Germany, France and Italy suspend use of Oxford/AstraZeneca coronavirus vaccine

Germany, France and Italy have become the latest EU members to suspend the use of the Oxford/AstraZeneca Covid vaccine following advice from its national regulator.

Berlin’s health ministry called it a “precaution” and there would be further investigation after reports of people suffering blood clots in the days and weeks after receiving a jab.

President Emmanuel Macron and the Italy Medicines Authority later confirmed France and Italy respectively are also suspending the vaccine.

At least nine countries, including Ireland, the Netherlands, Denmark, Norway and Indonesia, have temporarily stopped using the vaccine.

It follows reports from Denmark and Norway of possible serious side-effects, including bleeding and blood clots.

The World Health Organisation (WHO), Boris Johnson and British experts have sought to reassure people about the safety of the vaccine.

WHO said there is no indication of any links between blood clotting and the administration of the vaccine.

Prime Minister Boris Johnson told reporters: “In the MHRA [the UK’s medicines regulator], we have one of the toughest and most experienced regulators in the world. They see no reason at all to discontinue the vaccination programme

“So we continue to be very confident about the programme and it’s great to see it being rolled out at such speed across the UK.”

The UK medicines regulator said people should carry on getting their jabs as evidence “does not suggest” the vaccine causes clots

The head of the Oxford University vaccine group, Professor Andrew Pollard, said that while it was right that regulators investigated reports of blood clots in people who have had the vaccine, data from millions of people was “very reassuring” that there was no link.

Last week, WHO, the European Medicines Agency (EMA) and the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) said there was no evidence of a link between the jab and an increased risk of blood clots.

Prof Pollard said “safety is clearly absolutely paramount” but that about 3,000 cases of blood clots occur every month in the UK from other causes.

“So, when you then put a vaccination campaign on top of that, clearly those blood clots still happen and you’ve got to then try and separate out whether, when they occur, they are at all related to the vaccine or not,” he told BBC Radio 4’s Today programme.

Prof Pollard said that more than 11 million doses have now been given in the UK, and the MHRA has said “very clearly that they’re not seeing any increase in the number of cases of blood clots” over what they would see normally.

“I think at this moment we’ve got the most data from the UK, which looks very reassuring, but of course it’s absolutely right that there’s careful monitoring of safety and this gets looked into,” he said.

The professor pointed to the “huge risks” from Covid-19 for those who are unvaccinated, adding that “if we have no vaccination and we come out of lockdown in this country, we will expect tens of thousands of more deaths to occur during this year”.

He continued: “A number of countries around Europe are now seeing an increase in cases again.

“Italy and France and Germany and Poland – all have the start of a new surge in cases.

“It’s absolutely critical that we don’t have a problem of not vaccinating people and have the balance of a huge risk – a known risk of Covid – against what appears so far from the data that we’ve got from the regulators – no signal of a problem.”

Elsewhere, Professor Anthony Harnden, deputy chairman of the Joint Committee on Vaccination and Immunisation (JCVI), also sought to reassure the public and said people should attend their vaccine appointments.

He said that the EMA, the MHRA, the World Health Organisation and AstraZeneca have “all said this vaccine is safe”.

He told BBC Breakfast: “The data that we look at on a weekly basis on JCVI and a daily basis at MHRA are reassuring that there is no link, so we are right in this country to press on.

“We will keep monitoring this and if there is any safety signals that we are concerned about, we would let the public know straight away.

“At the moment, the message is absolutely clear – go and get your vaccine when offered.

“I spent all yesterday in our practice vaccinating with the Oxford/AstraZeneca vaccine – I would not be immunising my own patients unless I felt it was safe.”

Prof Harnden said analysis of the 11 million doses of the vaccine given so far in the UK had found “no demonstrable difference between the blood clots in those that have been vaccinated from those in the general population.

“We have to remember that there are 3,000 blood clots a month on average in the general population and because we’re immunising so many people, we are bound to see blood clots at the same time as the vaccination, and that’s not because they are due to the vaccination.

“That’s because they occur naturally in the population.

“One ought to also remember that Covid causes blood clots. So, the risks of not having the Covid vaccination far outweigh the risks from the vaccinations.”

Prof Harnden also told the programme that all over-50s in the UK can expect to be vaccinated in the next few weeks.

“Most people over the age of 50 will be vaccinated really within the next few weeks – so it is tremendously successful,” he said of the vaccination programme.

“Those first nine priority groups included 99% of all hospitalisations and deaths, certainly in wave one of the pandemic, so we’re feeling very optimistic.

“We’re seeing a very sharp reduction in the deaths and hospitalisations throughout the country.”

On the issue of side-effects, Prof Harnden said women were more likely to get them from the Oxford/AstraZeneca jab than were men.

“The Oxford/AstraZeneca vaccine – for the first dose – seems to give quite a lot of minor side effects like: a very sore arm; fever; malaise; headache and sometimes chills which may last for up to 48 hours afterwards,” he said.

“They do seem to be more common in women and in younger women.

“With the Pfizer vaccine, which we are given at the moment, it seems to be the reverse – side-effects are more likely with the second vaccine.

“The message is once you’ve had your first Oxford/AstraZeneca vaccine – if you do get some side-effects which are unpleasant, take some paracetamol.”

He said people should not be deterred from having a second dose.

On Sunday, Dr Phil Bryan, vaccines safety lead at the MHRA, said people “should still go and get their Covid-19 vaccine when asked to do so” despite reports from Norway and Denmark about potential cases of blood clots.

“We are closely reviewing reports but 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,” he said.

AstraZeneca also said its own review had found no evidence of an increased risk of pulmonary embolism, deep vein thrombosis (DVT) or thrombocytopenia, in any defined age group, gender, batch or in any particular country.

In clinical trials for the jab, the number of clotting incidents was small and “lower in the vaccinated group” than in those who were unvaccinated, it added.

“To overcome the pandemic, it is important that people get vaccinated when invited to do so,” the firm said in a statement.