Pneumococcal vaccine 13 Valens, in the process of approval, obtained positive evaluation by the European regulatory authorities.

Buenos Aires, September 2009.- Wyeth Pharmaceuticals, a division of Wyeth (NYSE: WYE) announced this week that the Committee for medicinal products for use in humans of the European Medicines Agency (EMEA) made a positive assessment on the Pneumococcal conjugate vaccine polysaccharide absorbed 13-valente (Prevenar13 ®), the conjugate pneumococcal vaccine that has developed company.

The Committee recommended the adoption of this vaccine for active immunization of children 6 weeks to 5 years, to prevent invasive pneumococcal disease and pneumonia and otitis media (middle ear infection) caused by 13 serotypes of Pneumococcus. The assessment made by the Committee will be forwarded to the European Commission and a final decision is expected in the coming months.

The positive assessment made by the Committee on this vaccine us closer to the goal of putting a Pneumococcal conjugate vaccine with a spectrum of greater protection available to children in the region ”, said doctor Emilio Emini, Executive Vice President of the area of research and development of vaccines for Wyeth Pharmaceuticals.

The vaccine 7-Valens we currently have available demonstrated efficacy and clinical effectiveness, which implies significant benefits at the level of public health. The vaccine 13-valente will be a vaccine capable of providing protection for the 13 most prevalent serotypes responsible for different pneumococcal disease, as for example the Serotype 19A, considered a threat to public health ”, noted Dr. Alejandro Cané, Director of Scientific Affairs of the Wyeth vaccines area for Latin America.

This will be the vaccine combined with greater protection against pneumococcal disease spectrum ”, stated Dr. Ernesto Ferreirós, Director doctor of Wyeth region cone South. administration scheme is compatible with 7-valente, i.e. that a baby that began the immunization with this vaccine schedule may complete it with the 13.valente, that will protect it against six additional serotypes ”.

The vaccine contains seven serotypes (4, 6B, 9V, 14, 18 c, one-half and 23F), included in the vaccine 7-Valens, the global standard of prevention of pneumococcal disease for infants and young children, with the additional benefit of other six serotypes (1, 3, 5, 6A, 7F and 19A), causing the remaining number of invasive disease. Both vaccines use CMR197, an immunological protein with 20 years of use in the history of vaccination in Pediatrics. Pneumococcal vaccine 7-Valens conjugate, available in Europe since 2001, is currently approved in 97 countries and the world more than 265 million doses were distributed.

To date, the company presented the request for approval the vaccine 13-Valens in over 50 countries in different parts of the world, including the Argentina. Its use was already approved in two countries, one of which is Chile, who authorized in July of this year also, the vaccine is in phase 3 study for use in adult patients, with the prospect of the application for approval for this indication by the year 2010.

Information of importance on the safety of pneumococcal vaccine conjugate 13-Valens

According to the clinical studies, the most common adverse effects that were reported were reactions at the place where applies injection, fever, irritability, decreased appetite and more or less drowsiness.

The risks associated with pneumococcal vaccine conjugate 13-valente are common to the risks associated with the use of other vaccines. Hypersensitivity to any component of the vaccine, such as diphtheria toxoid, is considered a reason for contraindicar use.

As with other vaccines, the administration of the vaccine should be suspended in subjects suffering from acute febrile illness. However, the presence of one minor, such as the one caused by a cold infection should not determine the postponement of the vaccination.

The use of this vaccine must be determined on the basis of the recommendations, taking into account the impact of the disease invasive in different age groups and the epidemiological variability of serotype according to the different geographical areas. The 13-Valens vaccine does not provide total protection against all serotypes included in the vaccine nor protects against serotypes for which there is no vaccination.

Important information about the safety of pneumococcal vaccine conjugate 7-Valens

According to clinical studies (n = 18. 168), adverse events reported more frequently are reactions at the site of injection (≥38 ° C) fever, irritability, drowsiness, light sleep, lack of appetite, vomiting, diarrhea and rash.

Any vaccine has risks, and this is no exception. Hypersensitivity to any component of the vaccine as, for example, tetanus diphtheria, is a sufficient condition for contraindicar application. It does not protect 100% of vaccinated children nor protects against serotypes for which there is no vaccine. The decision to administer this vaccine must be based on the effectiveness of this vaccine to prevent invasive pneumococcal disease.

The incidence of pneumococcal serotypes can vary from country to country, which can influence the effectiveness of the vaccine in each case.

Pneumococcal disease

According to the World Health Organization (who), pneumococcal disease is the leading cause of preventable death with a vaccine in children younger than 5 years and it is estimated that this disease is responsible for up to one million deaths each year worldwide.

Pneumococcal disease is complex and comprises a group of diseases 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 otitis media acute.

Wyeth Pharmaceuticals

Wyeth Pharmaceuticals, a division of Wyeth, has leading products in the area of women’s health, infectious disease, gastrointestinal health, central nervous system, inflammation, transplantation, hemophilia, Oncology, vaccines and nutritional products.

Wyeth is one of pharmaceutical research and the world’s largest health care companies. It is leader in the discovery, development, production and marketing of pharmaceutical products, vaccines, biotechnological, nutritional and over-the-counter medicines that improve the quality of life of patients around the world. The main divisions of the company are Wyeth Pharmaceuticals, Wyeth Consumer Healthcare and Fort Dodge Animal Health.