Series Would be Routinely Recommended Both
for Adults 65 Years and Older and for Adults Ages 19 to 64 at
Increased Risk for Disease, Such as Those with Certain Underlying
Medical Conditions
Merck (NYSE: MRK), known as MSD outside the United States and
Canada, today announced the U.S. Centers for Disease Control and
Prevention’s (CDC’s) Advisory Committee on Immunization Practices
(ACIP) unanimously voted in favor of updates to pneumococcal
vaccination recommendations for adults 65 years and older, and for
adults ages 19 to 64 with certain underlying medical conditions
(e.g., chronic conditions such as diabetes, chronic heart disease,
chronic lung disease, or chronic liver disease, as well as HIV, an
immunocompromising condition) or other disease risk factors (e.g.,
smoking, alcoholism). In both groups, the ACIP voted to
provisionally recommend vaccination either with a sequential
regimen of VAXNEUVANCE followed by PNEUMOVAX 23, or with a single
dose of 20-valent pneumococcal conjugate vaccine. These updates
would apply to adults who have not previously received a
pneumococcal conjugate vaccine or whose previous pneumococcal
vaccination history is unknown.
Further details will be available from the CDC. 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 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. VAXNEUVANCE is
contraindicated for individuals with a history of severe allergic
reaction (e.g., anaphylaxis) to any component of VAXNEUVANCE or to
diphtheria toxoid.
PNEUMOVAX 23 is indicated for active immunization for the
prevention of pneumococcal disease caused by the 23 serotypes
contained in the vaccine (1, 2, 3, 4, 5, 6B, 7F, 8, 9N, 9V, 10A,
11A, 12F, 14, 15B, 17F, 18C, 19F, 19A, 20, 22F, 23F and 33F), in
persons 50 years of age or older and persons aged ≥2 years who are
at increased risk for pneumococcal disease; PNEUMOVAX 23 will not
prevent disease caused by capsular types of pneumococcus other than
those contained in the vaccine. PNEUMOVAX 23 is contraindicated in
individuals with a history of a hypersensitivity reaction to any
component of PNEUMOVAX 23.
See additional Select Safety Information for each of these
vaccines below.
“Today’s vote reinforces the potential for VAXNEUVANCE in series
with PNEUMOVAX 23 to help address a significant unmet need in the
U.S. for adult populations at increased risk of invasive
pneumococcal disease (IPD). VAXNEUVANCE in series with PNEUMOVAX 23
elicits a strong immune response to the serotypes shared by both
vaccines, and together this regimen can help protect against
pneumococcal serotypes responsible for about two-thirds of IPD
cases in adults at increased risk,” said Dr. Roy Baynes, senior
vice president and head of global clinical development, chief
medical officer, Merck Research Laboratories. “We look forward to
the CDC’s final, published recommendations and applaud the ACIP and
the CDC for their continued efforts to address the significant
burden of IPD by continuously evaluating vaccination
recommendations utilizing a comprehensive body of scientific
evidence.”
Select Safety Information for VAXNEUVANCE (Pneumococcal
15-valent Conjugate Vaccine)
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.
Select Safety Information for PNEUMOVAX 23 (Pneumococcal
Vaccine Polyvalent)
Do not administer PNEUMOVAX 23 to individuals with a history of
a hypersensitivity reaction to any component of the vaccine.
Defer vaccination with PNEUMOVAX 23 in persons with moderate or
severe acute illness.
Use caution and appropriate care in administering PNEUMOVAX 23
to individuals with severely compromised cardiovascular and/or
pulmonary function in whom a systemic reaction would pose a
significant risk.
Available human data from clinical trials of PNEUMOVAX 23 in
pregnancy have not established the presence or absence of a
vaccine-associated risk.
Since elderly individuals may not tolerate medical interventions
as well as younger individuals, a higher frequency and/or a greater
severity of reactions in some older individuals cannot be ruled
out.
Persons who are immunocompromised, including persons receiving
immunosuppressive therapy, may have a diminished immune response to
PNEUMOVAX 23.
PNEUMOVAX 23 may not be effective in preventing pneumococcal
meningitis in patients who have chronic cerebrospinal fluid (CSF)
leakage resulting from congenital lesions, skull fractures or
neurosurgical procedures.
The most common adverse reactions, reported in >10% of
subjects vaccinated with PNEUMOVAX 23 for the first time in a
clinical trial, were: injection-site pain/soreness/tenderness,
injection-site swelling/induration, headache, injection-site
erythema, asthenia and fatigue, and myalgia.
For subjects aged 65 years or older in a clinical study,
systemic adverse reactions which were determined by the
investigator to be vaccine-related were higher following
revaccination than following initial vaccination.
Vaccination with PNEUMOVAX 23 may not offer 100% protection from
pneumococcal infection.
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 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.
Please see Prescribing Information for PNEUMOVAX 23 at
http://www.merck.com/product/usa/pi_circulars/p/pneumovax_23/pneumovax_pi.pdf
and Patient Information for PNEUMOVAX 23 at
http://www.merck.com/product/usa/pi_circulars/p/pneumovax_23/pneumovax_ppi.pdf.
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