- Millions of newly eligible U.S. adults aged 50 to 64 now
recommended to receive vaccination against invasive pneumococcal
disease (IPD) and pneumococcal pneumonia1
Pfizer Inc. (NYSE: PFE) announced today that the U.S. Centers
for Disease Control and Prevention’s (CDC) Advisory Committee on
Immunization Practice (ACIP) voted to expand its recommendation for
the use of certain pneumococcal vaccines, including PREVNAR 20®
(20-valent Pneumococcal Conjugate Vaccine) for all adults aged 50
and older. This recommendation is pending final approval by the
director of the CDC and the Department of Health and Human
Services. With respect to PREVNAR 20, ACIP recommended:
- Vaccination is recommended for all adults aged ≥50 years and
for adults aged 19–49 years with certain underlying conditions or
risk factors who have not received a PCV or whose vaccination
history is unknown.
“ACIP’s vote to expand adult pneumococcal vaccination to now
include all adults aged 50 and older marks an important milestone
in Pfizer’s long-standing commitment to reducing the burden of this
life-threatening disease,” said Luis Jodar, PhD, Senior Vice
President, Senior Vice President, Vaccines and Anti-Infectives
Chief Medical Affairs Officers, Pfizer. “PREVNAR 20 offers
protection against the serotypes responsible for the majority of
invasive pneumococcal disease cases in this age group. Expanding
its use also provides an opportunity to limit the re-emergence of
disease-causing strains like serotype 4, which has recently
affected certain U.S. adult populations and is covered by the
vaccine.”
In the U.S., the 20 serotypes contained in PREVNAR 20 are
estimated to cause over 2,000 deaths and more than 65,000 cases of
invasive pneumococcal disease (IPD), including bacteremia and
meningitis, and community-acquired pneumonia annually in adults
aged 50 to 64.2 Between 2018 and 2022, more than half of IPD cases
in people aged 50 to 64 were caused by these 20 serotypes.3
Vaccination with PREVNAR 20 helps prevent serotype 4 disease, which
incidence has been rising in certain populations in the western
U.S.4
About PREVNAR 20® PREVNAR 20® is Pfizer’s 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),5,6,7,8,9 and have been associated with high case-fatality
rates,10,11,12,13 antibiotic resistance,14,15,16 and/or
meningitis.17,18 PREVNAR 20 helps protect against disease caused by
the 20 Streptococcus pneumoniae serotypes in the vaccine.
On June 8, 2021, Pfizer announced the U.S. Food and Drug
Administration (FDA) approved PREVNAR 20 for the prevention of
invasive pneumococcal disease and pneumococcal pneumonia in adults
aged 18 years or older. On September 30, 2022, the FDA approved the
addition of information in the PREVNAR 20 prescribing information
regarding coadministration with an influenza vaccine, adjuvanted
(Fluad Quadrivalent19), in adults aged 65 years or older.
INDICATIONS FOR PREVNAR 20 PREVNAR 20® is a vaccine
indicated 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.
- The indication of PREVNAR 20 for the prevention of pneumonia
caused by S. pneumoniae serotypes 8, 10A, 11A, 12F, 15B, 22F, and
33F in individuals 18 years of age and older is approved based on
immune responses. Continued approval may depend on a supportive
study
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 you or your
child.
View the full Prescribing Information.
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 October 23, 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® (20-valent Pneumococcal Conjugate Vaccine), including its
potential benefits and a vote by ACIP to expand its recommendation
for the use of certain pneumococcal vaccines, including PREVNAR 20
for all adults aged 50 and older and for adults aged 19–49 years
with certain underlying conditions or risk factors who have not
received a PCV or whose vaccination history is unknown, 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 any potential indications; whether and when any such
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; 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 U.S. Census Bureau.
Population by age.
https://data.census.gov/table?q=Population%20by%20age. Accessed
October 2024. 2 Perdrizet J, Chilson E, Wasserman M, et al. Current
and future pneumococcal conjugate vaccine serotype-specific burden
in the United States adult population. Abstract No. ISP20-287
Presented at ISPPD-12, Toronto, June 21-25, 2020. Available at:
https://cslide.ctimeetingtech.com/isppd20/attendee/confcal/presentation/list?q=Perdrizet.
3 U.S. Centers for Disease Control and Prevention. Summary of Work
Group Interpretations of EtR and Policy Option on PCV21 Use in
Adults.
https://www.cdc.gov/acip/downloads/slides-2024-06-26-28/04-Pneumococcal-Kobayashi-508.pdf.
Presented June 27, 2024. Accessed October 11, 2024. 4 U.S. Centers
for Disease Control and Prevention. Summary of Risk-based
Pneumococcal Vaccination Recommendations.
https://www.cdc.gov/pneumococcal/hcp/vaccine-recommendations/risk-indications.html.
Updated October 10, 2024. Accessed October 11, 2024. 5 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. 6 Hausdorff W & Hanage W. Interim results of an
ecological experiment – conjugate vaccination against the
pneumococcus and serotype replacement. Hum Vaccin Immunother.
2016;12(2):358-374. 7 Cohen R, Cohen J, Chalumeau M, et al. Impact
of pneumococcal conjugate vaccines for children in high- and
non-high income countries. Expert Rev Vaccines. 2017;16(6):625-640.
8 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. 9 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.e9-60.e29. 10 Oligbu G, Collins S, Sheppard CL, et
al. Childhood deaths attributable to invasive pneumococcal disease
in England and Wales, 2006–2014. Clin Infect Dis.
2017;65(2):308-314. 11 van Hoek, 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):e39150. 12 Stanek R,
Norton N, Mufson M. A 32-years study of the impact of pneumococcal
vaccines on invasive Streptococcus pneumoniae disease. Am J Med
Sci. 2016;352(6):563-573. 13 Harboe ZB, Thomsen RW, Riis A, et al.
Pneumococcal serotypes and mortality following invasive
pneumococcal disease: A population-based cohort study. PlosOne.
2009;6(5):e1000081. 14 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. 15 Tomczyk S, Lynfield R, Schaffner W, et al.
Prevention of antibiotic-nonsusceptible invasive pneumococcal
disease with the 13-valent pneumococcal conjugate vaccine. Clin
Infect Dis. 2016;62(9):1119-1125. 16 Mendes RE, Hollingsworth RC,
Costello A, et al. Noninvasive Streptococcus pneumoniae serotypes
recovered from hospitalized adult patients in the United States in
2009 to 2012. Antimicrob Agents Chemother. 2015;59(9):5595-5601. 17
Olarte L, Barson WJ, Lin PL, et al. Impact of the 13-valent
pneumococcal conjugate vaccine on pneumococcal meningitis in US
children. Clin Infect Dis. 2015;61(5):767-775. 18 Thigpen MC,
Whitney CG, Messonnier NE, et al. Bacterial meningitis in the
United States, 1998–2007. NEJM. 2011;364(21):2016-2025. 19 Fluad
Quadrivalent is not a Pfizer product
Category: Vaccines
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