenteditable="false">
<div class="twitter-block" draggable="false">
<div class="videoWrapper trancodeVideo"><iframe allowfullscreen="" autoplay="1" class="includeVideo" frameborder="0" height="350" src="https://www.wionews.com/videos/gravitas-indias-vaccine-rollout-354478/embed" style="width:100%;max-width:560px;" width="560"></iframe></div>
</div>
<a class="close-mark close-div" href="#" id="jqclosemark">×</a></div>

Meanwhile, the Prime Minister of India Narendra Modi has assured people that India will soon be beginning the world's biggest&nbsp;inoculation drive. "World's biggest COVID-19 vaccination programme set to begin in India. For this, the country is proud of the contributions of its scientists and technicians," Modi said.

"As the largest vaccine producing country in the world, I want to give one more assurance to the global community today. India's vaccine production and delivery capacity will be used to help all humanity in fighting this crisis," he continued.

On Tuesday, the Indian government also announced that the country is all set to&nbsp;roll out its coronavirus vaccination campaign within ten days as part of emergency use authorisation(EUA).&nbsp;

Various global leaders such as tech genius Bill Gates and the Director-General of the World Health Organization Tedros Adhanom Ghebreyesus have congratulated India for its quick and decisive actions regarding the coronavirus vaccine.

Various global leaders such as tech genius Bill Gates and the Director-General of the World Health Organization Tedros Adhanom Ghebreyesus have congratulated India for its quick and decisive actions regarding the coronavirus vaccine. "It’s great to see India’s leadership in scientific innovation and vaccine manufacturing capability as the world works to end the COVID-19 pandemic," Bill Gates tweeted on Tuesday while tagging the Prime Minister's official Twitter account. Also read| India to begin coronavirus vaccine roll out in 10 days: Government It’s great to see India’s leadership in scientific innovation and vaccine manufacturing capability as the world works to end the COVID-19 pandemic @PMOIndia https://t.co/Ds4f3tmrm3 — Bill Gates (@BillGates) January 4, 2021 × The message has come two days after the Drug Controller General of India approved AstraZeneca/Oxford's vaccine Covishield — which is being manufactured by the Serum Institute of India — and Bharat Biotech's indigenously developed vaccine Covaxin. Director-General of the World Health Organization Tedros Adhanom Ghebreyesus also took to Twitter to congratulate India for this achievement. "India continues to take decisive action & demonstrate its resolve to end COVID19 pandemic. As the Earth globe europe-africa’s largest vaccine producer it’s well placed to do so," he said. "If we #ACTogether, we can ensure effective & safe vaccines are used to protect the most vulnerable everywhere." #India continues to take decisive action & demonstrate its resolve to end #COVID19 pandemic. As the 🌍’s largest vaccine producer it’s well placed to do so. If we #ACTogether, we can ensure effective & safe vaccines are used to protect the most vulnerable everywhere @narendramodi — Tedros Adhanom Ghebreyesus (@DrTedros) January 4, 2021 × WATCH| × Meanwhile, the Prime Minister of India Narendra Modi has assured people that India will soon be beginning the world's biggest inoculation drive. "World's biggest COVID-19 vaccination programme set to begin in India. For this, the country is proud of the contributions of its scientists and technicians," Modi said. "As the largest vaccine producing country in the world, I want to give one more assurance to the global community today. India's vaccine production and delivery capacity will be used to help all humanity in fighting this crisis," he continued. On Tuesday, the Indian government also announced that the country is all set to roll out its coronavirus vaccination campaign within ten days as part of emergency use authorisation(EUA).

Bill Gates and other world leaders applaud India for quick vaccine production

India's Central Drugs Standard Control Organization (CDSCO) expert panel on Saturday recommended approving restricted emergency use of Bharat Biotech's indigenous COVID vaccine Covaxin in India, said officials. 
 
<a href="https://www.wionews.com/india-news/indian-government-okays-emergency-use-of-astrazeneca-covid-vaccine-354050">Also read | Indian government okays emergency use of AstraZeneca COVID vaccine</a>

Covaxin has been indigenously developed by Bharat Biotech in collaboration with the Indian Council of Medical Research (ICMR).

This is the second Covid-19 vaccine which has been recommended for emergency use approval to DCGI after Serum's locally produced Oxford Covid-19 vaccine 'Covishield'

The Subject Expert Committee (SEC) on COVID-19 of the Central Drugs Standard Control Organisation (CDSCO) on Saturday again deliberated on the emergency use authorisation (EUA) application of the Hyderabad-based pharmaceutical firm after it submitted additional data, facts and analysis subsequent to Friday’s review meeting, a source said.

(With inputs from agencies)

India's Central Drugs Standard Control Organization (CDSCO) expert panel on Saturday recommended approving restricted emergency use of Bharat Biotech's indigenous COVID vaccine Covaxin in India, said officials.

India's Central Drugs Standard Control Organization (CDSCO) expert panel on Saturday recommended approving restricted emergency use of Bharat Biotech's indigenous COVID vaccine Covaxin in India, said officials. Also read | Indian government okays emergency use of AstraZeneca COVID vaccine Covaxin has been indigenously developed by Bharat Biotech in collaboration with the Indian Council of Medical Research (ICMR). This is the second Covid-19 vaccine which has been recommended for emergency use approval to DCGI after Serum's locally produced Oxford Covid-19 vaccine 'Covishield' The Subject Expert Committee (SEC) on COVID-19 of the Central Drugs Standard Control Organisation (CDSCO) on Saturday again deliberated on the emergency use authorisation (EUA) application of the Hyderabad-based pharmaceutical firm after it submitted additional data, facts and analysis subsequent to Friday’s review meeting, a source said. (With inputs from agencies)

Expert panel recommends India's indigenously developed Covid-19 vaccine Covaxin for restricted emergency use

A day after India's drug regulator approved COVAXIN for emergency use, various private clinics in Brazil are seeking Bharat Biotech's vaccine to fight against the increasing coronavirus tally.

The Brazilian Association of Vaccine Clinics (ABCVAC) has confirmed on its website that it has signed a&nbsp;memorandum of understanding with the Indian firm to purchase the Indian vaccine after the pharmaceutical company finishes its final stage of clinical trials.

Also read|&nbsp;<a href="https://www.wionews.com/india-news/india-approves-sii-and-bharat-biotechs-covid-19-vaccines-for-restricted-emergency-use-354141">India approves SII and Bharat Biotech's Covid-19 vaccines for restricted emergency use</a>

"We had been looking for solutions for the private market, and the possibility came up of using this Indian vaccine, which is very promising,"&nbsp;ABCVAC president Geraldo Barbosa told local reporters. "It's an additional sale that will not interfere with the quantity of vaccine doses the government has ordered."

This news has come out a few hours after the Indian drug regulator approved two vaccines —&nbsp;Serum Institute of India's Covishield, developed by Oxford University and pharma major AstraZeneca, and Bharat Biotech's COVAXIN — for emergency use in the country.

The order placement, however, depends on the approval by the far-right government, lead by the Brazilian President Jair Bolsonaro, and&nbsp;Brazil's health regulator, Anvisa. As of now, the regulator has not approved any vaccine against the new coronavirus.

This decision has been taken by private clinics as Brazil's coronavirus death toll saw an alarming increase. Private clinics and few state governments are now have decided to launch their own vaccinations to be able to protect locals.

<a href="https://www.wionews.com/videos/india-dcgi-approves-serum-bharat-biotech-vaccines-for-emergency-use-354148">WATCH|</a>

<div class="ui-state-default" contenteditable="false">
<div class="twitter-block" draggable="false">
<div class="videoWrapper trancodeVideo"><iframe allowfullscreen="" autoplay="1" class="includeVideo" frameborder="0" height="350" src="https://www.wionews.com/videos/india-dcgi-approves-serum-bharat-biotech-vaccines-for-emergency-use-354148/embed" style="width:100%;max-width:560px;" width="560"></iframe></div>
</div>
<a class="close-mark close-div" href="#" id="jqclosemark">×</a></div>

ABCVAC also explained that the reason private clinics are looking at other vaccines is to make sure all locals can access vaccines as the ones approved by the Bolsonaro government will first be reserved for high-priority groups, which will include leaders and vulnerable people.

Depending on the approval by&nbsp;Anvisa, the clinics are hoping to start mass inoculation drives by mid-March. On the other hand, Bolsonaro's government has not yet announced a start date for its vaccination campaign but is expected to make an announcement on Monday. Opposition leaders have accused the far-right government of waiting too long to make the announcement. "Neighboring countries have already started their vaccination campaigns. It is urgent we establish a timeframe to do the same. Ignorance must not prevail over science," Supreme Court Justice Gilmar Mendes tweeted.

A day after India's drug regulator approved COVAXIN for emergency use, various private clinics in Brazil are seeking Bharat Biotech's vaccine to fight against the increasing coronavirus tally.

A day after India's drug regulator approved COVAXIN for emergency use, various private clinics in Brazil are seeking Bharat Biotech's vaccine to fight against the increasing coronavirus tally. The Brazilian Association of Vaccine Clinics (ABCVAC) has confirmed on its website that it has signed a memorandum of understanding with the Indian firm to purchase the Indian vaccine after the pharmaceutical company finishes its final stage of clinical trials. Also read| India approves SII and Bharat Biotech's Covid-19 vaccines for restricted emergency use "We had been looking for solutions for the private market, and the possibility came up of using this Indian vaccine, which is very promising," ABCVAC president Geraldo Barbosa told local reporters. "It's an additional sale that will not interfere with the quantity of vaccine doses the government has ordered." This news has come out a few hours after the Indian drug regulator approved two vaccines — Serum Institute of India's Covishield, developed by Oxford University and pharma major AstraZeneca, and Bharat Biotech's COVAXIN — for emergency use in the country. The order placement, however, depends on the approval by the far-right government, lead by the Brazilian President Jair Bolsonaro, and Brazil's health regulator, Anvisa. As of now, the regulator has not approved any vaccine against the new coronavirus. This decision has been taken by private clinics as Brazil's coronavirus death toll saw an alarming increase. Private clinics and few state governments are now have decided to launch their own vaccinations to be able to protect locals. WATCH| × ABCVAC also explained that the reason private clinics are looking at other vaccines is to make sure all locals can access vaccines as the ones approved by the Bolsonaro government will first be reserved for high-priority groups, which will include leaders and vulnerable people. Depending on the approval by Anvisa, the clinics are hoping to start mass inoculation drives by mid-March. On the other hand, Bolsonaro's government has not yet announced a start date for its vaccination campaign but is expected to make an announcement on Monday. Opposition leaders have accused the far-right government of waiting too long to make the announcement. "Neighboring countries have already started their vaccination campaigns. It is urgent we establish a timeframe to do the same. Ignorance must not prevail over science," Supreme Court Justice Gilmar Mendes tweeted.

Brazil's private clinics seek India's COVAXIN vaccine

Indian Government to approve their vaccine called COVAXIN by Bharat Biotech, this could be a game changer in fight against covid pandemic. The vaccine is currently on Phase 3rd trial.

Indian vaccine could be the game changer in fight against COVID-19

VG Somani, the Drug Controller General of India said on Monday that Covishield and&nbsp;Covaxin are ''safe and provide a robust immune response.''

India's drugs regulator has given final emergency-use approval for two coronavirus vaccines, Serum Institute of India's Covishield, developed by Oxford University and pharma major AstraZeneca, and Bharat Biotech's Covaxin.

Also read:&nbsp;<a href="https://www.wionews.com/india-news/india-approves-sii-and-bharat-biotechs-covid-19-vaccines-for-restricted-emergency-use-354141" hreflang="en">India approves SII and Bharat Biotech's Covid-19 vaccines for restricted emergency use</a>

During an interview, Somani said&nbsp;"We'll never approve anything if there is slightest of safety concern. The vaccines are 110 per cent safe."&nbsp;

The country&nbsp;is now expected to start a massive immunisation programme within weeks.

Drug Controller General of India (DGCI) chief VG Somani said both firms submitted data on their trial runs and both have been granted permission for "restricted use".

"Safety immunogenicity data submitted by SII found efficacy was 70.42 per cent. Restricted use in emergency conditions allowed. The clinical trials will continue. Covaxin has been developed in collaboration with ICMR and NIV," he said in a press briefing on Sunday.

Indian Prime Minister Narendra Modi called the approval a decisive turning point to strengthen a spirited fight and congratulated&nbsp;scientists and&nbsp;innovators.

<div class="ui-state-default" contenteditable="false">
<div class="twitter-block" draggable="false">
<blockquote class="twitter-tweet">
A decisive turning point to strengthen a spirited fight! 
 
DCGI granting approval to vaccines of <a href="https://twitter.com/SerumInstIndia?ref_src=twsrc%5Etfw">@SerumInstIndia</a> and <a href="https://twitter.com/BharatBiotech?ref_src=twsrc%5Etfw">@BharatBiotech</a> accelerates the road to a healthier and COVID-free nation. 
 
Congratulations India. 
 
Congratulations to our hardworking scientists and innovators.
— Narendra Modi (@narendramodi) <a href="https://twitter.com/narendramodi/status/1345607618191007747?ref_src=twsrc%5Etfw">January 3, 2021</a></blockquote>
<script async src="https://platform.twitter.com/widgets.js" charset="utf-8"></script></div>
<a class="close-mark close-div" href="#" id="jqclosemark">×</a></div>

He said, "The DCGI granting approval to vaccines of Serum Institute of India and Bharat Biotech accelerates the road to COVID-free nation."

VG Somani, the Drug Controller General of India said on Monday that Covishield and Covaxin are ''safe and provide a robust immune response.'' India's drugs regulator has given final emergency-use approval for two coronavirus vaccines, Serum Institute of India's Covishield, developed by Oxford University and pharma major AstraZeneca, and Bharat Biotech's Covaxin.

VG Somani, the Drug Controller General of India said on Monday that Covishield and Covaxin are ''safe and provide a robust immune response.'' India's drugs regulator has given final emergency-use approval for two coronavirus vaccines, Serum Institute of India's Covishield, developed by Oxford University and pharma major AstraZeneca, and Bharat Biotech's Covaxin. Also read: India approves SII and Bharat Biotech's Covid-19 vaccines for restricted emergency use During an interview, Somani said "We'll never approve anything if there is slightest of safety concern. The vaccines are 110 per cent safe." The country is now expected to start a massive immunisation programme within weeks. Drug Controller General of India (DGCI) chief VG Somani said both firms submitted data on their trial runs and both have been granted permission for "restricted use". "Safety immunogenicity data submitted by SII found efficacy was 70.42 per cent. Restricted use in emergency conditions allowed. The clinical trials will continue. Covaxin has been developed in collaboration with ICMR and NIV," he said in a press briefing on Sunday. Indian Prime Minister Narendra Modi called the approval a decisive turning point to strengthen a spirited fight and congratulated scientists and innovators. A decisive turning point to strengthen a spirited fight! DCGI granting approval to vaccines of @SerumInstIndia and @BharatBiotech accelerates the road to a healthier and COVID-free nation. Congratulations India. Congratulations to our hardworking scientists and innovators. — Narendra Modi (@narendramodi) January 3, 2021 × He said, "The DCGI granting approval to vaccines of Serum Institute of India and Bharat Biotech accelerates the road to COVID-free nation."

Covishield, Covaxin are safe and provide robust immune response, says Drug Controller General of India VG Somani

India's Subject Expert Committee (SEC) in Central Drugs Standard Control Organisation (CDSCO) met on Wednesday to consider coronavirus vaccines for emergency use authorisation (EUA) requested by Pfizer-BioNTech, Bharat Biotech and <a href="https://www.wionews.com/india-news/indias-sec-to-decide-on-approving-serum-institute-of-indias-covishield-vaccine-for-emergency-use-authorisation-353405">Serum Institute of India(SII)</a>.

The government said Pfizer-BioNTech requested more time as the SEC analysed additional data and&nbsp;information presented by SII &amp; Bharat Biotech.

The SEC said it was persuing additional data&nbsp;and will meet again on January 1, 2021.

The UK had earlier in the day approved the&nbsp;Oxford-AstraZeneca COVID-19 vaccine. SII CEO Adar Poonawalla said: "This is great and encouraging news. We will wait for the final approval from Indian regulators."

The SII has entered into a collaboration with the University of Oxford and AstraZeneca to manufacture the vaccine. The Pune-based company has already stocked nearly 50 million dosages of the vaccine and aims to produce up to 100 million dosages per month by March, 2021.

India has the second-largest cases<a href="https://www.wionews.com/india-news/uk-virus-strain-detected-in-two-people-in-uttar-pradeshs-meerut-noida-353422"> coronavirus </a>cases in the world with over 10.2 million cases and over 148, 439 deaths.

Amid the rising number of cases, Tamil Nadu today reported 945 new coronavirus cases with 17 deaths in the last 24 hours with the total death toll rising to 12,109 and the number of active cases rising to 8,615.

In Karnataka, there were 973 new coronavirus cases including 7 deaths in the past 24 hours with the number of active cases rising to 11,610. The total number of COVID-19 cases stands at 9,18,544 in the state.

Maharashtra which is one of the hardest-hit states with the virus recorded &nbsp;3,537 new coronavirus cases and 70 fatalities on Wednesday with the total death toll rising to 49,463 and the number of cases rising to 19,28,603.

India's Subject Expert Committee (SEC) in Central Drugs Standard Control Organisation (CDSCO) met on Wednesday to consider coronavirus vaccines for emergency use authorisation (EUA) requested by Pfizer-BioNTech, Bharat Biotech and Serum Institute of India(SII).

India's Subject Expert Committee (SEC) in Central Drugs Standard Control Organisation (CDSCO) met on Wednesday to consider coronavirus vaccines for emergency use authorisation (EUA) requested by Pfizer-BioNTech, Bharat Biotech and Serum Institute of India(SII). The government said Pfizer-BioNTech requested more time as the SEC analysed additional data and information presented by SII & Bharat Biotech. The SEC said it was persuing additional data and will meet again on January 1, 2021. The UK had earlier in the day approved the Oxford-AstraZeneca COVID-19 vaccine. SII CEO Adar Poonawalla said: "This is great and encouraging news. We will wait for the final approval from Indian regulators." The SII has entered into a collaboration with the University of Oxford and AstraZeneca to manufacture the vaccine. The Pune-based company has already stocked nearly 50 million dosages of the vaccine and aims to produce up to 100 million dosages per month by March, 2021. India has the second-largest cases coronavirus cases in the world with over 10.2 million cases and over 148, 439 deaths. Amid the rising number of cases, Tamil Nadu today reported 945 new coronavirus cases with 17 deaths in the last 24 hours with the total death toll rising to 12,109 and the number of active cases rising to 8,615. In Karnataka, there were 973 new coronavirus cases including 7 deaths in the past 24 hours with the number of active cases rising to 11,610. The total number of COVID-19 cases stands at 9,18,544 in the state. Maharashtra which is one of the hardest-hit states with the virus recorded 3,537 new coronavirus cases and 70 fatalities on Wednesday with the total death toll rising to 49,463 and the number of cases rising to 19,28,603.

Pfizer-BioNTech requests more time, India's SEC to meet on January 1 to authorise SII, Bharat Biotech vaccines

Bharat Biotech, the maker of one of India's leading COVID-19 vaccine candidates said on Tuesday its recruitment of volunteers for a late-stage trial of the shot is half done.

Bharat Biotech has signed up 13,000 volunteers for the Phase 3 trial, backed by India's government medical research body, and is progressing towards its goal of 26,000, the company said. The trial began in mid-November at multiple sites across India.

With this, Covaxin is on track to continue its progress towards achieving the goal for Phase-3 clinical trials across multiple sites in India.

The indigenously developed COVID-19 vaccine has been developed in collaboration with the Indian Council of Medical Research (ICMR) - National Institute of Virology (NIV), it added.

"Covaxin is a highly purified and inactivated 2 dose SARS-CoV2 vaccine, manufactured in a vero cell manufacturing platform with an excellent safety track record of more than 300 million doses," Bharat Biotech said.

According to the company, the vaccine is developed and manufactured at Bharat Biotech's BSL-3, biocontainment facility.

The company has successfully recruited 13,000 volunteers for the Phase III clinical trials of the vaccine and the target is to have 26,000 participants, as per the statement.

"This is an unprecedented vaccine trial ever to take place in India, and we are overwhelmed with the steady rise in participation, "Bharat Biotech Joint MD Suchitra Ella said.

(With inputs from agencies)

Bharat Biotech, the maker of one of India's leading COVID-19 vaccine candidates said on Tuesday its recruitment of volunteers for a late-stage trial of the shot is half done.

Bharat Biotech, the maker of one of India's leading COVID-19 vaccine candidates said on Tuesday its recruitment of volunteers for a late-stage trial of the shot is half done. Bharat Biotech has signed up 13,000 volunteers for the Phase 3 trial, backed by India's government medical research body, and is progressing towards its goal of 26,000, the company said. The trial began in mid-November at multiple sites across India. With this, Covaxin is on track to continue its progress towards achieving the goal for Phase-3 clinical trials across multiple sites in India. The indigenously developed COVID-19 vaccine has been developed in collaboration with the Indian Council of Medical Research (ICMR) - National Institute of Virology (NIV), it added. "Covaxin is a highly purified and inactivated 2 dose SARS-CoV2 vaccine, manufactured in a vero cell manufacturing platform with an excellent safety track record of more than 300 million doses," Bharat Biotech said. According to the company, the vaccine is developed and manufactured at Bharat Biotech's BSL-3, biocontainment facility. The company has successfully recruited 13,000 volunteers for the Phase III clinical trials of the vaccine and the target is to have 26,000 participants, as per the statement. "This is an unprecedented vaccine trial ever to take place in India, and we are overwhelmed with the steady rise in participation, "Bharat Biotech Joint MD Suchitra Ella said. (With inputs from agencies)

Bharat Biotech recruits 13,000 volunteers for Phase III trials of Covaxin

The interim findings of phase 1 clinical trial of COVID-19 vaccine Covaxin, indigenously developed by Bharat Biotech in collaboration with the ICMR, showed that it was was well tolerated in all dose groups with no serious or adverse events.

The vaccine induced robust binding and neutralising antibody responses which were comparable to those observed in the convalescent serum collected from patients who had recovered from COVID-19, according to the findings which have appeared on medRxiv, a preprint server.

A preprint is a version of a scientific manuscript posted on a public server prior to formal peer review. One serious adverse event was reported, which was found to be unrelated to vaccination, the findings showed.

It was a double-blind randomised controlled phase 1 clinical trial to evaluate the safety and immunogenicity of Covaxin (BBV152).

The document mentions that BBV152 is stored between 2 degrees Celsius and 8 degrees Celsius, which is compatible with all national immunisation programme cold chain requirements and further efficacy trials are underway.

According to the "A Phase 1: Safety and Immunogenicity Trial of an Inactivated SARS-CoV-2 Vaccine BBV152", after the first vaccination, local and systemic adverse events were predominantly mild or moderate in severity and resolved rapidly, without any prescribed medication.

A similar trend was observed after the second shot was administered. Pain at the injection site was the most common local adverse event.

"One serious adverse event was reported. The participant was vaccinated on July 30. Five days later, the participant reported symptoms of COVID-19 and was found to be positive for SARS-CoV-2," according to the findings.

"The symptoms were mild in nature, but the patient was admitted to the hospital on August 15. The participant was discharged on August 22 following a negative nucleic acid result. The event was not causally associated with the vaccine," the findings showed.

To ensure generalisability, the trial was conducted on volunteers from diverse geographic locations and socioeconomic conditions, enrolling 375 participants across 11 hospitals.

"Despite the fact that enrolment occurred during a national lockdown, which led to several operational challenges, the overall participant retention rate was 97 per cent," the findings showed.

The sample size was intentionally large to enable the inference of meaningful conclusions regarding immunogenicity and safety, the document said.

BBV152 induced robust binding and neutralising antibody responses that were similar to those induced by other SARS-CoV-2 inactivated vaccine candidates, it said.

Two doses of the vaccine were administered at a volume of 0.5 mL/dose intramuscularly on days zero and 14. The follow-up visits were scheduled on days 7, 28, 42, 104, and 194.

The interim findings of phase 1 clinical trial of COVID-19 vaccine Covaxin, indigenously developed by Bharat Biotech in collaboration with the ICMR, showed that it was was well tolerated in all dose groups with no serious or adverse events.

The interim findings of phase 1 clinical trial of COVID-19 vaccine Covaxin, indigenously developed by Bharat Biotech in collaboration with the ICMR, showed that it was was well tolerated in all dose groups with no serious or adverse events. The vaccine induced robust binding and neutralising antibody responses which were comparable to those observed in the convalescent serum collected from patients who had recovered from COVID-19, according to the findings which have appeared on medRxiv, a preprint server. A preprint is a version of a scientific manuscript posted on a public server prior to formal peer review. One serious adverse event was reported, which was found to be unrelated to vaccination, the findings showed. It was a double-blind randomised controlled phase 1 clinical trial to evaluate the safety and immunogenicity of Covaxin (BBV152). The document mentions that BBV152 is stored between 2 degrees Celsius and 8 degrees Celsius, which is compatible with all national immunisation programme cold chain requirements and further efficacy trials are underway. According to the "A Phase 1: Safety and Immunogenicity Trial of an Inactivated SARS-CoV-2 Vaccine BBV152", after the first vaccination, local and systemic adverse events were predominantly mild or moderate in severity and resolved rapidly, without any prescribed medication. A similar trend was observed after the second shot was administered. Pain at the injection site was the most common local adverse event. "One serious adverse event was reported. The participant was vaccinated on July 30. Five days later, the participant reported symptoms of COVID-19 and was found to be positive for SARS-CoV-2," according to the findings. "The symptoms were mild in nature, but the patient was admitted to the hospital on August 15. The participant was discharged on August 22 following a negative nucleic acid result. The event was not causally associated with the vaccine," the findings showed. To ensure generalisability, the trial was conducted on volunteers from diverse geographic locations and socioeconomic conditions, enrolling 375 participants across 11 hospitals. "Despite the fact that enrolment occurred during a national lockdown, which led to several operational challenges, the overall participant retention rate was 97 per cent," the findings showed. The sample size was intentionally large to enable the inference of meaningful conclusions regarding immunogenicity and safety, the document said. BBV152 induced robust binding and neutralising antibody responses that were similar to those induced by other SARS-CoV-2 inactivated vaccine candidates, it said. Two doses of the vaccine were administered at a volume of 0.5 mL/dose intramuscularly on days zero and 14. The follow-up visits were scheduled on days 7, 28, 42, 104, and 194.

Bharat Biotech's phase 1 trial findings show COVID-19 vaccine well tolerated; no serious adverse events

In India, the head of the Serum Institute which has tasked to develop the AstraZeneca based Covishield vaccine in the country now says, that the positive late state trial results of the candidates will allow it to seek emergency use approval by the year end.

Serum Institute, Bharat Biotech vaccines applied for emergency use in India

In a major development related to COVID-19 vaccine, Subject Expert Committee (SEC) of Drugs Controller General of India (DCGI) has asked for more safety and efficacy data from Serum Institute of India (SII) and Bharat Biotech for their COVID-19 vaccines.

According to government sources, an SEC meeting was held on Wednesday to review the application submitted by the Pharma majors for emergency use authorisation (EUA) for their vaccine candidates.

"Serum Institute of India has been asked for an updated safety data of phase 2 and 3 clinical trial in the country and immunogenicity data from the clinical trial in the United Kingdom and India. While considering the application of Bharat Biotech Company, the SEC after detailed evaluation recommended that the pharma major should submit the safety and efficacy data from its ongoing phase 3 clinical trial in India for more analysis," a source said.

The application submitted by the Pfizer was not discussed at the SEC meeting as the company has requested for more time for giving its presentation, sources said.

In a major development related to COVID-19 vaccine, Subject Expert Committee (SEC) of Drugs Controller General of India (DCGI) has asked for more safety and efficacy data from Serum Institute of India (SII) and Bharat Biotech for their COVID-19 vaccines.

In a major development related to COVID-19 vaccine, Subject Expert Committee (SEC) of Drugs Controller General of India (DCGI) has asked for more safety and efficacy data from Serum Institute of India (SII) and Bharat Biotech for their COVID-19 vaccines. According to government sources, an SEC meeting was held on Wednesday to review the application submitted by the Pharma majors for emergency use authorisation (EUA) for their vaccine candidates. "Serum Institute of India has been asked for an updated safety data of phase 2 and 3 clinical trial in the country and immunogenicity data from the clinical trial in the United Kingdom and India. While considering the application of Bharat Biotech Company, the SEC after detailed evaluation recommended that the pharma major should submit the safety and efficacy data from its ongoing phase 3 clinical trial in India for more analysis," a source said. The application submitted by the Pfizer was not discussed at the SEC meeting as the company has requested for more time for giving its presentation, sources said.

DCGI expert panel asks SII, BHARAT Biotech to provide more safety, efficacy data for Covid-19 vaccines

India's ministry of health and family welfare dismissed a media report about the rejection of vaccines developed by Serum Institute of India(SII) and Bharat Biotech as "fake".

Watch:

<div class="videoWrapper trancodeVideo"><iframe allowfullscreen="" autoplay="1" class="includeVideo" frameborder="0" height="350" src="https://www.wionews.com/videos/india-envoys-from-60-nations-arrived-in-hyderabad-to-visit-bharat-biotech-hq-348466/embed" style="width:100%;max-width:560px;" width="560"></iframe></div>

India's government had said earlier that emergency use authorisation&nbsp;(EUA) for&nbsp;<a href="https://www.wionews.com/world/countries-like-china-and-saudi-arabia-used-covid-19-to-curtail-civil-liberties-finds-study-348604">coronavirus</a> vaccines developed by Hyderabad-based Bharat Biotech, Pune's Serum Institute of India and Pfizer were under consideration.

All three vaccine makers have applied to the Drugs Controller General of India (DCGI).

In India at least eight vaccines are in different stages of development in phase two and three clinical trials.

Covishield, manufactured by SII in collaboration with AstraZeneca, also Covaxin developed by Bharat Biotech in collaboration with the ICMR is in phase-3 of trials, according to the government.

Also in the running is ZyCOV-D developed by Cadila Healthcare in Ahmedabad which is in phase-2 of the trials.

Russia's Sputnik V is being manufactured by Dr Reddy's Lab, Hyderabad in collaboration with Gamaleya National Centre. The phase-2&nbsp;trial in India of Sputnik V is over and phase-3&nbsp;will begin next week, the government informed.

Russia has already started mass vaccination campaign of the Sputnik V even as testing is underway in India. Biological E Ltd Hyderabad's Recombinant Protein antigen-based vaccine is also undergoing tests in collaboration with MIT, USA.

HGCO 19 manufactured by Genova in Pune in collaboration with HDT, USA is set to begin phase-1 and 2 clinical trials and Bharat Biotech International Ltd's vaccine developed in collaboration with Thomas Jefferson University, USA is in pre-clinical stage.

India's ministry of health and family welfare dismissed a media report about the rejection of vaccines developed by Serum Institute of India(SII) and Bharat Biotech as "fake".

India's ministry of health and family welfare dismissed a media report about the rejection of vaccines developed by Serum Institute of India(SII) and Bharat Biotech as "fake". Watch: India's government had said earlier that emergency use authorisation (EUA) for coronavirus vaccines developed by Hyderabad-based Bharat Biotech, Pune's Serum Institute of India and Pfizer were under consideration. All three vaccine makers have applied to the Drugs Controller General of India (DCGI). In India at least eight vaccines are in different stages of development in phase two and three clinical trials. Covishield, manufactured by SII in collaboration with AstraZeneca, also Covaxin developed by Bharat Biotech in collaboration with the ICMR is in phase-3 of trials, according to the government. Also in the running is ZyCOV-D developed by Cadila Healthcare in Ahmedabad which is in phase-2 of the trials. Russia's Sputnik V is being manufactured by Dr Reddy's Lab, Hyderabad in collaboration with Gamaleya National Centre. The phase-2 trial in India of Sputnik V is over and phase-3 will begin next week, the government informed. Russia has already started mass vaccination campaign of the Sputnik V even as testing is underway in India. Biological E Ltd Hyderabad's Recombinant Protein antigen-based vaccine is also undergoing tests in collaboration with MIT, USA. HGCO 19 manufactured by Genova in Pune in collaboration with HDT, USA is set to begin phase-1 and 2 clinical trials and Bharat Biotech International Ltd's vaccine developed in collaboration with Thomas Jefferson University, USA is in pre-clinical stage.

Fake report on rejection of vaccines by Serum Institute, Bharat Biotech: Government

Ambassadors and High Commissioners of around 60 countries have landed in Hyderabad, India to visit Bharat Biotech headquarter and Biological E limited which are working on the COVID-19 vaccine.

India: Envoys from 60 nations arrived in Hyderabad to visit Bharat-Biotech HQ

Ambassadors and High Commissioners of around 80 countries will be landing in Hyderabad, India on December 9 to visit Bharat Biotech and BE limited which are working on the COVID-19 vaccine.

India: Envoys from 80 nations to visit Bharat-Biotech HQ

Indian Pharmaceuticals firm Bharat Biotech is seeking emergency authorisation of its Coronavirus vaccine 'Covaxin'. This comes after Pfizer & Serum institute producing AstraZeneca vaccine have applied for the emergency use authorisation from DGCI.

India: Bharat Biotech latest to seek emergency use authorisation

The Hyderabad-based pharmaceutical firm Bharat Biotech applied to the Drugs Controller General of India (DCGI) on Monday for granting emergency use authorisation for its COVID-19 vaccine Covaxin, becoming the third company after American pharma giant Pfizer and Pune-based Serum Institute of India (SII) to seek emergency use authorisation for its Covid-19 vaccine candidate. 
 
Also read | <a href="https://www.wionews.com/science/is-natural-immunity-from-covid-better-than-a-vaccine-347985">Is ‘natural immunity’ from COVID better than a vaccine?</a>

In its application for emergency use approval, Hyderabad-headquartered Bharat Biotech has included interim data from early- to mid-stage human trials of its vaccine candidate Covaxin. 
 
<a href="https://www.wionews.com/india-news/serum-institute-of-india-applies-for-emergency-use-authorisation-for-oxford-vaccine-348006">Also read: Serum Institute of India applies for emergency use authorisation for Oxford vaccine</a> 
 
The Drugs Controller General of India (DCGI) had on October 23 granted permission to the firm for conducting a phase-3 clinical trial of Covaxin after assessing the safety and immunogenicity data of phase 1 and 2 trials. 
 
Also read | <a href="https://www.wionews.com/world/chinas-sinovac-secures-515-million-to-boost-covid-vaccine-production-347999">China's Sinovac secures $515 million to boost covid vaccine production</a>&nbsp;

An expert committee of the Central Drugs Standard Control Organisation (CDSCO) will meet on Wednesday to review applications of Pfizer, Serum Institute of India and Bharat Biotech seeking emergency use authorisation for their COVID-19 vaccine candidates.

At an all-party meeting on December 4, Prime Minister Narendra Modi had expressed hope that a COVID-19 vaccine may be ready in a few weeks. That evening, the Indian arm of US pharmaceutical giant Pfizer had sought approval for its vaccine from the central drug regulator, after the firm secured such clearance in the UK and Bahrain.

The Serum Institute sought the nod for the Oxford COVID-19 vaccine, Covishield, on December 6.

"DCGI has already started processing the applications. The subject expert committee on COVID-19 at CDSCO will deliberate on the applications by Pfizer, Serum Institute of India and Bharat Biotech seeking emergency use authorisation for their COVID-19 vaccines on December 9," a source said.

(With inputs from agencies)

The Hyderabad-based pharmaceutical firm Bharat Biotech applied to the Drugs Controller General of India (DCGI) on Monday for granting emergency use authorisation for its COVID-19 vaccine Covaxin, becoming the third company after American pharma giant Pfizer and Pune-based Serum Institute of India (SII) to seek emergency use authorisation for its Covid-19 vaccine candidate.

The Hyderabad-based pharmaceutical firm Bharat Biotech applied to the Drugs Controller General of India (DCGI) on Monday for granting emergency use authorisation for its COVID-19 vaccine Covaxin, becoming the third company after American pharma giant Pfizer and Pune-based Serum Institute of India (SII) to seek emergency use authorisation for its Covid-19 vaccine candidate. Also read | Is ‘natural immunity’ from COVID better than a vaccine? In its application for emergency use approval, Hyderabad-headquartered Bharat Biotech has included interim data from early- to mid-stage human trials of its vaccine candidate Covaxin. Also read: Serum Institute of India applies for emergency use authorisation for Oxford vaccine The Drugs Controller General of India (DCGI) had on October 23 granted permission to the firm for conducting a phase-3 clinical trial of Covaxin after assessing the safety and immunogenicity data of phase 1 and 2 trials. Also read | China's Sinovac secures $515 million to boost covid vaccine production An expert committee of the Central Drugs Standard Control Organisation (CDSCO) will meet on Wednesday to review applications of Pfizer, Serum Institute of India and Bharat Biotech seeking emergency use authorisation for their COVID-19 vaccine candidates. At an all-party meeting on December 4, Prime Minister Narendra Modi had expressed hope that a COVID-19 vaccine may be ready in a few weeks. That evening, the Indian arm of US pharmaceutical giant Pfizer had sought approval for its vaccine from the central drug regulator, after the firm secured such clearance in the UK and Bahrain. The Serum Institute sought the nod for the Oxford COVID-19 vaccine, Covishield, on December 6. "DCGI has already started processing the applications. The subject expert committee on COVID-19 at CDSCO will deliberate on the applications by Pfizer, Serum Institute of India and Bharat Biotech seeking emergency use authorisation for their COVID-19 vaccines on December 9," a source said. (With inputs from agencies)

Bharat Biotech seeks emergency use authorisation for Indian Covid-19 vaccine; expert panel to review

Prime Minister Narendra Modi on Saturday, visited Bharat Biotech, a Hyderabad-based Pharmaceutical company to know about the progress made in the development of indigenous coronavirus vaccine. The visit was part of his inspection of vaccine development in vaccine-hubs of India.

"At the Bharat Biotech facility in Hyderabad, was briefed about their indigenous Covid vaccine," Modi tweeted.

During his visit, PM Modi congratulated the scientists for the progress they made in the trial so far.

The Prime Minister met with the company officials in a conference hall and deliberated on the progress made in bringing out a vaccine.

Later, he also briefly interacted with a few employees.

Before flying to Hyderabad, PM Modi visited pharma major Zydus-Cadilla's work on vaccine development in Ahmedabad.

After his Hyderabad visit, PM Modi was due to fly to Pune for a visit to Serum Institute of India, the company that will manufacture coronavirus vaccine being developed by Oxford University and Astrazeneca.

(With agency inputs)

Prime Minister Narendra Modi on Saturday, visited Bharat Biotech, a Hyderabad-based Pharmaceutical company to know about the progress made in the development of indigenous coronavirus vaccine.

Prime Minister Narendra Modi on Saturday, visited Bharat Biotech, a Hyderabad-based Pharmaceutical company to know about the progress made in the development of indigenous coronavirus vaccine. The visit was part of his inspection of vaccine development in vaccine-hubs of India. "At the Bharat Biotech facility in Hyderabad, was briefed about their indigenous Covid vaccine," Modi tweeted. During his visit, PM Modi congratulated the scientists for the progress they made in the trial so far. The Prime Minister met with the company officials in a conference hall and deliberated on the progress made in bringing out a vaccine. Later, he also briefly interacted with a few employees. Before flying to Hyderabad, PM Modi visited pharma major Zydus-Cadilla's work on vaccine development in Ahmedabad. After his Hyderabad visit, PM Modi was due to fly to Pune for a visit to Serum Institute of India, the company that will manufacture coronavirus vaccine being developed by Oxford University and Astrazeneca. (With agency inputs)

Bharat Biotech working with ICMR for speedy progress on vaccine: PM Modi

Prime Minister Narendra Modi on Saturday concluded his visit to Zydus Biotech Park in Ahmedabad after reviewing the development of COVID-19 vaccine candidate ZyCOV-D. This visit was the first of his three-city tour to personally review the vaccine development and manufacturing process in the country. Prime Minister Modi will now fly to Hyderabad to visit the Bharat Biotech facility.

During his visit to the Biotech Park in Ahmedabad, PM Modi interacted with the scientists at the Biotech Park and also greeted a crowd which gathered outside the plant.

The prime minister is now scheduled to visit vaccine maker Bharat Biotech`s facility next. Bharat Biotech`s Covaxin is undergoing phase-3 trials.

Also read|&nbsp;<a href="https://www.wionews.com/india-news/pm-modi-to-visit-vaccine-making-units-in-ahmedabad-hyderabad-and-pune-346004">PM Modi to visit vaccine making units in Ahmedabad, Hyderabad and Pune</a>

Biotech has partnered with the Indian Council of Medical Research (ICMR) for a country-made COVID-19 vaccine using the virus strain isolated by ICMR`s National Institute of Virology (NIV) based in Pune.

Post Bharat Biotech facility visit, PM Modi will head towards the Serum Institute of India (SII) in Pune. SII has partnered with global pharma giant AstraZeneca and Oxford University for the vaccine.

The SII is the largest producer of vaccines in the world by volume.

"As India enters a decisive phase of the fight against COVID-19, PM Narendra Modi`s visit to these facilities and discussions with the scientists will help him get a first-hand perspective of the preparations, challenges and roadmap in India`s endeavour to vaccinate its citizens," the Prime Minister`s Office had said on Friday.

Prime Minister Narendra Modi on Saturday concluded his visit to Zydus Biotech Park in Ahmedabad after reviewing the development of COVID-19 vaccine candidate ZyCOV-D.

Prime Minister Narendra Modi on Saturday concluded his visit to Zydus Biotech Park in Ahmedabad after reviewing the development of COVID-19 vaccine candidate ZyCOV-D. This visit was the first of his three-city tour to personally review the vaccine development and manufacturing process in the country. Prime Minister Modi will now fly to Hyderabad to visit the Bharat Biotech facility. During his visit to the Biotech Park in Ahmedabad, PM Modi interacted with the scientists at the Biotech Park and also greeted a crowd which gathered outside the plant. The prime minister is now scheduled to visit vaccine maker Bharat Biotech`s facility next. Bharat Biotech`s Covaxin is undergoing phase-3 trials. Also read| PM Modi to visit vaccine making units in Ahmedabad, Hyderabad and Pune Biotech has partnered with the Indian Council of Medical Research (ICMR) for a country-made COVID-19 vaccine using the virus strain isolated by ICMR`s National Institute of Virology (NIV) based in Pune. Post Bharat Biotech facility visit, PM Modi will head towards the Serum Institute of India (SII) in Pune. SII has partnered with global pharma giant AstraZeneca and Oxford University for the vaccine. The SII is the largest producer of vaccines in the world by volume. "As India enters a decisive phase of the fight against COVID-19, PM Narendra Modi`s visit to these facilities and discussions with the scientists will help him get a first-hand perspective of the preparations, challenges and roadmap in India`s endeavour to vaccinate its citizens," the Prime Minister`s Office had said on Friday.

PM Modi concludes Zydus Biotech Park visit, next stop Bharat Biotech facility in Hyderabad

As countries compete to grab doses of the <a href="https://www.wionews.com/india-news/vaccine-to-lowest-levels-pm-modi-speaks-on-covid-19-vaccine-cost-distribution-strategy-during-chief-ministers-meeting-345108">vaccines</a>, the world is turning to India for vaccine supplies.

India's plays a vital role in the vaccine chain. India is the world's vaccine manufacturing hub and is known for its pharmacy in vaccine production.

India supplies over 60 per cent of the vaccines for the developing world and the Wuhan virus pandemic will be no different. In July, the government had organised an online vaccine symposium with Peter Piot as one of the attendees. Piot is the director of the London School of Hygiene and Tropical Medicine.

Piot said without India there won't be enough <a href="https://www.wionews.com/india-news/russias-sputnik-v-vaccine-to-be-manufactured-in-india-345136">vaccines</a> to save the world. The Serum Institute in Pune is manufacturing one billion doses of the Wuhan virus vaccine being developed by the University of Oxford and AstraZeneca.

India's Serum Institute also happens to be the world's largest vaccine maker and at its full capacity, the company can make 60 to 70 million doses a month. The Serum Institute is also developing and testing four other Wuhan virus vaccines including the Novavax and Codagenix candidates.

There are other Indian firms that have entered into partnerships for manufacturing potential Wuhan virus vaccines. Hyderabad-based biological e has struck a deal for the shot being developed by Johnson and Johnson's subsidiary Belgium's Janssen Pharamaceutica.

Reports say biological e may also manufacture a candidate being developed by Houston's Baylor college of medicine. Indian immunologicals, a firm based out of Hyderabad has entered into a partnership with Australia's Griffith University.

The Indian firm will be testing and manufacturing the university's vaccine candidate. Bharat Biotech has a deal to manufacture 1 billion doses of Washington University's intranasal vaccine.

It also has a partnership with the University of Wisconsin Madison and US-based firm Flugen to make almost 300 million doses of a vaccine for global distribution.

Dr. Reddy's has a deal to produce 100 million doses of the Sputnik V. Ahmedabad-based Zydus Cadila is also working on a shot which is undergoing clinical trials.&nbsp;

Earlier this month, India's foreign secretary Harsh Vardhan Shringla said: "Several countries have been approaching us for receiving vaccine supply. I reiterate the prime minister’s commitment that India’s vaccine production and delivery capacity will be used to help all humanity in fighting this crisis."

Shringla added that India also help "interested countries in enhancing their cold chain and storage capacities for the delivery of the vaccines."

There is a difference between India's approach to the Wuhan virus vaccine, and how the world is looking at the vaccine race while there are countries looking at hoarding vaccines, pre-ordering at least a billin doses for a population of just 330 million.&nbsp;

India is not just manufacturing vaccines for its citizens, but also for the world and in doing so, India is not looking to discriminate on the basis on global economic rankings.

India exported its vaccine stock to other nations when the pandemic struck. In a visit to Dhaka in August this year, Harsh Vardhn Shringla promised that India would supply vaccines to Bangladesh on a priority basis. Dhaka signed a deal with the Serum Insitute for 30 million doses of the AstraZeneca vaccine.

India has stated that its closest neighbours, friends, partners and other countries will receive privileged access. On August, 7, the global vaccine alliance announced a collaboration with India's Serum Institute and the Bill &amp; Melinda Gates Foundation.

The deal gave the Indian company financial support of $150 million dollars in order to supply 100 million doses of vaccines for distribution in low and middle-income countries in 2021.

India's biologicals e has promised to push for equal procurement and distribution of the vaccine and stay committed to the COVAX vaccine alliance.&nbsp;

According to CEPI or coalition for epidemic preparedness innovations survey, India has the largest production capacity for drug substance and as the world battles a deadly Wuhan virus, India is not prioritising profit over the health of billions.

As countries compete to grab doses of the vaccines, the world is turning to India for vaccine supplies. India's plays a vital role in the vaccine chain. India is the world's vaccine manufacturing hub and is known for its pharmacy in vaccine production.

As countries compete to grab doses of the vaccines, the world is turning to India for vaccine supplies. India's plays a vital role in the vaccine chain. India is the world's vaccine manufacturing hub and is known for its pharmacy in vaccine production. India supplies over 60 per cent of the vaccines for the developing world and the Wuhan virus pandemic will be no different. In July, the government had organised an online vaccine symposium with Peter Piot as one of the attendees. Piot is the director of the London School of Hygiene and Tropical Medicine. Piot said without India there won't be enough vaccines to save the world. The Serum Institute in Pune is manufacturing one billion doses of the Wuhan virus vaccine being developed by the University of Oxford and AstraZeneca. India's Serum Institute also happens to be the world's largest vaccine maker and at its full capacity, the company can make 60 to 70 million doses a month. The Serum Institute is also developing and testing four other Wuhan virus vaccines including the Novavax and Codagenix candidates. There are other Indian firms that have entered into partnerships for manufacturing potential Wuhan virus vaccines. Hyderabad-based biological e has struck a deal for the shot being developed by Johnson and Johnson's subsidiary Belgium's Janssen Pharamaceutica. Reports say biological e may also manufacture a candidate being developed by Houston's Baylor college of medicine. Indian immunologicals, a firm based out of Hyderabad has entered into a partnership with Australia's Griffith University. The Indian firm will be testing and manufacturing the university's vaccine candidate. Bharat Biotech has a deal to manufacture 1 billion doses of Washington University's intranasal vaccine. It also has a partnership with the University of Wisconsin Madison and US-based firm Flugen to make almost 300 million doses of a vaccine for global distribution. Dr. Reddy's has a deal to produce 100 million doses of the Sputnik V. Ahmedabad-based Zydus Cadila is also working on a shot which is undergoing clinical trials. Earlier this month, India's foreign secretary Harsh Vardhan Shringla said: "Several countries have been approaching us for receiving vaccine supply. I reiterate the prime minister’s commitment that India’s vaccine production and delivery capacity will be used to help all humanity in fighting this crisis." Shringla added that India also help "interested countries in enhancing their cold chain and storage capacities for the delivery of the vaccines." There is a difference between India's approach to the Wuhan virus vaccine, and how the world is looking at the vaccine race while there are countries looking at hoarding vaccines, pre-ordering at least a billin doses for a population of just 330 million. India is not just manufacturing vaccines for its citizens, but also for the world and in doing so, India is not looking to discriminate on the basis on global economic rankings. India exported its vaccine stock to other nations when the pandemic struck. In a visit to Dhaka in August this year, Harsh Vardhn Shringla promised that India would supply vaccines to Bangladesh on a priority basis. Dhaka signed a deal with the Serum Insitute for 30 million doses of the AstraZeneca vaccine. India has stated that its closest neighbours, friends, partners and other countries will receive privileged access. On August, 7, the global vaccine alliance announced a collaboration with India's Serum Institute and the Bill & Melinda Gates Foundation. The deal gave the Indian company financial support of $150 million dollars in order to supply 100 million doses of vaccines for distribution in low and middle-income countries in 2021. India's biologicals e has promised to push for equal procurement and distribution of the vaccine and stay committed to the COVAX vaccine alliance. According to CEPI or coalition for epidemic preparedness innovations survey, India has the largest production capacity for drug substance and as the world battles a deadly Wuhan virus, India is not prioritising profit over the health of billions.

Amid race for vaccine, world turns to India for vaccine supply

India's pharmaceutical company&nbsp;Bharat Biotech International Ltd has now, months later, revealed that during Phase 1 of the human trial of COVID-19 vaccine, the company had an adverse event.

In August 2020, a patient who was given the vaccine was hospitalised after receiving the dose of the COVID-19 vaccine Covaxin. However, the company and the doctors involved made sure the issue was not made public, so as to not let the public panic. The decision was taken by the Central Drugs Standard Control Organisation and its head Drug Controller General of India V.G. Somani.

Also read|&nbsp;<a href="https://www.wionews.com/world/us-grants-emergency-use-authorisation-to-regeneron-covid-19-antibodies-344588">US grants emergency use authorisation to Regeneron Covid-19 antibodies</a>

“The adverse event during phase I clinical trials during August 2020 was reported to the CDSCO-DCGI within 24 hours of its occurrence and confirmation. The adverse event was investigated thoroughly and determined as not vaccine related," the company said in a statement.

As per local reports, the patient who was hospitalised is a 35-year-old volunteer from Western India, with no co-morbidities. He was admitted for treatment of&nbsp;viral pneumonitis, and was discharged within a week. It was made clear that the patient was not admitted due to the side effects of the vaccine. However, "all treatment costs for the subject was fully paid for by the sponsor, and the subject is safe," Bharat Biotech said.

The company also claimed that it got approval for the next two phases of trials only after going through a detailed investigation about this adverse event. the company has now started the third and final phase of human trials for Covaxin which will be conducted on nearly 26,000 participants which can cost the company approximately Rs. 250 crore.

The other coronavirus vaccines being developed by&nbsp;AstraZeneca and Johnson &amp; Johnson had temporarily paused their trials after similar events had taken place during their trials.

India's pharmaceutical company Bharat Biotech International Ltd has now, months later, revealed that during Phase 1 of the human trial of COVID-19 vaccine, the company had an adverse event.

India's pharmaceutical company Bharat Biotech International Ltd has now, months later, revealed that during Phase 1 of the human trial of COVID-19 vaccine, the company had an adverse event. In August 2020, a patient who was given the vaccine was hospitalised after receiving the dose of the COVID-19 vaccine Covaxin. However, the company and the doctors involved made sure the issue was not made public, so as to not let the public panic. The decision was taken by the Central Drugs Standard Control Organisation and its head Drug Controller General of India V.G. Somani. Also read| US grants emergency use authorisation to Regeneron Covid-19 antibodies “The adverse event during phase I clinical trials during August 2020 was reported to the CDSCO-DCGI within 24 hours of its occurrence and confirmation. The adverse event was investigated thoroughly and determined as not vaccine related," the company said in a statement. As per local reports, the patient who was hospitalised is a 35-year-old volunteer from Western India, with no co-morbidities. He was admitted for treatment of viral pneumonitis, and was discharged within a week. It was made clear that the patient was not admitted due to the side effects of the vaccine. However, "all treatment costs for the subject was fully paid for by the sponsor, and the subject is safe," Bharat Biotech said. The company also claimed that it got approval for the next two phases of trials only after going through a detailed investigation about this adverse event. the company has now started the third and final phase of human trials for Covaxin which will be conducted on nearly 26,000 participants which can cost the company approximately Rs. 250 crore. The other coronavirus vaccines being developed by AstraZeneca and Johnson & Johnson had temporarily paused their trials after similar events had taken place during their trials.

Bharat Biotech reveals adverse event during Phase 1 trial of COVID-19 vaccine

bharat-biotech

Bharat Biotech, News on Bharat Biotech, stories on Bharat Biotech, articles on Bharat Biotech, Bharat Biotech stories at Wion, Bharat Biotech news, Bharat Biotech latest news

bharat biotech