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
WHO statement on AstraZeneca COVID-19 vaccine safety signals
The World Health Organization (WHO) have released a statement following the recent reports of rare blood coagulation disorders in people who have received COVID-19 AstraZeneca.
In large immunisation campaigns it is expected that countries will signal adverse events to vaccination. Signals do not necessarily mean that the vaccine caused the events, but investigations into them are important. This signal detection confirms that the safety surveillance systems that are in place globally are effective and the proper processes are in place.
The Global Advisory Committee on Vaccine Safety is currently assessing all available safety data for COVID-19 AstraZeneca. Outcomes of the review will be communicated to the public as soon as they become available.
At this time, WHO recommends that vaccination with COVID-19 AstraZeneca continues as the benefits of immunisation outweigh potential risks.
To read the statement in full please follow the link below:
WHO statement on AstraZeneca COVID-19 vaccine safety signals
The Conversation: Data suggest no increased risk of blood clots from the AstraZeneca vaccine. Australia shouldn’t pause its rollout
With some European countries opting to pause the rollout of COVID-19 AstraZeneca in response to reports of blood clots, Australian experts have cautioned against any pauses whilst investigations are underway.
Thromboembolic events occur in approximately 17,000 Australians per year. In a global vaccine rollout it is therefore expected that some people will develop a blood clot coincidentally after they have received the vaccine. This does not meant that the vaccine caused it.
Since COVID-19 AstraZeneca vaccinations began, there have been 30 thromboembolic events reported (as of March 10, 2021) in approximately 5 million vaccine recipients. This is lower than the natural rate expected to occur.
All adverse events must be thoroughly investigated. The robust safety surveillance systems in Australia are established to effectively identify any signals requiring follow up. Extreme caution is urged when considering a pause in rollout while investigations are underway as this can damage vaccine confidence.
To read more, please read the article below:
The bmj: Covid-19: Booster dose will be needed in autumn to avoid winter surge, says government adviser
Anthony Harnden, Deputy Chair of the Joint Committee on Vaccination and Immunisation (JCVI) in the UK, has suggested that booster doses of COVID-19 vaccines are likely to be required.
With minimal data surrounding the duration of protection provided by COVID-19 vaccines and the emergence of new strain variants, the UK is considering commencing booster doses from August of this year.
अधिक पढ़ने के लिए नीचे दिए गए लिंक का अनुसरण करें:
The Guardian: Israel says 600 children given Covid jab had no serious side-effects
Following an expansion of Israel's COVID-19 vaccination program, around 600 children (≥ 12 years) have received the Pfizer/BioNTech COVID-19 vaccine. Reported side-effects in this age group have been minor and the vaccine has been well tolerated.
Due to the emergence of more transmissible strains of COVID-19, experts have now suggested that in order to achieve herd immunity closer to 90% coverage will be required. In a population of 9 million people, with approximately 1/4 of those aged under 16 years, lowering the age limit for COVID-19 vaccination is an important development for Israel.
अधिक पढ़ने के लिए नीचे दिए गए लिंक का अनुसरण करें:
The Guardian: Israel says 600 children given Covid jab had no serious side-effects
TGA: AstraZeneca ChAdOx1-S COVID-19 vaccine
Denmark, Iceland and Norway have temporarily paused the distribution of COVID-19 AstraZeneca as a precautionary measure in response to reports of blood clots following immunisation (including 1 death in Denmark). The European Medicines Agency's safety committee is conducting a rapid review into the events.
The Therapeutic Goods Administration (TGA) have advised that a link has not been confirmed and to date there have been no reports of similar events in Australia. Extensive international vaccination programs have not indicated an increased risk of blood clots associated with the vaccine.
Vaccination with COVID-19 AstraZeneca continues in other countries including the United Kingdom and France.
Please refer to the full alert below for more information:
TGA: AstraZeneca ChAdOx1-S COVID-19 vaccine
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:
ATAGI advice on seasonal influenza vaccines in 2021
ATAGI have published recommendations for the influenza vaccine program in 2021. This advice includes vaccine brand and dose information, the timing of administration, funding eligibility criteria as well as the requirement for reporting all vaccine administration to the ऑस्ट्रेलियाई टीकाकरण रजिस्टर (एआईआर).
To view the recommendations please follow the link below:
ATAGI advice on seasonal influenza vaccines in 2021
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