The FDA has approved the first-ever vaccine for RSV

Respiratory syncytial virus hospitalizes tens of thousands of people each year in the United States. Now there’s a powerful new tool against it: the first-ever RSV vaccine.

The U.S. Food and Drug Administration announced May 3 that it had granted approval for an RSV vaccine made by GlaxoSmithKline to be used in people 60 and older.

RSV is a respiratory virus that causes cold-like symptoms for many people, but can cause serious illness, hospitalization and death for infants and older people. In the United States, an estimated 60,000 to 160,000 older adults are hospitalized each year with lung infections caused by RSV, according to the U.S. Centers for Disease Control and Prevention. About 6,000 to 10,000 of them die from RSV infections each year. Older adults with chronic heart or lung disease, and those with weakened immune systems are especially vulnerable.

The newly approved vaccine reduced the risk of developing lung infections by 82.6 percent compared with a placebo. In a trial of about 25,000 people age 60 and over, only seven people who got the vaccine developed RSV lung infections, compared with 40 people who got a placebo. The vaccine’s efficacy against severe lung infection was even better at 94.1 percent: Just one person in the vaccine group and 17 in the placebo group developed that complication.

The FDA is expected to approve an RSV vaccine for older people made by Pfizer later in May. And on May 18 the agency will discuss Pfizer’s RSV vaccine given to pregnant women to protect newborns.

A number of other companies also have RSV vaccines in the works (SN: 4/27/23).

The FDA is requiring GSK to monitor for safety concerns from the vaccine. In the clinical trial, two people developed a rare type of inflammation that affects the brain and spinal cord after getting the RSV vaccine and a flu shot. One died of the condition, called acute disseminated encephalomyelitis.

And one person in the trial developed Guillain-Barré syndrome, a condition in which the immune system attacks nerves leading to muscle weakness or paralysis. The syndrome is a rare, but serious side effect of many vaccines. In addition, the company is voluntarily monitoring for a heart condition called atrial fibrillation.