AstraZeneca statement on blood clots

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A general view of AstraZeneca's Sydney headquarters, after Prime Minister Scott Morrison announced Australians will be among the first in the world to receive a coronavirus disease (COVID-19) vaccine, if it proves successful, through an agreement between the government and UK-based drug company AstraZeneca, in Sydney, Australia, August 19, 2020. AAP Image/Dan Himbrechts via REUTERS ATTENTION EDITORS - THIS IMAGE WAS PROVIDED BY A THIRD PARTY. NO RESALES. NO ARCHIVE. AUSTRALIA OUT. NEW ZEALAND OUT

Following a recent concern raised around thrombotic events, AstraZeneca would like to offer its reassurance on the safety of its COVID-19 vaccine based on clear scientific evidence. Safety is of paramount importance and the Company is continually monitoring the safety of its vaccine.

A careful review of all available safety data of more than 17 million people vaccinated in the European Union (EU) and UK with COVID-19 Vaccine AstraZeneca has shown no evidence of an increased risk of pulmonary embolism, deep vein thrombosis (DVT) or thrombocytopeniain any defined age group, gender, batch or in any particular country.

So far across the  EU and UK, there have been 15 events of DVT and 22 events of pulmonary embolism reported among those given the vaccine, based on the number of cases the Company has received as of 8 March.

This is much lower than would be expected to occur naturally in a general population of this size and is similar across other licensed COVID-19 vaccines. The monthly safety report will be made public on the European Medicines Agency website in the following week, in line with exceptional transparency measures for COVID-19.

Furthermore, in clinical trials, even though the number of thrombotic events was small, these were lower in the vaccinated group. There has also been no evidence of increased bleeding in over 60,000 participants enrolled.

Ann Taylor, Chief Medical Officer, said: “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. The nature of the pandemic has led to increased attention in individual cases and we are going beyond the standard practices for safety monitoring of licensed medicines in reporting vaccine events, to ensure public safety.”

In terms of quality, there are also no confirmed issues related to any batch of our vaccine used across Europe, or the rest of the world. Additional testing has, and is, being conducted by ourselves and independently by European health authorities and none of these re-tests have shown cause for concern. During the production of the vaccine more than 60 quality tests are conducted by AstraZeneca, its partners and by more than 20 independent testing laboratories. All tests need to meet stringent criteria for quality control and this data is submitted to regulators within each country or region for independent review before any batch can be released to countries.

The safety of the public will always come first. The Company is keeping this issue under close review but available evidence does not confirm that the vaccine is the cause. To overcome the pandemic, it is important that people get vaccinated when invited to do so.

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3 COMMENTS

  1. Anti vaccine prejudice will always exist and obviously everyone has freedom of choice and viewpoint. One can only hope that person’s undecided about this matter will carefully think before rejecting vaccination.

  2. He who fails to question and accept everything is like a statue. When one dies after recieving the vaccine its not the vaccine, but when one has covid and die the cause of death is covid, hypocrisy from the media, scientists, politicians has spread faster than the virus itself.

  3. Meanwhile the USA who has three different vaccines to include the single dose Johnson & Johnson are now purchaseing AstraZeneca vaccine and awaiting for it to be approved for distribution hump!!

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