Prevenar 13

Indications and Usage for Prevnar 13 Children 6 Weeks Through 5 Years of Age In children 6 weeks through 5 years of age (prior to the 6 th birthday), Prevnar 13 ® is indicated for: • active immunization for the prevention of invasive disease caused by Streptococcus pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F. • active immunization for the prevention of otitis media caused by S. pneumoniae serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F. No otitis media efficacy data are available for serotypes 1, 3, 5, 6A, 7F, and 19A. Children 6 Years Through 17 Years of Age In children 6 years through 17 years of age (prior to the 18 th birthday), Prevnar 13 is indicated for: • active immunization for the prevention of invasive disease caused by S. pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F. Adults 18 Years of Age and Older In adults 18 years of age and older, Prevnar 13 is indicated for: • active immunization for the prevention of pneumonia and invasive disease caused by S. pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F. Limitations of Prevnar 13 Use and Effectiveness • Prevnar 13 does not protect against disease caused by S. pneumoniae serotypes that are not in the vaccine. Prevnar 13 Dosage and Administration Preparation for Administration Since this product is a suspension containing an adjuvant, shake vigorously immediately prior to use to obtain a homogenous, white suspension in the vaccine contai...

Many primary care physicians may find it impractical to have this nuanced discussion with so many other preventive care and chronic disease management topics to address in a typical office visit. In addition, risk-based approaches to pneumococcal vaccination in younger adults have been complex and may be a contributing factor to suboptimal uptake in this population. Prior risk-based approaches included different recommendations for patients with immunosuppressing or chronic medical conditions. With the 2021 approval of PCV15 (Vaxneuvance) and PCV20 (Prevnar 20), the ACIP has greatly simplified pneumococcal vaccination recommendations. PCV15 and PCV20 are conjugate vaccines that provide durable protection because of a T cell–dependent mechanism of action and resulting memory B cell formation that provide mucosal immunity. In contrast, PPSV23, a capsular polysaccharide vaccine that induces an immune response via release of immunoglobulin from B cells, does not result in mucosal immunity, and protection wanes over five to six years. Compared with the PCV13 vaccine, the PCV15 and PCV20 vaccines cover additional strains that cause about 15% and 27% of invasive pneumococcal disease in patients 65 years or older and 13% and 28% of disease in patients 19 to 64 years of age with underlying conditions, repectively. The ACIP has removed distinctions among people with chronic medical conditions, immunocompromising conditions, or underlying conditions (e.g., cochlear implants, cerebros...

11 DESCRIPTION Prevnar 13, Pneumococcal 13-valent Conjugate Vaccine (Diphtheria CRM 197 Protein) is a sterile suspension of saccharides of the capsular antigens of Streptococcus pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F, individually linked to non-toxic diphtheria CRM 197 protein. Each serotype is grown in soy peptone broth. The individual polysaccharides are purified through centrifugation, precipitation, ultrafiltration, and column chromatography. The polysaccharides are chemically activated to make saccharides, which are directly conjugated by reductive amination to the protein carrier CRM 197, to form the glycoconjugate. CRM 197 is a nontoxic variant of diphtheria toxin isolated from cultures of Corynebacterium diphtheriae strain C7 (β197) grown in a casamino acids and yeast extract-based medium or in a chemically-defined medium. CRM 197 is purified through ultrafiltration, ammonium sulfate precipitation, and ion-exchange chromatography. The individual glycoconjugates are purified by ultrafiltration and column chromatography and analyzed for saccharide to protein ratios, molecular size, free saccharide, and free protein. The individual glycoconjugates are compounded to formulate Prevnar 13. Potency of the formulated vaccine is determined by quantification of each of the saccharide antigens and by the saccharide to protein ratios in the individual glycoconjugates. Each 0.5 mL dose of the vaccine is formulated to contain approximately 2....

Pfizer Inc. (NYSE:PFE) today announced that Prevnar 13 ® (Pneumococcal 13-valent Conjugate Vaccine [Diphtheria CRM197 Protein]) received U.S. Food and Drug Administration (FDA) approval for an expanded age indication to include adults 18 through 49 years of age, in addition to the already approved indication for adults 50 years and older, for active immunization for the prevention of pneumonia and invasive disease caused by 13 Streptococcus pneumoniae (S. pneumoniae) serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F). Prevnar 13 is the only pneumococcal vaccine approved across the lifespan. With today’s decision Prevnar 13 is approved for: • Adults 18 years of age and older for the prevention of pneumococcal pneumonia and invasive disease caused by 13 Streptococcus pneumoniae strains in the vaccine • Children 6 weeks through 17 years of age (prior to the 18th birthday) for the prevention of invasive disease caused by 13 Streptococcus pneumoniae strains in the vaccin The expanded age indication now more closely aligns with the 2012 U.S. Centers for Disease Control and Prevention’s Advisory Committee on Immunizations Practices (ACIP) recommendations for adults 19 years of age and older with immunocompromising conditions (e.g., HIV, chronic renal failure, cancer), functional or anatomic asplenia (e.g., sickle cell disease), cerebral spinal fluid leak, and Cochlear implants. This is in addition to recommendations set forth by ACIP in 2014 for adults 65 years an...

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