News releases
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
KENILWORTH, N.J.–(BUSINESS WIRE)–
(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.
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Source: Merck & Co., Inc., Rahway, NJ, USA