Safety Analysis Shows PPSV23 Is Not Associated With Higher Risk of Serious Outcomes

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The 23-valent pneumococcal polysaccharide vaccine was most likely associated with a higher risk of immunological events for those who were immunocompromised, but the events were low.

Updated safety evidence for the 23-valent pneumococcal polysaccharide vaccine (PPSV23) demonstrates that previous findings of the vaccine are not associated with a higher risk of serious systemic adverse events, according to results of an analysis published in JAMA Network Open. Although the vaccine has been widely used, there have been safety concerns due to outdated evidence, according to the study authors.

ands of doctor or nurse in medical gloves with medical syringe ready for injection a shot of Pneumococcal vaccine | Image Credit: SecondSide - stock.adobe.com

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According to the study authors, the Advisory Committee on Immunization Practices recommends that all older adults should receive 1 dose of PPSV23. The vaccine has more than 30 years of safety evidence and clinical experience, with most adverse events (AE) being mild in nature and resolving within a few days, according to the study authors. However, the study investigators aimed to assess any potential association between cardiovascular, neurological, and immunological AEs and PPSV23 in older adults to address any proposed limitations.

Investigators linked data ranging from July 2018 to 2022 from the Korea Immunization Registry Information System to the National Health Information Database, according to the study authors. The data included 18 different types of vaccines, demographics, and clinical information of the South Korean population. Investigators also used national codes to find the exposure and outcome data, according to the study authors.

3 Key Takeaways

  1. The study aimed to address previous safety concerns associated with the vaccine due to outdated evidence. The Advisory Committee on Immunization Practices recommends PPSV23 for all older adults.
  2. Null risks were found for most cardiovascular events, with significantly lower risk intervals for cardiomyopathy. Immunological events were found to have a slightly higher risk for immunocompromised individuals.
  3. Subgroup analysis did not show positive associations between PPSV23 and adverse events in any of the three categories.

Individuals aged 65 years and older who received PPSV23 were included in the study. Baseline characteristics including age at vaccination, sex, income level, comorbidities, history of medication use, and more were assessed, according to the study. Investigators included 4355 individuals who experienced events in the study. The population had a mean age of 72.4 years, were 52.1% male, and had a higher proportion of comorbidities when compared with those who did not have an event but were vaccinated.

The investigators used 6 cardiovascular outcomes, 2 neurological outcomes, and 3 immunological outcomes. Respectively, the outcomes included myocardial infarction, atrial fibrillation, cardiomyopathy, heart failure, hypotension, myocarditis or pericarditis, stroke, Bell palsy, Guillain-Barré syndrome, sepsis, thrombocytopenia, and anaphylaxis. Individuals who had a history of each diagnosis within 1 year before the cohort entry were excluded from the study.

In the self-controlled risk interval analysis, investigators found that there was not an increased risk of cardiovascular, neurological, or immunological events following vaccination, according to the results. Null risks were found for all cardiovascular events except for cardiomyopathy, which had a significantly lower risk interval. Bell palsy and Guillain-Barre syndrome were not associated with vaccination, and the vaccination did not increase the risk of sepsis, thrombocytopenia, or anaphylaxis, the study authors said.

Additionally, none of the subgroups showed positive associations between PPSV23 or any of the 3 event categories. Although the results were not significant, investigators did note that those with a history of cardiovascular disease tended to have an increased risk for cardiovascular events, according to the study investigators.

The study authors concluded that PPSV23 was most likely associated with a higher risk of immunological events for those who were immunocompromised, but the events were low. They noted limitations of the study, including the fact that AEs could have been underestimated due to having only 1 dose included in the study. Anyone with more than one dose was excluded from the study.

References

  1. Yoon D, Jeon HL, Kim JH, Lee H, Shin JY. Cardiovascular, Neurological, and Immunological Adverse Events and the 23-Valent Pneumococcal Polysaccharide Vaccine. JAMA Netw Open. 2024;7(1):e2352597. doi:10.1001/jamanetworkopen.2023.52597
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