The US Food and Drug Administration has approved RSV to combat the infection that kills babies

health

by Brock Steinberg

July 18, 2023 | 11:26 a.m

The Food and Drug Administration on Monday approved a new drug, Beyfortus (nirsevimab), to protect young children from the deadly infection known as respiratory syncytial virus.

Worldwide, RSV is the second leading cause of death during a newborn’s first year of life, second only to malaria, according to Nature Journal.

Babies six months of age or younger are at greater risk of severe disease. Globally, about 120,000 children die from respiratory syncytial virus each year.

“Respiratory syncytial virus can cause serious illness in infants and some children and results in a large number of emergency department and doctors’ office visits each year,” said Dr. John Farley of the FDA in a statement. “Today’s approval addresses an urgent need for products to help reduce the impact of RSV disease on children, families, and the health care system.”

The Food and Drug Administration has approved the monoclonal antibody, developed by Sanofi and AstraZeneca, for children 1 year of age and younger, making it the first RSV immunization for that age group.

The FDA approval also allows a second injection for children up to 24 months of age who are still susceptible to the virus in their second year.

Beyfortus can be given as a single injection to infants before the RSV season, which peaks in the fall and winter. Possible side effects of the drug include skin rash and injection site reactions.

According to the Centers for Disease Control and Prevention, an estimated 58,000 to 80,000 children under the age of 5 are hospitalized with RSV. 1 in 2 in 100 babies younger than 6 months old who are infected with RSV may need to be hospitalized.

Although RSV is more common in infants and young children, the respiratory disease can affect people of all ages. In healthy adults and children, symptoms of respiratory syncytial virus are similar to those of the common cold, according to the Mayo Clinic.

However, some children — especially those infected for the first time — “develop a lower respiratory tract illness such as pneumonia and bronchiolitis (swelling of the small air passages in the lungs), which often leads to an emergency department or a visit to the doctor’s office,” the Food and Drug Administration said.

Infected people usually show symptoms within four to six weeks, and symptoms usually include a runny nose, decreased appetite, coughing, sneezing, fever, and wheezing.

People infected with the virus are usually contagious for three to eight days. The virus is transmitted through direct contact with an infected person.

Children and people with weakened immune systems, such as the elderly and other vulnerable populations, can spread RSV for up to four weeks.

Beyfortus is expected to be released in the US in the fall — before the season starts this year. CDC advisors will need to sign off on the drug before it is widely available to the public.

Another shot, palivizumab, is already on the market, though it’s only for medically high-risk children and is given monthly.

In May, the U.S. Food and Drug Administration approved the world’s first RSV vaccine, Arixvi, a single-dose vaccine intended to prevent lower respiratory illnesses caused by respiratory syncytial virus in people 60 years of age or older.

It was reported in February that Pfizer had developed RSVpreF, a vaccine to prevent severe cases of RSV, and the Food and Drug Administration was speeding up the review approval process.

This vaccine is a single dose given to pregnant women in the late second or third trimester. If approved, it would be the first vaccine given to expectant mothers to protect against disease in infants from birth through the first six months.