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Dr K Aggarwal President CMAAO, HCFI, With input from Dr Monica Vasudev
India
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New Delhi, March 15, 2021 :
The Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA) is investigating cases of thromboembolic events related to AstraZeneca’s COVID-19 vaccine, but says the benefits currently still outweigh risks.
As of March 10, 30 cases of thromboembolic events had been reported among nearly 5 million people vaccinated with the AstraZeneca vaccine in the European Economic Area, which includes European Union (EU) countries as well as Iceland, Liechtenstein, and Norway.
The number of thromboembolic events in vaccinated people is no higher than the number seen in the general population EMA said in statement.
The Danish Health Authority has paused its vaccination campaign. Some other European countries have also temporarily stopped using the AstraZeneca vaccine based on reports of blood clots.
Thailand’s Prime Minister Prayut Chan-o-cha has canceled plans to publicly get the AstraZeneca vaccine.
The Austrian national competent authority suspended the use of AstraZeneca COVID-19 batch number ABV5300 after a person was diagnosed with multiple blood clots and died 10 days after vaccination, and another was hospitalized with pulmonary embolism after being vaccinated but is now recovering.
As of March 9, EMA had received two other reports of thromboembolic events associated with this batch.
“Batch ABV5300 contains one million doses and was delivered to 17 EU countries (Austria, Bulgaria, Cyprus, Denmark, Estonia, France, Greece, Iceland, Ireland, Latvia, Lithuania, Luxembourg, Malta, the Netherlands, Poland, Spain, Sweden). As of March 9, Estonia, Latvia, Lithuania, and Luxembourg have stopped using this batch.
Ireland suspended use of the Covid-19 vaccine by Oxford-AstraZeneca on Sunday, citing reports of unusual blood clotting problems among people who recently received shots in Norway. The decision followed a new advisory from Norway on Saturday that four people given the AstraZeneca vaccine had experienced blood clotting issues and all had low platelet counts. Leading public health agencies, including the World Health Organization, point out that millions of people have received the vaccine without experiencing such blood clotting issues, and that experts have not found a causative link between any of the vaccines and the conditions.
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