FDA Approves Expanded Use of Adacel® (Tdap) Vaccine for Repeat Vaccination

* First and only vaccine approved in the U.S. for repeat vaccination 8 years or more after the first vaccination to help protect against tetanus, diphtheria and pertussis, offering flexibility for health care providers to help manage their immunization schedules(2)

* Approval based on clinical study of more than 1,300 adults demonstrating a second dose of Adacel vaccine is safe and effective when administered 8-12 years after a previous dose(1)

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

Media Relations Contact Investor Relations Contact Nicolas Kressmann George Grofik Tel.: (732) 532-5318 Tel.: +33 (0)1 53 77 45 45 mr@sanofi.com ir@sanofi.com

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 absence of guarantee that the product candidates if approved will be commercially successful, the future approval and commercial success of therapeutic alternatives, Sanofi's ability to benefit from external growth opportunities 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 conditions, the impact of cost containment initiatives and subsequent changes thereto, the average number of shares outstanding as well as those 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, 2017. Other than as required by applicable law, Sanofi does not undertake any obligation to update or revise any forward-looking information or statements.

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

SOURCE Sanofi