Benefits of Oxford/AstraZeneca vaccine outweigh any risk, says EMA

Benefits of Oxford/AstraZeneca vaccine outweigh any risk, says EMA

13:37 - European agency seeks to allay blood clot fears as Germany, France and Italy temporarily suspend use

Europe’s medicines regulator has moved to stifle spiralling concern about the Oxford/AstraZeneca vaccine, saying the shot’s benefits outweigh the risks after four major EU countries announced they were suspending its use.

Germany, France, Italy and Spain temporarily halted inoculations with the vaccine on Monday after reported incidents of bleeding, blood clots and a low count of blood platelets in some people who had received the AstraZeneca shot.

The European Medicines Agency said in a statement that “many thousands of people develop blood clots annually in the EU for different reasons” and that the number of incidents in vaccinated people “seems not to be higher than that seen in the general population”.

It said it was working closely with AstraZeneca and national health regulators, including the MHRA in the UK, where 11 million people have received the shot, to analyse all available data and establish whether the vaccine might have contributed.

The MHRA, which collects reports of side-effects on drugs and vaccines in the UK through its “yellow card” scheme, told the Guardian it had received more notifications up until 28 February of blood clots on the Pfizer/BioNTech than the Oxford/AstraZeneca vaccine – 38 versus 30 - although neither exceed the level expected in the population.

“Such reports are not proven side effects of the vaccine,” a spokesman said. “Blood clots can occur naturally and are not uncommon.”

The EMA’s safety committee will meet on Tuesday and a decision on any further action will be announced on Thursday, it said, adding that it “currently remains of the view that the benefits of the AstraZeneca vaccine in preventing Covid-19, with its associated risk of hospitalisation and death, outweigh the risks of side-effects”.

Amid fears that the suspensions might lead to people refusing to have the vaccine, Downing Street said the AstraZeneca jab “remains both safe and effective”. Boris Johnson’s official spokesperson said there was “no evidence” that blood clots were any more likely to occur following vaccination.

Germany’s health ministry said earlier the country’s vaccine authority, the Paul Ehrlich Institute, “considers further investigation necessary after new reports of cerebral brain thrombosis in connection with vaccination in Germany and Europe”.

It said the EMA should decide “whether and how the new findings will affect the approval of the vaccine”. The health minister, Jens Spahn, said seven cases of cerebral vein thrombosis had been reported.

While this was a “very low risk” compared with the 1.6m jabs already given in the country, Spahn said, it would be above average if a link to the vaccine was confirmed. “The decision today is a purely precautionary measure,” he said.

The French president, Emmanuel Macron, said France would also stop administering the AstraZeneca shot “out of precaution … in the hope we can resume quickly if the EMA gives the green light” after this week’s meetings.

Joining a growing number of European countries to temporarily halt the use of the vaccine in recent days, Italy’s medicines authority, Aifa, said it was also suspending inoculations as a “precautionary and temporary measure” before the EMA decision. Spain and Slovenia later followed suit.

Denmark and Norway last week reported incidents of bleeding, blood clots and a low count of blood platelets in several people who had received the AstraZeneca shot, prompting Ireland and the Netherlands to join them on Sunday in making temporary suspensions.

A World Health Organization spokesperson, Christian Lindmeier, on Monday said it would communicate its findings and “any unlikely changes to current recommendations” as soon as it had investigated the incidents in Europe.

However, “as of today, there is no evidence that the incidents are caused by the vaccine, and it is important that vaccination campaigns continue so that we can save lives and stem severe disease from the virus”, Lindmeier said.

Karl Lauterbach, a professor of health economic and epidemiology at the University of Cologne and a German MP, criticised Germany’s decision. “Based on the data available, I consider this to be a mistake,” Lauterbach said.

“Testing without suspension of vaccination would have been better because of the rarity of the complication. In the third wave, which is now picking up speed, the first vaccinations with the AstraZeneca vaccine would be lifesavers.”

The Netherlands clarified on Monday that it had recorded 10 cases of “noteworthy adverse side-effects” from the AstraZeneca vaccine, while Denmark said “highly unusual” symptoms were seen in a 60-year-old recipient who died from a blood clot.

The agency said in a statement that the woman had “a low number of blood platelets and clots in small and large vessels, as well as bleeding”. Norway also spoke of “unusual symptoms” in three people under 50 being treated in hospital.

Two health workers in Norway have since died of brain haemorrhages, the national medicines agency said, adding that it could “neither confirm nor exclude that it has something to do with the vaccine”.

Austria stopped using one batch of the AstraZeneca vaccine on 8 March after a 49-year-old nurse died from “severe bleeding disorders”, and prosecutors in the northern Italian region of Piedmont on Monday seized a batch of 393,600 doses after a 57-year-old music teacher fell ill and died.

In the UK, Ruth Rankine, the primary care director at the NHS Confederation, said health leaders were concerned the decisions from some European countries “will affect how confident people in England are about getting immunised”.

Rankine said this was “particularly worrying as it is coming at a time when national lockdown restrictions are beginning to be relaxed, when our vaccine stock has increased this week, and when we can see the benefits of the vaccinations coming through in reduced transmission”.

Prof Andrew Goddard, the president of the Royal College of Physicians, said: “As far as we are aware, there has been no demonstrable evidence of an increase in thromboembolic events, such as blood clots, among those who have been vaccinated in the UK.”

Goddard said there was “evidence to suggest that those who are hospitalised with Covid-19 are at much higher risk of having a blood clot than the rest of the population, so we’d urge people to act responsibly and continue getting vaccinated when they’re invited to.”

AstraZeneca said 17 million people had so far received the jab and the 15 incidences of deep vein thrombosis (DVT) and 22 events of pulmonary embolism recorded were “much lower than would be expected to occur naturally in a general population” and “similar across other licensed Covid-19 vaccines”.

Adding to the pharmaceutical firm’s problems, AstraZeneca said at the weekend it would not be able to meet its delivery targets to the EU in the first quarter and could have problems in the second quarter too.

The company’s initial target was for 120m doses in the first quarter of the year and 180m in the second. It then lowered its first-quarter target to 40m, citing “lower-than expected output from the production process”, but is now looking at just 30m.

Although it still aims to supply 100m in the second quarter, leaked documents suggest that figure may now be only 70m – meaning the company would have supplied 100m of the 300m doses it promised the EU in the first half.

AstraZeneca said on Saturday it hoped it would be able to compensate for production difficulties in its European plants with supplies from its global network which were being stymied by some countries’ export restrictions.

The US is refusing to release 30m unused doses even though the vaccine has not been approved by US regulators, while the head of Sweden’s vaccination programme said at the weekend there were clear “contractual obstacles” to AstraZeneca exporting supplies to the EU from the UK.

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