Pneumococcal Vaccine

Pneumococcal Vaccine is a mixture of purified capsular polysaccharides from the 23 types of S. pneumoniae that are responsible for 90% of all pneumococcal infections. Pneumococcal Vaccine is used to provide selective immunity against infection caused by pneumococci in person over 2 years of age.

Pneumococcal Vaccine is primarily indicated in conditions like CSF leak, Pneumonia, and can also be given in adjunctive therapy as an alternative drug of choice in AIDS.

Pneumococcal Vaccine is contraindicated in conditions like Pregnancy, Hypersensitivity to any component of product.

The symptomatic adverse reactions produced by Pneumococcal Vaccine are more or less tolerable and if they become severe, they can be treated symptomatically, these include Fever, Rashes, Allergic reactions, Decreased appetite, Soreness, Redness, swelling and tenderness at injection site.

Allergic reactions, including anaphylactic/anaphylactoid reactions, rash, urticaria, bronchospasm, facial edema, erythema multiforme, and angioedema, reported with pneumococcal vaccines. Take all known precautions to prevent adverse reactions, including review of the patient’s history with respect to health status and possible sensitivity to the vaccine or similar vaccines. Epinephrine and other appropriate agents should be readily available in case anaphylaxis or other serious allergic reaction occurs. May be administered to individuals immunosuppressed as the result of disease or immunosuppressive therapy. Consider possibility that immune response to vaccines may be diminished or suboptimal in these individuals. If possible, administer pneumococcal vaccine at least 2 weeks prior to initiation of immunosuppressive therapy or defer until at least 3 months after immunosuppressive therapy is discontinued or at least 6 months following therapy with anti-B cell agents. Since antibody response may be impaired after splenectomy, ACIP and AAP recommend that vaccination with pneumococcal vaccines be completed at least 2 weeks prior to elective splenectomy, if possible. Apnea observed in some premature infants following IM vaccination with PCV13 (Prevnar 13 ) and PCV15 (Vaxneuvance ). Consider individual infant’s medical status and the potential benefits and possible risks of vaccination when deciding when to administer an IM vaccine. A decision to administer or delay administration of vaccination in an individual with a current or recent acute illness depends on the severity of symptoms and etiology of the illness. ACIP, AAP, and others state that minor acute illness, such as mild diarrhea or mild upper respiratory infection (with or without fever), usually does not preclude vaccination. However, vaccination of individuals with moderate or severe acute illness (with or without fever) generally should be deferred until they have recovered from the acute phase of the illness. Manufacturer of PPSV23 (Pneumovax 23) states to defer vaccination in individuals with moderate or severe illness. Manufacturer of PPSV23 (Pneumovax 23) states to administer with caution in individuals with severely compromised cardiovascular and/or pulmonary function in whom a systemic reaction could pose a substantial risk. May not protect all vaccine recipients against pneumococcal disease. Will not prevent pneumococcal infection caused by S. pneumoniae serotypes not represented in the vaccines. Primary immunization with the usually recommended age-appropriate vaccination regimen before an expected exposure to pneumococcal infection ensures the highest level of protection. The manufacturer of PCV13 (Prevnar 13 ) states that effectiveness of the vaccine has not been established in premature infants, children with sickle cell disease, individuals with hematopoietic stem cell transplant, or in adults with HIV infection. The manufacturer of PCV15 (Vaxneuvance ) states that effectiveness of the vaccine has not been established in premature infants, children with sickle cell disease, and children and adults with HIV infection. Although ACIP and AAP recommend use of PPSV23 (Pneumovax 23) in individuals with CSF leaks, the manufacturer states the vaccine may not be effective in preventing pneumococcal meningitis in patients with chronic CSF leakage resulting from congenital lesions, skull fractures, or neurosurgical procedures. Improper storage or handling of vaccines may reduce vaccine potency resulting in reduced or inadequate immune responses in vaccinees. Inspect all vaccines upon delivery and monitor during storage to ensure that the appropriate temperature is maintained. Do not administer vaccine that has been mishandled or has not been stored at the recommended temperature. Data are insufficient to date regarding use of pneumococcal vaccines in pregnant women to inform vaccine-associated risks during pregnancy. ACIP states the safety of pneumococcal polysaccharide vaccine and PCV13 during the first trimester of pregnancy has not been evaluated, although no adverse consequences have been reported among newborns whose mothers were inadvertently vaccinated during pregnancy. ACIP, AAP, and others state PPSV23 (Pneumovax 23) may be used when indicated in pregnant women at increased risk for pneumococcal disease. ACIP has not addressed pregnancy recommendations for PCV15 or PCV20 at this time. AAP states that pneumococcal vaccination generally should be deferred during pregnancy, but risk of severe pneumococcal disease in a pregnant woman who has not received PPSV23 (Pneumovax 23) within the previous 5 years and has underlying medical conditions that increase risk of invasive pneumococcal disease should prompt immunization with PPSV23 (Pneumovax ) 23. Not known whether antigens contained in PCV13 (Prevnar 13 ), PCV15 (Vaxneuvance ), PCV20 (Prevnar 20 ), or PPSV23 (Pneumovax 23) are distributed into milk. Consider the developmental and health benefits of breastfeeding along with the mother’s clinical need for vaccination and any potential adverse effects on the breastfed child from the vaccine or underlying maternal condition (susceptibility to disease prevented by the vaccine). Because inactivated vaccines do not multiply within the body, ACIP states they should not pose any unusual problems for lactating women or their infants. PCV13 (Prevnar 13 ) and PCV15 (Vaxneuvance ): Safety and efficacy not established in infants <6 weeks of age. Manufacturer of PCV13 (Prevnar 13 ) states immune response to the vaccine in preterm infants not adequately studied to date. Manufacturer of PCV15 (Vaxneuvance ) states the immune responses and safety profile in preterm infants receiving a 4-dose series were similar to those observed in term infants in clinical studies. Safety and efficacy of PCV20 (Prevnar 20 ) not been established in individuals <18 years of age. PPSV23 (Pneumovax 23): Safety and efficacy not established in children <2 years of age. Children <2 years of age may not have a satisfactory antibody response to PPSV23 (Pneumovax 23). PCV13 (Prevnar 13 ): Antibody responses in adults ≥65 years of age are lower compared with those in adults 50–59 years of age; no overall differences in safety between adults ≥65 years of age compared to adults 50–59 years of age. PPSV23 (Pneumovax 23): Rate of vaccine-related systemic adverse effects was higher following revaccination than primary vaccination in those ≥65 years of age. Possibility that some older adults may exhibit increased frequency and/or greater severity of adverse reactions cannot be ruled out. PCV15 (Vaxneuvance ): No clinically meaningful differences in the safety profile or immune responses observed in older individuals (65–74 years and ≥75 years of age) when compared to younger individuals. PCV20 (Prevnar 20 ): Prevnar 20 recipients 70–79 years of age and ≥80 years of age had lower antibody responses for all pneumococcal serotypes compared to Prevnar 20 recipients 18–49, 50–59, and 60–64 years of age.

Allergic reactions, including anaphylactic/anaphylactoid reactions, rash, urticaria, bronchospasm, facial edema, erythema multiforme, and angioedema, reported with pneumococcal vaccines. Take all known precautions to prevent adverse reactions, including review of the patient’s history with respect to health status and possible sensitivity to the vaccine or similar vaccines. Epinephrine and other appropriate agents should be readily available in case anaphylaxis or other serious allergic reaction occurs. May be administered to individuals immunosuppressed as the result of disease or immunosuppressive therapy. Consider possibility that immune response to vaccines may be diminished or suboptimal in these individuals. If possible, administer pneumococcal vaccine at least 2 weeks prior to initiation of immunosuppressive therapy or defer until at least 3 months after immunosuppressive therapy is discontinued or at least 6 months following therapy with anti-B cell agents. Since antibody response may be impaired after splenectomy, ACIP and AAP recommend that vaccination with pneumococcal vaccines be completed at least 2 weeks prior to elective splenectomy, if possible. Apnea observed in some premature infants following IM vaccination with PCV13 (Prevnar 13 ) and PCV15 (Vaxneuvance ). Consider individual infant’s medical status and the potential benefits and possible risks of vaccination when deciding when to administer an IM vaccine. A decision to administer or delay administration of vaccination in an individual with a current or recent acute illness depends on the severity of symptoms and etiology of the illness. ACIP, AAP, and others state that minor acute illness, such as mild diarrhea or mild upper respiratory infection (with or without fever), usually does not preclude vaccination. However, vaccination of individuals with moderate or severe acute illness (with or without fever) generally should be deferred until they have recovered from the acute phase of the illness. Manufacturer of PPSV23 (Pneumovax 23) states to defer vaccination in individuals with moderate or severe illness. Manufacturer of PPSV23 (Pneumovax 23) states to administer with caution in individuals with severely compromised cardiovascular and/or pulmonary function in whom a systemic reaction could pose a substantial risk. May not protect all vaccine recipients against pneumococcal disease. Will not prevent pneumococcal infection caused by S. pneumoniae serotypes not represented in the vaccines. Primary immunization with the usually recommended age-appropriate vaccination regimen before an expected exposure to pneumococcal infection ensures the highest level of protection. The manufacturer of PCV13 (Prevnar 13 ) states that effectiveness of the vaccine has not been established in premature infants, children with sickle cell disease, individuals with hematopoietic stem cell transplant, or in adults with HIV infection. The manufacturer of PCV15 (Vaxneuvance ) states that effectiveness of the vaccine has not been established in premature infants, children with sickle cell disease, and children and adults with HIV infection. Although ACIP and AAP recommend use of PPSV23 (Pneumovax 23) in individuals with CSF leaks, the manufacturer states the vaccine may not be effective in preventing pneumococcal meningitis in patients with chronic CSF leakage resulting from congenital lesions, skull fractures, or neurosurgical procedures. Improper storage or handling of vaccines may reduce vaccine potency resulting in reduced or inadequate immune responses in vaccinees. Inspect all vaccines upon delivery and monitor during storage to ensure that the appropriate temperature is maintained. Do not administer vaccine that has been mishandled or has not been stored at the recommended temperature. Data are insufficient to date regarding use of pneumococcal vaccines in pregnant women to inform vaccine-associated risks during pregnancy. ACIP states the safety of pneumococcal polysaccharide vaccine and PCV13 during the first trimester of pregnancy has not been evaluated, although no adverse consequences have been reported among newborns whose mothers were inadvertently vaccinated during pregnancy. ACIP, AAP, and others state PPSV23 (Pneumovax 23) may be used when indicated in pregnant women at increased risk for pneumococcal disease. ACIP has not addressed pregnancy recommendations for PCV15 or PCV20 at this time. AAP states that pneumococcal vaccination generally should be deferred during pregnancy, but risk of severe pneumococcal disease in a pregnant woman who has not received PPSV23 (Pneumovax 23) within the previous 5 years and has underlying medical conditions that increase risk of invasive pneumococcal disease should prompt immunization with PPSV23 (Pneumovax ) 23. Not known whether antigens contained in PCV13 (Prevnar 13 ), PCV15 (Vaxneuvance ), PCV20 (Prevnar 20 ), or PPSV23 (Pneumovax 23) are distributed into milk. Consider the developmental and health benefits of breastfeeding along with the mother’s clinical need for vaccination and any potential adverse effects on the breastfed child from the vaccine or underlying maternal condition (susceptibility to disease prevented by the vaccine). Because inactivated vaccines do not multiply within the body, ACIP states they should not pose any unusual problems for lactating women or their infants. PCV13 (Prevnar 13 ) and PCV15 (Vaxneuvance ): Safety and efficacy not established in infants <6 weeks of age. Manufacturer of PCV13 (Prevnar 13 ) states immune response to the vaccine in preterm infants not adequately studied to date. Manufacturer of PCV15 (Vaxneuvance ) states the immune responses and safety profile in preterm infants receiving a 4-dose series were similar to those observed in term infants in clinical studies. Safety and efficacy of PCV20 (Prevnar 20 ) not been established in individuals <18 years of age. PPSV23 (Pneumovax 23): Safety and efficacy not established in children <2 years of age. Children <2 years of age may not have a satisfactory antibody response to PPSV23 (Pneumovax 23). PCV13 (Prevnar 13 ): Antibody responses in adults ≥65 years of age are lower compared with those in adults 50–59 years of age; no overall differences in safety between adults ≥65 years of age compared to adults 50–59 years of age. PPSV23 (Pneumovax 23): Rate of vaccine-related systemic adverse effects was higher following revaccination than primary vaccination in those ≥65 years of age. Possibility that some older adults may exhibit increased frequency and/or greater severity of adverse reactions cannot be ruled out. PCV15 (Vaxneuvance ): No clinically meaningful differences in the safety profile or immune responses observed in older individuals (65–74 years and ≥75 years of age) when compared to younger individuals. PCV20 (Prevnar 20 ): Prevnar 20 recipients 70–79 years of age and ≥80 years of age had lower antibody responses for all pneumococcal serotypes compared to Prevnar 20 recipients 18–49, 50–59, and 60–64 years of age.

25 ug (25 (25)) As recommended. IM — (or 0.5 ml) . Same dose for children over 2 years of age

25 ug (25 (25)) As recommended. Intra Muscular — As Required 25 ug (25 (25)) As recommended. Subcutaneous — As Required

( ) — Not recommended in this age group

No data regarding the interactions of Pneumococcal Vaccine was found.

SC Inj, IM Inj Store in refrigerator. Do not Freeze. Protect from Sunlight.