CAPVAXIVE (V116) recommended for all adults
age 65 and older and for adults 19 to 64 with certain risk
conditions, and for those over 65 previously vaccinated with other
pneumococcal vaccines
Merck (NYSE: MRK), known as MSD outside of the United States and
Canada, announced today that the U.S. Centers for Disease Control
and Prevention’s (CDC’s) Advisory Committee on Immunization
Practices (ACIP) unanimously voted to recommend CAPVAXIVE™
(Pneumococcal 21-valent Conjugate Vaccine) as an option for adults
65 years of age and older for pneumococcal vaccination.
Specifically, the ACIP voted to recommend a single dose of
CAPVAXIVE for:
- Adults 65 years of age and older who have not previously
received a pneumococcal conjugate vaccine or whose previous
vaccination history is unknown;
- Adults 19-64 years of age with certain underlying medical
conditions or other risk factors who have not previously received a
pneumococcal conjugate vaccine or whose previous vaccination
history is unknown;
- Adults 19 years of age and older who have started their
pneumococcal vaccine series with PCV13 (pneumococcal 13-valent
conjugate vaccine) but have not received all recommended PPSV23
(pneumococcal 23-valent polysaccharide vaccine) doses.
Additionally, shared clinical decision-making is recommended
regarding use of a supplemental dose of CAPVAXIVE for adults 65
years of age and older who have completed their vaccine series with
both PCV13 and PPSV23.
CAPVAXIVE is indicated for:
- Active immunization for the prevention of invasive disease and
pneumonia caused by Streptococcus pneumoniae serotypes 3, 6A, 7F,
8, 9N, 10A, 11A, 12F, 15A, 15B, 15C, 16F, 17F, 19A, 20A, 22F, 23A,
23B, 24F, 31, 33F and 35B in adults individuals 18 years of age and
older;
- Active immunization for the prevention of pneumonia caused by
S. pneumoniae serotypes 3, 6A, 7F, 8, 9N, 10A, 11A, 12F, 15A, 15C,
16F, 17F, 19A, 20A, 22F, 23A, 23B, 24F, 31, 33F and 35B in
individuals 18 years of age and older.
Do not administer CAPVAXIVE to individuals with a history of a
severe allergic reaction (e.g., anaphylaxis) to any component of
CAPVAXIVE or to diphtheria toxoid; see additional Select Safety
Information below.
The indication for the prevention of pneumonia caused by S.
pneumoniae serotypes 3, 6A, 7F, 8, 9N, 10A, 11A, 12F, 15A, 15C,
16F, 17F, 19A, 20A, 22F, 23A, 23B, 24F, 31, 33F and 35B is approved
under accelerated approval based on immune responses as measured by
opsonophagocytic activity (OPA). Continued approval for this
indication may be contingent upon verification and description of
clinical benefit in a confirmatory trial.
These provisional recommendations will be official once reviewed
and finalized by the director of the CDC and the Department of
Health and Human Services.
“CAPVAXIVE represents an innovative approach to invasive
pneumococcal disease prevention in adults, as it is specifically
designed to help protect against the strains that cause the
majority of severe disease in adults 65 years of age and older,”
said Dr. Eliav Barr, senior vice president, head of global clinical
development and chief medical officer, Merck Research Laboratories.
“The ACIP vote recognizes the clinical profile of CAPVAXIVE for
adults in the U.S., and we look forward to the CDC’s final,
published recommendations.”
Select Safety Information for CAPVAXIVE Do not administer
CAPVAXIVE to individuals with a history of a severe allergic
reaction (eg, anaphylaxis) to any component of CAPVAXIVE or to
diphtheria toxoid.
Individuals with altered immunocompetence, including those
receiving immunosuppressive therapy, may have a reduced immune
response to CAPVAXIVE.
The most commonly reported (>10%) solicited adverse reactions
in individuals 18 through 49 years of age who received CAPVAXIVE
were: injection-site pain (73.1%), fatigue (36.0%), headache
(27.5%), myalgia (16.4%), injection-site erythema (13.8%), and
injection-site swelling (13.3%).
The most commonly reported (>10%) solicited adverse reactions
in individuals 50 years of age and older who received CAPVAXIVE
were: injection-site pain (41.2%), fatigue (19.7%), and headache
(11.0%).
Vaccination with CAPVAXIVE may not protect all vaccine
recipients.
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 X (formerly Twitter),
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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 pharmaceutical industry regulation and health care
legislation in the United States and internationally; global trends
toward health care cost containment; technological advances, new
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in new product development, including obtaining regulatory
approval; the company’s ability to accurately predict future market
conditions; manufacturing difficulties or delays; financial
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protections for innovative products; and the exposure to
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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, 2023 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 CAPVAXIVE
(Pneumococcal 21-valent Conjugate Vaccine) at
https://www.merck.com/product/usa/pi_circulars/c/capvaxive/capvaxive_pi.pdf
and Patient Information/Medication Guide for CAPVAXIVE at
https://www.merck.com/product/usa/pi_circulars/c/capvaxive/capvaxive_ppi.pdf.
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version on businesswire.com: https://www.businesswire.com/news/home/20240627540619/en/
Media: Julie Cunningham (617) 519-6264
julie.cunningham@merck.com Chrissy Trank (640) 650-0694
chrissy.trank@merck.com Investor: Peter Dannenbaum (732) 594-1579
peter.dannenbaum@merck.com Alexis Constantine (732) 594-1578
alexis.constantine@merck.com/
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