COLLEGEVILLE, Pa--28 Sep--PRNewswire-AsiaNet/InfoQuest
Wyeth Pharmaceuticals, a division of Wyeth (NYSE: WYE), announced today that the European Medicines Agency's (EMEA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion for the company's pneumococcal conjugate vaccine, Prevenar 13* (Pneumococcal Polysaccharide
"The CHMP's positive opinion brings us one step closer to providing infants and young children in Europe with the broadest serotype coverage of any pneumococcal conjugate vaccine," says Emilio Emini, Ph.D., Executive Vice President, Vaccine Research and Development, Wyeth Pharmaceuticals. "Prevenar,
Prevenar 13 is designed to provide the broadest serotype coverage of any pneumococcal conjugate vaccine. The vaccine contains the seven serotypes (4, 6B, 9V, 14, 18C, 19F and 23F) included in Prevenar (Pneumococcal Saccharide Conjugated Vaccine, Adsorbed) -- the global standard in pneumococcal disease
To date, the company has submitted pediatric regulatory applications for Prevenar 13 in more than 50 countries spanning six continents. Prevenar 13 has been approved in two countries, with Chile being the first in July 2009. Prevenar 13 is also being studied in global Phase 3 clinical trials in adults, with regulatory submissions expected in 2010.
Important Safety Information for Prevenar 13
In clinical studies, the most commonly reported adverse reactions were injection site reactions, fever, irritability, decreased appetite, and increased and/or decreased sleep.
Risks are associated with all vaccines, including Prevenar 13. Hypersensitivity to any component, including diphtheria toxoid, is a contraindication to its use.
As with other vaccines, the administration of Prevenar 13 should be postponed in subjects suffering from acute, febrile illness. However, the presence of a minor infection, such as a cold, should not result in the
The use of Prevenar 13 should be determined on the bases of official recommendations, taking into consideration the impact of invasive disease in different age groups as well as the variability of serotype epidemiology in different geographic areas. Prevenar 13 does not provide 100% protection against vaccine serotypes or protect against nonvaccine serotypes.
Important Safety Information for Prevenar
In clinical studies (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 Prevenar. Hypersensitivity to any vaccine component, including diphtheria toxoid, is a contraindication to its use. Prevenar does not provide 100% protection against
The frequency of pneumococcal serotypes and serogroups can vary from country to country, which could influence the effectiveness of the vaccine in any given country.
Pneumococcal Disease
According to the World Health Organization (WHO), pneumococcal disease is the leading cause of vaccine-preventable death worldwide in children younger than 5 years and is estimated to cause up to 1 million deaths worldwide in children each year.
Pneumococcal disease is complex and describes a group of illnesses, all caused by the bacterium Streptococcus pneumoniae. Pneumococcal disease affects both children and adults, and includes invasive infections such as bacteremia/sepsis and meningitis, as well as pneumonia and acute otitis media.
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, haemophilia, 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, nutritionals and non-prescription medicines that improve the quality
The statements in this press release that are not historical facts are forward-looking statements that are subject to risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. In particular, clinical trial data are subject to differing interpretations, and the views of regulatory agencies, medical and scientific experts and others may differ from ours. There can be no assurance that the European Commission will grant final approval to Prevenar 13 or that Prevenar 13 will be commercially successful or receive regulatory approval in other markets such as the United States. Other risks and uncertainties that could cause actual results to differ materially from those expressed or implied by
SOURCE: Wyeth Pharmaceuticals
CONTACT: Media,
Lili Gordon,
+1-484-865-6671,
or Douglas Petkus,
+1-973-660-5218,
or Investors,
Justin Victoria,
+1-973-660-5340,
all of Wyeth
(WYE)
--Distributed by AsiaNet ( www.asianetnews.net )--
ชิลีให้การอนุมัติวัคซีน Prevenar 13 เพื่อป้องกันโรคติดเชื้อนิวโมคอคคัสในทารกและเด็กเล็กเป็นครั้งแรก ไวเอท ฟาร์มาซูติคอลส์ (Wyeth Pharmaceuticals) ซึ่งเป็นบริษัทในเครือไวเอท (NYSE: WYE) ประกาศว่า กระทรวงสาธารณสุขของชิลีเป็นหน่วยงานภาครัฐแห่งแรกที่ให้การอนุมัติวัคซีน Prevenar 13* (ประกอบด้วยซีโรไทป์ของเชื้อนิวโมคอคคัส 13 ชนิด (โปรตีนของเชื้อคอตีบ Diphtheria CRM 197 protein))เพื่อใช้ในทารกและเด็กเล็ก โดยวัคซีนดังกล่าวได้ผ่านการรับรองว่ามีประสิทธิภาพในการสร้างภูมิคุ้มกันโรคที่เกิดจากการติดเชื้อนิว