Home Johnson & Johnson Announces European Commission Approval of Advance Purchase Agreement for 200 Million Doses of Janssen's COVID-19 Vaccine Candidate

Johnson & Johnson Announces European Commission Approval of Advance Purchase Agreement for 200 Million Doses of Janssen's COVID-19 Vaccine Candidate

Oct 12, 2020 10:53 CST Updated 10:53
Johnson & Johnson

Healthcare Product Manufacturers, Health Service Providers

Janssen Pharmaceuticals

Pharmaceutical R&D Developer

European Commission

The European Commission, abbreviated as the EU Commission, is a supranational body under the European Union. Within the EU political system, the European Commission primarily undertakes executive tasks, thus being roughly equivalent to the government in a national system. However, the European Commission has other functions as well. In particular, except for the few circumstances specified in the treaties, the European Commission is the only institution with legislative power in the EU legislative process.

 

NEW BRUNSWICK, N.J., Oct. 12, 2020 /PRNewswire/ -- Johnson & Johnson (NYSE: JNJ) (the “Company”) today announced that the European Commission (EC), acting on behalf of the European Union (EU) Member States, has approved an advance purchase agreement under which Janssen Pharmaceuticals will supply 200 million doses of its COVID-19 vaccine candidate to EU Member States following regulatory approval or authorization. EU Member States also have the option to procure up to an additional 200 million doses.

“The COVID-19 pandemic continues to pose a threat to communities around the world, and we have a responsibility to ensure that a coronavirus vaccine is developed as quickly as possible. We are deeply grateful to the European Commission and its member states for their support of our candidate vaccine and development efforts,” said Dr. Paul Stoffels, Vice Chairman of the Executive Committee and Chief Scientific Officer at Johnson & Johnson.

This contract is inExploratory Discussions with the European CommissionTo be signed subsequently. To fulfill its commitment to supply its alternative vaccine globally, the company is engaging in discussions with other stakeholders, including national governments and global organizations. Supply is contingent upon the vaccine demonstrating favorable safety and efficacy profiles and obtaining approval or authorization from regulatory authorities.

In addition to the agreement reached with the European Commission, Johnson & Johnson alsoAnnouncedRelevant plans allocate up to 500 million vaccine doses for international epidemic control efforts to ensure vaccine accessibility in low-income countries. This batch of vaccines will begin delivery by mid-next year following approval or authorization by regulatory authorities. We recognize the unique global demand for COVID-19 vaccines and are making every effort to further expand the available supply.

Johnson & Johnson is developing and testing its candidate COVID-19 vaccines in accordance with rigorous routine safety and ethical standards, as well as comprehensive scientific principles. The company is evaluating the...Large-Scale, Pivotal, Multinational Phase 3 Trial (ENSEMBLE)single-dose regimen. We plan to initiate the second Phase 3 study employing a two-dose treatment regimen later this year. The Company is committed to maintaining transparency and sharing, includingStudy Protocolinformation related to the Phase 3 ENSEMBLE study, including.

Janssen Companies Adopted Janssen in the Development of COVID-19 VaccinesAdVac®Technology. The same technology was also employed by Janssen in the development of an Ebola vaccine regimen approved by the European Commission, and it serves as the foundation for its HIV, RSV, and Zika candidate vaccines. To date, more than 100,000 people have received vaccinations based on Janssen’s AdVac®vaccine. Based on our understanding of the stability of our vaccine, these COVID-19 candidate vaccines are expected to be compatible with standard distribution channels, without the need for new distribution infrastructure.

To learn more about Johnson & Johnson’s multi-pronged approach to combating the pandemic, please visit:www.jnj.com/coronavirus

AboutJohnson & Johnson 
At Johnson & Johnson, we firmly believe that health is the foundation of vibrant lives, thriving communities, and continuous progress. For this reason, for more than 130 years, we have remained dedicated to advancing health, enabling people to stay healthy at every age and stage of life. Today, as the world’s largest and most broadly diversified healthcare company, we are committed to leveraging our extensive reach and scale to promote human health. We strive to improve access to and affordability of medicines, create healthier communities, and ensure that people around the world enjoy healthy minds, bodies, and environments. By integrating compassion, science, and wisdom, we drive meaningful change in the advancement of human health. For more information, please visitwww.jnj.com. Welcome via@JNJNewsFollow us.

AboutJanssen Pharmaceuticals
At Janssen, we strive to create a future free from disease. As the pharmaceutical subsidiary of Johnson & Johnson, we leverage science to conquer disease, wisdom to expand access, and compassion to inspire hope, relentlessly working to realize this future for patients worldwide. We focus on therapeutic areas where we can make the greatest positive impact: cardiovascular, metabolism, immunology, infectious diseases, vaccines, neuroscience, oncology, and pulmonary arterial hypertension. For more information, please visitwww.janssen.com. Welcome via@JanssenGlobalFollow Us.

TouCautionary Note to Investors Regarding Forward-Looking Statements
Ben XinPress release includes1995U.S. "Private“Securities Litigation Reform Act”-defined potential prevention and treatment development programs for the novel coronavirusProspectiveStatement. This newForward-looking statements in the press release are based on current expectations for future events, Readers should exercise caution and must not rely on the relevant content. If the underlying assumptions prove inaccurate, or if known or unknown risks or uncertainties arise, actual results may differ from those of Janssen Pharmaceuticals and/orSignificant discrepancies between Johnson & Johnson's expectations and forecasts. Risks and uncertainties includeincluding but not limited to:Inherent challenges and uncertainties in the product development process, including uncertainties regarding clinical success, regulatory approval, and commercialization; manufacturing difficulties or delays; competition, including technological advancements, new products and patents obtained by competitors; patent challenges; concerns about product efficacy and safety arising from product recalls or regulatory actions; changes in the purchasing and consumption behavior of buyers of medical products and services; changes in applicable laws and regulations, including global healthcare reform; and trends toward controlling healthcare costs. For a further list and description of these risks, uncertainties, and other factors, please refer to Johnson & Johnson’s as of2019Year12Month29Daily10-KAnnual in the TableReport, including the titleRegarding ProspectivityWarning StatementsandItem1ARisk Factorspart, as well as the company’s recently submitted10-QQuarterly Tablereport and the documents subsequently filed by the Company with the U.S. Securities and Exchange Commission. Copies of these documents are available atwww.sec.govandwww.jnj.comObtain or request from Johnson & Johnson. Janssen Pharmaceuticals and Johnson & Johnson assume no obligation to update or revise any forward-looking statements based on new information, future events, or developments.

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