The Johnson & Johnson Company announced the selection of a leading candidate for the COVID-19 vaccine it has been working on since January 2020 and, in association with the Janssen Company and the Advanced Biomedical Research and Development Authority (BARDA, in English), will expand its production capacity with the aim of providing a global supply of more than one billion doses of the vaccine.
The company is expected to initiate Phase 1 human clinical trials no later than September 2020 and anticipates that the first batches of the COVID-19 vaccine may be available for emergency use authorization in early 2021., a substantially accelerated period of time, compared to the typical vaccine development process.
Through a new historic partnership, BARDA, which is part of the United States Department of Health and Human Services Office of the Assistant Secretary for Preparedness and Response (ASPR), and Johnson & Johnson have committed more than $ 1 billion of investment to fund research, development and clinical testing of this vaccine. Johnson & Johnson will use its validated vaccine platform and is allocating resources, including personnel and infrastructure worldwide, as needed, to focus on these efforts. Both the pharmaceutical company and BARDA have allocated additional funds that will allow expanding efforts to identify possible antiviral treatments against the new coronavirus.
Johnson & Johnson is also expanding the company’s global manufacturing capacity, including by establishing new vaccine manufacturing capabilities in the United States and expanding capacity in other countries. The additional capacity will aid rapid vaccine production and enable the supply of more than one billion doses of a safe and effective vaccine globally. The company plans to begin production urgently and is committed to offering the public an affordable, non-profit vaccine to counter the pandemic.
In this regard, Alex Gorsky, President and CEO of Johnson & Johnson, said that “the world is facing an urgent public health crisis and we are committed to doing our part to make the COVID-19 vaccine available and affordable. globally as quickly as possible. As the world’s largest healthcare company, we feel a strong responsibility every day to improve the health of people around the world. Johnson & Johnson is well positioned through our combination of Scientific expertise, operational scale and financial strength to pool our resources in collaboration with others to accelerate the fight against this pandemic. “
Paul Stoffels, MD, Executive Committee Vice President and Chief Scientific Officer, Johnson & Johnson, added, “Johnson & Johnson’s global team of experts has increased 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 buildings we have been working on since January. We are moving forward on an accelerated schedule towards Phase 1 human clinical trials by September 2020 and, supported by the global production capacity that we are expanding in parallel with these tests, we hope that a vaccine will be ready for emergency use. in early 2021“
Candidate for the Johnson & Johnson COVID-19 vaccine
Johnson & Johnson began its efforts in January 2020, as soon as the new coronavirus sequence (COVID-19) was available, to investigate potential vaccine candidates. Janssen’s research teams, in collaboration with Beth Israel Deaconess Medical Center, part of the Harvard Medical School, built and tested multiple vaccine candidates using Janssen AdVac® technology.
Through collaborations with scientists from multiple academic institutions, vaccine constructs were tested to identify the most promising individuals in producing an immune response in preclinical testing.
Johnson & Johnson has identified a candidate for the COVID-19 vaccine (with two endorsements), which will advance to the first manufacturing steps. Under an accelerated schedule, the company aims to start 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 for the availability of vaccines for emergency use in early 2021. Usually, the typical vaccine development process involves several different research stages, spanning 5 to 7 years, even before a candidate is considered for approval.
The COVID-19 vaccine program is leveraging Janssen’s proven AdVac® and PER.C6® technologies, which provide the ability to rapidly develop new vaccine candidates and produce the optimal vaccine candidate. The same technology was used to develop and manufacture the Ebola vaccine and to build our Zika, respiratory syncytial virus and HIV vaccine candidates who are in the Phase 2 or Phase 3 clinical development stages.
Extended antiviral research
In addition to vaccine development efforts, BARDA and Johnson & Johnson have also expanded their partnership to accelerate Janssen’s ongoing work in examining compound libraries, including compounds from other pharmaceutical companies. The objective is identify possible treatments for the new coronavirus. Johnson & Johnson and BARDA are providing funding as part of this partnership. These antiviral detection efforts are carried out in association with the Rega Institute for Medical Research (KU Leuven / University of Leuven), in Belgium.
As announced in February 2020, Pharmaceutical and BARDA have been working closely with global partners to evaluate Janssen’s library of antiviral molecules to accelerate the discovery of possible COVID-19 treatments..
COVID-19 belongs to a group of viruses called coronaviruses that attack the respiratory system. Currently, there is no approved vaccine, treatment or cure for COVID-19.
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