Clinical data supporting approval demonstrated
non-inferior immune responses for all serotypes shared with PCV13
following a four-dose series and superior immune responses for
important disease-causing shared serotype 3 and unique serotypes
22F and 33F compared to PCV13
With this expanded indication, VAXNEUVANCE is
the first pneumococcal conjugate vaccine approved in almost a
decade to help protect pediatric populations against invasive
pneumococcal disease
Merck (NYSE: MRK), known as MSD outside the United States and
Canada, announced today that the U.S. Food and Drug Administration
(FDA) has approved an expanded indication for VAXNEUVANCE™
(Pneumococcal 15-valent Conjugate Vaccine) (pronounced
VAKS-noo-vans) to include children 6 weeks through 17 years of age.
VAXNEUVANCE is now 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 individuals 6 weeks of age and older. The approval
follows the FDA’s Priority Review of Merck’s supplemental
application. 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 below.
The U.S. Centers for Disease Control and Prevention’s (CDC)
Advisory Committee on Immunization Practices (ACIP) is expected to
meet today to discuss and make recommendations on the use of
VAXNEUVANCE in pediatric populations.
“Despite decreases in incidence of invasive pneumococcal disease
in children, certain key serotypes continue to cause serious
illness that can lead to death in children under the age of 5, with
serotypes 3, 22F and 33F responsible for more than a quarter of all
invasive pneumococcal disease cases in this population,” said Dr.
Steven Shapiro, chairman, department of pediatrics, Jefferson
Abington Hospital, and investigator for the PNEU-PED trial. “With
the robust clinical data supporting VAXNEUVANCE and this FDA
approval, VAXNEUVANCE will be an important new option to help
advance protection for children.”
Invasive pneumococcal disease (IPD) is an infection caused by
the bacterium Streptococcus pneumoniae, or pneumococcus. While
there are approximately 100 different types of S. pneumoniae,
called serotypes, a smaller number of serotypes are responsible for
IPD in children. Serotypes 3, 22F and 33F are three of the top five
serotypes causing childhood cases of IPD. IPD can lead to
hospitalization or death. Some examples of IPD are bacteremia (an
infection in the blood) and meningitis (an infection of the
coverings of the brain and spinal cord), which can also result in
long-term neurological complications. Children under the age of 2
are particularly vulnerable to IPD.
The FDA’s approval was based on data from seven randomized,
double-blind clinical studies assessing safety, tolerability and
immunogenicity of VAXNEUVANCE in infants, children and adolescents
(see “Clinical Data Supporting FDA Approval” below for additional
details). Clinical data from the pivotal study showed that immune
responses elicited by VAXNEUVANCE following a four-dose pediatric
series were non-inferior to the currently available 13-valent
pneumococcal conjugate vaccine (PCV13) for the 13 shared serotypes
based on serotype-specific immunoglobulin G (IgG) geometric mean
concentrations (GMCs).
In a secondary analysis, immune responses for VAXNEUVANCE
following a four-dose pediatric series were superior to PCV13 for
shared serotype 3 and 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.
Data from the clinical program also support the use of
VAXNEUVANCE concomitantly with other commonly administered routine
pediatric vaccines, and in a variety of clinical settings, such as
interchangeable use following initiation of an infant vaccination
schedule with PCV13 or in a catch-up setting for older children who
are either pneumococcal vaccine-naïve or who previously received an
incomplete series of another PCV. Additionally, data support the
use of VAXNEUVANCE in special populations, such as in preterm
infants and children living with HIV infection or sickle cell
disease.
“Our goal with VAXNEUVANCE is to expand coverage of key invasive
disease-causing serotypes and provide a strong immune response to
serotypes that pose substantial risk to infants and children,” said
Dr. Eliav Barr, senior vice president, head of global clinical
development and chief medical officer, Merck Research Laboratories.
“With this approval, we bring forward our first pediatric
pneumococcal conjugate vaccine – and the first pediatric
pneumococcal conjugate vaccine to be approved in almost a decade –
building on our commitment to preventing invasive pneumococcal
disease and on our legacy in pediatric vaccine development. We
thank the investigators and the families of our clinical trial
participants for participating in the research studies and the role
they played in this milestone.”
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 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. The
FDA initially approved VAXNEUVANCE in July 2021. The FDA previously
granted VAXNEUVANCE Breakthrough Therapy designation and Priority
Review for the pediatric indication.
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.
Dosage and administration for VAXNEUVANCE for infants and
children
VAXNEUVANCE is for intramuscular injection only and each dose is
0.5 mL. Administer VAXNEUVANCE as a four-dose series at 2, 4, 6,
and 12 through 15 months of age. Administer VAXNEUVANCE as a single
dose in children and adolescents 2 through 17 years of age who have
received an incomplete series of another pneumococcal conjugate
vaccine.
Clinical data supporting FDA approval of VAXNEUVANCE in
children 6 weeks through 17 years of age
VAXNEUVANCE was approved for use in infants and children based
on data from seven randomized, double-blind clinical studies
designed to evaluate its safety, tolerability and immunogenicity.
These clinical studies included:
- Children receiving a four-dose
series. The pivotal Phase 3, multicenter, randomized,
double-blind, active comparator-controlled study evaluated the
safety, tolerability and immunogenicity of a four-dose series of
VAXNEUVANCE in healthy infants (n=1720) (V114-029/PNEU-PED
[NCT03893448]). In the study, participants were randomized
one-to-one to receive a four-dose series of VAXNEUVANCE or PCV13 at
2, 4, 6, and 12-15 months of age.
The assessed immune responses included serotype specific IgG
response rates against capsular polysaccharides of S. pneumoniae at
30 days post-dose 3 (PD3) and IgG geometric mean concentrations
(GMCs) at 30 days PD3 and post-dose 4 (PD4). Additionally, antibody
responses to other routine licensed pediatric vaccines were
evaluated when administered concomitantly with VAXNEUVANCE or
PCV13.
VAXNEUVANCE elicited immune responses for all 15 serotypes
contained in the vaccine. Based on serotype-specific IgG GMCs, at
30 days PD4, VAXNEUVANCE was non-inferior to PCV13 for all 13
shared serotypes and the two serotypes unique to VAXNEUVANCE, 22F
and 33F. Serotypes 22F and 33F were compared with serotype 4, which
had the lowest IgG GMC of all shared serotypes in PCV13, excluding
serotype 3. Results of the secondary analysis showed superior
immune responses for VAXNEUVANCE in comparison to PCV13 for
serotypes 3, 22F and 33F.
- PCV interchangeability. A
Phase 3, randomized, double-blind, active comparator-controlled,
descriptive study evaluated the interchangeability of VAXNEUVANCE
and PCV13 with respect to safety, tolerability and immunogenicity
in healthy infants (n=900) (V114-027/PNEU-DIRECTION [NCT03620162]).
The study demonstrated generally comparable immune responses for
participants completing the vaccination series with VAXNEUVANCE
compared to those who completed series with PCV13, for the 13
shared serotypes. The safety profile observed when VAXNEUVANCE was
used to complete a four-dose pneumococcal conjugate vaccine series
initiated with PCV13 was similar to the safety profile following a
complete four-dose regimen of either VAXNEUVANCE or PCV13.
- Use as part of a catch-up
series. A Phase 3, randomized, double-blind, active
comparator-controlled, descriptive study evaluated the safety,
tolerability and immunogenicity of catch-up vaccination regimens of
VAXNEUVANCE in healthy infants, children and adolescents 7 months
to 17 years of age (n=606) (V114-024/PNEU-PLAN [NCT03885934]). The
study demonstrated generally comparable immune responses after
receipt of the last dose for the 13 serotypes targeted by
VAXNEUVANCE and PCV13, and higher immune responses for the two
serotypes unique to VAXNEUVANCE, 22F and 33F.
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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