Add after third paragraph of release new fourth paragraph: In
July 2021, VAXNEUVANCE received approval from the U.S. Food and
Drug Administration (FDA) 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 and older.
The updated release reads:
EUROPEAN COMMISSION APPROVES MERCK’S
VAXNEUVANCE™ (PNEUMOCOCCAL 15-VALENT CONJUGATE VACCINE) FOR
INDIVIDUALS 18 YEARS OF AGE AND OLDER
Merck (NYSE: MRK), known as MSD outside the United States and
Canada, announced today the European Commission (EC) has approved
VAXNEUVANCE™ (Pneumococcal 15-valent Conjugate Vaccine) for active
immunization for the prevention of invasive disease and pneumonia
caused by Streptococcus pneumoniae in individuals 18 years of age
and older. The approval allows marketing of VAXNEUVANCE in all 27
European Union (EU) Member States plus Iceland, Norway and
Lichtenstein. The use of VAXNEUVANCE in the EU should be in
accordance with official recommendations.
The EC’s decision follows a positive opinion from the European
Medicines Agency’s Committee for Medicinal Products on Human Use
(CHMP), which reviewed data from seven randomized, double-blind
clinical studies evaluating VAXNEUVANCE in 7,438 individuals from a
variety of adult populations and clinical circumstances. These
included healthy adults ages 50 years and older, adults ages 18 to
49 with risk factors for pneumococcal disease, and
immunocompromised adults living with HIV. In the pivotal, double
blind, active-comparator controlled study in 1,205 immunocompetent
pneumococcal vaccine-naïve adults ages 50 and older, 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) at 30
days post-vaccination. Additionally, immune responses for
VAXNEUVANCE were superior to PCV13 for shared serotype 3 and for
the two serotypes unique to VAXNEUVANCE, 22F and 33F. Randomized
controlled trials assessing the clinical efficacy of VAXNEUVANCE
compared to PCV13 have not been conducted.
“At Merck, we are committed to helping protect more people from
invasive pneumococcal disease (IPD), as well as from pneumococcal
pneumonia, the most common form of pneumococcal disease in adults,”
said Dr. Roy Baynes, senior vice president and head of global
clinical development, chief medical officer, Merck Research
Laboratories. “With VAXNEUVANCE, we developed a conjugate vaccine
that elicits a strong immune response to pneumococcal serotypes
that contribute substantially to the burden of disease, including
serotype 3, a leading cause of IPD in the EU. This approval
provides physicians and patients in the European Union with a new
option that can help protect against pneumococcal serotypes
responsible for around 40 percent of IPD cases in adults over 65 in
the largest EU member countries.”
In July 2021, VAXNEUVANCE received approval from the U.S. Food
and Drug Administration (FDA) 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 and older.
Select Safety Information for VAXNEUVANCE (Pneumococcal
15-valent Conjugate Vaccine) in Adults 18 Years of Age and Older in
the U.S.
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.
About Pneumococcal Disease
The global prevalence of pneumococcal disease, an infection
caused by bacteria called Streptococcus pneumoniae, is evolving.
Highly aggressive strains, or serotypes, threaten to put more
people at risk for invasive pneumococcal illnesses such as
bacteremia (infection in the bloodstream); bacteremic pneumonia
(pneumonia with bacteremia); and meningitis (infection of the
coverings of the brain and spinal cord), as well as non-invasive
pneumonia (when pneumococcal disease is confined to the lungs).
While healthy adults can suffer from pneumococcal disease, patient
populations particularly vulnerable to infection include older
adults such as those 65 years of age and older, people with HIV,
and those with certain chronic health conditions.
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 over 130 years, Merck, known as MSD outside 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 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 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 U.S. 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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