Rare clots possibly linked to AstraZeneca shot: EU agency

LONDON (AP) — The European Union drug regulator said yesterday that it found a “possible link” between the AstraZeneca coronavirus vaccine and a rare clotting disorder but declined to impose any new age restrictions, saying the benefits of the shot still outweigh risks.

Its United Kingdom (UK) counterpart, however, said it would offer people under 30 the choice of another product.

The European Medicines Agency (EMA) described the clots as “very rare” side effects. It said most of the cases reported have occurred in women under 60 within two weeks of vaccination — but based on the currently available evidence, it was not able to identify specific risk factors.

Experts reviewed several dozen cases that came mainly from Europe and the United Kingdom, where around 25 million people have received the AstraZeneca vaccine.

“The reported cases of unusual blood clotting following vaccination with the AstraZeneca vaccine should be listed as possible side effects of the vaccine,” said Emer Cooke, the agency’s executive director.

Vials of AstraZeneca vaccines are placed to be packaged inside a laboratory at Serum Institute of India. The European Medicines Agency said yesterday that it found a “possible link” between the AstraZeneca coronavirus vaccine and a rare clotting disorder but declined to impose any new age restrictions, saying the benefits of the shot still outweigh risks. PHOTO: AP
A vial of the AstraZeneca COVID-19 vaccine. PHOTO: AP

But it placed no new age restrictions on using the vaccine in people 18 and over, as some countries have done.

“The risk of mortality from COVID is much greater than the risk of mortality from these side effects,” Cooke said.

Head of Britain’s Medicines and Healthcare Products Regulatory Agency Dr June Raine echoed that sentiment, saying that the benefits “continue to outweigh the risks for the vast majority of people.”

She called the unusual clots a “potential side effect” of the vaccine and said the evidence was “firming up,” but more study was needed to be sure.

The EMA, the World Health Organization and numerous other health authorities have said repeatedly that the AstraZeneca vaccine is safe and effective and that the protection it offers against COVID-19 outweighs the small risks of rare blood clots.

The announcements could have far-reaching effects on the use of the shot that is key to global efforts to end the pandemic.

The EMA’s investigation was particularly focused on two types of rare blood clots: one that appears in multiple blood vessels and another that occurs in a vein that drains blood from the brain. It also evaluated reports of people who had low levels of blood platelets, which puts them at risk of severe bleeding.

As recently as last week, the EMA said “there is no evidence that would support restricting the use of this vaccine in any population” — a response to several countries doing just that — though an expert said more brain clots were being reported than would be expected.

In March, more than a dozen countries, mostly in Europe, suspended their use of AstraZeneca over the blood clot issue. Most restarted — some with age restrictions — after the EMA said countries should continue using the potentially life-saving vaccine.

Meanwhile, Britain, which relies heavily on AstraZeneca, never suspended use of the vaccine.

The suspensions were seen as particularly damaging for AstraZeneca because they came after repeated missteps in how the company reported data on the vaccine’s effectiveness and concerns over how well its shot worked in older people. That has led to frequently changing advice in some countries on who can take the vaccine, raising worries that AstraZeneca’s credibility could be permanently damaged, spurring more vaccine hesitancy and prolonging the pandemic.

Dr Peter English, who formerly chaired the British Medical Association’s Public Health Medicine Committee, said the back-and-forth over the AstraZeneca vaccine globally could have serious consequences.

“We can’t afford not to use this vaccine if we are going to end the pandemic,” he said.

That’s because the vaccine is cheaper and easier to store than many others, is critical to Europe’s immunisation campaign and a pillar of the United Nations (UN)-backed programme known as COVAX that aims to get vaccines to some of the world’s poorest countries. It has been endorsed for use in more than 50 countries, including by the 27-nation EU and WHO. US authorities are still evaluating the vaccine.