{"id":20311,"date":"2021-04-13T23:14:06","date_gmt":"2021-04-13T23:14:06","guid":{"rendered":"https:\/\/evaggelatos.com\/?p=20311"},"modified":"2021-04-13T23:23:56","modified_gmt":"2021-04-13T23:23:56","slug":"%cf%84%ce%b9-%ce%b5%ce%af%ce%bd%ce%b1%ce%b9-%cf%84%ce%bf-vipit-vaccine-induced-prothrombotic-immune-thrombocytopenia","status":"publish","type":"post","link":"https:\/\/evaggelatos.com\/?p=20311","title":{"rendered":"\u03a4\u03b9 \u03b5\u03af\u03bd\u03b1\u03b9 \u03c4\u03bf (VIPIT) Vaccine-Induced Prothrombotic Immune Thrombocytopenia \u03c0\u03b1\u03c1\u03b5\u03bd\u03ad\u03c1\u03b3\u03b5\u03b9\u03b1 \u03c4\u03b7\u03c2 Astra Zeneca \u03ba\u03b1\u03b9 \u03cc\u03c7\u03b9 \u03bc\u03cc\u03bd\u03bf"},"content":{"rendered":"
COVID<\/span>–<\/span>19 VACCINES <\/span>VIPIT <\/span>INTERIM <\/span>GUIDANCE <\/span>12<\/span>APRIL<\/span>202<\/span>1<\/span>1<\/span><\/div>\n
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Interim Guidelines: Diagnosis and Management of <\/span>Vaccine<\/span>–<\/span>Induced Prothrombotic Immune Thrombocytopenia (VIPIT) <\/span>following AstraZeneca COVID<\/span>–<\/span>19 Vaccinations<\/span>12<\/span>April 2021<\/span><\/div>\n
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Introduction<\/span>Rare cases of blood clots with low platelets <\/span>after receipt of<\/span>AstraZene<\/span>c<\/span>a<\/span>(AZ)<\/span>COVID<\/span>–<\/span>19 vaccine have <\/span>been reported.<\/span>At present there is no clear signal of risk factors<\/span>for this condition<\/span>.<\/span>This document <\/span>provides guidance to <\/span>UN <\/span>medical staff<\/span>globally <\/span>on the <\/span>d<\/span>iagnosis<\/span>, management and reporting<\/span>of <\/span>vaccine<\/span>–<\/span>induced <\/span>prothrombotic immune thrombocytopenia (<\/span>VIPIT<\/span>)<\/span>cases<\/span>.<\/span><\/div>\n
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UN <\/span>medical staff <\/span>need to <\/span>be alert for this <\/span>syndrome and<\/span>arrange for early re<\/span>ferral <\/span>to<\/span>local hospitals<\/span>or <\/span>h<\/span>a<\/span>ematologists<\/span>and\/<\/span>or<\/span>consider early medical evacuation for <\/span>further lab <\/span>confirmation and treatment <\/span>of this <\/span>condition<\/span>.<\/span><\/div>\n
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For any questions, <\/span>contact <\/span>DHMOSH <\/span>Public Health at<\/span>dos<\/span>–<\/span>dhmosh<\/span>–<\/span>public<\/span>–<\/span>health@un.org<\/span><\/div>\n
Note that <\/span>this is a living document which will be updated as more information emerges. <\/span>Current Situation Update <\/span>At the time of writing, t<\/span>he AstraZeneca vaccine is currently being authorized for use in the EU and <\/span>several other countries, including the UK, Canada and India. Based on a multinational Phase 3 trial, <\/span>the vaccine had 70.4% efficacy in preventing symptomatic COVID<\/span>–<\/span>19 at\/after 14 d<\/span>ays post second <\/span>dose.\u00a0\u00a0 <\/span><\/div>\n
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Although there is some concern about vaccine efficacy against certain \u201cvariants\u201d, the WHO <\/span>continues to recommend use of this vaccine <\/span>even <\/span>if those variants are circulating in a country<\/span>1<\/span>,<\/span>2<\/span>.<\/span><\/div>\n
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\u201c<\/span>V<\/span>accine induced prothrombotic immune thr<\/span>ombocytopenia<\/span>\u201d<\/span>,<\/span>or <\/span>VIPIT<\/span>,<\/span>is a<\/span>condition of blood clots <\/span>associated with low platelet counts<\/span>, that occurs <\/span>following receipt of the vaccine. <\/span>The likely mechanism <\/span>is antibodies that induce massive platelet activation, reducing platelet count and causing thro<\/span>mbosis <\/span>although the full mechanism remains to be elucidated<\/span>. <\/span><\/div>\n
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This syndrome <\/span>is thought to <\/span>mimic <\/span>\u201c<\/span>heparin<\/span>–<\/span>induced thrombocytopenia<\/span>\u201d<\/span>(HIT) <\/span>but <\/span>does not require heparin itself as a trigger.<\/span> Most <\/span>cases <\/span>occurred <\/span>5 to <\/span>2<\/span>8<\/span>days <\/span>3<\/span>after <\/span>receipt of the AZ <\/span>vaccine<\/span>, and in women <\/span>4 <\/span>under 60 years old<\/span>5<\/span>.<\/span>Available evidence so far<\/span>, at the time of writing, <\/span>continues to suggest that <\/span>this syndrome is extremely <\/span>ra<\/span>r<\/span>e<\/span>6 <\/span>though information continues to evolve.<\/span>Because of the rarity of events and potential severity of COVID<\/span>–<\/span>19, the European Medicines Agency <\/span>(EMA) concluded that the overall benefits of the vaccine continue to outweigh the risk. <\/span><\/div>\n
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The WHO has <\/span>also stated that the very rare incidence should be weighe<\/span>d against the risk of morbidity from COVID<\/span>–<\/span>1<\/span>https:\/\/www.who.int\/news<\/span>–<\/span>room\/feature<\/span>–<\/span>stories\/detail\/the<\/span>–<\/span>effects<\/span>–<\/span>of<\/span>–<\/span>virus<\/span>–<\/span>variants<\/span>–<\/span>on<\/span>–<\/span>covid<\/span>–<\/span>19<\/span>–<\/span>vaccines<\/span>2 <\/span>AstraZeneca ChAdOx1<\/span>–<\/span>S\/nCoV<\/span>–<\/span>19 [recombinant], COVID<\/span>–<\/span>19 vaccine (who.int)<\/span>3<\/span>https:\/\/b<\/span>–<\/span>s<\/span>–<\/span>h.org.uk\/media\/19530\/guidance<\/span>–<\/span>version<\/span>–<\/span>13<\/span>–<\/span>on<\/span>–<\/span>mngmt<\/span>–<\/span>of<\/span>–<\/span>thrombosis<\/span>–<\/span>with<\/span>–<\/span>thrombocytopenia<\/span>–<\/span>occurring<\/span>–<\/span>after<\/span>–<\/span>c<\/span>–<\/span>19<\/span>–<\/span>vaccine_20210407.pdf<\/span>4<\/span><\/div>\n
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Note that additional studies needed on this since many vaccine recipients ar<\/span>e women <\/span>as they fall under the high priority <\/span>first <\/span>responders <\/span>groups <\/span>such as teachers and healthcare workers being prioritized early for vaccination<\/span>.<\/span>5<\/span>https:\/\/www.ema.europa.eu\/en\/news\/astrazenecas<\/span>–<\/span>covid<\/span>–<\/span>19<\/span>–<\/span>vaccine<\/span>–<\/span>ema<\/span>–<\/span>finds<\/span>–<\/span>possible<\/span>–<\/span>link<\/span>–<\/span>very<\/span>–<\/span>rare<\/span>–<\/span>cases<\/span>–<\/span>unus<\/span>ual<\/span>–<\/span>blood<\/span>–<\/span>clots<\/span>–<\/span>low<\/span>–<\/span>blood<\/span>6 <\/span>At the time of writing, <\/span>Norway has reported a rate of 1 in every 25,000 doses, Germany reported 1 in 100,000 doses, while Europe\u2019s <\/span>overall figures are 1 in 210,000. The UK has reported about 1 in 500,000 doses. <\/span>S<\/span>pecifically, 169 <\/span>reported cases of cerebral venous <\/span>sinus thrombosis (CVST) and 53 cases of splanchnic vein thrombosis were reported in 34 million vaccine recipients in the UK a<\/span>nd <\/span>European Economic Area<\/span>as of time of writing this document<\/span>.<\/span><\/div>\n
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COVID<\/span>–<\/span>19 VACCINES<\/span>VIPIT INTERIM GUIDANCE <\/span>12<\/span>APRIL 2021 <\/span>2<\/span>19. See WHO statement <\/span>here<\/span>. The WHO has stated that <\/span>a causal relationship, while plausible, has <\/span>still yet to be confirmed.<\/span>Clinical <\/span>Presentation <\/span>of VIPIT<\/span>P<\/span>atients with <\/span>VIPIT <\/span>may present with <\/span>cerebral sinus vein thrombosis (CSVT), or with other arterial or <\/span>venous clots. <\/span>Symptoms that make you suspect VIPIT include:<\/span>\u2022<\/span>persistent and severe headache <\/span>\u2022<\/span>focal neurological symptoms<\/span>\u2022<\/span>seizures, or blurred or double vision (suggesting CSVT or <\/span>arterial stroke)<\/span>\u2022<\/span>shortness of breath or chest pain (suggesting pulmonary embolism or acute coronary <\/span>syndrome)<\/span>\u2022<\/span>abdominal pain (suggesting portal vein thrombosis) or limb swelling, redness, pallor, or <\/span>coldness (suggesting deep vein thrombosis or acute limb ischemia). <\/span><\/p>\n

VIPIT <\/span>cases usually present 5 to 28 days<\/span>7<\/span>after <\/span>vaccination<\/span>, so <\/span>the above <\/span>symptoms <\/span>occurring with<\/span>in <\/span>this time frame should raise clinical suspicion of VIPIT.<\/span>What To Do When<\/span>An Individual Presents with the Above Symptoms<\/span>1.<\/span>Ask patient about their COVID<\/span>–<\/span>19 vaccine history <\/span>and <\/span>note the <\/span>date <\/span>that t<\/span>hey received the <\/span>doses, if any<\/span>2. <\/span>D<\/span>raw a complete <\/span>blood count (CBC<\/span>)<\/span>from the patient<\/span>3.<\/span>If platelet count is equal o<\/span>r less than<\/span>150 x 10<\/span>9<\/span>\/L, <\/span>AND<\/span>their symptoms occur within <\/span>28 days <\/span>after COVID<\/span>–<\/span>19 vaccination<\/span>, <\/span>such patients<\/span>are considered a <\/span>suspect <\/span>case of <\/span>VIPIT<\/span>.<\/span>4. <\/span>Suspect VIPIT patients <\/span>need to be further evaluated <\/span>for VIPIT <\/span>through <\/span>D<\/span>–<\/span>dimer <\/span>and <\/span>fibrinogen <\/span>level<\/span>s, <\/span>blood films drawn <\/span>to confirm thrombocytopenia<\/span>,<\/span>PF4 antibody assay <\/span>(<\/span>ELISA HIT assay<\/span>)<\/span>,<\/span>and imaging<\/span>(<\/span>e.g. CT or MRI) <\/span>to rule out <\/span>in particular <\/span>CSVT<\/span>.<\/span>a. <\/span>Cases are often <\/span>characterized <\/span>also <\/span>with very <\/span>raised D Dimer<\/span>levels<\/span>(><\/span>4000 mcg\/L)<\/span>above the <\/span>level expected for VTE and many develop low fibrinogen levels<\/span>.<\/span>b. <\/span>Antibo<\/span>d<\/span>ies to platele<\/span>t <\/span>factor 4 (PF4)<\/span>, as detected by <\/span>ELI<\/span>SA <\/span>H<\/span>eparin<\/span>–<\/span>Induced <\/span>Thrombocytopenia (HIT) assay,<\/span>have also been id<\/span>entified in this syn<\/span>drome.<\/span><\/strong>5<\/strong>.<\/span><\/p>\n

If such <\/span>lab tests and <\/span>services <\/span>i<\/span>n #4 <\/span>are not available in your clinic, <\/span>you need to <\/span>organize <\/span>a<\/span>referral to <\/span>a local hospital<\/span>with <\/span>these<\/span>services<\/span>, or medical<\/span>ly <\/span>evacuat<\/span>e<\/span>to rule out <\/span>an<\/span>d\/or <\/span>treat <\/span>VIPIT<\/span>. <\/span>A summary of these steps <\/span>is<\/span>found<\/span>in Annex 1.<\/span>Treatment of VIPIT<\/span>Treatment of <\/span>suspect or confirmed <\/span>VIPIT requires <\/span>consultation with a s<\/span>pecialist <\/span>hematologist<\/span>. <\/span>However, <\/span>please<\/span>b<\/span>ear in mind the following principles for treating such patients:<\/span>1.<\/span>DO NOT give<\/span>heparin<\/span>7<\/span>https:\/\/b<\/span>–<\/span>s<\/span>–<\/span>h.org.uk\/media\/19530\/guidance<\/span>–<\/span>version<\/span>–<\/span>13<\/span>–<\/span>on<\/span>–<\/span>mngmt<\/span>–<\/span>of<\/span>–<\/span>thrombosis<\/span>–<\/span>with<\/span>–<\/span>thrombocytopenia<\/span>–<\/span>occurring<\/span>–<\/span>after<\/span>–<\/span>c<\/span>–<\/span>19<\/span>–<\/span>vaccine_2021<\/span>0407.pdf<\/span><\/p>\n

COVID<\/span>–<\/span>19 VACCINES<\/span>VIPIT INTERIM GUIDANCE <\/span>12<\/span>APRIL 2021 <\/span>3<\/span>2.<\/span>Avoid<\/span>platelet<\/span>transfusions<\/span>3.<\/span>Consult a hematologist (in <\/span>person, virtually, by phone)<\/span>4.<\/span>Give intravenous immunoglobulin 1 g\/kg daily for 2 days for severe or life<\/span>–<\/span>threatening clots<\/span>,<\/span>if <\/span>available.<\/span>Further IVIG may require balancing bleeding and thrombotic ris<\/span>5.<\/span>Use first line anticoagulants: direct oral anti<\/span>–<\/span>Xa inhibitors (e.g. rivaroxaban, apixaban, <\/span>edoxaban)<\/span><\/p>\n

Until VIPIT has b<\/span>een ruled out, anticoagulation with heparin (both unfractionated heparin and low <\/span>molecular weight heparins) should <\/span>not <\/span>be given<\/span>. Platelet <\/span>transfusions<\/span>should <\/span>not <\/span>be given. <\/span>Further <\/span>information concerning specialized guidance on how to confirm VIPIT<\/span>diagnosis and <\/span>its <\/span>clinical management is available at <\/span>UK: Guidance Produced from the Expert Haemato<\/span>logy Panel <\/span>(EHP) focused on Covid<\/span>–<\/span>19 Vaccine induced Thrombosis and Thrombocytopenia (VITT)<\/span>Treatment of VIPIT <\/span><\/p>\n

With Life Threatening Blood Clots<\/span>In patients with confirmed VIPIT and severe or life<\/span>–<\/span>threatening blood clots (e.g., CSVT, splanchnic <\/span>vein thrombosis), it is important to <\/span>administer <\/span>high dose<\/span>intravenous immunoglobulin (IVIG)<\/span>at <\/span>1<\/span>g\/kg of body weight daily for two days<\/span>urgently<\/span>, if availabl<\/span>e<\/span>.<\/span>This treatment should be<\/span>guided by <\/span>a <\/span>consulting hematologist<\/span>and <\/span>can <\/span>be given whilst awaiting confirmatory diagnosis<\/span>.<\/span>Reporting VIPIT<\/span>P<\/span>rompt reporting<\/span>of such cases amongst UN personnel <\/span>is essential to learn more about this rare but <\/span>serious thrombotic phenomenon. <\/span><\/p>\n

All <\/span>cases of <\/span>thrombosis, <\/span>thrombocytopenia occurring within 28 days of COVID<\/span>–<\/span>19 vaccine <\/span>must <\/span>be reported <\/span>immediately <\/span>to<\/span>DHMOSH Public Health at<\/span>dos<\/span>–<\/span>dhmosh<\/span>–<\/span>public<\/span>–<\/span>health@un.org<\/span>References<\/span>\u2022<\/span>UK: Guidance<\/span>Produced from the Expert Haemat<\/span>o<\/span>logy Panel (EHP) focused on Covid<\/span>–<\/span>19 Vaccine induced <\/span>Throm<\/span>bosis and Thrombocytopenia (VITT)<\/span>\u2022<\/span>Ontario: Vaccine<\/span>–<\/span>Induced Prothrombotic Immune Thrombocytopenia (VIPIT) Following AstraZeneca <\/span>COVID<\/span>–<\/span>19 <\/span>Vaccination<\/span>\u2022<\/span>Interim statement of the COVID<\/span>–<\/span>19 subcommittee of the WHO Global Advisory C<\/span>ommittee on Vaccine Safety on <\/span>AstraZeneca COVID<\/span>–<\/span>19 vaccine<\/span>\u2022<\/span>https:\/\/www.ema.europa.eu\/en\/news\/astrazenecas<\/span>–<\/span>covid<\/span>–<\/span>19<\/span>–<\/span>vaccine<\/span>–<\/span>ema<\/span>–<\/span>finds<\/span>–<\/span>possible<\/span>–<\/span>link<\/span>–<\/span>very<\/span>–<\/span>rare<\/span>–<\/span>cases<\/span>–<\/span>unusual<\/span>–<\/span>blood<\/span>–<\/span>clots<\/span>–<\/span>low<\/span>–<\/span>blood<\/span>\u2022<\/span>NEJM<\/span>: Thrombosis and Th<\/span>rombocytop<\/span>enia after <\/span>ChAdOx1 nCoV<\/span>–<\/span>19 Vaccination (<\/span>9 April 2021)<\/span><\/p>\n

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COVID–19 VACCINES VIPIT INTERIM GUIDANCE 12APRIL20211 Interim Guidelines: Diagnosis and Management of Vaccine–Induced Prothrombotic Immune Thrombocytopenia (VIPIT) following AstraZeneca COVID–19 Vaccinations12April 2021 IntroductionRare cases of blood clots with low platelets after receipt ofAstraZeneca(AZ)COVID–19 vaccine have been reported.At present there is no clear signal of risk factorsfor this condition.This document provides guidance to UN medical staffglobally … <\/p>\n

\u03a3\u03c5\u03bd\u03ad\u03c7\u03b5\u03b9\u03b1 \u03b1\u03bd\u03ac\u03b3\u03bd\u03c9\u03c3\u03b7\u03c2<\/a><\/p>\n","protected":false},"author":2,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[85],"tags":[244],"class_list":["post-20311","post","type-post","status-publish","format-standard","hentry","category-85","tag-244","item-wrap"],"_links":{"self":[{"href":"https:\/\/evaggelatos.com\/index.php?rest_route=\/wp\/v2\/posts\/20311","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/evaggelatos.com\/index.php?rest_route=\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/evaggelatos.com\/index.php?rest_route=\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/evaggelatos.com\/index.php?rest_route=\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/evaggelatos.com\/index.php?rest_route=%2Fwp%2Fv2%2Fcomments&post=20311"}],"version-history":[{"count":3,"href":"https:\/\/evaggelatos.com\/index.php?rest_route=\/wp\/v2\/posts\/20311\/revisions"}],"predecessor-version":[{"id":20318,"href":"https:\/\/evaggelatos.com\/index.php?rest_route=\/wp\/v2\/posts\/20311\/revisions\/20318"}],"wp:attachment":[{"href":"https:\/\/evaggelatos.com\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=20311"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/evaggelatos.com\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=20311"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/evaggelatos.com\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=20311"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}