Pneumococcal vaccines prevent pneumococcal disease caused by Streptococcus pneumoniae, a bacterium with more than 90 serotypes. A few of these serotypes produce the most invasive pneumococcal disease, says the U.S. CDC. The CDC's Advisory Committee on Immunization Practices vaccine recommendations is published on this webpage.
Although pneumococcal conjugate vaccines may reduce the incidence of pneumococcal infections, the immune protection conferred by the pneumococcal conjugate vaccines is serotype-specific, says the CDC.
On September 29, 2021, the ACIP reviewed pneumococcal vaccine presentation by Katherine A. Poehling, M.D.; Summary of three economic models assessing pneumococcal vaccines in U.S. adults, presented by Andrew J. Leidner; and Evidence to Recommendation Framework: Risk-based Use of 15-valent and 20-valent Pneumococcal Conjugate Vaccines in Adults presented by Miwako Kobayashi, M.D., MPH.
And on October 20, 2021, the ACIP committee reviewed Katherine A. Poehling, M.D., MPH., Pneumococcal Vaccines Work Group Chair's presentation overview; and Miwako Kobayashi, M.D., MPH, Considerations for Age-Based and Risk-Based Use of PCV15 and PCV20 among U.S. Adults and Proposed Policy Options.
Pneumococcal Vaccines Approved
Pneumovax 23 is a vaccine that protects against infection by 23 types of pneumococcal bacteria, common and often cause serious illnesses.
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. Food and Drug Administration (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.
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.
Serum Institute of India PNEUMOSIL is a Pneumococcal Conjugate Vaccine – 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.
Pneumococcal Vaccine Candidates
Vaxcyte - VAX-24 is a 24-valent investigational pneumococcal conjugate vaccine to prevent invasive pneumococcal disease, designed to provide the broad-spectrum coverage of Pneumovax 23 with an immunogenicity profile comparable to Prevnar 13.
Affinivax, Inc. and Astellas Pharma Inc. - ASP3772, a novel vaccine candidate, is targeting Streptococcus pneumoniae. ASP3772 is designed to offer both B-cell (antibody) and T-cell immune protection against Streptococcus pneumoniae. 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-25 is a 25 valent pneumococcal conjugate vaccine (PCV), designed to include the key strains that cause serious invasive disease in children.
Pneumococcal Vaccination Trends
About 69% of adults aged 65 and over have received a pneumococcal vaccination, and over 43,000 seniors died from Invasive pneumococcal disease-related causes.
The CDC reported on November 12, 2021, among the 2,230 PIC deaths reported for last week, 1,551 had COVID-19 listed as an underlying or contributing cause of death on the death certificate, 679 listed 'pneumonia-related, and none listed influenza.
Pneumococcal Vaccine News
December 1, 2021 - Merck announced the U.S. FDA accepted for Priority Review a supplemental Biologics License Application for VAXNEUVANCE for the prevention of invasive pneumococcal disease in children 6 weeks through 17 years of age.
November 12, 2021 - World Pneumonia Day is calling on governments to reduce air pollution-related pneumonia deaths by 50% by 2030.
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 20, 2021 - Merck announced the U.S. CDC's Advisory Committee on Immunization Practices unanimously voted in favor of updates to pneumococcal vaccination recommendations for adults 65 years and older and for adults ages 19 to 64 with certain underlying medical conditions or other disease risk factors. In both groups, the ACIP voted to provisionally recommend vaccination either with a sequential regimen of VAXNEUVANCE followed by PNEUMOVAX 23 or with a single dose of 20-valent pneumococcal conjugate vaccine. These updates would apply to adults who have not previously received a pneumococcal conjugate vaccine or whose previous pneumococcal vaccination history is unknown. And, Katherine A. Poehling, MD, MPH, presented an Introduction.
October 15, 2021 - Merck announced that the European Medicines Agency's Committee for Medicinal Products for Human Use had recommended the approval of VAXNEUVANCE™ (Pneumococcal 15-valent Conjugate Vaccine) for active immunization for the prevention of invasive disease and pneumonia caused by Streptococcus pneumoniae in individuals 18 years of age and older.
September 29, 2021 - Pfizer Inc. announced results from a Phase 3 study evaluating the safety and immunogenicity of PREVNAR 20™ in (1,727) adults 65 years of age or older when administered at the same time as the Fluad Quadrivalent flu shot. Responses elicited by PREVNAR 20 for all 20 serotypes and by seasonal influenza vaccine when given together were noninferior (the study's primary immunogenicity objectives) to those elicited by the vaccines when administered one month apart. In addition, the safety profile of PREVNAR 20 was similar when the vaccines were coadministered as compared to when each vaccine was administered separately, one month apart.
August 25, 2021 - Merck announced topline results from the pivotal PNEU-PED (V114-029) study evaluating the immunogenicity, safety, and tolerability of VAXNEUVANCE™ (Pneumococcal 15-valent Conjugate Vaccine) in 1,720 healthy infants enrolled between 42-90 days of age.
August 16, 2021 - A new study: Clinical Outcomes of Immunocompromised Adults Hospitalized with Pneumococcal Pneumonia: A Case-Control Study. In conclusion, 'we found that in hospitalized patients with S. pneumoniae CAP who are treated with appropriate antibiotic therapy, the presence of an abnormal immune system does influence clinical outcomes.'
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. 'In this study, we observed substantial indirect protection at lower levels of PCV coverage than previously described—challenging assumptions that high levels of PCV coverage (i.e., greater than 90%) are required. Understanding the association between PCV coverage and indirect protection is a priority. The control of vaccine-type pneumococcal disease is a prerequisite for reducing the number of PCV doses (from 3 to 2). Reduced dose schedules have the potential to reduce program costs while maintaining vaccine impact substantially.'
July 16, 2021 - Merck announced the U.S. Food and Drug Administration (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. The approval follows the FDA's Priority Review of Merck's application. VAXNEUVANCE is contraindicated for individuals with a history of a severe allergic reaction (e.g., anaphylaxis) to any component of VAXNEUVANCE or diphtheria toxoid; see additional Select Safety Information beIn addition, the. The U.S. Centers for Disease Control and Prevention's (CDC) Advisory Committee on Immunization Practices is expected to meet in October to discuss and recommend using VAXNEUVANCE in adults.
July 16, 2021 - The introduction of the pneumococcal conjugate vaccine to childhood routine 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 17, 2021 - The Global Pneumococcal Vaccine Market is estimated to be USD 8.4 Billion in 2021 and is expected to reach USD 11.8 Billion by 2026, growing at a CAGR of 7%.
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.
May 20, 2021 - A new study found 'antibiotic prescribing for children declined following implementing a pneumococcal conjugate vaccine (PCV) program in Israel.
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.
March 29, 2021 - Vaxcyte announcing that the Company would delay filing an Investigational New Drug ("IND") application for VAX-24 to H1 2022 from an earlier timeline of H2 2021. VAX-24 is a 24-valent investigational pneumococcal conjugate vaccine to prevent invasive pneumococcal disease. Vaxcyte stated it achieved several key manufacturing milestones for VAX-24 in preparation for the anticipated IND application submission and Phase 1/2 clinical study initiation.
March 23, 2021 - Pfizer Inc. announced plans to expand its vaccine business. Pfizer will develop new vaccines using mRNA technology to target other viruses and pathogens beyond the coronavirus, Chief Executive Albert Bourla said in an interview with the WSJ.
March 9, 2021 - Kaiser Study: Prevention of COVID-19 among older adults receiving pneumococcal conjugate vaccine suggests interactions between Streptococcus pneumoniae and SARS-CoV-2 in the respiratory tract. Discussion - Reduced risk of COVID-19 among PCV13 recipients, transiently attenuated by antibiotic exposure, suggesting pneumococci may interact with SARS-CoV-2.
February 26, 2021 - Mayo Clinic study published by the journal Nature: Exploratory analysis of immunization records highlights decreased SARS-CoV-2 rates in individuals with recent non-COVID-19 vaccinations.
February 26, 2021 - Pfizer Inc. announced that the European Medicines Agency (EMA) accepted for review the Marketing Authorization Application (MAA) for its 20-valent pneumococcal conjugate vaccine (20vPnC) candidate, as submitted for the prevention of invasive disease and pneumonia caused by Streptococcus pneumoniae serotypes in the vaccine in adults ages 18 years and older. With the MAA acceptance, the formal review process by the EMA's Committee for Medicinal Products for Human Use begins.
February 26, 2021 - Study: Exploratory analysis of immunization records highlights decreased SARS-CoV-2 rates in individuals with recent non-COVID-19 vaccinations. Findings: age, race/ethnicity, and blood group stratified analyses reveal significantly lower SARS-CoV-2 rate among black individuals who have taken the PCV13 vaccine, with a relative risk of 0.45 at the 5 year time horizon (n: 653, 95% CI (0.32, 0.64), p-value: 6.9e−05).
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 1 month to <19 years. 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 - Study: Effectiveness of the seven- and thirteen valent pneumococcal conjugate vaccines against vaccine-serotype otitis media. PCV7 and PCV13 vaccines were found effective against complex O.M. caused by the targeted serotypes.
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 12, 2021 - New Jersey-based Merck announced the U.S. Food and Drug Administration accepted for priority review a Biologics License Application for V114. The FDA set a Prescription Drug User Fee Act of July 18, 2021.
January 12, 2021 - PNAS RESEARCH ARTICLE: Synthesis and delivery of Streptococcus pneumoniae capsular polysaccharides by recombinant attenuated Salmonella vaccines. 'Our work provides an innovative strategy for mass-producing low-cost bioconjugated polysaccharide vaccines for needle-free mucosal delivery against pneumococcal infections.'
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.
January 5, 2020 - Although the U.S. CDC recommends vaccinating health care workers to reduce disease transmission and patient risk, the effect of these laws on pneumonia and influenza mortality is unknown. A new quasi-experimental observational study reported that implementing state laws requiring hospitals to offer influenza vaccination to their employees was associated with a 2.5% reduction in monthly pneumonia and influenza mortality rate during the years when the flu vaccine was well matched to the circulating influenza strains. These researchers concluded 'state laws promoting hospital worker vaccination against influenza may effectively prevent pneumonia- and influenza-related deaths, particularly among elderly persons.'
December 28, 2020 - Serum Institute of India announced the launch of India's first indigenously developed pneumococcal vaccine – PNEUMOSIL®, which has been developed through a collaboration spanning over a decade among Serum Institute of India Pvt Ltd, PATH, and Bill and Melinda Gates Foundation. PNEUMOSIL® is WHO pre-qualified for its procurement by United Nations Agencies and GAVI.
December 14, 2020 - Research: An in vivo atlas of host-pathogen transcriptomes during Streptococcus pneumoniae colonization and disease. We identified and experimentally verified host-defense pathways induced by Spn during invasive disease, including proinflammatory responses and the interferon response. These results shed light on the pathogenesis of Spn and identify therapeutic targets.
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.
December 8, 2020 - Pfizer Inc. announced that the U.S. Food and Drug Administration accepted for priority review a Biologics License Application for its 20-valent pneumococcal conjugate vaccine candidate, as submitted for the prevention of invasive disease and pneumonia caused by Streptococcus pneumoniae serotypes in the vaccine in adults ages 18 years and older.
November 23, 2020 - Merck announced the Company had submitted applications to the U.S. Food and Drug Administration and European Medicines Agency for licensure of V114, Merck's investigational 15-valent pneumococcal conjugate vaccine in adults 18 years of age and older. The Company awaits acceptance of the U.S. and European regulatory authorities' submissions.
October 23, 2020 - In the setting of an established national childhood PCV13 vaccination program, PPV23 vaccination of clinical at-risk patient groups and adults aged ≥65 years provided moderate long-term protection against hospitalization with PPV23 serotype pneumonia. These findings suggest that PPV23 vaccination may continue to have an important role in adult pneumococcal vaccine policy, including the possibility of revaccination of older adults.
October 20, 2020 - Merck announced findings from two additional Phase 3 studies evaluating the safety, tolerability, and immunogenicity of V114, the Company's investigational 15-valent pneumococcal conjugate vaccine.
October 1, 2020 - U.S. Health Officials Urge Influenza and Pneumococcal Vaccination Amid COVID-19 Pandemic.
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.
August 10, 2020 - Study: Factors associated with pneumococcal vaccination uptake by cancer survivors.
July 31, 2020 - Study: Pneumococcal vaccination in older adults: An initial analysis of social determinants of health and vaccine uptake. Social determinants of health, including local health literacy, poverty, residing in more liberal areas, and access to information, may be influencing the pneumococcal vaccine-related decisions of older adults. However, additional factors associated with the vaccine hesitancy matrix and more granular data (e.g., zip code-level) are needed to determine the impact of this thoroughly and other vaccines recommended in older adults.
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 27, 2020 - Influenza and pneumonia vaccinations are associated with a reduced risk of Alzheimer's disease, according to new research reported at the Alzheimer's Association International Conference 2020.
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. PCV13 implementation led to a major reduction in invasive pneumococcal disease incidence. However, a rebound in cases among children and adults since 2015, driven by several emerging non-PCV13 serotypes, jeopardizes the long-term PCV benefits. Nevertheless, if confirmed in the coming years, these findings should be considered in developing next-generation PCVs and might guide policymakers in selecting future pneumococcal vaccines.
July 15, 2020 - Serum Institute became the first research institute in India to manufacture a domestically developed, fully indigenously developed pneumococcal vaccine.
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.