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Friday 29 September 2023 Dublin: 13°C
Sam Boal/ HPRA Chief Executive Dr Lorraine Nolan,
# hpra
Irish regulator says government right to wait for EMA approval before using other vaccines
Dr Lorraine Nolan also said the public can be assured the AstraZeneca vaccine is safe.

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. 

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:

  • breathlessness,
  • pain in the chest or stomach,
  • swelling or coldness in an arm or leg,
  • severe or worsening headache or blurred vision after vaccination,
  • persistent bleeding,
  • multiple small bruises, reddish or purplish spots, or blood blisters under the skin,

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.

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