1887
Surveillance Open Access
Like 0

Abstract

Background

Unavailability of vaccines endangers the overall goal to protect individuals and whole populations against infections.

Methods

The German notification system includes the publication of vaccine supply shortages reported by marketing authorisation holders (MAH), information on the availability of alternative vaccine products, guidance for physicians providing vaccinations and an unavailability reporting tool to monitor regional distribution issues.

Aim

This study provides a retrospective analysis of supply issues and measures in the context of European and global vaccine supply constraints.

Results

between October 2015 and December 2020, the 250 notifications concerned all types of vaccines (54 products). Most shortages were caused by increased demand associated with immigration in Germany in 2015 and 2016, new or extended vaccine recommendations, increased awareness, or changes in global immunisation programmes. Shortages of a duration up to 30 days were mitigated using existing storage capacities. Longer shortages, triggered by high demand on a national level, were mitigated using alternative products and re-allocation; in a few cases, vaccines were imported. However, for long lasting supply shortages associated with increased global demand, often occurring in combination with manufacturing issues, few compensatory mechanisms were available. Nevertheless, only few critical incidents were identified: (i) shortage of hexavalent vaccines endangering neonatal immunisation programmes in 2015;(ii) distribution issues with influenza vaccines in 2018; and (iii) unmet demand for pneumococcal and influenza vaccines during the coronavirus disease (COVID)-19 pandemic.

Conclusion

Vaccine product shortages in Germany resemble those present in neighbouring EU states and often reflect increased global demand not matched by manufacturing capacities.

Loading

Article metrics loading...

/content/10.2807/1560-7917.ES.2022.27.17.2100167
2022-04-28
2022-05-23
http://instance.metastore.ingenta.com/content/10.2807/1560-7917.ES.2022.27.17.2100167
Loading
Loading full text...

Full text loading...

/deliver/fulltext/eurosurveillance/27/17/eurosurv-27-17-2.html?itemId=/content/10.2807/1560-7917.ES.2022.27.17.2100167&mimeType=html&fmt=ahah

References

  1. Doherty M, Schmidt-Ott R, Santos JI, Stanberry LR, Hofstetter AM, Rosenthal SL, et al. Vaccination of special populations: Protecting the vulnerable. Vaccine. 2016;34(52):6681-90.  https://doi.org/10.1016/j.vaccine.2016.11.015  PMID: 27876197 
  2. Iyengar S, Hedman L, Forte G, Hill S. Medicine shortages: a commentary on causes and mitigation strategies. BMC Med. 2016;14(1):124.  https://doi.org/10.1186/s12916-016-0674-7  PMID: 27683105 
  3. Gibson JL, Bean S, Chidwick P, Godkin D, Sibbald RW, Wagner F. Ethical framework for resource allocation during a drug supply shortage. Healthc Q. 2012;15(3):26-35.  https://doi.org/10.12927/hcq.2013.23040  PMID: 22986563 
  4. Wouters OJ, Shadlen KC, Salcher-Konrad M, Pollard AJ, Larson HJ, Teerawattananon Y, et al. Challenges in ensuring global access to COVID-19 vaccines: production, affordability, allocation, and deployment. Lancet. 2021;397(10278):1023-34.  https://doi.org/10.1016/S0140-6736(21)00306-8  PMID: 33587887 
  5. Jahn B, Sroczynski G, Bicher M, Rippinger C, Mühlberger N, Santamaria J, et al. Targeted COVID-19 Vaccination (TAV-COVID) Considering Limited Vaccination Capacities-An Agent-Based Modeling Evaluation. Vaccines (Basel). 2021;9(5):434.  https://doi.org/10.3390/vaccines9050434  PMID: 33925650 
  6. Privor-Dumm LA, Poland GA, Barratt J, Durrheim DN, Deloria Knoll M, Vasudevan P, et al. A global agenda for older adult immunization in the COVID-19 era: A roadmap for action. Vaccine. 2021;39(37):5240-50.  https://doi.org/10.1016/j.vaccine.2020.06.082  PMID: 32703743 
  7. Dinleyici EC, Borrow R, Safadi MAP, van Damme P, Munoz FM. Vaccines and routine immunization strategies during the COVID-19 pandemic. Hum Vaccin Immunother. 2021;17(2):400-7.  https://doi.org/10.1080/21645515.2020.1804776  PMID: 32845739 
  8. World Health Organization Regional Office for Europe (WHO/Europe). The organization and delivery of vaccination services in the European Union (2018). Copenhagen: WHO/Europe; 2018. Available from: https://www.euro.who.int/en/publications/abstracts/the-organization-and-delivery-of-vaccination-services-in-the-european-union-2018
  9. U.S. Food and Drug Administration. Drug Shortages: Root Causes and Potential Solutions; 2019. Washington: U.S. Food and Drug Administration; Oct 2019. Available from: https://www.fda.gov/drugs/drug-shortages/report-drug-shortages-root-causes-and-potential-solutions
  10. Danzon PM, Pereira NS, Tejwani SS. Vaccine supply: a cross-national perspective. Health Aff (Millwood). 2005;24(3):706-17.  https://doi.org/10.1377/hlthaff.24.3.706  PMID: 15886165 
  11. Ridley DB, Bei X, Liebman EB. No Shot: US Vaccine Prices And Shortages. Health Aff (Millwood). 2016;35(2):235-41.  https://doi.org/10.1377/hlthaff.2015.0420  PMID: 26858375 
  12. Preiss S, Garçon N, Cunningham AL, Strugnell R, Friedland LR. Vaccine provision: Delivering sustained & widespread use. Vaccine. 2016;34(52):6665-71.  https://doi.org/10.1016/j.vaccine.2016.10.079  PMID: 27884478 
  13. Vidor E, Soubeyrand B. Manufacturing DTaP-based combination vaccines: industrial challenges around essential public health tools. Expert Rev Vaccines. 2016;15(12):1575-82.  https://doi.org/10.1080/14760584.2016.1205492  PMID: 27345296 
  14. World Health Organization (WHO). Meeting of the Strategic Advisory Group of Experts on immunization, April 2016 – conclusions and recommendations. Wkly Epidemiol Rec. 2016;91(21):266-84. PMID: 27236869 
  15. The Lancet. The Lancet. Addressing decreasing vaccine coverage in the EU. Lancet. 2018;391(10131):1638.  https://doi.org/10.1016/S0140-6736(18)30942-5 
  16. Eurordis. Common Position adopted for preventing, managing and solving medicine shortages. Brussels: Eurordis; 23 Oct 2013. Available from: https://www.eurordis.org/content/common-position-adopted-preventing-managing-and-solving-medicine-shortages
  17. The Council of the European Union. Council Recommendation of 7 Dec 2018 on strengthened cooperation against vaccine-preventable diseases (2018/C 466/01). Brussels: The Council of the European Union; 7 Dec 2018. Available from: https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32018H1228(01)
  18. Musazzi UM, Di Giorgio D, Minghetti P. New regulatory strategies to manage medicines shortages in Europe. Int J Pharm. 2020;579:119171.  https://doi.org/10.1016/j.ijpharm.2020.119171  PMID: 32092455 
  19. Filia A, Rota MC, Grossi A, Martinelli D, Prato R, Rezza G. Are vaccine shortages a relevant public health issue in Europe? Results from a survey conducted in the framework of the EU Joint Action on Vaccination. Vaccine. 2022;40(13):1987-95.  https://doi.org/10.1016/j.vaccine.2022.02.041  PMID: 35190211 
  20. Bogaert P, Bochenek T, Prokop A, Pilc A. A Qualitative Approach to a Better Understanding of the Problems Underlying Drug Shortages, as Viewed from Belgian, French and the European Union’s Perspectives. PLoS One. 2015;10(5):e0125691.  https://doi.org/10.1371/journal.pone.0125691  PMID: 25942432 
  21. European Medicines Agency (EMA). Annual Report 2019: The European Medicines Agency’s contribution to science, medicines and health in 2019; Amsterdam: EMA; 2020. Available from: https://www.ema.europa.eu/en/annual-report-2019/index.html
  22. Ali I. Impact of COVID-19 on vaccination programs: adverse or positive? Hum Vaccin Immunother. 2020;16(11):2594-600.  https://doi.org/10.1080/21645515.2020.1787065  PMID: 32961081 
  23. Ständige Impfkommission (Standing Committee on Vaccination). Beschluss der STIKO zur 12. Aktualisierung der COVID-19-Impfempfehlung. [Recommendation of the Standing Committee on Vaccination on the 12th revision of the COVID19 vaccine recommendation]. Berlin: Rober Koch Institute; 18 Oct 2021. German.
  24. Kim JH, Marks F, Clemens JD. Looking beyond COVID-19 vaccine phase 3 trials. Nat Med. 2021;27(2):205-11.  https://doi.org/10.1038/s41591-021-01230-y  PMID: 33469205 
  25. Miranda-Garcia MA, Götz KB, Ruhaltinger D, Cichutek K, Bekeredjian-Ding I. (Vaccine Supply Shortages: Insight into Numbers and Background). Lieferengpässe von Impfstoffen: Einblick in Zahlen und Hintergründe. Dtsch Arztebl. 2017;114(17):A-844-8.
  26. Yaqub O, Castle-Clarke S, Sevdalis N, Chataway J. Attitudes to vaccination: a critical review. Soc Sci Med. 2014;112:1-11.  https://doi.org/10.1016/j.socscimed.2014.04.018  PMID: 24788111 
  27. Forster AS, Rockliffe L, Chorley AJ, Marlow LAV, Bedford H, Smith SG, et al. A qualitative systematic review of factors influencing parents’ vaccination decision-making in the United Kingdom. SSM Popul Health. 2016;2:603-12.  https://doi.org/10.1016/j.ssmph.2016.07.005  PMID: 28018959 
  28. Rieck T, Feig M, Wichmann O, Siedler A. Impfquoten von Kinderschutzimpfungen in Deutschland – aktuelle Ergebnisse aus der RKI-Impfsurveillance. [Vaccination Rates in Pediatric Vaccinations in Germany - Recent Results from the RKI Vaccination Surveillance]. Berlin: Robert Kock Institute; 6 Aug 2020.German.
  29. Lydon P, Schreiber B, Gasca A, Dumolard L, Urfer D, Senouci K. Vaccine stockouts around the world: Are essential vaccines always available when needed? Vaccine. 2017;35(17):2121-6.  https://doi.org/10.1016/j.vaccine.2016.12.071  PMID: 28364919 
  30. Li Z, Xu J, Xu J, Tan H, Zhang C. Current situation, causes, and countermeasures to NIP vaccine shortages in Guangzhou, China. Hum Vaccin Immunother. 2020;16(1):76-9.  https://doi.org/10.1080/21645515.2019.1644883  PMID: 31403888 
  31. Kretzschmar E, Muckenfuss H, Pfleiderer M. Official batch control of influenza vaccines: Is it still useful? Vaccine. 2018;36(17):2364-70.  https://doi.org/10.1016/j.vaccine.2018.02.078  PMID: 29580639 
  32. World Health Organization (WHO). Global Vaccine Action Plan. Monitoring, Evaluation and Accountability: Secretariat Annual Report. Geneva: WHO; 2017. Available from: https://www.nitag-resource.org/sites/default/files/ec25a0767549d01a94624681aa2a44be010f7249_1.pdf
  33. World Health Organization (WHO). Global Vaccine Action Plan. Monitoring, Evaluation & Accountability: Secretariat Annual Report. Geneva: WHO; 2016.
  34. Lewis I, Ottosen A, Rubin J, Blanc DC, Zipursky S, Wootton E. A Supply and Demand Management Perspective on the Accelerated Global Introductions of Inactivated Poliovirus Vaccine in a Constrained Supply Market. J Infect Dis. 2017;216(suppl_1):S33-9.  https://doi.org/10.1093/infdis/jiw550  PMID: 28838159 
  35. Sutter RW, Cochi SL. Inactivated Poliovirus Vaccine Supply Shortage: Is There Light at the End of the Tunnel? J Infect Dis. 2019;220(10):1545-6.  https://doi.org/10.1093/infdis/jiy739  PMID: 30958545 
  36. Zipursky S, Patel M, Farrell M, Gonzalez AR, Kachra T, Folly Y, et al. Lessons Learned From Managing the Planning and Implementation of Inactivated Polio Vaccine Introduction in Support of the Polio Endgame. J Infect Dis. 2017;216(suppl_1):S15-23.  https://doi.org/10.1093/infdis/jix185  PMID: 28838203 
  37. Vaccines Europe. From vaccines shortages to sustainable vaccine supply: Vaccines Europe Position. Brussels: Vaccines Europe. 29 Apr 2016. Available from: https://www.vaccineseurope.eu/
  38. Ziesenitz VC, Mazer-Amirshahi M, Zocchi MS, Fox ER, May LSUS. U.S. vaccine and immune globulin product shortages, 2001-15. Am J Health Syst Pharm. 2017;74(22):1879-86.  https://doi.org/10.2146/ajhp170066  PMID: 28970246 
  39. Foster M, Ramachandran S, Myatt K, Donovan D, Bohm S, Fiedler J, et al. Hepatitis A Virus Outbreaks Associated with Drug Use and Homelessness - California, Kentucky, Michigan, and Utah, 2017. MMWR Morb Mortal Wkly Rep. 2018;67(43):1208-10.  https://doi.org/10.15585/mmwr.mm6743a3  PMID: 30383739 
  40. Mandal S, Edelstein M, Ramsay M. Public health leadership in the UK’s response to hepatitis A and hepatitis B vaccine shortages. Vaccine. 2020;38(19):3515-6.  https://doi.org/10.1016/j.vaccine.2020.01.010  PMID: 31948821 
  41. Matthews PC, Barnes E. Hepatitis B vaccine shortage: another symptom of chronic neglect? BMJ. 2017;359j4686. PMID 29051262.
  42. Collier R. No end in sight for adult hepatitis B vaccine shortage. CMAJ. 2010;182(12):E580.  https://doi.org/10.1503/cmaj.109-3324  PMID: 20682737 
  43. Miranda-Garcia M, Cichutek K, Bekeredjian-Ding I. Wie lange bleibt der Kühlschrank leer?: Das Paul-Ehrlich-Institut analysierte die Lieferengpässe bei Reiseimpfstoffen. Dtsch Apoth Ztg. 2017; (51):24-5.
  44. Kmietowicz Z. Measles: Europe sees record number of cases and 37 deaths so far this year. BMJ. 2018;362k3596. PMID 30126938
  45. Dubé E, Laberge C, Guay M, Bramadat P, Roy R, Bettinger J. Vaccine hesitancy: an overview. Hum Vaccin Immunother. 2013;9(8):1763-73.  https://doi.org/10.4161/hv.24657  PMID: 23584253 
  46. Torjesen I. Flu vaccine shortages: NHS England must improve planning to avoid a repeat of this year's delays. BMJ. 2018;363k4547 PMID 30373915.
  47. Arie S. HPV: WHO calls for countries to suspend vaccination of boys. BMJ. 2019;367l6765. PMID 31792022.
  48. Doherty M, Buchy P, Standaert B, Giaquinto C, Prado-Cohrs D. Vaccine impact: Benefits for human health. Vaccine. 2016;34(52):6707-14.  https://doi.org/10.1016/j.vaccine.2016.10.025  PMID: 27773475 
  49. Ndaya-Oloo P, Pitisuttithum P, Tornieporth NG, Desgrandchamps D, Munoz FM, Kochhar S, et al. Vaccine Update: Recent Progress With Novel Vaccines, and New Approaches to Safety Monitoring and Vaccine Shortage. J Clin Pharmacol. 2018;58 Suppl 10S123-S139. PMID 30248195.
/content/10.2807/1560-7917.ES.2022.27.17.2100167
Loading

Data & Media loading...

Supplementary data

Submit comment
Close
Comment moderation successfully completed
This is a required field
Please enter a valid email address
Approval was a Success
Invalid data
An Error Occurred
Approval was partially successful, following selected items could not be processed due to error