Bridgewater, NJ, January 17th, 2023 — The U.S. Food and Drug Administration (FDA) has approved Adacel (Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed) during the third trimester of pregnancy to help protect against pertussis in infants younger than two months of age.[1] Adacel is an FDA-approved Tdap vaccine indicated for active booster immunization against tetanus, diphtheria, and pertussis for people 10 through 64 years of age.1
Pertussis, also known as whooping cough, is a highly contagious respiratory infection.[2] Very young infants are at the highest risk of pertussis complications because of their developing immune systems.2 Nearly half of babies 6 months and under who get pertussis may likely need care in the hospital, and one out of 100 babies who get treatment in the hospital die.[3] The Centers for Disease Control and Prevention (CDC) recommends Tdap vaccination during every pregnancy.[4] Adacel given during the third trimester of pregnancy can help a pregnant woman create antibodies against the bacteria that cause pertussis that are passed to her baby before birth.5 These antibodies help protect the baby against whooping cough during the first few months of life.5
Dr. Michael Greenberg
North America Medical Head, Vaccines, Sanofi
“We are pleased to receive the FDA’s approval for use of Adacel vaccine specifically during pregnancy to help protect young infants against pertussis, a potentially life-threatening disease. We pursued the label expansion to align fully with the long-standing health agency recommendations to provide Tdap vaccination to every woman in every pregnancy. We hope for higher and higher rates of Tdap vaccination in pregnancy so that fewer and fewer infants are likely to get pertussis.”
The vaccine effectiveness of Adacel administered during the third trimester to prevent pertussis among infants younger than 2 months of age was found to be 88% in the clinical study that used innovative real-world data to provide important real-world evidence for this submission.1
Available US Adacel safety data (retrospective passive surveillance study (NCT00258882) and on-going pregnancy registry) during the third trimester of pregnancy did not reveal any vaccine-related adverse effects on pregnancy or on the fetus/young infant.
Women who receive Adacel during pregnancy are encouraged to contact directly, or have their healthcare professional contact, Sanofi Pasteur Inc. at 1-800-822-2463 (1-800-VACCINE) or online at https://www.sanofipasteurpregnancyregistry.com.
Adacel was the first vaccine globally to have a licensed indication for use in pregnancy to help prevent pertussis in young infants.6 Since its first approval for vaccination during pregnancy in 2019, Adacel has been licensed for use in pregnancy in over 61 countries, including most countries in Europe, Canada, Australia, and New Zealand. Adacel has been prequalified for this use by the World Health Organization.
Indication
What is Adacel (tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine
adsorbed)?
Adacel is a vaccine given to people 10 through 64 years of age to help prevent tetanus (lockjaw), diphtheria, and pertussis (whooping cough).
Adacel given during the third trimester of pregnancy helps the pregnant woman create antibodies against the bacteria that cause whooping cough (pertussis) that are passed to her baby before birth.5 These antibodies help protect the baby against whooping cough during the first few months of life.5
IMPORTANT SAFETY INFORMATION FOR ADACEL (tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine absorbed)1
Adacel should not be given to anyone who has had a severe allergic reaction (e.g., anaphylaxis) to any component of the vaccine. Some signs and symptoms 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 seek treatment right away. These reactions are rare and usually occur before leaving the doctor’s office.
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, are pregnant or nursing, or had a tetanus, diphtheria, or pertussis vaccine within the last 5 years.
Fainting can occur with injectable 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, tiredness, and fever.
These are not all the possible side effects of Adacel. Call your doctor for medical advice about side effects.
Please see the Prescribing Information for Adacel.
About pertussis
Pertussis is a highly contagious respiratory infection.2 While it may be prevented through vaccination, pertussis often goes undiagnosed.2,7 It can lead to severe, sometimes life-threatening health problems, such as exacerbation of chronic medical conditions, including asthma.7 For persons beyond infancy, initial symptoms of pertussis, which typically develop within seven to 10 days after exposure, are those of the common cold (e.g., nasal congestion, little or no fever).7 The next stage is characterized by frequent bouts of paroxysmal cough and inspiratory whooping.7
About Sanofi
We are an innovative global healthcare company, driven by one purpose: we chase the miracles of science to improve people’s lives. Our team, across some 100 countries, is dedicated to transforming the practice of medicine by working to turn the impossible into the possible. We provide potentially life-changing treatment options and life-saving vaccine protection to millions of people globally, while putting sustainability and social responsibility at the center of our ambitions.
Sanofi Forward-Looking Statements
This press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements are statements that are not historical facts. These statements include projections and estimates and their underlying assumptions, statements regarding plans, objectives, intentions and expectations with respect to future financial results, events, operations, services, product development and potential, and statements regarding future performance. Forward-looking statements are generally identified by the words “expects”, “anticipates”, “believes”, “intends”, “estimates”, “plans” and similar expressions. Although Sanofi’s management believes that the expectations reflected in such forward-looking statements are reasonable, investors are cautioned that forward-looking information and statements are subject to various risks and uncertainties, many of which are difficult to predict and generally beyond the control of Sanofi, that could cause actual results and developments to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. These risks and uncertainties include among other things, the uncertainties inherent in research and development, future clinical data and analysis, including post marketing, decisions by regulatory authorities, such as the FDA or the EMA, regarding whether and when to approve any drug, device or biological application that may be filed for any such product candidates as well as their decisions regarding labelling and other matters that could affect the availability or commercial potential of such product candidates, the fact that product candidates if approved may not be commercially successful, the future approval and commercial success of therapeutic alternatives, Sanofi’s ability to benefit from external growth opportunities, to complete related transactions and/or obtain regulatory clearances, risks associated with intellectual property and any related pending or future litigation and the ultimate outcome of such litigation, trends in exchange rates and prevailing interest rates, volatile economic and market conditions, cost containment initiatives and subsequent changes thereto, and the impact that COVID-19 will have on us, our customers, suppliers, vendors, and other business partners, and the financial condition of any one of them, as well as on our employees and on the global economy as a whole. Any material effect of COVID-19 on any of the foregoing could also adversely impact us. This situation is changing rapidly and additional impacts may arise of which we are not currently aware and may exacerbate other previously identified risks. The risks and uncertainties also include the uncertainties discussed or identified in the public filings with the SEC and the AMF made by Sanofi, including those listed under “Risk Factors” and “Cautionary Statement Regarding Forward-Looking Statements” in Sanofi’s annual report on Form 20-F for the year ended December 31, 2021. Other than as required by applicable law, Sanofi does not undertake any obligation to update or revise any forward-looking information or statements.