mRNA Flu Shot Targets $8 Billion Respiratory Market

Moderna Inc.'s respiratory vaccine franchise is targeting an approximately $30 billion annual market, comprised of a $15 billion COVID-19 market, a $10 billion RSV market, and a $6 billion flu market, with the potential for growth with more effective vaccines.

According to Modern'a press release on September 13, 2023, the Company's respiratory products sales in 2027 are expected to be in the range of $8 billion to $15 billion, depending on certain variables.

"With today's positive Phase 3 flu results, along with previous results in COVID and RSV, we are now three for three on advancing respiratory disease programs to positive Phase 3 data," commented Stéphane Bancel, Chief Executive Officer of Moderna, in a press release.

Modera's press release specifically highlighted its Seasonal Influenza Vaccine business today.

The mRNA-1010 vaccine candidate has demonstrated an acceptable safety and tolerability profile across all clinical trials to date, including three Phase 3 trials (P301, P302, P303), and independent data and safety monitoring boards have raised no safety concerns.

In an interim analysis of the P303 study,mRNA-1010 met all co-primary endpoints across all four A and B strains (A/H1N1, A/H3N2, influenza B/Yamagata, B/Victoria).

Higher HAI geometric mean titers and seroconversion rates were observed for all four strains compared to a licensed comparator (Fluarix).

And local and systemic solicited adverse reactions were similar to those reported in previous mRNA-1010 studies.

Furthermore, improved immunogenicity was observed across age groups and, importantly, was seen in older adults.

mRNA-1010 also elicited higher HAI titers against A/H1N1, A/H3N2, B/Victoria, and comparable titers to B/Yamagata compared to Fluzone HD in a separate Phase 1/2 head-to-head study.

As the previous P302 efficacy study has not accrued its target case numbers by the end of the most recent season, the Company would need to enroll in a second season to accrue enough cases.

In light of P303 meeting all its primary endpoints, the Company has decided not to enroll in a second season in the P302 study.

The Company continues to advance a portfolio of 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 antigens to target multiple proteins involved in the influenza virus lifecycle to reduce the potential of viral antigenic escape (mRNA-1020 and mRNA-1030).

As of early September 2023, over 100 million influenza vaccines have been distributed in the U.S., preparing for the 2023-2024 flu season.