On May 3, the FDA approved a new vaccine for adults over 60, to prevent serious lung disease from RSV.
What is RSV?
Respiratory Syncytial Virus was identified in 1956, first in chimpanzees, and then shortly after in children. Since then, its been commonly associated with children but recently, scientists have discovered that it is far more common in adults than previously thought.
Most of the time, it causes a disease similar to “the common cold” and is more of a nuisance than a threat. More closely related to influenza, this virus mainly causes upper respiratory tract infections (runny nose and congestion) 3-5 days after exposure. Because of incomplete immunity, most people can get reinfected multiple times during their lives. In about 40% of infants, the disease becomes more serious as it infects the lower respiratory tract, causing coughing, wheezing. More rarely: pneumonia and respiratory failure. It may even be associated with long term problems like asthma and allergies.
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How big of a problem is this in adults?
RSV was conventionally thought of as a nuisance “cold” virus for adults, if a problem at all. But recent surveillance data paints a completely different picture. In adults over 60, and especially those with some predisposing conditions (see below), RSV can be as dangerous as influenza. New studies show that RSV causes 60,000-160,000 hospitalizations per year in America in adults over 65 (compared to 58,000-80,000 in children under 5). 6,000-10,000 adults over 65 die each year from RSV complications (compared to 100-300 children under 5).
The reason this slid under the radar for so long is because RSV disease looks like every other respiratory tract infection AND is more difficult to identify by laboratory testing. Since it was ‘conventional wisdom’ that this was a kid’s disease, many adults were misdiagnosed or received a delayed diagnosis.
Who is at risk?
Everyone is at risk for infection. However, most older children and healthy adults will present with an uncomplicated upper respiratory tract infection.
Groups that are at risk for a serious lower respiratory tract infection are:
Young children, especially those with:
prematurity
chronic lung disease
congenital heart disease
weakened immune systems
neuromuscular dysfunction (particularly those with problems swallowing)
Adults over 65, especially those with:
Chronic heart disease
Chronic lung disease (like COPD, asthma)
weakened immune systems
residency in a long term care facility or group home
What’s the new vaccine like?
GlaxoSmithKline received FDA approval for the RSV vaccine Arexvy for adults 60-years and older.
Arexvy is a recombinant, subunit vaccine. These types of vaccines do not contain the whole virus, and therefore it is impossible to get RSV from the vaccine. The antigen from RSV (the part of the virus that trains your immune system) is produced artificially in the lab, purified and then included in the vaccine. Other ingredients include adjuvants (components that make a vaccine work better… in this case they are derived from natural sources like plants and bacteria), salts, buffers, fats and water. It is given as a single injection into the muscle of the arm.
Clinical trials show that Arexvy reduces the risk of RSV-caused lower respiratory tract disease by 82% overall. It reduced the risk by 94% in those aged 70-79 and in those with a predisposing condition (heart or lung dysfunction).
In the safety studies, Arexvy caused pain, redness and swelling at injection site (51.3%, 6.7% and 4.9% of people, over placebo). Other side effects include: fatigue (17.5%), muscle ache (20.7%), headache (14.6%), and joint pain (11.7%) over placebo.
The hot take:
Arexvy is a safe and effective vaccine to prevent RSV-caused lower respiratory disease in adults over 60. Those with chronic lung/heart disease or weakened immune systems should strongly consider getting this vaccine. Consult with your doctor.
Stay happy, healthy and informed!
Jessica at TCA
FDA Approves First Respiratory Syncytial Virus (RSV) Vaccine, FDA press release.
RSV- Surveillance and Research, CDC.
People at High Risk for Severe RSV Infection, CDC
Busack, B. and Shorr, A. Going Viral—RSV as the Neglected Adult Respiratory Virus