Statement of the WHO Global Advisory Committee on Vaccine Safety (GACVS) COVID-19 subcommittee on safety signals related to the AstraZeneca COVID-19 vaccine
The WHO Global Advisory Committee on Vaccine Safety (GACVS) subcommittee on safety signals related to AstraZeneca COVID-19 vaccine have released a statement on recent reports of thromboembolic and thrombocytopenic events following vaccination with the AstraZeneca COVID-19 vaccine.
The committee notes that as of 17 March 2021 there have more than 120 million cases of COVID-19 infections and more than 2 million deaths worldwide. To date, more than 20 million doses of the AstraZeneca vaccine have been administered in Europe and more than 27 million doses of the Covishield, the AstraZeneca vaccine by the Serum Institute of India, have been administered in India.
They found that the vaccine continues to have a positive risk/benefit profile and that clotting conditions such as deep venous thrombosis or pulmonary embolism events have not increased following receiving this vaccine. In relation to reports of rare thromboembolic events such as cerebral venous sinus thrombosis, they note a causal relationship has not been established (the European Medicines Agency [EMA] have reviewed 18 cases of CVST out of more than 20 million doses of the AstraZeneca COVID-19 vaccine in Europe). The committee recommend that countries continue to monitor the safety of all COVID-19 vaccines and that healthcare workers should be educated in recognising signs and symptoms of adverse events following vaccination and agree with the EMA’s plans to investigate these events further.
Read the full statement below, including links to the EMA statement and the UK MHRA statement
TGA: AstraZeneca ChAdOx1-S COVID-19 vaccine
The TGA (Therapeutic Goods Association) have provided an update regarding the AstraZeneca COVID-19 vaccine in light of preliminary reviews by the European Medicines Agency (EMA) and United Kingdom Medicines and Healthcare products Regulatory Agency (MHRA), regarding the risk of blood clots in people who have received the AstraZeneca COVID-19 vaccine.
The findings of these reviews are that the benefits of the vaccine continue to outweigh the risks. The EMA’s safety meeting noted that the number of people with blood clots in large clinical trials and who have received the vaccine in global rollouts were less than is expected in the general population. 20 million people have received the vaccine in Europe and several more million in other parts of the world.
They noted there have been a very small amount of people who have experienced very rare clotting conditions – disseminated intravascular coagulation (DIC) with thrombocytopenia; and cerebral venous sinus thrombosis (CSVT). A causal link with the vaccine has not been established and these conditions are also seen in the general population.
Both the EMA and the MHRA are continuing to review cases of these rare clotting conditions.
The TGA has not received any reports of blood clots following vaccination with the AstraZeneca COVID-19 vaccine in Australia (as of 18 March 2021) and advise people to continue to receive the vaccine when eligible. Monitoring of the safety of this vaccine will continue and if there are any safety concerns these will be communicated to the public.
Please refer to the full alert below for more information:
TGA: AstraZeneca ChAdOx1-S COVID-19 vaccine
पंजीकरण अब अप्रैल सीवीयू मिनी इवेंट के लिए खुला है
The next Clinical Vaccinology Update (CVU) miniseries event, Hot Topics in Vaccine Science, will be held virtually on Monday 12th April 2021.
We are excited to welcome our panel who will be presenting on COVID-19 vaccine allergy and rollout, influenza vaccines for 2021, as well as an update of the Novovax NVX-CoV2373 vaccine candidate.
A full program of this free event can be found via our घटना पृष्ठ और नीचे दिया गया लिंक:
New immunisation reference page: The VicSIS (Victorian Specialist Immunisation Services) Network
Current vaccine safety clinics managed by SAEFVIC have historically had a paediatric focus. With the rollout of COVID-19 vaccines within Australia and the initial priority groups involving adults, the VicSIS (Victorian Specialist Immunisation Services) network has been created to enhance adult immunisation services in Victoria to address queries and safely vaccinate under supervision, if required. These services can provide specialist immunisation support and provide a link between the key stakeholders, the Department of Health, SAEFVIC and hospital sites that form part of the network.
The VicSIS network will provide specialist vaccination services for people who have experienced an adverse event following immunisation (AEFI) with a COVID-19 vaccine, or those who are identified as at risk of an AEFI (for example, people with a history of anaphylaxis). Most people are able to proceed with future vaccines following an AEFI. Clinical consults will be offered in which individual recommendations will be developed.
Find out more about where the VicSIS clinics are located and how to refer to them in our new immunisation reference page, linked below.
MVEC: The VicSIS (Victorian Specialist Immunisation Services) Network
A recording of the March CVU mini is now available
हमारे हालिया सीवीयू मिनिसरीज इवेंट में भाग लेने वाले सभी लोगों को धन्यवाद COVID-19 vaccines: Engagement, Communication and Safety on 9th March 2021.
Presentation topics included COVID-19 vaccine stakeholder engagement and participation, vaccine communication and hesitancy, and an update on the Victorian Specialist Immunisation Service (VicSIS) and international vaccine safety.
ए मुक्त इस घटना की एक रिकॉर्डिंग अब हमारे शिक्षा पोर्टल के माध्यम से उपलब्ध है।
इस रिकॉर्डिंग तक पहुँचने के लिए कृपया नीचे दिए गए लिंक का अनुसरण करें:
Save the date for our April CVU mini event: Monday 12 April 2021
MVEC invites you to Save the Date for our next CVU mini!
तारीख: Monday 12 April, 2021
समय: 7:00pm - 8:30pm AEST
अधिक विवरण और पंजीकरण की जानकारी जल्द ही हमारे पर उपलब्ध होगी घटना पृष्ठ और शिक्षा पोर्टल.
आने वाली घटनाओं सहित हमारे नवीनतम समाचारों के साथ अद्यतित रहने के लिए, आप हमारी सदस्यता ले सकते हैं साप्ताहिक समाचार पत्र.
Additional module added to Victorian COVID-19 eLearning Competency
An additional module titled Preparing Comirnaty™ (Pfizer BNT162b2) COVID-19 Vaccine has been added to the Victorian COVID-19 eLearning Competency.
Please note the advice contained in this module is specific to the COVID-19 mRNA Vaccine BNT162b2 (Comirnaty™).
If you have already completed the Victorian COVID-19 eLearning Competency you can login and access this additional module via your profile in the एमवीईसी शिक्षा पोर्टल.
COVID-19 वैक्सीन के बाद बगल के नीचे सूजन लिम्फ नोड्स स्तन कैंसर के लक्षणों की नकल कर सकते हैं
संयुक्त राज्य अमेरिका में सोसाइटी ऑफ़ ब्रैस्ट इमेजिंग (SBI) महिलाओं को बगल में सूजन या निविदा लिम्फ नोड्स के संभावित दुष्प्रभाव के कारण मैमोग्राम शेड्यूल करने के लिए COVID-19 वैक्सीन प्राप्त करने के बाद कम से कम चार सप्ताह प्रतीक्षा करने की सलाह दे रही है। लिम्फ नोड्स में परिवर्तन स्तन कैंसर का संकेत हो सकता है और चिंता यह है कि इससे मैमोग्राम पर गलत रीडिंग हो सकती है जिससे आगे अनावश्यक परीक्षण हो सकता है।
यह सलाह संयुक्त राज्य अमेरिका में मॉडर्न COVID-19 वैक्सीन और Pfizer BioNTech COVID-19 वैक्सीन के बाद लिम्फ नोड्स में सूजन और कोमलता की दरों के आधार पर जारी की गई थी। जबकि फाइजर बायोएनटेक वैक्सीन (जो वर्तमान में ऑस्ट्रेलिया में उपयोग के लिए अस्थायी रूप से पंजीकृत है) प्राप्त करने वाले लोगों में दुर्लभ है, एसबीआई नोट करता है कि घटना की दर रिपोर्ट की तुलना में सबसे अधिक होने की संभावना है और तदनुसार COVID-19 टीकों से मैमोग्राम को अलग करने के लिए उपरोक्त सलाह जारी की है। चार से छह सप्ताह।
नीचे दिए गए लिंक के माध्यम से और पढ़ें:
एस्ट्राजेनेका के कोविड-19 वैक्सीन के टीकाकरण के बाद की घटनाएं
टीकाकरण (AEFI) के बाद अस्थायी रूप से जुड़ी 2 गंभीर प्रतिकूल घटनाओं की रिपोर्ट के बाद, the स्वास्थ्य देखभाल में सुरक्षा के लिए ऑस्ट्रियाई संघीय कार्यालय (दवाओं के लिए राष्ट्रीय नियामक निकाय) के एक विशिष्ट बैच की आपूर्ति और वितरण को रोक दिया है कोविड-19 एस्ट्राजेनेका।
यह ध्यान रखना महत्वपूर्ण है कि क्लिनिकल परीक्षण के डेटा से आकस्मिक संबंध का कोई सबूत नहीं मिलता है और इस पड़ाव का उपयोग केवल एहतियाती उपाय के रूप में किया जा रहा है। समान AEFI की अंतर्राष्ट्रीय रिपोर्टों की तत्काल समीक्षा से चिंता का कोई संकेत नहीं मिलता है। कोविड-19 एस्ट्राजेनेका के वैकल्पिक बैचों का उपयोग करते हुए वैक्सीन रोलआउट जारी है और आगे की जांच जारी है।
आधिकारिक घोषणा पढ़ने के लिए नीचे दिए गए लिंक पर क्लिक करें:
Learning from Errors with the New COVID-19 Vaccines
In December 2020 COVID-19 vaccination commenced across the US. This article published by the Institute for Safe Medication Practices, discusses various reports of administration and preparation errors that have occurred since the rollout began.
Given the scope of the global COVID-19 vaccination campaign, it is expected that there will be mistakes made. As Australia begins its national rollout, a key learning is ensuring that all COVID-19 vaccine errors and adverse reactions are reported to the relevant authorities to help prevent these types of errors occurring here.
अधिक पढ़ने के लिए नीचे दिए गए लिंक का अनुसरण करें:
ISMP: Learning from Errors with the New COVID-19 Vaccines