By Ben Kerrigan
European safety regulators have launched an investigation into a batch of the Oxford University/AstraZeneca COVID-19 vaccine, as countries including Denmark suspended its use as a precaution following reports of blood clots.
Original inquiries revealed no issue with the shots suspended by Austrian authorities after a person was diagnosed with severe blood clotting and died 10 days after vaccination.
Concerns were raised after another man was hospitalised with pulmonary embolism after being vaccinated and is now recovering after being vaccinated.
Batch ABV5300 was delivered to 17 EU countries1 and comprises 1 million doses of the vaccine.
A preliminary review by the EMA’s safety committee said there is “no indication that the vaccination has caused these conditions, which are not listed as side effects with this vaccine.”
The Danish Health and Medicines Authority said the rollout out of the jab would be paused for at least 14 days while investigations are conducted.
“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.
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.
Italy has also banned the use of the same batch as a precaution, its medicines authority said on Thursday.
Since March 9, 22 cases of thromboembolic events had been reported among the three million people given the vaccine in the European Economic Area.
There have also been some 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.
Benefit/Risk Ratio
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 far from smooth 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.
Speed
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.
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.”
Today, Brits queuing up at London Bridge vaccination centre expressed concern about the news.
Malcolm Anderton 36, an electrician from Old Street told The Eye Of Media.Com: ” the news is really worrying, I just saw it on my mobile phone while queuing up. I am in two minds as to whether to come off this queue. From what I hear, more people who have taken the vaccine have been alright, but I’m not sure I want to risk being in the minority of those who may fall ill from it an die”.
Shelly Hall, a 41 year old care worker, said: ” It’s a bit unnerving hearing this news. I am actually a bit worried, but I think I’ll take the risk. The chances of being in the group of those who dies is small”
Ron Davies, a 32 year old school teacher said: ”I have just been considering it while on this queue. I teach in a secondary school, so must take the vaccine, for my safety and that of my pupils”
Michael Adams, 28 year old tesco security man, said: ”I was just about to leave this queue when you approached me. I certainly don’t think I will stay here by the end of this conversation, In fact, maybe I should leave now and we should go for a walk and talk some more.
I was going to do this for my wife and children, but I think maybe I should give this a lot more thought. I only have one life, and I’m not going to gamble with it”.
Public Queue up for vaccine at London Bridge Vaccination Centre Image: Michael Bartek
The news could set back the promotion of the vaccination programme, but authorities insist that the benefits far outweigh the risks, and only in relatively few cases that serious illness or death occurs.