Pfizer and BioNTech launch phase 1 trial of combined COVID-19 and flu vaccine

Pfizer and BioNTech have launched a clinical trial for a vaccine targeting both COVID-19 and influenza, the companies announced Thursday.

The Phase 1 trial is taking place in the United States with 180 participants between the ages of 18 and 64, with the first participant receiving this week, the companies said. The follow-up period for each participant will be six months.

PHOTO: In this September 8, 2022, file photo, a teenager receives the Pfizer-BioNTech COVID-19 booster vaccine targeting the BA.4 and BA.5 Omicron subvariants at Skippack Pharmacy in Schwenksville, Pennsylvania.

In this file photo from Sept. 8, 2022, a teenager receives the Pfizer-BioNTech COVID-19 booster vaccine targeting the BA.4 and BA.5 Omicron subvariants at Skippack Pharmacy in Schwenksville, Penn.

Hannah Beier/Reuters

“By combining the two indications in a single vaccine approach, we aim to provide individuals with an effective way to be vaccinated against two serious respiratory diseases with evolving viruses that require vaccine adaptation,” said Dr Ugur Sahin, CEO and co-founder of BioNTech. in a report.

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 treat more than one pathogen, Sahin said.

Annaliesa Anderson, Senior Vice President and Chief Scientific Officer of Vaccine Research and Development for Pfizer, called this “an exciting step in our ongoing journey with BioNTech as we collectively seek to transform infectious disease prevention in the world”.

“Even with existing seasonal flu vaccines, the burden of this virus is severe across the world, causing thousands of deaths and hospitalizations every year,” she said in a statement.

PHOTO: In this Sept. 9, 2022, file photo, a man gets his flu shot from a pharmacist at an event hosted by the Chicago Department of Public Health at the Southwest Senior Center in Chicago.

In this Sept. 9, 2022, file photo, a man gets his flu shot from a pharmacist at 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 fades over time, although it’s unclear whether every American will need an annual COVID-19 booster. As scientists continue to assess the need, several companies are working to create a single injection 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 combo shot.

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, hoping the vaccine be available for the 2023 season.

“We think there is a very big opportunity in front of us, if we could bring to market an annual high-efficiency pan-respiratory booster,” said Moderna COE Stéphane Bancel during the investor meeting on 9 september.

Last year, Novavax enrolled people in a Phase 1/2 study to assess the safety, tolerability and immune response of a combination vaccine using the company’s seasonal influenza and COVID-19 vaccines. . A confirmatory Phase 2 trial is expected to begin later this year, the company announced in October.

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