Ca-ssis/istock via Getty Images

Pfizer, BioNTech Reveals Data on Combined COVID and Flu Vaccine

The companies state that results from phase 1 and 2 clinical trials reflect promising outcomes for a combined vaccine.

Pfizer and its partner, BioNTech, announced positive clinical trial data for an mRNA-based combined vaccine for influenza and COVID-19. The announcement highlights data from a phase 1/2 clinical study in health participants ages 18–64.  

“We are encouraged by these early results in our Phase 1/2 study of our combination vaccine candidates against influenza and COVID-19. This vaccine has the potential to lessen the impact of two respiratory diseases with a single injection and may simplify immunization practices for providers, patients, and healthcare systems all over the world,” Annaliesa Anderson, PhD, FAAM, senior vice president and head of vaccine research and development at Pfizer, said in the press release. 

In December 2022, the United States Food and Drug Administration (FDA) granted the companies Fast Track Designation for this combinatory vaccine. According to the press release, the clinical study compared the combinatory vaccine to existing and approved influenza and COVID-19 vaccines.  

“mRNA-based vaccines have demonstrated their ability to induce robust antibody and T-cell responses, and we look forward to starting Phase 3 clinical development. Today’s results are an important achievement towards our ambition of providing a broad portfolio of respiratory combination vaccines,” added Anderson.  

The company announcement revealed that the combined formulation was safe and tolerable in clinical trial participants with a similar profile to the approved COVID-19 vaccine. The most common side effects of the Pfizer BioNTech CDOVID-19 vaccine are injection site pain and flu-like symptoms; however, some patients may experience more severe symptoms, including severe allergic reactions, myocarditis, pericarditis, and more.  

Recent studies have indicated that COVID-19 vaccine uptake has been low among immunocompromised individuals. Additionally, many KFF survey respondents indicated they would not get the updated booster or administer it to their children.  

Some experts hypothesize that a combined formulation may improve vaccine uptake and protect patients against co-infections.  

“Studies of confirmed viral infections suggest that COVID-19 adopts a seasonal pattern with peaks in fall and winter, similar to other respiratory diseases. Co-infections as well as consecutive respiratory infection during this period can further increase the risk of severe illness,” said Ugur Sahin, MD, chief executive officer and co-founder of BioNTech, in the release.  

“Combination vaccines have the potential to become a mainstay of routine vaccination against respiratory diseases, especially for the vaccination of populations who have a higher risk of severe illness.” 

Next Steps

Dig Deeper on Pharmaceuticals