BRIDGEWATER, N.J. and
KENILWORTH, N.J., June 1, 2021 /PRNewswire/ -- Vaxelis™
(Diphtheria and Tetanus Toxoids and Acellular Pertussis,
Inactivated Poliovirus, Haemophilus b Conjugate and Hepatitis B
Vaccine), developed as part of a partnership between Sanofi
Pasteur, the global vaccines business unit of Sanofi, and Merck
(NYSE: MRK),* known as MSD outside the United States and Canada, is now available in the U.S.
Vaxelis is the first and only hexavalent (six-in-one)
combination vaccine available in the U.S. Vaxelis is a vaccine
given to protect your child from getting diphtheria, tetanus
(lockjaw), pertussis (whooping cough), polio, Hib (Haemophilus
influenzae type b), and hepatitis B. Your child cannot get any
of these diseases from Vaxelis. Vaxelis may not completely protect
your child from these diseases. Vaxelis is given to children from 6
weeks through 4 years of age (up to the 5th birthday)
and is given as 3 shots, one at 2 months, one at 4 months and one
at 6 months of age.
"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 reduce the shot burden and improve coverage rates
and timeliness."
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.
"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 help protect age-appropriate children.
This news should also help to remind providers and parents of the
importance of continuing routine vaccinations and recommended well
visits."
About Combination Vaccines
Combination vaccines take two or more vaccines that could be
given individually and put them into a single shot. Combination
vaccines, which have been available for more than 50 years, can
help reduce the number of injections needed during a single clinic
visit. Public health authorities and leading professional
associations generally recommend the use of combination vaccines
over separate injections, 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
ingredients for diphtheria, tetanus (lockjaw), pertussis (whooping
cough), and polio from Sanofi Pasteur and ingredients for Hib and
hepatitis B from Merck.
Important Safety Information for Vaxelis
Your child should not get Vaxelis, if your child:
- is allergic to any of the ingredients.
- had an allergic reaction to any prior shot for diphtheria,
tetanus, pertussis, polio, Hib, or hepatitis B.
- had a serious reaction affecting their brain and nervous system
after a whooping cough shot.
- has a brain and nerve illness that is getting worse.
Before your child gets Vaxelis, tell your healthcare provider if
your child:
- had problems with any shots for these diseases.
- is taking steroids, getting treatment for cancer, or has
another problem that weakens the immune system.
The most common side effects of Vaxelis are:
- pain, redness, or swelling where the shot was given
- fever (100.4°F or higher)
- crying more than usual
- eating less than usual
- fussy more than usual
- sleepy more than usual
- throwing up
There may be other side effects that are not listed. If your
child has any side effects that worry you or seem to get worse,
tell your child's healthcare provider right away.
Please read the accompanying Patient Product Information for
Vaxelis, and discuss it with your doctor. The physician Prescribing
Information also is available.
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 (details with local affiliate)
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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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
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with respect to pipeline products that the products will receive
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Risks and uncertainties include but are not limited to, general
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health care legislation in the United
States and internationally; global trends toward health care
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ability to accurately predict future market conditions;
manufacturing difficulties or delays; financial instability of
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undertakes no obligation to publicly update any forward-looking
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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).
* Vaxelis™ is the result of the U.S.-based
partnership (MSP Vaccine Company) created in 1991 between Merck
& Co., Inc., Connaught Laboratories and Pasteur Mérieux Serums
& Vaccins, the latter two now known as Sanofi Pasteur, the
vaccines unit of Sanofi.
Source: Sanofi (EURONEXT: SAN) (NASDAQ: SNY)
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SOURCE Sanofi