Pfizer and BioNTech have launched a clinical trial of a vaccine targeting both COVID-19 and the flu, the companies announced Thursday.
The Phase 1 trial is being conducted in the United States with 180 participants aged 18 to 64, with the first participant being dosed this week, the companies said. The follow-up period for each participant will be six months.
In this Sept. 8, 2022, file photo, a teenager receives the Pfizer-BioNTech COVID-19 booster vaccine targeting the Omicron BA.4 and BA.5 subvariants at Skippack Pharmacy in Schwenksville, Penn.
Hannah Beier/Reuters
“By combining both indications into a vaccine approach, we aim to provide people with an efficient way to receive immunization against two serious respiratory diseases with evolving viruses that require vaccine adaptation,” said Dr. Ugur Sahin, CEO and co-founder of BioNTech. in a statement.
The combination vaccine is based on the currently available bivalent COVID-19 booster and a quadrivalent mRNA influenza vaccine, which is designed to protect against four different influenza viruses.
The phase 1 trial will test the safety, immune response and optimal dose level of the combination vaccine, before moving on to larger trials. The data will also provide insight into the potential of mRNA vaccines to address more than one pathogen, Sahin said.
Annaliesa Anderson, senior vice president and chief scientific officer of vaccine research and development at Pfizer, called this an “exciting step in our ongoing journey with BioNTech as we collectively seek to transform the prevention of infectious diseases worldwide “.
“Even with seasonal flu vaccines in place, the burden of this virus is severe worldwide, causing thousands of deaths and hospitalizations each year,” he said in a statement.
In this Sept. 9, 2022, file photo, a man receives a flu shot from a pharmacist during an event hosted by the Chicago Department of Public Health at the Southwest Senior Center in Chicago.
Scott Olson/Getty Images
Studies indicate that the effectiveness of the COVID-19 vaccine wears off over time, although it is unclear whether all Americans will need an annual COVID-19 booster. As scientists continue to assess the need, several companies are working to create a single shot each fall that protects against both seasonal flu and COVID-19.
In addition to Pfizer, pharmaceutical companies Moderna and Novavax have announced plans to work on a combination injection.
Moderna said it plans to begin clinical trials of a single-dose vaccine that combines a COVID-19 booster and a flu booster by the end of the year, with hopes that the vaccine will be available for the 2023 season.
“We think this is a very big opportunity ahead of us, if we could bring a highly effective pan-respiratory annual booster to market,” said Stéphane Bancel, COE of Moderna, during the Sept. 9 investor meeting .
Last year, Novavax enrolled people in a Phase 1/2 study to evaluate the safety, tolerability and immune response of a combination vaccine using the company’s seasonal flu and COVID-19 vaccines. A confirmatory Phase 2 trial is expected to begin later this year, the company said in October.