Monday, July 15, 2024

Respiratory Syncytial Virus Vaccine mRESVIA by Moderna Receives Positive CHMP Opinion, Awaiting EU Approval

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Moderna’s novel mRNA respiratory syncytial virus (RSV) vaccine, mRESVIA, has received a positive opinion from the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP). This endorsement marks a crucial advancement toward the vaccine’s authorization within the European Union (EU) to combat lower respiratory tract disease caused by the respiratory syncytial virus. The vaccine, leveraging the same lipid nanoparticle technology as Moderna’s COVID-19 vaccines, targets the F glycoprotein of RSV, a critical component in the virus’s ability to infect host cells.

The CHMP’s positive opinion rests on findings from the Phase III ConquerRSV clinical trial, which included approximately 37,000 participants across 22 countries. The primary analysis, with a median follow-up of 3.7 months, demonstrated a vaccine efficacy (VE) of 83.7% against respiratory syncytial virus lower respiratory tract disease (LRTD). Moreover, a supplementary analysis with a median follow-up of 8.6 months indicated a sustained VE of 63.3% against RSV-LRTD, even in cases with two or more symptoms. These robust results underscore the vaccine’s potential to significantly mitigate the impact of respiratory syncytial virus-related diseases.

Highlighting Ease of Administration for mRESVIA as EU Approval Anticipated Following CHMP Recommendation

Moderna CEO Stéphane Bancel emphasized the ease of administration with mRESVIA, which comes in a pre-filled syringe. This design can save healthcare professionals time and reduce administrative errors, enhancing the overall vaccination process. Bancel noted that mRESVIA represents a significant stride in addressing global public health challenges posed by respiratory diseases. The European Commission is expected to follow the CHMP’s recommendation and grant marketing authorization for the vaccine.

The US Food and Drug Administration (FDA) had already approved the vaccine under a breakthrough therapy designation in May, marking Moderna’s second approved mRNA product. Additionally, Moderna has submitted marketing authorization applications for mRNA-1345 in several global markets.

Respiratory Syncytial Virus

Respiratory Syncytial Virus Vaccine mRESVIA by Moderna Shows High Efficacy, Awaits EU Approval

mRESVIA employs advanced lipid nanoparticle technology similar to Moderna’s COVID-19 vaccines. The vaccine has demonstrated high efficacy rates in extensive clinical trials. A pre-filled syringe design facilitates easier administration and reduces errors. Approval from the European Commission is anticipated following the CHMP’s endorsement. The vaccine has already received FDA approval in the US, signaling strong regulatory backing.

The endorsement from CHMP for mRESVIA is a promising development for combating respiratory syncytial virus-related respiratory diseases in older adults. With the European Commission likely to grant marketing authorization soon, healthcare professionals can look forward to a new tool in their arsenal. The vaccine’s design, which simplifies administration, coupled with its robust clinical trial results, highlights its potential to significantly reduce the burden of respiratory syncytial virus. As Moderna continues to expand its portfolio with innovative mRNA solutions, the healthcare community can expect more breakthroughs that address critical public health needs effectively.


Resource: Moderna, June 28, 2024

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