Moderna’s RSV Vaccine launch faces FDA delay

USA —Moderna, an established pharmaceutical and biotechnology firm based in Cambridge, Massachusetts, has reported that the FDA has postponed clearance of their experimental respiratory syncytial virus vaccine (RSV).

In a statement, Moderna stated that the postponement was due to “administrative constraints,” extending a review that the regulator had planned to finish by May 12 deadline.

The company further  noted that the regulator was yet to provide feedback about any difficulties that may hinder approval of its application, and is trying to finish its examination before the end of the month.

The FDA’s decision is significant for Moderna, which expects the shot, known as mRNA-1345, to become its second commercial medications.

This vaccine is being developed to prevent sickness caused by respiratory syncytial virus (RSV), a common lung infection. The corporation is requesting clearance in older adults.

Moderna has been preparing to commercialize the injection ahead of the fall immunization season. The business claimed it is still on track to accomplish that objective, as the shot may be authorized in time for a Centers for Disease Control and Prevention advisory panel meeting in June.

Moderna expects to rely on its RSV shot to counter declining demand for its COVID-19 vaccination due to declining cases.

This is comparable to Astrazeneca, Moderna’s competitor, which last week announced  that it is withdrawing its COVID-19 vaccine from the market citing  declining demand and availability of new vaccines.

However, some analysts are wary of its commercial prospects, considering that the vaccine would be available a year after competitor vaccines from GSK and Pfizer were first sold.

Both had strong acceptance last fall, but GSK’s shot has proved dominant, accounting for two-thirds of the entire market share and generating more than US$1 billion in revenue last year.

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