• A new drug to help prevent RSV in newborns and infants has been approved by the FDA.
  • Experts agree Beyfortus can be helpful in preventing serious RSV infections and hospitalizations.
  • Beyfortus has demonstrated safety and efficacy with minimal risks and side effects.

The FDA recently announced the approval of a new preventative drug called Beyfortus (nirsevimab-alip) to be used for the prevention of Respiratory Syncytial Virus (RSV) lower respiratory tract disease in newborns and infants. Specifically, this will be for children heading into their first RSV season, up to 24 months old who remain vulnerable to severe RSV.

As a monoclonal antibody, Beyfortus that is able to mimic aspects of the immune system to fight off a viral infection. The drug is given as a preventative measure and one injection is expected to last all season.

RSV is an infection of the lungs and while this virus can affect people of any age, it leads to more serious concerns for infants or the elderly. According to the CDC, approximately 58,000-80,000 children younger than 5 years old are hospitalized due to RSV each year.

“RSV is a viral illness that occurs every winter for infants and babies. It results in doctor visits, ED visits and too often hospitalizations,” said Dr. Sharon Nachman, Chief of the Division of Pediatric Infectious Diseases at Stony Brook Children’s Hospital. “Babies run fevers and often have problems breathing. There is no specific therapy except for fluids and O2 when needed. Remember, babies have immature immune systems and also small and young lungs, leading to their problems handling this virus.”

RSV is the most common cold virus that affects infants and toddlers every year.

It is very contagious and irritates the airways, which can become very serious if it causes bronchiolitis or pneumonia (infection in small airways or air sacks of the lung respectively) in infants and young children, Dr. Thomas Truman, specialty medical officer for pediatric critical care medicine, explained. Babies that have congenital heart conditions, chronic lung disease, or have a history of being born prematurely are the most vulnerable, or highest risk group, to suffer moderate to severe respiratory disease from RSV.

Approximately 1 to 2% of all infants will be hospitalized each year because of RSV, and in rare cases the condition can result in death.

Bottom line: it is common, contagious, and can cause serious disease in young infants resulting in hospitalization and sometimes death, Truman added.

“This monoclonal [antibody] (it’s not a vaccine and it’s not a treatment for RSV) will help prevent both doctor and ED visits as well as hospitalizations,” Nachman explained. “The key to its success is the long half-life, meaning it stays active in a child’s body for many months, and allows the medicine to prevent RSV over the entire winter.”

Beyfortus appears to be a game changer when it comes to preventing serious RSV infections in infants and young children, Truman explained.

“While all children will eventually get an RSV illness, reducing those infections in the youngest and most vulnerable infants is key,” said Truman. “The COVID experience showed us very well that RSV and other contagious viral illnesses are just a part of doing business in our society, and Beyfortus will reduce that cost of doing business by preventing or reducing serious disease in our youngest, most vulnerable children.”

Monoclonal antibody therapy has been shown to be very safe and effective as shown by three large clinical trials.

Risks were noted in studies to be minimal and limited to rashes, injection site irritation, and fever, but severe allergic reaction, anaphylaxis, always remains a rare potential side effect, Truman stated.

Older children will not be candidates, but RSV illness in the older age groups is much less severe and rarely results in hospitalization.

Currently, there isn’t a good antiviral medication to treat RSV.

“Preventing the disease in young and high-risk infants is key and always starts with good handwashing and minimizing exposure to infected individuals,” said Truman. “There is a vaccine approved for older adults and one that is expected to be approved soon for pregnant women that would result in antibodies being passed on to the fetus and therefore prevent or reduce the likelihood of severe infection in those babies following birth.”

Nachman agrees prevention is key.

“Since none of us live in a bubble, your child will be exposed to both children and adults who have the virus and can easily pass it to them,” Nachman stated. “Good nutrition and good sleep habits will help keep children healthy. There are no approved or documented vitamins, over-the-counter therapies or herbal remedies that can either prevent RSV or treat it better than placebo.”

The FDA recently approved a new drug, Beyfortus to help prevent RSV in newborns and infants.

Physicians agree Beyfortus can be beneficial in preventing serious RSV infections and hospitalizations.

This drug has proven to be safe and effective with limited risks and side effects.

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