Survey on Hepatitis vaccine shortage among VHPB advisors. March 2018
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1 Survey on Hepatitis vaccine shortage among VHPB advisors March 2018
2 Questions Survey Hepatitis A vaccine Is there currently a hepatitis A vaccination shortage: Yes/No since: until: which type: Brand: Is there currently a Hepatitis A outbreak in which risk groups Are there prioritisation guidelines created Is there a need for prioritisation guidelines? Hepatitis B Is there currently a hepatitis B vaccination shortage: Yes/No since: until: which type: Brand: Are there prioritisation guidelines created Is there a need for prioritisation guidelines?
3 Public Health International organisation VHPB Advisors Nedret Emiroglu WHO-Eurov Antons Mozalevskis WHO-Euro Marc Bulterys WHO Erika Duffell ECDC Andrew Amato ECDC John Ward CDC Fiona Godfrey EASL Tatjana Reic ELPA Hans Blystad Norway David Goldberg Scotland Mira Kojouharova Bulgaria Johannes Hallauer Germany Silvia Bino Albania
4 Academic/University VHPB Advisors Paolo Bonanni Italy Vladimir Chulanov Russia Angela Dominguez Spain Wolfgang Jilg Germany Helène Norder Sweden Vana Papaevangelou Greece Mojca Maticic Slovenia Françoise Roudot- Thoraval France Rui Tato Morinho Portugal Daniel Shouval Israel Alessandro Zanetti Italy
5 Shortage Hepatitis A 13/17countries shortage NO shortage No Reply
6 Hepatitis A vaccine Country since Until Type Brand Belgium 4/ /07/2018 Havarix Not for Sanofi Bulgaria Croatia Last moths? Havarix France 11/2016 Havrix1440 (adult) / Greece 12/ /2018 Pediatric (Vaqta) Ped/adult Not for Israel 12/ /2018 Monovalent HAV HAVrix Italy 02/ / /2018 Avaxim Havrix Sanofi Norway Autum/2017 Adult dose Havrix() Vaqta(Sanofi) Avax Portugal Russia Slovenia replaced by Sanofi UK Mid 2017? Hep monovalent USA Summer 17 Spring 18 Merck production suspended unable to increase production
7 Hepatitis A vaccine Country since Until Type Brand Belgium 4/ /07/2018 Havarix Comment Belgium: Not for Sanofi - there is one more hep A vaccine from Merck: Bulgaria Croatia Last moths? Vaqta and Vaqta Junior (25U) is no longer available since Havarix 10/7/2017 till 31/5/2018. the adult form of Vaqta is available. France 11/2016 -pediatric form Havrix1440 of Avaxim(adult) is not on / the market in Greece 12/2017 Belgium 05/2018 Pediatric (Vaqta) Ped/adult Not for Israel 12/ /2018 Monovalent HAV HAVrix Italy 02/ /2018 Greece: limited amount of vaccines possible stock out in coming months 05/2018 Avaxim Havrix Sanofi Norway Autum/2017 Adult dose Havrix() Vaqta(Sanofi) Avax Portugal Russia Slovenia replaced by Sanofi Comment Slovenia: There is an increase in hepatitis A vaccination, mostly in MSM and, interestingly enough, in children (ie in January 2018 instead of usual 50 vaccines per month, there were 150 children vaccinated). No UK Mid 2017 shortage of combined HAV+HBV vaccine (Twinrix)? Hep monovalent was observed. USA Summer 17 Spring 18 Merck production suspended unable to increase production
8 Hepatitis A vaccine Country outbreak Guidelines Need for guidelines Belgium No No Usefull Bulgaria No No Yes Croatia France No (sporadic cases) Yes (since 03/17) No Greece No (sporadic cases) No Israel No Yes Yes Italy No No Usefull Norway Small in MSM Yes Usefull on national level not EU Portugal Russia 28 outbreaks of HAV registered NO Slovenia No No NO UK Outbreak linked to food yes USA Substance users/ Homeless Yes YES
9 recommendations France: guidelines for Haut conseil de la santé publicquea Israel: RECOMMENDED TO USE OF HAVRIX ONLY FOR SECOND DOSE, RECOMMENDED TWO SIMULTANEOUS DOSES OF HAVRIX JUNIOR UNTIL HAVRIX ADULT AVAILABLE (BOTH DOSE FORMS OF HAVRIX ARE CURRENTLY AVAILABLE, RETURNED TO STANDARD IMMUNIZATION PROCEDURES. WOULD BE WILLING TO CONSIDER UK GUIDELINES OF USING HAVRIX ) Norway: MSM and close contacts to cases prioritised. Alternative for travel related vaccination published: 1. Use of Twinrix 2. Use of Havrix720 EU (child dose) at 0,1 and 6-12 months for adults (off-label) (Italy During 2017 epidemics of hepatitis A, vaccination was primarly reccommended to people at higher risk (MSM) and to close contacts with patient with hepatitis A) USA
10 Shortage Hepatitis B shortage NO shortage No Reply
11 Hepatitis B vaccine Country since Until Type Brand Belgium 06/ /2017 Bulgaria Croatia France Since a year but replace product 03/ /2018 Engerix 20μg HBVaxPro 10ug Twinrix Greece 06/ /2018 adult HBVaxPro 10mcg/1ml Israel Italy 05/ / /2017 Norway 02/ /2018 Engerix 20μg HBVaxPro 10ug Twinrix No shortage No shortage for No shortage Portugal Russia Slovenia replaced by Sanofi UK June 2017 Summer 2018 HBV monovalent USA 12/2017 Adult one manufacturer - adult - through 2018; pediatric April 1, 2018 Merck
12 Hepatitis B vaccine Country since Until Type Brand Belgium 06/ /2017 Bulgaria Croatia France Since a year but replaced product 03/ /2018 Engerix 20μg HBVaxPro 10ug Twinrix Greece 06/ /2018 adult HBVaxPro 10mcg/1ml Israel Italy 05/ / /2017 Norway Portugal Russia Slovenia replaced by Sanofi 02/ /2018 UK June 2017 Summer 2018 Engerix 20μg HBVaxPro 10ug Twinrix No shortage No shortage for No shortage Slovenia: The authorities would like to increase a supply for the year 2018 compared to the year 2017, however both and Merck could provide only the amount mentioned in the previous year. To avoid possible future shortages, contracts have been already signed for the 2019 and 2020 suplies. USA 12/2017 Adult one manufacturer - adult - through 2018; pediatric April 1, 2018 Merck
13 Hepatitis B vaccine Country Guidelines Need for Guidelines Comments Belgium No Usefull FAGG, Belgian Regulatory Agency has all information on nonavailability of drugs and vaccins on her website: Bulgaria No Yes Croatia France Yes, created in march 2017, have been removed since March 1st 2018 NO Greece No Limited amount-possible stock out in the following months Israel No Italy No Usefull Norway No No Portugal Russia No NO The vaccine needs are covered mainly by two domestic manufacturers. Slovenia No Not so UK Yes USA No - supply from other manufacturer adequate Not at this time Dialysis formulation not affected
14 Company information (source: National Drug regulatory agencies and manufacturers) Hepatitis A Sharp & Dohme GmbH Hepatitis A vaccine (virus vaccine, inactivated) Available again mid June 18 Havrix Adult Restored capacity 2018 Havrix Junior June 18 Hepatitis B Merck Engerix (paediatric/ Adult) Hepatitis adult Paediatric Resolved return to historic volume during 2018 (due to increase demand shortage 17 constraints expected in 2018 End 2018 April 2018
15 Conclusion end 2017 after first survey There are supply related constrains on securing access Mentioned by companies and countries Difficult to assess real consequences due to limited information No supply issues in the WHO EURO Region in the recent years for HBV new situation Country specific HBV vaccine supply challenges (some countries yes, other no!) Need for recommendations specific for managing supply issues (cfr. ECDC recommendations for pertussis Ag containing vaccine shortages) Some NITAG made such product specific recommendations for HAV/HBV vaccines Centralized emergency stock (at level of EU, WHO EURO, companies ) Have companies guaranteeing supply every 6 months, or switch tendere to competitor Room for VHPB to draft guidelines to assist countries in making such recommendations
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