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 5. FDA Approves First Respiratory Syncytial Virus (RSV) Vaccine

 1. Press Announcements

FDA News Release


FDA APPROVES FIRST RESPIRATORY SYNCYTIAL VIRUS (RSV) VACCINE


AREXVY APPROVED FOR INDIVIDUALS 60 YEARS OF AGE AND OLDER

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For Immediate Release: May 03, 2023



Español

Today, the U.S. Food and Drug Administration approved Arexvy, the first
respiratory syncytial virus (RSV) vaccine approved for use in the United States.
Arexvy is approved for the prevention of lower respiratory tract disease caused
by RSV in individuals 60 years of age and older.

“Older adults, in particular those with underlying health conditions, such as
heart or lung disease or weakened immune systems, are at high risk for severe
disease caused by RSV,” said Peter Marks, M.D., Ph.D., director of the FDA’s
Center for Biologics Evaluation and Research. “Today’s approval of the first RSV
vaccine is an important public health achievement to prevent a disease which can
be life-threatening and reflects the FDA’s continued commitment to facilitating
the development of safe and effective vaccines for use in the United States.”

RSV is a highly contagious virus that causes infections of the lungs and
breathing passages in individuals of all age groups. RSV circulation is
seasonal, typically starting during the fall and peaking in the winter. In older
adults, RSV is a common cause of lower respiratory tract disease (LRTD), which
affects the lungs and can cause life-threatening pneumonia and bronchiolitis
(swelling of the small airway passages in the lungs). 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 safety and effectiveness of Arexvy is based on the FDA’s analysis of data
from an ongoing, randomized, placebo-controlled clinical study conducted in the
U.S. and internationally in individuals 60 years of age and older. The main
clinical study of Arexvy was designed to assess the safety and effectiveness of
a single dose administered to individuals 60 years of age and older.
Participants will remain in the study through three RSV seasons to assess the
duration of effectiveness and the safety and effectiveness of repeat
vaccination. Data for a single dose of Arexvy from the first RSV season of the
study were available for the FDA’s analysis.  

In this study, approximately 12,500 participants have received Arexvy and 12,500
participants have received a placebo. Among the participants who have received
Arexvy and the participants who have received a placebo, the vaccine
significantly reduced the risk of developing RSV-associated LRTD by 82.6% and
reduced the risk of developing severe RSV-associated LRTD by 94.1%.

Among a subset of these clinical trial participants, the most commonly reported
side effects by individuals who received Arexvy were injection site pain,
fatigue, muscle pain, headache and joint stiffness/pain. Among all clinical
trial participants, atrial fibrillation within 30 days of vaccination was
reported in 10 participants who received Arexvy and 4 participants who received
placebo. 

In two other studies, approximately 2,500 participants 60 years of age and older
received Arexvy. In one of these studies, in which some participants received
Arexvy concomitantly 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, seven and 22 days,
respectively, after receiving Arexvy and the influenza vaccine. One of the
participants who developed ADEM died. In the other study, one participant
developed Guillain-Barré syndrome (a rare disorder in which the body’s immune
system damages nerve cells, causing muscle weakness and sometimes paralysis)
nine days after receiving Arexvy.

The FDA is requiring the company to conduct a postmarketing study to assess the
signals of serious risks for Guillain-Barré syndrome and ADEM. In addition,
although not an FDA requirement, the company has committed to assess atrial
fibrillation in the postmarketing study.

This application was granted Priority Review designation. 

The FDA granted approval of Arexvy to GlaxoSmithKline Biologicals.

###

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   05/04/2023


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