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Wednesday 27 September 2023 Dublin: 14°C

# EMA

Last year
2022
Debunked: Self-proclaimed ‘inventor’ of mRNA vaccines makes nonsense claims about spike proteins
A COVID-19 infection can unleash literally billions of virions inside the body, each with dozens of spike proteins on their surface.
EU backs new Omicron vaccines for first jabs, and not just for boosters
The vaccines are currently only authorised as boosters but could now be used for people’s first vaccinations.
EU medicines watchdog approves vaccine targeting Omicron sub-variants
European nations have been keen to rush through the new generation of jabs so they can start booster campaigns ahead of a feared Covid surge in the latter part of this year.
European Medicines Agency approves first Omicron-specific Covid vaccines
The so-called “bivalent” vaccines protect against the earlier BA.1 strain of Omicron, but do not target the latest strains.
European health agencies say it's 'too early' for fourth Covid vaccine for general population
NIAC today recommended a second mRNA booster dose for people aged 65 or over and those who are immunocompromised.
European Medicines Agency recommends Pfizer booster for children over 12
It also announced that it has recommended the approval of the Spikevax vaccine for children aged between six and 11.
All time
EU health watchdog approves fifth Covid vaccine
This will be the fifth Covid-19 vaccine approved for use in the European Union.
EU watchdog says Omicron 'mostly mild' as WHO warns on vaccine hoarding
The European Medicines Agency also said that early data suggested the new variant is more infectious than Delta.
Tánaiste says NIAC could approve Pfizer jab for 5-11 age group in coming days, following EMA approval
The European Medicines Agency approved the vaccine for the 5-11 age group earlier today.
The rollout of the vaccine to this age group in Ireland may not happen until next year.
The EMA has said a study showed 90.7% efficacy among the age group.
The dose recommended is lower than for children aged 12 and older.
Six in 10 people have reduced social contacts over the last week, new poll shows
Antigen tests: How do they work, when do I use them, and how accurate are they?
EMA approves two new antibody treatments to stop Covid-19 patients developing symptoms
The move adds to the European Union’s toolbox of drugs.
EU medicines agency starts review of Merck oral Covid drug
The move comes two weeks after Merck applied for emergency use in the US of the anti-coronavirus drug.
Donnelly says he would like to see healthcare workers get the green light for the booster jab
The booster shots for the over 60s will begin ‘imminently’, said the minister.
Here is the current guidance on vaccinating children against Covid-19
Niac is expected to issue guidance to the Government and HSE this week.
EU regulator approves Moderna vaccine for 12-17 year-olds
It is the first time the shot has been authorised for people under 18.
EU watchdog reviewing Janssen vaccine data after US regulator warns of rare neurological reaction
US experts said there had been reports of people who had the jab developing Guillain-Barre syndrome.
Ireland to receive extra Pfizer vaccines after EMA approves additional manufacturing
The approval is expected to have “a significant and immediate impact” on the supply of Comirnaty.
Pfizer vaccine can be kept in fridges for up to a month rather than just five days, EU medicines regulator says
The European Medicines Agency said this could improve the flexibility in countries’ vaccine rollout.
EU regulator says unusual blood clots should be listed as 'very rare side effect' of J&J vaccine
The European Medicines Agency said that the “overall benefits” of the vaccine in preventing Covid-19 outweigh the risks of side effects.
Unusual blood clots should be listed as "very rare side effects" - but the "overall benefits" of the vaccine in preventing Covid-19 outweigh the risks.
Eight rare blood clots with low levels of blood platelets were recorded among over 7 million doses of the J&J vaccine administered in the US.
The statement by the EMA is similar to its conclusion for the Oxford-AstraZeneca vaccine - which NIAC decided to limit to those aged over 60.
EMA decision on Johnson & Johnson will influence whether Ireland spaces out Pfizer vaccine doses
EMA decision on Johnson & Johnson will influence whether Ireland spaces out Pfizer vaccine doses
It follows concerns that the vaccine could be linked to extremely rare blood clots.
Decision on J&J one-shot dose expected on Tuesday as EMA assesses blood clot data
The rollout of the one-shot dose was paused in the United States after six rare blood clots were identified post-vaccination.
UK releases new data about AstraZeneca-linked blood clots as EMA continues to support use of vaccine
Several European countries have paused the use of the jab.
The EMA has granted approval for AstraZeneca plant at centre of diplomatic dispute
The Dutch plant has been at the centre of a bitter spat between the UK and the EU over AstraZeneca’s vaccine production shortfall.
EU medicine regulator evaluating Russia's Sputnik V vaccine for use in Europe
The EMA has also been in touch with representatives of the Chinese Sinopharm jab.
HSE will 'immediately endeavour' to begin using AstraZeneca jab again if EMA gives all clear
The agency is holding an extraordinary meeting to finalise its conclusions on the blood clot issue. A number of countries across Europe, including Ireland, paused use of the vaccine in recent days.
EMA 'firmly convinced' benefits of AstraZeneca vaccine 'outweigh the risks of the side effects'
The EMA is continuing to carry out its investigation into the vaccine after reports of rare blood-clotting events.
The single-dose Johnson & Johnson Covid-19 vaccine has been approved by the European Medicines Agency
Governments across the EU have been eagerly awaiting its approval as they struggle to roll-out vaccinations on a large scale.
The is the fourth coronavirus vaccine given the green light by the European Medicines Agency (EMA)
The vaccine data was "robust and met the criteria for efficacy, safety and quality"
Ireland is set to received 600,000 initial doses but that could be hampered by supply issues
J&J vaccine to be approved today - but will supply issues hamper Ireland's progress?
Explainer: Here's what we know about Johnson & Johnson's one-dose vaccine
AstraZeneca vaccine not to blame for Austria death, says EU medicines agency
Austria announced it would stop using doses from an AstraZenca batch after the 49-year-old nurse died.
Covid-19: EMA to review Russian-developed vaccine as part of first step towards EU approval
Russia said it is ready to provide vaccines for 50 million Europeans.
Johnson & Johnson subsidiary applies to EMA for Covid-19 vaccine approval
The single-dose vaccine could be approved as early as next month.
Pfizer and Moderna vaccines to be used for over 70s 'where practicable and timely'
This follows a recommendation from the National Immunisation Advisory Committee.
European Medicines Agency confirms no deaths have been linked to the Pfizer/BioNTech vaccine
It followed reports in recent weeks that people had died after receiving the vaccine.
European Medicines Agency head hopes for decision on Astrazeneca vaccine approval 'by end of this week'
Despite the supply issues, a European approval for the Astrazeneca vaccine this Friday will pave the way for its rollout in Ireland.
EMA says shorter process can be used if vaccines have to be adapted for new strains
Developers have said they could adapt the vaccine quickly if a new variant is resistant to it.
EU regulator brings Moderna vaccine decision forward to 6 January
The date for a decision had been 12 January.
EU medicines regulator says data 'looks robust' as it plans toward Pfizer vaccine approval by end of month
A decision on the approval of the Pfizer/BioNtech is due on 29 December.
European Medicines Agency says it has been targeted in cyber attack
The agency says it has launched a full investigation.
Reader Q&A: What do you want to know about Covid-19 vaccines?
The HSE expects Ireland’s vaccination programme to begin in January.
MS drug pulled from Irish and EU market after 12 patients worldwide suffer 'serious brain disorders'
The European Medicines Agency has recommended the immediate suspension and recall of Zinbryta.
Epilepsy drug which has left 400 Irish children with disabilities to come under EU review today
An Irish woman whose three children have disabilities will give evidence at a public hearing today.
So, Ron Burgundy hung out with Daft Punk over the weekend
By the beard of Zeus!