Study Finds Significant Reduction In Antibiotic-Resistant Pneumococcal Disease Since the Introduction of PREVNAR

06/04/06 MADISON, N.J.,  – Antibiotic resistance is a worldwide public health issue.  Physicians around the world face an increasing clinical challenge as many life-threatening bacterial infections, once responsive to therapy, are building resistance to the most commonly prescribed antibiotic treatments.  However, preventing the occurrence of disease through vaccination may help alleviate the challenges of antibiotic resistance.

A study published in today’s New England Journal of Medicine (NEJM) – “Effect of Introduction of the Pneumococcal Conjugate Vaccine on Drug-Resistant Streptococcus pneumoniae” has found that, since the introduction of PREVNAR®, Pneumococcal 7-valent Conjugate Vaccine (Diphtheria CRM197 Protein), in the United States, the rate of antibiotic-resistant invasive pneumococcal disease (IPD) has substantially decreased in infants and young children.  In addition, the rate of antibiotic-resistant IPD decreased in adults over 65 years of age, an unvaccinated group, suggesting an indirect effect in the non-vaccinated population.

The study analyzed population-based data from the Active Bacterial Core Surveillance, part of the Emerging Infections Program of the Centers for Disease Control and Prevention (CDC), and found that since the introduction of PREVNAR, IPD caused by penicillin-resistant strains targeted by the vaccine has been reduced by:

– 87 percent among the full study population (persons of any age);
– 98 percent among children younger than two years of age;
– 79 percent among adults aged 65 years or older.

The study documented significant overall reductions in antibiotic-resistant IPD, irrespective of pneumococcal serotype, although the rate of penicillin non-susceptible disease due to non-vaccine serotypes increased from 0.2 per 100,000 in 1999 to 0.5 per 100,000 in 2004.  Wyeth Pharmaceuticals is developing a 13-valent pneumococcal conjugate vaccine which targets additional pneumococcal serotypes.  This new vaccine is currently undergoing clinical development.

The New England Journal of Medicine findings continue to document the impact of routine immunization with PREVNAR on public health.  In addition, the development of the 13-valent pneumococcal conjugate vaccine further demonstrates Wyeth’s continued dedication to helping protect infants and toddlers against invasive pneumococcal infection and its potentially devastating consequences.

IPD describes a group of illnesses, some of which may be life threatening, caused by the bacterium Streptococcus pneumoniae.  S. pneumoniae has been associated with the highest level of morbidity and mortality due to bacterial meningitis in children.  IPD includes serious diseases such as bacteremia/sepsis, meningitis, and bacteremic pneumonia.

PREVNAR is the first and only vaccine indicated for active immunization of infants and toddlers against invasive disease caused by S. pneumoniae due to capsular serotypes included in the vaccine (4, 6B, 9V, 14, 18C, 19F, and 23F).  These seven serotypes accounted for approximately 80 percent of IPD in children under age six in the United States prior to the licensure of PREVNAR.

PREVNAR is recommended by the CDC and the American Academy of Pediatrics for infants two months of age and older, and children younger than two years of age.  The routine schedule is 2, 4, 6, and 12 to 15 months of age.

Since the introduction of PREVNAR in the United States, IPD incidence has decreased dramatically.  Three years after the introduction of routine PREVNAR use in the United States, surveillance sites of the CDC noted a 94 percent reduction in IPD in children younger than five years of age caused by pneumococcal serotypes targeted by the vaccine, as well as a reduction in the incidence of vaccine serotype IPD in adult populations.  However, reduction in IPD rates due to non-vaccine serotypes should not be expected, and PREVNAR is not indicated for use in adults.

Important Safety Information

In clinical trials (n=18,168), the most frequently reported adverse events included injection site reactions, fever (≥38°C/100.4°F), irritability, drowsiness, restless sleep, decreased appetite, vomiting, diarrhea and rash.

Risks are associated with all vaccines, including PREVNAR.  Hypersensitivity to any vaccine component, including diphtheria toxoid, is a contraindication to its use.  PREVNAR does not provide 100% protection against vaccine serotypes or protect against nonvaccine serotypes.

Wyeth Pharmaceuticals

Wyeth Pharmaceuticals, a division of Wyeth, has leading products in the areas of women’s health care, cardiovascular disease, central nervous system, inflammation, transplantation, hemophilia, oncology, vaccines and nutritional products.  Wyeth is one of the world’s largest research-driven pharmaceutical and health care products companies.  It is a leader in the discovery, development, manufacturing, and marketing of pharmaceuticals, vaccines, biotechnology products and non-prescription medicines that improve the quality of life for people worldwide.  The Company’s major divisions include Wyeth Pharmaceuticals, Wyeth Consumer Healthcare and Fort Dodge Animal Health.