VAXNEUVANCE is the first new pneumococcal
conjugate vaccine for pediatric populations to be recommended in
almost a decade
Merck (NYSE: MRK), known as MSD outside 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 include VAXNEUVANCETM
(Pneumococcal 15-valent Conjugate Vaccine) as a recommended option
for vaccination in infants and children, including routine use in
children under 2 years of age. Specifically, the ACIP voted to
recommend that VAXNEUVANCE may be used as an option to the
currently available 13-valent pneumococcal conjugate vaccine
(PCV13) for children aged under 19 years according to currently
recommended PCV13 dosing and schedules. Additionally, the ACIP
unanimously voted to include VAXNEUVANCE in the Vaccines for
Children program.
These provisional recommendations will be reviewed by the
director of the CDC and the Department of Health and Human
Services, and final recommendations will become official when
published in the CDC’s Morbidity and Mortality Weekly Report
(MMWR).
VAXNEUVANCE is indicated for active immunization for the
prevention of invasive disease caused by the Streptococcus
pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F,
22F, 23F and 33F in individuals 6 weeks of age and older.
VAXNEUVANCE is contraindicated for individuals with a severe
allergic reaction (e.g., anaphylaxis) to any component of
VAXNEUVANCE or to diphtheria toxoid. See additional Select Safety
Information for VAXNEUVANCE below.
“VAXNEUVANCE includes key serotypes that continue to cause
serious disease in children under 5 years of age, specifically the
13 serotypes shared with PCV13, and the two unique serotypes, 22F
and 33F. Serotypes 3, 22F and 33F are responsible for more than a
quarter of all invasive pneumococcal disease cases in children.
Today’s vote reinforces the importance of VAXNEUVANCE as an option
to help reduce the burden of invasive disease in the pediatric
population,” said Dr. Eliav Barr, senior vice president, head of
global clinical development and chief medical officer, Merck
Research Laboratories. “We applaud the ACIP and the CDC for their
continued efforts to address invasive pneumococcal disease in
children, and look forward to its final, published
recommendations.”
Select Safety Information for VAXNEUVANCE for infants and
children
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%).
Vaccination with VAXNEUVANCE 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 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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