Side Effects of pneumococcal conjugate vaccine (pcv13: A Synthesis of Findings from 17 Studies

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Original Abstract of the Article

Major Research Findings

Numerous studies have demonstrated the safety and immunogenicity of the 13-valent pneumococcal conjugate vaccine (PCV13) across various age groups, including adults between 18 and 49 years old. 12 , 15 , 5 , 8 , 10 . These studies highlight that PCV13 remains safe and effective even when administered concurrently with the influenza vaccine. 9 . Moreover, PCV13 has proven to be safe and immunogenic in elderly populations. 16 , 13 . Additionally, PCV13 has shown efficacy and safety in children with compromised immune systems and those receiving cancer treatment. 11 .

Reasons for Side Effects

Side effects associated with PCV13 are generally attributed to the immune system's response to the vaccine's components. 1 . Certain individuals may experience allergic reactions to these components. Local reactions such as inflammation and pain at the injection site have also been documented. 10 , 13 . These reactions typically tend to be mild and resolve within a few days.

Common Side Effects

Injection Site Reactions

The most prevalent side effect of PCV13 is injection site reactions. These can manifest as pain, redness, and swelling. 9 , 13 . These reactions are generally mild and subside within a few days. 10 .

Systemic Reactions

PCV13 can occasionally trigger systemic reactions in addition to injection site reactions. These reactions may include fever, fatigue, headache, muscle aches, and joint aches. 9 , 1 . These reactions are typically mild and resolve within a few days. 10 .

Rare Side Effects

In rare instances, PCV13 may cause more severe side effects. These can include allergic reactions, Guillain-Barré syndrome, encephalitis, and rhabdomyolysis. 1 . These reactions are extremely uncommon and tend to occur shortly after vaccination. If you experience any of these side effects, seek immediate medical attention.

Measures to Counter Side Effects

Injection Site Reactions

To alleviate injection site reactions, applying a cold compress to the injection site can be helpful. Over-the-counter pain relievers can also be used to manage pain. 10 .

Systemic Reactions

To mitigate systemic reactions, fever reducers can be taken to lower fever. Rest is also crucial. 9 .

Rare Side Effects

To prevent the occurrence of rare side effects, it is essential to consult your doctor about your allergy history and any other health concerns prior to vaccination. 1 .

Comparison Between Studies

Common Points of Studies

Numerous studies have demonstrated the safety and immunogenicity of PCV13 across diverse age groups. 12 , 15 , 5 , 8 , 10 . Additionally, PCV13 has been found to be safe and effective when administered alongside the influenza vaccine. 9 . These studies strongly suggest that PCV13 is an effective means of safeguarding against pneumococcal disease.

Differences in Studies

Certain studies have indicated that the immunogenicity and safety of PCV13 may vary based on factors such as age and health status. 15 , 13 . Some studies have also reported discrepancies in the incidence and severity of PCV13 side effects. 13 . It is crucial to comprehensively assess these research findings.

Precautions for Application to Real Life

PCV13 stands as an effective means of protecting against pneumococcal disease, but like all vaccines, it carries the risk of side effects. 1 . It is essential to consult your doctor about your allergy history and any other health concerns prior to vaccination. If you experience side effects such as fever, fatigue, or injection site pain after vaccination, seek immediate medical attention. 9 . PCV13 is an important vaccination for maintaining a healthy life. 16 . Getting the appropriate vaccinations can significantly reduce your risk of pneumococcal disease. 4 .

Limitations of Current Research

The long-term effects of PCV13 remain inadequately understood. 11 . Furthermore, the immunogenicity and safety of PCV13 may potentially differ based on race and ethnicity. 8 . Additional research is needed to address these areas.

Future Research Directions

Further investigation into the long-term impact of PCV13 and potential variations in immunogenicity and safety across different races and ethnicities is warranted. 11 , 8 . The development of novel vaccines aimed at enhancing the efficacy of PCV13 is also crucial. 14 . These research endeavors hold the promise of further improving the safety and effectiveness of PCV13.

Conclusion

PCV13 has been demonstrated to be safe and immunogenic across various age groups. 12 , 15 , 5 , 8 , 10 . PCV13 stands as an effective means of safeguarding against pneumococcal disease. 16 . However, like all vaccines, it carries the risk of side effects. 1 . It is crucial to consult your doctor about your allergy history and any other health concerns prior to vaccination. 1 . PCV13 is an important vaccination for maintaining a healthy life. 16 . Getting the appropriate vaccinations can significantly reduce your risk of pneumococcal disease. 4 .

Literature analysis of 17 papers
Positive Content
16
Neutral Content
0
Negative Content
1
Article Type
8
1
0
0
17
1.

Erythema multiforme following pneumococcal vaccination.

Author: MonastirliAlexandra, PasmatziEfstathia, BadavanisGeorge, TsambaosDionysios

Reduced pneumococcal disorders
EM from PCV13

This study reports a rare case of Erythema Multiforme (EM) in a 2.5-year-old boy following pneumococcal vaccination (PCV13). Although the association between PCV13 and EM is not definitively confirmed, the evidence suggests a possible link, as other potential causes were ruled out.

Case ReportsIn the medical field, a report that describes in detail a unique case, an unusual medical condition, or the effect of a treatment. Provides new insights and possibilities for treatment through individual patient cases.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.

Language : English

3.

Safety and immunogenicity of a 13-valent pneumococcal conjugate vaccine manufactured with and without polysorbate 80 given to healthy infants at 2, 3, 4 and 12 months of age.

Author: GadzinowskiJanusz, TanseySusan P, WysockiJacek, KopińskaElzbieta, Majda-StanisławskaEwa, CzajkaHanna, KorbalPiotr, PietrzykJacek J, BakerSherryl A, GiardinaPeter C, GruberWilliam C, EminiEmilio A, ScottDaniel A

Vaccine efficacy
Vaccine safety

Polysorbate 80 (P80) is a nonionic detergent used to solubilize proteins and is used in both oral and injectable medications, including vaccines. This study investigated the immunogenicity and safety of 13-valent pneumococcal conjugate vaccine (PCV13) with and without P80 before adding P80 to the formulation.

Clinical Trial, Phase IIIA Phase III trial is a trial that further rigorously verifies the efficacy and safety of a new drug or treatment, whose efficacy and safety have been confirmed in a Phase II trial, in a large number of patients, and evaluates whether it is superior to existing treatments.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Multicenter StudyResearch conducted in collaboration with multiple research institutions. It aims to collect a wide range of data and obtain more generalizable results.
Randomized Controlled TrialA clinical trial that randomly assigns participants to treatment and control groups to evaluate the effects of an intervention.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Language : English

4.

Safety of 13-valent pneumococcal conjugate vaccine in infants and children: meta-analysis of 13 clinical trials in 9 countries.

Author: ThompsonAllison, GurtmanAlejandra, PattersonScott, JuergensChristine, LaudatFrance, EminiEmilio A, GruberWilliam C, ScottDaniel A

Safety events

This meta-analysis aims to identify potentially important rare safety events related to the use of 13-valent pneumococcal conjugate vaccine (PCV13) in infants and young children by analyzing safety data from various clinical trials.

Comparative StudyResearch that compares multiple groups/interventions to determine differences/similarities in outcomes/characteristics.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Meta-AnalysisA statistical technique that integrates the results of multiple studies to draw more general conclusions about a particular issue.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Language : English

5.

Immunogenicity, safety and tolerability of 3 lots of 13-valent pneumococcal conjugate vaccine given with routine pediatric vaccinations in the United States.

Author: PaytonTerry, GirgentiDouglas, FrenckRobert W, PattersonScott, LoveJack, RazmpourAhmad, SidhuMohinder S, EminiEmilio A, GruberWilliam C, ScottDaniel A

Pneumococcal disease prevention

This study assesses the immunogenicity, safety, and manufacturing consistency of a 13-valent pneumococcal conjugate vaccine (PCV13) that expands serotype coverage compared to the previous 7-valent vaccine.

Clinical Trial, Phase IIIA Phase III trial is a trial that further rigorously verifies the efficacy and safety of a new drug or treatment, whose efficacy and safety have been confirmed in a Phase II trial, in a large number of patients, and evaluates whether it is superior to existing treatments.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Multicenter StudyResearch conducted in collaboration with multiple research institutions. It aims to collect a wide range of data and obtain more generalizable results.
Randomized Controlled TrialA clinical trial that randomly assigns participants to treatment and control groups to evaluate the effects of an intervention.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Language : English

6.

Immunogenicity and safety of a 13-valent pneumococcal conjugate vaccine in healthy infants in Japan.

Author: TogashiTakehiro, YamajiMasako, ThompsonAllison, GiardinaPeter C, AizawaMasakazu, PattersonScott, GruberWilliam C, ScottDaniel A,

Broader pneumococcal protection
Safety

This study evaluated the immunogenicity and safety of a 13-valent pneumococcal conjugate vaccine (PCV13) in Japanese infants. PCV13 is designed to provide broader protection against Streptococcus pneumoniae than the 7-valent PCV.

Clinical Trial, Phase IIIA Phase III trial is a trial that further rigorously verifies the efficacy and safety of a new drug or treatment, whose efficacy and safety have been confirmed in a Phase II trial, in a large number of patients, and evaluates whether it is superior to existing treatments.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Multicenter StudyResearch conducted in collaboration with multiple research institutions. It aims to collect a wide range of data and obtain more generalizable results.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Language : English

7.

13-Valent pneumococcal conjugate vaccine (PCV13) in children partially immunized with 7-valent pneumococcal conjugate vaccine (PCV7): a phase 3, open-label trial.

Author: SilfverdalSven Arne, FlodmarkCarl-Erik, RomboLars, TanseySusan P, SidhuMohinder, TrammelJames, EminiEmilio A, GruberWilliam C, ScottDaniel A, GurtmanAlejandra,

PCV13 immunogenicity
PCV13 safety

A study evaluated the immunogenicity and safety of 13-valent pneumococcal conjugate vaccine (PCV13) in infants and toddlers who previously received one or two doses of 7-valent pneumococcal conjugate vaccine (PCV7). The study found PCV13 to be immunogenic and safe in these children.

Clinical Trial, Phase IIIA Phase III trial is a trial that further rigorously verifies the efficacy and safety of a new drug or treatment, whose efficacy and safety have been confirmed in a Phase II trial, in a large number of patients, and evaluates whether it is superior to existing treatments.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Language : English

8.

Immunogenicity and safety of a 13-valent pneumococcal conjugate vaccine in healthy infants and toddlers given with routine vaccines in India.

Author: AmdekarYeshwant K, LalwaniSanjay K, BavdekarAshish, BalasubramanianS, ChhatwalJugesh, BhatSwarna Rekha, VergheseValsan Philip, TanseySusan P, GadgilDurga, JiangQin, PrideMichael, EminiEmilio A, GruberWilliam C, ScottDaniel A

Immunogenicity
Safety

Streptococcus pneumoniae infections are a significant health problem in children, especially in India. This study compares the effectiveness and safety of two pneumococcal vaccines: 13-valent pneumococcal conjugate vaccine (PCV13) and 7-valent pneumococcal conjugate vaccine (PCV7). The study is being conducted at 12 sites in India.

Clinical Trial, Phase IIIA Phase III trial is a trial that further rigorously verifies the efficacy and safety of a new drug or treatment, whose efficacy and safety have been confirmed in a Phase II trial, in a large number of patients, and evaluates whether it is superior to existing treatments.
Comparative StudyResearch that compares multiple groups/interventions to determine differences/similarities in outcomes/characteristics.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Multicenter StudyResearch conducted in collaboration with multiple research institutions. It aims to collect a wide range of data and obtain more generalizable results.
Randomized Controlled TrialA clinical trial that randomly assigns participants to treatment and control groups to evaluate the effects of an intervention.

Language : English

9.

Randomized, controlled trial of a 13-valent pneumococcal conjugate vaccine administered concomitantly with an influenza vaccine in healthy adults.

Author: FrenckRobert W, GurtmanAlejandra, RubinoJohn, SmithWilliam, van CleeffMartin, JayawardeneDeepthi, GiardinaPeter C, EminiEmilio A, GruberWilliam C, ScottDaniel A, Schmöle-ThomaBeate

Vaccine response

This randomized, double-blind, phase 3 trial evaluated the immunogenicity, safety, and tolerability of a 13-valent pneumococcal conjugate vaccine (PCV13) coadministered with trivalent inactivated influenza vaccine (TIV) in pneumococcal vaccine-naive adults. The study found that coadministration of PCV13 and TIV was well tolerated but associated with lower PCV13 antibody responses.

Clinical Trial, Phase IIIA Phase III trial is a trial that further rigorously verifies the efficacy and safety of a new drug or treatment, whose efficacy and safety have been confirmed in a Phase II trial, in a large number of patients, and evaluates whether it is superior to existing treatments.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Multicenter StudyResearch conducted in collaboration with multiple research institutions. It aims to collect a wide range of data and obtain more generalizable results.
Randomized Controlled TrialA clinical trial that randomly assigns participants to treatment and control groups to evaluate the effects of an intervention.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Language : English

10.

Safety and immunogenicity of a 13-valent pneumococcal conjugate vaccine in healthy infants and toddlers given with routine pediatric vaccinations in Canada.

Author: VanderkooiOtto G, ScheifeleDavid W, GirgentiDouglas, HalperinScott A, PattersonScott D, GruberWilliam C, EminiEmilio A, ScottDaniel A, KellnerJames D,

broader coverage
safe and immunogenic

This study compared the compatibility, safety, and immunogenicity of PCV13 and PCV7, two pneumococcal conjugate vaccines. The study found that both vaccines were compatible with other vaccines and were safe and immunogenic.

Clinical Trial, Phase IIIA Phase III trial is a trial that further rigorously verifies the efficacy and safety of a new drug or treatment, whose efficacy and safety have been confirmed in a Phase II trial, in a large number of patients, and evaluates whether it is superior to existing treatments.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Multicenter StudyResearch conducted in collaboration with multiple research institutions. It aims to collect a wide range of data and obtain more generalizable results.
Randomized Controlled TrialA clinical trial that randomly assigns participants to treatment and control groups to evaluate the effects of an intervention.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Language : English

11.

Immunogenicity and safety of single-dose, 13-valent pneumococcal conjugate vaccine in pediatric and adolescent oncology patients.

Author: HungTe-Yu, KotechaRishi S, BlythChristopher C, SteedSarah K, ThorntonRuth B, RyanAnne L, ColeCatherine H, RichmondPeter C

Prevent pneumococcal disease

This study discusses the benefit of the 13-valent pneumococcal conjugate vaccine (PCV13) in immunocompromised children with cancer.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.

Language : English

12.

Immunogenicity and safety of a 13-valent pneumococcal conjugate vaccine in adults 18-49 years of age, naive to 23-valent pneumococcal polysaccharide vaccine.

Author: BryantK A, FrenckR, GurtmanA, RubinoJ, TreanorJ, ThompsonA, JonesT R, SundaraiyerV, BaxterL M, GruberW C, EminiE A, ScottD A, Schmoele-ThomaB

Pneumococcal conjugate vaccine

This study evaluated the immunogenicity, tolerability, and safety of the 13-valent pneumococcal conjugate vaccine (PCV13) and the 23-valent pneumococcal polysaccharide vaccine (PPSV23) in adults. PCV13 was found to be immunogenic, safe, and well-tolerated in both PPSV23-naive adults aged 60-64 years and adults aged 18-49 years.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Randomized Controlled TrialA clinical trial that randomly assigns participants to treatment and control groups to evaluate the effects of an intervention.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Language : English

13.

Immunogenicity and safety of the 13-valent pneumococcal conjugate vaccine compared to the 23-valent pneumococcal polysaccharide vaccine in elderly Japanese adults.

Author: ShiramotoMasanari, HanadaRyuzo, JuergensChristine, ShojiYasuko, YoshidaMizuki, BallanBarry, CooperDavid, GruberWilliam C, ScottDaniel A, Schmoele-ThomaBeate

Pneumococcal disease prevention
Local reactions
Systemic adverse events

PCV13 is safe and well-tolerated, and it elicits greater functional immune responses than PPSV23.

Comparative StudyResearch that compares multiple groups/interventions to determine differences/similarities in outcomes/characteristics.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Multicenter StudyResearch conducted in collaboration with multiple research institutions. It aims to collect a wide range of data and obtain more generalizable results.
Randomized Controlled TrialA clinical trial that randomly assigns participants to treatment and control groups to evaluate the effects of an intervention.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Language : English

14.

Antibody and plasmablast response to 13-valent pneumococcal conjugate vaccine in chronic lymphocytic leukemia patients--preliminary report.

Author: PasiarskiMarcin, RolinskiJacek, GrywalskaEwelina, Stelmach-GoldysAgnieszka, Korona-GlowniakIzabela, GozdzStanislaw, HusIwona, MalmAnna

Immune response enhancement
Pneumococcal infection prevention

This study aimed to compare the immune response to PCV13 in 24 previously untreated CLL patients and healthy subjects.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Language : English

15.

Open-label trial of immunogenicity and safety of a 13-valent pneumococcal conjugate vaccine in adults ≥ 50 years of age in Mexico.

Author: TinocoJuan Carlos, JuergensChristine, Ruiz PalaciosGuillermo M, Vazquez-NarvaezJorge, Enkerlin-PauwellsHermann Leo, SundaraiyerVani, PathiranaSudam, KalininaElena, GruberWilliam C, ScottDaniel A, Schmoele-ThomaBeate

Pneumococcal disease protection
Safety in adults
Strong immune response

This open-label multicenter clinical trial assessed the immunogenicity and safety of a 13-valent pneumococcal conjugate vaccine (PCV13) in adults ≥ 50 years of age not previously vaccinated with the 23-valent pneumococcal polysaccharide vaccine (PPSV23).

Clinical TrialA clinical trial is a planned study conducted on humans to evaluate the efficacy and safety of pharmaceuticals, medical devices, and treatment methods. It aims to explore the possibilities of new treatments and improve the health of patients.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Multicenter StudyResearch conducted in collaboration with multiple research institutions. It aims to collect a wide range of data and obtain more generalizable results.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Language : English

16.

Safety and tolerability of 13-valent pneumococcal conjugate vaccine in the elderly.

Author: DurandoPaolo, RosselliRoberto, CremonesiIlaria, OrsiAndrea, AlbaneseErika, BarberisIlaria, PaganinoChiara, TrucchiCecilia, MartiniMariano, MarensiLorenzo, TurelloValter, Study GroupThe Ligurian Pneumococcal, BreganteAlessandro, CaccianiRoberto, IudiciRocco, La MarcaDiego, PedanoLeonardo, PetrucciAmadio Franco, SantoliniMaria, SbisàValentina, ZacconiMonica

Pneumococcal disease prevention

The European Medical Agency and the Food and Drug Administration have authorized the use of 13-valent pneumococcal conjugate vaccine (PCV13) in adults aged ≥50 years for the prevention of invasive pneumococcal diseases and community acquired pneumonia. The Liguria Region, in Italy, implemented an active and free of charge immunization strategy with PCV13 among adults with specific risk conditions and the elderly aged ≥70 years.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Multicenter StudyResearch conducted in collaboration with multiple research institutions. It aims to collect a wide range of data and obtain more generalizable results.
Observational StudyResearch that observes and collects data on participants' behavior and outcomes in their natural state, without intervention.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Language : English

17.

Evaluation of 13-valent pneumococcal conjugate vaccine and concomitant meningococcal group C conjugate vaccine in healthy infants and toddlers in Spain.

Author: Diez-DomingoJavier, GurtmanAlejandra, BernaolaEnrique, Gimenez-SanchezFrancisco, Martinon-TorresFederico, Pineda-SolasValentin, DelgadoAlfonso, Infante-MarquezPilar, LiangJohn Z, GiardinaPeter C, GruberWilliam C, EminiEmilio A, ScottDaniel A

Acceptable safety profile
Expanded pneumococcal coverage
Lower GMTs

This phase 3 randomized controlled trial compared 13-valent pneumococcal conjugate vaccine (PCV13) to 7-valent PCV (PCV7) for their effect on the immunogenicity of concomitantly administered meningococcal group C conjugated to diphtheria toxin cross-reactive material 197 (MnCCV-CRM197). PCV13 elicited substantial antipneumococcal responses against all 13 serotypes. Immunogenicity of MnCCV-CRM197 was similar between the PCV13 and PCV7 groups, with a comparable proportion of infants achieving protective MenC antibody titers.

Clinical Trial, Phase IIIA Phase III trial is a trial that further rigorously verifies the efficacy and safety of a new drug or treatment, whose efficacy and safety have been confirmed in a Phase II trial, in a large number of patients, and evaluates whether it is superior to existing treatments.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Multicenter StudyResearch conducted in collaboration with multiple research institutions. It aims to collect a wide range of data and obtain more generalizable results.
Randomized Controlled TrialA clinical trial that randomly assigns participants to treatment and control groups to evaluate the effects of an intervention.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Language : English

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