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FDA Approves Preventive RSV Treatment For Infants And Toddlers

The Food and Drug Administration (FDA) has approved a treatment for the prevention of RSV among infants and toddlers, making it the first preventive drug for the common virus that surged last winter among small children.

The FDA approved nirsevimab-alip, or Beyfortus, for the prevention of respiratory syncytial virus (RSV) among newborns and infants born during or entering into their first RSV season, which typically starts in the fall, peaks in the winter and ends in the spring.

Beyfortus is a monoclonal antibody administered in one dose. The safety of efficacy of the medicine is supported by three clinical trials, according to the FDA's release Monday.

"Today's approval addresses the great need for products to help reduce the impact of RSV disease on children, families and the health care system," John Farley, director of the FDA's Office of Infectious Diseases, said in a statement.

In June, the FDA's antimicrobial drug advisory panel unanimously voted to recommend that nirsevimab be approved, with the committee of experts finding the overall benefit-risk assessment to be favorable.

The shot has been approved for children up to 24 months of age.

The drug is manufactured by AstraZeneca and will be marketed by Sanofi. The FDA indicated a rash around the injection site as a possible side effect of Beyfortus and advised that it be administered with caution in children with clinically significant bleeding disorders.

"Beyfortus represents an opportunity for a paradigm-shift in preventing serious respiratory disease due to RSV across a broad infant population in the U.S," Iskra Reic, executive vice president of AstraZeneca, said in a release.

Known as a "daycare disease," RSV is extremely common with the vast majority of people being exposed to it by the time they're two-years-old. During COVID lockdowns, however, infants and toddlers born shortly before or during the pandemic were unlikely to be exposed to the pathogen, leading to lower immunity among this younger age group.

The majority of those who get RSV experience cold-like symptoms that go away with rest and self-care. But first-time infections in infants can lead to respiratory diseases like pneumonia and bronchiolitis.

Infants younger than six months are at the highest risk of developing severe cases of RSV that lead to hospitalization, which was seen last winter when hospitals were inundated with sick children, with many quickly reaching capacity.

The surge this past winter brought attention to the lack of real treatment options for RSV. There were no preventive medicines for anybody at that time and the only treatment available was monoclonal antibodies that were typically reserved for extremely high-risk cases. Apart from that, clinicians could only provide supplemental oxygen or place children on ventilators in cases of respiratory failure.

The FDA has already approved two RSV vaccines for use in older adults this year, but the announcement on Monday marks the first preventive treatment approved by the agency for children.

An RSV vaccine candidate for infants is currently under review. Created by Pfizer, the shot is administered to pregnant mothers to confer immunity to their children before they're born. An FDA advisory panel unanimously voted in favor of approving the shot in May.

The Advisory Committee on Immunization Practices under the Centers for Disease Control and Prevention (CDC) is scheduled to meet on August 3 to discuss and vote on recommending Beyfortus for children.

This story was updated at 2:19 p.M.

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RSV Testing: How Do You Know If You Or Your Child Has RSV?

Respiratory syncytial virus (RSV) can be difficult to diagnose. As with many viral illnesses, including COVID-19 and the flu, RSV can cause symptoms resembling those of the common cold. This can make it hard for people to know if they have RSV or a different kind of respiratory infection.

On top of that, it's possible for a person to be infected with more than one virus at the same time, complicating diagnosis even further.

[1]

But there are a number of tests for adults with RSV and sick babies and older children that can help reveal the source of an illness. Read on to learn more about the different kinds of RSV tests — plus why doctors usually don't use these tests except in specific circumstances.

Main Types of RSV Tests

There are two main kinds of tests used to diagnose an RSV infection.

Rapid Tests This test, also called an antigen test, is used in the majority of cases. It is accurate 80 to 90 percent of the time, returning results in about an hour.

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The test analyzes a fluid sample taken from the nose and can detect the presence of certain proteins from the virus, called antigens. Antigens trigger the immune system to attack the virus.

"Usually, rapid tests are available at walk-in or urgent care centers, and ERs," says Sharon Nachman, MD, the chief of the division of pediatric infectious diseases at Stony Brook Medicine in New York.

RT-PCR Tests Polymerase chain reaction tests, also called molecular tests, look for genetic material from the virus in a nasal sample. Because these tests can find smaller amounts of virus than antigen tests, doctors may use them for adults and older children, who tend to have less of the virus in their noses than infants and younger children.

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The samples are usually sent to a lab for testing, and the amount of time it takes to get results can vary.

A type of molecular test called a respiratory pathogens panel checks for numerous viruses and bacteria at the same time, including RSV.

Is There an RSV Home Test?

Unlike with COVID-19, there is no home test for RSV in the United States, says Dr. Nachman.

Americans do have the option of a home collection kit from Labcorp, which is available without a prescription. You swab your nose at home, then send the sample to Labcorp via overnight mail for analysis. Testing searches for three viral infections at once — RSV, COVID-19, and the flu. The analysis takes a day or two, at a cost of $129 (without insurance coverage).

Doctors Typically Diagnose RSV Without Testing Healthy adults and older children who haven't had direct contact with an infected person usually don't need an RSV test, experts say.

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Most of the time, RSV is a clinical diagnosis, says David Banach, MD, MPH, an associate professor of medicine and the head of infection prevention at UConn Health in Farmington, Connecticut. That means that a doctor may diagnose RSV based on the season (RSV typically spreads from the fall to the early spring)

[5] and information about circulating viruses as well as the person's contact history, health history, and symptoms.

People sick with RSV usually show signs of infection within four to six days of exposure.

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Generally speaking, adults and children with RSV have similar symptoms, says Nachman.

Symptoms of RSV infection usually include:

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Runny nose

Decrease in appetite

Coughing

Sneezing

Fever

Wheezing

These symptoms usually appear at stages in the illness and not all at once.

Very young infants with RSV may not develop all the above symptoms; sometimes the only indications that a baby is sick are irritability, decreased activity, and trouble breathing.

Should You Get an RSV Test? There are some cases where doctors will want to make or confirm an RSV diagnosis with a test — for example, in people who are at high risk of severe complications or those with moderate to severe symptoms.

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It's important to identify RSV in these cases because of the possibility of serious RSV-related illness, such as bronchiolitis (inflammation of the small airways in the lungs) and pneumonia (infection of the lungs), which can lead to hospitalization. 

A Positive RSV Test Doesn't Usually Lead to RSV Treatment

"The beauty of a diagnostic test is to help with treatment," says Nachman. That's useful for COVID-19 and the flu, both of which can be treated with antiviral medication. "But unfortunately, RSV doesn't have a specific antiviral treatment," Nachman says.

Instead, doctors will tell you to recover at home by drinking lots of fluids, taking over-the-counter medications such as Tylenol for pain and fever, and resting. "Those things will help you, but they are nonspecific for respiratory viruses," Nachman says.

The rare exceptions: Babies born at less than 29 weeks and immunocompromised adults who are very sick with RSV may be treated in the hospital with the drug ribavirin, says Nachman.

Study Finds RSV Treatment Beyfortus Prevents 5,800 Hospitalisations In France

Roughly 5,800 hospitalisations from bronchiolitis were avoided in France thanks to the new preventive medicine nirsevimab, Public Health France said on Friday.

The health agency cited two studies that showed that the antibody, which is marketed under the name Beyfortus, was effective at preventing severe cases of the illness in newborns caused by respiratory syncytial virus (RSV).

The common respiratory virus causes cold-like symptoms but can be dangerous for newborns and older adults. It is the leading cause of paediatric hospitalisation in Europe.

Cases of the virus surged following the COVID-19 pandemic, with a triple epidemic of RSV, COVID-19, and flu co-circulating in many countries.

Beyfortus, a preventive monoclonal antibody approved in Europe in late 2022, was provided to newborns in France starting in September 2023 as part of a preventive campaign.

But the government faced heavy criticism as demand for the antibody was much higher than expected.

The medicine is given as a single injection at birth. The active substance, nirsevimab, is a type of protein that attaches to a specific RSV protein to neutralise the virus.

In France, bronchiolitis is estimated to affect nearly 30 per cent of newborns under two years old every year, with two to three per cent of newborns under one being hospitalised for it.

Health authorities monitored RSV cases in hospitals, including instances of severe illness following preventive treatment.

Public Health France said that one study the agency carried out in collaboration with the Paris-based Pasteur Institute found that Beyfortus was between 75.9 and 80.6 per cent effective in preventing severe RSV requiring hospitalisation for newborns.

This was similar to the results of phase III clinical trials.

"We were able to evaluate in a very short time the positive effects in real life of nirsevimab (Beyfortus) on the health of infants, with the treatment's effectiveness estimated between 76% and 81%," said Isabelle Parent du Chatelet, head of the respiratory infections and vaccination unit at Public Health France.

She added that these results were sent to inform future policy decisions regarding the prevention of RSV.

A second study determined, using a mathematical model, that between September 2023 and February 2024, nirsevimab prevented 5,800 hospitalisations, including 4,200 for newborns up to two months old.

This represented a 23 per cent reduction in hospitalisation for babies who arrived in an emergency department for RSV compared to a scenario where the antibody was not administered.

"The two studies use different approaches. One analyses real-time data in paediatric intensive care units while the other models surveillance data in the population," Simon Cauchemez, head of mathematic modelling of infectious diseases at the Pasteur Institute, said in a statement.

"But they result in similar calculations of nirsevimab's effectiveness," he added.

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