Johnson & Johnson Announces Submission to World Health Organization for Emergency Use Listing of Investigational Single-Shot Janssen COVID-19 Vaccine Candidate

NEW BRUNSWICK, N.J., February 19, 2021– 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 today includes interim efficacy and safety results from the Phase 3 ENSEMBLE clinical trial. The Company’s rolling submission of clinical data to WHO is now complete.“Our filing with the World Health Organization marks another important step in our effort to combat COVID-19 and also in our unwavering commitment to equitable access,” said Paul Stoffels, M.D., Vice Chairman of the Executive Committee and Chief Scientific Officer of Johnson &Johnson. "If we are to end the global pandemic, life-saving innovations like vaccines must be within reach for all countries.”The EUL procedure streamlines the process by which new or unlicensed products can be assessed for use during public health emergencies by governments and UN procurement agencies. The EUL process expedites access to such products in many countries around the world and is also a prerequisite to supply vaccines to the new COVAX Facility, a global mechanism for pooled procurement and distribution of COVID-19 vaccines in 190 participating countries, including 92 lower-income countries.In December 2020, the Company entered into an agreement in principle with Gavi, the Vacc...
Source: Johnson and Johnson - Category: Pharmaceuticals Tags: Our Company Source Type: news

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New Brunswick, N.J., October 8, 2020 – Johnson &Johnson (NYSE: JNJ) (the Company) today 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 EU Member States also have the option to secure up to 200 million additional doses.“The COVID-19 pandemic continues to threaten communities worldwide and we have a responsibility to ensure access t...
Source: Johnson and Johnson - Category: Pharmaceuticals Tags: Our Company Source Type: news
NEW BRUNSWICK, N.J., September 23, 2020 – Johnson &Johnson (NYSE: JNJ) (the Company) today 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 and immunogenicity after a single vaccination were supportive of further development. These results have been submitted to medRxiv and are due to be published online im...
Source: Johnson and Johnson - Category: Pharmaceuticals Tags: Our Company Source Type: news
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Source: Johnson and Johnson - Category: Pharmaceuticals Tags: Innovation Source Type: news
NEW BRUNSWICK, N.J., March 30, 2020 – Johnson &Johnson (NYSE: JNJ) (the Company) today announced the selection of a lead COVID-19 vaccine candidate from constructs it has been working on since January 2020; the significant expansion of the existing partnership between the Janssen Pharmaceutical Companies of Johnson &Johnson and the Biomedical Advanced Research and Development Authority (BARDA); and the rapid scaling of the Company’s manufacturing capacity with the goal of providing global supply of more than one billion doses of a vaccine. The Company expects to initiate human clinical studies of its le...
Source: Johnson and Johnson - Category: Pharmaceuticals Tags: Our Company Source Type: news
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