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

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

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

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

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

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

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

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

Cambodia has become the latest country to request India for <a href="https://www.wionews.com/topics/coronavirus-vaccine?page=1">COVID-19 vaccine</a> even as New Delhi has been reached out by other countries for it. Cambodian PM Hun Sen had met the Indian envoy to Cambodia Devyani Khobragade and requested for the vaccine.&nbsp;

The Cambodians have not quantified their requests for the Indian vaccines, but it comes, two days after China promised a donation of one million doses. The development shows Cambodians are open to getting more vaccines from India and not totally reliant on China. Cambodia is seen close to Bejing, which makes it more significant.

India will kickstart the&nbsp;vaccine exports on Wednesday. The Maldives will become the first country to receive the Indian coronavirus vaccine tomorrow. The Indian Ocean Island country will receive the Covishield vaccine produced by Serum Institute of India (SII) with the Indian consignment arriving at 2:00 pm local time in the country's national capital Male by Air India.

Also read|&nbsp;<a href="https://www.wionews.com/india-news/nepal-requests-indias-covid-19-vaccines-on-priority-india-approves-357360" hreflang="en">Nepal requests India's COVID-19 vaccines on priority; India approves</a>

India is sending 100,000 doses under emergency use approvals for vaccinating the frontline workers, healthcare workers, and those with comorbidities.

Meanwhile, the Bangladeshi government has confirmed the WION's break of Monday that India will be gifting vaccines to the country. The Bangladesh foreign ministry in a Facebook post said, "Bangladesh will receive 20 lakh doses of Oxford-Astrazenca Covid-19 vaccines (Covishield) from India as a gift on 21 January."

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A special flight of India carrying the consignment will land at Hazrat Shahjalal International Airport in Dhaka the day after tomorrow. The ruling Awami League party of the country also tweeted the same and highlighted that the govt will also procure additional 30 million Covishield vaccines from Serum Institute of India (SII).

This comes even as South African government in a fact sheet released today said that the country will be getting one million doses of the vaccine in January and 500,000 doses in February of the Oxford University-Astrazeneca vaccine from SII.

Also read|&nbsp;<a href="https://www.wionews.com/india-news/maldives-to-be-the-first-country-to-receive-indian-covid-19-vaccine-357723" hreflang="en">Maldives to be the first country to receive Indian COVID-19 vaccine</a>

India reaffirmed its position as the pharma capital of the world amid the COVID-19 pandemic last year sending HCQ and paracetamol to 150 countries. When it comes to coronavirus vaccines, India has assured that its vaccines will be for the entire humanity, with priority being given to the neighbourhood.

In the neighborhood, talks are on with Bhutan, Sri Lanka, Afghanistan, and Nepal for the vaccine. In fact, Nepal's Foreign minister Pradeep Gyawali was in India last week and requested India for 20 per cent i.e. 12 million doses of the vaccine. Indian authorities have given approval to two coronavirus vaccines — one being SII's Covishield&nbsp;and another being Bharat Biotech's COVAXIN with the mega vaccination programme starting over the weekend.

Also read|&nbsp;<a href="https://www.wionews.com/india-news/neighbourhood-first-india-to-gift-covid-19-vaccines-to-bangladesh-357558" hreflang="en">Neighbourhood first: India to gift COVID-19 vaccines to Bangladesh</a>

It's just not the Indian subcontinent that is the focus. Even in Latin America, India is sought after for the COVID-19 vaccine. Brazilian President Jair Bolsonaro on Monday met Indian envoy to Brazil Suresh Reddy.

In a tweet he said, "It was a great pleasure meeting you Excellency! Our relations are growing stronger by the day under your and @narendramodi 's leadership! @PMOIndia @DrSJaishankar @harshvshringla @rivagdas".&nbsp;

While the elements of the discussions are not known, the meet happens in the backdrop of the Brazilian President writing to PM Modi for 2 million doses of the immunizer produced by the SII.

Cambodia has become the latest country to request India for COVID-19 vaccine even as New Delhi has been reached out by other countries for it. Cambodian PM Hun Sen had met the Indian envoy to Cambodia Devyani Khobragade and requested for the vaccine.

Cambodia has become the latest country to request India for COVID-19 vaccine even as New Delhi has been reached out by other countries for it. Cambodian PM Hun Sen had met the Indian envoy to Cambodia Devyani Khobragade and requested for the vaccine. The Cambodians have not quantified their requests for the Indian vaccines, but it comes, two days after China promised a donation of one million doses. The development shows Cambodians are open to getting more vaccines from India and not totally reliant on China. Cambodia is seen close to Bejing, which makes it more significant. India will kickstart the vaccine exports on Wednesday. The Maldives will become the first country to receive the Indian coronavirus vaccine tomorrow. The Indian Ocean Island country will receive the Covishield vaccine produced by Serum Institute of India (SII) with the Indian consignment arriving at 2:00 pm local time in the country's national capital Male by Air India. Also read| Nepal requests India's COVID-19 vaccines on priority; India approves India is sending 100,000 doses under emergency use approvals for vaccinating the frontline workers, healthcare workers, and those with comorbidities. Meanwhile, the Bangladeshi government has confirmed the WION's break of Monday that India will be gifting vaccines to the country. The Bangladesh foreign ministry in a Facebook post said, "Bangladesh will receive 20 lakh doses of Oxford-Astrazenca Covid-19 vaccines (Covishield) from India as a gift on 21 January." Bangladesh will receive 20 lakh doses of Oxford-Astrazenca Covid-19 vaccines (Covishield) from India as a gift on 21... Posted by Ministry of Foreign Affairs, Bangladesh on Monday, January 18, 2021 × A special flight of India carrying the consignment will land at Hazrat Shahjalal International Airport in Dhaka the day after tomorrow. The ruling Awami League party of the country also tweeted the same and highlighted that the govt will also procure additional 30 million Covishield vaccines from Serum Institute of India (SII). This comes even as South African government in a fact sheet released today said that the country will be getting one million doses of the vaccine in January and 500,000 doses in February of the Oxford University-Astrazeneca vaccine from SII. Also read| Maldives to be the first country to receive Indian COVID-19 vaccine India reaffirmed its position as the pharma capital of the world amid the COVID-19 pandemic last year sending HCQ and paracetamol to 150 countries. When it comes to coronavirus vaccines, India has assured that its vaccines will be for the entire humanity, with priority being given to the neighbourhood. In the neighborhood, talks are on with Bhutan, Sri Lanka, Afghanistan, and Nepal for the vaccine. In fact, Nepal's Foreign minister Pradeep Gyawali was in India last week and requested India for 20 per cent i.e. 12 million doses of the vaccine. Indian authorities have given approval to two coronavirus vaccines — one being SII's Covishield and another being Bharat Biotech's COVAXIN with the mega vaccination programme starting over the weekend. Also read| Neighbourhood first: India to gift COVID-19 vaccines to Bangladesh It's just not the Indian subcontinent that is the focus. Even in Latin America, India is sought after for the COVID-19 vaccine. Brazilian President Jair Bolsonaro on Monday met Indian envoy to Brazil Suresh Reddy. In a tweet he said, "It was a great pleasure meeting you Excellency! Our relations are growing stronger by the day under your and @narendramodi 's leadership! @PMOIndia @DrSJaishankar @harshvshringla @rivagdas". While the elements of the discussions are not known, the meet happens in the backdrop of the Brazilian President writing to PM Modi for 2 million doses of the immunizer produced by the SII.

Vaccine diplomacy: India to begin exports tomorrow, more requests sent

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.

India to review vaccine applications on Dec 9

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

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

Vaccine diplomacy: India to begin exports tomorrow, more requests sent

India to review vaccine applications on Dec 9