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

LAST UPDATE | 25 Nov 2021

TÁNAISTE LEO VARADKAR has told the Dáil that he expects Ireland’s immunisation advisory group to approve Covid-19 vaccines for children aged 5-11 years old “in the next couple of days”. 

It comes as the European Medicines Agency (EMA) today recommended the approval of the Pfizer-BioNtech Covid-19 vaccine for children aged 5-11. 

The recommendation from the EMA must be considered and approved by Ireland’s National Immunisation Advisory Committee (Niac) before the vaccine is rolled out to the younger age group.

The vaccine is already in use in adults and children aged 12 and above, with the EMA saying today that the dose of the vaccine will be lower for children aged 5-11.

As in the older age group, it is advised that the vaccine be given as two injections in the muscles of the upper arm, three weeks apart.  

The Pfizer jab has already been approved for use in the 5-11 age group in the US, with the pharmaceutical manufacturer last month submitting data to the EMA from a study involving 2,268 children.

In a statement today, the EMA said that the study showed 90.7% efficacy in preventing symptomatic Covid-19. 

“The most common side effects in children aged 5 to 11 are similar to those in people aged 12 and above. They include pain at the injection site, tiredness, headache, redness and swelling at the site of injection, muscle pain and chills. These effects are usually mild or moderate and improve within a few days of vaccination,” the statement said. 

The EMA’s human medicines committee  therefore concluded that the benefits of the Comirnaty (Pfizer) vaccine in children aged 5 to 11 outweigh the risks, particularly in those with conditions that increase the risk of severe Covid-19. 

Taoiseach Micheál Martin said earlier this week: “We will have to go to Niac here, but I would support the roll out to children in due course once it’s authorised by the relevant authorities who have the clinical expertise to make that recommendation but that’s something we will look at very closely.”

In Ireland, Covid-19 vaccines have been approved for children aged over 12 for a number of months. The latest figures show that 66.6% of 12-15 year-olds are fully vaccinated, with 80.9% of 16-17 year-olds also fully vaccinated. 

NIAC has recommended that children with underlying conditions avail of a Covid-19 vaccine as soon as possible but that all parents should equally consider vaccinating their children.

Chair of National Immunisation Advisory Committee Prof Karina Butler has said that Covid-19 is most often a mild disease in children but that some will suffer from severe disease and that “the benefits of vaccination exceeded any risk”.

Minister for Justice Helen McEntee said the EMA decision is a “very positive development”.

“We now would anticipate that NIAC will look at this recommendation and in turn make a recommendation [on its use in Ireland],” the minister said.

“We have to look at the overall capacity in the system and at the moment we have a huge process underway to roll out a third jab or a booster for those who have been vaccinated to date.

“We’re encouraging those who haven’t received a vaccine at all to still get that

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But this would be included, I think, in the overall capacity and it’s absolutely vital we try to cover as many people as possible as soon as possible

The EMA approval for the vaccine developed by Pfizer and BioNTech has to be rubber-stamped by the European Commission before health authorities in member states can begin administering jabs.

Earlier this week, German health minister Jens Spahn said shipping of vaccines for younger children in the EU would begin on 20 December.

The US signed off on Pfizer’s vaccine for children earlier this month, followed by other countries including Canada.

Pfizer tested a dose that is a third of the amount given to adults for primary school-age children.

Even with the smaller jab, children who are five to 11 years old developed antibody levels as strong as teenagers and young adults getting the regular-strength vaccines, Pfizer said in September.

US officials noted that Covid-19 has caused more deaths in children in the five to 11 age group than some other diseases, such as chicken pox, did before children were routinely vaccinated.

With reporting by Lauren Boland and Press Association