LONDON (AP) – Nearly a dozen countries, including Germany, France and Italy, have all temporarily halted their use of AstraZeneca’s coronavirus vaccine following 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 the available data does not suggest that the vaccine caused the blood clots and that people should continue to undergo immunization. Here’s a look at what we know – and what we don’t know.
WHAT HAPPENED?
Denmark was the first country to discontinue use of the AstraZeneca COVID-19 vaccine last week after reports of blood clots in some people, including one person who developed multiple blood clots and died 10 days after receiving at least one dose. Danish health authorities said the suspension would last at least two weeks while the cases were being investigated, even if they noted that “it cannot be concluded at this time whether there is a link between the vaccine and the blood clots.”
Norway, Iceland, Bulgaria, Thailand and Congo soon followed. On Saturday, Norwegian authorities reported that four people under 50 who had received the AstraZeneca vaccine had unusually low platelet counts. This can lead to serious bleeding. Shortly thereafter, Ireland and the Netherlands announced that they too were temporarily discontinuing their use of the AstraZeneca vaccine.
Authorities in the Netherlands – like those elsewhere – said their suspension of the AstraZeneca vaccine was strictly as a precaution.
“We always have to be careful, so it is wise to press the pause button now as a precaution,” said Hugo de Jonge, the Dutch Minister of Health.
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 suspend its use following new reports of new issues, based on the advice of the medicines regulatory agency. French President Emmanuel Macron said France would also suspend its use and Italy said it would also stop using the shot shortly afterwards. The Spanish authorities said they were reviewing the situation.
In response to the suspensions of its vaccine, AstraZeneca said it had carefully studied data from 17 million people who received doses across Europe and found there were 37 cases of people developing blood clots. It 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 would naturally be expected in a general population of this size and is comparable to other approved COVID-19 vaccines,” the company said.
IS THERE ANY PROOF THAT THE VACCINE IS RESPONSIBLE?
No. The European Medicines Agency says there is “no evidence that vaccination has caused these conditions”. The EU regulator said reports of blood clots in people who received the AstraZeneca vaccine were no higher than those who did not receive 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 about 11 people developing blood clots after receiving an injection. None were proven to be caused by the vaccine.
Some doctors pointed out that since vaccination campaigns began administering doses to the most vulnerable people, those now immunized are more likely to have health problems. Experts say this could make it difficult to determine if a vaccination shot is responsible.
Blood clots that form in the arms, legs, or elsewhere can sometimes detach and travel to the heart, brain, or lungs and cause strokes, heart attacks, or a deadly blockage of blood flow.
WHY DID THEY STOP THE VACCINATION?
Every time vaccines are rolled out on a large scale, scientists expect some serious health problems and deaths to be reported – simply because millions of people are getting the injections and problems are expected to occur randomly in such a large group. The vast majority of these are ultimately unrelated to the vaccine, but because COVID-19 vaccines are still experimental, scientists must investigate every possibility that the injection could have some unforeseen side effects. The recordings are considered experimental because the vaccines were only developed in the last year, so there is no long-term data for any of them.
“People die every day, and there are more than 300 million people worldwide who are immunized and who will die from other causes,” said Dr. Mariangela Simao, an assistant director general at WHO.
IS THIS A CONCERN WITH OTHER COVID-19 VACCINES?
The EMA is currently investigating whether COVID-19 images taken by Pfizer-BioNTech, Moderna Inc. and AstraZeneca can cause low platelet counts, a condition that can cause bruising and bleeding, in some patients.
DID ASTRAZENECA RUN ANY OTHER PROBLEM?
The vaccine has been approved for use in adults in more than 50 countries and has been proven to be safe and effective in research conducted in Great 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, have questioned the vaccine’s effectiveness.
Britain first approved the vaccine based on partial results that suggested the injections were about 70% effective. But those results were clouded by a manufacturing flaw that caused some participants to receive only half a dose in their first shot – a flaw that the researchers didn’t immediately recognize. When the EMA recommended that the vaccine be licensed, the EMA estimated the vaccine’s efficacy at about 60%.
Data on whether the vaccine protected older adults was also incomplete, leading some European countries to withhold injection from older adults at first.
In the US, the Food and Drug Administration suspended a survey of 30,000 Americans for an unusual six weeks as frustrated regulators sought information about some of the potential side effects reported in Britain.
“All the data we’ve seen on the AstraZeneca vaccine suggests it is very safe and saves people from death from COVID,” said Dr. Paul Hunter, a professor of medicine at the University of East Anglia. “But this may be more of a perception problem, because every time there is a vaccine problem, we hear the name ‘AstraZeneca’ shortly afterwards.”
WHAT ARE EXPERTS WHO SHOULD TELL PEOPLE?
The WHO and EMA – as well as regulators in several countries – say people should continue to be immunized and that the minor risks of vaccination far outweigh the potential harm.
“Public safety will always come first,” said the UK drug regulator. “People still need to get their COVID-19 vaccine when asked.”