Novavax is ready to test a new vaccine that aims to provide protection against both COVID-19 and seasonal influenza.
The biotechnology company is enrolling patients in an early-stage clinical trial that will evaluate the safety and efficacy of combining its NanoFlu shot and its protein-based COVID-19 vaccine.
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Both of these vaccines have shown positive results when tested as standalone immunizations in late-stage clinical trials. An adjuvant has been added to the combined vaccine.
"This study is the first-of-its-kind to evaluate the vaccine's potential to induce a robust immune response, augmented by our Matrix-M adjuvant, against two life-threatening diseases simultaneously," said Dr. Gregory M. Glenn, president of research and development at Novavax.
"The combination of these two vaccines, which have individually delivered outstanding results with favorable safety and tolerability profiles, may lead to greater efficiencies for the health care system and achieve high levels of protection against COVID-19 and influenza with a single regimen."
In a Phase 3 trial of almost 30,000 adults in the United States and Mexico, Novavax's standalone COVID-19 vaccine has shown to be 100% protective against moderate and severe COVID-19 illness, with an overall efficacy of 90.4%.
NanoFlu has proven to generate a robust immune response to a variety of influenza strains in a Phase 3 trial of adults ages 65 and older.
Both illnesses are serious health threats throughout world. More than 647,400 people have died of COVID-19 in the United States. And the flu has killed 12,000 to 61,000 people annually since 2010, according to the U.S. Centers for Disease Control and Prevention.
The Phase 1/2 trial will evaluate the safety, tolerability and immune response in 640 healthy adults ages 50-70. Participants must have been either previously infected with the coronavirus or fully vaccinated to enroll in the study. It is being conducted in Australia.
Participants will receive two shots given 56 days apart, Reuters reported. The researchers hope to have results within the first six months of 2022. Preclinical studies have suggested that the combined vaccine can provide a robust immune response against COVID-19 and influenza.
Other vaccine manufacturers also are investigating combined vaccines for the two infectious diseases, including Vivaldi Bioscience. Their vaccine is still in preclinical studies. In March, Moderna CEO Stephane Bancel told The Wall Street Journal that the company also was planning to develop a combined vaccine, but the process most likely will take a few years.