Raw research data for Shingrix
Executive summary
Shingrix (recombinant zoster vaccine, RZV) has a substantial published evidence base: pivotal phase III trials (ZOE‑50/70 and ZOE‑HSCT), regulatory reviews (FDA, EMA), company pooled datasets and post‑licensure studies that together report high efficacy (>90% in pooled younger cohorts, lower but still strong in older and immunocompromised groups) and a predictable reactogenicity profile (local injection‑site reactions, transient systemic symptoms) [1] [2] [3] [4]. Public sources for trial results, regulatory reviews, and real‑world effectiveness exist, but fully de‑identified individual‑participant “raw” datasets are not linked directly in the supplied reporting and require targeted requests to regulators, sponsors, or data repositories referenced by those reports [5] [3] [6].
1. The anatomy of the evidence base: where the “raw” research lives
Pivotal efficacy and safety results are published in peer‑reviewed journals and summarized on sponsor and regulator pages: the ZOE‑50 and ZOE‑70 trials and their pooled analyses appear in NEJM and GSK trial pages (ZOE data pooled by GSK) and are summarized in FDA and EMA clinical reviews and product information [2] [3] [5] [7] [6]. Post‑licensure observational effectiveness studies and safety surveillance—such as CDC reviews and independent real‑world studies—are available via PubMed and public health reporting [8] [9]. Clinical trial registry entries (ClinicalTrials.gov) and company press releases cite ongoing follow‑up and region‑specific phase III trials [10] [11] [12].
2. What the trials actually reported on efficacy and durability
The randomized, placebo‑controlled phase III program demonstrated very high vaccine efficacy in preventing herpes zoster: pooled ZOE-50 showed ≈97% VE in adults ≥50 and ZOE‑70 showed ≈89.8% in ≥70, with similarly strong prevention of postherpetic neuralgia in pooled analyses [1] [2] [3]. Subsequent long‑term follow‑up (ZOSTER‑049, ZOE‑LTFU) reported sustained protection years after vaccination, with company‑released figures showing efficacy persisting but declining by years 6–11 to levels reported as 79.7% in one end‑of‑trial summary [13] [3].
3. Safety, reactogenicity, and real‑world surveillance
Pre‑licensure trials and post‑licensure monitoring consistently describe a reactogenic profile dominated by injection‑site reactions and transient systemic symptoms such as fatigue; serious adverse events and potential immune‑mediated diseases were reported at similar rates between vaccine and placebo arms in immunocompromised trials [4] [1]. Early CDC post‑licensure surveillance found no unexpected safety signals compared with trials, while noting administration errors that contributed to some reports (e.g., subcutaneous vs intramuscular administration) [9].
4. Real‑world effectiveness: outcomes outside trials
Observational, real‑world analyses find that completing the 2‑dose regimen confers meaningful protection and that dosing delays beyond the recommended window did not materially impair effectiveness, though effectiveness estimates in observational settings were lower than trial efficacy—an expected result given differences in case ascertainment and outcome specificity [8]. Region‑specific trials and post‑licensure studies (including in China) replicate high efficacy but emphasize the need for local data where pivotal trials did not enroll participants [12] [11].
5. Access to raw participant‑level data and documented limitations
The supplied sources point to comprehensive clinical trial reports and regulatory statistical reviews that summarize endpoints, subgroup analyses, and safety tables (FDA reviews and clinical reviewer documents), and sponsor pages provide pooled trial tables and long‑term summaries [5] [6] [3]. Those documents are the principal public records referenced here; however, direct links to downloadable, fully de‑identified individual‑participant datasets are not presented in the provided reporting. Requests for participant‑level data are typically handled through sponsor data‑sharing portals or regulator data‑access procedures referenced in formal reviews, a path implied but not explicitly linked in the supplied snippets [5] [6] [3].
6. Bottom line and investigative caveats
The body of evidence assembled by regulators, independent journals, and sponsor reports consistently supports high efficacy and an expected reactogenicity profile for Shingrix, with real‑world studies confirming benefit of the two‑dose course and long‑term follow‑up showing sustained protection though with waning over a decade [1] [8] [13]. For journalists or investigators seeking “raw” participant‑level datasets, the next steps are explicit: consult the FDA statistical review and clinical reviewer appendices, GSK’s study data pages for data‑sharing instructions, and ClinicalTrials.gov entries for protocol identifiers to trigger formal data‑access requests—none of which are supplied here as direct raw files in the provided reporting and therefore must be pursued through the documented channels [5] [3] [10] [6].