Parliamentary Group

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DRAFT RESOLUTION NO. 59 /XI/1ª

It recommends the Government to study the possibility of the inclusion in the National Plan for Vaccination of the pneumococcal vaccine or, alternatively, its comparticipation, at the very least,

by step C. I-Infant mortality is one of the main indicators of the development and well-being of a society. Portugal has in recent decades met an improvement in infant and neo-natal mortality indicators having, today, one of the lowest rates in the World. In 1970, they died 53 nados alive in every 1,000 before they reached 1 year of age and 62 before they reached the age of five. Two decades ago, they died 24 nados alive in every 1,000 before they reached 1 year of life. At present, the rate stands at 3.3 for every 1,000. Only between 2004 and 2006 a mortality rate in Continental Portugal decreased by 13.2% percent. For infant and neo-natal mortality contribute several factors, highlighting poor neo-natal conditions, poor nutrition and infectious diseases. Among us, the improvement of the indicators resulted from a conjugation between a plan to 9 years started in the 80, with the establishment of the network of health centres, the specialized transport of newborns and the rise in vaccination rates. This development must, however, continue and we should not accommodate ourselves to the results achieved. Only the constant pursuit of progress and the refusal of immobilism allow to achieve and maintain excellence. It will never be too much to recall the constant principle of the National Plan of Vaccination, according to which " vaccines allow to save more lives and prevent more cases of illness than any medical treatment ". Also the Health Portal states that " vaccines are the most effective and safe means against certain diseases. Even when immunity is not total, who is vaccinated has greater capacity for resistance in the eventuality of the disease arising " . II-There exists in the Portuguese market, since June 2001, a pneumococcal vaccine of seven conjugated valences, " indicated for the active immunization of infants and children against the invasive disease caused by Streptococcus Pneumoniae1 ". The vaccine, with the trade name Prevenar, " aims at the prevention of invasive disease (bacteriaemia, septicemia, otitis, bacteriemic pneumonia) in particular, and meningitis triggered by Streptococcus Pneumoniae . "

1 Source: Inpharmed Circular Informative 033 /CA

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Preferentially must " be applied at 3, 5 and 7 months of age and, after the 12 months, two doses with two months interval .2 " It presents the serotypes 4, 6B, 9V, 14, 18C, 19F and 23F. It is to be reflected that Streptococcus Pneumoniae is the bacterium responsible for the most severe form of meningitis. The World Health Organization (WHO) recommends countries to include this vaccine in the respective national vaccination plans. In 2006, WHO stated that the application of this vaccine in the U.S. led to an exceptional break in the rates of pneumococcal diseases, including among the unimmunized population, as prevention limits overall contagion as well. In tests carried out in South Africa, there was a 83% reduction in the incidence of invasive diseases caused by the serotypes covered by the Prevenar. 3 These WHO indications are listed, incidentally, of the same document recommending the application of the vaccine against the Human Papilloma Virus, better known as the cervical cancer vaccine. For several years, pediatricians have recommended the vaccine against pneumococcal disease that, being invasive, affects both children and adults. There are many deaths of elderly people resulting from contact with infected children. According to the INE, in 2005 died 4,648 people due to pneumonia, 825 due to septicaemia and 45, mainly children, with meningitis. The Study Group of Pneumococcal Invasive Disease (DIP) carried out a pioneering study in 28 hospitals. They identified 375 children with DIP: 196 came to have meningitis, 102 pneumonias with bacteriaemia, 36 septicaemia and 59 other diseases. It should also be recalled that, in time, diseases due to pneumococcal bacterium can cause deafness, delay in development, epilepsy and difficulties in learning. On the occasion of the discussion of the changes to the National Vaccination Plan that came into effect in 2006, the Portuguese Society of Pediatrics suggested 3 updates: the introduction of the vaccine against meningitis, the polio vaccine and to Prevenar. The latter was rejected. The Prevenar is on the market by about 75 euros each dose. Taking into account the posology recommended by the manufacturers, each child needs 4 doses to stay immunized, pertaining a charge of 300 euros for the family, as it does not benefit from any state comparticipation. III-In March 2008, the CDS-PP presented a Draft Resolution recommending to the Government to adopt " measures for equality in access to the pneumococcal vaccine of seven valences indicated for the active immunization of infants and children " . This initiative of the CDS-PP was rejected by the Socialist Party, on the grounds that a new vaccine was being prepared, with more valour and that, for that reason, it did not make sense to include the heptavalent pneumococcal vaccine (Prevenar) in the Plan National of Vaccination.

2 Source: Health Portal-Vaccination

3 Source: Fact Sheet See WHO/289

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Very recently has been put on the market a new pneumococcal polysaccharid vaccine conjugated (absorbed), with the trade name Synflorix. This vaccine has ten serotypes; three more than Prevenar-the serotypes 1, 5 and 7F. This vaccine is indicated for active immunization against invasive disease and the acute mean otitis (middle ear infection) caused by Streptococcus Pneumoniae in children aged between six weeks and the two years of age. In accordance with the European Public Assessment Report (EPAR), " the invasive disease occurs when the bacterium propagates by the organism, causing a severe infection, such as septicaemia (infection of the blood), meningitis (infection of the membranes involving the brain and the spinal cord) and pneumonia (infection of the lungs). " Still according to the EPAR, " o Synflorix contains small amounts of polysaccharides (a type of sugar) extracted from the "capsule" that involves the bacterium of S. pneumoniae. These polysaccharides have been purified and followed by "conjugates" (linked to) with a carrier that helps that the immune system recognize them. The vaccine is also "adsorlife" (fixed) in an aluminum compound, to stimulate a better response. The Synflorix contains the polysaccharides of 10 different types of S. pneumoniae (the serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F). In Europe, it is estimated that these are those responsible for about 56 a to 90% percent of cases of invasive disease in children under the age of five. " This vaccine is administered in four doses (three doses plus reinforcement) if the child is between 6 weeks and 6 months of age; in three doses (two doses plus reinforcement) between the ages of 7 and 11 months of age; or in two doses between the ages of 12 and 23 months of age. The vaccine is on the market by 57.48 euros each dose, which implies for each family an expense among the 114.96 euros (in the case of the child taking only two doses) and the 229.92 euros (when they are administered four doses), as it does not benefit from any state comparticipation. This value is obviously inaccessible to many budgets. Just remember that the national minimum ordinance for 2010 is from 475 euros . IV-In addition to the recent inclusion in the ten-valour vaccine market is now making available a pneumococcal vaccine of thirteen valences, with the trade name of Prevenar 13. This new vaccine features serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F, i.e., six more serotypes than Prevenar and three more than Synflorix. According to the experts, it is anticipated that, with the introduction into the pneumococcal vaccine market of thirteen valences, if between in a period of stability in what pneumococcal vaccines concern, it is not being predicted that in the coming years it may emerge any more. Thus, the pneumococcal vaccine of thirteen valences brings, without a doubt, an enormous benefit to public health. The argument then used by the Socialist Party to reject the previous initiative of the CDS-PP is therefore outdated. The price of this new vaccine is from 75.99 euros thus not being very far from the prices of the other vaccines available on the market. Your administration should be done in three doses for children up to the age of two, plus one dose when the child reaches the two

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years of age. Ora, the four doses perdo a total of 303.96 euros . Once again, we are facing a situation of social injustice, as prevention remains only accessible to households with more incomes, leaving out or penalizing excessively the families with fewer resources. Every year is born in Portugal approximately 100,000 children and all should have the guarantee of this immunization. By being included in the National Plan of Vaccination the application of vaccines becomes universal and free for the population. As far as the charges for the state are concerned, it is foreseeable that it will be possible for its acquisition about 25% below the PVP, strength of the mass purchase. In addition to the evident health and human advantages, the inclusion of the vaccine in the National Plan of Vaccination, avoids subsequent SNS expenses in the treatment of diseases. It should also be pointed out that the option for vaccine comparticipation would already be a breakthrough in the face of the situation of current iniquity, and that vaccines for less lethal diseases, such as influenza and hepatitis A, are already attended by the C-level, the exposed, Assembly of the Republic, pursuant to Article 156º (b) of the Constitution of the Portuguese Republic, to recommend to the Government: -That studies the possibility of inclusion in the National Plan for Vaccination of the pneumococcal vaccine or, alternatively, its comparticipation, at a minimum, by the C-level.

Palace of S. Bento, January 14, 2010.

The Deputies,