EMA Recommends Approval for Moderna's Advanced Covid-19 Vaccine

The European Medicines Agency (EMA) has announced that its Committee for Medicinal Products for Human Use (CHMP) has recommended the authorization of a next-generation Covid-19 vaccine developed by Moderna, known as mNexspike. This new vaccine is intended for the prevention of Covid-19 in individuals aged twelve years and older.

Unlike previous Covid-19 vaccines, mNexspike utilizes a modified approach in its design. The vaccine contains messenger RNA (mRNA) encapsulated in lipid nanoparticles, but rather than encoding the entire spike protein of the SARS-CoV-2 virus, it targets only specific segments. Specifically, the mRNA-1283 sequence in mNexspike encodes the membrane-bound N-terminal domain and the receptor-binding domain (RBD) of the spike protein, linked by a flexible peptide. In contrast, both earlier mRNA vaccines and protein-based vaccines commonly encode or contain the full-length spike protein.

The vaccine will be supplied as a ready-to-use injection in pre-filled syringes, offering convenience for both healthcare providers and recipients. This product is registered under the ATC code J07BN01.

mNexspike's efficacy and safety were evaluated in a large-scale Phase III clinical trial, comparing its results with those of Spikevax, Moderna's currently approved Covid-19 vaccine (mRNA-1273). The findings, previously disclosed in June 2024, demonstrated that mNexspike achieved a similar rate of preventing symptomatic Covid-19 cases compared to Spikevax. This establishes the new vaccine as non-inferior in its effectiveness for preventing disease.

The most common side effects reported among study participants were localized pain at the injection site, fatigue, headaches, muscle and joint pain, chills, swelling or tenderness in the underarm area, as well as nausea and vomiting. The overall side effect profile was comparable between mNexspike and the original Spikevax, suggesting consistent safety outcomes.

Data published in the medical journal The Lancet by Moderna's research team highlighted that mNexspike induces a stronger antibody response than its predecessor. This increased immunogenicity could potentially translate into improved protection, although the clinical significance of this advantage remains to be determined through ongoing post-marketing studies. Regulatory authorities will continue to monitor the vaccine's performance after its introduction to broader populations to gather more data on its effectiveness and safety in real-world settings.

The decision to focus the mRNA sequence on key domains of the spike protein, rather than the entire protein, may offer several advantages, including more targeted immune responses and possibly improved storage or handling characteristics. The shorter mRNA molecule could also contribute to increased vaccine stability and longer shelf-life, making distribution and administration more efficient.

With the CHMP's positive recommendation, mNexspike moves one step closer to availability in the European Union, pending formal approval by the European Commission. If authorized, this vaccine will join a portfolio of Covid-19 immunizations that continue to evolve in response to emerging variants and ongoing public health needs.

This development marks another step in the advancement of vaccine technology and the ongoing efforts to provide effective and accessible protection against Covid-19 for populations across Europe and beyond.