Have your say: EMA approves Pfizer jab for children aged 5 to 11

Courtney Martin, left, a nurse at the University of Washington Medical Center, gives the first shot of the Pfizer COVID-19 vaccine to Ani Hahn, 7, Tuesday, Nov. 9, 2021, in Seattle. Picture: AP Photo/Ted S. Warren

The European Medicines Agency (EMA) has approved the Pfizer/BioNTech Covid-19 vaccine for us for children between the ages of 5 and 11-years.

Both the US and Canada have already authorised the use of Pfizer's Covid-19 vaccine for children in the age grouping.

In children from 5 to 11 years of age, a study found that a lower dose of the Comirnaty vaccine was comparable to a larger dose used in people aged 12 and above. 

Children in the group will be given two injections, three weeks apart, into the muscle of the upper arm.

In a statement, the EMA said: "Of the 1,305 children receiving the vaccine, three developed Covid-19 compared with 16 out of the 663 children who received placebo. 

"This means that, in this study, the vaccine was 90.7% effective at preventing symptomatic Covid-19 (although the true rate could be between 67.7% and 98.3%)."

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.

Earlier in the week, Taoiseach Micheál Martin said Ireland is ready to administer the vaccines to primary school children once European regulators sign off on the decision.

However, the Taoiseach said it was unlikely children in that cohort will get the jab here before Christmas, given the timeline and logistics involved.

“My view there is that we will then have to go to Niac here but I would support the rollout to children in due course once it’s authorised by the relevant authorities who have the clinical expertise to make that recommendation,” he said.

Pfizer and its German partner BioNTech submitted data to the EMA that they say supports the use of their mRNA vaccine for young children.

The vaccine was found to induce a strong immune response in five- to 11-year-olds in a clinical trial of 2,268 participants, the companies said in September.

'Good news'

An infectious disease specialist who earlier this year warned that Ireland was allowing Covid-19 to "rip through" schools welcomed the approval.

Dr Cliona Ni Cheallaigh, consultant in general medicine and infectious diseases consultant at St James Hospital in Dublin, said it was a "brilliant" development.

"I am hoping we will soon be vaccinating our five to eleven years and I can get my own eight-year-old vaccinated," she said, speaking on RTÉ radio.

"I think it is great. The initial data that has come out looks like it works well. It is about 90% effective in the time period they looked at at preventing Covid infection in children and they didn't detect any serious side effects in children that were in the study so that is really good news."

Dr Ni Cheallagh said extra layers of protection are also needed, including improved ventilation and masks in classrooms.