- One dose of PREVNAR 20 is recommended by ACIP for adults ages
65 and older and adults ages 19 to 64 with certain risk
conditions
- New PREVNAR 20 one-dose guidance helps simplify long-standing
adult pneumococcal recommendations
Pfizer Inc. (NYSE:PFE) announced today that the Centers for
Disease Control and Prevention’s (CDC) Advisory Committee on
Immunization Practices (ACIP) voted to recommend PREVNAR 20™
(Pneumococcal 20-valent Conjugate Vaccine) for routine use to help
protect adults against invasive disease and pneumonia caused by the
20 Streptococcus pneumoniae (pneumococcus) serotypes in the
vaccine. Specifically, the ACIP voted to recommend the
following:
- Adults 65 years of age or older who have not previously
received a pneumococcal conjugate vaccine or whose previous
vaccination history is unknown should receive a pneumococcal
conjugate vaccine (either PCV20 or PCV15). If PCV15 is used, this
should be followed by a dose of PPSV23.
- Adults aged 19 years of age or older with certain underlying
medical conditions or other risk factors1 who have not previously
received a pneumococcal conjugate vaccine or whose previous
vaccination history is unknown should receive a pneumococcal
conjugate vaccine (either PCV20 or PCV15). If PCV15 is used, this
should be followed by a dose of PPSV23.
The recommendations will be forwarded to the director of the CDC
and the U.S. Department of Health and Human Services for review and
following approval, the recommendations are published in the
Morbidity and Mortality Weekly Report. This will represent the
first-time any pneumococcal conjugate vaccine has been routinely
recommended for certain risk populations ages 19 to 64 years, such
as people with diabetes and asthma.
“A single dose of PREVNAR 20 helps protect adults against
vaccine-type pneumococcal pneumonia and invasive pneumococcal
disease during a period where their risk is gradually increasing
due to aging among other factors. Today’s vote acknowledges the
important role of adult immunizations in helping protect eligible
populations against certain potentially serious respiratory
diseases during the current pandemic and beyond,” said Luis Jodar,
Ph.D., Senior Vice President and Chief Medical Officer, Pfizer
Vaccines. “The ACIP recommendation recognizes the significance as
well of helping protect more populations under age 65 with
co-morbid and immunocompromising conditions who are at increased
risk of disease against these 20 disease-causing serotypes.”
The seven additional serotypes in PREVNAR 20 represent 30
percent of overall of invasive pneumococcal disease burden in U.S.
adults.2 Pneumococcal pneumonia results in more than 180,000 adult
hospital admissions and more than 150,000 adult outpatient visits
in the U.S. each year.3
“The new simplified ACIP recommendation may offer the
opportunity to improve immunization rates and therefore help
prevent more disease,” said Nanette Cocero, Ph.D., Global
President, Pfizer Vaccines. “We believe that as U.S. health care
professionals start implementing this ACIP recommendation, once
endorsed by the CDC Director, PREVNAR 20 recommended as a single
dose has the potential to provide an important public health
benefit for adults. Building on Pfizer’s more than 20-year legacy
of developing and supplying pneumococcal conjugate vaccines, we
remain committed to working with the healthcare and public health
communities to raise awareness of the importance of adult
immunization and encourage recommended individuals to get
vaccinated.”
About PREVNAR 20
PREVNAR 20 is a next-generation pneumococcal conjugate vaccine
that includes capsular polysaccharide conjugates for the 13
serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F)
already included in Prevnar 13® (Pneumococcal 13-valent Conjugate
Vaccine [Diphtheria CRM197 Protein]). The vaccine also contains
capsular polysaccharide conjugates for seven additional serotypes
(8, 10A, 11A, 12F, 15B, 22F and 33F) that cause invasive
pneumococcal disease (IPD),4,5,6,7,8 and have been associated with
high case-fatality rates,9,10,11,12 antibiotic resistance,13,14,15
and/or meningitis.16,17 PREVNAR 20 contains the broadest serotype
coverage of any conjugate vaccine available; and helps protect
against more strains of the bacteria that cause pneumococcal
pneumonia than any conjugate vaccine available.
On June 8, 2021, Pfizer announced the U.S. Food and Drug
Administration (FDA) approved PREVNAR 20 for the prevention of
invasive disease and pneumonia in adults age 18 years or older. On
February 26, 2021, the European Medicines Agency (EMA) accepted for
review Pfizer’s Marketing Authorization Application (MAA) for the
20-valent pneumococcal conjugate vaccine candidate, as submitted
for the prevention of invasive disease and pneumonia caused by S.
pneumoniae serotypes in the vaccine in adults ages 18 years and
older. The formal review process by the EMA’s Committee for
Medicinal Products for Human Use (CHMP) currently is ongoing.
INDICATIONS FOR PREVNAR 20™
- PREVNAR 20™ is a vaccine indicated for active immunization for
the prevention of pneumonia and invasive disease caused by
Streptococcus pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 8, 9V,
10A, 11A, 12F, 14, 15B, 18C, 19A, 19F, 22F, 23F, and 33F in adults
18 years of age and older
- This indication for the prevention of pneumonia caused by S.
pneumoniae serotypes 8, 10A, 11A, 12F, 15B, 22F, and 33F is
approved under accelerated approval based on immune responses as
measured by opsonophagocytic activity (OPA) assay. Continued
approval for this indication may be contingent upon verification
and description of clinical benefit in a confirmatory trial.
U.S. IMPORTANT SAFETY INFORMATION
- PREVNAR 20™ should not be given to anyone with a history of
severe allergic reaction to any component of PREVNAR 20™ or any
diphtheria toxoid–containing vaccine
- Some adults with weakened immune systems may have a lower
response to PREVNAR 20™. Safety data are not available for these
groups. Your healthcare provider can tell you if PREVNAR 20™ 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, and
headache
- Ask your healthcare provider about the risks and benefits of
PREVNAR 20™. Only a healthcare provider can decide if PREVNAR 20™
is right for you
Please see full prescribing information for PREVNAR 20™.
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
more than 170 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
Twitter 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 October 20,
2021. 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™ (Pneumococcal 20-valent Conjugate Vaccine [Diphtheria CRM197
Protein]), including its potential benefits and a recommendation by
ACIP for routine use to help protect adults in the U.S. against
invasive disease and pneumonia caused by the 20 Streptococcus
pneumoniae (pneumococcus) serotypes in the vaccine, 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 and
uncertainties regarding the commercial impact of ACIP’s
recommendation; 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 any other jurisdictions for
PREVNAR 20 for the prevention of invasive disease and pneumonia in
adults age 18 years or older and in any jurisdictions for any other
potential indications; whether and when the MAA pending in the EU
may be approved and whether and when any such other applications
that may be pending or filed 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 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;
uncertainties regarding the ability to obtain recommendations from
vaccine advisory or technical committees and other public health
authorities regarding PREVNAR 20 and uncertainties regarding the
commercial impact of any such recommendations; 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, 2020 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 Alcoholism, chronic heart/liver/lung
disease, cigarette smoking, diabetes mellitus, chronic renal
failure, nephrotic syndrome, immunodeficiency, iatrogenic
immunosuppression, generalized malignancy, human immunodeficiency
virus, Hodgkin disease, leukemia, lymphoma, multiple myeloma, solid
organ transplants, congenital or acquired asplenia, sickle cell
disease or other hemoglobinopathies, CSF leak, or cochlear implant.
2 Gierke R, Advisory Committee on Immunization Practices (ACIP).
Current Epidemiology of Pneumococcal Disease and Pneumococcal
Vaccine Coverage among Adults, United States. Centers for Disease
Control and Prevention (CDC). February 25, 2021.
https://www.cdc.gov/vaccines/acip/meetings/downloads/slides-2021-02/24-25/02-Pneumococcal-Gierke.pdf.
3 Data on file. Pfizer Inc., New York, NY 4 Baisells E, Guillot L,
Nair H, et al. Serotype distribution of Streptococcus pneumoniae
causing invasive disease in children in the post-PCV era: A
systematic review and meta-analysis. PlosOne. 2017;12(5): e0177113.
5 Hausdorff W & Hanage W. Interim results of an ecological
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serotype replacement. Hum Vaccin Immunother. 2016;12(2):358-374. 6
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conjugate vaccines for children in high- and non-high income
countries. Expert Rev Vaccines. 2017;16(6):625-640. 7 Moore M,
Link-Gelles R, Schaffner W, et al. Effect of use of 13-valent
pneumococcal conjugate vaccine in children on invasive pneumococcal
disease in children and adults in the USA: analysis of multisite,
population-based surveillance. Lancet Infect Dis.
2015;15(3):301-309. 8 Metcalf B, Gertz RE, Gladstone RA, et al.
Strain features and distributions in pneumococci from children with
invasive disease before and after 13-valent conjugate vaccine
implementation in the USA. Clin Microbiol Infect. 2016;22(1):60.
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Deaths Attributable to Invasive Pneumococcal Disease in England and
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Andrews N, Waight PA, et al. Effect of Serotype on Focus and
Mortality of Invasive Pneumococcal Disease: Coverage of Different
Vaccines and Insight into Non-Vaccine Serotypes. PlosOne. 2012;7(7:
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Impact of Pneumococcal Vaccines on Invasive Streptococcus
pneumoniae Disease. Am J Med Sci. 2016;352(6):563-573. 12 Harboe
ZB, Thomsen RW, Riis A, et al. Pneumococcal Serotypes and Mortality
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Study. PlosOne. 2009;6(5): e 1000081. 13 Azzari C, Cortimiglia M,
Nieddu F, et al. Pneumococcal serotype distribution in adults with
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Immunother. 2016;12(2):344-350. 14 Tomczyk S, Lynfield R, Schaffner
W, et al. Prevention of Antibiotic-Nonsusceptible Invasive
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Vaccine. Clin Infect Dis. 2016;62(9):1119-1125. 15 Mendes RE,
Hollingsworth RC, Costello A, et al. Noninvasive Streptococcus
pneumoniae Serotypes Recovered from Hospitalized Adult Patients in
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