CAPVAXIVE (V116) is specifically designed
for adults and covers serotypes responsible for approximately 84%
of invasive pneumococcal disease in adults 50 years of age and
older
Across four Phase 3 studies, CAPVAXIVE
demonstrated robust immune responses in both vaccine-naïve and
vaccine-experienced adult populations
Merck (NYSE: MRK), known as MSD outside of the United States and
Canada, announced today that the U.S. Food and Drug Administration
(FDA) has approved CAPVAXIVE™ (Pneumococcal 21-valent Conjugate
Vaccine) for:
- Active immunization for the prevention of invasive disease
caused by Streptococcus pneumoniae serotypes 3, 6A, 7F, 8, 9N, 10A,
11A, 12F, 15A, 15B, 15C, 16F, 17F, 19A, 20A, 22F, 23A, 23B, 24F,
31, 33F and 35B in individuals 18 years of age and older;
- Active immunization for the prevention of pneumonia caused by
S. pneumoniae serotypes 3, 6A, 7F, 8, 9N, 10A, 11A, 12F, 15A, 15C,
16F, 17F, 19A, 20A, 22F, 23A, 23B, 24F, 31, 33F and 35B in
individuals 18 years of age and older.
CAPVAXIVE is specifically designed to help protect adults
against the serotypes that cause the majority of invasive
pneumococcal disease (IPD) cases. The approval follows the FDA’s
Priority Review of Merck’s application. Do not administer CAPVAXIVE
to individuals with a history of a severe allergic reaction (e.g.,
anaphylaxis) to any component of CAPVAXIVE or to diphtheria toxoid;
see additional Select Safety Information below.
This indication for the prevention of pneumonia caused by S.
pneumoniae serotypes 3, 6A, 7F, 8, 9N, 10A, 11A, 12F, 15A, 15C,
16F, 17F, 19A, 20A, 22F, 23A, 23B, 24F, 31, 33F and 35B is approved
under accelerated approval based on immune responses as measured by
opsonophagocytic activity (OPA). Continued approval for this
indication may be contingent upon verification and description of
clinical benefit in a confirmatory trial.
The U.S. Centers for Disease Control and Prevention’s (CDC)
Advisory Committee on Immunization Practices is expected to meet
later this month to discuss and make recommendations for the use of
CAPVAXIVE in adults.
“Complications from invasive pneumococcal disease can lead to
hospitalization, organ damage and even death. Many cases of adult
disease are caused by serotypes not included in other approved
pneumococcal conjugate vaccines,” said Dr. Walter Orenstein,
professor emeritus of medicine, epidemiology, global health and
pediatrics at Emory University and member of Merck’s Scientific
Advisory Committee. “CAPVAXIVE is designed to include the serotypes
that cause the majority of invasive pneumococcal disease in adults,
helping to protect adults against invasive pneumococcal disease and
pneumococcal pneumonia.”
Based on CDC data from 2018-2021, the serotypes covered by
CAPVAXIVE are responsible for more cases of IPD in adults compared
to PCV20 (pneumococcal 20-valent conjugate vaccine).
- In adults 50 years of age and older, CAPVAXIVE covers the
serotypes responsible for approximately 84% of IPD cases, compared
to approximately 52% covered by PCV20.
- In adults 65 years of age and older, CAPVAXIVE covers the
serotypes responsible for approximately 85% of IPD cases, compared
to approximately 51% covered by PCV20.
These values are based on CDC epidemiologic data and do not
reflect the efficacy of the respective vaccines. There are
currently no studies comparing the efficacy of CAPVAXIVE and
PCV20.
CAPVAXIVE includes eight unique serotypes not covered by other
currently approved pneumococcal vaccines; those serotypes were
responsible for approximately 27% of IPD cases in adults 50 years
of age and older and approximately 30% in adults 65 years of age
and older, based on the same CDC data.
“Today’s approval is a testament to our population-specific
strategy behind CAPVAXIVE, which demonstrated robust immunogenicity
in a range of adult populations and is driven by a deep
understanding of pneumococcal disease,” said Dr. Dean Y. Li,
president, Merck Research Laboratories. “We are proud to provide
CAPVAXIVE as a new option specifically designed to help protect
against the majority of invasive pneumococcal disease-causing
serotypes in adults.”
Among the clinical data supporting the approval are results from
the pivotal Phase 3 STRIDE-3 trial (NCT05425732), which evaluated
CAPVAXIVE compared to PCV20 in adults 18 years of age and older who
had not previously received a pneumococcal vaccine. The approval is
also supported by results from the Phase 3 STRIDE-5 (NCT05526716)
and STRIDE-6 (NCT05420961) trials evaluating CAPVAXIVE in
vaccine-naïve and vaccine-experienced adults (see “Clinical Data
Supporting FDA Approval,” below, for additional details).
About CAPVAXIVE
CAPVAXIVE is Merck’s approved 21-valent pneumococcal conjugate
vaccine indicated for active immunization for the prevention of
invasive disease and pneumonia in adults 18 years of age and older.
CAPVAXIVE is specifically designed to help address Streptococcus
pneumoniae serotypes predominantly responsible for adult invasive
pneumococcal disease (IPD), including eight unique serotypes, 15A,
15C, 16F, 23A, 23B, 24F, 31 and 35B compared to other pneumococcal
vaccines. CAPVAXIVE is administered as a single dose.
Select Safety Information for CAPVAXIVE
Do not administer CAPVAXIVE to individuals with a history of a
severe allergic reaction (eg, anaphylaxis) to any component of
CAPVAXIVE or to diphtheria toxoid.
Individuals with altered immunocompetence, including those
receiving immunosuppressive therapy, may have a reduced immune
response to CAPVAXIVE.
The most commonly reported (>10%) solicited adverse reactions
in individuals 18 through 49 years of age who received CAPVAXIVE
were: injection-site pain (73.1%), fatigue (36.0%), headache
(27.5%), myalgia (16.4%), injection-site erythema (13.8%), and
injection-site swelling (13.3%).
The most commonly reported (>10%) solicited adverse reactions
in individuals 50 years of age and older who received CAPVAXIVE
were: injection-site pain (41.2%), fatigue (19.7%), and headache
(11.0%).
Vaccination with CAPVAXIVE may not protect all vaccine
recipients.
Clinical Data Supporting FDA Approval
CAPVAXIVE was approved based on data that included Phase 3
clinical studies designed to evaluate its safety and immunogenicity
in a variety of adult populations. These included studies of:
- Vaccine-naïve adults:
STRIDE-3 (NCT05425732) is a double-blind, Phase 3 study which
evaluated CAPVAXIVE compared to PCV20 in individuals 18 years of
age and older who had not previously received a pneumococcal
conjugate vaccine. Participants 50 years of age and older were
enrolled in cohort 1 (n=2,362), and participants 18 through 49
years of age were enrolled in cohort 2 (n=300). Participants were
randomized to receive a single dose of either CAPVAXIVE or PCV20.
Results from the study include:
- In adults 50 years of age and older (cohort 1), CAPVAXIVE was
non-inferior to PCV20 for the 10 serotype polysaccharides shared
with both vaccines (3, 6A, 7F, 8, 10A, 11A, 12F, 19A, 22F, 33F), as
assessed by serotype-specific OPA geometric mean titers (GMTs) at 1
month postvaccination;
- CAPVAXIVE was superior to PCV20 for 10 of 11 serotype
polysaccharides included in CAPVAXIVE but not in PCV20 (9N, 15A,
16F, 17F, 20A, 23A, 23B, 24F, 31, 35B), as assessed by
serotype-specific OPA GMTs 1 month postvaccination and the
proportions of patients with a greater than or equal to four-fold
increase in OPA from prevaccination to 1 month
postvaccination;
- Immune responses were observed for serotype 15C in participants
receiving CAPVAXIVE but did not meet criteria for statistical
significance.
- In individuals 18 through 49 years of age (cohort 2), CAPVAXIVE
elicited non-inferior immune responses (immunobridged) compared to
individuals 50 through 64 years of age, as assessed by
serotype-specific OPA GMTs 1 month postvaccination;
- Across both cohorts, CAPVAXIVE had a safety profile comparable
to PCV20.
- Co-administration of CAPVAXIVE with
quadrivalent influenza vaccine (QIV): STRIDE-5
(NCT05526716) is a randomized, double-blind, Phase 3 study which
evaluated CAPVAXIVE when administered concomitantly or sequentially
(30 days later) with QIV in adults 50 years of age and older
(n=1,080). Results from the study include:
- For the primary immunogenicity endpoints, CAPVAXIVE
administered concomitantly with QIV was non-inferior to CAPVAXIVE
administered sequentially with QIV for 20 of 21 serotypes in
CAPVAXIVE (as assessed by OPA GMTs at 1 month postvaccination), as
well as for three of four influenza strains in QIV (as assessed by
hemagglutination inhibition (HAI) GMTs at 1 month
postvaccination);
- The rates and severity of solicited systemic adverse reactions
and solicited local adverse reactions at the CAPVAXIVE injection
site were similar when CAPVAXIVE was administered with or without
inactivated QIV.
- Vaccine-experienced adults:
STRIDE-6 (NCT05420961) is a randomized descriptive Phase 3 study
which evaluated CAPVAXIVE in individuals 50 years of age and older
who had previously received a pneumococcal vaccine at least one
year before enrollment. Participants were enrolled into one of
three cohorts based on their previous pneumococcal vaccination
history (cohort 1: PPSV23 [pneumococcal 23-valent polysaccharide
vaccine], cohort 2: PCV13 [pneumococcal 13-valent conjugate
vaccine], or cohort 3: PPSV23 followed by or preceded by PCV13,
PPSV23 preceded by PCV15 [pneumococcal 15-valent conjugate
vaccine], or PCV15 alone). Participants in cohort 1 were randomized
to receive CAPVAXIVE (n=231) or PCV15 (n=119), participants in
cohort 2 were randomized to receive CAPVAXIVE (n=176) or PPSV23
(n=85), and participants in cohort 3 were allocated to receive
CAPVAXIVE (n=106). In each of the 3 cohorts, serotype-specific OPA
GMTs and the proportion of individuals with ≥4-fold rise in OPA
responses from baseline to 1-month postvaccination were assessed.
Results from the study include:
- In cohort 1, CAPVAXIVE elicited OPA responses that were
comparable to PCV15 for the 6 common serotypes, and higher for the
15 unique serotypes and serotype 15B;
- In cohort 2, CAPVAXIVE elicited OPA responses comparable to
PPSV23 for the 12 common serotypes and serotype 15B, and higher for
the 9 unique serotypes;
- OPA responses to CAPVAXIVE were similar across the 3 cohorts of
participants who previously received one or more pneumococcal
vaccines;
- CAPVAXIVE had a safety profile comparable to both PCV15 and
PPSV23.
About Pneumococcal Disease
Pneumococcal disease is an infection caused by a bacteria called
Streptococcus pneumoniae. There are about 100 different types
(referred to as serotypes) of pneumococcal bacteria, which can
affect adults differently than children. Pneumococcal disease can
be invasive or non-invasive. Non-invasive pneumococcal illnesses
include pneumonia (when pneumococcal disease is confined to the
lungs), whereas invasive pneumococcal illnesses include
pneumococcal bacteremia (infection in the bloodstream), bacteremic
pneumococcal pneumonia (pneumonia with bacteremia) and pneumococcal
meningitis (infection of the coverings of the brain and spinal
cord). Pneumococcal pneumonia is a type of bacterial pneumonia,
which is the most common clinical presentation of pneumococcal
disease in adults. It’s estimated that over 150,000 adults are
hospitalized from pneumococcal pneumonia each year in the U.S.
About Merck
At Merck, known as MSD outside of the United States and Canada,
we are unified around our purpose: We use the power of leading-edge
science to save and improve lives around the world. For more than
130 years, we have brought hope to humanity through the development
of important medicines and vaccines. We aspire to be the premier
research-intensive biopharmaceutical company in the world – and
today, we are at the forefront of research to deliver innovative
health solutions that advance the prevention and treatment of
diseases in people and animals. We foster a diverse and inclusive
global workforce and operate responsibly every day to enable a
safe, sustainable and healthy future for all people and
communities. For more information, visit www.merck.com and connect
with us on X (formerly Twitter), Facebook, Instagram, YouTube and
LinkedIn.
Forward-Looking Statement of Merck & Co., Inc., Rahway,
N.J., USA
This news release of Merck & Co., Inc., Rahway, N.J., USA
(the “company”) includes “forward-looking statements” within the
meaning of the safe harbor provisions of the U.S. Private
Securities Litigation Reform Act of 1995. These statements are
based upon the current beliefs and expectations of the company’s
management and are subject to significant risks and uncertainties.
There can be no guarantees with respect to pipeline candidates that
the candidates will receive the necessary regulatory approvals or
that they will prove to be commercially successful. If underlying
assumptions prove inaccurate or risks or uncertainties materialize,
actual results may differ materially from those set forth in the
forward-looking statements.
Risks and uncertainties include but are not limited to, general
industry conditions and competition; general economic factors,
including interest rate and currency exchange rate fluctuations;
the impact of pharmaceutical industry regulation and health care
legislation in the United States and internationally; global trends
toward health care cost containment; technological advances, new
products and patents attained by competitors; challenges inherent
in new product development, including obtaining regulatory
approval; the company’s ability to accurately predict future market
conditions; manufacturing difficulties or delays; financial
instability of international economies and sovereign risk;
dependence on the effectiveness of the company’s patents and other
protections for innovative products; and the exposure to
litigation, including patent litigation, and/or regulatory
actions.
The company undertakes no obligation to publicly update any
forward-looking statement, whether as a result of new information,
future events or otherwise. Additional factors that could cause
results to differ materially from those described in the
forward-looking statements can be found in the company’s Annual
Report on Form 10-K for the year ended December 31, 2023 and the
company’s other filings with the Securities and Exchange Commission
(SEC) available at the SEC’s Internet site (www.sec.gov).
Please see Prescribing Information for CAPVAXIVE (Pneumococcal
21-valent Conjugate Vaccine) at
https://www.merck.com/product/usa/pi_circulars/c/capvaxive/capvaxive_pi.pdf
and Patient Information/Medication Guide for CAPVAXIVE at
https://www.merck.com/product/usa/pi_circulars/c/capvaxive/capvaxive_ppi.pdf.
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version on businesswire.com: https://www.businesswire.com/news/home/20240614126575/en/
Media Contacts: Julie Cunningham (617) 519-6264
julie.cunningham@merck.com Chrissy Trank (640) 650-0694
chrissy.trank@merck.com Investor Contacts: Peter Dannenbaum (732)
594-1579 peter.dannenbaum@merck.com Alexis Constantine (732)
594-1578 alexis.constantine@merck.com
Merck (NYSE:MRK)
過去 株価チャート
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Merck (NYSE:MRK)
過去 株価チャート
から 6 2023 まで 6 2024
