VAXNEUVANCE Also Met Key Safety Objectives
in the Phase 3 PNEU-LINK (V114-031) Study in Infants
Merck (NYSE: MRK), known as MSD outside the United States and
Canada, today announced topline results from the pivotal PNEU-PED
(V114-029) study evaluating the immunogenicity, safety and
tolerability of VAXNEUVANCE™ (Pneumococcal 15-valent Conjugate
Vaccine) in healthy infants enrolled between 42-90 days of age
(n=1720). In the trial, infants were given a 4-dose regimen of
either VAXNEUVANCE or the licensed 13-valent pneumococcal conjugate
vaccine (PCV13) at 2, 4, 6, and 12-15 months of age.
In the PNEU-PED study, primary endpoints demonstrated:
- VAXNEUVANCE had a safety profile generally comparable to PCV13
following receipt of any vaccine dose.
- At 30 days following the third dose in the series (PD3),
VAXNEUVANCE was non-inferior to PCV13 for all 13 shared serotypes
based on serotype-specific response rates (proportions of
individuals achieving the accepted immunoglobulin G (IgG) threshold
value of 0.35mcg/mL) and for 12 of the 13 shared serotypes based on
serotype-specific IgG geometric mean concentrations (GMCs).
- The lower bounds of the two-sided 95 percent confidence
intervals (CI) for the serotype-specific IgG GMC ratios were
greater than 0.5 for 12 shared serotypes; the lower bound was 0.48
for serotype 6A, narrowly missing non-inferiority criteria.
- At 30 days following the fourth (toddler) dose (PD4),
VAXNEUVANCE was non-inferior to PCV13 for all 13 shared serotypes
based on serotype-specific IgG GMCs.
Secondary endpoints demonstrated statistically superior immune
responses for VAXNEUVANCE in comparison to PCV13 for shared
serotype 3 and unique serotypes 22F and 33F based on prespecified
criteria, as well as non-inferior immune responses to antigens
contained in several routinely used pediatric vaccines when
administered concomitantly with VAXNEUVANCE or PCV13.
“By nature, pneumococcal disease is constantly evolving. Strains
of the disease associated with invasiveness cause significant
disease burden in children, calling for innovation to help protect
this vulnerable population worldwide,” said Dr. Roy Baynes, senior
vice president and head of global clinical development, chief
medical officer, Merck Research Laboratories. “At Merck, our goal
is to design pneumococcal vaccines that target strains causing the
greatest proportion of disease while maintaining a strong immune
response to these serotypes. With the inclusion of serotypes 22F
and 33F, VAXNEUVANCE has the potential to play an important role in
the prevention of invasive pneumococcal disease in children.”
In PNEU-LINK (V114-031), a Phase 3 study to evaluate the safety
and tolerability of VAXNEUVANCE in healthy infants, VAXNEUVANCE was
generally well-tolerated with a safety profile generally comparable
to PCV13 in healthy infants enrolled at 42-90 days of age (n=2409).
Full results from the PNEU-PED and PNEU-LINK studies will be
presented at an upcoming scientific congress.
There are 100 different types of pneumococcal bacteria, which
can affect children differently than adults. Children under the age
of 2 are particularly vulnerable to pneumococcal infection, and
incidence of invasive pneumococcal disease remains highest in the
first year of life. Certain pneumococcal serotypes continue to put
children at risk, including serotypes 22F, 33F and 3, which
represent more than a quarter of all cases of invasive pneumococcal
disease in children under the age of 5.
The VAXNEUVANCE Phase 3 clinical development program is
comprised of 16 trials investigating the safety, tolerability and
immunogenicity of VAXNEUVANCE in a variety of populations who are
at increased risk for pneumococcal disease, including 10 that
investigated VAXNEUVANCE for use in children and infants.
On July 16, 2021, the U.S. Food and Drug Administration (FDA)
approved VAXNEUVANCE for adults 18 years of age and older for
active immunization for the prevention of invasive disease caused
by the 15 S. pneumoniae serotypes contained in the vaccine. Plans
are on track for submission of a supplemental regulatory licensure
application to the FDA for use in children before the end of the
year.
About PNEU-PED
PNEU-PED is a Phase 3, multicenter, randomized, double-blind,
active-comparator-controlled study evaluating the safety,
tolerability and immunogenicity of a 4-dose regimen of VAXNEUVANCE
in healthy infants enrolled at 42-90 days of age (n=1720).
In the primary analysis, participants were randomized to receive
VAXNEUVANCE or PCV13. Immune responses for the 13 shared serotypes
contained in VAXNEUVANCE and PCV13 were measured at 30 days
post-dose three (PD3) and post-dose four (PD4). Immune responses
were assessed based on anti-pneumococcal polysaccharide (PnPs)
serotype-specific immunoglobulin G (IgG) response rates at 30 days
PD3 and geometric mean concentrations (GMCs) at 30 days PD3 and
PD4.
In the secondary analysis, antibody responses to select licensed
pediatric vaccines were evaluated when administered concomitantly
with VAXNEUVANCE or PCV13. Additionally, immune responses for
serotypes 22F and 33F, the two serotypes unique to VANXNEUVANCE,
were assessed based on anti-PnPs serotype-specific IgG response
rates at 30 days PD3 and PD4, and immune responses for serotype 3
were assessed based on anti-PnPs serotype-specific IgG response
rates at 30 days PD3 and IgG GMCs 30 days PD3 and PD4.
Safety analyses were performed in the
All-Participants-As-Treated (APaT) population, defined as all
randomized participants who received at least one dose of study
vaccination.
About PNEU-LINK
PNEU-LINK is a Phase 3, multicenter, randomized, double-blind
active-comparator-controlled study evaluating the safety and
tolerability of VAXNEUVANCE in healthy infants enrolled at 42-90
days of age (n=2409).
In the primary analysis, healthy infants were randomized to
receive either VAXNEUVANCE or PCV13. Safety analyses were performed
on the All-Participants-As-Treated (APaT) population, defined as
all randomized participants who received at least one dose of study
vaccination.
About VAXNEUVANCE (Pneumococcal 15-valent Conjugate
Vaccine)
VAXNEUVANCE, Merck’s 15-valent pneumococcal conjugate vaccine,
consists of purified capsular polysaccharides from S. pneumoniae
serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F
and 33F individually conjugated to CRM197 carrier protein.
VAXNEUVANCE is indicated for active immunization of adults 18 years
of age and older for the prevention of invasive disease caused by
the S. pneumoniae serotypes contained in the vaccine. It is
currently under investigation in the pediatric population.
VAXNEUVANCE previously received Breakthrough Therapy designation
from the FDA for the prevention of invasive pneumococcal disease in
pediatric patients 6 weeks to 18 years of age.
Merck is involved in litigation challenging the validity of
several Pfizer Inc. patents that relate to pneumococcal vaccine
technology in the United States and several foreign
jurisdictions.
Select Safety Information for VAXNEUVANCE in Adults 18 Years
of Age and Older
Do not administer VAXNEUVANCE to individuals with a severe
allergic reaction (e.g., anaphylaxis) to any component of
VAXNEUVANCE or to diphtheria toxoid.
Some individuals with altered immunocompetence, including those
receiving immunosuppressive therapy, may have a reduced immune
response to VAXNEUVANCE.
The most commonly reported solicited adverse reactions in
individuals 18 through 49 years of age were: injection site pain
(75.8%), fatigue (34.3%), myalgia (28.8%), headache (26.5%),
injection site swelling (21.7%), injection site erythema (15.1%)
and arthralgia (12.7%).
The most commonly reported solicited adverse reactions in
individuals 50 years of age and older were: injection site pain
(66.8%), myalgia (26.9%), fatigue (21.5%), headache (18.9%),
injection site swelling (15.4%), injection site erythema (10.9%)
and arthralgia (7.7%).
Vaccination with VAXNEUVANCE may not protect all vaccine
recipients.
Merck’s Commitment to Infectious Diseases
For more than 100 years, Merck has contributed to the discovery
and development of novel medicines and vaccines to combat
infectious diseases. In addition to a combined portfolio of
vaccines and antibacterial, antiviral and antifungal medicines,
Merck has multiple programs that span discovery through late-stage
development. To learn more about Merck’s infectious diseases
pipeline, visit www.merck.com.
About Merck
For 130 years, Merck, known as MSD outside of the United States
and Canada, has been inventing for life, bringing forward medicines
and vaccines for many of the world’s most challenging diseases in
pursuit of our mission to save and improve lives. We demonstrate
our commitment to patients and population health by increasing
access to health care through far-reaching policies, programs and
partnerships. Today, Merck continues to be at the forefront of
research to prevent and treat diseases that threaten people and
animals – including cancer, infectious diseases such as HIV and
Ebola, and emerging animal diseases – as we aspire to be the
premier research-intensive biopharmaceutical company in the world.
For more information, visit www.merck.com and connect with us on
Twitter, Facebook, Instagram, YouTube and LinkedIn.
Forward-Looking Statement of Merck & Co., Inc.,
Kenilworth, N.J., USA
This news release of Merck & Co., Inc., Kenilworth, 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 products that
the products 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 the global outbreak of novel coronavirus disease
(COVID-19); 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 2020
Annual Report on Form 10-K 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 VAXNEUVANCE
(pneumococcal 15-valent conjugate vaccine) at
https://www.merck.com/product/usa/pi_circulars/v/vaxneuvance/vaxneuvance_pi.pdf
and Patient Information at
https://www.merck.com/product/usa/pi_circulars/v/vaxneuvance/vaxneuvance_ppi.pdf.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20210825005054/en/
Media:
Melissa Moody (215) 407-3536
Steve Wanczyk (267) 305-5563
Investors:
Peter Dannenbaum (908) 740-1037
Raychel Kruper (908) 740-2107
Merck (NYSE:MRK)
Historical Stock Chart
From Apr 2024 to May 2024
Merck (NYSE:MRK)
Historical Stock Chart
From May 2023 to May 2024