Tick-borne encephalitis vaccine: Difference between revisions

{{Short description|Vaccine against tick-borne encephalitis}}

{{Use dmy dates|date=August 2021}}

{{Infobox drug

| Verifiedfields = changed

| verifiedrevid = 376123091

| image = Očkovací sada FSME-IMMUN.jpg

| caption= FSME-Immun (European TBE vaccine)

<!-- Vacine data -->

| type = vaccine

| target = [[Tick-borne encephalitis virus]]

| vaccine_type = inactivated

<!-- Clinical data -->

| tradename = Encepur N, FSME-Immun CC, Ticovac, others

| pregnancy_AU = <!-- A / B1 / B2 / B3 / C / D / X -->

| pregnancy_category =

| legal_AU = <!-- S2, S3, S4, S5, S6, S7, S8, S9 or Unscheduled -->

| legal_CA = <!-- Schedule I, II, III, IV, V, VI, VII, VIII -->

| legal_UK = POM

| legal_UK_comment = <ref name="TicoVac SmPC">{{cite web | title=TicoVac 0.5 ml Suspension for injection in a prefilled syringe - Summary of Product Characteristics (SmPC) | website=(emc) | url=https://www.medicines.org.uk/emc/product/1923/smpc | access-date=23 August 2021}}</ref>

| legal_US = Rx-only

| legal_US_comment = <ref name="FDA Ticovac">{{cite web | title=Ticovac | website=U.S. [[Food and Drug Administration]] (FDA) | date=16 August 2021 | url=https://www.fda.gov/vaccines-blood-biologics/ticovac | access-date=23 August 2021 | id=STN: 125740 }} {{PD-notice}}</ref><ref name="Pfizer PR">{{cite press release | title=U.S. FDA Approves Ticovac, Pfizer's Tick-Borne Encephalitis (TBE) Vaccine | website=Pfizer | url=https://www.pfizer.com/news/press-release/press-release-detail/us-fda-approves-ticovactm-pfizers-tick-borne-encephalitis | access-date=23 August 2021}}</ref>

| legal_status =

| routes_of_administration = [[Intramuscular]]

| ATC_prefix = J07

| ATC_suffix = BA01

<!-- Identifiers -->

| ChemSpiderID_Ref = {{chemspidercite|changed|chemspider}}

| ChemSpiderID = none

| CAS_number = 1704520-39-7

| PubChem =

| KEGG = D12206

| DrugBank_Ref = {{drugbankcite|correct|drugbank}}

| DrugBank = DB16611

<!-- Chemical data -->

<!-- Definition and medical uses -->

'''Tick-borne encephalitis vaccine''' is a [[vaccine]] used to prevent [[tick-borne encephalitis]] (TBE).<ref name=WHO2011/> The disease is most common in [[Central Europe|Central]] and [[Eastern Europe]], and Northern [[Asia]].<ref name=WHO2011/> More than 87% of people who receive the vaccine develop immunity.<ref name=Dem2009>{{cite journal | vauthors = Demicheli V, Debalini MG, Rivetti A | title = Vaccines for preventing tick-borne encephalitis | journal = The Cochrane Database of Systematic Reviews | volume = 2009 | issue = 1 | pages = CD000977 | date = January 2009 | pmid = 19160184 | pmc = 6532705 | doi = 10.1002/14651858.CD000977.pub2 }}</ref> It is not useful following the bite of an infected tick.<ref name=WHO2011/> It is given by [[intramuscular|injection into a muscle]].<ref name=WHO2011/>

<!-- Recommendations -->

The [[World Health Organization]] (WHO) recommends immunizing all people in areas where the disease is common.<ref name=WHO2011/> Otherwise the vaccine is just recommended for those who are at high risk.<ref name=WHO2011/> Three doses are recommended followed by additional doses every three to five years.<ref name=WHO2011/> The vaccines can be used in people more than one or three years of age depending on the formulation.<ref name=WHO2011/> The vaccine appears to be safe during [[pregnancy]].<ref name=WHO2011/>

<!-- Safety -->

Serious side effects are very uncommon.<ref name=WHO2011/> Minor side effects may include [[fever]], and redness and pain at the site of injection.<ref name=WHO2011/> Older formulations were more commonly associated with side effects.<ref name=WHO2011/>

<!-- History, society, and culture -->

The first vaccine against TBE was developed in 1937.<ref name=WHO2011>{{cite journal | vauthors = | title = Vaccines against tick-borne encephalitis: WHO position paper | journal = Relevé Épidémiologique Hebdomadaire | volume = 86 | issue = 24 | pages = 241–256 | date = June 2011 | pmid = 21661276 | url = https://www.who.int/immunization/position_papers/WHO_pp_tbe_2011_summary.pdf | author-link = World Health Organization | hdl = 10665/241769 }}</ref> It is on the [[WHO Model List of Essential Medicines|World Health Organization's List of Essential Medicines]].<ref name="WHO21st">{{cite book | vauthors = ((World Health Organization)) | title = World Health Organization model list of essential medicines: 21st list 2019 | year = 2019 | hdl = 10665/325771 | author-link = World Health Organization | publisher = World Health Organization | location = Geneva | id = WHO/MVP/EMP/IAU/2019.06. License: CC BY-NC-SA 3.0 IGO | hdl-access=free }}</ref><ref name="WHO22nd">{{cite book | vauthors = ((World Health Organization)) | title = World Health Organization model list of essential medicines: 22nd list (2021) | year = 2021 | hdl = 10665/345533 | author-link = World Health Organization | publisher = World Health Organization | location = Geneva | id = WHO/MHP/HPS/EML/2021.02 | hdl-access=free }}</ref> The vaccine was approved for medical use in the United States in August 2021.<ref name="FDA Ticovac" /><ref name="Pfizer PR" /><ref>{{cite web |url=https://www.medpagetoday.com/infectiousdisease/vaccines/94059|title=First Tick-Borne Encephalitis Vax Approved in the U.S.|date=16 August 2021}}</ref><ref>{{cite book|title=CDC Health Information for International Travel 2016|date=1 June 2015|publisher=Oxford University Press|isbn=978-0199379156|url=http://wwwnc.cdc.gov/travel/yellowbook/2016/infectious-diseases-related-to-travel/tickborne-encephalitis|chapter=3: Infectious Diseases Related to Travel|url-status=live|archive-url=https://web.archive.org/web/20160611133327/http://wwwnc.cdc.gov/travel/yellowbook/2016/infectious-diseases-related-to-travel/tickborne-encephalitis|archive-date=11 June 2016}}</ref>

==Medical uses==

In the United States, tick-borne encephalitis vaccine is indicated for active immunization to prevent tick-borne encephalitis (TBE) in individuals one year of age and older.<ref name="FDA Ticovac" />

The efficacy of these vaccines has been well documented.<ref name=WHO2011/> They have also been shown to protect mice from a lethal challenge with several TBE-virus isolates obtained over a period of more than 30 years from all over Europe and the Asian part of the former Soviet Union. In addition, it has been demonstrated that antibodies induced by vaccination of human volunteers neutralized all tested isolates.

===Pregnancy and breastfeeding===

The vaccine appears to be safe during [[pregnancy]],<ref name=WHO2011/> but because of insufficient data the vaccine is only recommended during pregnancy and breastfeeding when it is considered urgent to achieve protection against TBE infection and after careful consideration of risks versus benefits.<ref name="GabuttiConforti2016">{{cite journal | vauthors = Gabutti G, Conforti G, Tomasi A, Kuhdari P, Castiglia P, Prato R, Memmini S, Azzari C, Rosati GV, Bonanni P | display-authors = 6 | title = Why, when and for what diseases pregnant and new mothers "should" be vaccinated | journal = Human Vaccines & Immunotherapeutics | volume = 13 | issue = 2 | pages = 283–290 | date = February 2017 | pmid = 27929742 | pmc = 5328236 | doi = 10.1080/21645515.2017.1264773 }}</ref>

===Schedule===

Two to three doses are recommended depending on the formulation.<!-- <ref name=WHO2011/> --> Typically one to three months should occur between the first doses followed by five to twelve months before the final dose.<!-- <ref name=WHO2011/> --> Additional doses are then recommended every three to five years.<ref name=WHO2011/> A study from 2006 suggests that the FSME-Immun/Ticovac and Encepur are interchangeable for booster vaccination, but cautions against change during the primary immunization course.<ref name="tbe-vaccine-inter">{{cite journal | vauthors = Bröker M, Schöndorf I | title = Are tick-borne encephalitis vaccines interchangeable? | journal = Expert Review of Vaccines | volume = 5 | issue = 4 | pages = 461–466 | date = August 2006 | pmid = 16989626 | doi = 10.1586/14760584.5.4.461 | s2cid = 32915267 }}</ref>

==History==

The first vaccine against TBE was developed in the late 1930s in the [[Soviet Union]], based on the Sofyin strain of the TBE virus. The vaccine was prepared from a suspension of infected mouse brain, inactivated with [[formalin]]. Initial trials were conducted on forced [[Gulag]] laborers, before research was replicated in other countries.<ref name="Mazanik">{{cite journal |last1=Mazanik |first1=Anna |title=Arbovirology and Cold War Collaborations: A Transnational History of the Tick-borne Encephalitis Vaccine, 1930-1980 |journal=Journal of the History of Medicine and Allied Sciences |year=2023 |pages= |doi=10.1093/jhmas/jrad054 |pmid=37681759 |url=https://doi.org/10.1093/jhmas/jrad054 |doi-access=free |pmc=11302950 }}</ref>

As there were frequent reports of negative side effects towards the mouse brain components of the vaccine, scientists across countries worked on developing new vaccines. The Institute of Poliomyelitis and Viral Encephalitis developed new TBE vaccines in the late 1950s based on cell cultures from chicken embryos.<ref name="Mazanik"></ref>

Later, in 1972, the veterinary microbiologist James Keppie at [[Porton Down]] in the United Kingdom led development into a new TBE vaccine. It was based on the Neudörfl strain of the TBE virus provided by [[Christian Kunz]], an Austrian virologist. Kunz then led human trials in Austria; after these trials were successful, public vaccination campaigns soon began.<ref name="Mazanik"></ref><ref name="Kunz Austrian experience">{{cite journal |last1=Kunz |first1=C. |title=TBE vaccination and the Austrian experience |journal=Vaccine |volume=21 |pages=S50–S55 |year=2003 |doi=10.1016/S0264-410X(02)00813-7 |pmid=12628814 }}</ref><ref>{{cite journal |last1=Heinz |first1=FX |title=Development of a highly purified tick-borne encephalitis vaccine: A personal historical account |journal=Wien Klin Wochenschr |volume=136 |issue=7–8 |pages=215–219 |year=2024 |doi=10.1007/s00508-023-02240-1 |pmid=37391599 |pmc=11006719 |url=}}</ref> This vaccine was patented in 1980 in Austria by [[Immuno AG]],<ref name="Mazanik"></ref><ref name="Kunz Austrian experience"></ref> which was later purchased by [[Baxter International]].

== Society and culture ==

=== Economics ===

Per dose it costs between {{GBP|50}} and {{GBP|70}} in the United Kingdom.<ref>{{cite web|title=Tick-borne encephalitis - Prevention|url=https://www.nhs.uk/conditions/tick-borne-encephalitis/ |work=NHS.uk |access-date=15 December 2015|date=15 October 2015|url-status=live|archive-url=https://web.archive.org/web/20151222092835/http://www.nhs.uk/Conditions/Tick-borne-encephalitis/Pages/Beforeyougopage.aspx|archive-date=22 December 2015}}</ref>

=== Brand names ===

Brand names of the vaccines include Encepur N,<ref>{{Cite web|url=https://compendium.ch/mpro/mnr/27219/html/de|title=Encepur N|website=compendium.ch|access-date=21 January 2018|date=28 April 2016}}</ref> FSME-Immun CC<ref>{{Cite web|url=https://compendium.ch/mpro/mnr/26452/html/de|title=FSME-Immun CC|website=compendium.ch|access-date=21 January 2018|date=11 August 2017}}</ref> and Ticovac,<ref name="TicoVac SmPC" /> Encevir-Neo, Klesh-E-Vak.

== References ==

== External links ==

* {{cite web | title=Tick-borne Encephalitis Vaccine | website=[[World Health Organization]] (WHO) | date=12 October 2011 | url=https://www.who.int/biologicals/areas/vaccines/tick_encephalitis/en/ | archive-url=https://web.archive.org/web/20060515224806/http://www.who.int/biologicals/areas/vaccines/tick_encephalitis/en/ | url-status=dead | archive-date=15 May 2006 }}

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[[Category:Inactivated vaccines]]

[[Category:World Health Organization essential medicines (vaccines)]]

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[[Category:Soviet inventions]]