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

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


New immunisation reference page: COVID-19 vaccines and allergy

Suspected hypersensitivity reactions, particularly non-urticarial skin rashes following immunisation, are common, however true vaccine allergy, where a person is contraindicated from being immunised with the same vaccine in the future, is rare (in most studies reported as less than 1 case per million doses).

Post-licensure surveillance of COVID-19 vaccines show anaphylaxis following administration of COVID-19 AstraZeneca occurring at similar rates to routine vaccines.  Anaphylaxis following Comirnaty™ (Pfizer/BioNTech), while still extremely rare, occurs at a slightly higher rate of approximately 4.7 cases per million doses.

A confirmed vaccine allergy usually requires a specialist consultation with a vaccine allergy specialist, often with specific testing or a vaccine challenge under supervision.

Find out more about allergies to COVID-19 vaccines, allergies to components of COVID-19 vaccines, and management of these allergies in our new immunisation reference page, COVID-19 टीके और एलर्जी.

 

 


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

थक्के की स्थिति के इतिहास वाले लोगों में COVID-19 टीकाकरण की उपयुक्तता पर स्वास्थ्य देखभाल प्रदाताओं के लिए ATAGI बयान

 


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:

The BMJ opinion: Restoring confidence after the covid-19 Oxford/AstraZeneca vaccine pause will be an uphill battle


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

WHO: Statement of the WHO Global Advisory Committee on Vaccine Safety (GACVS) COVID-19 subcommittee on safety signals related to the AstraZeneca COVID-19 vaccine


TGA: AstraZeneca COVID-19 vaccine update- Expert review finds no evidence of increased risk of anaphylaxis

An independent panel of experts from the TGA's Advisory Committee on Vaccines (ACV) and the Australian Technical Advisory Group on Immunisation (ATAGI) have reviewed the recent reports of 4 cases of anaphylaxis in Queensland in people who have received COVID-19 AstraZeneca.

Utilising the internationally-accepted Brighton Collaboration case definition, it has been concluded that only 1 of the 4 reported cases meets the criteria for anaphylaxis. Whilst the other adverse events reported are not classified as anaphylaxis, they may still represent allergic reactions or immediate stress responses and therefore close monitoring and follow up is warranted.

The findings of this review confirm that the incidence of anaphylaxis following receipt of COVID-19 AstraZeneca does not occur at a rate higher than that expected for any vaccine.

To see the full alert from the TGA please follow the link below:

TGA: AstraZeneca COVID-19 vaccine update- Expert review finds no evidence of increased risk of anaphylaxis


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:

CVU mini: April 12th 2021


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