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IRELAND’S MEDICINES REGULATOR has said the Irish government is right to wait for approval from the European Medicines Agency (EMA) before using any vaccines.
Speaking to The Journal, Dr Lorraine Nolan, Chief Executive of the Health Products Regulatory Authority (HPRA) said it is important that the regulatory system for vaccines is seen to be robust so people have confidence in Covid-19 jabs.
This need to maintain confidence in vaccine programmes, she said, played a big part in recent decision by the EMA to advise countries to update their clinician and patient information on the AstraZeneca jab.
Although a definitive link with rare blood clotting conditions has not been established, the European regulator has advised that vaccinators and those receiving the jab should be made aware of symptoms while it conducts further investigations.
“The decision to update the vaccine information is precautionary and it’s unusual for them to do that given a link hasn’t been proven,” she said. “But this will provide information for healthcare professionals on occurrence and it will let both healthcare professionals and patients know what to look out for”.
There have been calls for Ireland to address the current shortage in vaccine supplies by ordering jabs from manufacturers who have not yet received Conditional Marketing Authorisation (CMA) from the EMA.
Currently there are four vaccines approved by the European regulator; the Pfizer/BioNTech vaccine, the Moderna vaccine, the Oxford/AstraZeneca jab and the Janssen (Johnson & Johnson) vaccine.
Hungary has begun using both the Chinese Sinopharm and the Russian Sputnik V vaccines, despite the fact that neither have received the green light from the EMA. EU member states Slovakia and Czech Republic have also started administering doses of the Russian vaccine before EMA approval.
On Friday the Russian Ambassador to Ireland Yuriy Filatov, said his home country is ready to help vaccinate people in Ireland against Covid-19.
He said the Irish authorities had not yet approached Russia about ordering its Sputnik V vaccine, which President Vladamir Putin is due to receive today.
“The government viewpoint is one I totally confer with,” Dr Nolan said. “There’s that question of are we approving things too fast or too slow and the thing about the EU system is that there are established procedures. We can see that safety is a number one priority and it’s important that they are put through the highest level of scrutiny.
That’s not to say the Sputnik V vaccine isn’t something we’d consider safe. A rolling review has been started by the EMA and that means they are reviewing the data in realtime as its generated. So they have started to look at the non-clinical and clinical packages.
“It’s hard to know timewise when this might come through. The telling point will be when the Gamaleya Research Institute, which developed the vaccine, is told to submit an application for Conditional Marketing Authorisation. Once we reach that point we’ll have a better indication of timing – it normally takes three to four weeks from that point.”
Two other vaccines – Curevac and Novavax – are also currently undergoing rolling reviews.
#COVID19vaccines: where are we now?
— EU Medicines Agency (@EMA_News) March 19, 2021
Rolling reviews in progress, submitted applications, authorisations completed 👇 pic.twitter.com/cskA485pRL
Nolan said the PRAC consulted heavily with experts in blood coagulation and clotting and in neurology from across the European system.
The resumption of the use of the AstraZeneca vaccine in Ireland should help to address supply issues, particularly as we move into the second quarter of the year, with significantly increased deliveries expected from all manufacturers.
Dr Nolan said she can understand that people may be concerned about getting the AStraZeneca vaccine after seeing recent news about the potential link to blood clotting conditions, but stressed that all EMA-approved vaccines have had to go through large clinical trials and the same safety standards of pre-pandemic vaccines.
A review by the EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) found there was no increased risk of blood clots following am AstraZeneca jab, with just 18 of the two severe conditions identified out of almost 20 million vaccinated people.
The conditions in question are cerebral venous sinus thrombosis (CVST), which involves clotting in the veins at the back of the brain and disseminated intravascular coagulation (DIC), which involves multiple clots across the vein structure.
Dr Nolan said even if a definitive link between the vaccine and these very rare conditions is identified, there is still “a very strong case for vaccination”.
“I’ve always said, and we’ve been open and transparent about this from the beginning, clinical trials are carried out with tens of thousands of people and when you go on to use a vaccine on millions and billions of people there is always potential that this escalation in scale could throw up very rare side effects not shown in a clinical trial,” she said.
“Vaccines have such an important role to play, we need as many as possible authorised and we need to vaccinate as many people as possible because we know the serious risks associated with Covid-19.
“It has yet to be proven that these very rare cases are linked [to the vaccine] but if they are we can indicate the frequency and characterise it and hopefully identify people who are at risk as well as identifying treatment pathways for them.”
The refreshed EMA guidance lists a number of symptoms for patients to be aware of following their vaccine:
Neither of the two conditions in question have been reported in Ireland following vaccination and general incidence of these conditions is rare.
Dr Nolan said the best experts in haematology and neurology in Europe will come together now and conduct a range of tests as well as looking at observational studies to try to determine whether there is a link.
You’d have to have sympathy for Theresa May in the whole scenario. She’s been left to sort out the whole mess while the main instigators have gone into hiding.
@Damo.f: i respect her, for sure, but have zero sympathy.
In addition to being an extremely honorable and well paid job (plus pension), she volunteered for this job in full knowledge of her own views, and the array of views about Brexit.
She will also not have to live with the potential consequences of her actions and mistakes, like the average person.
@Damo.f: sure she’s playing a game. She’s denying NI and Scotland European membership – its those you should have sympathy for.
UK: We are leaving the 29th of March OK??
EU: Ok.
UK: OK??
EU: Ok.
UK: OK??
EU: Ok.
UK: OK??
EU: Ok.
UK: OK??
EU: Ok.
UK: OK??
……………….
@Ooby Dooby: ‘Acknowledge my importance dammit’
….and the Horror Show continues :-(
Fair play to Coveney “This parliament will meet if it has to,”
@Aidan Dorney: Direct rule would brake the Good Friday Agreement, serious own goal in the making
@George O Neill: In the absence of a functioning government in Stormont, who should rule?
We love a drama in this country, there’s nothing crucial about tonight’s vote, it’ll be voted down and then there’ll be an extension, following that a possible general election and a possible referendum and ultimately the U.K. will vote themselves back into Europe with their tails between their legs. Germany 1 – United Kingdom 0. The brexiteers missed their golden opportunity last night to leave the EU and give the two fingers to the bloc.
@Eugene Doyle: unless the EU refuse to give them an extension, which I know is unlikely
@Eugene Doyle: I like your comment Eugene.
@Eugene Doyle: Just imagine all the “EU is a dictatorship” trolls if that happened!
Please,
Please,
Please,
Leave without a deal – then start dealing from a position of strength rather than the groveling tactics adopted so far.
@Beircheart Breathnach:
A position of strength ????
That’s deluded
@Beircheart Breathnach: They have zero leverage, no skilled negotiators and the US and Japan are already lining up to screw them. The ex colony and soon to be world superpower India will do them no favours. Apart from the likes of this, they’ll be grand
Honest question. Does this vote matter if the EU says no we already negotiated a deal, feck off.
@Ned Flanders: Good question.
It’s really just a precursor to the extension vote.
Unless they vote in favour of no-deal…. then it’s all over on the 29th.
The report that “Sinn Fein are having their say” gave me a good laugh. They have no place saying anything about this if they are not willing to participate in working on a solution i.e taking up their place in Westminster and getting their asses back into to Stormont.
@Seán Kinsella: yeah like their seven votes would have done so much to counter the loss by 150 votes.
@Seán Kinsella: I don’t vote Sinn Fein but I cannot for the life of me understand how people can consistently post comments like yours. When running for election they specifically tell the electorate they will not take up their seats. It’s part of their mandate. If they took up the seats they would be breaking an election promise. Don’t we have enough parties doing this?
@Niallers: could say the same for DUP
Be no shock if no deal is off the table after today. Brexiteers will pee themselves
Would it be too much of a stretch at this point to get a representive(s) from
The EU i.e Michel Barnier
The UK Parliament i.e Theresa May
The DUP i.e Arleen Foster
The Irish Government i.e Simon Coveney and Leo Varadkar
and get into a f*cking room and sort this clusterf*ck once and for all. Stop the trips over to Brussels every 2 weeks and get to a decision between them.
@Ben Jamen: it is sorted except UK dup don’t like the result
@Ben Jamen: they, with the exception of Arlene, are not the problem. the problem is the large Brexiteer wing of the Tory party who are still stuck back in the heyday of empire
What is becoming blindingly clear every day is that the vast majority of MP’s and cabinet ministers have no idea how the current border works…you have the Government saying they’ll be no checks and a Secretary to the Treasurey saying that checks already exist??!! What checks? Where are they carried out? Its It’s unbelievable…..the British really are the definition of “cutting your nose off to spite your face”!!
Has anyone noticed the Irony of yesterdays vote, if the 75 Brexiteers had voted for the Deal they would have gotten Brexit passed without the Need of DUP votes. Looks like their vote has ruled any possibility of them getting a Brexit now, or a very Soft Brexit.
https://ichef.bbci.co.uk/news/624/cpsprodpb/431B/production/_105997171_optimised-mv2_breakdown_chart-nc.png
**Correction** ‘ruled any possibility’ should have said ‘ruled out any possibility’ and the vote would have been 317 to 316, would have just passed by 1 vote if they had stuck with party vote.
@Fred Cahill: No it simply rejected a very bad deal, tonight’s vote is meaning less, Eu and UK law still states that they part company on 29th, with or without a deal.
@Larry Sneeg: The vote for No Deal Exit is going to fail tonight, the extension is going to pass tomorrow meaning UK is not leaving on the 29th. With the extension the only possibilities are a Soft Brexit by working with Labour, 2nd Referendum, or a General Election.
@Fred Cahill: if tomorrow’s vote passes then they have to ask the EU for an extension so there’s no guarantee. The EU will bluster about the point of this right up to midnight of the 28th but will more that likely give a short term extension in the hope that the Torys are turfed out, Labour get in and there’s more chance for a second referendum. I know Corbyn is ambivalent about the EU but I reckon he will cave to pressure to hold a second vote.
@Fred Cahill: the EU have to grant an extension, and with the EC elections coming up, the EC won’t want Farage back,
@Larry Sneeg: I can tell you the Majority of MEP’s do not give a hoot about Farage and whether his back or not. That fool is going to be ignored. They will grant a delay and UK will not be leaving on the 29th unless Theresa Mays Plan passes via a third vote. It could have all been taken care of last night if the Conservatives stuck together.
@David Guiney: They will grant a delay as there is too much to loose.
This is like watching a country play Russian roulette and knowing its gonna get very messy, very soon.
omg what a surprise another crucial Brexit vote … I cant wait … guffaw chortle.. sneer ..
No Brexit deal averted by FOUR votes!
A split tory party, parliament and country! It’s hard to see who is actually good enough the fix the place, drag them through Brexit and into success.
@Paul Furey: no that was an amendment to the main vote, which passed by about 50.
The amendment was that there would never be a no deal. The original was just taking no deal off the table until the deadline of Article 50.
So essentially they voted that they can never accept no deal.
But it doesn’t matter if they don’t do a deal with the EU none of that matters and they crash out.
What is “direct rule in Northern Ireland”?
@Peter: ruled from London
One brexit in the hand is worth 2 in the bush I always maintain
That vote was too close for comfort. But I for one am glad that a no deal brexit is off the table. That would be a disaster. Looks like we are heading for an extension to article 5o which was prematurely triggered in the first place in my opinion. I know people here in Ireland are sick of hearing about brexit but the impact it will have on Ireland if the right deal is not found is massive. And the worse thing is we have very little control of it, other than the same control that any of the other eu member states have which is ridiculous. Let’s hope we are not collateral damage in this mess.
This has to be one of the most dangerous comments I’ve heard from a UK politician during the whole Brexit debacle.
DUP voted against ruling out No Deal Brexit..
This complete shit show makes me so glad I moved back from the UK!
I’ll tell you how ready we are. I’m sure everyone agrees that second hand imports of cars are a huge part of the Irish car business. Rang NCT centre who register imports and are paid the VRT. They do not know if VAT will be payable as UK will no longer be in EU. There said ring revenue. Rang three different numbers and as well as no one knowing, I was passed onto other sections who did not know either. Told to ring NCT twice. NCT then said they do not know why revenue are saying to ring them. Ring your local tax office. Did. Told to contact t NVT
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