First-Ever RSV Vaccine Approved by FDA

Respiratory syncytial virus (RSV) is responsible for the hospitalization of tens of thousands of people every year in the United States. However, there is now a powerful new tool in the fight against RSV: the first-ever RSV vaccine.

The U.S. Food and Drug Administration (FDA) announced on May 3rd that it had granted approval for an RSV vaccine manufactured by GlaxoSmithKline for use in people aged 60 and above.

While RSV is a respiratory virus that typically causes cold-like symptoms in most people, it can cause serious illness, hospitalization and even death for infants and older adults. According to the U.S. Centers for Disease Control and Prevention, an estimated 60,000 to 160,000 older adults are hospitalized annually in the US due to lung infections caused by RSV. Roughly 6,000 to 10,000 of these people die each year due to RSV infections, making older adults with chronic heart or lung disease and weakened immune systems especially vulnerable.

The newly approved RSV vaccine reduced the risk of developing lung infections by 82.6% compared with a placebo. In a clinical trial of about 25,000 individuals aged 60 and above, only seven individuals who received the vaccine developed RSV lung infections, compared with 40 individuals from the placebo group. The vaccine’s efficacy against severe lung infection was even higher at 94.1%, with only one person from the vaccine group compared to seventeen from the placebo group experiencing the complication.

The FDA is expected to approve a similar RSV vaccine for older people manufactured by Pfizer later in May. On May 18th, the organization will further consider Pfizer’s RSV vaccine provided to pregnant women to safeguard newborns.

Other companies are also developing RSV vaccines, as reported on April 27th.

While the FDA is requiring GSK to monitor the vaccine for any safety concerns, two individuals who received both RSV vaccine and flu shots developed a rare form of inflammation that affects the brain and spinal cord. One patient who developed acute disseminated encephalomyelitis sadly died from the condition. Another individual developed Guillain-Barré syndrome, a rare but serious side effect of several vaccines that occurs when the immune system attacks nerves leading to muscle weakness or paralysis. The company is also voluntarily screening for a heart condition known as atrial fibrillation.

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