AstraZeneca Covid-19 vaccine: ongoing evaluation of very rare cases of blood clots with unusual signs The European Medicines Agency (EMA) Safety Committee (PRAC) held a meeting on 31 March 2021 in connection with its ongoing evaluation of very rare and unusual blood clots. low platelet counts in people who have been vaccinated with AstraZeneca’s Covid-19 vaccine “Vaxzevria”.
On March 29 of this year, EZA hosted to this an expert group meeting to obtain further information in the context of the current evaluation. Independent experts in various disciplines, such as hematology, neurology and epidemiology, discussed specific aspects, including possible mechanisms of development, the possibility of detecting risk factors and the necessary additional data to better characterize the observed events and potential risks. The PRAC will discuss the outcome of this meeting and take it into account in the ongoing evaluation.
To date, this assessment has not identified specific risk factors, such as age, gender or a history of coagulation disorders, for these very rare events.
As already was announced on 19 March, The EZA is of the opinion that the benefits of AstraZeneca in preventing Covid-19 and the associated risk of hospitalization and death outweigh the risk of side effects with this vaccine.
Further information and advice for healthcare professionals and the general public is available in the vaccine product information (in the summary of product characteristics and package leaflet) and related letter to healthcare professionals. Vaccinated individuals should be aware of the low potential for blood clots to occur. If symptoms suggestive of coagulation problems described in the product information are observed, individuals should seek immediate medical attention and inform healthcare professionals about recent vaccinations.
The State Agency of Medicines states that it is necessary to seek immediate medical attention and inform that you have recently received the vaccine if a person shows any of the following symptoms after receiving Covid-19 AstraZeneca:
– lack of breath,
– chest or abdominal pain
– swollen or sore legs;
– severe or more severe headache or blurred vision after vaccination;
– persistent bleeding;
– Lots of small bruises, red or purple patches or blisters under the skin.
Healthcare professionals should be alert to the possibility of thromboembolism, thrombosis in various blood vessels (disseminated intravascular coagulation) and rare cases of thrombosis in the blood vessels of the brain (cerebral venous sinus thrombosis) in vaccinated individuals.
Vaccinated individuals should be encouraged to seek immediate medical attention if they develop symptoms of thromboembolism, especially signs of thrombocytopenia and cerebral thrombosis, such as mild bruising or bleeding, and prolonged or severe headache, especially within 3 days of vaccination.
The ESA continues to work with the national authorities of the EU Member States to ensure the reporting of possible abnormal blood clots, which are being analyzed in the current PRAC assessment.
Based on all currently available data, the PRAC is expected to make the latest recommendations following the assessment of the reported cases at a meeting on 6-9 September. April.
A report is available outlining PRAC initial assessment and conclusions reported cases of blood clots.
More about this procedure
The assessment of very rare, unusual blood clots associated with low platelet counts (thrombocytopenia) is performed as part of an accelerated safety signal assessment. A safety alert is information about a new or incompletely documented adverse event that is potentially caused by a drug, such as a vaccine, and that requires further investigation.
The assessment is carried out by the ESA Pharmacovigilance Risk Assessment Committee (PRAC) or the Safety Committee, which is responsible for assessing the safety of medicines for human use. Once the assessment is complete, the PRAC will make the necessary recommendations to reduce the risk and protect patients’ health. The PRAC’s recommendations will be forwarded to the Committee for Medicinal Products for Human Use (CHMP), which is responsible for matters relating to medicinal products for human use, and will quickly adopt the ESA’s opinion.
The ESA provides scientific advice on which the safe and effective use of Covid-19 vaccines is based.
The design and implementation of national vaccination campaigns in EU Member States is based on ESA recommendations. Vaccination programs may vary from country to country, depending on national needs and circumstances, such as the incidence of infection, priority groups, the availability of vaccines, and the frequency of hospitalization of patients.
State Agency of Medicines