LONDON (AP) – Almost a dozen countries, including Germany, France and Italy, have temporarily suspended the use of the AstraZeneca coronavirus vaccine after reports last week that some people in Denmark and Norway who received a dose developed blood clots , although there is no evidence that the shot was responsible.
The European Medicines Agency and the World Health Organization say that the available data does not suggest that the vaccine caused the clots and that people should continue to be immunized. Here is a view of what we know – and what we don’t know.
WHAT HAPPENED?
Denmark was the first country to suspend the use of the AstraZeneca COVID-19 vaccine last week, after reports of blood clots in some people, including a person who developed multiple clots and died 10 days after receiving at least one dose. Danish health officials said the suspension would last at least two weeks while the cases were being investigated, even when they noted that “at the moment, it cannot be concluded if there is a link between the vaccine and blood clots”.
Norway, Iceland, Bulgaria, Thailand and Congo soon followed suit. On Saturday, Norwegian authorities reported that four people under the age of 50 who received the AstraZeneca vaccine had an unusually low number of platelets in their blood. This can cause severe bleeding. Shortly afterwards, Ireland and the Netherlands announced that they would also temporarily stop using the AstraZeneca vaccine.
Officials in the Netherlands – as elsewhere – said the suspension of the AstraZeneca vaccine was strictly preventive.
“We must always err on the side of caution, so it is wise to press the pause button now as a precaution,” said Hugo de Jonge, the Dutch health minister.
On Monday, Norwegian doctors announced that one of the people hospitalized after receiving the AstraZeneca vaccine had died. After saying last week they would continue with the vaccine, German officials said on Monday that they would stop using it after new reports of new problems, based on advice from your drug regulator. French President Emmanuel Macron said that France would also suspend its use and Italy said shortly afterwards that it would also stop using the injector. Spanish authorities said they are reviewing the situation.
In response to the suspensions of its vaccine, AstraZeneca said it carefully reviewed the data for 17 million people who received doses in Europe and found that there were 37 cases of people who developed blood clots. He said there was “no evidence of an increased risk” of blood clots in any age group or sex in any country.
“This is much smaller than would be expected to occur naturally in a general population of this size and is similar to other licensed COVID-19 vaccines,” said the company.
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IS THERE ANY PROOF THAT THE VACCINE IS RESPONSIBLE?
No. The European Medicines Agency states that there is “no indication that vaccination has caused these conditions”. The EU regulator said the number of reports of blood clots in people who received the AstraZeneca vaccine was not higher than in those who did not get the vaccine.
In Britain, where 11 million doses of the AstraZeneca vaccine have been administered – more than in any other country – there have been reports of about 11 people who developed blood clots after receiving an injection. None have been proven to be caused by the vaccine.
Some doctors pointed out that, since vaccination campaigns started with administering doses to the most vulnerable people, those who are being immunized are more likely to already have health problems. Experts say this may make it difficult to determine whether a vaccine injection is responsible.
Blood clots that form in your arms, legs, or elsewhere can sometimes break free and travel to your heart, brain, or lungs, causing strokes, heart attacks, or deadly blood flow.
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THEN WHY DID THE VACCINATION STOP?
Whenever vaccines are widely distributed, scientists expect some serious health problems and deaths to be reported – simply because millions of people are receiving the vaccines and the problems are expected to occur randomly in such a large group. The vast majority of them end up not being connected to the vaccine, but since the COVID-19 vaccines are still experimental, scientists must investigate all possibilities that the injection may have some unforeseen side effects. Vaccines are considered experimental because the vaccines were only developed last year, so there is no long-term data for any of them.
“People die every day and we have over 300 million people worldwide who have been immunized and will die from other causes,” said Dr. Mariangela Simão, WHO assistant director-general.
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IS THIS A CONCERN WITH OTHER COVID-19 VACCINES?
EMA is currently examining whether injections of COVID-19 by Pfizer-BioNTech, Moderna Inc. and AstraZeneca may be causing low levels of blood platelets in some patients, a condition that can lead to bruising and bleeding.
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DOES ASTRAZENECA HAVE ANOTHER PROBLEM?
The vaccine has been approved for use in adults in more than 50 countries and has proven to be safe and effective in research in Britain, Brazil and South Africa. But concerns have been raised about how the vaccine data was released, and some European leaders, including French President Emmanuel Macron, questioned the vaccine’s effectiveness.
Great Britain authorized the vaccine for the first time on the basis of partial results that suggested that vaccines were about 70% effective. But those results were overshadowed by a manufacturing error that led some participants to receive only half a dose on their first dose – a mistake that the researchers did not immediately recognize. When it recommended licensing the vaccine, the EMA estimated the vaccine’s effectiveness to be around 60%.
Data on whether the vaccine protected the elderly was also incomplete, leading some European countries to initially refuse the vaccine to the elderly.
In the United States, the Food and Drug Administration suspended a study of 30,000 Americans for an unusual six weeks, while frustrated regulators sought information about some possible side effects reported in Britain.
“All the data we saw on the AstraZeneca vaccine suggests that it is very safe and is preventing people from dying from COVID,” said Dr. Paul Hunter, professor of medicine at the University of East Anglia. “But this can be more of a perception problem, because every time there is a vaccine problem, we hear the name ‘AstraZeneca’ right after.”
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SO, WHAT ARE THE EXPERTS TELLING PEOPLE?
WHO and EMA – as well as regulators in several countries – say that people should continue to be immunized and that the small risks of being vaccinated far outweigh any potential harm.
“Public safety will always come first,” said Britain’s drug regulator. “People should still go and get their COVID-19 vaccine when asked to do so.”