Ireland and the Netherlands have joined a growing list of countries to have temporarily suspended the administration of the AstraZeneca Covid vaccines over reports of blood clotting.
Authorities in Denmark, Norway and Iceland halted use of the vaccine this week and several others have stopped using a batch of AstraZeneca doses while investigating any possible link to coagulation disorders.
The EU regulator, the European Medicines Agency (EMA), has said there is no indication that the events were caused by the vaccination, a view that was echoed by the World Health Organisation (WHO). Which countries have suspended rollout of the AstraZeneca vaccine?
Last week Denmark, Norway, Iceland and Bulgaria announced they were pausing the rollout of the AstraZeneca vaccine after reports of cases of blood clots forming, including one death.
The move, which was described by Danish officials as “precautionary”, came after Austria stopped using a batch of AstraZeneca doses while investigating a death from coagulation disorders and an illness from a pulmonary embolism – a lung disease caused by a dislodged blood clot.
Thailand became the first country outside of Europe to delay use of the vaccine, followed by Congo. Health officials in Bangkok have since given the green light for AstraZeneca jabs to be administered.
Estonia, Lithuania, Luxembourg, Romania and Latvia have stopped inoculations from the batch while an investigation continues. The batch of 1 million doses went to 17 EU countries.
Four Spanish regions – Castille and Leon, Andalusia, Asturias and the Canary Islands – have also stopped administering doses from the suspect batch but said they would continue giving jabs from other deliveries.
On Sunday, Ireland “temporarily deferred” the rollout of the AstraZeneca Covid vaccine following a recommendation by Irish health officials.
Prof Karina Butler, chair of Ireland’s National Immunisation Advisory Committee, called it a “precautionary move”.
She said: “This vaccine is proven to be very effective against severe Covid-19 disease, which is associated with a risk of clotting events. We have taken this step out of an abundance of caution.”
The Netherlands also said on Sunday that it was suspending use of the vaccinations as a precaution for two weeks.
The same day, Italy’s northern region of Piedmont said it too would temporarily suspend AstraZeneca coronavirus jabs after a teacher from the town of Biella died following his vaccination on Saturday.
“It is an act of extreme prudence, while we verify whether there is a connection. There have been no critical issues with the administration of vaccines to date,” Luigi Genesio Icardi, head of regional health services, said in a statement.
Kuwait’s Ministry of Health (MoH) said Friday it was closely following up on updates by the European Medicines Agency (EMA) and World Health Organization (WHO) regarding the safety of Covid-19 vaccine Oxford-Astrazeneca.
An MoH statement stated that EMA said there was no indication Astrazeneca has caused blood clotting, after few European countries paused their vaccinations with Astrazeneca. A spokesman of Astrazeneca confirmed to the MoH there was no indication that the use of the vaccine contributed to blood clot or lung blockage, following vaccination of more than 10 million people.
Astrazeneca reiterated that safety of people was of prime importance, MoH quoted the spokesman as saying, and the company was following strict criteria to approve new medications and vaccines. The company tested safety of the Covid-19 vaccine on a large number of people during the clinical trials, and results were assuring. WHO also said earlier today there was no reason to stop using Astrazeneca vaccine following blood clot fears.
Why have they suspended AstraZeneca vaccine?
The rollout of the AstraZeneca vaccine has been affected in more than a dozen countries following reports of possible harmful effects centering on blood clotting.rious clotting in adults in Norway left four people in hospital and there were also reports of lowered levels of blood platelets in people aged under 50.
As of 10 March, 30 cases were reported in the EMA’s database of side effects following vaccination of close to five million people in the European Economic Area.
These include a case on Thursday, when a 57-year-old woman from a village in southern Bulgaria died of heart failure 15 hours after receiving an AstraZeneca jab.
In Austria, a 49-year-old woman died as a result of severe coagulation disorders, while a 35-year-old woman developed a pulmonary embolism and is recovering.
However, nearly every country that has issued a suspension has acknowledged that it has no evidence to prove that the vaccine caused the blood clots.
Health experts have pointed out that the people most likely to currently be receiving Covid vaccinations are also more likely to have other health problems, which could put them at higher risk for blood clots.
What do the experts say?
The overwhelming scientific opinion is that there is no certain link between blood clots and the vaccine, and the reported cases could easily be coincidental.
Most argue the risks from Covid-19 far outweigh any potential side-effects from the jab, with many saying blood clots are fairly common, regardless of vaccination.
The WHO has said it is looking into the issue but said there was no reason not to use the drug, while Europe’s EMA medicines regulator backed it and said the benefits outweigh the risks.
WHO spokesperson Margaret Harris said 268 million doses of Covid-19 vaccines from various developers had been administered worldwide without being proven to have caused a single death.
Britain’s medicines regulator also said it had not received any reports of blood clots in people that were caused by the AstraZeneca vaccine. More than 11 million doses of AstraZeneca have been administered in the UK.
Dr Phil Bryan, MHRA vaccines safety lead in the UK, said: “Reports of blood clots received so far are not greater than the number that would have occurred naturally in the vaccinated population.”
Silvestro Scotti, a doctor in Naples and head of the Italian Federation of General Practitioners, said: “The crazy thing is that, even if the correlation between the vaccine and blood clots were proved, it would be a rate of 0.007 out of a thousand.
“To give an example: the birth control pill, which is used widely and doesn’t worry anyone, has a proven risk rate of 0.6 in a thousand. Even in the worst-case scenario, the risk/benefit ratio for this vaccine is extraordinarily favourable. That needs to be explained to people.”
Stephen Evans, professor of pharmacoepidemiology at the London School of Hygiene and Tropical Medicine, described the suspension of vaccinations as a “super-cautious approach based on some isolated reports in Europe”.
He 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 and there have been hundreds if not many thousands of deaths caused by blood clotting as a result of Covid-19 disease. The first thing to do is to be absolutely certain that the clots did not have some other cause, including Covid-19.
“A sensible approach is to investigate and be sure that the benefit and risk balance is in favour of the vaccine.
“Since we know with great certainty that the vaccine prevents Covid-19 with its attendant disease, and we are almost totally uncertain that the vaccine can have caused this problem, the risk and benefit balance is still very much in favour of the vaccine in my view.
“If, however, there is no shortage whatsoever of alternative vaccines, then an extreme precautionary approach as taken in Denmark may be justified; if however this action stops some people getting the vaccine who are then vulnerable to Covid-19, then it is a mistaken use of precaution.
“As far as one can tell there has not been a ‘signal’ of such problems in the UK and even if there were a ‘signal’, based on spontaneous reports, there needs to be a proper, rapid, epidemiological study to see if it is coincidence or not.”
What does AstraZeneca say?
In a statement on Thursday, AstraZeneca said it had found no evidence of an increased risk of pulmonary embolism or deep vein thrombosis in safety data of more than 10 million records.
Commenting on the Irish suspension, a spokesperson for the pharmaceutical giant said: “An analysis of our safety data that covers reported cases from more than 17 million doses of vaccine administered has shown no evidence of an increased risk of pulmonary embolism, deep vein thrombosis or thrombocytopenia with Covid-19 Vaccine AstraZeneca.
“In fact, the reported numbers of these types of events for Covid-19 Vaccine AstraZeneca are not greater than the number that would have occurred naturally in the unvaccinated population.
“In clinical trials, no trends or patterns were observed with regard to pulmonary embolism, deep vein thrombosis, or events possibly related to thrombocytopenia.
“A careful review of all available safety data including these events is ongoing and AstraZeneca is committed to sharing information without delay.”
Source: The Independent