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J&J COVID Vaccine: "We are counting on a 10 euro vaccine against coronavirus"
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translated from Dutch to english:
https://www.tijd.be/ondernemen/farma-biotech/we-rekenen-op-een-vaccin-van-10-euro-tegen-coronavirus/10217795.html
March 30, 2020 9:30 PM
The American pharmaceutical giant Johnson & Johnson has a candidate vaccine against corona ready. Belgian Paul Stoffels, chief scientific officer at the giant, expects to have the first doses ready in early 2021.
"We are counting on hundreds of millions of people worldwide to access this vaccine," said Paul Stoffels, who started his career as a researcher in Congo and became one of the leading Belgians in the industry through his work at Janssen Pharmaceutica, part of J&J.
How many doses will be available early next year?
Paul Stoffels: "We expect 5 to 10 million doses. In the course of the year, that number will rise to 100-300 million and then to 1 billion. "
It is primarily a vaccine for urgent cases. What does that mean?
Stoffels: "Think of care providers in intensive care, such as nurses, doctors and ambulance providers who are frequently exposed to the coronavirus and are not yet infected. They are the first candidates. It is up to health authorities to determine who follows, perhaps older people. For example, the vaccine will be administered gradually. "
When will it become available to everyone?
Stoffels: "We are counting on hundreds of millions of people, so a wide audience, to have access to the vaccine by the end of 2021 and in the course of 2022."
You work closely with the US health authorities. Can that speed up the approval and market introduction process?
Stoffels: "Johan Van Hoof, head of vaccines at Janssen Pharmaceutica, has previously met twice with the FDA, the American health watchdog and the world's most recognized authority for the approval of medicines. We have a great relationship of trust with them. That will undoubtedly accelerate things. "
J&J will distribute the vaccine at cost and speaks of a feasible price. How much is that?
Stoffels: "I count on $ 10 or Euro per vaccine. That is quite cheap. Everything depends on the output of our production lines, the worldwide availability of hypodermic needles and the ability to sterile fill hundreds of millions of those vaccines on site. "
Where was the vaccine developed?
Stoffels: "In Leiden, although it is the result of the close virology network between our locations in Beerse and Leiden. It happened based on the vaccine technology that the biotech company Crucell brought into our group. "
You also screen other antiviral medicines with the Rega Institute of KU Leuven.
Will Belgium become a hotspot in the fight against corona?
Stoffels: "Yes, absolutely. The Rega has been an important knowledge center for thirty years and more. We have fully automated in-house knowledge to screen highly dangerous viruses live according to the highest safety standards in the world. "
You also do the screening for competing pharmaceutical companies. Have you seen such solidarity in the industry before?
Stoffels: "Nobody is" untouched "by this crisis. Every company is involved. While the world is largely at a standstill, our production is 100 percent active. I know few colleagues who now calculate what they could earn from corona. That is a very normal human response. We want vaccines and antiviral drugs to be available as soon as possible. "
Are you still able to travel sufficiently?
Stoffels: "No. I came back to Belgium when President Donald Trump closed the United States to non-citizens. I normally work in the US and now live in Belgium, where my children and grandchildren live. These are difficult times to work from home, but it's a good environment to be in quarantine (laughs). "
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Johnson & Johnson Announces a Lead Vaccine Candidate for COVID-19; Landmark New Partnership with U.S. Department of Health & Human Services; and Commitment to Supply One Billion Vaccines Worldwide for Emergency Pandemic Use
Mon March 30, 2020 7:22 AM|PR Newswire
https://seekingalpha.com/pr/17821865-johnson-johnson-announces-lead-vaccine-candidate-for-covidminus-19-landmark-new-partnership-u
Johnson & Johnson (JNJ) and BARDA Together Commit More than $1 Billion to Novel Coronavirus Vaccine Research and Development; Company Expects to Initiate Phase 1 Human Clinical Studies of Vaccine Candidate at Latest by September 2020
Johnson & Johnson Will Establish New U.S. Vaccine Manufacturing Capabilities and Additional Production Capacity Outside the U.S. to Begin Production at Risk to Help Ensure Global Vaccine Supply
NEW BRUNSWICK, N.J., March 30, 2020 /PRNewswire/ -- Johnson & Johnson (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 lead vaccine candidate at the latest by September 2020 and anticipates the first batches of a COVID-19 vaccine could be available for emergency use authorization in early 2021, a substantially accelerated timeframe in comparison to the typical vaccine development process.
Through a landmark new partnership, BARDA, which is part of the Office of the Assistant Secretary for Preparedness and Response (ASPR) at the U.S. Department of Health and Human Services, and Johnson & Johnson together have committed more than $1 billion of investment to co-fund vaccine research, development, and clinical testing. Johnson & Johnson will use its validated vaccine platform and is allocating resources, including personnel and infrastructure globally, as needed, to focus on these efforts. Separately, BARDA and the Company have provided additional funding that will enable expansion of their ongoing work to identify potential antiviral treatments against the novel coronavirus.
As part of its commitment, Johnson & Johnson is also expanding the Company's global manufacturing capacity, including through the establishment of new U.S. vaccine manufacturing capabilities and scaling up capacity in other countries. The additional capacity will assist in the rapid production of a vaccine and will enable the supply of more than one billion doses of a safe and effective vaccine globally. The Company plans to begin production at risk imminently and is committed to bringing an affordable vaccine to the public on a not-for-profit basis for emergency pandemic use.
Alex Gorsky, Chairman and Chief Executive Officer, Johnson & Johnson, said, "The world is facing an urgent public health crisis and we are committed to doing our part to make a COVID-19 vaccine available and affordable globally as quickly as possible. As the world's largest healthcare company, we feel a deep responsibility to improve the health of people around the world every day. Johnson & Johnson is well positioned through our combination of scientific expertise, operational scale and financial strength to bring our resources in collaboration with others to accelerate the fight against this pandemic."
Paul Stoffels, M.D., Vice Chairman of the Executive Committee and Chief Scientific Officer, Johnson & Johnson, said, "We greatly value the U.S. government's confidence and support for our R&D efforts. Johnson & Johnson's global team of experts has ramped up our research and development processes to unprecedented levels, and our teams are working tirelessly alongside BARDA, scientific partners, and global health authorities. We are very pleased to have identified a lead vaccine candidate from the constructs we have been working on since January. We are moving on an accelerated timeline toward Phase 1 human clinical trials at the latest by September 2020 and, supported by the global production capability that we are scaling up in parallel to this testing, we expect a vaccine could be ready for emergency use in early 2021."
Johnson & Johnson's Lead COVID-19 Vaccine Candidate
Johnson & Johnson began efforts in January 2020, as soon as the novel coronavirus (COVID-19) sequence became available, to research potential vaccine candidates. Research teams at Janssen, in collaboration with Beth Israel Deaconess Medical Center, part of Harvard Medical School, constructed and tested multiple vaccine candidates using the Janssen AdVac® technology.
Through collaborations with scientists at multiple academic institutions, the vaccine constructs were then tested to identify those with the most promise in producing an immune response in preclinical testing.
Based on this work, Johnson & Johnson has identified a lead COVID-19 vaccine candidate (with two back-ups), which will progress into the first manufacturing steps. Under an accelerated timeline, the Company is aiming to initiate a Phase 1 clinical study in September 2020, with clinical data on safety and efficacy expected to be available by the end of the year. This could allow vaccine availability for emergency use in early 2021. For comparison, the typical vaccine development process involves a number of different research stages, spanning 5 to 7 years, before a candidate is even considered for approval.
For more than 20 years, Johnson & Johnson has invested billions of dollars in antivirals and vaccine capabilities. The COVID-19 vaccine program is leveraging Janssen's proven AdVac® and PER.C6® technologies that provide the ability to rapidly develop new vaccine candidates and upscale production of the optimal vaccine candidate. The same technology was used to develop and manufacture the Company's Ebola vaccine and construct our Zika, RSV, and HIV vaccine candidates which are in Phase 2 or Phase 3 clinical development stages.
Expanded Antiviral Research
In addition to the vaccine development efforts, BARDA and Johnson & Johnson have also expanded their partnership to accelerate Janssen's ongoing work in screening compound libraries, including compounds from other pharmaceutical companies. The Company's aim is to identify potential treatments against the novel coronavirus. Johnson & Johnson and BARDA are both providing funding as part of this partnership. These antiviral screening efforts are being conducted in partnership with the Rega Institute for Medical Research (KU Leuven/University of Leuven), in Belgium.
As announced in February 2020, the Company and BARDA have been working closely with global partners to screen Janssen's library of antiviral molecules to accelerate the discovery of potential COVID-19 treatments.
COVID-19 belongs to a group of viruses called coronaviruses that attack the respiratory system. There is currently no approved vaccine, treatment or cure for COVID-19.
For more information on Johnson & Johnson's multi-pronged approach to combatting the pandemic, visit: www.jnj.com/coronavirus.
About Johnson & Johnson
At Johnson & Johnson, we believe good health is the foundation of vibrant lives, thriving communities and forward progress. That's why for more than 130 years, we have aimed to keep people well at every age and every stage of life. Today, as the world's largest and most broadly-based healthcare company, we are committed to using our reach and size for good. We strive to improve access and affordability, create healthier communities, and put a healthy mind, body and environment within reach of everyone, everywhere. We are blending our heart, science and ingenuity to profoundly change the trajectory of health for humanity. Learn more at www.jnj.com. Follow us at @JNJNews.
About the Janssen Pharmaceutical Companies
At Janssen, we're creating a future where disease is a thing of the past. We're the Pharmaceutical Companies of Johnson & Johnson, working tirelessly to make that future a reality for patients everywhere by fighting sickness with science, improving access with ingenuity, and healing hopelessness with heart. We focus on areas of medicine where we can make the biggest difference: Cardiovascular & Metabolism, Immunology, Infectious Diseases & Vaccines, Neuroscience, Oncology, and Pulmonary Hypertension. Learn more at www.janssen.com. Follow us at @JanssenGlobal.
Notice to Investors Concerning Forward-Looking Statements
This press release contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995 regarding development of potential preventive and treatment regimens for COVID-19. The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of the Janssen Pharmaceutical Companies and/or Johnson & Johnson. Risks and uncertainties include, but are not limited to: challenges and uncertainties inherent in product research and development, including the uncertainty of clinical success and of obtaining regulatory approvals; uncertainty of commercial success; manufacturing difficulties and delays; competition, including technological advances, new products and patents attained by competitors; challenges to patents; product efficacy or safety concerns resulting in product recalls or regulatory action; changes in behavior and spending patterns of purchasers of health care products and services; changes to applicable laws and regulations, including global health care reforms; and trends toward health care cost containment. A further list and descriptions of these risks, uncertainties and other factors can be found in Johnson & Johnson's Annual Report on Form 10-K for the fiscal year ended December 29, 2019, including in the sections captioned "Cautionary Note Regarding Forward-Looking Statements" and "Item 1A. Risk Factors," and in the company's most recently filed Quarterly Report on Form 10-Q, and the company's subsequent filings with the Securities and Exchange Commission. Copies of these filings are available online at www.sec.gov, www.jnj.com or on request from Johnson & Johnson. None of the Janssen Pharmaceutical Companies nor Johnson & Johnson undertakes to update any forward-looking statement as a result of new information or future events or developments.
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