Overwhelming Demand for Beyfortus Leads to Supply Shortage
The latest development in infant health care has hit a snag as demand for the new respiratory syncytial virus (RSV) vaccine, Beyfortus, significantly surpasses its supply. The manufacturer has ceased orders for some doses, creating a challenging situation for parents and healthcare providers.
CDC’s Recommendations for Scarce Beyfortus Doses
In response to the limited supply, the US Centers for Disease Control and Prevention (CDC) has advised doctors to allocate the scarce doses of Beyfortus, a new therapy known as nirsevimab, to infants who are at the highest risk. This includes babies under six months and those with health conditions that increase their vulnerability to severe RSV.
Alternatives and Prioritization Strategies
For babies between 8 and 19 months who qualify for the older RSV therapy, palivizumab, or Synagis, the CDC recommends discontinuing the use of Beyfortus. Unlike Beyfortus, which offers 6-month protection with a single dose, Synagis requires monthly administration throughout the RSV season.
Frustration among Healthcare Professionals
Dr. Buddy Creech, a pediatric infectious disease specialist, expresses disappointment over the inability to protect as many children as hoped due to the supply issues. The new guidelines mean that healthy infants over six months might miss out on Beyfortus, despite its benefits.
The Severity of RSV in Infants
RSV can cause serious respiratory issues in infants, leading to hospitalization. It primarily infects the lower lungs, causing difficulty in breathing and eating due to fluid-filled airways. Last season, a study found that 81% of infants requiring intensive care for RSV were full-term with no prior medical conditions.
CDC’s Initial Warning and Pediatrician Concerns
The CDC had previously alerted about rising RSV cases in the Southeast, signaling the start of the RSV season. Despite the initial enthusiasm for Beyfortus, pediatricians faced challenges, including its high cost (approximately $500 per dose) and uncertainty about insurance reimbursements, complicating access for many parents.
Marketing and Supply Challenges
Sanofi, in partnership with AstraZeneca, markets the immunization. Despite an aggressive supply plan that aimed to exceed previous pediatric vaccine rollouts, demand, especially for the 100 mg doses for babies born before RSV season, was higher than expected. Currently, Sanofi is not taking new orders for the 100mg doses.
CDC’s Response to Limited Supply
The CDC had briefly paused orders for the vaccine through its Vaccines for Children program, only to reopen it later for the 50-milligram dose, prioritizing providers with no initial orders or small quantities. The CDC expects more doses, both 50 and 100 milligrams, to become available every 2 to 3 weeks.
Pediatrician Perspectives and AAP’s Stance
Unexpected supply challenges have caught pediatricians off-guard. Dr. Sean O’Leary of the American Academy of Pediatrics (AAP) voiced concerns over these supply issues, which were not anticipated. The AAP urges doctors against using two 50 mg doses as a substitute for a 100 mg dose, as it hasn’t been studied and isn’t approved.
Future Outlook and Maternal Vaccine Option
As the shortage continues, the AAP seeks more detailed information about its duration. Meanwhile, the CDC advises counseling for pregnant individuals about the maternal RSV vaccine, Abryvso, which can protect newborns against severe RSV in their early months.
