Amid a tough respiratory syncytial virus (RSV) season, drugmakers Sanofi and AstraZeneca are facing supply shortages of their newly approved antibody, Beyfortus. Recognizing the severity of the issue, the CDC has expedited the distribution of tens of thousands of additional doses. However, several Senate Democrats have now joined forces to urge the drugmakers to address the underlying cause of the shortage.
Senator Tammy Duckworth expressed disappointment in Sanofi and AZ, suggesting that they significantly underestimated the quantity of Beyfortus, also known as nirsevimab, required to protect young children during this disease season.
The immunization, which received approval in July, encountered supply problems shortly after its launch. The CDC issued an advisory recommending that doctors prioritize available Beyfortus 100mg doses for infants at the highest risk of severe RSV. Sanofi attributed the shortfall to an unexpected surge in demand that disrupted supplies, despite their pre-planned extensive supply strategy.
Duckworth and fellow Senate Democrats are now seeking a comprehensive briefing from Sanofi and AZ regarding the availability of Beyfortus and the reasons behind the supply issues.
The lawmakers are eager to determine when the drugmakers became aware of the shortage in North America and the date they voluntarily reported it to the FDA. Additionally, they want to understand the factors that led to the significant underestimation of demand and the measures taken to address this issue.
The senators are also concerned about the pricing of Beyfortus. Sanofi charged the same amount, $495, for both the 50mg and 100mg doses, prompting Duckworth to question this decision.
Sanofi acknowledged the challenges of the antibody’s first rollout but emphasized that the demand for Beyfortus has been unprecedented. They assured that they are actively collaborating with AstraZeneca, the manufacturing partner, in close coordination with the FDA and CDC to meet the demand for this RSV season.
In response to the senators’ concerns, the drugmakers have committed to submitting a detailed response to the letter by November 30. As the supply shortage of Beyfortus continues, doctors and patients await a resolution to ensure adequate protection against RSV.