Pfizer and BioNTech release COVID/flu vaccine test data (NYSE:PFE)

Pfizer (NYSE: PFE) and BioNTech (NASDAQ: BNTX) announced Friday that a Phase 3 clinical trial for its combined mRNA vaccine against influenza and COVID-19 met only one of its two main goals.

The study, which involved more than 8,000 healthy adults aged 18 to 64, was Designed to test the combination vaccine compared to an approved flu vaccine and the companies' FDA-approved COVID-19 vaccine. Researchers then measured participants' antibody responses to flu strains A and B, as well as COVID-19.

Citing topline data, Pfizer (PFE) and BioNTech (BNTX) stated that the combination vaccine did not meet the primary immunogenicity objective related to comparable performance (non-inferiority) to the influenza B strain.

However, there were higher reactions to influenza A and comparable reactions to COVID-19 compared to the comparator vaccines. An ongoing safety analysis showed no evidence of safety for the combination vaccine.

In addition, the duo provided an update on Pfizer's (PFE) second-generation trivalent influenza vaccine (tIRV). Citing data from people ages 18 to 64 who received tIRV as part of a Phase 2 trial, the companies said the mRNA vaccine showed encouraging responses to influenza A and B, including more robust responses to influenza A compared to an approved flu shot.

PFE and BNTX added that the results show no new safety signals and that data from adults aged 65 and over would be made available later.