On Jul. 16, 2020, Dynavax Technologies and the Icahn School of Medicine at Mount Sinai announced they had entered into a collaboration to develop a universal influenza (flu) vaccine. Mount Sinai’s work in this area was funded under a contract award from the National Institute of Allergy and Infectious Diseases as part of the Collaborative Influenza Vaccine Innovation Centers (CIVICs) program established by the National Institute of Allergy and Infectious Diseases (NIAID). The Mount Sinai CIVICs team planned to evaluate a novel approach they have developed called chimeric hemagglutinin (cHA) designed to protect against all strains of influenza in combination with Dynavax’s CpG 1018TM adjuvant.

The development program will support an Investigational New Drug (IND) application for Phase I clinical trials. Drs. Peter Palese, PhD, Professor and Chair of the Department of Microbiology at Mount Sinai, Adolfo-Garcia-Sastre, PhD, Director of the Global Health and Emerging Pathogens Institute, and the Irene and Dr. Arthur M. Fishberg Professor of Microbiology and Medicine (Infectious Diseases) at Mount Sinai, and Florian Krammer, PhD, Professor of Microbiology at Mount Sinai will be leading the development of the program.

There are no approved universal flu vaccines.  The effectiveness of seasonal influenza vaccine ranges between 10% and 60%. A universal vaccine could eliminate the need to update and administer the seasonal flu vaccine annually and could protect against newly emerging flu strains, potentially including those that could cause a flu pandemic.

Influenza is a contagious respiratory illness caused by influenza viruses. It can cause mild to severe illness. Serious outcomes of flu infection can result in hospitalization or death. Some people, such as older people, young children, and people with certain health conditions, are at high risk of serious flu complications.  There are 2 epidemiological forms of influenza, seasonal and pandemic. Seasonal influenza epidemics, caused by influenza A and B viruses, result in 3–5 million severe cases and 300 000–500 000 deaths globally each year. Influenza pandemics caused by influenza A virus emerge at unpredictable intervals. They cause significantly increased morbidity and mortality, compared with seasonal influenza.

The U.S. Centers for Disease Control (CDC) annually estimates the burden of flu to the U.S. health system.  CDC estimates that the burden of illness during the 2018–2019 season included an estimated 35.5 million people getting sick with influenza, 16.5 million people going to a health care provider for their illness, 490,600 hospitalizations, and 34,200 deaths from influenza.