FDA approves first vaccine for RSV. Here's 11 things you should know

The Food and Drug Administration Wednesday approved Arexvy, the first vaccine against severe respiratory syncytial virus, more commonly known as RSV.

Highly contagious, RSV causes infections of the lungs and breathing passages. It can affect people of all ages.

In older adults, RSV is a common cause of lower respiratory tract disease, which affects the lungs and can cause life-threatening pneumonia and bronchiolitis.

According to the U.S. Centers for Disease Control and Prevention, each year in the U.S., RSV leads to approximately 60,000-120,000 hospitalizations and 6,000-10,000 deaths among adults 65 years of age and older.

The FDA granted approval of Arexvy to GlaxoSmithKline Biologicals.

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Who can get the RSV vaccine?

The vaccine was approved for those 60 and older.

How effective is the RSV vaccine?

The vaccine was 82% effective at preventing lower respiratory tract illness caused by RSV, according to trial data. It was also 94% effective in those who had at least one underlying medical condition.

What are the side effects from the RSV vaccine?

The most commonly reported side effects were injection site pain, fatigue, muscle pain, headache and joint stiffness/pain.

Is the RSV vaccine dangerous?

During an FDA advisory panel meeting February, GSK researchers reported a few cases of neurological disorders post-vaccination, including one case of Guillain-Barré.

In another study, in which some participants received Arexvy with an FDA-approved influenza vaccine, two participants developed acute disseminated encephalomyelitis (ADEM), a rare type of inflammation that affects the brain and spinal cord. One of the participants who developed ADEM died.

However, panel members voted to recommend the vaccine, saying it was still safe and effective for older adults. The FDA is requiring the company to conduct a postmarketing study to assess the signals of serious risks for Guillain-Barré syndrome and ADEM.

When will the RSV vaccine be available?

GlaxoSmithKline Biologicals said the launch of the vaccine in the U.S. is planned before the 2023/2024 RSV season.

Is there a RSV season in Florida?

In most regions of the United States and other areas with similar climates, RSV season generally starts during fall and peaks in the winter.

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In Florida, RSV season lasts longer than the rest of the country, according to the Florida Department of Health.

The department breaks the state up into five regions. Here are the RSV seasons for each region:

Northwest

October-April

North

September-March

Central

August-March

Southeast

January-December

Southwest

September-April

What does RSV stand for?

RSV is an abbreviation for severe respiratory syncytial virus.

What are the symptoms of RSV?

People infected with RSV usually show symptoms four to six days after getting infected, according to the CDC. In very young infants with RSV, the only symptoms may be irritability, decreased activity, and breathing difficulties.

Almost all children will have had an RSV infection by their second birthday.

Symptoms of RSV infection, which usually appear in stages and not all at once, usually include:

  • Runny nose

  • Decrease in appetite

  • Coughing

  • Sneezing

  • Fever

  • Wheezing

What can you do if you think you have RSV?

Most RSV infections go away on their own in a week or two.

To relieve symptoms:

  • Manage fever and pain with over-the-counter fever reducers and pain relievers, such as acetaminophen or ibuprofen. (Never give aspirin to children.)

  • Drink fluids. It is important for people with RSV infection to drink enough fluids to prevent dehydration (loss of body fluids).

  • Talk to your healthcare provider before giving your child nonprescription cold medicines. Some medicines contain ingredients that are not good for children.

RSV can cause serious health problems

Healthy adults and infants infected with RSV do not usually need to be hospitalized.

People at highest risk for severe disease include:

  • Premature infants

  • Young children with congenital heart or chronic lung disease

  • Young children with weakened immune systems due to a medical condition or medical treatment

  • Children with neuromuscular disorders

  • Adults with compromised immune systems

  • Older adults, especially those with underlying heart or lung disease

Some people with RSV infection, especially older adults and infants younger than 6 months of age, may need to be hospitalized if they are having trouble breathing or are dehydrated.

How do you catch RSV?

RSV can spread when:

  • An infected person coughs or sneezes

  • You get virus droplets from a cough or sneeze in your eyes, nose, or mouth

  • You have direct contact with the virus, like kissing the face of a child with RSV

  • You touch a surface that has the virus on it, like a doorknob, and then touch your face before washing your hands

People infected with RSV are usually contagious for three to eight days and may become contagious a day or two before they start showing signs of illness.

This article originally appeared on Treasure Coast Newspapers: FDA OKs Arexvy as RSV vaccine. When is it coming, should you get it?