References
- Mackey TK, Purushothaman V, Haupt M, et al. Application of unsupervised machine learning to identify and characterise hydroxychloroquine misinformation on Twitter. Lancet Digit Health. 2021;3(2):e72–e75. doi: 10.1016/S2589-7500(20)30318-6
- Managing the COVID-19 infodemic: promoting healthy behaviours and mitigating the harm from misinformation and disinformation [Internet]. [cited 2024 Jun 1]. Available from: https://www.who.int/news/item/23-09-2020-managing-the-covid-19-infodemic-promoting-healthy-behaviours-and-mitigating-the-harm-from-misinformation-and-disinformation
- Tangcharoensathien V, Calleja N, Nguyen T, et al. Framework for managing the COVID-19 infodemic: methods and results of an online, crowdsourced WHO technical consultation. J Med Internet Res. 2020;22(6):e19659. doi: 10.2196/19659
- Flay BR. Efficacy and effectiveness trials (and other phases of research) in the development of health promotion programs. Prev Med. 1986;15(5):451–474. doi: 10.1016/0091-7435(86)90024-1
- Selker HP, Eichler H, Stockbridge NL, et al. Efficacy and effectiveness too trials: clinical trial designs to generate evidence on efficacy and on effectiveness in wide practice. Clin Pharmacol Ther. 2019;105(4):857–866. doi: 10.1002/cpt.1347
- Sedgwick P. External and internal validity in clinical trials. BMJ. 2012;344(feb16 1):e1004. doi: 10.1136/bmj.e1004
- Collins R, Bowman L, Landray M, et al. The magic of randomization versus the myth of real-world evidence. N Engl J Med. 2020;382(7):674–678. doi: 10.1056/NEJMsb1901642
- Polack FP, Thomas SJ, Kitchin N, et al. Safety and efficacy of the BNT162b2 mRNA Covid-19 vaccine. N Engl J Med. 2020;383:2603–2615. doi: 10.1056/NEJMoa2034577
- Baden LR, Sahly HME, Essink B, et al. Efficacy and safety of the mRNA-1273 SARS-CoV-2 vaccine. N Engl J Med [Internet]. 2020 [cited 2021 Jan 4]. https://www.nejm.org/doi/full/10.1056/NEJMoa2035389
- Gould S, Norris SL. Contested effects and chaotic policies: the 2020 story of (hydroxy) chloroquine for treating COVID‐19. Cochrane Database Syst Rev [Internet]. 2021 [cited 2024 Feb 19]. https://www.cochranelibrary.com/cdsr/doi/10.1002/14651858.ED000151/full
- Axfors C, Schmitt AM, Janiaud P, et al. Mortality outcomes with hydroxychloroquine and chloroquine in COVID-19 from an international collaborative meta-analysis of randomized trials. Nat Commun. 2021;12(1):2349. doi: 10.1038/s41467-021-22446-z
- Pradelle A, Mainbourg S, Provencher S, et al. Deaths induced by compassionate use of hydroxychloroquine during the first COVID-19 wave: an estimate. Biomed Pharmacother. 2024;171:116055. doi: 10.1016/j.biopha.2023.116055
- Société Française de Pharmacologie et de Thérapeutique. Livre blanc. De la nécessité de la méthodologie dans l’évaluation des médicaments [Internet]. [cited 2022 Mar 16]. Available from: https://sfpt-fr.org/livreblancmethodo/index.htm
- Hodgson SH, Mansatta K, Mallett G, et al. What defines an efficacious COVID-19 vaccine? A review of the challenges assessing the clinical efficacy of vaccines against SARS-CoV-2. Lancet Infect Dis. 2021; 21(2):e26–e35. doi: 10.1016/S1473-3099(20)30773-8
- Riggs BL, Hodgson SF, O’Fallon WM, et al. Effect of fluoride treatment on the fracture rate in postmenopausal women with osteoporosis. N Engl J Med. 1990;322(12):802–809. doi: 10.1056/NEJM199003223221203
- Sarri G, Patorno E, Yuan H, et al. Framework for the synthesis of non-randomised studies and randomised controlled trials: a guidance on conducting a systematic review and meta-analysis for healthcare decision making. BMJ Evid-Based Med. 2022;27(2):109–119. doi: 10.1136/bmjebm-2020-111493
- Sommet A, Pariente A. Methods in pharmacoepidemiology. Therapies. 2019;74(2):187–197. doi: 10.1016/j.therap.2018.11.015
- Barraud D, Besançon L, Bik EM, et al. Why the article that led to the widespread use of hydroxychloroquine in COVID-19 should be retracted. Therapie. 2023;78(4):437–440. doi: 10.1016/j.therap.2023.06.001
- Renoux C, Azoulay L, Suissa S. Biases in evaluating the safety and effectiveness of drugs for the treatment of COVID-19: designing real-world evidence studies. Am J Epidemiol. 2021;190(8):1452–1456. doi: 10.1093/aje/kwab028
- Furukawa TA, Guyatt GH, Griffith LE. Can we individualize the ‘number needed to treat’? An empirical study of summary effect measures in meta-analyses. Int J Epidemiol. 2002;31(1):72–76. doi: 10.1093/ije/31.1.72
- Hammond J, Leister-Tebbe H, Gardner A, et al. Oral nirmatrelvir for high-risk, nonhospitalized adults with Covid-19. N Engl J Med. 2022;386(15):1397–1408. doi: 10.1056/NEJMoa2118542
- Lewnard JA, McLaughlin JM, Malden D, et al. Effectiveness of nirmatrelvir–ritonavir in preventing hospital admissions and deaths in people with COVID-19: a cohort study in a large US health-care system. Lancet Infect Dis. 2023;23(7):806–815. doi: 10.1016/S1473-3099(23)00118-4
- Laupacis A, Sackett DL, Roberts RS. An assessment of clinically useful measures of the consequences of treatment. N Engl J Med. 1988;318(26):1728–1733. doi: 10.1056/NEJM198806303182605
- Brown RB. Relative risk reduction: misinformative measure in clinical trials and COVID-19 vaccine efficacy. Dialogues In Health. 2022;1:100074. doi:10.1016/j.dialog.2022.100074
- Correia LCL, Matias D. COVID-19 vaccines: effectiveness and number needed to treat. Lancet Microbe. 2021;2(7):e281. doi: 10.1016/S2666-5247(21)00119-1
- Olliaro P, Torreele E, Vaillant M. COVID-19 vaccine efficacy and effectiveness—the elephant (not) in the room. Lancet Microbe. 2021;2(7):e279–e280. doi: 10.1016/S2666-5247(21)00069-0
- Christensen PM, Kristiansen IS. Number-needed-to-Treat (NNT) – needs treatment with care. Basic Clin Pharmacol Toxicol. 2006;99(1):12–16. doi: 10.1111/j.1742-7843.2006.pto_412.x
- Altman DG. Confidence intervals for the number needed to treat. BMJ. 1998;317(4):1309–1312. doi: 10.1136/bmj.317.7168.1309
- Montastruc J, Biron P, Sommet A. Efficacy of COVID‐19 vaccines: several modes of expression should be presented in scientific publications. Fundam Clin Pharmacol. 2022;36(1):218–220. doi: 10.1111/fcp.12715
- Adams K, Riddles JJ, Rowley EAK, et al. Number needed to vaccinate with a COVID-19 booster to prevent a COVID-19-associated hospitalization during SARS-CoV-2 Omicron BA.1 variant predominance, December 2021–February 2022, VISION Network: a retrospective cohort study. Lancet Reg Health – Am [Internet]. 2023 [cited 2024 Mar 1];23: 100530. https://www.thelancet.com/journals/lanam/article/PIIS2667-193X(23)00104-7/fulltext
- Thomas SJ, Moreira ED, Kitchin N, et al. Safety and efficacy of the BNT162b2 mRNA Covid-19 vaccine through 6 months. N Engl J Med. 2021;385(19): 1761–1773.
- Feikin DR, Higdon MM, Abu-Raddad LJ, et al. Duration of effectiveness of vaccines against SARS-CoV-2 infection and COVID-19 disease: results of a systematic review and meta-regression. Lancet Lond Engl. 2022;399:924–944. doi: 10.1016/S0140-6736(22)00152-0
- CIOMS cumulative glossary, with a focus on pharmacovigilance (Version 2.1) • Council for international organizations of medical sciences [Internet]. Counc Int Organ Med Sci. [cited 2024 Mar 21]. https://cioms.ch/publications/product/cioms-cumulative-pharmacovigilance-glossary/
- The use of the WHO-UMC system for standardised case causality assessment [Internet]. [cited 2024 Jan 5]. Available from: https://www.who.int/publications/m/item/WHO-causality-assessment
- Miremont-Salamé G, Théophile H, Haramburu F, et al. Causality assessment in pharmacovigilance: the French method and its successive updates. Therapies. 2016;71(2):179–186. doi: 10.1016/j.therap.2016.02.010
- Onakpoya IJ. Rare adverse events in clinical trials: understanding the rule of three. BMJ Evid-Based Med. 2018; 23(1 6):. doi: 10.1136/ebmed-2017-110885
- Berlin JA, Glasser SC, Ellenberg SS. Adverse event detection in drug development: recommendations and obligations beyond phase 3. Am J Public Health. 2008;98(8):1366–1371. doi: 10.2105/AJPH.2007.124537
- Shimabukuro T, Nair N. Allergic reactions including anaphylaxis after receipt of the first dose of pfizer-BioNTech COVID-19 vaccine. JAMA [Internet]. 2021 [cited 2021 Feb 1];325(8):780. https://jamanetwork.com/journals/jama/fullarticle/2775646
- Shimabukuro TT, Cole M, Su JR. Reports of anaphylaxis after receipt of mRNA COVID-19 vaccines in the US—December 14, 2020-January 18, 2021. JAMA. 2021;325:1101. doi: 10.1001/jama.2021.1967
- Le Vu S, Bertrand M, Jabagi M-J, et al. Age and sex-specific risks of myocarditis and pericarditis following Covid-19 messenger RNA vaccines. Nat Commun. 2022;13(1):3633. doi: 10.1038/s41467-022-31401-5
- Salmon DA, Chen RT, Black S, et al. Lessons learned from COVID-19, H1N1, and routine vaccine pharmacovigilance in the United States: a path to a more robust vaccine safety program. Expert Opin Drug Saf. 2024;23(2):161–175. doi: 10.1080/14740338.2024.2305707
- Greinacher A, Thiele T, Warkentin TE, et al. A prothrombotic thrombocytopenic disorder resembling heparin-induced thrombocytopenia following coronavirus-19 vaccination [Internet]. Review. 2021 [cited 2021 Mar 30]. https://www.researchsquare.com/article/rs-362354/v1
- Shimabukuro T. COVID-19 vaccine safety updates cdc.gov [Internet]. 2021. https://www.cdc.gov/vaccines/acip/meetings/downloads/slides-2021-06/03-COVID-Shimabukuro-508.pdf
- Conti V, Bertini N, Ricciardi R, et al. Adverse events related to drug–drug interactions in COVID-19 patients. A persistent concern in the post-pandemic era: a systematic review. Expert Opin Drug Metab Toxicol. 2024;20(4):275–292. doi: 10.1080/17425255.2024.2339397
- Lemaitre F, Grégoire M, Monchaud C, et al. Management of drug-drug interactions with nirmatrelvir/ritonavir in patients treated for Covid-19: guidelines from the French society of pharmacology and therapeutics (SFPT). Therapie. 2022;77(5):509–521. doi: 10.1016/j.therap.2022.03.005
- Bihan K, Lipszyc L, Lemaitre F, et al. Nirmatrelvir/ritonavir (Paxlovid®): French pharmacovigilance survey 2022. Therapie. 2023;78(5):531–547. doi: 10.1016/j.therap.2023.03.001
- Mt-Isa S, Hallgreen CE, Wang N, et al. Balancing benefit and risk of medicines: a systematic review and classification of available methodologies. Pharmacoepidemiol Drug Saf. 2014;23:667–678. doi: 10.1002/pds.3636
- Benefit-risk methodology | European medicines agency [Internet]. [cited 2024 Feb 22]. Available from: https://www.ema.europa.eu/en/about-us/what-we-do/regulatory-science-research/benefit-risk-methodology
- Research C for DE and. Benefit-risk assessment for new drug and biological products [Internet]. FDA; 2023 [cited 2024 Feb 22]. Available from: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/benefit-risk-assessment-new-drug-and-biological-products
- Covid-19 – Dr Chris Cates’ EBM Website [Internet]. 2020 [cited 2024 Mar 8]. Available from: https://www.nntonline.net/topics/covid-19/
- European Medicines Agency. Annex to Vaxzevria Art.5.3 - Visual risk contextualisation. Available from: https://www.ema.europa.eu/system/files/documents/chmp-annex/visuals_risk_contextualisation_az_vaccine_annex_for_chmp_opinion-corr_en.pdf
- Bozkurt B, Kamat I, Hotez PJ. Myocarditis with COVID-19 mRNA vaccines. Circulation. 2021;144(6):471–484. doi: 10.1161/CIRCULATIONAHA.121.056135
- Buyse M, Saad ED, Peron J, et al. The Net Benefit of a treatment should take the correlation between benefits and harms into account. J Clin Epidemiol. 2021;137:148–158. doi: 10.1016/j.jclinepi.2021.03.018
- Pocock SJ, Ariti CA, Collier TJ, et al. The win ratio: a new approach to the analysis of composite endpoints in clinical trials based on clinical priorities. Eur Heart J. 2012;33(2):176–182. doi: 10.1093/eurheartj/ehr352
- Chou W-Y, Oh A, Klein WMP. Addressing health-related misinformation on social media. JAMA. 2018;320(23):2417–2418. doi: 10.1001/jama.2018.16865
- [Internet]. [cited 2024 Mar 26]. Available from: https://sfpt-fr.org/covid19-foire-aux-questions
- Larrouquere L, Gabin M, Poingt E, et al. Genesis of an emergency public drug information website by the French society of pharmacology and therapeutics during the COVID‐19 pandemic. Fundam Clin Pharmacol. 2020; 34(3):389–396. doi: 10.1111/fcp.12564
- Ward JK, Gauna F, Gagneux-Brunon A, et al. The French health pass holds lessons for mandatory COVID-19 vaccination. Nat Med. 2022; 28:232–235. doi: 10.1038/s41591-021-01661-7
- Khouri C, Larabi A, Verger P, et al. Impact of vaccine hesitancy on onset, severity and type of self-reported adverse events: a French cross-sectional survey. Drug Saf. 2022;45(10):1049–1056. doi: 10.1007/s40264-022-01220-0