Evaluation of Guillain-Barré syndrome following Respiratory Syncytial Virus Vaccination among Medicare Beneficiaries 65 Years and Older
Notice bibliographique
Résumé
Abstract Importance The United States Food and Drug Administration conducts routine post-market surveillance of approved vaccines to identify and characterize health outcomes risk associated with vaccination. Pre-licensure clinical trials of RSVPreF3+AS01 and RSVPreF vaccines identified a small number of Guillain-Barré syndrome cases, a serious acute demyelinating disease, following vaccination. Objective To use Centers for Medicare & Medicaid Services Medicare Fee-for-Service administrative claims and Medicare Part D data to evaluate risk of Guillain-Barré syndrome following respiratory syncytial virus vaccination. Design, Settings, and Participants We studied vaccines administered between May 3, 2023, when vaccines were first approved, through January 28, 2024. This self-controlled case series study design compared the incidence of Guillain-Barré syndrome during risk intervals of 1–42 days following vaccination to the incidence in subsequent control intervals (43–90 days) among Medicare beneficiaries, aged 65 years and older, enrolled in Fee-for-Service and Medicare Part D. Exposures Receipt of a single dose of RSVPreF3+AS01 or RSVPreF vaccines. Outcomes Guillain-Barré syndrome was identified using diagnosis code G61.0 in the primary diagnosis position on hospital inpatient claims; returned cases were confirmed via medical record review using Brighton Collaboration’s case definition. Results We captured approximately 3.23 million Medicare beneficiaries that received respiratory syncytial virus vaccination during the study period. A total of 95 incident Guillain-Barré syndrome cases were observed following respiratory syncytial virus vaccination. In our chart-confirmed self-controlled case series analysis, we observed an increased incidence of Guillain-Barré syndrome following RSVPreF3+AS01 (IRR: 2.46, [95% CI: 1.19, 5.08]) with an attributable risk of 6.5 cases per 1 million doses. We observed an increased, yet not statistically significant, incidence of Guillain-Barré syndrome following RSVPreF (IRR: 2.02, [95% CI: 0.93, 4.40]) with an attributable risk of 9 cases per 1 million doses. Conclusion and Relevance Findings from this self-controlled case series study suggest an increased risk of Guillain-Barré syndrome during 1-42 days following respiratory syncytial virus vaccination, with fewer than 10 excess Guillain-Barré syndrome cases per 1 million vaccine doses among Medicare beneficiaries 65 years and older. The U.S. Food and Drug Administration maintains that the substantial benefits of RSV vaccination outweigh these identified risks associated with vaccines. Key Points Question Is there an increased risk of developing Guillain-Barré syndrome (GBS) following vaccination with RSVPreF3+AS01 (AREXVY®) and RSVPreF (ABRYSVO®) among Medicare beneficiaries aged 65 years and older? Findings In a self-controlled case series analysis of Medicare beneficiaries with medical record review, we estimated the incidence rate ratio (IRR) comparing GBS in pre-specified risk and control intervals following vaccination with RSVPreF3+AS01 (IRR: 2.46, 95%CI: 1.19-5.08) or RSVPreF (IRR: 2.02, 95%CI: 0.93-4.40). RSV vaccines were associated with fewer than 10 excess GBS cases per 1 million vaccine doses. Meaning These findings suggest an increased risk of GBS following RSV vaccination.
Récupéré en direct depuis OpenAlex et désinversé. Les résumés ne sont pas conservés dans cette base de données : les index inversés représentent 8,6 Go des 9,3 Go de texte de la base, et le serveur dispose de 13 Go libres.
Comment cette classification a été obtenuedéplier
Prédiction machine sur la base complète
Imitation des enseignantsNi prévalence calibrée, ni vérité terrain. Validation humaine à venir. Le volet Gemma est une étiquette directe du modèle pour chaque travail de la base, lue sur la notice réduite au titre. Le volet Codex est un classifieur appris des 10 348 étiquettes directes de Codex et calibré sur les taux pondérés de l'échantillon; les champs sans appui suffisant ne portent aucun appel Codex. Le mode candidate est l'union des deux volets; le consensus est leur intersection. Ces sorties portent le statut machine_predicted_unvalidated et ne sont pas des étiquettes humaines.
Scores du classifieur distillé par catégorie (deux têtes)
| Catégorie | Codex | Gemma |
|---|---|---|
| Métarecherche | 0,002 | 0,005 |
| Méta-épidémiologie (sens strict) | 0,000 | 0,000 |
| Méta-épidémiologie (sens large) | 0,000 | 0,001 |
| Bibliométrie | 0,001 | 0,001 |
| Études des sciences et des technologies | 0,001 | 0,000 |
| Communication savante | 0,001 | 0,001 |
| Science ouverte | 0,001 | 0,001 |
| Intégrité de la recherche | 0,001 | 0,000 |
| Charge utile insuffisante (le modèle a refusé de juger) | 0,001 | 0,000 |
Scores machine (provisoires)
Les deux têtes enseignantes du modèle étudiant, lues sur ce travail. Un score ordonne la base pour la relecture; il n'affirme jamais une catégorie, et le statut de validation accompagne chaque rangée tel quel.
Scores de référence d'un modèle non mature (critères de maturité non atteints, 7 itérations). Un score ordonne; il n'affirme jamais une catégorie.
score_only:v0-immature-baseline · tel quel depuis la passe de notation : score_only signifie que le nombre peut ordonner les travaux, et qu'aucune étiquette de catégorie n'en découleClassification
machine, non validéePrédiction automatique; un appel candidat d’une seule source (Gemma direct ou Codex distillé), pas un consensus.
Le détail, modèle par modèle et score par score, se trouve en fin de page sous « Comment cette classification a été obtenue ».