CHMP positive for mResvia, intended for the prevention of lower respiratory tract disease caused by respiratory syncytial virus(RSV).- Moderna Biotech.
On 27 June 2024, The Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product mResvia, intended for the prevention of lower respiratory tract (LRT) disease caused by respiratory syncytial virus(RSV). The applicant for this medicinal product is Moderna Biotech Spain S.L.
mResvia will be available as a dispersion for injection. mResvia is an mRNA vaccine (ATC code: J07BX05) containing single-stranded 5' capped mRNA encoding RSV glycoprotein F stabilised in the prefusion conformation. The prefusion F glycoprotein is the target of neutralising antibodies that mediate protection against RSV-associated respiratory tract disease. mResvia stimulates production of RSV A and RSV B neutralising antibodies and induction of antigen-specific cellular immune responses.
The benefit of mResvia is the prevention of RSV-confirmed lower respiratory tract disease in adults 60 years of age and older, as shown in a phase II/III randomised, placebo-controlled study. The most common side effects are injection site pain, fatigue, headache, myalgia and arthralgia.
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