Johnson & Johnson Announces European Commission Approval of Agreement to Supply 200 Million Doses of Janssen ’s COVID-19 Vaccine Candidate

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 to our COVID-19 vaccine as soon as we can. We appreciate the Commission’s and the Member States’ support for our COVID-19 vaccine candidate and development efforts,” said Paul Stoffels, M.D., Vice Chairman of the Executive Committee and Chief Scientific Officer, Johnson &Johnson. This contract follows the conclusion of exploratory talks with the EC. The Company is in ongoing discussions with other stakeholders, including national governments and global organizations, as part of its efforts to meet its commitment to make its vaccine candidate accessible globally, provided the vaccine has a good safety profile, is efficacious and receives approval or authorization from regulators. Separate to the agreement with the EC, as part of the Company’s larger commitment to respond to the COVID-19 pandemic, Johnson &Johnson has also announ...
Source: Johnson and Johnson - Category: Pharmaceuticals Tags: Our Company Source Type: news

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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
Discussions with the FDA are ongoing to define the required data set for filing Janssen’s Ebola vaccine regimen under the FDA’s Animal Rule licensure pathway. About Janssen’s Ebola Vaccine Regimen The Janssen investigational preventive Ebola vaccine regimen (Ad26.ZEBOV, MVA-BN-Filo) utilizes a viral vector strategy in which viruses – in this case adenovirus serotype 26 (Ad26) and Modified Vaccinia Virus Ankara (MVA) – are genetically modified so that they cannot replicate in human cells. In addition, these vectors are modified to safely carry the genetic code of an Ebola virus protein in order...
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
NEW BRUNSWICK, N.J., March 13, 2020 – Johnson &Johnson today announced that its Janssen Pharmaceutical Companies have entered a collaboration with the Beth Israel Deaconess Medical Center (BIDMC) to support the development of a preventive vaccine candidate for COVID-19. The parties have commenced preclinical testing of multiple vaccine prospects, with the aim to identify by the end of the month a COVID-19 vaccine candidate for clinical trials.Janssen is optimistic that, in collaboration with multiple global strategic partners, it can initiate a Phase 1 clinical study of a potential vaccine candidate by the end of...
Source: Johnson and Johnson - Category: Pharmaceuticals Tags: Our Company Source Type: news
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