General Medicine

Moderna Seeks Approval of mRNA-Based RSV Vaccine for Older Adults

Diana Ernst, RPh
|
Publish Date
The investigational RSV vaccine consists of a single mRNA sequence encoding for a stabilized prefusion F glycoprotein.

Moderna has initiated a rolling submission of a Biologics License Application (BLA) for mRNA-1345, an investigational respiratory syncytial virus (RSV) vaccine for the prevention of RSV-associated lower respiratory tract disease (RSV-LRTD) and acute respiratory disease in adults aged 60 years or older.

The BLA is supported by data from the double-blind, placebo-controlled ConquerRSV trial (ClinicalTrials.gov Identifier: NCT05127434). The study enrolled approximately 37,000 adults 60 years of age and older. Participants were randomly assigned to receive a single dose of mRNA-1345 or placebo. The primary endpoint was vaccine efficacy, defined as the prevention of the first episode of RSV-LRTD with 2 or more symptoms, or with 3 or more symptoms, from 14 days post vaccination through 12 months.

“
Our mRNA platform has allowed us to move from initial clinical testing to our first international phase 3 trial to initiation of regulatory submissions for mRNA-1345 in just 2 years, enabling us to tackle this pervasive public health burden with speed and clinical rigor.

According to a prespecified interim analysis, vaccine efficacy was 83.7% (95.88% CI, 66.1-92.2; P <.0001) against RSV-LRTD, defined by 2 or more symptoms. There were 64 cases of RSV-LRTD with 2 or more symptoms reported in the interim analysis; 55 of these cases occurred in the placebo group while 9 occurred in the mRNA-1345 group. 

Vaccine efficacy against RSV-LRTD with 3 or more symptoms was reported to be 82.4% (96.36% CI, 34.8-95.3; P =.0078). Among the 20 cases of RSV-LRTD with 3 or more symptoms, 17 cases were observed in the placebo group and 3 cases were observed in the mRNA-1345 group.

The most commonly reported adverse reactions were injection site pain, fatigue, headache, myalgia, and arthralgia. The vaccine candidate was generally found to be well tolerated; no safety concerns were identified.

“RSV is a major cause of lower respiratory tract infections in older adults and can cause a signicant burden to health systems through hospitalizations and emergency care admissions,” said Stéphane Bancel, CEO of Moderna. “Our mRNA platform has allowed us to move from initial clinical testing to our first international phase 3 trial to initiation of regulatory submissions for mRNA-1345 in just 2 years, enabling us to tackle this pervasive public health burden with speed and clinical rigor.”

Additional efficacy analyses from the ConquerRSV study are planned as cases accrue. A phase 1 trial evaluating mRNA-1345 in pediatric patients (ClinicalTrials.gov Identifier: NCT05743881) has also been initiated.

This article originally appeared on MPR

References:
  1. Moderna announces global regulatory submissions for its respiratory syncytial virus (RSV) vaccine, mRNA-1345. News release. Moderna. July 5, 2023. https://investors.modernatx.com/news/news-details/2023/Moderna-Announces-Global-Regulatory-Submissions-For-Its-Respiratory-Syncytial-Virus-RSV-Vaccine-MRNA-1345/default.aspx.
  2. Moderna announces mRNA-1345, an investigational respiratory syncytial virus (RSV) vaccine, has met primary efficacy endpoints in phase 3 trial in older adults. News release. Moderna. January 17, 2023. Accessed July 6, 2023. https://news.modernatx.com/news/news-details/2023/Moderna-Announces-mRNA-1345-an-Investigational-Respiratory-Syncytial-Virus-RSV-Vaccine-Has-Met-Primary-Efficacy-Endpoints-in-Phase-3-Trial-in-Older-Adults/default.aspx.