- PREVENAR 20® (20-valent Pneumococcal Conjugate Vaccine) offers
the broadest serotype coverage of any pediatric pneumococcal
conjugate vaccine to help protect infants and children from the 20
serotypes responsible for the majority of currently circulating
pneumococcal disease in the EU and
globally1,2,3,4,5,6,7,8
Pfizer Inc. (NYSE: PFE) today announced that the European
Commission (EC) has granted marketing authorization for the
company’s 20-valent pneumococcal conjugate vaccine, marketed in the
European Union under the brand name PREVENAR 20®, for active
immunization for the prevention of invasive disease, pneumonia and
acute otitis media caused by Streptococcus pneumoniae in infants,
children and adolescents from 6 weeks to less than 18 years of
age.
“The EC’s authorization of PREVENAR 20 for infants and children
represents a significant opportunity to improve public health by
helping to protect against the 20 serotypes responsible for the
majority of currently circulating pneumococcal disease in the EU,”
said Alexandre de Germay, Chief International Commercial Officer,
Executive Vice President, Pfizer. “PREVENAR 20 builds on Pfizer’s
decades-long commitment to develop vaccines to help prevent
potentially life-threatening infections, and we are proud to now
provide the broadest serotype coverage of any pneumococcal
conjugate vaccine for children in Europe.”
Today’s authorization follows the recent positive opinion from
the European Medicines Agency's Committee for Medicinal Products
for Human Use (CHMP). The authorization is valid in all 27 EU
member states plus Iceland, Lichtenstein and Norway. It also
follows the approval of PREVNAR 20 for infants and children by the
U.S. Food and Drug Administration (FDA) in April 2023, and
approvals in several other countries including Canada, Australia
and Brazil. Regulatory applications for PREVENAR 20 for the
pediatric indication have been submitted to additional countries
around the world.
The EC authorization of PREVENAR 20 is based on evidence from
the Phase 3 clinical trial program comprised of four core pediatric
studies (NCT04546425, NCT04382326, NCT04379713, NCT04642079), which
helped to expand the data on the safety, tolerability, and
immunogenicity of the vaccine. These studies collectively enrolled
more than 4,700 infants and 800 toddlers and children of all
ages.
About PREVENAR 20®
Pfizer’s PREVENAR 20® includes 13 serotypes already included in
PREVENAR 13® – 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and
23F. The seven new serotypes included in PREVENAR 20 – 8, 10A, 11A,
12F, 15B, 22F, and 33F – are global causes of invasive pneumococcal
disease (IPD), and are associated with high case-fatality rates,
antibiotic resistance, and/or meningitis.9 Together, the 20
serotypes included in PREVENAR 20 are responsible for the majority
of currently circulating pneumococcal disease in the EU and
globally.1,2,3,4,5,6,7,8
In February 2022, the European Commission Decision was adopted
for APEXXNAR® (20-valent Pneumococcal Conjugate Vaccine) for the
prevention of invasive disease and pneumonia caused by the 20 S.
pneumoniae (pneumococcus) serotypes in the vaccine in adults ages
18 years and older. Pfizer is changing the tradename of APEXXNAR to
PREVENAR 20 following the expansion of its indication to include
individuals from 6 weeks of age and older.
In April 2023, the United States Food and Drug Administration
(FDA) approved PREVNAR 20® (20v PnC) for the prevention of invasive
pneumococcal disease (IPD) caused by the 20 S. pneumoniae
(pneumococcal) serotypes contained in the vaccine in infants and
children six weeks through 17 years of age, and for the prevention
of otitis media in infants six weeks through five years of age
caused by the original seven serotypes contained in PREVNAR®.
EU INDICATION FOR PREVENAR 20®
- Active immunization for the prevention of invasive disease,
pneumonia and acute otitis media caused by Streptococcus pneumoniae
in infants, children and adolescents from 6 weeks to less than 18
years of age.
- Active immunization for the prevention of invasive disease and
pneumonia caused by Streptococcus pneumoniae in individuals 18
years of age and older.
US INDICATIONS FOR PREVNAR 20®
PREVNAR 20® is a vaccine approved for:
- the prevention of invasive disease caused by 20 Streptococcus
pneumoniae strains (1, 3, 4, 5, 6A, 6B, 7F, 8, 9V, 10A, 11A, 12F,
14, 15B, 18C, 19A, 19F, 22F, 23F, and 33F) in individuals 6 weeks
and older.
- the prevention of otitis media (middle ear infection) caused by
7 of the 20 strains in individuals 6 weeks through 5 years.
- active immunization for the prevention of pneumonia caused by
Streptococcus pneumoniae strains 1, 3, 4, 5, 6A, 6B, 7F, 8, 9V,
10A, 11A, 12F, 14, 15B, 18C, 19A, 19F, 22F, 23F, and 33F in
individuals 18 years of age and older.
IMPORTANT SAFETY INFORMATION FOR PREVNAR 20®
- PREVNAR 20® should not be given to anyone who has had a severe
allergic reaction to any component of PREVNAR 20 or to
diphtheria–toxoid-containing vaccine.
- Individuals with weakened immune systems may have a lower
immune response. Safety data are not available for these
groups.
- A temporary pause in breathing after getting the vaccine has
been observed in some infants who were born prematurely. For
premature infants, talk to your doctor about the infant's medical
status when deciding to get vaccinated with PREVNAR 20.
- In individuals 2, 4, 6, and 12 through 15 months of age
vaccinated with a 4-dose schedule, the most common side effects
reported at a rate of >10% were irritability, pain at the
injection site, drowsiness, decreased appetite and injection site
redness, injection site swelling, and fever.
- In individuals 15 months through 17 years of age vaccinated
with a single dose, the most common side effects reported at a rate
of >10% were irritability, pain at the injection site,
drowsiness, fatigue and muscle pain, decreased appetite, injection
site swelling and injection site redness, headache, and fever.
- In individuals 18 years and older, the most common side effects
reported at a rate of >10% were pain at the injection site,
muscle pain, fatigue, headache, and joint pain. Also, injection
site swelling was common in individuals 18 years through 59 years
of age.
- Ask your doctor about the risks and benefits of PREVNAR 20.
Only a doctor can decide if PREVNAR 20 is right for your
child.
View the full Prescribing Information.
EU INDICATION FOR APEXXNAR®
- Active immunization for the prevention of invasive disease and
pneumonia caused by Streptococcus pneumoniae in individuals 18
years of age and older. APEXXNAR® should be used in accordance with
official recommendations.
IMPORTANT SAFETY INFORMATION
- APEXXNAR® should not be given to anyone with a history of
severe allergic reaction to any component of APEXXNAR or to
diphtheria toxoid.
- Adults with weakened immune systems may have a lower response
to APEXXNAR. Safety data are not available for these groups. Your
healthcare provider can tell you if APEXXNAR is right for you.
- In adults 18 years of age and older, the most common side
effects were pain at the injection site, muscle pain, fatigue,
headache, and joint pain. Additionally, injection site swelling was
also common in adults 18 through 49 years of age.
- Ask your healthcare provider about the risks and benefits of
APEXXNAR. Only a healthcare provider can decide if APEXXNAR is
right for you.
About Pfizer: Breakthroughs That Change Patients’
Lives
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, including innovative medicines and vaccines. 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
175 years, we have worked to make a difference for all who rely on
us. We routinely post information that may be important to
investors on our website at www.Pfizer.com. In addition, to learn
more, please visit us on www.Pfizer.com and follow us on X at
@Pfizer and @Pfizer News, LinkedIn, YouTube and like us on Facebook
at Facebook.com/Pfizer.
DISCLOSURE NOTICE:
The information contained in this release is as of March 13,
2024. 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
20/Prevenar 20, including its potential benefits, a marketing
authorization granted by the European Commission for active
immunization for the prevention of invasive disease, pneumonia and
acute otitis media caused by Streptococcus pneumoniae in infants,
children and adolescents from 6 weeks to less than 18 years of age
and applications pending in other jurisdictions, that involves
substantial risks and uncertainties that could cause actual results
to differ materially from those expressed or implied by such
statements. Risks and uncertainties include, among other things,
uncertainties regarding the commercial success of Prevnar
20/Prevenar 20; the uncertainties inherent in research and
development, including the ability to meet anticipated clinical
endpoints, commencement and/or completion dates for our clinical
trials, regulatory submission dates, regulatory approval dates
and/or launch dates, as well as the possibility of unfavorable new
clinical data and further analyses of existing clinical data; the
risk that clinical trial data are subject to differing
interpretations and assessments by regulatory authorities; whether
regulatory authorities will be satisfied with the design of and
results from our clinical studies; whether and when any biologics
license applications may be filed in particular jurisdictions for
Prevnar 20/Prevenar 20 for any potential indications; whether and
when any applications that may be pending or filed for Prevnar
20/Prevenar 20 may be approved by regulatory authorities, which
will depend on myriad factors, including making a determination as
to whether the product’s benefits outweigh its known risks and
determination of the product’s efficacy and, if approved, whether
Prevnar 20/Prevenar 20 will be commercially successful; decisions
by regulatory authorities impacting labeling, manufacturing
processes, safety and/or other matters that could affect the
availability or commercial potential of Prevnar 20/Prevenar 20;
uncertainties regarding the ability to obtain recommendations from
vaccine advisory or technical committees and other public health
authorities regarding Prevnar 20/Prevenar 20 and uncertainties
regarding the commercial impact of any such recommendations;
uncertainties regarding the impact of COVID-19 on our business,
operations and financial results; and competitive developments.
A further description of risks and uncertainties can be found in
Pfizer’s Annual Report on Form 10-K for the fiscal year ended
December 31, 2023, and in its subsequent reports on Form 10-Q,
including in the sections thereof captioned “Risk Factors” and
“Forward-Looking Information and Factors That May Affect Future
Results”, as well as in its subsequent reports on Form 8-K, all of
which are filed with the U.S. Securities and Exchange Commission
and available at www.sec.gov and www.pfizer.com.
1 Active Bacterial Core (ABCs) surveillance. National Center for
Immunization and Respiratory Diseases. Atlanta, GA. CDC. Published
March 2020. Updated May 22, 2020. Accessed February 6, 2024.
Available at:
https://www.cdc.gov/abcs/reports-findings/survreports/spneu18.pdf.
2 Ladhani, SN, Collins S, Djennad A, et al. Rapid increase in
non-vaccine serotypes causing invasive pneumococcal disease in
England and Wales, 2000-17: a prospective national observational
cohort study [published correction appears in Lancet Infect Dis.
2018 Feb 6;:]. Lancet Infect Dis. 2018;18(4):441-451.
doi:10.1016/S1473-3099(18)30052-5 3 Menéndez R, España PP,
Pérez-Trallero E, et al. The burden of PCV13 serotypes in
hospitalized pneumococcal pneumonia in Spain using a novel urinary
antigen detection test. CAPA study. Vaccine. 2017;35(39):5264-5270.
doi:10.1016/j.vaccine.2017.08.007 4 Azzari C, Cortimiglia M, Nieddu
F, et al. Pneumococcal serotype distribution in adults with
invasive disease and in carrier children in Italy: Should we expect
herd protection of adults through infants’ vaccination?. Hum Vaccin
Immunother. 2016;12(2):344-350. doi:10.1080/21645515.2015.1102811 5
Pivlishi T. Impact of PCV13 on invasive pneumococcal disease (IPD)
burden and the serotype distribution in the U.S. CDC. ACIP.
Published October 24, 2018. Accessed February 6, 2024. Available
at: https://stacks.cdc.gov/view/cdc/61449. 6 Invasive pneumococcal
disease. In: ECDC. Annual epidemiological report for 2016. ECDC.
Published August 8, 2018. Accessed February 6, 2024. Available at:
https://www.ecdc.europa.eu/sites/default/files/documents/AER_for_2016-invasive-pneumococcal-disease_0.pdf.
7 Beall B, Chochua S, Gertz RE Jr, et al. A population-based
descriptive atlas of invasive pneumococcal strains recovered within
the US during 2015-2016. Published November 2018. Accessed February
6, 2024. Available at: https://pubmed.ncbi.nlm.nih.gov/30524382/. 8
Grant L, Suaya J, Pugh S, et. al. Coverage of the 20-Valent
Conjugate Vaccine Against Invasive Pneumococcal Disease By Age
Group in the United States, 2017. Abstract No. ISP20-237. 9
Senders, S., et al. (2021, October 1). Safety and immunogenicity of
a 20-valent pneumococcal conjugate vaccine in healthy infants in
the United States. The Pediatric Infectious Disease Journal.
Published September 13, 2021. Accessed February 6, 2024. Available
at: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8443440/.
Category: Vaccines
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