🌎 Resumen en español · traducción automática
El comité asesor de la FDA votó unánimemente el 18 de junio para recomendar la vacuna contra la influenza mFlusiva de Moderna para adultos mayores de 50 años, aunque el camino hacia la aprobación final enfrenta incertidumbre debido a que la FDA carece de un jefe de vacunas permanente y comisionado, y debe tomar una decisión antes del 5 de agosto. La vacuna de ARNm ofrece ventajas significativas sobre las vacunas tradicionales, ya que puede desarrollarse más rápidamente y adaptarse durante el año para coincidir mejor con las cepas de virus predominantes, lo que la posiciona como una herramienta importante para prepararse ante futuras cepas emergentes o pandémicas.
Traducción y resumen generados por IA a partir del artículo en inglés. Puede contener errores; consulte el texto original.
The U.S. Food and Drug Administration‘s advisory panel voted unanimously on June 18 to recommend Moderna’s mRNA influenza vaccine, mFlusiva, for adults 50 and older, Nathaniel Weixel reports for The Hill.
“Moderna is seeking standard approval for its vaccine in the younger group and an accelerated approval in the latter. The company will be required to run an additional clinical trial after the vaccine reaches the market in the older group,” Weixel writes.
However, the path forward for the vaccine is uncertain. That’s because the advisory committee recommendations are nonbinding, and the FDA needs to make a final decision on approval by Aug. 5. That said, Weixel reports that it is not clear who will make this final decision since the FDA has no permanent vaccine chief nor a commissioner.
And on top of that, Weixel reports that the vaccine will then need to be formally recommended by the Centers for Disease Control and Prevention’s advisory committee, “which a federal judge has blocked from meeting with its current membership.” National Institutes of Health Director Jay Bhattacharya is the acting CDC director.
Because adults 65 and older are at increased risk of developing serious complications from flu, this population needs to get vaccinated. And while there are vaccines on the market that are specifically meant for older populations, Weixel reports that they take longer to manufacture and are not as flexible as the mRNA platform in targeting a specific strain of virus.
