(credits: Dr John Campbell) Moderna Receives U.S. FDA Approval for RSV Vaccine mRESVIA(R)

https://news.modernatx.com/new....s/news-details/2024/

May 31, 2024

Moderna, today announced that the U.S. Food and Drug Administration (FDA) has approved mRESVIA (mRNA-1345),

an mRNA respiratory syncytial virus (RSV) vaccine,

to protect adults aged 60 years and older from lower respiratory tract disease caused by RSV infection.

The approval was granted under a breakthrough therapy designation and marks the second approved mRNA product from Moderna.

Stéphane Bancel, Chief Executive Officer of Moderna.

The FDA approval of our second product, mRESVIA, builds on the strength and versatility of our mRNA platform

Moderna expects to have mRESVIA available for eligible populations in the U.S. by the 2024/2025 respiratory virus season.

Moderna has filed for mRNA-1345 approval with regulators in multiple markets around the world.

https://www.clinicaltrialsaren....a.com/news/moderna-r

Moderna races ahead in flu and Covid-19 combo vaccine race with Phase III win

Moderna injection mRNA-1083

Comprises a seasonal influenza vaccine candidate, mRNA-1010,

and a next-generation Covid-19 vaccine prospect called mRNA-1283.

Moderna announces positive data from a Phase III trial of its mRNA vaccine candidate.

Now, in a Phase III trial (NCT06097273) for mRNA-1083

Moderna

“statistically significantly higher immune responses” compared to existing vaccines on the market.

The trial met its primary endpoints, Moderna said in a 10 June press release.

Immune response was seen across three influenza virus strains (H1N1, H3N2, and B/Victoria) and against SARS-CoV-2.

Although Moderna has not published the full dataset from the Phase III trial,

it plans to present the results in more detail at an upcoming medical conference,

in addition to a submission for publication.

The company said it “will engage with regulators on next steps”.

Other mRNA vaccines in development

Moderna Advances Multiple Vaccine Programs to Late-Stage Clinical Trials

https://news.modernatx.com/new....s/news-details/2024/

Cytomegalovirus (CMV)

CMVictory is a pivotal Phase 3 trial evaluating mRNA-1647 against primary CMV infection in women 16 to 40 years of age.

Epstein-Barr virus (EBV)

mRNA-1189

The randomized, observer-blind, placebo-controlled study is fully enrolled.

Herpes simplex virus (HSV)

mRNA-1608

Phase 1/2 trial

The randomized 1:1:1:1, observer-blind, controlled study is fully enrolled with 300 participants in the U.S.

Varicella-Zoster virus (VZV)

Moderna's VZV vaccine candidate mRNA-1468 has initial data available from a Phase 1/2 trial

Norovirus

The Company is advancing mRNA-1403 toward a pivotal Phase 3 trial.