HHS, Janssen Join To Develop Coronavirus Vaccine
Johnson & Johnson’s Janssen reports it will further expedite its investigational coronavirus (COVID-19) vaccine program through an expanded collaboration with the Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response (ASPR) at the US Department of Health & Human Services (HHS).
Janssen and BARDA will share research and development costs and expertise to help accelerate Janssen’s AdVac and PER.C6 technologies that provide the ability to rapidly upscale production of the optimal vaccine candidate. These same technologies were used to develop and manufacture Janssen’s investigational Ebola vaccine with BARDA support; that vaccine is being used in the Democratic Republic of the Congo as part of the current Ebola outbreak response. They were also used to construct the company’s Zika, respiratory syncytial, and HIV vaccine candidates.
In addition to an investigational Ebola vaccine, the BARDA and Janssen partnership has supported development of other products and technologies, including a treatment for blood injuries caused by acute levels of radiation and a treatment for injuries caused by inhaled sulfur mustard. The partnership has also supported two JLABS respiratory protection technology innovation challenges and established a health-security innovation zone at the new JLABS facility in Washington, DC. In addition to Janssen’s efforts to develop a vaccine candidate, the company is working closely with global partners to screen its library of antiviral molecules to accelerate the discovery of potential COVID-19 treatments to provide to people in China and globally.
In addition to an expanded collaboration with Janssen, BARDA is working with counterparts across the government, including within HHS and with the US Department of Defense. The team is reviewing potential vaccines, treatments and diagnostics from the public and private sectors, particularly products in development for Middle East Respiratory Syndrome (MERS) or Severe Acute Respiratory Syndrome (SARS), to identify promising candidates for development to detect, protect against, or treat people with novel coronavirus infections. This task force is interested in identifying products and technologies that have progressed into or beyond non-clinical studies, have established large-scale cGMP manufacturing capability, or utilize a US Food and Drug Administration (FDA)-cleared diagnostic platform.
There is currently no approved vaccine, treatment, or diagnostic for novel coronavirus infections; however, the FDA issued an emergency use authorization (EUA) to enable emergency use of a diagnostic test developed by the Centers for Disease Control and Prevention. To further support the novel coronavirus response, BARDA also opened an easy broad agency announcement, an EZ-BAA, specific to diagnostics that utilize FDA-cleared platforms, with a viable plan to meet requirements for the FDA to consider issuing an EUA within 12 weeks of an award.