Advertisement
#Open journalism No news is bad news

Your contributions will help us continue to deliver the stories that are important to you

Support The Journal
Dublin: 3°C Saturday 28 May 2022

#EMA

# ema - Wednesday 6 April, 2022

European health agencies say it's 'too early' for fourth Covid vaccine for general population
# Booster Dose
# Booster Dose

European health agencies say it's 'too early' for fourth Covid vaccine for general population

Apr 6th 2022, 5:24 PM 68,668 Views 43 Comments

NIAC today recommended a second mRNA booster dose for people aged 65 or over and those who are immunocompromised.

# ema - Thursday 24 February, 2022

European Medicines Agency recommends Pfizer booster for children over 12
# Vaccines
# Vaccines

European Medicines Agency recommends Pfizer booster for children over 12

Feb 24th 2022, 5:19 PM 6,387 Views 3 Comments

It also announced that it has recommended the approval of the Spikevax vaccine for children aged between six and 11.

# ema - Monday 20 December, 2021

EU health watchdog approves fifth Covid vaccine
# Novavax
# Novavax

EU health watchdog approves fifth Covid vaccine

Updated Dec 20th 2021, 3:36 PM 41,950 Views 90 Comments

This will be the fifth Covid-19 vaccine approved for use in the European Union.

# ema - Thursday 9 December, 2021

EU watchdog says Omicron 'mostly mild' as WHO warns on vaccine hoarding
# European Medicines Agency
# European Medicines Agency

EU watchdog says Omicron 'mostly mild' as WHO warns on vaccine hoarding

Dec 9th 2021, 9:25 PM 20,599 Views 18 Comments

The European Medicines Agency also said that early data suggested the new variant is more infectious than Delta.

# ema - Thursday 25 November, 2021

Tánaiste says NIAC could approve Pfizer jab for 5-11 age group in coming days, following EMA approval
# Covid-19
# Covid-19

Tánaiste says NIAC could approve Pfizer jab for 5-11 age group in coming days, following EMA approval

Updated Nov 25th 2021, 7:00 PM 43,691 Views 187 Comments
  • 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.

# ema - Thursday 11 November, 2021

EMA approves two new antibody treatments to stop Covid-19 patients developing symptoms
# European Medicines Agency
# European Medicines Agency

EMA approves two new antibody treatments to stop Covid-19 patients developing symptoms

Nov 11th 2021, 6:25 PM 17,755 Views 14 Comments

The move adds to the European Union’s toolbox of drugs.

# ema - Monday 25 October, 2021

EU medicines agency starts review of Merck oral Covid drug
# Merck
# Merck

EU medicines agency starts review of Merck oral Covid drug

Oct 25th 2021, 2:41 PM 27,115 Views 35 Comments

The move comes two weeks after Merck applied for emergency use in the US of the anti-coronavirus drug.

# ema - Wednesday 20 October, 2021

Donnelly says he would like to see healthcare workers get the green light for the booster jab
# Booster Shots
# Booster Shots

Donnelly says he would like to see healthcare workers get the green light for the booster jab

Oct 20th 2021, 3:59 PM 10,682 Views 12 Comments

The booster shots for the over 60s will begin ‘imminently’, said the minister.

# ema - Monday 26 July, 2021

Here is the current guidance on vaccinating children against Covid-19
# Explainer
# Explainer

Here is the current guidance on vaccinating children against Covid-19

Jul 26th 2021, 6:00 PM 30,395 Views 14 Comments

Niac is expected to issue guidance to the Government and HSE this week.

# ema - Friday 23 July, 2021

EU regulator approves Moderna vaccine for 12-17 year-olds
# For The Kids
# For The Kids

EU regulator approves Moderna vaccine for 12-17 year-olds

Jul 23rd 2021, 4:50 PM 20,585 Views 58 Comments

It is the first time the shot has been authorised for people under 18.

# ema - Tuesday 13 July, 2021

EU watchdog reviewing Janssen vaccine data after US regulator warns of rare neurological reaction
# Guillain Barré Syndrome
# Guillain Barré Syndrome

EU watchdog reviewing Janssen vaccine data after US regulator warns of rare neurological reaction

Jul 13th 2021, 1:47 PM 39,145 Views 68 Comments

US experts said there had been reports of people who had the jab developing Guillain-Barre syndrome.

# ema - Wednesday 2 June, 2021

Ireland to receive extra Pfizer vaccines after EMA approves additional manufacturing
# Comirnaty
# Comirnaty

Ireland to receive extra Pfizer vaccines after EMA approves additional manufacturing

Jun 2nd 2021, 8:24 AM 33,448 Views 41 Comments

The approval is expected to have “a significant and immediate impact” on the supply of Comirnaty.

# ema - Monday 17 May, 2021

Pfizer vaccine can be kept in fridges for up to a month rather than just five days, EU medicines regulator says
# EMA
# EMA

Pfizer vaccine can be kept in fridges for up to a month rather than just five days, EU medicines regulator says

May 17th 2021, 10:15 PM 15,854 Views 11 Comments

The European Medicines Agency said this could improve the flexibility in countries’ vaccine rollout.

# ema - Tuesday 20 April, 2021

EU regulator says unusual blood clots should be listed as 'very rare side effect' of J&J vaccine
# One-shot Vaccine
# One-shot Vaccine

EU regulator says unusual blood clots should be listed as 'very rare side effect' of J&J vaccine

Apr 20th 2021, 3:24 PM 21,766 Views 28 Comments
  • 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
# European Medicines Agency
# European Medicines Agency

EMA decision on Johnson & Johnson will influence whether Ireland spaces out Pfizer vaccine doses

Updated Apr 20th 2021, 2:28 PM 35,506 Views 22 Comments

It follows concerns that the vaccine could be linked to extremely rare blood clots.

# ema - Monday 19 April, 2021

Decision on J&J one-shot dose expected on Tuesday as EMA assesses blood clot data
# One Shot Dose
# One Shot Dose

Decision on J&J one-shot dose expected on Tuesday as EMA assesses blood clot data

Apr 19th 2021, 12:25 PM 14,268 Views 17 Comments

The rollout of the one-shot dose was paused in the United States after six rare blood clots were identified post-vaccination.

# ema - Saturday 3 April, 2021

UK releases new data about AstraZeneca-linked blood clots as EMA continues to support use of vaccine
# AstraZeneca
# AstraZeneca

UK releases new data about AstraZeneca-linked blood clots as EMA continues to support use of vaccine

Apr 3rd 2021, 3:19 PM 163,751 Views 44 Comments

Several European countries have paused the use of the jab.

# ema - Friday 26 March, 2021

The EMA has granted approval for AstraZeneca plant at centre of diplomatic dispute
# AstraZeneca
# AstraZeneca

The EMA has granted approval for AstraZeneca plant at centre of diplomatic dispute

Mar 26th 2021, 2:54 PM 26,862 Views 24 Comments

The Dutch plant has been at the centre of a bitter spat between the UK and the EU over AstraZeneca’s vaccine production shortfall.

# ema - Tuesday 23 March, 2021

EU medicine regulator evaluating Russia's Sputnik V vaccine for use in Europe
# EMA
# EMA

EU medicine regulator evaluating Russia's Sputnik V vaccine for use in Europe

Mar 23rd 2021, 5:03 PM 36,994 Views 69 Comments

The EMA has also been in touch with representatives of the Chinese Sinopharm jab.

# ema - Thursday 18 March, 2021

HSE will 'immediately endeavour' to begin using AstraZeneca jab again if EMA gives all clear
# Decision Day
# Decision Day

HSE will 'immediately endeavour' to begin using AstraZeneca jab again if EMA gives all clear

Updated Mar 18th 2021, 10:24 AM 28,760 Views 50 Comments

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 - Tuesday 16 March, 2021

EMA 'firmly convinced' benefits of AstraZeneca vaccine 'outweigh the risks of the side effects'
# AstraZeneca
# AstraZeneca

EMA 'firmly convinced' benefits of AstraZeneca vaccine 'outweigh the risks of the side effects'

Mar 16th 2021, 1:33 PM 17,283 Views 22 Comments

The EMA is continuing to carry out its investigation into the vaccine after reports of rare blood-clotting events.

# ema - Thursday 11 March, 2021

The single-dose Johnson & Johnson Covid-19 vaccine has been approved by the European Medicines Agency
# You Only Get One Shot
# You Only Get One Shot

The single-dose Johnson & Johnson Covid-19 vaccine has been approved by the European Medicines Agency

Mar 11th 2021, 1:18 PM 69,219 Views 92 Comments
  • 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

# ema - Wednesday 10 March, 2021

AstraZeneca vaccine not to blame for Austria death, says EU medicines agency
# EMA
# EMA

AstraZeneca vaccine not to blame for Austria death, says EU medicines agency

Mar 10th 2021, 7:54 PM 29,819 Views 32 Comments

Austria announced it would stop using doses from an AstraZenca batch after the 49-year-old nurse died.

# ema - Thursday 4 March, 2021

Covid-19: EMA to review Russian-developed vaccine as part of first step towards EU approval
# Sputnik V
# Sputnik V

Covid-19: EMA to review Russian-developed vaccine as part of first step towards EU approval

Mar 4th 2021, 11:54 AM 13,314 Views 25 Comments

Russia said it is ready to provide vaccines for 50 million Europeans.

# ema - Tuesday 16 February, 2021

Johnson & Johnson subsidiary applies to EMA for Covid-19 vaccine approval
# Shot In The Arm
# Shot In The Arm

Johnson & Johnson subsidiary applies to EMA for Covid-19 vaccine approval

Feb 16th 2021, 4:02 PM 24,302 Views 31 Comments

The single-dose vaccine could be approved as early as next month.

# ema - Wednesday 3 February, 2021

Pfizer and Moderna vaccines to be used for over 70s 'where practicable and timely'
# Vaccines
# Vaccines

Pfizer and Moderna vaccines to be used for over 70s 'where practicable and timely'

Updated Feb 3rd 2021, 7:12 PM 44,891 Views 43 Comments

This follows a recommendation from the National Immunisation Advisory Committee.

# ema - Friday 29 January, 2021

European Medicines Agency confirms no deaths have been linked to the Pfizer/BioNTech vaccine
# Covid-19
# Covid-19

European Medicines Agency confirms no deaths have been linked to the Pfizer/BioNTech vaccine

Jan 29th 2021, 4:57 PM 12,016 Views 3 Comments

It followed reports in recent weeks that people had died after receiving the vaccine.

# ema - Tuesday 26 January, 2021

European Medicines Agency head hopes for decision on Astrazeneca vaccine approval 'by end of this week'
# Emer Cooke
# Emer Cooke

European Medicines Agency head hopes for decision on Astrazeneca vaccine approval 'by end of this week'

Jan 26th 2021, 4:50 PM 13,226 Views 19 Comments

Despite the supply issues, a European approval for the Astrazeneca vaccine this Friday will pave the way for its rollout in Ireland.

# ema - Friday 15 January, 2021

EMA says shorter process can be used if vaccines have to be adapted for new strains
# Covid19
# Covid19

EMA says shorter process can be used if vaccines have to be adapted for new strains

Jan 15th 2021, 12:25 PM 9,937 Views 7 Comments

Developers have said they could adapt the vaccine quickly if a new variant is resistant to it.

# ema - Thursday 17 December, 2020

EU regulator brings Moderna vaccine decision forward to 6 January
# EMA
# EMA

EU regulator brings Moderna vaccine decision forward to 6 January

Updated Dec 17th 2020, 6:05 PM 18,044 Views 16 Comments

The date for a decision had been 12 January.

# ema - Thursday 10 December, 2020

EU medicines regulator says data 'looks robust' as it plans toward Pfizer vaccine approval by end of month
# EMA
# EMA

EU medicines regulator says data 'looks robust' as it plans toward Pfizer vaccine approval by end of month

Dec 10th 2020, 4:31 PM 12,497 Views 8 Comments

A decision on the approval of the Pfizer/BioNtech is due on 29 December.

# ema - Wednesday 9 December, 2020

European Medicines Agency says it has been targeted in cyber attack
# Cyber Attack
# Cyber Attack

European Medicines Agency says it has been targeted in cyber attack

Dec 9th 2020, 6:57 PM 13,287 Views 4 Comments

The agency says it has launched a full investigation.

# ema - Saturday 5 December, 2020

Reader Q&A: What do you want to know about Covid-19 vaccines?
# Covid19
# Covid19

Reader Q&A: What do you want to know about Covid-19 vaccines?

Dec 5th 2020, 10:30 AM 12,118 Views 0 Comments

The HSE expects Ireland’s vaccination programme to begin in January.

# ema - Thursday 8 March, 2018

MS drug pulled from Irish and EU market after 12 patients worldwide suffer 'serious brain disorders'
# Zinbryta
# Zinbryta

MS drug pulled from Irish and EU market after 12 patients worldwide suffer 'serious brain disorders'

Mar 8th 2018, 10:07 PM 50,109 Views 28 Comments

The European Medicines Agency has recommended the immediate suspension and recall of Zinbryta.

# ema - Tuesday 26 September, 2017

Epilepsy drug which has left 400 Irish children with disabilities to come under EU review today
# Valproate
# Valproate

Epilepsy drug which has left 400 Irish children with disabilities to come under EU review today

Sep 26th 2017, 6:25 AM 20,673 Views 8 Comments

An Irish woman whose three children have disabilities will give evidence at a public hearing today.

# ema - Monday 11 November, 2013

So, Ron Burgundy hung out with Daft Punk over the weekend
# Rich Mahogany
From The Daily Edge
# Rich Mahogany

So, Ron Burgundy hung out with Daft Punk over the weekend

Nov 11th 2013, 7:12 AM 1,919 Views 0 Comments

By the beard of Zeus!

# ema - Tuesday 17 September, 2013

Ronan Keating's hair! And other things that happened at the '99 EMAs in Dublin
# Vengaboys Alert
From The Daily Edge
# Vengaboys Alert

Ronan Keating's hair! And other things that happened at the '99 EMAs in Dublin

Sep 17th 2013, 4:27 PM 2,669 Views 0 Comments

Nice lipstick Ronan.

# ema - Saturday 7 January, 2012

Medicines board critical of Irish plastic surgery clinic over breast implant scare
# Breast Implants
# Breast Implants

Medicines board critical of Irish plastic surgery clinic over breast implant scare

Jan 7th 2012, 10:19 AM 2,679 Views 0 Comments

The IMB has revealed that the Harley Medical Group failed to communicate properly with their patients over the faulty PIP breast implants.

# ema - Sunday 6 November, 2011

Watch: Hotel staff struggle to keep Bieber fans out as MTV hits Belfast
# MTV EMAs
From The Daily Edge
# MTV EMAs

Watch: Hotel staff struggle to keep Bieber fans out as MTV hits Belfast

Nov 6th 2011, 3:31 PM 1,476 Views 12 Comments

Music fans have overtaken Belfast as the MTV Europe Music Awards come to the city. Lady Gaga, Justin Bieber, Red Hot Chili Peppers and Snow Patrol will all perform tonight.