AstraZeneca says its vaccine is safe amid new suspensions

More countries pause use of the company’s shot, citing blood clot cases

A nurse fills a syringe with the AstraZeneca Covid-19 vaccine during a mass vaccination campaign for people between ages of 50 to 55 in Vigo, northwestern Spain. AFP

AstraZeneca said its Covid-19 vaccine is safe after a review of data showed there was no evidence the shot increased the risk of blood clots.

The British company’s review covered more than 17 million people who were immunised in the UK or EU.

It comes amid a flurry of suspensions over reports of clotting.

AstraZeneca’s shot is among the cheapest available and forms the bulk of deliveries to poorer nations under the WHO-backed Covax initiative, which aims to ensure vaccines reach all parts of the globe.

But authorities in some countries, including Ireland, Austria and the Netherlands, have suspended use of the vaccine. Norwegian officials reported a few cases of people "bleeding under the skin" and "severe cases of blood clots or brain haemorrhages in younger people" who had received the shot.

A 60-year-old Danish woman who died of a blood clot after receiving AstraZeneca’s Covid-19 vaccine had “highly unusual” symptoms, the Danish Medicines Agency said.

It said the woman had a low number of blood platelets and clots in small and large vessels, as well as bleeding.

But the number of cases of blood clots reported is lower than the hundreds of cases that would be expected among the general population, AstraZeneca’s chief medical officer Ann Taylor said.

The pharmaceutical company said its review had found no evidence of an increased risk of pulmonary embolism, deep-vein thrombosis or thrombocytopenia in either sex or within any specific age group, country or batch.

“Around 17 million people in the EU and UK have now received our vaccine, and the number of cases of blood clots reported in this group is lower than the hundreds of cases that would be expected among the general population,” Dr Taylor said.

“The nature of the pandemic has led to increased attention in individual cases and we are going beyond the standard practices for safety monitoring of licensed medicines in reporting vaccine events, to ensure public safety.”

The drugmaker said 37 blood-related incidents were reported, a figure it said was similar to that seen with other licensed Covid vaccines.

The World Health Organisation, Europe’s medicines watchdog, governments and medical experts stressed that no causal link had been established between the vaccine and blood clotting. They said the shot was safe.

Politicians are acting with an abundance of caution, but run the risk of hurting global efforts to immunise, said Helen Petousis-Harris, a vaccine safety expert at the University of Auckland who has advised the World Health Organisation on immunisation.

“You have to be very careful because it’s also sending a message that there could be something very wrong with the vaccine when in fact, it’s very unlikely that there is,” she said.

“We’re doing massive mass-vaccination campaigns and people get sick all the time. We can’t panic every time it happens. But we also need to take all precautions. And it’s a hard balance.”

The AstraZeneca Covid-19 vaccine is safe, Saudi Arabia’s Health Ministry said.

More than 2.1 million people have been immunised with several approved drugs at 500 medical centres in Saudi Arabia, ministry spokesman Dr Mohammed Al Abdulaali said.

On Monday, Thailand said it would resume its use of the shot this week, four days after suspending it, as a medical panel had decided that the vaccine did not lead to clots.

People across the UK are still being urged to have the vaccine.

After Ireland announced on Sunday that it was suspending use of the shots as a “precautionary step”, the UK’s medicines regulator said the available evidence “does not suggest the vaccine is the cause” of clots.

“Given the large number of doses administered, and the frequency at which blood clots can occur naturally, the evidence available does not suggest the vaccine is the cause,” said Dr Phil Bryan, vaccines safety lead at the Medicines and Healthcare products Regulatory Agency.

“People should still go and get their Covid-19 vaccine when asked to do so.”

AstraZeneca became embroiled in a bitter row with European leaders earlier in the year when it announced it would not be able to supply the number of doses it had promised.

Since then, EU leaders have criticised the company and cast doubt on the vaccine’s efficacy while at the same time blocking some exports of doses to destinations outside the bloc.

But French Prime Minister Jean Castex defended his country’s decision to continue vaccination with the AstraZeneca shot, saying France had found no reason to suspend its use.

“At this stage, we must have confidence in this vaccine,” he said.

Mr Castex highlighted the danger of leaving large sections of the population unprotected from Covid.

France is facing a hospital crisis with a severe shortage of intensive care beds in the Paris region that led to patients being taken elsewhere in the country.

While the country hopes to avoid being plunged back into a national lockdown, neighbouring Italy reimposed widespread restrictions on Monday, a year after it became the first European nation to report a major outbreak.

Schools, restaurants, shops and museums will close. Health Minister Roberto Speranza said he hoped the measures and mass vaccination would mean restrictions could be relaxed before summer.

“Each dose of vaccine injected is a step in the direction of the way out of the crisis,” he said.

More than 350 million vaccine doses have been distributed globally.