References
- World Health Organization. Novel Coronavirus - China [Internet]. 2020 [cited 2020 Sep 9]. Available from: https://www.who.int/csr/don/12-january-2020-novel-coronavirus-china/en/
- European Centre for Disease Prevention and Control. COVID-19 pandemic - Situation update 28 July 2020 [Internet]. 2020 [cited 2020 Sep 9]. Available from: https://www.ecdc.europa.eu/en/covid-19-pandemic
- World Health Organization. Coronavirus [Internet]. 2020 [cited 2020 Sep 9]. Available from: https://www.who.int/health-topics/coronavirus#tab=tab_1
- Chumakov K, Benn CS, Aaby P, et al. Can existing live vaccines prevent COVID-19? Science. 2020 Jun 12;368(6496):1187–1188.
- Jehi L, Ji X, Milinovich A, et al. Individualizing risk prediction for positive COVID-19 testing: results from 11,672 patients. Chest. 2020 Jun 10:S0012-3692(20)31654–8.
- Escobar LE, Molina-Cruz A, Barillas-Mury C. BCG vaccine protection from severe Coronavirus Disease 2019 (COVID19). Proc Natl Acad Sci U S A. 2020Jul;9:202008410.
- Gostin LO, Salmon DA. The dual epidemics of COVID-19 and influenza: vaccine acceptance, coverage, and mandates. JAMA. 2020 Jun 11;324:335.
- Zhu N, Zhang D, Wang W, et al. A novel coronavirus from patients with pneumonia in China, 2019. N Engl J Med. 2020 Feb 20;382(8):727–733.
- Jackson LA, Anderson EJ, Rouphael NG, et al. An mRNA vaccine against SARS-CoV-2 — preliminary report. N Engl J Med [Internet]. 2020;NEJMoa2022483. Available from http://www.nejm.org/doi/10.1056/NEJMoa2022483
- Deming ME, Michael NL, Robb M, et al. Accelerating development of SARS-CoV-2 vaccines — the role for controlled human infection models. N Engl J Med. 2020 Jul 1;383:e63.
- Guimarães LE, Baker B, Perricone C, et al. Vaccines, adjuvants and autoimmunity. Pharmacol Res. 2015 Oct;100:190–209.
- Chaplin DD. Overview of the immune response. J Allergy Clin Immunol. 2010 Feb;125(2 Suppl 2):S3–23.
- Wolff GG. Influenza vaccination and respiratory virus interference among department of defense personnel during the 2017–2018 influenza season. Vaccine. 2020;38:350–354.
- Hollm-Delgado M-G, Stuart EA, Black RE. Acute lower respiratory infection among Bacille Calmette-Guérin (BCG)–vaccinated children. Pediatrics. 2014;133:e73–81.
- Hegarty PK, Sfakianos JP, Giannarini G, et al. COVID-19 and Bacillus Calmette-Guérin: what is the link? Eur Urol Oncol. 2020;3:259–261.
- Redelman-Sidi G. Could BCG be used to protect against COVID-19? Nat Rev Urol. 2020 Jun;17(6):316–317.
- Gursel M, Gursel I. Is global BCG vaccination-induced trained immunity relevant to the progression of SARS-CoV-2 pandemic? Allergy Eur Allergy. 2020 Jul;75(7):1815–1819.
- Cohen IR. Antigenic mimicry, clonal selection and autoimmunity. J Autoimmun. 2001 May;16(3):337–340.
- Segal Y, Shoenfeld Y. Vaccine-induced autoimmunity: the role of molecular mimicry and immune crossreaction. Cell Mol Immunol. 2018 Jun;15(6):586–594.
- Tough DF, Borrow P, Sprent J. Induction of bystander T cell proliferation by viruses and Type I interferon in vivo. Science. 1996 Jun 28;272(5270):1947–1950.
- Beverley PCL. Is T-cell memory maintained by crossreactive stimulation? Immunol Today. 1990 Jun;11(6):203–205.
- Matzinger P. Memories are made of this? Nature. 1994 Jun 23;369(6482):605–606.
- Unutmaz D, Pileri P, Abrignani S. Antigen-independent activation of naive and memory resting T cells by a cytokine combination. J Exp Med. 1994 Sep 1;180(3):1159–1164.
- Netea MG, Quintin J, Van Der Meer JWM. Trained immunity: A memory for innate host defense. Cell Host Microbe. 2011;9:355–361.
- Netea MG, Domínguez-Andrés J, Barreiro LB, et al. Defining trained immunity and its role in health and disease. Nat Rev Immunol. 2020 Jun;20(6):375–388.
- Netea MG, Joosten LAB, Latz E, et al. Trained immunity: A program of innate immune memory in health and disease. Science. 2016 Apr 22;352(6284):aaf1098.
- Kleinnijenhuis J, Quintin J, Preijers FJ, et al. Bacille Calmette-Guérin induces NOD2-dependent nonspecific protection from reinfection via epigenetic reprogramming of monocytes. Proc Natl Acad Sci U S A. 2012 Oct 23;109(43):17537–17542.
- Cook PC, MacDonald AS. Dendritic cells in lung immunopathology. Semin Immunopathol. 2016 Jul;38(4):449–460.
- Hamiel U, Kozer E. Youngster I. SARS-CoV-2 rates in BCG-vaccinated and unvaccinated young adults. JAMA. 2020 May 13;323(22):2340–2341.
- Clement CG, Evans SE, Evans CM, et al. Stimulation of lung innate immunity protects against lethal pneumococcal pneumonia in mice. Am J Respir Crit Care Med. 2008 Jun 15;177(12):1322–1330.
- Evans SE, Xu Y, Tuvim MJ, et al. Inducible innate resistance of lung epithelium to infection. Annu Rev Physiol. 2010;72:413–435.
- World Health Organization. Types of seasonal influenza vaccine [Internet]. 2020 [cited 2020 Sep 9]. Available from: https://www.euro.who.int/en/health-topics/communicable-diseases/influenza/vaccination/types-of-seasonal-influenza-vaccine
- World Health Organization. Recommendations on Influenza Vaccination During the 2019–2020 Winter Season [Internet]. 2019 [cited 2020 Sep 9]. Available from: https://www.euro.who.int/en/health-topics/communicable-diseases/influenza/publications/2019/recommendations-on-influenza-vaccination-during-the-20192020-winter-season-2019
- Electronic Medicines Compendium (eMC). Adjuvanted Trivalent Influenza Vaccine (Surface Antigen, Inactivated) Suspension for Injection in Pre-filled Syringe Influenza Vaccine, Adjuvanted with MF59C.1 [Internet]. 2020 [cited 2020 Sep 9]. Available from: https://www.medicines.org.uk/emc/product/10444/smpc#PHARMACOLOGICAL_PROPS
- Electronic Medicines Compendium (eMC). Fluarix Tetra suspension for injection in pre-filled syringe [Internet]. 2020 [cited 2020 Sep 9]. Available from: https://www.medicines.org.uk/emc/product/3021/smpc
- (eMC) EMC. Trivalent Influenza Vaccine (Split Virion, Inactivated) High Dose [Internet]. 2019 [cited 2020 Sep 9]. Available from: https://www.medicines.org.uk/emc/product/10012/smpc
- European Medicines Agency. EPAR summary for the public: Fluenz Tetra [Internet]. 2016 [cited 2020 Sep 9]. Available from: https://www.ema.europa.eu/en/medicines/human/EPAR/fluenz-tetra
- Mohn KG-I, Smith I, Sjursen H, et al. Immune responses after live attenuated influenza vaccination. Hum Vaccin Immunother. 2018 Mar 4;14(3):571–578.
- Marín-Hernández D, Schwartz RE, Nixon DF. Epidemiological evidence for association between higher influenza vaccine uptake in the elderly and lower COVID-19 deaths in Italy. J Med Virol. 2020 Jun 4. DOI:10.1002/jmv.26120.
- Zanettini C, Omar M, Dinalankara W, et al. Influenza vaccination and COVID19 mortality in the USA. medRxiv [Preprint]. 2020 Jun 26.
- Hui KPY, Cheung MC, Perera RAPM, et al. Tropism, replication competence, and innate immune responses of the coronavirus SARS-CoV-2 in human respiratory tract and conjunctiva: an analysis in ex-vivo and in-vitro cultures. Lancet Respir Med. 2020 Jul;8(7):687–695.
- Thindwa D, Garcia Quesada M, Liu Y, et al. Use of seasonal influenza and pneumococcal polysaccharide vaccines in older adults to reduce COVID-19 mortality. Vaccine. 2020 Jul 22;38(34):5398–5401.
- World Health Organization. Q&A: Influenza and COVID-19 - similarities and differences [Internet]. 2020 [cited 2020 Sep 9]. Available from: https://www.who.int/emergencies/diseases/novel-coronavirus-2019/question-and-answers-hub/q-a-detail/q-a-similarities-and-differences-covid-19-and-influenza
- Australian Government - Department of Health. How to protect yourself and others from coronavirus (COVID-19) [Internet]. 2020 [cited 2020 Sep 9]. Available from: https://www.health.gov.au/news/health-alerts/novel-coronavirus-2019-ncov-health-alert/how-to-protect-yourself-and-others-from-coronavirus-covid-19
- Italian Ministry of Health. Covid-19 - Che cos’è il nuovo coronavirus [Internet]. [cited 2020 Sep 9]. Available from: http://www.salute.gov.it/portale/malattieInfettive/dettaglioFaqMalattieInfettive.jsp?lingua=italiano&id=228
- Zhou F, Yu T, Du R, et al. Clinical course and risk factors for mortality of adult inpatients with COVID-19 in Wuhan, China: a retrospective cohort study. Lancet. 2020 Mar 28;395(10229):1054–1062.
- Du Y, Tu L, Zhu P, et al. Clinical features of 85 fatal cases of COVID-19 from Wuhan: A retrospective observational study. Am J Respir Crit Care Med. 2020;201(11):1372–1379.
- Centers for Disease Control and Prevention. Pneumococcal Vaccination [Internet]. [cited 2020 Sep 9]. Available from: https://www.cdc.gov/vaccines/vpd/pneumo/index.html
- (eMC) EMC. Pneumococcal Polysaccharide Vaccine [Internet]. 2019 [cited 2020 Sep 9]. Available from: https://www.medicines.org.uk/emc/medicine/1446/SPC/Pneumovax%2BII/
- World Health Organization. Introduction of pneumococcal vaccine PCV13. A handbook for district and health facility staff [Internet]. [cited 2020 Sep 9]. Available from: https://apps.who.int/iris/bitstream/handle/10665/90380/WHO_IVB_13.10_eng.pdf?sequence=1
- Feldman C, Anderson R. The role of streptococcus pneumoniae in community-acquired pneumonia. Semin Respir Crit Care Med. 2020;41:455–469.
- Ferner RE, Aronson JK. Chloroquine and hydroxychloroquine in covid-19. BMJ. 2020 Apr 8;369: m1432.
- Metlay JP, Waterer GW. Update in adult community-acquired pneumonia. Curr Opin Pulm Med. 2020 May;26(3):203–207.
- Bonten MJM, Huijts SM, Bolkenbaas M, et al. Polysaccharide conjugate vaccine against pneumococcal pneumonia in adults. N Engl J Med. 2015 Mar 19;372(12):1114–1125.
- Rossi PG, Ferroni E, Alegiani SS, et al. Survival of hospitalized COVID-19 patients in Northern Italy a population-based cohort study by the ITA-COVID19 network. Medrxiv. 2020. DOI:10.1101/2020.05.15.20103119.
- Mendelson M. Could enhanced influenza and pneumococcal vaccination programs help limit the potential damage from SARS-CoV-2 to fragile health systems of southern hemisphere countries this winter? Int J Infect Dis. 2020 May;94:32–33.
- Palacios G, Hornig M, Cisterna D, et al. Streptococcus pneumoniae coinfection is correlated with the severity of H1N1 pandemic influenza. PLoS One. 2009 Dec 31;4(12):e8540.
- World Health Organization. Coronavirus disease (COVID-19) advice for the public: Mythbusters [Internet]. 2020 [cited 2020 Sep 9]. Available from: https://www.who.int/emergencies/diseases/novel-coronavirus-2019/advice-for-public/myth-busters
- NSW Government. Immunisation services during COVID-19 [Internet]. 2020 [cited 2020 Sep 9]. Available from: https://www.health.nsw.gov.au/immunisation/Pages/vaccination-advice-during-covid-19.aspx
- Luca S, Mihaescu T. History of BCG vaccine. Maedica (Buchar). 2013 Mar;8(1):53–58.
- Electronic Medicines Compendium (eMC). BCG Vaccine AJV [Internet]. 2020 [cited 2020 Sep 9]. Available from: https://www.medicines.org.uk/emc/product/9890#PRODUCTINFO
- Leentjens J, Kox M, Stokman R, et al. BCG vaccination enhances the immunogenicity of subsequent influenza vaccination in healthy volunteers: A randomized, placebo-controlled pilot study. J Infect Dis. 2015 Dec 15;212(12):1930–1938.
- Moorlag SJCFM, Arts RJW, van Crevel R, et al. Non-specific effects of BCG vaccine on viral infections. Clin Microbiol Infect. 2019 Dec;25(12):1473–1478.
- O’Neill LAJ, Netea MG. BCG-induced trained immunity: can it offer protection against COVID-19? Nat Rev Immunol. 2020 Jun;20(6):335–337.
- Netea MG, Giamarellos-Bourboulis EJ, Domínguez-Andrés J, et al. Trained immunity: a tool for reducing susceptibility to and the severity of SARS-CoV-2 infection. Cell. 2020 May 28;181(5):969–977.
- Osama El-Gendy A, Saeed H, Ali AMA, et al. Bacillus Calmette–Guérin vaccine, antimalarial, age and gender relation to COVID-19 spread and mortality. Vaccine. 2020;38:5564–5568.
- Klinger D, Blass I, Rappoport N, et al. Significantly improved COVID-19 outcomes in countries with higher BCG vaccination coverage: a multivariable analysis. medRxiv. 2020. DOI:10.1101/2020.04.23.20077123
- World Health Organization. Bacille Calmette-Guérin (BCG) vaccination and COVID-19 [Internet]. 2020 [cited 2020 Sep 9]. Available from: https://www.who.int/publications/i/item/bacille-calmette-guérin-(bcg)-vaccination-and-covid-19
- Lurie N, Saville M, Hatchett R, et al. Developing covid-19 vaccines at pandemic speed. N Engl J Med. 2020 May 21;382(21):1969–1973.
- National Institute of Allergy and Infectious Diseases. NIH Clinical Trial of Investigational Vaccine for COVID-19 Begins [Internet]. 2020 [cited 2020 Sep 9]. Available from: https://www.nih.gov/news-events/news-releases/nih-clinical-trial-investigational-vaccine-covid-19-begins
- Long QX, Liu BZ, Deng HJ, et al. Antibody responses to SARS-CoV-2 in patients with COVID-19. Nat Med. 2020 Jun;26(6):845–848.
- McMichael TM, Currie DW, Clark S, et al. Epidemiology of covid-19 in a long-term care facility in King County, Washington. N Engl J Med. 2020 May 21;382(21):2005–2011.
- Graham BS. Rapid COVID-19 vaccine development. Science. 2020 May 29;368(6494):945–946.
- Corey L, Mascola JR, Fauci AS, et al. A strategic approach to COVID-19 vaccine R&D. Science. 2020 May 29;368(6494):948–950.
- Thanh LT, Andreadakis Z, Kumar A, et al. The COVID-19 vaccine development landscape. Nat Rev Drug Discov. 2020 May;19(5):305–306.
- World Health Organization. Draft landscape of COVID-19 candidate vaccines [Internet]. 2020 [cited 2020 Sep 9]. Available from: https://www.who.int/publications/m/item/draft-landscape-of-covid-19-candidate-vaccines
- World Health Organization. Vaccine safety basics – learning manual [Internet]. 2013 [cited 2020 Sep 9]. Available from: https://www.who.int/vaccine_safety/initiative/tech_support/Vaccine-safety-E-course-manual.pdf
- Ropeik D. How society should respond to the risk of vaccine rejection. Hum Vaccin Immunother. 2013 Aug;9(8):1815–1818.
- European Medicines Agency. Guideline on good pharmacovigilance practices (GVP). Product- or Population-Specific Considerations I: Vaccines for prophylaxis against infectious diseases [Internet]. 2013 [cited 2020 Sep 9]. Available from: https://www.ema.europa.eu/en/documents/other/guideline-good-pharmacovigilance-practices-gvp-product-population-specific-considerations-i-vaccines_en.pdf
- World Health Organization. Definition and Application of Terms for Vaccine Pharmacovigilance [Internet]. 2012 [cited 2020 Sep 9]. Available from: https://www.who.int/vaccine_safety/initiative/tools/CIOMS_report_WG_vaccine.pdf?ua=1
- Trifirò G, Coloma PM, Rijnbeek PR, et al. Combining multiple healthcare databases for postmarketing drug and vaccine safety surveillance: why and how? J Intern Med. 2014 Jun;275(6):551–561.
- European Medicines Agency. Guideline on good pharmacovigilance practices (GVP): Module VI - collection, management and submission of reports of suspected adverse reactions to medicinal products (Rev 2). [Internet]. 2017 [cited 2020 Sep 9]. Available from: https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-good-pharmacovigilance-practices-gvp-module-vi-collection-management-submission-reports_en.pdf
- Vestergaard LS, Nielsen J, Richter L, et al. Excess all-cause mortality during the COVID-19 pandemic in Europe - preliminary pooled estimates from the EuroMOMO network, March to April 2020. Euro Surveill. 2020;25:26.
- Istituto Nazionale di Statistica (ISTAT). Impatto dell’epidemia COVID-19 sulla mortalità totale della popolazione residente - Primo Trimestre 2020 [Internet]. 2020 [cited 2020 Sep 9]. Available from: https://www.istat.it/it/files//2020/07/Rapp_Istat_Iss_9luglio.pdf
- Sanyaolu A, Okorie C, Marinkovic A, et al. Comorbidity and its impact on patients with COVID-19. SN Compr Clin Med. 2020;25:1–8.
- Istituto Superiore di Sanità. Characteristics of SARS-CoV-2 patients dying in Italy Report based on available data on May 14th, 2020 [Internet]. 2020 [cited 2020 Sep 9]. Available from: https://www.epicentro.iss.it/en/coronavirus/bollettino/Report-COVID-2019_14_May_2020.pdf
- Esposito S, Principi N, Rezza G, et al. Vaccination of 50+ adults to promote healthy ageing in Europe: the way forward. Vaccine. 2018 Sep 18;36(39):5819–5824.
- Maggi S. Vaccination and healthy aging. Expert Rev Vaccines. 2010 Mar;9(3 Suppl):3–6.
- Joseph C, Togawa Y, Shindo N. Bacterial and viral infections associated with influenza. Influenza Other Respir Viruses. 2013 Sep 7 [cited 2020 Sep 9];(Suppl2):105–113.
- European Centre for Disease Prevention and Control. Preparedness planning [Internet]. [cited 2020 Sep 9]. Available from: https://www.ecdc.europa.eu/en/all-topics-z/preparedness/preparedness-planning
- Italian Ministry of Health. National Plan for Preparedness and Respons to an Influenza Pandemic [Internet]. 2020 [cited 2020 Sep 9]. Available from: http://www.salute.gov.it/imgs/C_17_pubblicazioni_511_allegato.pdf
- Bell L, Peters L, Heffelfinger JD, et al. Preparedness for influenza vaccination during a pandemic in the World Health Organization Western Pacific region. Western Pac Surveill Response J. 2018 Dec 20;9(5 Suppl 1):11–14.
- Jorgensen P, Mereckiene J, Cotter S, et al. How close are countries of the WHO European region to achieving the goal of vaccinating 75% of key risk groups against influenza? Results from national surveys on seasonal influenza vaccination programmes, 2008/2009 to 2014/2015. Vaccine. 2018 Jan 25;36(4):442–452.
- Rebmann T, Zelicoff A. Vaccination against influenza: role and limitations in pandemic intervention plans. Expert Rev Expert Rev Vaccines. 2012 Aug;11(8):1009–1019.
- Rizzo C, Rota MC, Bella A, et al. Response to the 2009 influenza A (H1N1) pandemic in Italy. Euro Surveill. 2010 Dec 9;15(49):19744.
- Cloes R, Ahmad A, Reintjes R. Risk communication during the 2009 influenza A (H1N1) pandemic: stakeholder experiences from eight European countries. Disaster Med Public Health Prep. 2015 Apr;9(2):127–133.
- Verger P, Fressard L, Cortaredona S, et al. Trends in seasonal influenza vaccine coverage of target groups in France, 2006/07 to 2015/16: impact of recommendations and 2009 influenza A(H1N1) pandemic. Euro Surveill. 2018 Nov;23(48):1700801.
- Bramer CA, Kimmins LM, Swanson R, et al. Decline in child vaccination coverage during the COVID-19 pandemic - Michigan care improvement registry, May 2016-May 2020. MMWR Morb Mortal Wkly Rep. 2020 May 22;69(20):630–631.
- McDonald HI, Tessier E, White JM, et al. Early impact of the coronavirus disease (COVID-19) pandemic and physical distancing measures on routine childhood vaccinations in England, January to April 2020. Euro Surveill. 2020;25(19):2000848.
- Siedner MJ, Kraemer JD, Meyer MJ, et al. Access to primary healthcare during lockdown measures for COVID-19 in rural South Africa: a longitudinal cohort study. medRxiv [Preprint]. 2020 May 20.
- Hungerford D, Cunliffe NA. Coronavirus disease (COVID-19) – impact on vaccine preventable diseases. Euro Surveill. 2020 May;25(18):2000756.
- Li Q, Tang B, Bragazzi NL, et al. Modeling the impact of mass influenza vaccination and public health interventions on COVID-19 epidemics with limited detection capability. Math Biosci. 2020 Jul;325:108378.
- Food and Drug Administration. FDA information regarding FluMist quadrivalent vaccine. 2018 [cited 2020 Sep 24]. Available from: https://www.fda.gov/vaccines-blood-biologics/vaccines/fda-information-regarding-flumist-quadrivalent-vaccine
- Metlay JP, Waterer GW, Long AC, et al. Diagnosis and treatment of adults with community-acquired pneumonia. Am J Respir Crit Care Med. 2019;200:E45–67.
- Wang L, He W, Yu X, et al. Coronavirus disease 2019 in elderly patients: characteristics and prognostic factors based on 4-week follow-up. J Infect. 2020 Jun;80(6):639–645.
- Barrasa H, Rello J, Tejada S, et al. SARS-CoV-2 in Spanish intensive care units: early experience with 15-day survival in Vitoria. Anaesth Crit Care Pain Med. 2020 Apr 9;S2352–5568(20)30064–3.
- Palmieri L, Vanacore N, Donfrancesco C, et al. Clinical characteristics of hospitalized individuals dying with COVID-19 by age group in Italy. J Gerontol A Biol Sci Med Sci. J Gerontol A Biol Sci Med Sci. 2020 Sep 16;75(9):1796–1800.
- Trifirò G, Gini R, Barone-Adesi F, et al. The role of European healthcare databases for post-marketing drug effectiveness, safety and value evaluation: where does Italy stand? Drug Saf. 2019 Mar;42(3):347–363.
- Gadroen K, Dodd CN, Masclee GMC, et al. Impact and longevity of measles-associated immune suppression: A matched cohort study using data from the THIN general practice database in the UK. BMJ Open. 2018 Nov 8;8(11):e021465.
- Vermeer-de Bondt PE, Schoffelen T, Vanrolleghem AM, et al. Coverage of the 2011 Q fever vaccination campaign in the Netherlands, using retrospective population-based prevalence estimation of cardiovascular risk-conditions for chronic Q fever. PLoS One. 2015 Apr 24;10(4):e0123570.
- Braeye T, Bauchau V, Sturkenboom M, et al. Estimation of vaccination coverage from electronic healthcare records; methods performance evaluation – A contribution of the ADVANCE-project. PLoS One. 2019 Sep 18;14(9):e0222296.
- Dodd CN, De Ridder M, Huang WT, et al. Incidence rates of narcolepsy diagnoses in Taiwan, Canada, and Europe: the use of statistical simulation to evaluate methods for the rapid assessment of potential safety issues on a population level in the SOMNIA study. PLoS One. 2018 Oct 17;13(10):e0204799.
- Weibel D, Sturkenboom M, Black S, et al. Narcolepsy and adjuvanted pandemic influenza A (H1N1) 2009 vaccines – multi-country assessment. Vaccine. 2018 Oct 1;36(41):6202–6211.
- Bollaerts K, de Smedt T, McGee C, et al. ADVANCE: towards near real-time monitoring of vaccination coverage, benefits and risks using European electronic health record databases. Vaccine. 2019 Oct 31;S0264–410X(19)31051–5.
- European Medicines Agency. EMA commissions independent research to prepare for real-world monitoring of COVID-19 vaccines [Internet]. 2020 [cited 2020 Sep 9]. Available from: https://www.ema.europa.eu/en/news/ema-commissions-independent-research-prepare-real-world-monitoring-covid-19-vaccines