The EU's drug regulator has approved the use of Pfizer-BioNTech's Covid-19 vaccine for children between the ages of five and 11, opening the way for them to be given a first shot as Europe battles surging infections.
The European Medicines Agency said that a panel of experts "recommended granting an extension of indication for the Covid-19 vaccine Comirnaty to include use in children aged 5 to 11", using the jab's brand name.
The vaccine is already cleared for use in people aged 12 and over in the 27-nation EU.
The HSE chief Paul Reid said the health service has "already started preliminary planning" for offering Covid-19 vaccines to children aged between 5 and 11.
Mr Reid said the smaller vaccine doses are due to start being delivered across Europe towards the end of December.
A consultant paediatric radiologist said that unvaccinated primary school children have the highest Covid-19 infection rates at present.
Dr Gabriel Colleran said the safety data from vaccine trials for children was "very good" and while there may be some side effects, they are very generally very mild
She told RTÉ's Six One News that she hoped parents in Ireland "will soon be given the option to register their children for vaccination".
Tánaiste Leo Varadkar told the Dáil that he expects the National Immunisation Advisory Committee (NIAC) will approve vaccines for children in Ireland in this age group "in the coming days".
He also said that over a million people will receive a booster vaccine by early December.
Tánaiste Leo Varadkar says he expects NIAC to approve vaccines for children aged between five and 11 in the coming days. The EMA has approved the use of Pfizer-BioNTech's Covid-19 vaccine for children in that age group | https://t.co/4vczkKhYSU pic.twitter.com/Y8tfcqcLLJ— RTÉ News (@rtenews) November 25, 2021
Pfizer's jab has so far only been approved in a small number of countries for children aged five to 11, including in the United States, Israel and Canada.
Children aged five to 11 will be given one third of the dose that older people receive, with two injections, three weeks apart, the EMA said.
The vaccine was 90.7% effective in a study of nearly 2,000 children of that age, it added.
Side effects were usually "mild or moderate" lasting for a few days, and included pain in the injection site, tiredness, headache, muscle pain and chills.
The EMA "therefore concluded that the benefits of Comirnaty in children aged five to 11 outweigh the risks, particularly in those with conditions that increase the risk of severe Covid-19".
Dr Clíona Ní Cheallaigh, Infectious Diseases and Internal Medicine physician at St James's Hospital, said that while vaccinating children will help to tackle the spread of the virus, it is just one part of a "multi-layer" approach that is needed.
Speaking on RTÉ's News at One, Dr Ní Cheallaigh said it is "brilliant news", but there is also a need to look at the introduction of mask wearing in schools and the improvement of ventilation of classrooms.
"I think what we've learnt unfortunately, and particularly with the Delta strain, is that vaccination alone isn't enough to control things, but it's part of the multiple layers of things that we need to do to keep Covid under control.
"So vaccination of children may help reduce overall community levels and then we can also look at additional measures, like masks in primary school aged children and improving ventilation in classrooms."
Tens of millions of children in this age group will be eligible for the shot in the EU.
Germany will get 2.4 million doses with the first shipment, enough to inoculate about half the country's children aged 5-11, a BioNTech spokeswoman said.
For paediatric shots, the US regulator authorised a new version of the vaccine, which uses a new buffer and allows them to be stored in refrigerators for up to ten weeks.
The incidence of infection in primary school children in Ireland has been high over the last few months.
The National Public Health Emergency Team meets today and is expected to consider proposals around increased mask wearing at outdoor events and possibly in primary schools.
In the Netherlands, where the EMA is based, authorities said earlier this week that the largest increase in cases was among children up to the age of 12.
The regulator has so far approved four vaccines for use in the EU: Pfizer and Moderna, which use mRNA technology, and AstraZeneca and Janssen (Johnson & Johnson), which use viral vector technology.
Latest coronavirus stories
RTÉ Brainstorm: What we know so far about Covid vaccines for children