A Maryland-based biotechnology company on Sept. 8 announced the launch of a clinical trial that will examine the efficacy and safety of a combined flu/COVID-19 vaccine.
The early-stage phase 1/2 study will examine a combination of a seasonal influenza vaccine candidate from Novavax and a COVID-19 vaccine candidate the company makes, neither of which have been authorized or approved for use in the United States.
Approximately 640 healthy adults between the ages of 50 and 70 will participate in the trial, which will take place in Australia. Only people who have been previously infected with the CCP (Chinese Communist Party) virus, which causes COVID-19, or have been vaccinated with an authorized COVID-19 vaccine at least eight weeks prior to enrollment will be considered.
Results are expected during the first half of 2022.
“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,” Dr. Gregory M. Glenn, president of research and development at Novavax, said in a statement.
“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 healthcare system and achieve high levels of protection against COVID-19 and influenza with a single regimen.”
Earlier findings suggested the combination of the shots could be a “viable immunization strategy,” the company stated over the summer. Preclinical trials of the combo vaccine showed good results, Novavax scientists said in a study that hasn’t been peer-reviewed.
NanoFlu, the company’s flu vaccine, has been studied for years but never has been authorized or approved. Work on the COVID-19 vaccine began last year but the company still hasn’t applied for emergency use authorization in the United States, though it did in India and the Philippines last month.
Novavax received $1.6 billion from the Trump administration to develop a COVID-19 vaccine.
A phase 3 trial for the COVID-19 vaccine showed 100 percent protection against moderate and severe disease and 90.4 percent efficacy overall, according to a June statement from the company.
The vaccine is in the subunit class, meaning it doesn’t contain live components of the CCP virus. Subunits instead contain components, or antigens, of the pathogen that are believed to best trigger the immune system.
The two most widely used COVID-19 vaccines in the United States are based on messenger RNA technology. The new type of vaccine also doesn’t contain the virus. Instead, the messenger RNA is utilized to teach cells how to make a protein that triggers an immune response.
The third, from Johnson & Johnson, is an adenovirus-based vaccine that uses a common virus combined with a gene from the CCP virus’s spike protein to stimulate the immune system.
If the Novavax COVID-19 vaccine ultimately gains authorization, it would offer an option to people “that are uncomfortable with the genetic vaccine strategy,” Dr. Robert Malone, a vaccine inventor, told The Epoch Times in a recent interview.