Clinical Data Supporting Approval
Demonstrated Non-Inferior Immune Responses for the Serotypes Shared
with PCV13 (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and
23F)
VAXNEUVANCE Elicited Superior Immune
Responses for Serotypes 3, 22F and 33F Compared to PCV13, Which Are
Major Causes of Disease
(NYSE: MRK), known as MSD outside the United States and Canada,
today announced the U.S. Food and Drug Administration (FDA)
approved VAXNEUVANCE™ (Pneumococcal 15-valent Conjugate
Vaccine) (pronounced VAKS-noo-vans) for active immunization for the
prevention of invasive disease caused by Streptococcus pneumoniae
serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F
and 33F in adults 18 years of age and older. The approval follows
the FDA’s Priority Review of Merck’s application. VAXNEUVANCE is
contraindicated for individuals with a history of severe allergic
reaction (e.g., anaphylaxis) to any component of VAXNEUVANCE or to
diphtheria toxoid; see additional Select Safety Information
below.
The U.S. Centers for Disease Control and Prevention’s (CDC)
Advisory Committee on Immunization Practices (ACIP) is expected to
meet in October to discuss and make recommendations on the use of
VAXNEUVANCE in adults.
VAXNEUVANCE was approved based on data from seven randomized,
double-blind clinical studies assessing safety, tolerability, and
immunogenicity in adults (see “Clinical Data Supporting FDA
Approval” below for additional details). Clinical data showed that
immune responses elicited by VAXNEUVANCE were non-inferior to the
currently available 13-valent pneumococcal conjugate vaccine
(PCV13) for the 13 shared serotypes, as assessed by
opsonophagocytic activity (OPA) Geometric Mean Titers (GMTs).
Additionally, immune responses for VAXNEUVANCE were superior to
PCV13 for shared serotype 3 and for the two serotypes unique to
VAXNEUVANCE, 22F and 33F. In the pivotal Phase 3 PNEU-AGE
(V114-019) study, superiority for VAXNEUVANCE relative to PCV13 was
based on statistically significantly greater OPA GMT ratios for
serotypes 22F [GMT Ratio 32.52 (95% Confidence Interval (CI) 25.87,
40.88)] and 33F [GMT Ratio 7.19 (95% CI 6.13, 8.43)], as well as
for the key secondary objective assessing serotype 3 [GMT Ratio
1.62 (95% CI 1.40, 1.87)]. Randomized controlled trials assessing
the clinical efficacy of VAXNEUVANCE compared to PCV13 have not
been conducted.
“Some adults, including older adults or those with certain
chronic medical conditions or immunocompromising conditions, are at
increased risk for pneumococcal disease and its serious, sometimes
life-threatening complications,” said Dr. Jose Cardona, Indago
Research and Health Center, coordinating investigator for the
PNEU-AGE trial. “The FDA’s approval of VAXNEUVANCE is based on
robust Phase 2 and 3 studies assessing immune responses in a broad
range of adult populations and provides an important new option in
protection from invasive pneumococcal disease.”
Pneumococcal disease is an infection caused by bacteria called
Streptococcus pneumoniae, or pneumococcus. Different strains of
this bacteria are called serotypes. Invasive pneumococcal disease
(IPD) occurs when the bacteria infect parts of the body that are
usually free from germs. Approximately 80 percent of all adult IPD
burden is among adults 50 years of age and older. Serotypes 3, 22F
and 33F contribute significantly to the burden of IPD, and serotype
3 is the leading cause of IPD in adults in the U.S.
“At Merck, we are committed to helping protect more people from
invasive pneumococcal disease. That’s why we set out to develop a
conjugate vaccine that includes pneumococcal serotypes that pose
the greatest threat and elicits a strong immune response to each
serotype covered,” said Dr. Roy Baynes, senior vice president and
head of global clinical development, chief medical officer, Merck
Research Laboratories. “The FDA approval of VAXNEUVANCE builds on
Merck’s more than 40 years of experience in pneumococcal disease
prevention with a new option that includes serotypes responsible
for substantial disease burden in adults, like serotype 3, as well
as serotypes 22F and 33F, which are associated with a high degree
of invasiveness and antibiotic resistance.”
About VAXNEUVANCE
VAXNEUVANCE, Merck’s approved 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 for the prevention
of invasive disease caused by the S. pneumoniae serotypes contained
in the vaccine. VAXNEUVANCE previously received Breakthrough
Therapy designation from the FDA for the prevention of IPD in
adults 18 years of age and older. In January 2021, it received
Priority Review designation.
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
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.
Clinical Data Supporting FDA Approval
VAXNEUVANCE was approved based on data from seven randomized,
double-blind clinical studies designed to evaluate its safety,
tolerability, and immunogenicity in 7,438 individuals from a
variety of adult populations and clinical circumstances, 5,630 of
whom received VAXNEUVANCE. These included studies of:
- Healthy adults 50 years of age and
older. The pivotal Phase 3 active comparator-controlled
study assessed serotype-specific OPA responses for each of the 15
serotypes contained in VAXNEUVANCE at 30 days post-vaccination in
pneumococcal vaccine naïve participants randomized to receive
either VAXNEUVANCE (n=604) or PCV13 (n=601) (V114-019/PNEU-AGE
[NCT03950622]). The study demonstrated that VAXNEUVANCE was
non-inferior to PCV13 for the 13 shared serotypes and induces
statistically significantly greater OPA GMTs compared to PCV13 for
shared serotype 3 and for the two unique serotypes (22F, 33F).
- Adults 18-49 years of age with no
history of pneumococcal vaccination, including individuals at
increased risk of developing pneumococcal disease.
A Phase 3 descriptive study included individuals with stable
underlying medical conditions (e.g., diabetes mellitus, renal
disorders, chronic heart disease, chronic liver disease, chronic
lung disease including asthma) and/or behavioral risk factors
(e.g., smoking, increased alcohol use) that increased their risk of
developing pneumococcal disease. Participants were randomized to
receive VAXNEUVANCE (n=1,135) or PCV13 (n=380), followed by
PNEUMOVAX® 23 (pneumococcal vaccine polyvalent) six months later
(V114-017/PNEU-DAY [NCT03547167]). VAXNEUVANCE elicited immune
responses to all 15 serotypes as assessed by OPA GMTs at 30 days
following vaccination. Additionally, following vaccination with
PNEUMOVAX 23, the OPA GMTs for the 15 serotypes in VAXNEUVANCE were
numerically similar among subjects who had received VAXNEUVANCE or
PCV13 for the first vaccination.
- Adults living with HIV, an
immunocompromising condition. A Phase 3 descriptive
study assessed the use of VAXNEUVANCE in pneumococcal vaccine naïve
HIV-infected adults 18 years of age and older with CD4+ T cell
count ≥50 cells per microliter and plasma HIV RNA value <50,000
copies/mL (V114-018/PNEU- WAY [NCT03480802]). Participants were
randomized to receive VAXNEUVANCE (n=152) or PCV13 (n=150),
followed by PNEUMOVAX 23 two months later. OPA GMTs were higher
after administration of VAXNEUVANCE, compared to pre-vaccination,
for the 15 serotypes contained in VAXNEUVANCE. After sequential
administration with PNEUMOVAX 23, OPA GMTs were numerically similar
between the two vaccination groups for all 15 serotypes contained
in VAXNEUVANCE.
- Co-administration of VAXNEUVANCE with
seasonal quadrivalent influenza vaccine (QIV). A Phase 3
trial evaluated adults 50 years of age and older who were
randomized to receive VAXNEUVANCE concomitantly with a seasonal
inactivated QIV (Fluarix Quadrivalent) (n=600) or non-concomitantly
30 days after QIV (n=600) (V114-021/PNEU-FLU [NCT03615482]). The
non-inferiority criteria for the comparisons of GMTs were met for
the 15 pneumococcal serotypes in VAXNEUVANCE and for the 4
influenza vaccine strains tested. VAXNEUVANCE can be administered
concomitantly with seasonal inactivated influenza vaccine.
- Use of VAXNEUVANCE as part of a
sequential regimen with PNEUMOVAX 23.
A Phase 3 active comparator-controlled descriptive study in
pneumococcal vaccine-naïve adults 50 years of age or older assessed
the use of VAXNEUVANCE (n=327) or PCV13 (n=325), followed by
PNEUMOVAX 23 one year later (V114-016/PNEU-PATH [NCT03480763]).
Following vaccination with PNEUMOVAX 23, OPA GMTs were numerically
similar between the two vaccination groups for the 15 serotypes in
VAXNEUVANCE.
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.
Brands mentioned are trademarks of their respective owners.
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