TL/DR –
The monoclonal antibody Beyfortus, used to prevent serious lung disease caused by RSV in infants, is in short supply with demand outpacing expectations. The CDC has issued a health advisory recommending available doses be prioritized for high-risk infants including those under 6 months of age and those with underlying conditions. The agency has also advised against doubling up 50mg doses for infants over 11 pounds and recommended suspending Beyfortus use in infants eligible for palivizumab, another RSV antibody treatment.
Monoclonal Antibody, Beyfortus, in Short Supply Amid High Demand
Due to unexpectedly high demand, the monoclonal antibody used to prevent Respiratory Syncytial Virus (RSV) in infants, Beyfortus, is in short supply. Federal officials suggest prioritizing doses for infants with the highest risk of severe illness. The drug’s manufacturer, Sanofi, has reported that demand has exceeded predictions.
The Centers for Disease Control and Prevention (CDC) issued a health advisory this Monday, recommending the allocation of available Beyfortus 100mg doses for infants under six months old and those with underlying conditions, who are at a higher risk for severe RSV disease.
Beyfortus Dosage Information and Recommendations
Beyfortus comes in two dosages – 100mg for infants weighing over 11 pounds, and 50mg for those weighing less. The CDC warns of a shortage of the 100mg doses due to manufacturing capacity and stock availability, thus, it can’t cater to all infants this season. Recommendations for the 50mg dose remain unchanged, with the CDC advising against doubling the smaller dose for infants over 11 pounds.
The use of Beyfortus amongst infants eligible for another RSV monoclonal antibody, palivizumab, should be halted, the CDC further recommended. Palivizumab is reserved for premature infants under six months old, and those with lung disease or heart conditions.
Sanofi Addresses High Demand for Beyfortus
Sanofi, the drug manufacturer, reported an unprecedented demand for Beyfortus, which received approval in August. They admitted the demand, particularly for the 100mg doses, has surpassed even their aggressive supply plan. The company confirmed it’s working with the CDC to enable even distribution of doses via the federal Vaccines For Children Program.
Beyfortus’ Indication and Popularity
Beyfortus is intended to prevent serious lung disease caused by RSV in infants under a year entering their first RSV season. It’s also suitable for children up to 24 months old entering their second RSV season who are at high risk of severe illness. As the first approved preventive treatment for RSV in infants, demand was anticipated to be high, especially after last year’s sever RSV season.
However, the rollout of the drug has been challenging, with parents struggling to find locations offering the shot. Priced at $495 per dose in the private sector, physicians are uncertain about insurance reimbursements for Beyfortus.
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