Medical syringes and small figures of people can be seen in front of the AstraZeneca logo displayed on a screen. On Saturday March 26th 2021 in Dublin, Ireland.
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Germany has stopped using the coronavirus vaccine developed by AstraZeneca and Oxford University in the under 60s due to renewed concerns over reports of blood clots.
The move comes after the country’s medicines agency found 31 cases of a rare type of blood clot in a small number of people immunized with the coronavirus vaccine made by the Anglo-Swedish drug maker. The suspension is likely to deal another blow to the vaccine’s reputation.
Initially, some regions suspended the use of the shot on Tuesday due to concerns about a possible link to rare but serious forms of blood clots. However, it was announced on Tuesday that the entire country will no longer distribute the vaccine to anyone under the age of 60 after the country’s independent vaccine committee known as STIKO recommended it.
The committee said in a statement on Tuesday that “after several consultations, the majority of the STIKO, with the help of external experts, decided to only recommend the Covid-19 AstraZeneca vaccine to people aged 60 and over.”
This decision was based “on the currently available data on the occurrence of rare but very severe thromboembolic side effects. This side effect occurred 4 to 16 days after vaccination, mainly in people (under) 60 years of age,” it said.
Regarding the question of giving the second dose of vaccine to younger people who have already received a first dose of the AstraZeneca vaccine, the German vaccine committee announced that it would issue guidelines on the matter by the end of April.
Germany’s Paul Ehrlich Institute, a federal agency and medical regulator, told CNBC that there have been 31 cases of blood clots in the cerebral veins – a condition known as sinus vein thrombosis or cerebral venous sinus thrombosis – reported as part of a spontaneous admission.
Out of that number, thrombocytopenia (a condition characterized by abnormally low blood platelet levels) has also been reported in 19 cases. In nine of these cases, those affected died.
All but two of the 31 cases concerned women between the ages of 20 and 63, while the two men affected were 36 and 57 years old, according to the Paul Ehrlich Institute.
It added that it “continues to examine and evaluate all incoming case reports and actively participate in the relevant discussions at EMA, the European Medicines Agency, where case reports from all EU Member States are evaluated.
To put the numbers in context: By Monday, almost 2.7 million people in Germany had received a first dose of the AstraZeneca vaccine, 767 people had received a second dose, according to the German health department, the Robert Koch Institute.
“Everything is based on a principle and that is trust,” said Merkel at a press conference, reported Reuters. “Trust arises from the knowledge that every suspicion is counted in every individual case.” The 66-year-old Chancellor added that she would also be ready to receive the AstraZeneca vaccine “when it is my turn,” reported Deutsche Welle.
Still, the German move is sure to cause AstraZeneca more pain and confuse the public and worry about the vaccine.
AstraZeneca has already suspended its shot in a handful of European countries before the EMA and World Health Organization reviewed the vaccine’s safety data and concluded that it was “safe and effective” and that the benefits outweigh the risks.
The EMA said at the time, however, that it could not rule out a connection between the shot and the blood clots, which at least occur regularly in the general population. Enough concerns have been raised for Canada to suspend use of the vaccine in those under 55 due to fears of a possible association with blood clots.
However, clinical and real world data has shown the vaccine to drastically reduce Covid cases, hospital stays and deaths. The vaccine is a key part of vaccination programs in the UK and other countries and is viewed as an inexpensive vaccine that is easy to transport and store.
Drugmaker defends himself
Many scientists and the UK government have defended the shot, claiming it had saved thousands of lives.
In a statement to CNBC, AstraZeneca said that international regulators had determined that the benefits of the sting significantly outweighed any possible risks.
It said it continues to analyze its database of tens of millions of records for the vaccine to understand “whether these very rare cases of thrombocytopenia-related blood clots are more common than would naturally be expected in a population of millions of people “.
“We will continue to work with the German authorities to answer any questions,” he added.
The drug company stressed that “tens of millions of people around the world have received our vaccine. The vast amounts of data from two large clinical datasets and real evidence demonstrate its effectiveness and reinforce the role the vaccine can play in this public health crisis.”
Germany had previously not given the vaccine to people aged 65 and over because there was insufficient data on its effectiveness in this age group. However, when more data emerged showing it was safe and effective, it reversed that policy.