Pneumococcal Vaccines July 2023
The U.S. Food and Drug Administration (FDA) has approved two types of vaccines to prevent pneumococcal disease; the Pneumococcal conjugate vaccine and the Pneumococcal polysaccharide vaccine (PPSV23). Pneumococcal vaccines prevent pneumococcal disease caused by Streptococcus pneumoniae, a bacterium with more than 90 serotypes. While vaccines can not prevent every kind of community-acquired pneumonia, they work against the thirty most common bacteria types. According to Prophecy Market Insights, in May 2023, the Pneumococcal Vaccine Market is anticipated to register a ten-year CAGR of 5.3%.
Pneumococcal Vaccine Recommendations U.S. CDC
The U.S. Centers for Disease Control and Prevention (CDC) Advisory Committee on Immunization Practices (ACIP) met on June 22, 2023, to review presentations: Economic Assessment of Routine PCV20 for Children; Summary of three economic analyses of the use of the 20-valent pneumococcal conjugate vaccine (PCV20) in children in the U.S.; Evidence to Recommendations Framework and Policy Options: Use of 20-valent Pneumococcal Conjugate Vaccine in U.S. Children.
The JAMA Network published a Research Letter on July 3, 2023: Reports of Injection Site Necrosis After 23-Valent Pneumococcal Vaccine Use. Injection-site necrosis reporters were filed following Pneumovax 23 vaccine administration.
On February 22, 2023, Katherine A. Poehling, MD, MPH Pneumococcal Vaccines Work Group Chair, led the following presentations: Current Epidemiology of Pediatric Pneumococcal Disease, Pediatric outpatient ARI visits and antibiotic use attributable to serotypes in higher valency PCVs, Pfizer's 20 -valent Pneumococcal Conjugate Vaccine (PCV20) Phase 3 in Pediatrics, Evidence to Recommendations Framework (Preliminary): Use of 20-valent Pneumococcal Conjugate Vaccine in U.S. Children, Pneumococcal Vaccines Work Group Considerations and Next Steps.
On October 19, 2022, and reviewed the following presentations: Introduction; Economic Assessment of PCV20 for Adults Vaccinated with PCV13; Evidence to Recommendations Framework: PCV20 Use among Adults who Previously Received PCV13; Updates to Clinical Guidance. On June 22, 2022, the ACIP committee presented the following information: PCV15 Pediatric Clinical Development Program – Dr. N Banniettis; Economic analysis and public health impact of PCV15 use among children in the U.S. - Dr. A Leidner; Summary of W.G. interpretation on EtR and Proposed recommendations for PCV15 use in children by Dr. M Kobayashi. Furthermore, the CDC recommends that all adults 65 years and older and adults with underlying medical conditions receive one dose of PCV15 or one dose of PCV20. On September 16, 2022, the CDC published: Use of 15-Valent Pneumococcal Conjugate Vaccine Among U.S. Children: Updated Recommendations of the ACIP — the United States, 2022.
The U.S. CDC's pneumococcal vaccine schedules were updated in February 2023.
Pneumococcal Vaccines Approved
Pneumovax 23™ is a vaccine that protects against infection by 23 types of pneumococcal bacteria, common and often cause serious illnesses. Pneumovax23 is used in adults 19 and older. It is also used in children two or older with underlying medical conditions.
Prevnar 20® is a newly approved vaccine indicated for active immunization for the prevention of pneumonia and invasive disease caused by Streptococcus pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 8, 9V, 10A, 11A, 12F, 14, 15B, 18C, 19A, 19F, 22F, 23F, and 33F in adults 18 years of age and older.
Prevnar 13® is a vaccine that protects against invasive disease caused by Streptococcus pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F.
VAXNEUVANCE™ is a 15-valent pneumococcal conjugate vaccine. The U.S. FDA approved VAXNEUVANCE (Pneumococcal 15-valent Conjugate Vaccine) 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, 22F, 23F and 33F in adults 18 years of age and older on July 16, 2021. The E.C. issued its initial authorization for adults on December 15, 2021, and minors on October 24, 2022.
Synflorix PCV10 is a decavalent vaccine containing ten serotypes of pneumococcus conjugated to a carrier protein produced by GlaxoSmithKline. Synflorix received a positive opinion from the European Medicines Agency for use in the European Union in January 2009.
Sinovac PPV23 is a Chinese vaccine that protects against infection by 23 types of pneumococcal bacteria in adults and children ages two and older.
Serum Institute of India PNEUMOSIL is a PCV, adsorbed, 10 Valent, a well-designed vaccine with relevant serotypes and provides comparable protection by targeting the most prevalent serotypes bacterium causing severe illness in developing countries. PNEUMOSIL is approved for use in infants and toddlers from 6 weeks to 2 years of age, conducting phase 3 studies.
Pneumococcal Vaccine Candidates
Vaxcyte Inc. VAX-24 is a 24-valent investigational pneumococcal conjugate vaccine to prevent invasive pneumococcal disease and pneumonia.
Merck's 21-valent pneumococcal conjugate vaccine candidate V116 is designed to prevent IPD and pneumococcal pneumonia caused by 21 Streptococcus pneumoniae serotypes. The broad Phase 3 clinical program for V116 in vaccine-naïve and vaccine-experienced adults will start in July 2022.
Affinivax, Inc. and Astellas Pharma Inc. - ASP3772, a novel vaccine candidate, targets Streptococcus pneumoniae. ASP3772 offers B-cell (antibody) and T-cell immune protection against Streptococcus pneumoniae. In addition, ASP3772 includes 24 pneumococcal polysaccharides, as well as two conserved pneumococcal proteins. The U.S. Food and Drug Administration has also granted Breakthrough Therapy designation for ASP3772 to prevent pneumonia and invasive disease caused by Streptococcus pneumoniae serotypes included in ASP3772 in adults aged 50 years older.
Inventprise IVT-PCV-25 is an investigational 25 valent PCV designed to include the key strains that cause serious invasive diseases in children. IVT-PCV-25 is being developed by Inventprise in collaboration with the non-profit global health organization PATH.
Note: This content is reviewed by healthcare professionals such as Dr. Robert Carlson.
