Introduction of Pneumococcal Vaccine - PCV10 Synflorix Frequently Asked Questions for Health Workers 17 December 2010 I. Pneumococcal Disease 1. What is pneumococcus? Pneumococcus, also called Streptococcus pneumoniae, is a bacterium that is commonly found in the nose and throat of healthy people without causing disease. It can spread to different parts of the body to cause a variety of diseases, one of which is pneumonia. Streptococcus pneumoniae is the leading cause of bacterial pneumonia. 2. What diseases does pneumococcus cause? a) Severe infections known as invasive pneumococcal disease (IPD) occur when the pneumococcus enters the bloodstream (bacteraemia) and then through the bloodstream may infect other sites in the body. IPD results in significant morbidity and mortality. IPD includes: - pneumonia (bacteraemic) - meningitis - febrile bacteraemia - arthritis - peritonitis - osteomyelitis b) Less severe but more common diseases occur when the pneumococcus spreads locally from the nasopharynx to the nearby ears, sinuses, and bronchi and include: – otitis media (middle ear infection) – sinusitis – bronchitis 3. How common is pneumococcal disease? The most common types of pneumococcal infections include middle ear infections, sinus infections, pneumonia, bacteraemia, and meningitis. Diseases caused by Streptococcus pneumoniae constitute a major global public health problem. In 2000, about 14.5 million episodes of serious pneumococcal disease (range 11.1–18.0 million) were estimated to occur, resulting in about 826 000 deaths (range: 582 000–926 000) in children aged 1–59 months, of which an estimated 91 000 (range: 63 000–102 000) were in HIV-positive and 735 000 (range:519 000–825 000) in HIV-negative children. Of the deaths in HIV-negative children, over 61% occurred in ten African and Asian countries. 4. Who is at increased risk of pneumococcal disease? Children under five years of age, and especially those under two years of age Older people over age 65 years Individuals at higher risk for pneumococcal infection include those with HIV infection, sickle cell disease, asplenia, and chronic kidney disease. Among infants, additional 1 higher risk groups are those infants who are not breast-fed and who have indoor smoke exposure. 5. How is pneumococcal disease spread? It is spread from person to person through respiratory droplets (e.g., due to coughing or sneezing). The noses and throats of up to 70% of healthy people contain pneumococcus at any given time. 6. Can pneumococcal disease be treated? Pneumococcal disease can be treated with antibiotics. Amoxicillin, penicillin, or cotrimoxazole are commonly used to treat pneumococcal infections. These are usually prescribed at a health centre or hospital. In many countries, strains of pneumococcus are becoming increasingly resistant to these antibiotics. Pneumococcal infections which are resistant to the commonly used antibiotics require treatment using other antibiotics such as cephalosporins and vancomycin, particularly when the infection is a resistant pneumococcal meningitis. 7. Why do we vaccinate children against pneumococcal disease? The risk of serious pneumococcal disease is highest in the first year of life, but remains high throughout the first 24 months of life. Vaccinating against pneumococcal disease is a cost-effective way of preventing the disease. Vaccination can prevent substantial mortality and morbidity in the underserved populations of the poorer countries. II. Pneumococcal Vaccine 1. What is pneumococcal vaccine? Pneumococcal vaccine protects against severe forms of pneumococcal disease, such as meningitis, pneumonia and bacteraemia. It will not protect against these conditions if they are caused by agents other than pneumococcus. The PCV-10 vaccine will protect against the 10 most important types of the bacterium that account for 75-85% of all serious disease caused by pneumococcal disease. 2. What is the presentation of pneumococcal conjugate vaccine 10 (PCV10) and how is it stored? There are two presentations of the PCV-10 vaccine: a) PCV-10 in a single dose vial. b) PCV-10 in a two-dose vial, liquid presentation. However, as this presentation does not contain a preservative, it must be discarded at the end of each session, or after 6 hours from first opening. The vaccine should be stored between 2-8 degrees Celsius and must not be frozen. 3. What is the vaccination schedule for the pneumococcal vaccine? This vaccine should be given in 3 doses. The minimum age to receive the first dose is 6 weeks, with a minimum interval of four weeks between the three doses - e.g., 6, 10 2 and 14 weeks. Ideally, PCV-10 should be given at the same time/age as DTP, Hepatitis B, Hib, and OPV administration. The vaccination of infants and children who have partially completed their immunization schedule with other EPI vaccines should be decided in accordance with the national policy of the country. However, if the child is under one year of age, they need to be given three doses of the vaccine, with a minimum interval of four weeks between the doses. For previously unvaccinated, older infants and children who are beyond the age of routine infant immunization, a single catch-up dose may be given to children aged 1224 months and to children aged 2-5 years who are considered to be at high risk. It is not known whether re-vaccination is necessary later in life. 4. Can the pneumococcal vaccine be administered at the same time as other vaccines? The pneumococcal conjugate vaccine can be co-administered with other EPI vaccines. When co-administered with other vaccines, the PCV-10 injection should be given in a different injection site - for example, the opposite thigh. The vaccine cannot be mixed with other vaccines in the same syringe. 5. Can a premature child be vaccinated? Yes, a premature child can and should be vaccinated at or after 6 weeks of age 6. What schedule is recommended for children who are immunodeficient? The proposed vaccination schedule is the same for all children aged ≤23 months, regardless of the presence of underlying medical conditions (e.g., children with HIV infection, sickle cell disease or who are otherwise immunocompromised). Pneumococcal conjugate vaccine has been proven to be safe and well-tolerated even among children infected with HIV. Children with sickle cell disease or HIV infection may be given PCV vaccine. 7. Who should not get a vaccine? The pneumococcal vaccine should not be given to the following persons: those who have had severe allergic reactions to a prior dose those who have had a severe reaction to a vaccine containing diphtheria toxoid those who have a severe illness (e.g., temperature ≥39°C); vaccination should be delayed until the condition improves. 8. How effective is pneumococcal vaccine? Pneumococcal vaccine is highly effective and protects against meningitis, pneumonia and bacteraemia due to Streptococcus pneumoniae. After receiving all doses of pneumococcal vaccine, a child is protected against infections due to Streptococcus pneumoniae but may still get meningitis, pneumonia, or bacteraemia due to other organisms. 9. How safe is pneumococcal vaccine? Pneumococcal conjugate vaccine is safe and well tolerated; severe adverse reactions attributable to the vaccine are extremely rare. Mild side effects such as soreness at the 3 injection site, and transient fever of ≥39oC has been reported in less than 5% of vaccines. It is important to note that, as DTP-HepB-Hib may be given during the same visit as pneumococcal vaccine, the child may also be reacting to co-administered vaccines. It will be important to inform parents that although this vaccine is safe, these mild side effects may occur. A single dose of paracetamol may need to be administered if the child develops fever. 10. What messages should be given to the parents or care-giver? The following messages can be given to parents/care-givers: Date of next visit to complete the schedule: three visits for pneumococcal vaccine in the first year of life! It is safe and effective to have two or more EPI injections at the same visit, and vaccination ensures early protection when the child is most at risk. The Hib and pneumococcal vaccines prevent many but not all cases of pneumonia: if your child has a persistent cough or difficulty breathing, please urgently take the child for treatment. In addition to vaccination, you can protect your child with early and exclusive breast feeding for 6 months; adequate nutrition; frequent hand-washing; and keeping a house free of smoke from open fires and tobacco use. 11. What can I do to make sure that the child is vaccinated on time? Offer vaccines every day of the year to reduce missed opportunities for vaccinating children. Infants' immunization records should be screened for completeness during their visits. At each visit, infants should be given all vaccines that they are eligible to receive. When an infant is brought to the health centre, his/her age and previous immunization status should be determined before deciding which vaccine doses to provide. Implement accurate recording of immunizations on child health cards. Remind parents of next visits and of the importance of completing the full immunization schedule. Follow up with care-givers of children who are overdue for their immunizations, through defaulter tracing and other mechanisms. 12. Why do I need to encourage the mother to go to the immunization post nearest to her house? This is important because: It will be easier for her to return, if the her infant has any unexpected complications Returning for subsequent vaccinations is easier. This allows health workers to more easily follow-up with mothers for missed doses. Using the same immunization post consistently helps with the calculation of accurate coverage. 4