COLLEGEVILLE, Pa., Oct. 4 /PRNewswire-FirstCall/ -- Wyeth Pharmaceuticals, a division of Wyeth , comments on studies to be presented this week at the 45th Annual Meeting of the Infectious Diseases Society of America (IDSA) concerning PREVNAR(R) (Pneumococcal 7-valent Conjugate Vaccine [Diphtheria CRM197 Protein]), a vaccine which helps to protect against the seven pneumococcal serotypes causing the majority of disease worldwide. Key studies report the broad public health impact of routine use of PREVNAR in the United States, including a 98 percent reduction in vaccine-type invasive pneumococcal disease (IPD) among children younger than five years of age compared with a pre-vaccine baseline; the data also detail the emergence of disease caused by non-vaccine serotype 19A, underscoring the need for broader spectrum pneumococcal vaccines.
“It is important to note that some non-vaccine serotypes, most notably 19A, are emerging globally and have been documented both in regions where PREVNAR is available, as well as in areas where it is not widely used,” says Peter Paradiso, Ph.D., Vice President, Scientific Affairs, Wyeth Vaccines. “For example, data to be presented at IDSA from Korea show an increase in disease caused by serotype 19A prior to the introduction of PREVNAR; this indicates that such events may occur in the absence and independent of vaccination. While data suggest that some antibiotic-resistant strains of nonvaccine serotype 19A are emerging, it should be noted that the overuse of antibiotics has long been established as the primary cause of antibiotic- resistant bacteria, not vaccine use.”
Since the introduction of PREVNAR in the United States in 2000, the rate of antibiotic-resistant IPD decreased through 2004 by 98 percent (95% CI: 97.6-98.4) for vaccine serotypes and 81 percent (95% CI: 80-82) for all serotypes in children younger than two years of age.
Wyeth has a 13-valent pneumococcal conjugate vaccine in late-stage development that includes serotype 19A, as well as serotypes 1, 3, 5, 6A and 7F, in addition to the seven serotypes (4, 6B, 9V, 14, 18C, 19F and 23F) included in PREVNAR. The investigational 13-valent vaccine currently is in global Phase 3 clinical trials and may offer broader coverage than the 7- valent vaccine.
In view of the demonstrated vaccine efficacy and high disease burden in young children, the World Health Organization (WHO) recently recommended priority inclusion of the pneumococcal conjugate vaccine in national immunization programs worldwide. The Advisory Committee on Immunization Practices for the Centers for Disease Control and Prevention recommends pneumococcal conjugate vaccine for all infants as do many other countries. PREVNAR, the only licensed pneumococcal conjugate vaccine, now is available in more than 80 countries worldwide and is part of the routine national childhood immunization schedule in 17 of these countries.
Pneumococcal Disease
Pneumococcal disease affects both children and adults and is a leading cause of illness and death worldwide. Pneumococcal disease is caused by the bacterium Streptococcus pneumoniae and describes a group of illnesses, including invasive infections, such as bacteremia/sepsis and meningitis, as well as pneumonia and upper respiratory tract infections, including otitis media and sinusitis. WHO estimates that pneumococcal disease results in up to one million deaths each year in young children worldwide. Further, according to WHO, pneumococcal disease is the number one vaccine-preventable cause of death in children less than five years of age worldwide.
Important Safety Information about PREVNAR
In clinical trials (n=18,168), the most frequently reported adverse events included injection site reactions, fever (greater than or equal to 38 degrees C/100.4 degrees 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 percent 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, infectious disease, gastrointestinal health, 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.
The statements in this press release that are not historical facts are forward-looking statements based on current expectations of future events and are subject to risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. These risks and uncertainties include the inherent uncertainty of the timing and success of, and expense associated with, research, development, regulatory approval and commercialization of our products, including with respect to our pipeline products; government cost-containment initiatives; restrictions on third-party payments for our products; substantial competition in our industry, including from branded and generic products; data generated on our products; the importance of strong performance from our principal products and our anticipated new product introductions; the highly regulated nature of our business; product liability, intellectual property and other litigation risks and environmental liabilities; uncertainty regarding our intellectual property rights and those of others; difficulties associated with, and regulatory compliance with respect to, manufacturing of our products; risks associated with our strategic relationships; economic conditions including interest and currency exchange rate fluctuations; changes in generally accepted accounting principles; trade buying patterns; the impact of legislation and regulatory compliance; risks and uncertainties associated with global operations and sales; and other risks and uncertainties, including those detailed from time to time in our periodic reports filed with the Securities and Exchange Commission, including our current reports on Form 8-K, quarterly reports on Form 10-Q and annual report on Form 10-K, particularly the discussion under the caption “Item 1A, RISK FACTORS.” The forward-looking statements in this press release are qualified by these risk factors. We assume no obligation to publicly update any forward-looking statements, whether as a result of new information, future developments or otherwise.
CONTACT: Media Contacts, Lili Gordon, +1-484-865-6671, or Natalie de Vane,
+1-484-865-5139, both of Wyeth Pharmaceuticals; or Investor Contact, Justin
Victoria of Wyeth, +1-973-660-5340
Web site: http://www.wyeth.com//
