mRNA-based Flu Shot Advances in Clinical Research

Moderna Inc. today announced one of five influenza vaccine candidates in its portfolio published interim results from its pivotal Phase 3 safety and immunogenicity trial.

mRNA-1010 (P301) is an mRNA-based seasonal influenza (flu) vaccine candidate for adults.

mRNA-1010 encodes for hemagglutinin (HA) glycoproteins of the four influenza strains recommended by the World Health Organization (WHO) to prevent influenza.

Interim results indicate that mRNA-1010 achieved superiority on seroconversion rates for A/H3N2 and A/H1N1 and superiority on geometric mean titer ratios for A/H3N2 and non-inferiority on geometric mean titer ratios for A/H1N1.

Non-inferiority was not met for either endpoint for the influenza B/Victoria- and B/Yamagata-lineage strains.

"Today's results represent an important step forward in developing mRNA-based influenza vaccines to address the substantial burden of disease caused by influenza."

"We are encouraged by the safety and tolerability profile and the strong immunogenicity results against Influenza A viruses which cause the overwhelming majority of flu-related disease in older adults."

"We now look forward to the efficacy results from the ongoing pivotal Phase 3 efficacy study being conducted in parallel," said Stephen Hoge, M.D., Moderna's President, in a press release on February 16, 2023.

"While we did not achieve non-inferiority for the Influenza B strains, which are more frequent in younger populations, we have already updated the vaccine that we believe could improve immune responses against Influenza B and will seek to quickly confirm those improvements in an upcoming clinical study thanks to the agility of our mRNA platform."

The first per-protocol interim analysis of efficacy is now expected to be reviewed by an independent Data and Safety Monitoring Board (DSMB) before the end of the first quarter of 2023.

Based on these results, the DSMB will notify the Company whether the primary efficacy endpoint has been met or whether the study should continue accruing further cases toward the final analysis.

Moderna is advancing a portfolio of five influenza vaccine candidates that include additional HA antigens for broader coverage of circulating influenza A strains (mRNA-1011 and mRNA-1012) and candidates that incorporate both HA and neuraminidase (NA) antigens to target multiple proteins involved in the influenza virus lifecycle to reduce the potential of viral antigenic escape (mRNA-1020 and mRNA-1030).

Moderna is also developing combination vaccine candidates, including vaccine candidates against influenza and SARS-CoV-2, influenza and RSV, and influenza, SARS-CoV-2, and RSV.

The goal of Moderna's combination vaccine candidates is to protect against multiple respiratory pathogens in a single vaccine.

Moderna's unedited press release is available at this link.

Other flu shot news is posted at PrecisionVaccinations.