Pharma Focus Asia

Johnson & Johnson anuncia contrato com o governo dos EUA para fornecer 100 milhões de doses da vacina investigacional para COVID-19

Thursday, August 06, 2020

Johnson & Johnson announced  that the Janssen Pharmaceutical Companies have signed an agreement with the United States government for the large-scale local production and distribution in the United States of 100 million doses of Janssen's experimental SARS-CoV-2 vaccine, Ad26.COV2.S, for use in the United States after approval or release. US Food and Drug Administration (FDA) Emergency Use Authorization.

The Authority for Advanced Biomedical Research and Development ( BARDA ), which belongs to the Office of the Assistant Secretary for Preparedness and Response of the United States Department of Health and Human Services, in collaboration with the United States Department of Defense, is committing more than US $ 1 billion for this deal. The vaccine will be provided on a global non-profit basis for emergency pandemic use. The United States government may also purchase an additional 200 million doses of Ad26.COV2.S under a following agreement.

"Johnson & Johnson's global team of experts worked tirelessly with BARDA and scientific partners to search for a SARS-CoV-2 vaccine that can help stop the spread of Covid-19. We greatly appreciate the government's trust and support. from the United States to our platform and our R&D initiatives and the scalability of our vaccine technology. We are increasing production in the United States and around the world to deliver a SARS-CoV-2 vaccine for emergency use "says Dr. Paul Stoffels , Vice Chairman of the Executive Committee and Chief Scientific Officer of Johnson & Johnson.

Johnson & Johnson's efforts to develop a vaccine for SARS-CoV-2 have been conducted pursuant to an ongoing research and development collaboration with BARDA and under the supervision of the FDA. Based on positive preclinical data recently published in the peer-reviewed journal Nature , the first phase 1 / 2a human clinical trial of the Ad26.COV2.S candidate vaccine is being conducted with healthy volunteers in the United States and Belgium.

The Company is evaluating one- and two-dose regimens in its clinical program and working diligently to ensure broad and global access to the vaccine after approval or clearance by regulators. Johnson & Johnson aims to meet its goal of delivering more than 1 billion doses globally by 2021, provided the vaccine is safe and effective.

Johnson & Johnson's SARS-CoV-2 vaccine program uses Janssen's AdVac ® technology . The same technology was used to develop Janssen's Ebola vaccine approved by the European Commission and to make its candidate vaccines for HIV, RSV and Zika. To date, more than 90,000 people have been vaccinated using the Janssen platform based on AdVac ® .

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