Ocugen Inc., Bharat Biotech's partner for the USA and Canada for <a href="https://www.wionews.com/topics/coronavirus-vaccine">COVID-19 vaccine</a> Covaxin has initiated a rolling submission to Health Canada for the jab, the US company said in a regulatory filing.

The move follows the release by Bharat Biotech of Phase 3 clinical trial results, which demonstrated efficacy and safety in nearly 25,800 adults, it said on Thursday.

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Often referred to as a rolling review, this allows Health Canada to start its review right away, as information continues to come in, to accelerate the overall review process.

Ocugen initiated the rolling submission through its affiliate, Vaccigen, Ltd.

Health Canada will make a decision upon review of the evidence submitted that supports its safety, efficacy and quality.

The rolling submission process was recommended and accepted under the Minister of Health's Interim Order Respecting the Importation, Sale and Advertising of Drugs for Use in Relation to COVID-19 and transitioned to a new drug, Ocugen said.

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"We thank Health Canada for their upcoming review of Covaxin and look forward to working with them so that we can offer the possibility of another safe and effective option to be used in their fight against COVID-19 and its Delta variant," Dr Shankar Musunuri, Chairman of the Board, Chief Executive Officer and Co-Founder of Ocugen said.

Covaxin was developed in collaboration with the Indian Council of Medical Research (ICMR) National Institute of Virology (NIV)

Ocugen Inc., Bharat Biotech's partner for the USA and Canada for COVID-19 vaccine Covaxin has initiated a rolling submission to Health Canada for the jab, the US company said in a regulatory filing.

Ocugen Inc., Bharat Biotech's partner for the USA and Canada for COVID-19 vaccine Covaxin has initiated a rolling submission to Health Canada for the jab, the US company said in a regulatory filing. The move follows the release by Bharat Biotech of Phase 3 clinical trial results, which demonstrated efficacy and safety in nearly 25,800 adults, it said on Thursday. Often referred to as a rolling review, this allows Health Canada to start its review right away, as information continues to come in, to accelerate the overall review process. Ocugen initiated the rolling submission through its affiliate, Vaccigen, Ltd. Health Canada will make a decision upon review of the evidence submitted that supports its safety, efficacy and quality. The rolling submission process was recommended and accepted under the Minister of Health's Interim Order Respecting the Importation, Sale and Advertising of Drugs for Use in Relation to COVID-19 and transitioned to a new drug, Ocugen said. "We thank Health Canada for their upcoming review of Covaxin and look forward to working with them so that we can offer the possibility of another safe and effective option to be used in their fight against COVID-19 and its Delta variant," Dr Shankar Musunuri, Chairman of the Board, Chief Executive Officer and Co-Founder of Ocugen said. Covaxin was developed in collaboration with the Indian Council of Medical Research (ICMR) National Institute of Virology (NIV)

Bharat Biotech's partner seeks approval for India-made Covaxin in Canada

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

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