Johnson & Johnson Announces Submission to World Health Organization for Emergency Use Listing of investigational single-shot Janssen COVID-19 vaccine candidate

Johnson & Johnson (NYSE: JNJ) (the Company) announced that Janssen-Cilag International N.V. has submitted for Emergency Use Listing (EUL) to the World Health Organization (WHO) for the investigational single-dose Janssen COVID-19 vaccine candidate. The data package delivered includes interim efficacy and safety results from the Phase 3 ENSEMBLE clinical trial. The Company’s rolling submission of […]

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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 (NYSE: JNJ) (the Company) 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 clinical […]

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Johnson & Johnson announces initiation of rolling submission for its single-dose Janssen COVID-19 vaccine candidate with the European Medicines Agency

Janssen-Cilag International N.V., part of the Janssen Pharmaceutical Companies of Johnson & Johnson, has initiated a rolling submission with the European Medicines Agency (EMA) for its investigational single-dose vaccine candidate for the prevention of COVID-19. The EMA’s Committee for Medicinal Products for Human Use (CHMP) enabled a rolling review of the investigational single-dose Janssen COVID-19 […]

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Johnson & Johnson initiates second global Phase 3 clinical trial of its Janssen COVID-19 vaccine candidate

The Phase 3 ENSEMBLE study of the single-dose regimen of JNJ-78436735, the investigational vaccine candidate for the prevention of COVID-19 being developed by the Janssen Pharmaceutical Companies of Johnson & Johnson, continues to enroll and vaccinate study participants. ENSEMBLE is proceeding to enroll up to 60,000 participants worldwide. In addition to the single-dose regimen ENSEMBLE […]

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Johnson & Johnson prepares to resume Phase 3 ENSEMBLE Trial of its Janssen COVID-19 vaccine candidate in the U.S.

Johnson & Johnson is preparing to resume recruitment in the pivotal Phase 3 ENSEMBLE trial of its investigational Janssen COVID-19 vaccine in the United States after a temporary pause. The independent Data Safety and Monitoring Board (DSMB) overseeing the ENSEMBLE study has recommended resuming trial recruitment. Following consultation with the U.S. Food and Drug Administration […]

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Johnson & Johnson announces European Commission approval of agreement to supply 200 million doses of Janssen’s COVID-19 vaccine candidate

Johnson & Johnson (NYSE: JNJ) (the Company) announced the European Commission (EC), acting on behalf of the European Union (EU) Member States, has approved an Advance Purchase Agreement in which the Janssen Pharmaceutical Companies will supply 200 million doses of its COVID-19 vaccine candidate to EU Member States following approval or authorization from regulators. The […]

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Johnson & Johnson initiates pivotal global Phase 3 clinical trial of Janssen’s COVID-19 vaccine candidate

Johnson & Johnson (NYSE: JNJ) (the Company) announced the launch of its large-scale, pivotal, multi-country Phase 3 trial (ENSEMBLE) for its COVID-19 vaccine candidate, JNJ-78436735, being developed by its Janssen Pharmaceutical Companies. The initiation of the ENSEMBLE trial follows positive interim results from the Company’s Phase 1/2a clinical study, which demonstrated that the safety profile […]

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Johnson & Johnson announces that Janssen’s COVID-19 investigational vaccine candidate prevents severe clinical disease in pre-clinical studies

Janssen’s lead SARS-CoV-2 investigational vaccine candidate, Ad26.COV2.S, prevented severe clinical disease in Syrian golden hamsters, upon challenge with SARS-CoV-2, the virus that causes COVID-19 in people. The data, published in Nature Medicine, demonstrated that the Company’s investigational adenovirus serotype 26 (Ad26) vector-based vaccineJanssen’s lead SARS-CoV-2 investigational vaccine candidate, Ad26.COV2.S, prevented severe clinical disease in Syrian […]

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Johnson & Johnson announces agreement with U.S. government for 100 million doses of investigational COVID-19 vaccine

Johnson & Johnson (NYSE: JNJ) (the Company) announced its Janssen Pharmaceutical Companies have entered into an agreement with the U.S. government for the large scale domestic manufacturing and delivery in the U.S. of 100 million doses of Janssen’s SARS-CoV-2 investigational vaccine, Ad26.COV2.S, for use in the United States following approval or Emergency Use Authorization by […]

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Single dose of Johnson & Johnson COVID-19 vaccine candidate demonstrates robust protection in pre-clinical studies

Johnson & Johnson (NYSE: JNJ) (the Company) today announced that its lead vaccine candidate protected against infection with SARS-CoV-2, the virus that causes COVID-19, in pre-clinical studies. The data, published in Nature, show the Company’s investigational adenovirus serotype 26 (Ad26) vector-based vaccine elicited a robust immune response as demonstrated by “neutralizing antibodies,” successfully preventing subsequent […]

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