Europe—not US—first to authorize Moderna's combo mRNA flu-COVID vaccine

Moderna’s combo flu-COVID mRNA vaccine gets EU approval first, as U.S. withdrawal under RFK Jr. raises questions | Contesto: cronaca

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• Europe—not US—first to authorize Moderna's combo mRNA flu-COVID vaccine

Contesto

LONDON — European regulators on Friday became the first to authorize Moderna’s combined mRNA vaccine targeting both influenza and COVID-19, a milestone that underscores a transatlantic divergence in vaccine policy amid shifting political winds in the United States. The European Medicines Agency granted marketing authorization for the shot, known as mRNA-1083, which is designed to protect adults 50 and older against two respiratory viruses in a single injection. The approval comes more than a year after Moderna withdrew its application for the same vaccine from the U.S. Food and Drug Administration, a decision the company attributed to the anti-vaccine stance of Robert F. Kennedy Jr., who was then a prominent presidential candidate and has since been appointed to a key health advisory role. Industry analysts said the move reflected a broader recalibration of Moderna’s U.S. strategy, as Kennedy’s vocal skepticism of mRNA technology gained traction among some Republican lawmakers and voters. The combined vaccine represents a significant advance in respiratory illness prevention, potentially simplifying annual immunization schedules for older adults who are most vulnerable to severe outcomes from both influenza and COVID-19. Clinical trials showed that mRNA-1083 generated robust antibody responses against several flu strains and the SARS-CoV-2 virus, with a safety profile similar to existing standalone vaccines. Public health officials in Europe have emphasized that the authorization could help boost lagging vaccination rates in the region, particularly among seniors. Moderna’s decision to withdraw its FDA application last year was a stark illustration of how political pressures are reshaping the vaccine landscape in the United States. Kennedy, who has long promoted unsubstantiated claims linking vaccines to chronic diseases, has used his platform to question the safety and necessity of mRNA shots. While the FDA does not typically comment on withdrawn applications, sources familiar with the matter said Moderna executives feared that the approval process would become mired in partisan controversy, delaying access to a product that could benefit millions of...

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Categoria: cronaca