Last year, a season of increased Respiratory Syncytial Virus (RSV) cases in infants concerned medical experts across the country. Following research by West Virginia University doctors, nurses, and pharmacists, Beyfortus, a new drug preventing severe RSV in vulnerable babies, has received approval from the U.S. Food and Drug Administration (FDA).
RSV is a virus affecting all age groups, but more commonly causes serious infection in at-risk infants – this includes infants younger than 6 months, premature infants, children with weakened immune systems or chronic lung or heart issues, and children with neuromuscular disorders. Infection commonly includes mild, cold-like symptoms. However, in vulnerable groups, this can progress into pneumonia or bronchitis resulting in hospitalization. According to the Center for Disease Control (CDC), RSV leads to around 70,000 hospitalizations and 100-300 deaths in children younger than 5 years old each year.
“RSV can cause very severe disease in children, especially the youngest among us. I have seen RSV cause kids to get really sick, making it very challenging for them [to] breathe to the point they need oxygen or additional breathing support. Protecting children from RSV, particularly children at higher risk — like preterm infants — is important to help them stay out of the hospital and reduce their chances of getting really sick,” said WVU School of Medicine Department of Pediatrics Division of Pediatric General Medicine assistant professor Dr. Lisa Costello.
Beyfortus is not a vaccine, but a monoclonal antibody injection, delivering antibodies through passive immunization rather than pushing the immune system to develop its own resistance. This was proven to reduce the risk of hospitalization in all infants, including healthy children and those with pre-existing health conditions, during clinical trials of the drug – including three pivotal Phase 3 clinical trials by WVU School of Medicine professor of pediatrics and WVU Medicine Children’s Hospital NICU attending neonatologist Dr. Mark J. Polak and a team of WVU Pediatric Research Unit physicians, nurse practitioners, nurses and pharmacists.
“RSV is a sneaky virus and attempts at making a vaccine against it in the past have not been successful. However, in the last several years there have been great leaps in understanding the RSV virus and gaining knowledge of where its weak points are that can be successfully attacked by a vaccine,” said Dr. Polak.
This success is not only attributed to the lengthy research accomplished by WVU experts, but also local families whose infants participated in clinical trials and provided vital information on the drug’s efficacy and safety.
Medical professionals across the country are anticipating another severe RSV season this fall and winter. In anticipation of this, pharmaceutical company AstraZeneca intends to make Beyfortus available to the public before the 2023-24 RSV season.
