
Prevenar Vaccine 13-valent pneumococcal conjugate to “Immunization of children aged 2, 4, 6 and 12 to 15 months of age to prevent invasive pneumococcal disease and active immunization of infants from 6 weeks of age, pneumonia and otitis media caused by Streptococcus pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F.
In February 2004, Wyeth Lederle Vaccines SA, informed the EMEA (European Medicines Agency) and its Scientific Committee for Human Medicinal Products, CPMP (now called CHMP) of the Company was experiencing irregular supply of Prevenar and believed that continuing until the second half of 2004.
Such restrictions in the supply of Prevenar was due to the temporary closure in November 2003 of one of the manufacturing lines in the United States to perform preventive maintenance and modifications of the same team. The manufacture of this line was restored in February 2004.
On April 12 it was reported the recommendations agreed with the EMEA / CPMP to reduce the impact of the shortage of Prevnar.
Wyeth currently restored her normal supply of Prevenar, with ability to deliver sufficient doses to European markets where is marketed.
Therefore, dosage recommendation establishes the following:
The high-risk children (those in the stories that conditions such as alterations spleen, immunosuppressed or chronically ill) should continue with the full vaccination schedule (consisting of primary vaccination in 3 doses and a fourth doses in the second year of life ).
Prevention is not included in the immunization schedule in the Autonomous Communities, so that immunization of other children not included in the previous paragraph, there is a medical test. In this case, the vaccination schedule is described in the Product Data Sheet.
For incompletely vaccinated children follow the recommended dosage scheme detailed in the following table:
Age (months) |
History of previous vaccination with the pneumococcal vaccine |
Scheme recommended dosage * |
2-6 months |
1 dosis |
2 doses with an interval of at least 1 month between them. A fourth dose in the second year of life |
2 dosis |
1 dose. A fourth dose in the second year of life |
|
7-11 months |
1 ó 2 dosis before 7 months |
1 dose between 7 and 11 months, plus another dose in the second year of life (at least 2 months later) |
12-23 months |
1 dosis before 12 months |
2 doses with an interval of at least 2 months |
1 dosis when 12 months or after |
1 dose at an interval of at least 2 months since the previous dose |
|
2 ó 3 dosis before 12 months |
1 dose at an interval of at least 6 months after the last dose |
Children from 24 months to 5 years of age not previously immunized: a single dose
* For children vaccinated in the first year of life, the interval between doses is 4 weeks. For the dose administered after 12 months should be a minimum interval of 8 weeks between doses.
If vaccination of Prevenar coincide with that of other vaccines, see data sheet for more information approved on coadministration.