Pfizer Inc. (NYSE:PFE) today announced positive top-line results
from a Phase 3 study (B74710126) describing the safety and
immunogenicity of PREVNAR 20™ (Pneumococcal 20-valent Conjugate
Vaccine) in 570 adults in the United States 65 years of age or
older when administered at the same time as the Pfizer-BioNTech
COVID-19 Vaccine or when each vaccine was given with placebo.
Responses elicited by PREVNAR 20 for all 20 serotypes were
similar whether given with a dose of the Pfizer-BioNTech COVID-19
Vaccine (n=190) or with placebo (n=191). Responses to a booster
dose of the Pfizer-BioNTech COVID-19 Vaccine were also similar when
given with PREVNAR 20 or given with placebo (n=189). The safety
profile of co-administering PREVNAR 20 with a booster dose of the
Pfizer-BioNTech COVID-19 Vaccine generally reflected that observed
with the Pfizer-BioNTech COVID-19 Vaccine booster dose.
“Pfizer is steadfast in its commitment to address the burden of
certain respiratory diseases while raising awareness of the
importance of adult immunizations,” said Kathrin U. Jansen, Ph.D.,
Senior Vice President and Head of Vaccine Research &
Development, Pfizer. “These new safety and immunogenicity data
provide further evidence supporting the potential to administer
PREVNAR 20 and the Pfizer-BioNTech COVID-19 Vaccine at the same
time, thereby reducing the number of visits adults make to their
doctor’s office or pharmacy for recommended immunization. As the
COVID-19 vaccines and booster doses continue to be administered, we
believe that healthcare providers have an opportunity to talk to
their adult patients about other recommended vaccines in line with
CDC guidance.”
The initiation of the study exploring the coadministration of
PREVNAR 20 along with a booster dose of the Pfizer-BioNTech
COVID-19 Vaccine in older adults was announced in May 2021. The
study recruited adults from the pivotal Phase 3 Pfizer-BioNTech
COVID-19 Vaccine clinical trial and included adults who received
their second dose of the vaccine at least six months prior to
entering the coadministration study. Pfizer will seek to present
and publish detailed outcomes from this clinical trial at a future
date. At this time no coadministration data are included in the
PREVNAR 20 or Pfizer-BioNTech COVID-19 Vaccine prescribing
information.
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),1,2,3,4,5 and have been associated with high case-fatality
rates,6,7,8,9 antibiotic resistance,10,11,12 and/or
meningitis.13,14 PREVNAR 20 contains the broadest conjugate
serotype coverage and helps protect against more strains of the
bacteria that cause pneumococcal pneumonia than any other conjugate
vaccine available.
On June 8, 2021, Pfizer announced the U.S. Food and Drug
Administration (FDA) approved PREVNAR 20, which is the U.S. trade
name, for the prevention of invasive disease and pneumonia in
adults age 18 years or older. On December 16, 2021, the Committee
for Medicinal Products for Human Use (CHMP) of the European
Medicines Agency (EMA) issued a positive opinion to recommend the
granting of a marketing authorization for the 20-valent
pneumococcal conjugate vaccine candidate for the prevention of
invasive disease and pneumonia caused by 20 Streptococcus
pneumoniae (pneumococcus) serotypes in adults ages 18 years and
older in the 27 European Union (EU) member states plus Iceland,
Lichtenstein and Norway. The EMA had previously accepted review of
Pfizer’s Marketing Authorization Application (MAA) for the
20-valent pneumococcal conjugate vaccine candidate on February 26,
2021.
Pfizer has recently submitted to the FDA a supplemental
Biologics License Application to include data in the PREVNAR 20
prescribing information for adults age 18 years or older regarding
coadministration of PREVNAR 20 with a seasonal inactivated
influenza vaccine.
Pivotal Phase 3 studies of the 20-valent pneumococcal conjugate
vaccine candidate in infants are expected to read out in the second
half of 2022 and, if positive, form the basis of potential
regulatory submissions to the FDA and EMA later this year.
U.S. 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™.
COMIRNATY® U.S. Indication & Authorized Use HOW
IS THE VACCINE GIVEN? The vaccine will be given to you as an
injection into the muscle.
Primary Series: In individuals 5 years of age and older, the
vaccine is administered as a 2-dose series, 3 weeks apart.
In individuals 5 years of age and older, a third primary series
dose may be administered at least 28 days after the second dose to
individuals who are determined to have certain kinds of
immunocompromise.
Booster Dose:
- A single booster dose of the vaccine may be administered at
least 5 months after completion of a primary series of the
Pfizer-BioNTech COVID-19 Vaccine or COMIRNATY® (COVID-19 Vaccine,
mRNA) to individuals 12 years of age and older
- A single booster dose of the vaccine may be administered to
individuals 18 years of age and older who have completed primary
vaccination with a different authorized COVID-19 vaccine.
Individuals should check with their healthcare provider regarding
timing of the booster dose
WHAT IS THE INDICATION AND AUTHORIZED USE?
The Pfizer-BioNTech COVID-19 Vaccine has received EUA from FDA
to provide:
- a 2-dose primary series to individuals 5 years of age and
older
- a third primary series dose to individuals 5 years of age and
older who have been determined to have certain kinds of
immunocompromise
- a single booster dose to individuals 12 years of age and older
who have completed a primary series with Pfizer-BioNTech COVID-19
Vaccine or COMIRNATY® (COVID-19 Vaccine, mRNA)
- a single booster dose to individuals 18 years of age and older
who have completed primary vaccination with a different authorized
COVID-19 vaccine. The booster schedule is based on the labeling
information of the vaccine used for the primary series
COMIRNATY® (COVID-19 Vaccine, mRNA) is an FDA-approved COVID-19
vaccine made by Pfizer for BioNTech.
- It is approved as a 2-dose series for prevention of COVID-19 in
individuals 16 years of age and older
- It is also authorized under EUA to provide:
- a 2-dose primary series to individuals 12 through 15 years of
age
- a third primary series dose to individuals 12 years of age and
older who have been determined to have certain kinds of
immunocompromise
- a single booster dose to individuals 12 years of age and older
who have completed a primary series with Pfizer-BioNTech COVID-19
Vaccine or COMIRNATY® (COVID-19 Vaccine, mRNA)
- a single booster dose to individuals 18 years of age and older
who have completed primary vaccination with a different authorized
COVID-19 vaccine. The booster schedule is based on the labeling
information of the vaccine used for the primary series
EUA Statement
Emergency uses of the vaccine have not been approved or licensed
by FDA, but have been authorized by FDA, under an Emergency Use
Authorization (EUA) to prevent Coronavirus Disease 2019 (COVID-19)
in individuals 5 years of age and older. The emergency uses are
only authorized for the duration of the declaration that
circumstances exist justifying the authorization of emergency use
of the medical product under Section 564(b)(1) of the FD&C Act
unless the declaration is terminated or authorization revoked
sooner. Please see EUA Fact Sheets at www.cvdvaccine-us.com.
IMPORTANT
SAFETY INFORMATION
Individuals should not get the vaccine if they:
- had a severe allergicreaction after a previous dose of this
vaccine
- had a severe allergicreaction to any ingredient of this
vaccine
Individuals should tell the vaccination provider about all of
their medical conditions, including if they:
- have any allergies
- have had myocarditis (inflammation of the heart muscle) or
pericarditis (inflammation of the lining outside the heart)
- have a fever
- have a bleeding disorder or are on a blood thinner
- are immunocompromised or are on a medicine that affects the
immune system
- are pregnant, plan to become pregnant, or are
breastfeeding
- have received another COVID-19 vaccine
- have ever fainted in association with an injection
The vaccine may not protect everyone.
Side effects reported with the vaccine include:
- There is a remote chance that the vaccine could cause a severe
allergic reaction
- A severe allergic reaction would usually occur within a few
minutes to 1 hour after getting a dose of the vaccine. For this
reason, vaccination providers may ask individuals to stay at the
place where they received the vaccine for monitoring after
vaccination
- Signs of a severe allergic reaction can include difficulty
breathing, swelling of the face and throat, a fast heartbeat, a bad
rash all over the body, dizziness, and weakness
- If an individual experiences a severe allergic reaction, they
should call 9-1-1 or go to the nearest hospital
- Myocarditis (inflammation of the heart muscle) and pericarditis
(inflammation of the lining outside the heart) have occurred in
some people who have received the vaccine, more commonly in males
under 40 years of age than among females and older males. In most
of these people, symptoms began within a few days following receipt
of the second dose of the vaccine. The chance of having this occur
is very low. Individuals should seek medical attention right away
if they have any of the following symptoms after receiving the
vaccine:
- chest pain
- shortness of breath
- feelings of having a fast-beating, fluttering, or pounding
heart
- Additional side effects that have been reported with the
vaccine include:
- severe allergic reactions; non-severe allergic reactions such
as rash, itching, hives, or swelling of the face; myocarditis
(inflammation of the heart muscle); pericarditis (inflammation of
the lining outside the heart); injection site pain; tiredness;
headache; muscle pain; chills; joint pain; fever; injection site
swelling; injection site redness; nausea; feeling unwell; swollen
lymph nodes (lymphadenopathy); decreased appetite; diarrhea;
vomiting; arm pain; fainting in association with injection of the
vaccine
- These may not be all the possible side effects of the vaccine.
Serious and unexpected side effects may occur. The possible side
effects of the vaccine are still being studied in clinical trials.
Call the vaccination provider or healthcare provider about
bothersome side effects or side effects that do not go away
Data on administration of this vaccine at the same time as other
vaccines have not yet been submitted to FDA. Individuals
considering receiving this vaccine with other vaccines, should
discuss their options with their healthcare provider.
Patients should always ask their healthcare providers for
medical advice about adverse events. Individuals are encouraged to
report negative side effects of vaccines to the US Food and Drug
Administration (FDA) and the Centers for Disease Control and
Prevention (CDC). Visit https://www.vaers.hhs.gov or call
1-800-822-7967. In addition, side effects can be reported to Pfizer
Inc. at http://www.pfizersafetyreporting.com or by calling
1-800-438-1985.
Click for
Fact Sheets and Prescribing Information for
individuals 12 years of age and older
Full Prescribing Information (16 years of age
and older) DILUTE BEFORE USE, Purple Cap Full Prescribing
Information (16 years of age and older) DO NOT DILUTE, Gray Cap EUA
Fact Sheet for Vaccination Providers (12 years of age and older),
Purple Cap EUA Fact Sheet for Vaccination Providers (12 years of
age and older), Gray Cap Recipients and Caregivers Fact Sheet (12
years of age and older)
Fact Sheets for individuals 5 through 11
years of age
EUA Fact Sheet for Vaccination Providers (5
through 11 years of age), Orange Cap Recipients and Caregivers Fact
Sheet (5 through 11 years of age)
When prepared according to their respective instructions for
use, the FDA-approved COMIRNATY® (COVID-19 Vaccine, mRNA) and the
Pfizer-BioNTech COVID-19 Vaccine for individuals 12 years of age
and older (purple cap and gray cap) can be used interchangeably
without presenting any safety or effectiveness concerns.
Individuals 5 through 11 years can only receive the
FDA-authorized Pfizer-BioNTech COVID-19 Vaccine formulation
identifiable with an orange cap.
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 January 12, 2022. 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), Pfizer’s efforts to
combat COVID-19, the collaboration between BioNTech and Pfizer to
develop a COVID-19 vaccine, the BNT162 mRNA vaccine program and the
Pfizer-BioNTech COVID-19 Vaccine, also known as COMIRNATY
(BNT162b2), including their potential benefits, involving
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 our vaccines; the
uncertainties inherent in research and development, including the
ability to meet anticipated clinical endpoints, commencement and/or
completion dates for clinical trials, regulatory submission dates,
regulatory approval dates and/or launch dates, as well as risks
associated with preclinical and clinical data (including the Phase
3 data), including the possibility of unfavorable new preclinical,
clinical or safety data and further analyses of existing
preclinical, clinical or safety data; the ability to produce
comparable clinical or other results, including the rate of vaccine
effectiveness and safety and tolerability profile observed to date,
in additional analyses of the Phase 3 trial and additional studies
or in larger, more diverse populations following commercialization;
the ability of BNT162b2 to prevent COVID-19 caused by emerging
virus variants; the risk that more widespread use of the vaccine
will lead to new information about efficacy, safety, or other
developments, including the risk of additional adverse reactions,
some of which may be serious; the risk that preclinical and
clinical trial data are subject to differing interpretations and
assessments, including during the peer review/publication process,
in the scientific community generally, and by regulatory
authorities; whether and when additional data from our vaccine
programs will be published in scientific journal publications and,
if so, when and with what modifications and interpretations;
whether regulatory authorities will be satisfied with the design of
and results from these and any future preclinical and 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 submissions to request emergency use or
conditional marketing authorizations for a potential booster dose,
pediatric populations and/or other biologics license and/or
emergency use authorization applications or amendments to any such
applications may be filed in particular jurisdictions for BNT162b2
or any other potential vaccines that may arise from the BNT162
program, including a potential variant-specific vaccine, and if
obtained, whether or when such emergency use authorizations or
licenses will expire or terminate; whether and when the MAA pending
in the EU for the 20-valent pneumococcal conjugate vaccine
candidate may be approved, whether and when any other applications
that may be pending or filed for PREVNAR 20 may be approved by
particular regulatory authorities and whether and when any
applications that may be pending or filed for BNT162b2 (including
any requested amendments to the emergency use or conditional
marketing authorizations) or other vaccines that may result from
the BNT162 program may be approved by particular regulatory
authorities, which will depend on myriad factors, including making
a determination as to whether the vaccine’s benefits outweigh its
known risks and determination of the vaccine’s efficacy and, if
approved, whether it will be commercially successful; decisions by
regulatory authorities impacting labeling or marketing,
manufacturing processes, safety and/or other matters that could
affect the availability or commercial potential of a vaccine,
including development of products or therapies by other companies;
disruptions in the relationships between us and our collaboration
partners, clinical trial sites or third-party suppliers; the risk
that demand for any products may be reduced or no longer exist;
risks related to the availability of raw materials to manufacture a
vaccine; challenges related to BNT162b2’s formulation, two-dose
schedule and attendant storage, distribution and administration
requirements, including risks related to storage and handling after
delivery by Pfizer; the risk that we may not be able to
successfully develop other vaccine formulations, booster doses or
new variant-specific vaccines; the risk that we may not be able to
create or scale up manufacturing capacity on a timely basis or
maintain access to logistics or supply channels commensurate with
global demand for our vaccine, which would negatively impact our
ability to supply the estimated numbers of doses of our vaccine
within the projected time periods as previously indicated; whether
and when additional supply agreements for BNT162b2 will be reached;
uncertainties regarding the ability to obtain recommendations from
vaccine advisory or technical committees and other public health
authorities and uncertainties regarding the commercial impact of
any such recommendations; challenges related to public vaccine
confidence or awareness; uncertainties regarding the impact of
COVID-19 on Pfizer’s 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 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. 2 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. 3 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. 4 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. 5 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. 6 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. 7 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. 8 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. 9 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): e 1000081. 10 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. 11 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. 12 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. 13
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. 14 Thigpen MC,
Whitney CG, Messonnier NE, et al. Bacterial Meningitis in the
United States, 1998–2007. NEJM. 2011;364(21):2016-2025.
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