EXPERT PITCH: WVU medical experts help RSV medication gain FDA approval

Medical experts at West Virginia University are lauding the Food and Drug Administration’s approval of Beyfortus to prevent RSV as a major advancement in keeping infants and toddlers from developing serious conditions because of the virus.

Dr. Mark J. Polak and a team of physicians, nurse practitioners, nurses and pharmacists in the WVU Pediatric Research Unit participated in three pivotal Phase 3 clinical trials. Area families allowed their infants to join the projects which provided critical data on the safety and efficacy of the monoclonal antibody to prevent severe RSV.

Polak, professor in the WVU School of Medicine Department of Pediatrics Section of Neonatal and Newborn Medicine, is available to discuss the clinical trials and how Beyfortus can protect infants and toddlers. Dr. Lisa Costello, assistant professor in pediatrics, and Dr. Kathy Moffett, professor in pediatrics, are available to talk about the importance of protecting children, especially those at high risk for developing more serious conditions, from RSV.

Quotes:

“Last year, West Virginia and the whole country saw a very bad RSV season with many babies with no other health complications getting extremely sick, needing to see a doctor, visiting the emergency department and, in some cases, requiring hospitalization with a need for respiratory support with breathing machines. Some even needed a heart-lung bypass.

“If enough of our babies and toddlers receive this medication as a single intramuscular shot in the fall, we can avoid a repeat of the past and babies will fly through their first year without suffering from this virus.

“Since 1998 there has been a monoclonal antibody, Synagis (palivizumab), that can protect at-risk infants from severe RSV. However, because of limitations of this monoclonal antibody that requires monthly shots, this medication is only given to the most at-risk babies — those who are extremely immature infants, infants who need prolonged oxygen therapy or those with significant congenital heart defects.

“Beyfortus, like Synagis, is a monoclonal antibody called nirsevimab. The key difference between Synagis and Beyfortus is that the new medication is much stronger. It grabs onto RSV virus and won’t let it go. It also lasts longer. Synagis requires monthly shots for protection, while Beyfortus will provide protection for up to a year with just one shot.

“Beyfortus is not a vaccine. It is a monoclonal antibody and as such provides passive immunity to infants and toddlers who receive it. Also, unlike an antibiotic which kills bacteria, the monoclonal antibody enhances the baby’s immune system. The baby may still get RSV, but it stays as a mild cold.

“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. We will soon see RSV vaccines for pregnant mothers allowing them to pass immunity to the fetus and likely a vaccine that will be successfully given to babies.” — Dr. Mark J. Polak, professor of pediatrics, WVU School of Medicine and attending neonatologist, WVU Medicine Children’s Hospital, NICU

“As a pediatric hospitalist caring for children admitted to the hospital, I have taken care of hundreds of families who have had a child or children needing hospital care due to RSV.

“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 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.” – Dr. Lisa Costello, assistant professor, Department of Pediatrics Division of Pediatric General Medicine, WVU School of Medicine 

“We know that babies and young children with prematurity, especially chronic lung disease, are vulnerable to severe infection from viral infections, especially RSV in the first year after birth. Other infants as well with lowered reserve, such as congenital heart disease and neuromuscular disorders, also are at increased risk for hospitalization and severe disease course from RSV. In addition, every year we will have several term, healthy infants who develop severe RSV. For all these infants, it is because of the lack of any immunity/protection from this potentially deadly virus.” – Dr. Kathy Moffett, professor, Department of Pediatrics Division of Infectious Disease, WVU School of Medicine

West Virginia University experts can provide commentary, insights and opinions on various news topics. Search for an expert by name, title, area of expertise, or college/school/department in the Experts Database at WVUToday.

-WVU-

ls/07/26/23

MEDIA CONTACT: Linda Skidmore
Health Research Writer
WVU Research Communications
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