COVID-19 Information and Resources
During the uncertainty caused by the COVID-19 pandemic, Dynavax has acted quickly to focus on four key areas – these include safeguarding the health and safety of our employees and customers; continuing effective operations to ensure patient access to HEPLISAV-B® [Hepatitis B Vaccine (Recombinant), Adjuvanted]; maintaining our financial strength and stability; and supporting efforts to develop a COVID-19 vaccine.
Protecting Our Workforce and Minimizing the Spread of COVID-19
- The health and safety of Dynavax’s employees and customers is of paramount importance.
- The Company has implemented remote working operations for employees at its corporate offices in Emeryville, California.
- The Company’s manufacturing facility in Dusseldorf, Germany is employing special measures to continue operations safely.
- Dynavax has shifted from in-person interactions by its field sales force to virtual field calls in order to allow Dynavax to continue to serve the needs of physicians, patients, and customers during this critical time.
Support to the Front-line Healthcare Workforce
- Dynavax is donating 10,000 doses of HEPLISAV-B adult vaccine to help protect healthcare professionals on the front lines of the COVID-19 response against hepatitis B, a potentially deadly virus that is spread through contact with infected blood and bodily fluids and can live on surfaces for at least seven days.
- Direct Relief is administering the donation program on behalf of Dynavax. Interested healthcare providers and facilities throughout the U.S. who are vaccinating surge healthcare workers and hospital staff can visit DirectRelief.org/apply to learn more about accessing the donated vaccine supply of HEPLISAV-B.
Ensuring Access to HEPLISAV-B
- Dynavax has a secure supply chain that is able to meet U.S. market demand for HEPLISAV-B.
- The Company continues to produce hepatitis B surface antigen at its facility in Dusseldorf, Germany.
- The Contract Manufacturing Organization (CMO), located in the U.S., that produces the CpG 1018 adjuvant used in HEPLISAV-B remains capable of production.
- Dynavax estimates it currently has inventory of finished drug product sufficient to meet more than one year of projected demand and drug substance to fulfill approximately an additional year of estimated demand.
Continuing to Advance Clinical Trials of HEPLISAV-B
- HEPLISAV-B post marketing observational studies are fully enrolled and continuing uninterrupted. Due to the design and conduct of the studies, the Company does not anticipate an impact to the integrity of the studies as a result of the “shelter in place” mandates in California.
- HEPLISAV-B dialysis study continues to enroll patients. The study is focused on patients entering dialysis treatment, which is classified under the ‘essential travel’ exemptions and therefore is expected to continue during this period of reduced medical services. The Company anticipates reporting data from the study’s interim analysis later this month (April). This data was selected for presentation at the 2020 Annual Conference on Vaccinology Research (ACVR), which has been cancelled.
Delivering on the Promise of CpG 1018
- Dynavax has been actively pursuing opportunities to collaborate with other organizations on the development of additional vaccines, including a COVID-19 vaccine, by leveraging the Company’s proprietary toll-like receptor 9 (TLR9) agonist adjuvant, CpG 1018, the adjuvant used in HEPLISAV-B, an adult hepatitis B vaccine approved by the U.S. Food and Drug Administration (FDA).
- Dynavax developed CpG 1018 to provide an increased vaccine immune response, which has been demonstrated in HEPLISAV-B. CpG 1018 provides a well‑developed technology with a significant safety database, potentially accelerating the development and large-scale manufacturing of vaccines for emerging pathogens, such as pandemic influenza and coronavirus.
- The Company has recently announced multiple collaborations focused on COVID-19, including with the Coalition for Epidemic Preparedness Innovations (CEPI), the University of Queensland, and Clover Biopharmaceuticals, and continues to work to identify other programs where CpG 1018 can be utilized to enhance the immune response to a coronavirus vaccine. The Company and its CMO are developing plans for scale-up activities to support pandemic level of production of CpG 1018 adjuvant, as necessary to support the Company’s multiple collaborations to develop a coronavirus vaccine.