Countries including France, Denmark, Ireland and Thailand have temporarily suspended their use of AstraZeneca’s coronavirus vaccine following reports that some people developed blood clots, although there is no evidence that the shot was responsible.
The European Medicines Agency (EMA) and the World Health Organization (WHO) say the available data do not indicate that the vaccine caused blood clots and that people should continue to be vaccinated as the benefits outweigh the risks.
Here’s a look at what we know – and what we do not know.
What are the concerns?
Denmark was the first country to stop using the AstraZeneca Covid-19 vaccine last week following reports of blood clots in some people, including one person who had multiple blood clots and died 10 days after receiving at least one dose. The Danish health authorities said that the suspension would last for at least two weeks while the cases were investigated, while noting that “at present it cannot be concluded whether there is a link between the vaccine and the blood clots”.
Norway, Iceland, Bulgaria, Thailand and the Congo soon followed. On Saturday, Norwegian authorities reported that four people under the age of 50 who had received the AstraZeneca vaccine had an unusually low platelet count, which could lead to severe bleeding. Shortly afterwards, Ireland and the Netherlands announced that they were also temporarily suspending their use of the AstraZeneca vaccine.
Most national health authorities emphasized that the suspension of the AstraZeneca vaccine was a strict precaution.
“We must always go wrong on the side of caution, which is why it is wise to press the pause button now as a precautionary measure,” said Hugo de Jonge, the Dutch Minister for Health.
Norwegian doctors announced on Monday that one of the people who was in hospital after receiving the AstraZeneca vaccine had died. German officials said they would discontinue use after new reports of problems and based on advice from the drug authority.
French President Emmanuel Macron said France would also suspend its use until the European Health Authority, EMA, could examine the vaccine, expected within a few days. Slovenia, Spain and Portugal also stopped AstraZeneca vaccinations on Monday.
In response to the suspensions, AstraZeneca said it had carefully examined the data on 17 million people receiving doses across Europe. It is said that there was no evidence of an increased risk of blood clots in any age group or gender in any country.
Is there evidence that the vaccine is responsible?
The EMA says there is “no indication that vaccination has caused these conditions” and added that the number of reports of blood clots in people who received the AstraZeneca vaccine was not higher than in those who did not receive the shot.
In the UK, where 11 million doses of the AstraZeneca vaccine have been administered – more than any other country – there have been reports of around 11 people developing blood clots after being shot. No one was proven to be caused by the vaccine.
Some doctors pointed out that since vaccination campaigns began with giving doses to the most vulnerable people, those who are now being vaccinated are more likely to already have health problems, making it more difficult to determine if the vaccine is responsible.
Blood clots that form in the arms, legs or elsewhere can sometimes break loose and travel to the heart, brain or lungs and cause a stroke, heart attack or a fatal blockage of blood flow.
Why did so many countries stop AstraZeneca vaccinations?
Whenever vaccines are rolled out on a large scale, researchers expect serious health problems and deaths to be reported – simply because millions of people are shot and problems can be expected to arise in such a large group. The vast majority of these do not cease to be associated with the vaccine, but since Covid-19 vaccines are still experimental, researchers must investigate all possibilities that the shot may have some unintended side effects. The shots are considered experimental because the vaccines were only developed in the last year, so there are no long-term data for any of them.
“People are dying every day, and we have more than 300 million people worldwide who have been vaccinated who will die of other causes,” says Dr. Mariangela Simao, Deputy Director – General of the WHO.
Is this a problem with other Covid-19 vaccines?
The EMA is currently investigating whether Cfid-19 shots of Pfizer-BioNTech, Moderna and AstraZeneca can cause low platelet levels in some patients, a condition that can lead to bruising and bleeding.
Has AstraZeneca encountered 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 the United Kingdom, Brazil and South Africa. However, concerns have been raised about the release of vaccine data, and some European leaders, including French President Macron, have questioned the vaccine’s effectiveness.
The UK first approved the vaccine based on partial results which suggested that the shots were about 70 percent effective. However, these results were obscured by a manufacturing defect that resulted in some participants receiving only half a dose in their first shot – a defect that the researchers did not immediately acknowledge. When it recommended that the vaccine be licensed, the EMA estimated the vaccine’s efficacy at about 60 percent.
Information on whether the vaccine protected older adults was also incomplete, which led some European countries to initially keep the shot from older people.
In the United States, the Food and Drug Administration suspended a study of 30,000 Americans for an unusual six weeks because frustrated regulators sought information on some possible side effects reported in the UK.
“All the information we have seen about the AstraZeneca vaccine suggests that it is 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 of a perceptual problem, because every time there is a vaccine problem, we hear the name ‘AstraZeneca’ shortly after.”
What do experts recommend?
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 being vaccinated outweigh any harm.
“Public safety will always come first,” said the UK Medicines Agency. “People should still go and get their Covid-19 vaccine when asked to do so.”
( Jowharwith AP)