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Following a recent concern raised around blood clots and other thrombotic events, AstraZeneca assured that its Covid-19 vaccine is safe based on clear scientific evidence.
In a statement, the company said that a careful review of all available safety data from more than 17 million people vaccinated in the European Union (EU) and the United Kingdom with the Covid-19 AstraZeneca vaccine has shown no evidence of a increased risk of pulmonary embolism, deep vein thrombosis (DVT) or thrombocytopenia, in any defined age group, sex, lot or in any particular country.
15 DVT events and 22 pulmonary embolism events have been reported among those who received the vaccine in the EU and the UK, based on the number of cases the company has received as of March 8, 2021.
The company said this is much lower than what would be expected to occur naturally in a general population of this size and is similar in other licensed Covid-19 vaccines.
The monthly safety report will be made public on the European Medicines Agency website the following week, in line with the exceptional transparency measures for Covid-19.
Furthermore, in clinical trials, although the number of thrombotic events was small, they were lower in the vaccinated group. There has also been no evidence of increased bleeding in more than 60,000 enrolled participants, the company added.
“Around 17 million people in the EU and UK have received our vaccine, and the number of cases of blood clots reported in this group is less than the hundreds of cases that would be expected in the general population,” Ann said. Taylor, chief medical officer.
“The nature of the pandemic has led to increased attention in individual cases and we are going beyond standard practices for monitoring the safety of authorized drugs when reporting vaccine events, to ensure public safety,” he added.
In terms of quality, there are also no confirmed problems related to any lot of the AstraZeneca vaccine used in Europe or the rest of the world.
“Additional tests have been, and are being performed, ourselves and independently by the European health authorities, and none of these new tests have proven to be a cause for concern,” Taylor said.
During vaccine production, AstraZeneca, its partners, and more than 20 independent testing laboratories perform more than 60 quality tests.
All tests must meet strict quality control criteria and this data is submitted to regulators in each country or region for independent review before any lot can be shipped to countries.
“The safety of the public will always come first. The company is closely examining this problem, but available evidence does not confirm that the vaccine is the cause. To overcome the pandemic, it is important that people get vaccinated when they are invited to do so, ”said the company.
The Covid-19 AstraZeneca vaccine, formerly AZD1222, was co-invented by the University of Oxford and its spin-off company, Vaccitech.
It uses a replication-deficient chimpanzee viral vector based on a weakened version of a common cold virus (adenovirus) that causes infections in chimpanzees and contains the genetic material for the Sars-CoV-2 virus spike protein.
After vaccination, the surface spike protein is produced, which primes the immune system to attack the Sars-CoV-2 virus if it then infects the body.
The vaccine has received a conditional marketing authorization or emergency use in more than 70 countries on six continents. The recent emergency use list issued by the World Health Organization accelerates the path to access in up to 142 countries through the Covax Facility. (SunStar Philippines from PR)
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