With the FDA approval of nirsevimab-alip (Beyfortus), which is indicated for prevention of respiratory syncytial virus (RSV) in infants, clinicians will need to have important conversations with families around this monoclonal antibody, beginning this fall.
When a new agent or vaccine is FDA approved, there are a variety of important elements that happen during rollout, and certainly 1 area applies directly to clinicians—specifically, the framing of the discussion around the therapy with patients.
A good example of this aforementioned scenario is going to be happening this fall around the new monoclonal antibody, nirsevimab.
Back in July, the FDA approved nirsevimab to help prevent RSV in the infant population. In fact, it is the first-ever prophylactic product indicated for the prevention of RSV lower respiratory tract disease (LRTD) in newborns and infants born during or entering their first RSV season, and for children up to 24 months of age who remain vulnerable to severe RSV disease through their second RSV season.
In framing conversations between the clinicians and families, one of the novel aspects of nirsevimab is that it is a monoclonal antibody and not a vaccine. It is administered as a shot, but it has a different mechanism of action. One of the major differences is the immediacy of the protection of the monoclonal antibody.
“We need to clarify this point,” Octavio Ramilo, MD, chair, Department of Infectious Diseases, St. Jude Children’s Research Hospital said. “We give a [monoclonal] shot to the baby and we give them the antibodies and they are there in their blood...Obviously, the vaccines have a different mechanism…the minute we give the antibody, the person is protected. The vaccine takes time to build the antibody that can have a more prolonged benefit.”
Ramilo says these conversations with all families are important, but especially for those families who may be hesitant about giving their infant nirsevimab.
“When I talk with families that are hesitant, I think it's very important to understand what the concern is, and why,” Ramilo stated. “[Afterwards, we can explain] why we think that despite some theoretical concerns that they may have, we think the advantages are to prevent [RSV]. And I think once you explain that with them, you can make tremendous progress.”
He also says the vast experience with monoclonals overall has shown them to be safe and well-tolerated.
In the second part of our conversation with Ramilo, he discusses the differences between nirsevimab and vaccines, and ways clinicians can counsel families on it.
Watch the first part of the interview with Ramilo here where he discusses what it’s like to treat infants with RSV, and what the addition of nirsevimab could mean to clinicians and families with young infants.