Pneumococcal Vaccines For 2023
The U.S. Food and Drug Administration (FDA) has approved two types of vaccines to prevent pneumococcal disease; Pneumococcal conjugate vaccines (PCV13, PCV15, PCV20) 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.
U.S. CDC Pneumoccoal Vaccine Recommendations
The U.S. Centers for Disease Control and Prevention (CDC) Advisory Committee on Immunization Practices (ACIP) met 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 on February 17, 2022. All children younger than five years old and 5 -18 with certain medical conditions that increase their risk of pneumococcal disease should receive PCV13 or PCV15. Children 2-18 years old with underlying medical conditions should also receive PPSV23. When both PCV13/PCV15 and PPSV23 are indicated, the two vaccines should not be administered simultaneously. Adults who have never received a pneumococcal conjugate vaccine should receive PCV15 or PCV20 if they are 65 years and older or if they are 19-64 and have certain medical conditions or other risk factors. If PCV15 is used, it should be followed by a dose
On October 20, 2021, the ACIP recommended PCV15 or PCV20 for PCV–naïve adults who are either aged ≥65 years or aged 19–64 years with certain underlying conditions. When PCV15 is used, it should be followed by a dose of PPSV23, typically ≥1 year later. In January 2022, the CDC confirmed eligible adults may receive either PCV15 in series with PPSV23 or PCV20 alone.
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 and older with certain 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. Prevnar 13 is used in children six weeks to 18 years of age.
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 serious illness in developing countries. PNEUMOSIL is approved for use in infants and toddlers from 6 weeks to 2 years of age and is conducting phase 3 studies.
Pneumococcal Vaccine Candidates
Pfizer's 20vPnC pediatric vaccine candidate includes 13 serotypes already included in Prevnar 13® – 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F. The seven new serotypes included in 20vPnC are global causes of invasive pneumococcal disease (IPD) and are associated with high case-fatality rates, antibiotic resistance, and/or meningitis. On January 6, 2023, the U.S. FDA accepted a supplemental Biologics License Application for the 20vPnC vaccine candidate for priority review.
Vaxcyte VAX-24 is a 24-valent investigational pneumococcal conjugate vaccine to prevent invasive pneumococcal disease and pneumonia announced on Oct. 24, 2022, positive topline results from the Phase 1/2 clinical proof-of-concept study evaluating the safety, tolerability, and immunogenicity of VAX-24 in healthy adults aged 18-64. All 20 VAX-24 Serotypes Common with PCV20 Met Standard OPA Response Non-Inferiority Criteria, of Which 16 Achieved Higher Immune Responses at 2.2mcg VAX-24 Dose. On January 5, 2023, the FDA awarded Breakthrough Therapy Designation.
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 is planned to 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.
Pneumococcal Vaccine Market
The global Pneumococcal Conjugate Vaccine (PCV) and Pneumococcal Polysaccharide Vaccine (PPSV/PPV) market is expected to reach about US$13 billion by 2030.
Pneumococcal Vaccine News 2023
January 11, 2023 - The Lancet published a phase 3 study that concluded Serum Institute of India Pvt. Ltd.-PCV vaccine was safe and immunogenic when given to infants in The Gambia according to a 2 + 1 schedule. This PCV is expected to provide similar protection against invasive and mucosal pneumococcal disease to the protection provided by PCV13 and PHiD-CV, for which effectiveness data are available. This trial was registered with the Pan African Clinical Trials Registry, PACTR201907754270299.
January 5, 2023 - "The FDA's Breakthrough Therapy designation supports the further acceleration of the VAX-24 development program in adults while also providing validation of the potential of VAX-24 to deliver broader coverage and better immune responses relative to the standard of care," said Grant Pickering, Chief Executive Officer and Co-Founder of Vaxcyte.
November 10, 2022 - Inventprise announced that a Phase 1/2 clinical study of its 25-valent pneumococcal conjugate vaccine (IVT PCV-25) has begun in Halifax, Canada. This first-in-human study is an essential step in the efforts to develop an affordable, expanded-coverage pneumococcal conjugate vaccine (PCV). This vaccine is designed to prevent pneumococcal disease caused by serotypes not covered in the current vaccines and to protect people globally, including in low- and middle-income regions where the disease burden is greatest.
October 24, 2022 - Vaxcyte, Inc. announced positive topline results from the Phase 1/2 clinical proof-of-concept study. All 4 Serotypes Unique to VAX-24 Exceeded Standard Superiority Criteria. The study also demonstrated that VAX-24 met or exceeded the established regulatory immunogenicity standards for all 24 serotypes at the conventional 2.2mcg dose, which the Company intends to move forward into a pivotal Phase 3 program. In addition, at this dose, VAX-24 met the standard opsonophagocytic activity response non-inferiority criteria for all 20 serotypes common with PCV20, of which 16 achieved higher immune responses.
September 19, 2022 - Pfizer announced positive pivotal topline data demonstrating that 20vPnC, if approved, can likely help protect against all 20 vaccine serotypes in three-dose series and potentially offer the broadest serotype coverage of any available PCV. The 20vPnC also showed robust functional antibody responses to the vaccine serotypes post Dose 2 and 3, similar to Prevenar® and Prevenar 13®.
September 16, 2022 - Merck announced today that the European Medicines Agency's Committee for Medicinal Products for Human Use recommended the approval of VAXNEUVANCE™ for active immunization for the prevention of invasive disease, pneumonia, and acute otitis media caused by Streptococcus pneumoniae in infants, children and adolescents from 6 weeks to less than 18 years of age.
August 12, 2022 - Pfizer Inc. announced positive topline results from its pivotal U.S. Phase 3 study (NCT04382326) in infants evaluating its 20-valent pneumococcal conjugate vaccine candidate. The 20vPnC elicited robust immune responses to all 20 serotypes meeting the statistical non-inferiority criteria for the co-primary objective after Dose 4 and demonstrating a favorable safety and tolerability profile similar to Prevnar 13®.
July 28, 2022 - Merck confirmed the U.S. CDC Advisory Committee on Immunization Practices Unanimously Voted to Provisionally Recommend the Use of Merck's VAXNEUVANCE as an Option for Pneumococcal Vaccination in Infants and Children and announced Positive Results From a Phase 1/2 Study for V116, Merck's Investigational Pneumococcal 21-Valent.
July 21, 2022 - Pfizer Canada ULC announced that PREVNAR 20 is now available in Canada to prevent pneumonia and invasive pneumococcal disease (including sepsis, meningitis, bacteremic pneumonia, pleural empyema, and bacteremia) caused by the 20 Streptococcus pneumoniae serotypes in the vaccine in adults.
June 21, 2022 - Merck presented positive results from the Phase 1/2 study for V116, Merck's investigational Pneumococcal 21-Valent Conjugate Vaccine designed to target serotypes that account for 85% of all invasive pneumococcal diseases in U.S. adults 65 years and older as of 20193, and enrolled the first patient into the Phase 3 STRIDE-3 trial evaluating V116 in vaccine-naïve adults. V116 contains eight serotypes not included in any currently licensed pneumococcal vaccine.
June 21, 2022 - Merck announced the presentation of positive results from the Phase 1/2 study, V116-001, evaluating the safety, tolerability, and immunogenicity of V116, the Company's investigational 21-valent PCV, in pneumococcal vaccine-naïve adults 18-49 years of age (Phase 1) and 50 years of age and older (Phase 2).
June 1, 2022 - Researchers at Karolinska Institutet in Stockholm identified a new vaccine candidate against pneumococci bacteria. The vaccine molecules comprise nano-sized membrane vesicles produced by the bacteria and provide protection in mice, a new study published in PNAS. The study shows that pneumococcal membrane particles evoke a serotype-independent cross-protection against invasive pneumococcal disIn addition, thee.
May 31, 2022 - GSK announced that it has entered into a definitive agreement to acquire Affinivax, Inc. The proposed acquisition provides GSK access to a next-generation 24-valent pneumococcal vaccine candidate (AFX3772) currently in phase II development and highly innovative MAPSTM technology.
May 10, 2022 - Inventprise announced the inauguration of its new manufacturing facility for a high-capacity supply of a 25-valent Pneumococcal Conjugate Vaccine (IVT-PCV-25) for low- and middle-income countries.
April 26, 2022 - BMJ Journals published - Respiratory infection, Original Research in Japan (Observational study): High prevalence of multiple pneumococci serotypes in pneumonia patients and their associated risk factors. Conclusions Multiple serotypes of pneumococci are common in the sputum of adult patients with pneumonia. However, the risk of multiple-serotype pneumococcal pneumonia is lower than single-serotype pneumococcal pneumonia among PPSV23-vaccinated patients.
April 14, 2022 - Merck announced the investigational 21-valent pneumococcal conjugate vaccine V116 had received Breakthrough Therapy Designation from the U.S. FDA. As a result, phase 3 clinical trials for V116 will be initiated later in 2022. The FDA's decision was informed by data from a two-part randomized, comparator-controlled, double-blind Phase 1/2 study, V116-001.
April 1, 2022 - Merck announced that the U.S. FDA extended the Prescription Drug User Fee Act date of the supplemental biologics license application for VAXNEUVANCE in infants and children to July 1, 2022. The FDA has requested no new studies.
March 22, 2022 - The Annals of Internal Medicine reported Original Research - Risk for Shoulder Conditions After Vaccination: A Population-Based Study Using Real-World Data - Among 3.7 million administered vaccinations, the incidence rate was 1.22 (CI, 1.10 to 1.35) for the adult (aged ≥18 years) and 0.05 (CI, 0.02 to 0.14) for the pediatric (3 to 17 years) vaccinated populations. Conclusion: These population-based data suggest a small absolute risk for shoulder conditions after vaccination.
February 25, 2022 - The Journal of the American Geriatrics Society published a Clinical Investigation: U.S. nursing home (N.H.) residents receiving PCV13 in the SNF by recorded pneumococcal vaccination up-to-date status, 2014–2018. Of the 1,459,814 residents recorded as 'not up-to-date,' (78.2%) had no Part B claims for PCV13 before or in N.H., most of whom (71.5%) were reported to have refused the vaccine when offered.
February 24, 2022 - Miwako Kobayashi, MD, MPH, CDC's ACIP Pneumococcal Vaccines Work Group, presented: Next Steps for the Pneumococcal Vaccines Work Group.
February 15, 2022 - Pfizer Inc. announced that the European Medicines Agency approved the Company's 20-valent pneumococcal conjugate vaccine, which will be marketed under the brand name APEXXNAR. Additionally, the vaccine is approved for active immunization to prevent invasive disease and pneumonia caused by Streptococcuspneumoniae in individuals 18 years of age and older.
February 8, 2022 - Pfizer, Inc. confirmed Prevnar / Prevenar 13 & 20 sales decreased 25% during 2021, driven by a 27% decline in the U.S. primarily due to unfavorable timing of government purchases for the pediatric indication and disruptions to healthcare activity, and a 24% operational decline internationally primarily due to the impact of increased adult uptake in the prior-year period from greater vaccine awareness for respiratory illnesses.
December 15, 2021 - Merck announced today the European Commission had approved VAXNEUVANCE™ for adults.
November 10, 2021 - Inventprise announced an investment of up to $90 million to advance its 25-valent pneumococcal conjugate vaccine candidate into proof-of-concept clinical trials
October 15, 2021 - Merck announced that the European Medicines Agency's Committee for Medicinal Products for Human Use had recommended the approval of VAXNEUVANCE™.
August 3, 2021 - The journal PLOS published a RESEARCH ARTICLE: Levels of pneumococcal conjugate vaccine coverage and indirect protection against invasive pneumococcal disease and pneumonia hospitalizations in Australia: An observational study.
July 16, 2021 - Introducing the pneumococcal conjugate vaccine to routine childhood vaccination in The Gambia reduced severe infections associated with pneumococcal disease, according to new research published in The Lancet Infectious Diseases.
July 13, 2021 - Affinivax, Inc. and Astellas Pharma Inc. announced results from the Phase 2 clinical trial of ASP3772, a novel vaccine candidate targeting Streptococcus pneumoniae. The results from the Phase 2 clinical trial demonstrated that ASP3772 was well tolerated.
June 8, 2021 - Pfizer Inc. announced today that the U.S. Food and Drug Administration approved PREVNAR 20™ for the prevention of invasive disease and pneumonia caused by the 20 Streptococcus pneumoniae serotypes in the vaccine in adults ages 18 years and older.
April 6, 2021 - The Serum Institute of India confirmed it would start supplying 2.4 crore doses of the first indigenously developed pneumococcal conjugate vaccine, PNEUMOSIL to the Centre by December 2021.
February 16, 2021 - PLOS published RESEARCH ARTICLE: Estimated impact of the pneumococcal conjugate vaccine on pneumonia mortality in South Africa, 1999 through 2016: An ecological modeling study. This study found that the introduction of PCV was associated with a substantial reduction in all-cause pneumonia deaths in children aged one month to <19 years. In addition, the model predicted an effect of PCV in age groups eligible for vaccination (1 month to 4 years) and an indirect effect in those too old (8 to 18 years) to be vaccinated. These findings support sustaining pneumococcal vaccination to reduce pneumonia-related mortality in children.
January 28, 2021 - The Lancet study: Immunogenicity and safety of a novel ten-valent pneumococcal conjugate vaccine in healthy infants in The Gambia: a phase 3, randomized, double-blind, non-inferiority trial. Interpretation: The immunogenicity of SIIPL-PCV was non-inferior to that of PHiD-CV, for which efficacy and effectiveness data against pneumococcal disease are available. The vaccine is safe and can be coadministered with routine EPI vaccines. The data generated in this trial have supported the licensure and pre-qualification of SIIPL-PCV, making the vaccine available for introduction into national immunization programs. Generating post-implementation data confirming vaccine impact remains important.
January 9, 2021 - Beijing-based Sinovac Biotech Ltd. announced that the China National Medical Products Administration has approved and issued a Product license for the Company's 23-Valent Pneumococcal Polysaccharide Vaccine to prevent the infection by streptococcus pneumonia in adults and children ages 2 years old and above.
December 28, 2020 - Serum Institute of India announced the launch of India's first indigenously developed pneumococcal vaccine – PNEUMOSIL®.
December 9, 2020 - Sinovac Biotech Ltd. announced that the China National Medical Products Administration has approved and issued a Product license for the Company's 23-Valent Pneumococcal Polysaccharide Vaccine to prevent streptococcus pneumonia infections in adults and children ages 2 years old and above.
September 30, 2020 - Study: A seven-year nationwide matched cohort study, the impact of 23‐valent pneumococcal polysaccharide vaccination on the frequency of pneumonia‐related hospitalization and survival in elderly patients with prostate cancer.
September 27, 2020 - Study: Pneumococcal vaccine uptake and vaccine effectiveness in older adults with invasive pneumococcal disease in Germany.
September 25, 2020 - A multicentre, retrospective observational study is the direct effect of pneumococcal conjugate vaccines on the invasive pneumococcal disease in children in the Latin American and Caribbean region (SIREVA 2006–17).
August 25, 2020 - The Lancet published: Assessing reduced-dose pneumococcal vaccine schedules in South Africa.
August 25, 2020 - Immunogenicity of a single-dose compared with a two-dose primary series followed by a booster dose of ten-valent or 13-valent pneumococcal conjugate vaccine in South African children: an open-label, randomized, non-inferiority trial - The non-inferiority in post-booster immune responses following a single-dose compared with a 2-dose primary series of PCV13 or PCV10 indicates the potential for reducing PCV dosing schedules from a 2 + 1 to 1 + 1 series in low-income and middle-income settings with well-established PCV immunization programs.
July 31, 2020 - Study: Can Flu and Pneumonia Vaccines Prevent Alzheimer's Disease?
July 28, 2020 - The protective effect of pneumococcal vaccination on cardiovascular disease in adults: A systematic review and meta-analysis. The 23-valent polysaccharide pneumococcal vaccine protects against adverse cardiovascular events, including heart attacks and congestive heart failure, according to a meta-analysis of 18 studies published in the International Journal of Infectious Diseases.
July 20, 2020 - The Lancet study: Invasive pneumococcal disease incidence in children and adults in France during the pneumococcal conjugate vaccine era: an interrupted time-series analysis of data 17-year national prospective surveillance study.
July 13, 2020 - The risk for invasive pneumococcal disease increases when contracting influenza, but could be lessened in high humidity environments, according to a study involving approximately 20,000 individuals in 3 countries, reported JAMA.
January 23, 2020 - Exposure to diesel exhaust particles linked to pneumococcal disease susceptibility.
Note: This content is reviewed by healthcare professionals such as Dr. Robert Carlson.