‘Blood clots’ in Europe prompt investigation into Oxford vaccine
Austria and Italy have stopped using a batch of the jab, while Denmark, Iceland and Norway have halted use of the vaccine.
The European Medicines Agency is now launching an investigation but at present there is no firm evidence to suggest the two are linked and incidents of clotting have not been reported in the UK.
Denmark, Norway and Iceland have suspended the rollout of the vaccine, while Italy and Austria have stopped using a certain batch as a precaution.
The Danish Health and Medicines Authority said the rollout out of the jab would be paused for at least 14 days while investigations are carried out. They did not say how many reports of blood clots there had been.
“It is currently not possible to conclude whether there is a link. We are acting early, it needs to be thoroughly investigated,” Danish health minister Magnus Heunicke said on Twitter.
Søren Brostrøm, director of the National Board of Health, added: “It is important to emphasise that we have not opted out of the AstraZeneca vaccine, but that we are putting it on hold. There is good evidence that the vaccine is both safe and effective.”
Professor Anthony Harnden, from the Joint Committee on Vaccinations and Immunisations, told Sky News there is no reason to doubt the safety of the jab in the UK.
He said: “People shouldn’t be worried, we have given 11 million doses and our regulator reviews the safety reports as they come in.”
He said evidence to suggest there was more instances of blood clots in the vaccinated population, than the general population “just isn’t there“.
He added it is already known that COVID can cause “quite severe blood clots“.
And Dr Phil Bryan, MHRA Vaccines Safety Lead said: “The Danish authorities’ action to temporarily suspend use of the vaccine is precautionary whilst they investigate. Reports of blood clots received so far are not greater than the number that would have occurred naturally in the vaccinated population.”
It comes as Austrian authorities said they were halting the use of a batch of the vaccine after two people also developed clots.
The first person developed multiple thrombosis (formation of blood clots within blood vessels) and died 10 days after vaccination, while another was hospitalised with pulmonary embolism (blockage in arteries in the lungs) but is now recovering. Two further cases linked to the batch were also reported.
The affected batch of one million doses was delivered to 17 EU countries, the Austrian national competent authority said.
Italy has also banned the use of the same batch as a precaution, its medicines authority said on Thursday.
It is not likely to have been used in the UK, Sky’s science correspondent Thomas Moore said.
As of 9 March, 22 cases of thromboembolic events had been reported among the three million people given the vaccine in the European Economic Area.
There have been reports in Estonia, Lithuania, Luxembourg, Latvia – but not at a higher rate than would be expected in the general population. These nations have stopped inoculations from the batch while investigations continue.
Spain has not registered any such cases and will continue administering the shots, health minister Carolina Darias said on Thursday.
“So far, no causal relation between the vaccine and the blood clot events has been established,” Ms Darias said, adding that the European regulator is evaluating the situation.
A statement from the European Medicines Agency, said: “There is currently no indication that vaccination has caused these conditions, which are not listed as side effects with this vaccine. The position of EMA’s safety committee PRAC is that the vaccine’s benefits continue to outweigh its risks and the vaccine can continue to be administered while investigation of cases of thromboembolic events is ongoing.”
Professor Stephen Evans from the London School of Hygiene and Tropical Medicine said: “The problem with spontaneous reports of suspected adverse reactions to a vaccine are the enormous difficulty of distinguishing a causal effect from a coincidence. This is especially true when we know that COVID-19 disease is very strongly associated with blood clotting. A sensible approach is to investigate and be sure that the benefit and risk balance is in favour of the vaccine.”
The AstraZeneca rollout in the EU has been bumpy due to shortages, delays and concerns from some states over its use in over 65s.
The vaccine was approved for all adults by the EU’s drugs regulator but it is up to each member to set out its own policy, with many initially saying an early trial did not have enough data on the effectiveness on over 65s.
In the UK, the AstraZeneca vaccine has helped the rollout progress at speed since it began being used alongside the Pfizer vaccine in January, with 22,809,829 people now given a first jab.
Boris Johnson has previously said he is “very confident” about all the vaccines being used and that he has “no doubt that vaccines generally are going to offer the way out” of the pandemic.
An AstraZeneca spokesperson said “Patient safety is the highest priority for AstraZeneca.
“Regulators have clear and stringent efficacy and safety standards for the approval of any new medicine, and that includes COVID-19 Vaccine AstraZeneca. The safety of the vaccine has been extensively studied in Phase III clinical trials and Peer-reviewed data confirms the vaccine has been generally well tolerated.”
Oxford University declined to comment on the reports.
Analysis by Thomas Moore, Sky News science correspondent
Nearly 23 million people in the UK have now had at least one dose of a COVID vaccine – 11 million have had the AstraZeneca/Oxford jab.
Both have a strong safety record.
There is a comprehensive system for medical professionals to flag side effects, called the Yellow Card system, and the MHRA publishes weekly statistics.
There really isn’t anything out of the ordinary in its latest report – pain at the injection site, muscle soreness, fever and headache are by far the most common adverse reactions.
The reports of clots on the Continent have all been after immunisation with one batch of the AstraZeneca vaccine, which will almost certainly be made in a different factory to the jab used here in the UK.
The European Medicines Agency is investigating but says that 22 cases out of 3 million people is no higher than would be seen in people who haven’t had the vaccine. Blood clots can be caused by many medical conditions and there is no causal link with the jab.
These are new vaccines and people are on watch for any potential side effects – and with heightened vigilance they are more likely to spot issues that may normally go unnoticed.
Certainly here in the UK there seems no reason to be worried about either of the vaccines being used.
Read more here: https://news.sky.com/story
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