Each 0.5 ml dose of the vaccine contains 25 micrograms of each of the following 23 pneumococcal polysaccharide serotypes: 1, 2, 3, 4, 5, 6B, 7F, 8, 9N, 9V, 10A, 11A, 12F, 14, 15B, 17F, 18C, 19F, 19A, 20, 22F, 23F, 33F. This vaccine is indicated for active immunization against pneumococcal disease in children aged 2 years and above, as well as in adolescents and adults.

This vaccine is prepared from purified pneumococcal capsular polysaccharide antigens obtained from 23 serotypes that account for approximately 90% of invasive pneumococcal disease. The included serotypes are: 1, 2, 3, 4, 5, 6B, 7F, 8, 9N, 9V, 10A, 11A, 12F, 14, 15B, 17F, 18C, 19F, 19A, 20, 22F, 23F, 33F.

Primary vaccination:

• Adults and children aged 2 years and above: A single dose of 0.5 ml is administered via intramuscular or subcutaneous injection. This vaccine is not recommended for children below 2 years of age, as safety and effectiveness have not been established and the immune response may be inadequate.

Special dosing:

• The pneumococcal vaccine should preferably be given at least two weeks before elective splenectomy or before starting chemotherapy or other immunosuppressive treatments. Vaccination during chemotherapy or radiotherapy should be avoided.
• After completion of chemotherapy and/or radiation therapy for neoplastic diseases, immune response to vaccination may remain reduced. Vaccination should not be given earlier than three months after completion of such therapy. A longer delay may be appropriate for patients who have received intensive or prolonged treatment.
• Individuals with asymptomatic or symptomatic HIV infection should be vaccinated as soon as possible after diagnosis is confirmed.

Revaccination:

• A single dose of 0.5 ml via intramuscular or subcutaneous injection.
• The timing and necessity of revaccination should be determined based on official recommendations.
• Revaccination at intervals of less than three years is not recommended due to increased risk of adverse reactions. In individuals aged 65 years or older, local and some systemic reactions may occur more frequently after revaccination compared to primary vaccination when given within three to five years.

Adults: Healthy adults do not require routine revaccination. However, revaccination may be considered for individuals at increased risk of serious pneumococcal infection who were vaccinated more than five years earlier or those with rapidly declining antibody levels. For certain high-risk groups (e.g., asplenic individuals), revaccination after three years may be considered.

Children: Healthy children should not receive routine revaccination.

Children 10 years and older: May be considered for revaccination according to adult recommendations.

Children aged 2 to 10 years: Revaccination should only be considered after three years in high-risk children (e.g., those with nephrotic syndrome, asplenia, or sickle cell disease).

Pneumococcal vaccine may be administered at the same time as the influenza vaccine, provided that separate syringes and different injection sites are used.

This vaccine should not be administered to:

• Individuals with known hypersensitivity or allergic reactions to any component of the vaccine.
• Individuals with fever, acute infection, or chronic diseases in an active phase.
• Individuals with uncontrolled epilepsy or progressive neurological disorders.
• Revaccination within 3 years is not recommended unless clearly necessary.

The most common adverse reactions (reported in more than 10% of individuals) following pneumococcal vaccination in clinical trials include: pain, soreness, or tenderness at the injection site (60.0%), swelling or induration at the injection site (20.3%), headache (17.6%), injection-site redness (16.4%), fatigue and weakness (13.2%), and muscle pain (11.9%).

Animal studies are insufficient to determine the effects on reproductive toxicity. The vaccine should not be used during pregnancy unless clearly necessary, where the potential benefits outweigh any possible risks to the fetus. It is not known whether the vaccine is excreted in human breast milk. Caution should be exercised when administered to breastfeeding mothers. The vaccine has not been evaluated in fertility studies.

Vaccination should be postponed in cases of significant fever, active infection, or when a systemic reaction may pose a serious risk, unless delaying vaccination would result in greater danger. The vaccine must never be administered intravascularly, and care should be taken to ensure that the needle does not enter a blood vessel. Intradermal administration should also be avoided, as it may lead to increased local reactions. In individuals who are immunocompromised due to disease or treatments such as chemotherapy or radiation therapy, the expected antibody response may be reduced after vaccination. As a result, these individuals may not achieve the same level of protection as immunocompetent persons. The recovery of immune response following immunosuppressive therapy varies depending on the condition and treatment. Improved antibody responses have been observed within two years after completion of such therapies, especially when there is a longer interval between treatment completion and vaccination.

As with all vaccines, appropriate medical support, including epinephrine (adrenaline), should be readily available to manage possible anaphylactic reactions. Preventive antibiotic therapy against pneumococcal infection should not be discontinued after vaccination. Individuals at high risk of severe pneumococcal disease (e.g., asplenic patients or those receiving immunosuppressive therapy) should be advised about the potential need for early antimicrobial treatment in cases of sudden severe febrile illness. The vaccine may not be effective in preventing infections related to basilar skull fractures or conditions involving communication with cerebrospinal fluid.

Vaccines, Anti-sera & Immunoglobulin

Store the vaccine in a refrigerator at 2°C to 8°C and protect the vials from light.