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Everything Parents Need to Know About the New FDA-Approved RSV Shot for Babies and Toddlers

Everything Parents Need to Know About the New FDA-Approved RSV Shot for Babies and Toddlers

Guest Post By Genevieve Kane, MSN, RN

Respiratory syncytial virus, commonly known as RSV, can be dangerous for infants and young children. According to the Centers for Disease Control and Prevention (CDC), RSV is responsible for 58,000-80,000 yearly hospitalizations for children five years old and younger. And it is responsible for several more visits to doctor’s offices and urgent care.

Previously, monoclonal antibody shots given to high-risk infants and children was one of the only ways to prevent RSV. These original monoclonal antibody shots are expensive and typically given monthly.

However, as of July 17th, 2023, parents and caregivers now have another option to prevent RSV. This shot is also a monoclonal antibody. However, per the U.S. Food and Drug Administration (FDA), the new option, called Beyfortus™, can last for an entire RSV season and requires only one shot. Additionally, Beyfortus™ is approved for all infants, and should be widely available.

 New FDA-Approved RSV Shot for Babies and Toddlers

Everything Parents Need to Know About the New FDA-Approved RSV Shot for Babies and Toddlers

If you are expecting a new baby or have a little one and are concerned about RSV, here is everything you need to know about the FDA-approved RSV shot for babies and toddlers.

What is Beyfortus™?

Beyfortus™ is an FDA-approved RSV shot. The FDA explains that like the other RSV shots available, Beyfortus™ is a monoclonal antibody. However, what makes Beyfortus™ different is that only one dose is required for the entirety of the RSV season and that this shot will be widely available to all infants for RSV prevention.

Monoclonal antibodies are special proteins that are made in a lab, per the FDA. They work by copying some of your body’s immune defenses. Monoclonal antibodies can recognize specific harmful targets, such as RSV, and help your body fight them off.

The new RSV shot was created by the companies Sanofi and AstraZeneca. Beyfortus™ is approved for infants and children up to 24 months old who are born during RSV season, are about to experience their first RSV season, or who are up to 24 months old and have risk factors for severe RSV.

According to Sanofi, the goal is to have Beyfortus™ available in the United States before the 2023-2024 RSV season.  

Safety of Beyfortus™

In order to receive approval, Beyfortus™ underwent three clinical trials and demonstrated both its safety and efficacy, per the FDA. This means that the RSV shot Beyfortus™ is considered safe for use and effective at preventing RSV.

Two of those clinical trials, 3 and 4, were randomized, double-blind, placebo controlled, multicenter clinical trials. Randomized, double-blind, placebo controlled trials are generally considered the gold standard for clinical testing.

The FDA explained that to measure Beyfortus’s™ effectiveness, they looked at the incidence of Medically Attended RSV Lower Respiratory Tract Infection (MA RSV LRTI) during the 150 day period after Beyfortus™ was given.

The FDA notes that the MA RSV LRTI includes visits from several health care providers, including, but not limited to doctors, nurse practitioners, and other health care personnel involved with a child’s care. The visits measured in the 150 day period could take place in an outpatient setting like a primary care office and urgent care, or inpatient setting in a hospital.

The results from each of the clinical trials were promising. The RSV shot’s ability to prevent a MA RSV LRTI was effective in each trial for the 150 day period, which is approximately 5 months. The 5 month benchmark was used as that is the typical length of an average RSV season.

 New FDA-Approved RSV Shot for Babies and Toddlers

While Beyfortus™ is generally considered safe, there are side effects to be aware of. These include, but are not limited to a rash and injection site reactions.

Additionally, the FDA notes that Beyfortus™ should be used with caution in children with a history of serious hypersensitivity reactions to any of the ingredients found in Beyfortus™. 

Caution should also be used in administering Beyfortus™ to infants and children with significant bleeding disorders.

Looking for more information on RSV and respiratory diseases in kids? You’ll find these helpful:

Key Takeaways for the Beyfortus™ RSV Shot for Babies and Toddlers

RSV causes children, parents, and providers a significant amount of stress each year. Sanofi notes that RSV is the leading cause of hospitalization for infants under a year of age in the United States. Each year nearly 600,000 infants and children seek medical care for RSV — this number includes both outpatient visits such as to a primary care provider, and inpatient stays.

Having an effective RSV shot that is widely available is a big step at reducing the burden of RSV every year. Most children experience a case of RSV at some point in their lives. For those who aren’t severely affected, it can simply resemble a common cold. 

 New FDA-Approved RSV Shot for Babies and Toddlers

However, for parents and caregivers who have experienced a more severe case of RSV with their little one, it can be scary watching your little one struggle to breathe. The hope is that the new RSV shot from Beyfortus™ will prevent several of these RSV cases from happening.

If you have a baby or child younger than 24 months or are expecting a baby during RSV season (which runs closely with cold and flu season), ask your healthcare provider about the new RSV shot Beyfortus™. Your child’s healthcare provider is a great source of information for any questions and recommendations about Beyfortus™.

Genevieve Kane, MSN, RN, is a mother of four and a registered nurse with a background in pediatrics. When she's not working, you can find her cooking up tasty family dinners or keeping up with her kids on a hiking trail in her home state of Colorado.

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