BRIDGEWATER, N.J., Jan. 14, 2019 /PRNewswire/ -- The U.S. Food
and Drug Administration has approved the expanded use of
Adacel® (Tetanus Toxoid, Reduced Diphtheria Toxoid and
Acellular Pertussis (Tdap) Vaccine Adsorbed) to include repeat
vaccination to help protect against tetanus, diphtheria and
pertussis. It is now the first and only Tdap vaccine in the U.S.
approved for a repeat dose in people 10 through 64 years of age 8
years or more after the first vaccination. Adacel is also the only
Tdap vaccine available in a syringe made without natural rubber
latex, which may help reduce risk to patients with an
allergy.2
"While strong vaccination programs are in place for young
adolescents, a single Tdap immunization does not offer lifetime
protection against pertussis due to waning immunity," said
David P. Greenberg, M.D., Regional
Medical Head North America at Sanofi Pasteur. "The licensure of
Adacel as the first Tdap vaccine in the U.S. for repeat vaccination
is an important step for eligible patients and offers flexibility
for health care providers to help manage their immunization
schedules."
The FDA licensure was based on clinical data from a study of the
safety and effectiveness of repeat Adacel vaccination in adults. In
the study of more than 1,300 adults (aged 18 through 64 years),
participants received either Adacel vaccine or a tetanus-diphtheria
(Td) vaccine 8-12 years after a previous dose of Adacel vaccine.
The results of the study published in the Journal of the
Pediatric Infectious Diseases Society showed a second dose
of Adacel vaccine in adults administered 8-12 years after a
previous dose found no significant differences in adverse events
between vaccine groups.1 A total of 87.7% of Tdap
vaccine recipients (n=999) and 88.0% of Td vaccine recipients
(n=328) reported at least 1 injection-site
reaction.1
Sanofi Pasteur has provided the results of the study to the
CDC's Advisory Committee on Immunization Practices for their
consideration in future recommendations.
The U.S. Centers for Disease Control and Prevention (CDC)
currently recommends a single dose of Tdap vaccine for adolescents
and adults, and for pregnant women during every
pregnancy.3 Tdap helps protect adolescents and adults
and may prevent the spread of the infection to babies and young
children who are still building immunity.5 Despite the
CDC-recommendation, nearly three of four adults have not received
the Tdap vaccine.4
Indication for Adacel Vaccine
Adacel vaccine is given
to people 10 through 64 years of age to help prevent tetanus
(lockjaw), diphtheria, and pertussis (whooping cough).
Important Safety Information for Adacel Vaccine
Adacel vaccine should not be given to anyone who has had a severe
allergic reaction (eg, anaphylaxis) to any component of the
vaccine. Some signs of severe allergic reactions are hives,
swelling of the throat, low blood pressure, shock, and difficulty
breathing. If you begin to experience any of these signs seek
treatment right away. These reactions are rare and usually occur
before leaving the doctor's office.
For one presentation of Adacel, the tip caps of the prefilled
syringes may contain natural rubber latex, which may cause allergic
reactions in latex‐sensitive individuals. The vial stopper is not
made with natural rubber latex.
Tell your doctor if you have ever experienced a severe brain
disorder, such as encephalopathy (altered consciousness),
Guillain‐Barré syndrome (severe muscle weakness), brachial neuritis
(inflammation of nerves in the arms), or an Arthus‐type reaction
(severe, exaggerated swelling involving an injection site) after a
previous dose of a tetanus toxoid‐ or pertussis
antigen‐containing vaccine.
Fainting can occur shortly after injecting vaccines, including
Adacel.
If you notice any other problems or symptoms following
vaccination, please contact your health care professional
promptly.
After the first and second dose of Adacel, the most frequently
reported side effects were pain, swelling, and redness at the
injection site; headache, body ache or muscle weakness, tiredness,
muscle aches, and general discomfort.
For more information about Adacel vaccine, please see the full
Prescribing Information, Patient
Information,
www.sanofi.us and www.vaccineshoppe.com.
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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Source: Sanofi (EURONEXT: SAN) (NASDAQ:
SNY)
References:
1 Halperin, Scott A., Donovan, Catherine,
Marshall, Gary S., Pool, Vitali, Decker, Michael D., Johnson, David
R., Greenberg, David P. "Randomized Controlled Trial of Safety and
Immunogenicity of Revaccination With Tetanus-Diphtheria-Acellular
Pertussis Vaccine (Tdap) in Adults 10 Years After a Previous Dose."
Journal of the Pediatric Infectious Diseases Society.
February 8, 2018.
2 Adacel vaccine [Prescribing Information].
Swiftwater, PA: Sanofi Pasteur
Inc.
3 Diphtheria, Tetanus, and Pertussis Vaccine
Recommendations." Centers for Disease Control and
Prevention, Centers for Disease Control and Prevention,
8 May 2018.
https://www.cdc.gov/vaccines/vpd/dtap-tdap-td/hcp/recommendations.html
4 "Morbidity and Mortality Weekly Report (MMWR)."
Centers for Disease Control and Prevention, Centers for
Disease Control and Prevention, 24 Aug.
2018.
https://www.cdc.gov/mmwr/volumes/67/wr/mm6733a1.htm
5 "Help Protect Babies From Whooping Cough."
Centers for Disease Control and Prevention, Centers for
Disease Control and Prevention, 10 Aug
2018.
https://www.cdc.gov/features/pertussis/index.html
SAUS.ADAC.18.12.7222
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SOURCE Sanofi