FDA approves RSV drug to fight infection that kills thousands of children each year

Health

From Brooke Steinberg

July 18, 2023 | 11:26

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

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

Babies six months old and younger have an even higher risk of becoming seriously ill. Globally, approximately 120,000 children die from RSV each year.

RSV can cause serious illness in infants and some children and results in large numbers of emergency room and doctor’s office visits each year, said Dr. FDA’s John Farley in a statement. Today’s approval addresses a great need for products that help reduce the burden of RSV disease on children, families and healthcare systems.

The FDA has approved the monoclonal antibody, developed by Sanofi and AstraZeneca, for children one year of age and younger, making it the first immunization against RSV for that age group.

The FDA approval also allows for a second injection for babies up to 24 months who are still vulnerable to the virus in their second year.

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

According to the Centers of Disease Control and Prevention, an estimated 58,000 to 80,000 children younger than age 5 are hospitalized due to RSV. One to two out of 100 infants younger than 6 months with RSV may need to be hospitalized.

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

However, some newborns, especially with their first infection, develop lower respiratory tract illnesses such as pneumonia and bronchiolitis (swelling of the small airways in the lungs), often leading to an emergency room or doctor visit, the FDA said.

Infected people typically show symptoms within 4 to 6 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 by close person-to-person 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 release in the US in the fall before this year’s season begins. CDC advisers will need to approve the drug before it is made widely available to the public.

Another hit, palivizumab, is already on the market, though it’s only for children at high medical risk and given monthly.

In May, the FDA approved the world’s first vaccine for RSV, Arexvy, a single-dose injection that aims to prevent lower respiratory tract illnesses caused by RSV in people ages 60 and older.

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

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