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Home » The FDA has approved the first-ever vaccine for RSV
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The FDA has approved the first-ever vaccine for RSV

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The FDA has approved the first-ever vaccine for RSV
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Each year in the United States, tens of thousands of people are hospitalized due to respiratory syncytial virus (RSV). However, there is now a powerful new tool available – the first-ever RSV vaccine.

On May 3, the U.S. Food and Drug Administration granted approval for an RSV vaccine created 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 even death for infants and older people.

According to the U.S. Centers for Disease Control and Prevention, an estimated 60,000 to 160,000 older adults are hospitalized each year with lung infections caused by RSV, and about 6,000 to 10,000 of them die from RSV infections each year. Older adults with chronic heart or lung disease, as well as those with weakened immune systems, are especially vulnerable.

The newly approved vaccine has been shown to reduce the risk of developing lung infections by 82.6 percent compared to a placebo. In a trial of around 25,000 people aged 60 and over, only seven people who received the vaccine developed RSV lung infections, compared to 40 people who received a placebo.

The vaccine’s efficacy against severe lung infection was even better at 94.1 percent, with just one person in the vaccine group and 17 in the placebo group developing that complication.

The FDA is expected to approve another vaccine for older people made by Pfizer later in May. Additionally, on May 18, the agency will discuss Pfizer’s RSV vaccine given to pregnant women to protect newborns. Several other companies are also in the process of developing RSV vaccines.

The FDA is requiring GSK to monitor the vaccine for safety concerns. In the clinical trial, two people developed a rare type of inflammation that affects the brain and spinal cord after receiving the RSV vaccine and a flu shot.

One person died from the condition, called acute disseminated encephalomyelitis. One person in the trial also developed Guillain-Barré syndrome, a condition in which the immune system attacks nerves leading to muscle weakness or paralysis, although this is a rare, but serious side effect of many vaccines. In addition, the company is voluntarily monitoring for a heart condition called atrial fibrillation.

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