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EU Medicines Agency Says AstraZeneca Safe, but Can’t Rule Out Link to Blood Clots

The European Union's medicines agency said the very small risk of using the Oxford-AstraZeneca vaccine is preferable to not using the vaccine to fight the coronavirus pandemic.

(CN) --- Amid a new wave in the coronavirus pandemic and a crisis over vaccines, the European Union's medical agency on Thursday assured Europeans that it is safe to use the AstraZeneca vaccine, even though it said it may cause blood clots in a very small number of people.

Numerous European countries, and others around the world, temporarily suspended the use of the Oxford-AstraZeneca vaccine after people died from blood clots following inoculation. At least nine deaths from blood clots were potentially caused by the vaccine, experts say. In the EU, 7 million AstraZeneca doses have been administered and 11 million in the United Kingdom.

Fears over the AstraZeneca vaccine have compounded the EU's vaccine woes and come at a moment when the continent is seeing a rise in infections and deaths. The EU has fallen far behind the United States and the United Kingdom in the race to inoculate populations and the bloc's top bureaucrats are under fire for botching the vaccination drive.

On Thursday, the European Medicines Agency tried to allay fears over the AstraZeneca vaccine.

“This is a safe and effective vaccine,” said Emer Cooke, the agency's executive director. “Its benefits in protecting people from Covid-19 – with the associated risks of death and hospitalization – outweigh the possible risks."

Still, the EU's medical regulatory agency said it could not rule out that taking the vaccine may cause blood clots in a small number of people. The majority of blood clots have been reported in women under the age of 55.

“We still cannot rule out definitively a link between these cases and the vaccine,” Cooke said during a news briefing at the agency's headquarters in Amsterdam.

“When you vaccinate millions of people, it is inevitable that rare or serious instances or illnesses will occur in the time immediately following vaccination,” said Dr. Sabine Straus, the head of a panel of experts investigating the blood clots.

The agency, known as EMA, said the vaccine will now come with warnings about the possibility that it may cause blood clots. Its recommendations were based on the findings of an emergency panel of experts that analyzed clinical reports, autopsy reports and data from the vaccine maker's clinical trials.

Several EU countries lifted their temporary suspensions of the vaccine following EMA's findings on Thursday.

The exterior of the European Medicines Agency, EMA, is seen in Amsterdam, Netherlands, Tuesday March 16, 2021. At least a dozen countries including Germany, France, Italy and Spain have now temporarily suspended their use of AstraZeneca's coronavirus vaccine after reports last week that some people in Denmark and Norway who got a dose developed blood clots, even though there's no evidence that the shot was responsible. The European Medicines Agency and the World Health Organization say the data available don't suggest the vaccine caused the clots and that people should continue to be immunized. (AP Photo/Peter Dejong)

When the University of Oxford and British-Swedish drug maker AstraZeneca announced last November that their vaccine was ready for use, the world hailed it as a major step in the fight to end the pandemic.

Unlike the BioNTech-Pfizer and Moderna vaccines, which are based on a new and costly technique known as mRNA, the AstraZeneca product relies on the more common method of using a bioengineered version of a harmless common-cold virus found in chimpanzees to tell human cells to make antigens. Unlike the mRNA vaccines, it doesn't need to be stored at subzero temperatures, making it an ideal candidate to transport around the world. The EU and World Health Organization envisioned it playing a major role in global vaccination efforts.

But in the past three months, the euphoria has turned to controversy.

Doubts surfaced about the robustness of AstraZeneca's clinical trials following revelations a large group of participants in the trials mistakenly were given only one dose instead of two.

Then in late January the company said it was delaying the shipment of millions of doses to the EU due to supply problems at its EU facilities. A political row erupted with the U.K. after the EU demanded AstraZeneca ship doses to the EU from its British laboratories. Allegations that the company favored Britain over the EU also surfaced.

In turn, British politicians accused the EU of trashing AstraZeneca to cover up its own mistakes in its botched EU-wide vaccination program. Making the controversy worse, the EU said it was blocking AstraZeneca doses made in Europe from leaving the continent. Italy did just that last week.

The fight between the EU and AstraZeneca – and by extension, the British government – got uglier last week when Denmark became the first country to suspend the use of the vaccine because of a possible link between it and blood clots.

On Friday, British Prime Minister Boris Johnson is set to add a new twist to the controversy by receiving an AstraZeneca shot to both assure people about the vaccine's safety and take a jab at European leaders, who have been accused by many commentators of exaggerating the blood clot risk to damage the vaccine maker's reputation.

But in saying it could not rule out a link between blood clots and the vaccine, the EMA's statements may do little to rub out many Europeans' concerns. Large percentages of Europeans were wary of coronavirus vaccines even before the AstraZeneca problems. This reluctance was part of the EU's reasoning to not fast track the approval of vaccines, as was done in the U.K., the U.S., China and Russia. By not issuing emergency approvals, the EU hoped to win the confidence of Europeans.

EMA said it studied seven cases of blood clots in multiple blood vessels – a condition known as disseminated intravascular coagulation – and 18 other cases of blood clots, including cases where clots appeared in the vessels draining blood from the brain. Nine of the 25 people died.

The agency said there were a total of 469 reports of blood clots in people who'd been vaccinated, which it said was lower than that expected in the general population. The agency said this means the vaccine carries no increased risk in blood clots to the overall population.

It said most of the blood clots it studied occurred in women under the age of 55. Straus said it was too early to say why more of the cases involved younger women, though she said contraceptives could one reason. She noted that more younger women may also have been vaccinated. Many countries are vaccinating medical workers, such as nurses, and school staff first.

The experts ruled out any problems linked to specific batches of the vaccine or to specific manufacturing sites. The agency said it will continue investigating.

After vaccinations with AstraZeneca, people should be told to see a doctor if they suffer breathlessness, chest or stomach pains, swelling or coldness in an arm or leg, blurred vision, persistent bleeding or small bruises within two weeks of getting a shot.

Courthouse News reporter Cain Burdeau is based in the European Union.

Follow @cainburdeau
Categories / Government, Health, International

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