Pfizer Receives European Approval For Label Update Regarding The Use Of Prevenar 13 In Certain High-Risk Populations
NEW YORK--(BUSINESS WIRE)--
Pfizer Inc. (NYSE:PFE) announced today that the European Commission
approved updates to the Summary of Product Characteristics (SmPC) for
the companys pneumococcal conjugate vaccine Prevenar 13* (pneumococcal
polysaccharide conjugate vaccine [13-valent, adsorbed]), regarding its
use in certain populations at high risk of pneumococcal disease. The
updated label now includes information describing the use of the vaccine
in preterm infants, children and adolescents with sickle cell disease
who were previously vaccinated with the 23-valent pneumococcal
polysaccharide vaccine, and adults with human immunodeficiency virus
(HIV) infection who were previously vaccinated with the 23-valent
pneumococcal polysaccharide vaccine.
People with conditions that compromise the immune system, such as HIV,
those with sickle cell disease, and infants born prematurely are all at
an increased risk of pneumococcal disease, said
Luis Jodar, Ph.D., vice president, Vaccines, Global Medicines
Development Group and Scientific Affairs, Pfizer. The Prevenar 13 label
in the European Union now includes important information about
appropriate use of the vaccine for the prevention of pneumococcal
disease for health care professionals who care for these patients.
The decision to approve the SmPC for Prevenar 13 followed the European
Medicines Agencys review of data submitted by Pfizer from several
studies assessing immunogenicity and safety of vaccination with Prevenar
13 in these three risk groups. These data are under
review by the U.S. Food and Drug Administration.
Prevenar 13 received an expanded indication in the European Union (EU)
in July 2013 to include adults aged 18 to 49 years for active
immunization for the prevention of invasive disease caused by
vaccine-type . Previously
approved in the EU for use in infants, young children and adolescents
aged 6 weeks to 17 years, and adults 50 years of age and older, Prevenar
13 is now the only pneumococcal vaccine in the EU that offers protection
against invasive pneumococcal disease from infancy through adulthood.
Pfizer is dedicated to improving public health through vaccination, and
to supporting health care professionals in their efforts to reduce the
impact of pneumococcal disease among those most at risk, said Susan
Silbermann, president, Vaccines at Pfizer.
Preterm infants (gestational age 19 to 36 weeks) have an increased risk
for pneumococcal disease compared with infants born full term
(gestational age 37 to 42 weeks), according to studies. A
Phase 4 study of Prevenar 13 administered at 2, 3, 4 and 12 months to
approximately 100 preterm infants (born at 26 to 36 weeks) found a less
robust immune response among preterm infants compared to term infants.
An acceptable safety profile was demonstrated. Adverse
events were generally consistent with those expected in this study
Individuals with sickle cell disease are 30 to 600 times more likely to
contract invasive pneumococcal disease than healthy individuals.
A Phase 3, open-label, single-arm study evaluated the safety,
tolerability and immunogenicity of two doses of Prevenar 13 given six
months apart in 158 children and adolescents aged 6 years to 17 years
with sickle cell disease who were previously vaccinated with one or more
doses of the 23-valent pneumococcal polysaccharide vaccine. The study
showed that Prevenar 13 elicited antibody levels after the first dose
that were statistically significantly higher when compared with levels
prior to vaccination. Antibody levels after the second dose were
comparable to those after the first dose. An acceptable safety profile
was demonstrated. Adverse events were generally consistent
with those expected in this study population.
HIV-infected individuals are more vulnerable to invasive pneumococcal
disease, with an incidence that has been reported to be 6 to 324 times
that of uninfected adults. Studies estimating the risk in
the current setting of antiretroviral therapy use suggest the risk
remains 20 to 40 times higher in HIV-infected adults than the general
A Phase 3, open-label, single-arm study assessed the safety,
tolerability and immunogenicity of three doses of Prevenar 13 given six
months apart in 331 individuals with HIV infection (with a CD4 count of
=200 cells/µL, HIV viral load <50,000 copies/mL) aged 18 years or older
who had been previously vaccinated with at least one dose of 23-valent
pneumococcal polysaccharide vaccine. The study showed that Prevenar 13
elicited antibody levels after the first dose that were statistically
significantly higher when compared with levels prior to vaccination.
After the second and third doses of Prevenar 13, immune responses were
comparable or higher than those after the first dose. An acceptable
safety profile was demonstrated. Adverse events were generally
consistent with those expected in this study population.
Pneumococcal disease (PD) is a group of illnesses caused by the
bacterium , also known as pneumococcus.
It includes invasive manifestations such as bacteremia (bacteria in the
blood) and meningitis (infection of the tissues surrounding the brain
and spinal cord), as well as non-invasive infections such as pneumonia.
PD can affect people of all ages, but infants and young children, older
adults and individuals with immunocompromising or certain chronic
medical conditions are at heightened risk of infection.
Prevenar 13, or Prevnar 13 as it is called in the United States, Canada
and Taiwan, was first introduced for use in infants and young children
in December 2009 in Europe and is now approved for such use in more than
120 countries worldwide, including the United States and Japan.
It is the most widely used pneumococcal conjugate vaccine (PCV) in the
world, and more than 575 million doses of Prevenar/Prevenar 13 have been
distributed worldwide. In addition, Prevenar 13 is approved
for use in adults 50 years of age and older in more than 90 countries,
and is also approved in the United States and European Union (EU) for
use in older children and adolescents aged 6 to 17 years.
Recently, Prevenar 13 was also approved in the EU for use in adults 18
to 49 years of age, making it the only pneumococcal vaccine
in the EU approved to help protect against invasive pneumococcal disease
from infancy through adulthood.
Prevenar 13 is approved in the EU for the prevention of invasive
disease, pneumonia and acute otitis media caused by serotypes
(1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) in children and
adolescents aged 6 weeks to 17 years. It is also approved in the EU for
the prevention of invasive disease caused by 13 serotypes
(single dose) in adults 18 years of age and older. For the
full prescribing information for Prevenar 13 in the EU, please see the
Summary of Product Characteristics.
Prevnar 13 should not be given to anyone with a history of severe
allergic reaction to any component of Prevnar 13 or any diphtheria
Children and adults with weakened immune systems (e.g., HIV infection,
leukemia) may have a reduced immune response.
A temporary pause of breathing following vaccination has been observed
in some infants born prematurely.
The most commonly reported serious adverse events in infants and
toddlers were bronchiolitis (an infection of the lungs) (0.9%),
gastroenteritis (inflammation of the stomach and small intestine)
(0.9%), and pneumonia (0.9%).
In children 6 weeks through 17 years, the most common side effects were
tenderness, redness, or swelling at the injection site, irritability,
decreased appetite, decreased or increased sleep, and fever. Most
commonly reported side effects in children 5 years through 17 years also
In adults, immune responses to Prevnar 13 were reduced when given with
injected seasonal flu vaccine.
In adults, the common side effects were pain, redness, or swelling at
the injection site, limitation of arm movement, fatigue, headache,
muscle pain, joint pain, decreased appetite, chills, or rash.
Ask your health care provider about the risks and benefits of Prevnar
13. Only a health care provider can decide if Prevnar 13 is right for
you or your child.
For the full prescribing information for Prevnar 13 in the United
States, please click here: http://labeling.pfizer.com/ShowLabeling.aspx?id=501.
At Pfizer, we apply science and our global resources to bring therapies
to people that extend and significantly improve their lives. We strive
to set the standard for quality, safety and value in the discovery,
development and manufacture of health care products. Our global
portfolio includes medicines and vaccines as well as many of the world's
best-known consumer health care products. Every day, Pfizer colleagues
work across developed and emerging markets to advance wellness,
prevention, treatments and cures that challenge the most feared diseases
of our time. Consistent with our responsibility as one of the world's
premier innovative biopharmaceutical companies, we collaborate with
health care providers, governments and local communities to support and
expand access to reliable, affordable health care around the world. For
more than 150 years, Pfizer has worked to make a difference for all who
rely on us. To learn more, please visit us at www.pfizer.com.
DISCLOSURE NOTICE: The information contained in this release is as of
October 17, 2013. Pfizer assumes no obligation to update forward-looking
statements contained in this release as the result of new information or
future events or developments.
This release contains forward-looking information about Prevnar
13/Prevenar 13 that involves substantial risks and uncertainties. Such
risks and uncertainties include, among other things, whether and when
the U.S. Food and Drug Administration may approve an update to the U.S.
label for Prevnar 13 regarding its use in certain high-risk populations.
A further description of risks and uncertainties can be found in
Pfizers Annual Report on Form 10-K/A for the fiscal year ended December
31, 2012 and in its reports on Form 10-Q and Form 8-K.
* Trademark. Prevnar 13 is the trade name in the United
States, Canada, and Taiwan.
Pfizer Inc.Media:Kim Bencker, +1 610-329-1340 (m)Kim.Bencker@pfizer.comInvestor:Suzanne
Harnett, +1 212-733-8009 (o)Suzanne.Harnett@pfizer.com
Source: Pfizer Inc.