This Combination Vaccine May Simplify
Execution and Reduce Shots Needed to Complete CDC’s Recommended
Child and Adolescent Immunization Schedule
VAXELIS™ (Diphtheria and Tetanus Toxoids and Acellular
Pertussis, Inactivated Poliovirus, Haemophilus b Conjugate and
Hepatitis B Vaccine), developed as part of a U.S.-based partnership
between Merck (NYSE: MRK), known as MSD outside the United States
and Canada, and Sanofi Pasteur, the global vaccines business unit
of Sanofi, is now available in the U.S. VAXELIS is the first and
only hexavalent (six-in-one) combination vaccine available in the
U.S. indicated for active immunization to help prevent diphtheria,
tetanus, pertussis, poliomyelitis, hepatitis B, and invasive
disease due to Haemophilus influenzae type b. VAXELIS is approved
for use as a 3-dose series in children 6 weeks through 4 years of
age (prior to the 5th birthday).
“Given the potential to reduce the number of shots by as many as
three in the first six months of life, as compared to pentavalent
vaccines plus hepatitis B or Haemophilus influenzae type b
vaccines, VAXELIS represents an important option for healthcare
professionals and parents,” said Joanne Monahan, senior vice
president, U.S. Vaccines, Merck. “Merck and Sanofi have been in
contact with the major insurers and the appropriate pricing
publications to notify them of the availability of VAXELIS, and we
look forward to working with payers and providers to deliver this
novel hexavalent vaccine to age-appropriate children. This news
should also help to remind providers and parents of the importance
of continuing routine vaccinations and recommended well
visits.”
On February 11, 2021, the U.S. Centers for Disease Control and
Prevention’s Advisory Committee included VAXELIS as a combination
vaccine option in the CDC’s Recommended Child and Adolescent
Immunization Schedule. VAXELIS will be widely available in the U.S.
through traditional public and private channels, including directly
from Sanofi Pasteur via vaccineshoppe.com.
“As the first six-in-one vaccine in the U.S., VAXELIS is now
available to help protect infants and children against diseases
caused by six infectious agents. We are proud to offer this vaccine
to healthcare professionals and the patients they serve,” said
Elaine O’Hara, Head of Sanofi Pasteur Commercial Operations North
America. “Studies have shown that combination vaccines may help
increase vaccination compliance and reduce disease burden by
improving vaccine timeliness and coverage rates.
Do not administer VAXELIS to anyone with a history of severe
allergic reaction to a previous dose of VAXELIS, any ingredient of
VAXELIS, or any other diphtheria toxoid, tetanus toxoid,
pertussis-containing vaccine, inactivated poliovirus vaccine,
hepatitis B vaccine, or H. influenzae type b vaccine, anyone with a
history of encephalopathy within 7 days of a pertussis-containing
vaccine with no other identifiable cause, or anyone with a history
of progressive neurologic disorder until a treatment regimen has
been established and the condition has stabilized.
About Combination Vaccines
Combination vaccines take two or more vaccines that could be
given individually and put them into a single shot. Combination
vaccines have been a significant catalyst for change for the
healthcare industry since their introduction more than 50 years
ago. Public health authorities and leading professional
associations generally recommend the use of combination vaccines
over separate injections, when appropriate, including the American
Academy of Pediatrics, The American Academy of Family Physicians,
U.S. Centers for Disease Control and Prevention, The World Health
Organization and others.
About VAXELIS
VAXELIS was developed as part of a U.S.-based partnership
established in 1991 between Merck and Sanofi Pasteur and draws upon
both companies' experience in the development, manufacturing and
marketing of individual and combination vaccines. VAXELIS includes
antigens for diphtheria, tetanus, pertussis (whooping cough), and
poliomyelitis from Sanofi Pasteur and antigens for Haemophilus
influenzae type b and hepatitis B from Merck.
VAXELIS is a vaccine indicated for active immunization to
prevent diphtheria, tetanus, pertussis, poliomyelitis, hepatitis B,
and invasive disease due to Haemophilus influenzae type b. VAXELIS
is approved for use as a 3-dose series in children 6 weeks through
4 years of age (prior to the 5th birthday).
Important Safety Information for VAXELIS
Do not administer VAXELIS to anyone with a history of severe
allergic reaction to a previous dose of VAXELIS, any ingredient of
VAXELIS, or any other diphtheria toxoid, tetanus toxoid,
pertussis-containing vaccine, inactivated poliovirus vaccine,
hepatitis B vaccine, or H. influenzae type b vaccine.
Do not administer VAXELIS to anyone with a history of
encephalopathy within 7 days of a pertussis-containing vaccine with
no other identifiable cause.
Do not administer VAXELIS to anyone with a history of
progressive neurologic disorder until a treatment regimen has been
established and the condition has stabilized.
Carefully consider benefits and risks before administering
VAXELIS to persons with a history of fever of ≥40.5°C (≥105°F),
hypotonic-hyporesponsive episode (HHE), or persistent, inconsolable
crying lasting ≥3 hours within 48 hours after a previous
pertussis-containing vaccine; and/or seizures within 3 days after a
previous pertussis-containing vaccine.
If Guillain-Barré syndrome occurred within 6 weeks of receipt of
a prior vaccine containing tetanus toxoid, the risk for
Guillain-Barré syndrome may be increased following VAXELIS.
Apnea following intramuscular vaccination has been observed in
some infants born prematurely. Consider the individual infant’s
medical status and potential benefits and possible risks of
intramuscular vaccination in deciding when to administer VAXELIS to
an infant born prematurely.
Vaccination with VAXELIS may not protect all individuals.
The solicited adverse reactions 0-5 days following any dose were
irritability (≥55%), crying (≥45%), injection site pain (≥44%),
somnolence (≥40%), injection site erythema (≥25%), decreased
appetite (≥23%), fever ≥38.0°C (≥19%), injection site swelling
(≥18%), and vomiting (≥9%).
The 3-dose immunization series consists of a 0.5 mL
intramuscular injection, administered at 2, 4, and 6 months of
age.
A 3-dose series of VAXELIS does not constitute a primary
immunization series against pertussis; an additional dose of
pertussis-containing vaccine is needed to complete the primary
series.
Please see Prescribing Information for VAXELIS™ (Diphtheria and
Tetanus Toxoids and Acellular Pertussis, Inactivated Poliovirus,
Haemophilus b Conjugate and Hepatitis B Vaccine) at
https://www.merck.com/product/usa/pi_circulars/v/vaxelis/vaxelis_pi.pdf
and Patient Information for VAXELIS™ at
https://www.merck.com/product/usa/pi_circulars/v/vaxelis/vaxelis_ppi.pdf.
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.
About Sanofi
Sanofi is dedicated to supporting people through their health
challenges. We are a global biopharmaceutical company focused on
human health. We prevent illness with vaccines, provide innovative
treatments to fight pain and ease suffering. We stand by the few
who suffer from rare diseases and the millions with long-term
chronic conditions.
With more than 100,000 people in 100 countries, Sanofi is
transforming scientific innovation into healthcare solutions around
the globe.
Sanofi, Empowering Life.
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