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Johnson & Johnson Announces Submission of Application to the U.S. FDA for Emergency Use Authorization of its Investigational Single-Shot Janssen COVID-19 Vaccine Candidate

Johnson & Johnson Announces Submission of Application to the U.S. FDA for Emergency Use Authorization of its Investigational Single-Shot Janssen COVID-19 Vaccine Candidate
Johnson & Johnson today announced that Janssen Biotech, Inc., has submitted an application to the U.S. Food and Drug Administration requesting Emergency Use Authorization for its investigational single-dose Janssen COVID-19 vaccine candidate. The Company’s EUA submission is based on topline efficacy and safety data from the Phase 3 ENSEMBLE clinical trial, demonstrating that the investigational single-dose vaccine …
– Johnson & Johnson (NYSE: JNJ) (the Company) today announced that Janssen Biotech, Inc., has submitted an application to the U.S. Food and Drug Administration (FDA) requesting Emergency Use Authorization (EUA) for its investigational single-dose Janssen COVID-19 vaccine candidate. The Company’s EUA submission is based on topline efficacy and safety data from the Phase 3 ENSEMBLE cli ....

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Johnson & Johnson seeks emergency use approval for its single-dose Covid vaccine

Johnson & Johnson seeks emergency use approval for its single-dose Covid vaccine
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Johnson & Johnson has asked U.S. regulators to clear the world’s first single-dose COVID-19 vaccine, an easier-to-use option that could boost scarce supplies
(AP)
Johnson & Johnson s vaccine would be the third authorized US, after those of Pfizer-BioNTech and Moderna
The vaccine was overall 66% effective, the company said. And it is 85% effective in preventing severe forms of the disease
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Pharma giant Johnson & Johnson on Thursday sought emergency use authorization (EUA) of its Covid-19 vaccine from US health authorities, the company said in a statement. ....

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Johnson & Johnson (NYSE:JNJ), Moderna, Inc. (MRNA) - Johnson & Johnson Seeks US Emergency Approval For Single Dose COVID-19 Vaccine

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Johnson & Johnson (NYSE: JNJ) said Wednesday that its subsidiary Janssen Biotech Inc is requesting approval from the United States Food and Drug Administration for its single-dose COVID-19 vaccine candidate.
What Happened: The multinational pharma company said in a statement that it is asking for an emergency use authorization from the FDA based on the results of the vaccine’s Phase 3 clinical trial.
“Upon authorization of our investigational COVID-19 vaccine for emergency use, we are ready to begin shipping,” said Johnson & Johnson’s Chief Scientific Officer Paul Stoffels.
The drugmaker said it will also submit a Conditional Marketing Authorisation Application (cMAA) with the European Medicines Agency in the coming weeks. ....

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GoLocalProv | Johnson & Johnson Submits Application to FDA for Vaccine Approval

Friday, February 05, 2021

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Johnson & Johnson announced Thursday night that Janssen Biotech, Inc., has submitted an application to the U.S. Food and Drug Administration (FDA) requesting Emergency Use Authorization (EUA) for its investigational single-dose Janssen COVID-19 vaccine candidate.
The Company’s EUA submission is based on topline efficacy and safety data from the Phase 3 ENSEMBLE clinical trial, demonstrating that the investigational single-dose vaccine met all primary and key secondary endpoints. The Company expects to have product available to ship immediately following authorization.
On January 29, Johnson & Johnson announced that its single-shot coronavirus vaccine was 66% effective in protecting against moderate to severe COVID-19 disease in Phase 3 trials, which was comprised of nearly 44,000 participants across eight countries.GET THE LATEST BREAKING NEWS HERE SIGN UP FOR GOLOCAL FREE DAILY EBLAST ....

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J&J submits COVID-19 vaccine data to FDA for emergency authorisation

J&J submits COVID-19 vaccine data to FDA for emergency authorisation
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J&J have submitted Phase III trial data in their application to the FDA for emergency authorisation of their COVID-19 vaccine candidate.
Johnson & Johnson (J&J) has announced that Janssen has submitted an application to the US Food and Drug Administration (FDA) requesting Emergency Use Authorization (EUA) for its investigational single-dose Janssen COVID-19 vaccine candidate.
The company’s EUA submission is based on topline efficacy and safety data from the Phase III ENSEMBLE clinical trial, demonstrating that the investigational single-dose vaccine met all primary and key secondary endpoints. The company expects to have product available to ship immediately following authorisation. ....

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