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THE EUROPEAN MEDICINES Agency (EMA) yesterday stated that the AstraZeneca Covid-19 vaccine is safe and is not associated with an increased risk of blood clots, following a review of a number of reported incidents following vaccinations.
The agency said it cannot definitively rule out a link between these cases and the vaccine, so it has recommended that health services draw attention to possible rare blood clotting conditions by including details in vaccine leaflets about symptoms associated with them.
A number of countries across Europe, including Ireland, paused use of the vaccine in recent following reports by the Norwegian Medicines Agency of serious events in four patients. It is expected that the HSE will resume using the vaccine in the coming days.
What happens next
Italy has already decided to resume administering AstraZeneca vaccines today, but other countries are taking a more cautious approach.
In Ireland, the next step will be a meeting of the National Immunisation Advisory Committee (NIAC) to assess the advice from the EMA.
At last night’s briefing of the National Public Health Emergency Team (NPHET), deputy chief medical officer Dr Ronan Glynn said he welcomed the clarity from the EMA and said that NIAC would discuss the issue last night and this morning.
“They’ll be considering it further this evening and tomorrow morning, and the HPRA (Health Products Regulatory Authority) are reviewing the statement and the findings,” he said.
“We’ll be deliberating between the organisations tonight and tomorrow morning, and we’ll issue an update tomorrow once we have come to a position.”
NIAC will issue guidance to NPHET and NPHET will then make recommendations to the Minister for Health.
These recommendations will include a view on whether Ireland should re-commence use of the vaccine. NPHET will also likely advise the roll-out of updated information for vaccinators as well as new patient leaflets that include details of these rare conditions.
HSE CEO Paul Reid yesterday said it will take “a period of days” to re-start the roll-out of the AstraZeneca vaccine in Ireland once fresh recommendations are issued from public health officials.
He said the health service will attempt to deliver the vaccines – around 30,000 jabs – that were delayed as a result of the decision last week as soon as possible. A further 10,000 doses from AstraZeneca are due to be delivered to Ireland next week.
What we know about the blood clotting conditions
The EMA said its review, conducted by its pharmacovigilance risk Assessment Committee (PRAC), involved days of in-depth analysis of lab results, clinical reports, autopsy reports and further information from clinical trials.
Dr Sabine Straus, who is a member of PRAC, noted that the number of thromboembolic events reported after vaccination is lower than the expected rate in the general population.
“Moreover, because the vaccine is effective in preventing Covid-19 disease, which in itself, of course, is a cause of blood clots, it likely reduces the risks of thrombotic events,” she explained.
She said the committee found no evidence of a quality or batch issue.
Dr Straus said there are still some uncertainties as there have been reports of some very rare cases describing “unusual events of a combination of thrombosis (clotting) and thrombocytopenia (low levels of platelets) and bleeding.
“In a few cases tiny clots developed in multiple blood vessels in the first seven to 14 days after vaccination, a condition called disseminated intravascular coagulation (DIC).
“Also in a few cases we saw clots developing in blood vessels, draining blood from the brain. And this condition is known as a cerebral venous sinus thrombosis (CVST).
These conditions are linked to low levels of blood platelets, also known as thrombocytopenia, and the evidence we have is, at the moment, not sufficient to conclude with certainty whether these adverse events are indeed caused by the vaccine or not.
As of Wednesday night, seven cases of DIC and 18 cases of CVST were reported out of almost 20 million vaccinated people. She said such cases were not identified in large clinical trials.
Dr Straus said PRAC will continue to gather more information on these conditions, including additional studies.
Speaking at the EMA’s briefing, head of the agency Dr Emer Cooke said the vaccine’s benefits in protecting people from Covid-19, with the associated risks of death and hospitalisation, outweigh the possible risks.
Because the EMA cannot “definitively” rule out a link between these cases and the vaccine, Dr Cooke said the committee has recommended raising awareness of the possible risks. This should be done, she said, by including details in product information so that healthcare professionals and people who are vaccinated will be able to “spot and mitigate any possible side effects”.
At a European level, additional investigations are to be launched to understand more about these rare cases and the EMA is conducting targeting observational studies.
“When you vaccinate millions of people it’s inevitable that rare or serious instances or illnesses will occur in the time immediately following vaccination,” Dr Cooke said yesterday.
Our role in the EU regulatory system is to rapidly detect these incidents and investigate whether there may be a link to the vaccine or whether they are the result of illnesses which occur by chance close in time to the vaccination.
“We are permitted to ensure that any new suspected adverse reactions are rapidly investigated to support decisions based on science, which can then support competence in vaccines which is so important in dealing with this devastating pandemic that we are facing, and we remain fully mobilised to ensure our public health.”
If only the kitchen was slightly bigger.
Yeah, I was considering buying it till I saw that. I mean, what’s the point in buying a house where me, Mr Shalakalananaka, my 15 kids, my 36 kids, my great-grandkids and my cats can’t all spin around like helicopters in the kitchen without touching each other and knocking over dishes?
wifi is awful in these places. walls are too thick for a decent signal. does my head in. ill never live in a castle again
I don’t get the red thumbs, I was being genuine.
Mrs Shalakalananaka, if you want us to believe you’re genuine telling us you have 51 kids isn’t the way to go about it!
15 kids
You backwards reading twit …. And that’s no way to speak to a lady.
“my 15 kids, my 36 kids” add em together you’ve got 51
Nice save hardly !! Nice save indeed.
thank’s nelg !!
Oh feckballs, I meant 36 grandkids. 51 kids, Jesus, I couldn’t think of anything worse. xD The 15 I have are bad enough (only messing, I love my little angels!).
Thank you for looking out for me, Glen. You are a true gentleman, rare in this day and age, but no less adored. <3
Glen, every single story you post. Go get a pint or something, jeez…
So what, he can post if he wants Chinaski. No need to be a biznatch about it.
i’m buying it on wednesday after i win the euromillions on tuesday…
Id buy to let it out only the law now says ive to accept rent allowance
The broadband is dial up though, or eircom as it’s known
If I won the Euro lotto I would by it.
Yeah very nice but how many bedrooms? I’ve a family to consider.
Dunno why you’d bother when for just a million more you could have a 4 bed semi-d with on street parking in south county Dublin
nice place for someone deserving
Not even one topic,not even one !!!!!!.
you appear to be upset about something mike?
Yeah Mike what’s upsetting you Mike ;)
they mustnt take rent allowance…
Oh look,the other cheek of the arse.
The circle is complete.
you must have the mother of all hangovers mike your like a briar :D
That’s how harry price likes him
I actually hope Mr Price takes my advice and reports you to twitter with a view to suing you for bullying and slander.
You really are a clown aren’t you.
I hope he does too :)
who exactly am i supposed to be bullying and slandering? why do you have to persistently insult people. you don’t agree with me, i get it, that is your choice, but disagreeing isn’t enough for you you have embarked on some personal vendetta and are now ranting about slander and other such nonsense.
I’m not talking about you , you overestimate your importance on the planet.
You gillwhoever are nothing but a mild irritation.
Cool, I was just asking
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