Merck (NYSE: MRK), known as MSD outside of the United States and
Canada, announced today that the European Medicines Agency’s
Committee for Medicinal Products for Human Use (CHMP) has
recommended the approval of VAXNEUVANCE™ (Pneumococcal 15-valent
Conjugate Vaccine) (pronounced VAKS-noo-vans) for active
immunization for the prevention of invasive disease, pneumonia and
acute otitis media caused by Streptococcus pneumoniae in infants,
children and adolescents from 6 weeks to less than 18 years of age.
VAXNEUVANCE is currently authorized for use in the European Union
(EU) for individuals 18 years of age and older.
The CHMP opinion will now be considered by the European
Commission (EC) for amending the marketing authorization in the EU,
and a final decision is expected by the end of the year.
“We are committed to advancing protection for those at increased
risk for pneumococcal disease, which includes those under the age
of 2 years and children of any age who have certain underlying
conditions,” said Dr. Eliav Barr, senior vice president, head of
global clinical development and chief medical officer, Merck
Research Laboratories. “We are pleased with the CHMP’s positive
opinion as it brings us one step closer to our goal of helping to
protect against pneumococcal strains that pose substantial risk to
infants and children in Europe.”
Pneumococcal disease is an infection caused by the bacterium
Streptococcus pneumoniae, or pneumococcus. While there are more
than 100 different types of S. pneumoniae, called serotypes, a
selected number of serotypes are responsible for the majority of
pneumococcal infections. Invasive pneumococcal disease (IPD) can
cause serious and potentially life-threatening infections such as
bacteremia (infection in the bloodstream); bacteremic pneumonia
(pneumonia with bacteremia); and meningitis (infection of the
coverings of the brain and spinal cord).
The CHMP opinion was based on data from eight randomized,
double-blind clinical studies that enrolled approximately 8,400
individuals from a variety of pediatric populations and clinical
circumstances; of these, approximately 5,400 received
VAXNEUVANCE.
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 of age and older, and in June 2022, the
FDA approved an expanded indication for VAXNEUVANCE to include
individuals 6 weeks through 17 years of age.
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 in the EU for active immunization for
the prevention of invasive pneumococcal disease and pneumonia
caused by S. pneumoniae in individuals 18 years of age and
older.
VAXNEUVANCE is indicated in the U.S. for active immunization of
individuals 6 weeks of age and older for the prevention of invasive
disease caused by the S. pneumoniae serotypes contained in the
vaccine.
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.
Apnea following intramuscular vaccination has been observed in
some infants born prematurely. Vaccination of premature infants
should be based on the infant’s medical status and the potential
benefits and possible risks.
The most commonly reported solicited adverse reactions in
children vaccinated with a four-dose series at 2, 4, 6, and 12
through 15 months of age, provided as a range across the series,
were: irritability (57.3% to 63.4%), somnolence (24.2% to 47.5%),
injection-site pain (25.9% to 40.3%), fever ≥38.0°C (13.3% to
20.4%), decreased appetite (14.1% to 19.0%), injection-site
induration (13.2% to 15.4%), injection-site erythema (13.7% to
21.4%) and injection-site swelling (11.3% to 13.4%).
The most commonly reported solicited adverse reactions in
children and adolescents 2 through 17 years of age vaccinated with
a single dose were: injection-site pain (54.8%), myalgia (23.7%),
injection-site swelling (20.9%), injection-site erythema (19.2%),
fatigue (15.8%), headache (11.9%) and injection-site induration
(6.8%).
The most commonly reported solicited adverse reactions in adults
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 adults
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 Pneumococcal Disease Protection
Merck has been at the forefront of pneumococcal disease
prevention through vaccination for more than four decades and
remains committed to helping to protect people of all ages from
this disease. Merck’s ongoing pneumococcal vaccine development
program is designed to provide tailored options to address the
specific needs of different populations, including infants and
children, healthy adults and at-risk subgroups. This approach
recognizes that disease burden in pediatric and adult populations
is often driven by different bacterial strains, or serotypes, and
aims to address unmet needs by offering vaccine options that target
serotypes posing the greatest global risk to each population. To
learn more about Merck’s pneumococcal portfolio and pipeline, visit
https://www.merck.com.
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 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 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 Annual
Report on Form 10-K for the year ended December 31, 2021 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/Medication Guide for VAXNEUVANCE at
https://www.merck.com/product/usa/pi_circulars/v/vaxneuvance/vaxneuvance_ppi.pdf.
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