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Pneumococcal Vaccines 2022

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November 15, 2022
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Pneumococcal Vaccines For 2022

Pneumococcal vaccines prevent pneumococcal disease caused by Streptococcus pneumoniae, a bacterium with more than 90 serotypes. And to prevent pneumococcal disease, the U.S. FDA has approved two types of vaccines, Pneumococcal conjugate vaccines (PCV13, PCV15, PCV20) and the Pneumococcal polysaccharide vaccine (PPSV23), protecting people from different types of pneumococcal bacteria. 

None of these vaccines can prevent every kind of community-acquired pneumonia, but they work against the 30 most common bacteria types. The U.S. General Accounting Offices published Routine Vaccinations data on September 15, 2022: Adult Rates Vary by Vaccine Type and Other Factors.

U.S. CDC Pneumoccoal Recommendations

The U.S. 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 US - Dr. A Leidner; Summary of WG 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
of PPSV23.

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 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. PNEUMOSIL is approved for use in infants and toddlers from 6 weeks to 2 years of age.

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.

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.

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 For 2019 - 2022

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 important 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 provide protection to 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.

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. 

September 6, 2022 - Vaxcyte, Inc. announced the completion of enrollment in the Phase 2 study evaluating VAX-24 in healthy adults 65 years of age and older.

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®.

August 4, 2022 - Vaxcyte, Inc. announced that the U.S. FDA granted Fast Track designation to VAX-24, the Company's 24-valent pneumococcal conjugate vaccine candidate.

July 28, 2022 - Merck confirmed the U.S. CDC Advisory Committee on Immunization Practices Unanimously Voted to Provisionally Recommend 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 for the prevention of 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.

July 1, 2022 - The AAP published - Factors Associated With Antibiotic Use for Children Hospitalized With Pneumonia. CONCLUSIONS: Inpatient antibiotic utilization was associated with ED antibiotic decisions, CXR findings, and clinical factors. Nearly one-third of children with non-radiographic CAP received antibiotics, highlighting the need to reduce likely overuse.

June 22, 2022 - Merck announced the U.S. FDA approved an expanded indication for VAXNEUVANCE™ to include children 6 weeks through 17 years of age.

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). In both populations, V116 met the primary immunogenicity objectives and was well-tolerated with an overall safety profile generally comparable to PNEUMOVAX®23 (Pneumococcal Vaccine Polyvalent) across age groups. In the Phase 2 part of the study, V116 demonstrated non-inferior immune responses to PNEUMOVAX 23 for all shared serotypes and superior immune responses for the serotypes included in V116 but not included in PNEUMOVAX 23, based on study-defined criteria. Responses were measured 30 days post-vaccination by serotype-specific opsonophagocytic activity geometric mean titers, a measure of functional antibody activity.

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 disease.

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 31, 2022 - Professor Lee Sara of obstetrics and gynecology at Asan Medical Center explained the importance of preventing diseases through pneumococcal vaccination and the risk of developing pneumococcal infections in female patients with menopause.

May 31, 2022 - In this study, patients with pneumonia admitted to hospitals with a high all-cause readmission rate were more likely to develop adverse events during hospitalization.

May 17, 2022 - Finnish researchers reported in the journal Clinical Infectious Diseases a systematic review and meta-analysis of antibiotic treatment clinical trials for children with community-acquired pneumonia (CAP). A shorter antibiotic treatment duration of 3–5 days was equally effective and safe compared to the longer (current) recommendation of 7–10 days in children over six months with CAP.

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 4, 2022 - Vaxcyte, Inc. announced today that the first participants were dosed in the Phase 2 portion of its ongoing Phase 1/2 clinical study evaluating VAX-24 to prevent invasive pneumococcal disease and pneumonia in adults.

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. No new studies have been requested by the FDA.

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 25, 2022 - Vaxcyte, Inc. recently announced that the first participants were dosed in the Phase 1/2 clinical study of VAX-24, a 24-valent PCV candidate designed to prevent P.D. and pneumonia in adults.

February 24, 2022 - Miwako Kobayashi, MD, MPH, ACIP Pneumococcal Vaccines Work Group, presented: Next Steps for the Pneumococcal Vaccines Work Group.

February 23, 2022 - California-based Vaxcyte, Inc. announced the first participants were dosed in the Phase 1/2 clinical study of VAX-24, a 24-valent pneumococcal conjugate vaccine candidate designed to prevent invasive pneumococcal disease and pneumonia in adults. The Company expects to announce topline results by the end of 2022.

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 for the prevention of 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.

January 6, 2022 - Vaxcyte, Inc. announced today that the U.S. FDA cleared the Investigational New Drug application for VAX-24, its lead, 24-valent pneumococcal conjugate vaccine candidate designed to prevent invasive pneumococcal disease. Vaxcyte expects to initiate the VAX-24 Phase 1/2 clinical proof-of-concept study in adults in the first quarter of 2022.

December 15, 2021 - Merck announced today the European Commission had approved VAXNEUVANCE™ for adults.

December 1, 2021 - Merck announced the U.S. FDA accepted for Priority Review a supplemental Biologics License Application for VAXNEUVANCE to prevent invasive pneumococcal disease in children six weeks through 17 years of age.

November 12, 2021 - World Pneumonia Day calls 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 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 other 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.

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