The FDA has granted Fast Track status to Pfizer and BioNTech’s investigational vaccine for protection against both COVID-19 and influenza.

The vaccine combines messenger RNA strands encoding the original SARS-CoV-2 protein, the spike protein of Omicron BA.4/BA.5 and the hemagglutinin of four different influenza strains. Hemagglutinins are glycoproteins that bind to receptors on red blood cells to initiate viral attachment.

The vaccine candidate is currently in a phase 1 trial.

The FDA grants Fast Track regulatory reviews to drugs that treat a serious or life-threatening condition and fill an unmet medical need.