The Risk of Narcolepsy Following Receipt of Adjuvanted Pandemic 2009 The Subtype of Influenza A Virus (H1N1) Vaccines: Results of the SOMNIA Global Collaborative Study
Bibliographic record
Abstract
Background. An increased risk of narcolepsy following AS03-adjuvanted 2009 pandemic H1N1 influenza vaccine was observed in children in some countries in Europe, but the impact of media attention bias could not be excluded. The SOMNIA study was an international investigation of the association between AS03- and MF-59-adjuvanted monovalent pandemic H1N1 vaccines and narcolepsy. Methods. Objectives: To assess trends in narcolepsy incidence rates (IRs) before, during, and after the pandemic influenza (A)H1N1 vaccination campaigns and to perform a case-control study to estimate the relative risk of narcolepsy in children and adults for both MF-59 and AS03 adjuvanted pandemic (H1N1) 2009 vaccines. A dynamic retrospective cohort study was conducted to estimate incidence rates of narcolepsy diagnoses using a common protocol on electronic data in 7 countries during 2003–2013. For the case control study, conducted according to a common protocol in 6 countries, cases were identified from sleep center records. The referral date for the sleep latency test was the index date. Controls were matched for country, age, sex, and index date. Conditional logistic regression was used to estimate the odds ratio of narcolepsy with AS03 and MF59 containing H1N1 vaccines. Results. No changes in incidence rates of narcolepsy diagnoses were observed between the period after the start of AS03- or MF-59-containing H1N1 vaccination programs and the period before H1N1 circulation, in any of the age groups or countries except for Sweden, where a steep increase was observed in children 5-19 years in 2010. In the primary case control analysis, no association was observed for AS03-containing vaccines in children or adults. Based on three exposed cases, an association with MF-59 vaccine was observed in Argentina in the primary analysis in children, but no association was found when cases from Europe were included. Conclusion. Overall, our results do not support an association between receipt of AS03-adjuvanted 2009 H1N1 vaccine and narcolepsy although our results are based almost exclusively on Arepanrix use in Ontario. Power to assess risk following MF-59 vaccine was limited. Funding. The study is funded by the Centers for Disease Control and Prevention (CDC), Atlanta, Georgia, USA, under CDC contract number 200-2012-53425_addendum 0001. Disclosures. S. Black, GSK Vaccines: Scientific Advisor, Consulting fee
Fetched live from OpenAlex and de-inverted. Abstracts are not stored in this database: the inverted indexes are 8.6 GB of the frame’s 9.3 GB of text, and the host has 13 GB free.
How this classification was reachedexpand
Full frame distilled prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. Learned from the 10,348 direct Codex labels and 10,348 direct Gemma labels. Candidate is the union of thresholded teacher heads; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels or direct frontier model labels.
Codex and Gemma teacher scores by category
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.001 | 0.010 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.000 | 0.000 |
| Bibliometrics | 0.000 | 0.002 |
| Science and technology studies | 0.001 | 0.001 |
| Scholarly communication | 0.000 | 0.000 |
| Open science | 0.002 | 0.001 |
| Research integrity | 0.000 | 0.000 |
| Insufficient payload (model declined to judge) | 0.000 | 0.000 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one teacher head, not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".