ATAGI statement on AstraZeneca vaccine in response to new vaccine safety concerns
Following investigations nationally and internationally into a rare blood clotting condition known as थ्रोम्बोसाइटोपेनिया सिंड्रोम (टीटीएस) के साथ घनास्त्रता occurring in people who have received COVID-19 AstraZeneca, ATAGI have provided updated advice for the administration of COVID-19 vaccines in Australia.
ATAGI recommends that Comirnaty™ is the preferred brand for immunisation of those under 50 years of age who have not already received dose 1 of COVID-19 AstraZeneca, with COVID-19 AstraZeneca available for immunisation of those over 50 years of age. Individuals who have had their first dose of COVID-19 AstraZeneca without any serious adverse events can proceed with the second dose. COVID-19 AstraZeneca can continue to be used in adults aged under 50 years where the benefits are likely to outweigh the risks for an individual (an informed decision can be made following a discussion on the risks and benefits).
TTS is a newly described serious condition, which presents with unusual blood clots (thrombosis) in the brain or other parts of the body, accompanied by a low number of platelets (thrombocytopenia). It has been noted to develop 4-20 days following vaccination with COVID-19 AstraZeneca. Global reports show TTS may occur in approximately 4-6 people per million doses delivered, with 1 case recorded in Australia to date. It is noted to predominantly occur in younger adults however there have been some cases reported in older vaccine recipients. So far there has been no pre-existing conditions or biological factors identified that may predispose or decrease the risk of someone developing TTS. The exact mechanism leading to this condition is not fully understood however antibodies (anti-PF4 antibodies) that activate platelets have been detected in some people who have developed TTS. These antibodies have also been detected in people with similar symptoms following administration of the drug heparin (heparin induced thrombocytopenia).
ATAGI has made this recommendation after considering the current level of community transmission of COVID-19 disease in Australia, as well as the likely severity of disease according to age if exposed to COVID-19. Should the level of risk change or more information becomes available these recommendations may change. ATAGI continues to recommend all adults be vaccinated against COVID-19 as the virus continues to cause severe disease globally.
To read the advice in full refer to:
ATAGI statement on AstraZeneca vaccine in response to new vaccine safety concerns
The Age: Victorian hospitals search for rare blood clots linked to AstraZeneca
Victorian hospitals are retrospectively reviewing patient records to determine if there have been further cases of patients presenting with a rare blood clotting disorder, temporally associated with the administration of COVID-19 AstraZeneca. A 44 year old health care worker in Victoria recently presented with abdominal pain, low platelet count and thrombosis, 12 days after being immunised. This follows reports of similar cases internationally where investigations by medical regulators are ongoing.
Professor Jim Buttery from SAEFVIC (Victoria's vaccine safety service) suggests that it is unlikely that there would be many undetected cases due to the clotting disorder being so rare.
The TGA and ATAGI have recommended the continued rollout of the AstraZeneca vaccine whilst investigations continue, and considers the benefit of vaccination outweighs any potential risks. ATAGI has urged anyone receiving COVID-19 AstraZeneca to be on alert for severe persistent headaches that are not resolved with over the counter pain relief. Health care professionals are advised that the threshold for reporting adverse events is low, with all serious adverse events thoroughly reviewed by an expert panel.
अधिक पढ़ने के लिए नीचे दिए गए लिंक का अनुसरण करें:
The Age: Victorian hospitals search for rare blood clots linked to AstraZeneca
Updated ATAGI statements on a specific clotting condition being reported after COVID-19 vaccination
Following a report in Australia of a rare blood clotting condition in a person who received COVID-19 AstraZeneca, ATAGI have released a statement for consumers and an updated statement for health providers.
Internationally, a small number of cases of thrombosis (blood clots) with associated thrombocytopenia (low platelet count) have been reported in the time period 4-20 days following vaccination. These cases have either presented as central venous sinus thrombosis (CVST) or thrombosis in other sites, such as intra-abdominal venous systems.
Vaccination against COVID-19 disease continues to be of high importance in groups who are most at risk of disease exposure or disease complications. Common or expected side effects of vaccination include headache, muscle aches, fever and chills, with onset typically beginning within the first 24 hours and symptoms lasting 1-2 days.
Health care providers and vaccine recipients are encouraged to be alert for any new, severe, persistent headache or other significant symptoms, such as severe abdominal pain, features of raised intracranial pressure (severe headache, vomiting, confusion) or neurological deficits with an onset between 4 to 20 days after vaccination. In suspected cases a referral to hospital is recommended and the appropriate investigations (full blood count, D-dimer, fibrinogen) and imaging completed.
Patients suspected to have this condition should not receive heparin or platelets.
As a precaution, anyone with a past history of CVST or heparin induced thrombocytopenia (HIT) is not recommended to receive the COVID-19 vaccine until further information is available. Investigations internationally and within Australia are ongoing.
To read the statement for consumers in full please refer to the link below:
To read the the updated advice for health providers please refer to the link below:
Information about COVID-19 vaccines for Aboriginal and Torres Strait Islander people
The National Aboriginal Community Controlled Health Organisation (NACCHO) और NCIRS have joined together to develop new resources on COVID-19 vaccines for Aboriginal and Torres Strait Islander people. This information includes frequently asked questions surrounding the safety and effectiveness of available vaccines, as well as the immunisation recommendations for special risk groups.
To access these resources please follow the link below:
NACCHO: COVID-19 Vaccine Updates and Information
Further information on the immunisation recommendations for Aboriginal and Torres Strait Islander people can be found on our reference page:
एमवीईसी: आदिवासी और टोरेस स्ट्रेट आइलैंडर टीकाकरण सिफारिशें
New immunisation reference page: COVID-19 weekly vaccine update
The rapid development of multiple COVID-19 vaccines globally has been a tremendous success story for public health. However, it can prove challenging to stay up to date with the increasing literature on various aspects of these vaccines. The COVID-19 weekly vaccine update summarises the data available on COVID-19 vaccines and includes: the specifications of COVID-19 vaccines, vaccine efficacy and effectiveness including against variants of concern; comorbidities and the elderly; vaccine safety; the pipeline for vaccine development; and the WHO SAGE timeline for vaccine authorisation. Each week, the document is updated and contains newly released information on the vaccines.
To subscribe to the update, email [email protected]
Alternatively you can access the update via our reference page below:
MVEC: COVID-19 weekly vaccine update
ATAGI- COVID-19 vaccine guidance for patients with immunocompromise
ATAGI have published recommendations for the vaccination of immune compromised patients with COVID-19 vaccines, Comirnaty™ and COVID-19 AstraZeneca.
COVID-19 vaccination is recommended for all immunocompromised people due to an increased risk of developing severe disease if infected with SARS-CoV-2. Administration of COVID-19 vaccines should be planned with the treating specialist and in some instances the timing of immune suppressive therapies may be altered to maximise immune responses to vaccination. Reducing the interval between COVID-19 vaccine doses to allow for planning of treatments can also be considered.
इन सुझावों को देखने के लिए कृपया देखें
- ATAGI – Provider guide to COVID-19 vaccination of people with immunocompromise
- ATAGI – COVID-19 vaccination decision guide for people with immunocompromise
For other information on the immunisation of immune compromised people please refer to:
एमवीईसी: इम्यूनोसप्रेशन और टीके
Falsified COVID-19 Vaccine BNT162b2 identified in the WHO region of the Americas
The World Health Organization (WHO) have released a medical product alert pertaining to a falsified COVID-19 vaccine identified as "BNT162b2" that has been detected in Mexico in February 2021, and which has been confirmed as falsified to the WHO. This product has been supplied and administered to patients external to authorised vaccination programs.
The alert has been issued as this falsified COVID-19 vaccine may still be in circulation which poses a risk to public health. Further details of the falsified vaccine and advice from the WHO can be found via the link to the full medical product alert below:
WHO: Falsified COVID-19 Vaccine BNT162b2 identified in the WHO region of the Americas
थक्के की स्थिति के इतिहास वाले लोगों में COVID-19 टीकाकरण की उपयुक्तता पर स्वास्थ्य देखभाल प्रदाताओं के लिए ATAGI बयान
ATAGI ने थक्के की स्थिति वाले लोगों में COVID-19 टीकाकरण की उपयुक्तता पर स्वास्थ्य प्रदाताओं (25 मार्च 2021) के लिए एक बयान जारी किया है।
ATAGI ने नोट किया कि विश्व स्वास्थ्य संगठन (WHO), यूरोपियन मेडिसिन एजेंसी (EMA) और थेराप्यूटिक गुड्स एडमिनिस्ट्रेशन (TGA) ने दुनिया भर में AstraZeneca COVID-19 वैक्सीन प्राप्त करने वाले लाखों लोगों के डेटा की समीक्षा की है जो सामान्य दरों में कोई वृद्धि नहीं दर्शाता है। थ्रोम्बोम्बोलिक घटनाएँ इस टीके को प्राप्त करने के बाद। सेरेब्रल वेनस साइनस थ्रॉम्बोसिस (सीवीएसटी) के साथ कोई संबंध है या नहीं, इसकी जांच चल रही है।
टीकाकरण के बाद आज तक ऑस्ट्रेलिया में सीवीएसटी का कोई मामला सामने नहीं आया है।
बयान में इस बात पर जोर दिया गया है कि टीके के लाभ इस संभावित जोखिम से कहीं अधिक हैं।
ATAGI ने एस्ट्राजेनेका COVID-19 वैक्सीन या Comirnaty (फाइजर COVID-19 वैक्सीन) के साथ टीकाकरण की सिफारिश करना जारी रखा है, जिसमें गहरी शिरा घनास्त्रता (DVT), फुफ्फुसीय अन्त: शल्यता, थ्रोम्बोसाइटोपेनिया, थ्रोम्बोफिलिक विकार जैसे थक्के की स्थिति वाले लोगों के लिए शामिल है। एंटीकोआगुलंट्स पर, हृदय रोग के इतिहास वाले लोग या घनास्त्रता के जोखिम वाले कारकों जैसे धूम्रपान करने वालों या मौखिक गर्भ निरोधकों वाले लोग।
अभी के लिए, एक एहतियाती उपाय के रूप में जब तक यूरोप में जांच से आगे की जानकारी उपलब्ध नहीं होती है, ATAGI अनुशंसा करता है कि किसी भी COVID-19 वैक्सीन के साथ टीकाकरण CVST के एक पुष्ट चिकित्सा इतिहास वाले लोगों और हेपरिन प्रेरित थ्रोम्बोसाइटोपेनिया (HIT) के पुष्ट चिकित्सा इतिहास वाले लोगों में टाल दिया जाए। .
स्वास्थ्य कर्मियों को लगातार, अप्रत्याशित और/या गंभीर प्रतिकूल घटनाओं के लिए सतर्क रहना चाहिए, विशेष रूप से टीकाकरण के बाद 1-2 सप्ताह में जैसा कि किसी भी टीके के साथ होता है, और आवश्यकतानुसार अपनी स्थानीय टीका सुरक्षा सेवा को रिपोर्ट करना चाहिए।
नीचे दिए गए लिंक के माध्यम से पूरा बयान पढ़ें
The BMJ opinion: Restoring confidence after the covid-19 Oxford/AstraZeneca vaccine pause will be an uphill battle
In the past week several countries suspended or delayed the rollout of the Oxford/AstraZeneca COVID-19 vaccine whilst the European Medicines Agency (EMA) safety committee investigated whether or not the vaccine was linked to reports of thromboembolic events.
The EMA’s investigation concluded that the vaccine is safe and effective and not associated with an increased risk of blood clots, and that they will continue to monitor this (whilst noting that there is a possible link with very rare cases of blood clots associated with thrombocytopenia).
Professor Julie Leask notes that people’s willingness to have a vaccine is influenced by its perceived safety, and the suspension of vaccination programs, even if temporary, has long-lasting effects on public confidence. Even if a causal link is found between the Oxford/AstraZeneca COVID-19 vaccine and these thromboembolic events, the risks of these are likely outweighed by the risks of COVID-19. Currently, approximately 20,000 people die from COVID-19 in the European WHO region each week.
She further notes the impacts suspensions like these can have beyond the aversion of harm that is behind them.
Professor Leask suggests early and frequent updates as events happen, communication with empathy, messaging that caters to different levels of health literacy and prioritisation of healthcare worker information and reiterates the importance of research and development into vaccine uptake.
नीचे दिए गए लिंक के माध्यम से और पढ़ें:
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