LONDON (AP) – Nearly a dozen countries, including Germany, France and Italy, have temporarily suspended the use of AstraZeneca’s coronavirus vaccine after reporting last week that some people in Denmark and Norway who go receiving 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 the available data do not suggest that the vaccine caused the clots and that people should continue to be immunized. Here’s a look at what we know and what we don’t.
WHAT HAPPENED?
Denmark was the first country to stop the use of the AstraZeneca COVID-19 vaccine last week, after reports of blood clots in some people, including a person who developed several clots and died 10 days after receiving at least one dose. The Danish health authorities said the suspension would last at least two weeks while the cases were investigated, although they noted that “it is currently impossible to conclude whether there is a link between the vaccine and the blood clots.”
Norway, Iceland, Bulgaria, Thailand and the Congo soon followed suit. On Saturday, Norwegian authorities reported that four people under the age of 50 who had received the AstraZeneca vaccine had an unusually low number of blood platelets. This could cause severe bleeding. Shortly afterwards, Ireland and the Netherlands announced that they too would temporarily stop using the AstraZeneca vaccine.
Authorities in the Netherlands, like those elsewhere, said the suspension of the AstraZeneca vaccine was strictly preventive.
“We always have to err on the side of precaution, so it’s reasonable to press the pause button now as a precaution,” said Dutch Health Minister Hugo de Jonge.
On Monday, Norwegian doctors announced that one of the people hospitalized after receiving the AstraZeneca vaccine had died. After saying that last week would continue with the vaccine, German officials said Monday they would suspend its use after new reports of new problems, based on the advice of your drug regulator. French President Emmanuel Macron said France would also suspend use and Italy said it would soon stop using the shot. Spanish authorities said they were reviewing the situation.
In response to suspensions of its vaccine, AstraZeneca said it had carefully reviewed data from 17 million people receiving doses across 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 gender in any country.
“This is much lower than expected to occur naturally in a general population of this size and is similar in other licensed COVID-19 vaccines,” the company said.
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IS THERE ANY EVIDENCE OF VACCINE RESPONSIBILITY?
No. The European Medicines Agency says that “there is no evidence 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 that of people who had not received the shot.
In Britain, where 11 million doses of the AstraZeneca vaccine have been administered, more than any other country, there have been reports of some 11 people developing blood clots after receiving a shot. None of the people were shown to be caused by the vaccine.
Some doctors noted that since vaccination campaigns began giving doses to the most vulnerable people, it is likely that people who are vaccinated already have health problems. Experts say this could make it difficult to determine the responsibility of a vaccine.
Sometimes blood clots that form in the arms, legs, or anywhere else can be released and travel to the heart, brain, or lungs, causing strokes, heart attacks, or a deadly blockage of blood flow.
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WHY DID THEY STOP THE VACCINATION?
Whenever vaccines are widely developed, scientists expect serious health problems and deaths to be reported, simply because millions of people receive the vaccines and random problems are expected to occur in such a large group. The vast majority of these are not connected to the vaccine, but because COVID-19 vaccines are still experimental, scientists need to investigate all the possibilities that the shot could have some unforeseen side effect. The traits are considered experimental because the vaccines were only developed during the last year, so there is no long-term data for any of them.
“People die every day and we have more than 300 million people worldwide who have been immunized and will die from other causes,” said Dr Mariangela Simao, WHO Deputy Director-General.
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IS IT A CONCERN WITH OTHER COVID-19 VACCINES?
The EMA is currently examining whether COVID-19 features performed by Pfizer-BioNTech, Moderna Inc. and AstraZeneca could cause low blood platelet levels in some patients, a condition that could cause bruising and bleeding.
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DOES ASTRAZENECA CORRECT THE OTHER PROBLEMS?
The vaccine has been approved for use in adults in more than 50 countries and has been shown to be safe and effective in research conducted in Britain, Brazil and South Africa. But there have been concerns about how vaccine data have been released, and some European leaders, including French President Emmanuel Macron, have questioned the vaccine’s effectiveness.
Britain first authorized the vaccine based on partial results that suggested the shots were about 70% effective. But these results were clouded by a manufacturing error that led some participants to get only half a dose in their first shot, a mistake the researchers did not immediately recognize. When recommending the vaccine license, the EMA estimated that the effectiveness of the vaccine was approximately 60%.
Data on whether the vaccine protects older adults was also incomplete, which led some European countries to initially retain the shot of older people.
In the United States, the Food and Drug Administration suspended a study on 30,000 Americans for six unusual weeks as frustrated regulators sought information on some possible side effects reported in Britain.
“All the data we’ve seen about the AstraZeneca vaccine suggests that it’s very safe and saves people from dying from COVID,” said Dr. Paul Hunter, a professor of medicine at the University of East Anglia. “But this can be more than a perception problem because every time there is a vaccine problem, we hear the name ‘AstraZeneca’ shortly afterwards.”
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WHAT ARE THE EXPERTS THAT TELL PEOPLE?
The WHO and the EMA, as well as regulators in several countries, say that people should continue to be vaccinated and that the small risks of getting vaccinated far outweigh the potential damage.
“Public safety will always come first,” the British drug regulator said. “People should still go get the COVID-19 vaccine when asked.”