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The benefits of Vaxzevria (formerly COVID-19 Vaccine AstraZeneca) outweigh its risks in adults of all age groups, however, very rare cases of blood clots with low blood platelets were detected post-inoculation, European Union's drug watchdog, European Medicines Agency (EMA) said in a report on Thursday. Vaccine formally known as the AstraZeneca was authorized in the EU to provide protection against the COVID-19 disease and mitigate deaths and severity of the respiratory ailment. Following the reports of several cases of unusual blood clots and low levels of platelets in patients, the University of Oxford / AstraZeneca (AZ) COVID-19 vaccine was suspended across several EU countries including Denmark, Norway, Iceland, Austria, Italy, Bulgaria, Romania, Estonia, Lithuania, Luxembourg, and Latvia until an accurate and “clearly confirmed diagnosis came from the European Medicines Agency (EMA).”
We recently released data from our COVID-19 vaccine US Phase III trial. We maintain our commitment to supplying our vaccine broadly and equitably at no profit during the pandemic. pic.twitter.com/a0wLTtLaUc— AstraZeneca (@AstraZeneca) March 25, 2021
To support governments in making decisions on how to best use the AstraZeneca vaccine, EMA’s human medicines committee (CHMP) analyzed available data and declared that there was no evidence of pulmonary embolism (PE), deep vein thrombosis (DVT), or thrombocytopenia (TTP) in any age group or gender. “Around 17 million people in the EU and UK have now received our vaccine and the number of cases of blood clots reported in this group is lower than the hundreds of cases that would be expected among the general population,” AstraZeneca’s chief medical officer Ann Taylor said in a statement. The pharmaceutical firm was going beyond the standard practices for safety monitoring of licensed medicines in reporting vaccine events to ensure public safety, she added.
The very rare occurrence of a mysterious blood-clotting disorder among some recipients of the Oxford–AstraZeneca COVID-19 vaccine has got researchers scrambling to uncover whether, and if so, how the inoculation could trigger such an unusual reaction. https://t.co/hG0M3Ukcbp— Nature (@nature) April 22, 2021
Publishing the safety report on the EMA website, AstraZeneca said, that the risk of incidences of blood clots with its vaccine was very rare in the context of the jab’s benefits across different age groups and different rates of infection. The Committee analyzed the vaccine’s benefits and the risk of unusual blood clots with low platelets in different age groups in the context of the monthly infection rates. It also analyzed hospitalizations, ICU admissions, deaths, and benefits of vaccination increase with increasing age. Vaxzevria is effective at preventing COVID-19 hospitalizations, intensive care unit (ICU) admissions, and deaths due to COVID-19 said AstraZeneca. It added, that the most common side effects associated with the inoculation were usually mild or moderate and disappeared within the first few days. “The most serious side effects are very rare cases of unusual blood clots with low blood platelets, which are estimated to occur in 1 in 100,000 vaccinated people. People should seek medical assistance if they have symptoms," the company said.