Pfizer, BioNTech prep flu-COVID mRNA combo shot for phase 3, reprising Moderna race after seeing early data

The race is on—again. Having already gone up against Moderna in COVID-19 and influenza, Pfizer and BioNTech have now followed their recurring rival in reporting early-phase data on an mRNA combination vaccine against both pathogens—and in outlining plans to start a pivotal trial.

Moderna shared phase 1/2 data on its combination candidate, mRNA-1083, at the start of the month and moved quickly into the next stage of development, dosing the first participant in a pivotal trial early this week. The biotech’s progress ratcheted up the pressure on Pfizer and BioNTech. Now, in a reprise of the race for the COVID-19 market, the partners have outlined plans to join Moderna in phase 3.

Pfizer and BioNTech committed to moving lead formulations of their combination vaccine candidate into a pivotal trial in the coming months after getting a look at phase 1/2 data. The partners are yet to post detailed data, but the limited look shared to date suggests they may be evenly matched with Moderna again.

Point estimates of geometric mean titer (GMT) ratios, a measure of antibody response, for all matched flu strains were greater than 1 relative to a licensed quadrivalent influenza shot.

Moderna, on the other hand, gave a slightly more detailed breakdown of its data, splitting the data up by age group, but the headline message was the same. The GMT ratios for Moderna’s candidate were 1 or greater compared to licensed flu vaccines. 

Pfizer and BioNTech said the safety profile of their lead combination formulations were consistent with that of their COVID-19 vaccine. Annaliesa Anderson, Ph.D., senior vice president and head, vaccine research and development at Pfizer, outlined what safe vaccines that protect against two key respiratory viruses would mean for healthcare.

“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. Today’s results are an important achievement towards our ambition of providing a broad portfolio of respiratory combination vaccines,” Anderson said in a statement.

As happened in COVID-19, providers, patients and healthcare systems may have at least two mRNA combination vaccines to choose from. Moderna is setting the pace so far, with the biotech aiming to file for approval of its combination candidate in 2025.