Sanofi Pasteur, the vaccines division of sanofi-aventis Group, announced today that its Pentacel®, Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Inactivated Poliovirus and Haemophilus b Conjugate (Tetanus Toxoid Conjugate) Vaccine will be included in the federal government's Vaccines for Children (VFC) program. The U.S. Centers for Disease Control and Prevention (CDC) Advisory Committee on Immunization Practices (ACIP) voted today to add Pentacel vaccine to the VFC program. The VFC program provides vaccines at no cost to children who might not otherwise be vaccinated because of inability to pay.
Pentacel vaccine was licensed by the U.S. Food and Drug Administration (FDA) on June 20, 2008, for active immunization against diphtheria, tetanus, pertussis, poliomyelitis, and invasive disease due to Haemophilus influenzae type b (Hib). It is the first and only four-dose diphtheria, tetanus and acellular pertussis (DTaP)-based combination vaccine licensed in the U.S. that includes both poliovirus and Hib vaccine antigens. Pentacel vaccine is approved for use in infants and children 6 weeks through 4 years of age (prior to fifth birthday) and is administered as a four-dose series at 2, 4, 6, and 15-18 months of age. The use of the five-in-one combination Pentacel vaccine for immunization could reduce the number of shots a child receives by 2 years of age by almost one third as compared to immunization with single-entity vaccines.
The ACIP, American Academy of Family Physicians (AAFP) and the American Academy of Pediatrics (AAP) prefer combination vaccines because they offer a way to reduce the constraints associated with the administration of separate vaccines. Using combination vaccines may help avoid missed opportunities to protect children through vaccination during their vulnerable early months. Additionally, a reduction in the overall number of shots given during one office or clinic visit is preferred by many immunization providers, parents and children. Other potential advantages of combination vaccines include reducing the cost of stocking and administering vaccines, as well as fewer office visits, which can save parents time and money.
About Pentacel vaccine
The FDA licensure of Pentacel vaccine is based on the results of multi-center clinical studies conducted in the U.S. and Canada involving more than 5,000 children who received at least one dose of Pentacel vaccine. The immunogenicity of Pentacel vaccine was compared to separately administered DAPTACEL®,a IPOL®b and ActHIB®c vaccines (studies P3T06 and M5A10), as well as to other single-entity vaccine formulations (study 494-01). The safety of Pentacel vaccine was compared both to separately administered DAPTACEL, IPOL and ActHIB vaccines (study P3T06) and to other single-entity vaccine formulations (study 494-01).
In clinical studies, local and systemic reactions following administration of Pentacel vaccine were reported at rates consistent with those of the separately administered vaccines used in each trial. The most common local and systemic adverse reactions to Pentacel vaccine include injection site redness, swelling and tenderness; fever, fussiness and crying. Other adverse reactions may occur. Known systemic hypersensitivity reaction to any component of Pentacel vaccine or a life-threatening reaction after previous administration of the vaccine or a vaccine containing the same substances are contraindications to vaccination.
The decision to give Pentacel vaccine should be based on the potential benefits and risks; if Guillain- Barré syndrome has occurred within 6 weeks of receipt of a prior vaccine containing tetanus toxoid; or if adverse events have occurred in temporal relation to receipt of pertussis-containing vaccine. Encephalopathy within 7 days of administration of a previous dose of a pertussis-containing vaccine or a progressive neurologic disorder is a contraindication. Vaccination with Pentacel vaccine may not protect all individuals.
Before administering Pentacel vaccine, please see accompanying full Prescribing Information. The full Prescribing Information for Pentacel vaccine is available on www.pentacel.com and www.vaccineshoppe.com.
About the VFC Program
The VFC program is administered by the CDC, and was designed to help families of children who may not otherwise have access to vaccines by providing free vaccines to doctors and clinics who serve them. The VFC program provides federally purchased vaccines through public and private providers at no cost to the families.
Children who meet at least one of the following criteria are eligible to receive VFC vaccines:
• Are 18 years of age or younger
• Are eligible for Medicaid
• Have no health insurance
• Are Native American or Alaskan
• Have health insurance that does not cover vaccination, requiring these children go to a Federally Qualified Health Center or Rural Health Clinic for immunizations
About sanofi-aventis
Sanofi-aventis, a leading global pharmaceutical company, discovers, develops and distributes therapeutic solutions to improve the lives of everyone. Sanofi-aventis is listed in Paris (EURONEXT: SAN) and in New York (NYSE: SNY).
Sanofi Pasteur, the vaccines division of sanofi-aventis Group, provided more than a 1.6 billion doses of vaccine in 2007, making it possible to immunize more than 500 million people across the globe. A world leader in the vaccine industry, sanofi pasteur offers the broadest range of vaccines protecting against 20 infectious diseases. The company's heritage, to create vaccines that protect life, dates back more than a century. Sanofi Pasteur is the largest company entirely dedicated to vaccines. Every day, the company invests more than EUR1 million in research and development. For more information, please visit: www.sanofipasteur.com or www.sanofipasteur.us
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 financial projections and estimates and their underlying assumptions, statements regarding plans, objectives, intentions and expectations with respect to future events, operations, products and services, 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-aventis’ 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-aventis, 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 those discussed or identified in the public filings with the SEC and the AMF made by sanofi-aventis, including those listed under “Risk Factors” and “Cautionary Statement Regarding Forward-Looking Statements” in sanofi-aventis’ annual report on Form 20-F for the year ended December 31, 2007. Other than as required by applicable law, sanofi-aventis does not undertake any obligation to update or revise any forward-looking information or statements.
a The true name for DAPTACEL vaccine is: Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed.
b The true name for IPOL vaccine is: Poliovirus Vaccine Inactivated. c The true name for ActHIB vaccine is: Haemophilus b Conjugate Vaccine (Tetanus Toxoid Conjugate).
