COVID, flu combo jab from Pfizer/BioNTech heads for phase 3

A combination COVID-19 and influenza vaccine being developed by Pfizer and BioNTech has generated immune responses against the viruses in a phase 1/2 trial, setting up a pivotal phase 3 programme.

The mRNA-based vaccine, which includes antigens for influenza A and B, as well as SARS-CoV-2, is being compared to Pfizer and BioNTech’s Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine and a licensed flu shot in the study, which is enrolling up to 990 subjects.

According to the companies, the vaccine stimulated “robust” antibody and T-cell responses against the viruses, in the same ballpark as approved vaccines, with a safety profile similar to their already-marketed Comirnaty COVID-19 shot.

Specifically, point estimates for geometric mean titre (GMT) ratios were consistent with the criteria applied to approved vaccines against the respective influenza and SARS-CoV-2 strains and were at least as good as a licensed quadrivalent flu vaccine.

“This vaccine has the potential to lessen the impact of two respiratory diseases with a single injection and may simplify immunisation practices for providers, patients, and healthcare systems all over the world,” remarked Annaliesa Anderson, head of Pfizer’s vaccine R&D.

The expectation is that combining protection against multiple respiratory pathogens could produce savings to healthcare systems, with fewer vaccines needed and reduced administration, refrigeration, and transport costs.

The data has emerged just a few weeks after rival mRNA vaccine developer Moderna reported phase 1/2 results showing that its combined COVID-19 and flu vaccine was at least as effective as comparator vaccines given separately.

Moderna has also said it plans to start a phase 3 programme for its shot later this year, with an eye on getting regulatory approval in 2025.

Both companies see the combination as a way to offset plunging sales of their COVID-19 vaccines in a post-pandemic world, where the commercial model has shifted from government-funded vaccination programmes to a conventional commercial model.

Earlier this month, Pfizer launched a major cost-cutting drive in response to declining sales of its COVID-19 vaccines and therapeutics, which it expects to be around $9 billion lower than its earlier predictions.

“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 Professor Ugur Sahin, BioNTech’s chief executive.

“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,” he added.