The U.S. Food and Drug Administration has approved the expanded use of Prevnar 13, a pneumococcal 13-valent conjugate vaccine for people ages 50 years
and older to prevent pneumonia and invasive disease caused by the
bacterium, Streptococcus pneumoniae.
Pneumococcal pneumonia,
caused when the bacterium Streptococcus pneumoniae infects the lungs, is
the most common disease caused by this bacterium in adults. When the
bacterium invades parts of the body that are normally free from germs,
such as the blood or spinal fluid, the disease is considered “invasive.”
“According
to recent information for the United States, it is estimated that
approximately 300,000 adults 50 years of age and older are hospitalized
yearly because of pneumococcal pneumonia,” said Karen Midthun, M.D.,
director of FDA’s Center for Biologics Evaluation and Research.
The
new use for Prevnar 13 was approved under the agency’s accelerated
approval pathway, which allows for earlier approval of treatments for
serious and life-threatening illnesses. The pathway allows for the
demonstration of effectiveness of a vaccine using an immune marker that
is reasonably likely to predict clinical benefit.
In randomized,
multi-center studies in the United States and Europe, people 50 and
older received either Prevnar 13 or Pneumovax 23, a licensed
pneumococcal vaccine also approved for use in this age group. The
studies showed that for the 12 common serotypes, Prevnar 13 induced
antibody levels that were either comparable to or higher than the levels
induced by Pneumovax 23.
The safety of Prevnar 13 was evaluated
in about 6,000 people ages 50 and older who received Prevnar 13 and who
had and had not previously received Pneumovax 23. Common adverse
reactions reported with Prevnar 13 were pain, redness, and swelling at
the injection site, limitation of movement of the injected arm, fatigue,
headache, chills, decreased appetite, generalized muscle pain, and
joint pain. Similar reactions were observed in those who received
Pneumovax 23.
Accelerated approval is granted on the condition
that a clinical trial is conducted during the post-approval marketing of
the vaccine to verify the anticipated clinical benefit. An additional
trial in 85,000 people ages 65 and older, with no previous history of
receiving Pneumovax 23, is underway to confirm the clinical benefit of
Prevnar 13 in the prevention of pneumococcal pneumonia.
Prevnar 13
is already approved for use in children ages 6 weeks through 5 years
for the prevention of invasive disease caused by 13 different serotypes
of the bacterium Streptococcus pneumoniae and for the prevention of
otitis media caused by seven of the serotypes of the bacterium.
The
approval of Prevnar 13 for adults 50 years and older supports the
Department of Health and Human Services’ Healthy People 2020 objectives
Prevnar 13 is manufactured by Collegeville, Pa.-based Wyeth Pharmaceuticals.
Source: FDA
