Moderna Vaccine EU Approval: New Recommendation

Moderna’s Next-Generation Covid-19 Vaccine Receives Favorable Review in Europe

A new weapon in the fight against Covid-19 may soon be available to Europeans, as Moderna announced on Tuesday a positive scientific opinion from the European Medicines Agency (EMA) for its updated vaccine, mNexspike (mRNA-1283). The final decision regarding authorization now rests with the European Commission.

The EMA’s Committee for Medicinal Products for Human Use (CHMP) recommended marketing authorization for mNexspike in individuals aged 12 and older, according to a company release. This positive assessment marks a meaningful step toward bolstering Europe’s defenses against evolving strains of the virus.

Did you know?– Moderna’s original Covid-19 vaccine, Spikevax, was among the first authorized for emergency use globally, paving the way for mRNA vaccine technology.

The CHMP plays a crucial role in evaluating the safety and efficacy of medicines intended for use across the European Union. While the committee’s opinion is highly influential, the ultimate authority to approve a vaccine lies with the European Commission, which typically aligns with the CHMP’s recommendations.

According to a statement from Moderna’s leadership, the new vaccine represents “an additional tool to meet a public health need.” Specifically, the company highlighted that individuals aged 65 and over in Europe continue to be disproportionately affected by severe cases of Covid-19, and mNexspike could offer enhanced protection for this vulnerable population.

Pro tip:– Staying up-to-date with recommended Covid-19 vaccinations,including boosters,remains the most effective way to protect yourself and others.

Moderna first pioneered messenger RNA (mRNA) technology with its original Covid-19 vaccine, Spikevax, in 2020, alongside Pfizer-BioNTech. The CHMP’s favorable opinion for mNexspike was based on data from advanced clinical trials demonstrating higher relative vaccine effectiveness (rVE) compared to Spikevax.

The mNexspike vaccine,also utilizing mRNA technology,received authorization in the United States in June for individuals 65 years and older,as well as those aged 12 to 64 who are at increased risk of complications from covid-19. This prior approval underscores the potential benefits of the updated vaccine and provides further confidence in its safety profile.

Reader question:– How might updated vaccines impact the long-term trajectory of the Covid-19 pandemic? Share your thoughts.