The HSE is stepping up its planning on how it will vaccinate children between the ages of five and 11 after the EU’s drug regulator approved use of the Pfizer Covid-19 vaccine for that age group.
The European Medicines Agency (EMA) has approved the use of the Pfizer Covid-19 vaccine in children aged between five and 11.
The EMA has said the under-12s should get a lower dose of the vaccine than teenagers and adults.
The move paves the way for Ireland’s National Immunisation Advisory Committee (Niac) to consider the rollout of the vaccine to children here.
It is understood the special shots for children will not be delivered to Ireland until around December 20th, and it is seen as unlikely that the vaccine will be administered to primary school children here before the new year.
Paul Reid, the chief executive of the HSE, said that it welcomed today’s decision of the European Medicines Agency to extend vaccinations to younger age groups and awaited sign-off from the National Immunisation Advisory Committee on the vaccinations for younger children.
“Our understanding is that the delivery of those vaccines right across Europe will be towards the end of December, so what we will be doing in the meantime is mobilising a plan and the channels in which we would prepare the vaccinaion of those younger age groups,” he told the HSE’s weekly Covid-19 briefing.
Damien McCallion, the HSE’s national lead for vaccinations, said that they had already started preliminary planning about how it would vaccinate the estimated 480,000 children in this group.
He said the rollout would depend on what other vaccinations were taking place at the time but that it planned to start vaccinations “as quickly as possible” after delivery of the vaccines.
Currently, Covid-19 vaccines are only being administered to people aged 12 and over.
The development comes as the latest figures show primary school-aged children now have the highest Covid-19 incidence of any age group in Ireland, with some 10,000 positive cases in the past fortnight.
The vaccine, as with older age groups, is given as two injections in the muscles of the upper arm, three weeks apart.
The EMA said the main study among children aged five to 11 showed the immune response to the Pfizer (Comirnaty) vaccine, given at a lower dose (10 µg) in this age group, was comparable to that seen with the higher dose (30 µg) in 16- to 25-year-olds as measured by the level of antibodies against Sars-Co V-2.
The most common side effects in children aged five 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.
The EMA said: “These effects are usually mild or moderate and improve within a few days of vaccination.”
It added that its human medicines committee “therefore concluded that the benefits of Comirnaty in children aged 5 to 11 outweigh the risks, particularly in those with conditions that increase the risk of severe Covid-19”.
The EMA said: “The safety and efficacy of the vaccine in both children and adults will continue to be monitored closely as it is used in vaccination campaigns in EU Member states.”
Dr Clíona Ní Cheallaigh, consultant in general medicine and infectious diseases consultant at St James’s Hospital in Dublin, told RTÉ’s Brendan O’Connor that the news from the EMA was a “brilliant” development.
“The initial data that has come out looks like it works well. It is about 90 per cent 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 Ní Cheallaigh said she also feels that the wearing of masks among young primary school children is inevitable.
Marco Cavaleri, Head of Biological Health Threats and Vaccines Strategy at EMA, said he was pleased to announce the approval of the vaccine for young children.
Meanwhile, Tánaiste Leo Varadkar on Thursday said it is important not to rush into a decision in relation to possible new restrictions, stressing it was important to stay positive.
Although the virus is not under control currently and the situation in ICUs was “worrying”, the Tánaiste said there were reasons to be hopeful.
Mr Varadkar told the Claire Byrne Show on RTÉ Radio 1: "We should keep the faith. There are a lot of things that are still under our control. There are a lot of things that could yet go in our favour."
In relation to making a decision about whether to introduce new measures to combat the fourth wave of the virus, Mr Varadkar stressed he did not want to speculate. “We need another week or so to see where we are going,” he said.
Efforts are being put into getting people who have been hesitant about taking the vaccine to go for their first dose, he said. The Tánaiste is also encouraging the public to attend for their booster vaccine if it is offered to them.
“It is becoming increasingly clear that this is a three-dose vaccine,” he said.
Mr Varadkar acknowledged the issues around obtaining PCR tests but stated the HSE has done a “phenomenal job with testing”, with current rates at about 30,000 tests per day. He said he was in favour of antigen tests but warned people they need a PCR test if they have symptoms. He said a decision has been made to subsidise the test and that the details are being ironed out.
Mr Varadkar said a requirement for primary-school children to wear face masks was under consideration, acknowledging it would be “very hard” to ask young children to wear masks.
The move is also expected to be discussed by the National Public Health Emergency Team (Nphet) when it meets on Thursday.
Kingston Mills, professor of experimental immunology at Trinity College Dublin, on Thursday said mask wearing among children would lower infection. However, he said getting young children to wear masks is “going to be challenging”.
Speaking ahead of the EMA announcement regarding vaccine use for children aged five to 11, Prof Mills said a significant number of children had been vaccinated already in the United States and Israel.
When asked to comment on parents who are wary of their children receiving a vaccine, Prof Kingston told Newstalk Breakfast it was up to every family to consider its position on the matter.
On balance, the risk of getting the vaccine is less than the risk of getting Covid, said Prof Mills. In most children, Covid-19 is very mild, but for some it can persist for months, he said.
Prof Mary Horgan, Nphet member and president of the Royal College of Physicians in Ireland, on Thursday said it has been known for the past few months that the increase of infection in primary-school children is higher than the rest of the population.
“Probably for two reasons or many reasons. Firstly they are a group that haven’t been vaccinated,” she said, adding the age group still does not use masks, while the rest of the population does.
Prof Horgan said she hoped Ireland can avoid a lockdown: “A lockdown is just a blunt instrument, and it is really the last resort. We have developed loads of tools that we need to effectively use to avoid a lockdown. The current situation in hospitals is steady.”
Although Prof Mills said Ireland was not moving quickly enough with its booster-vaccination campaign, Prof Horgan said the rollout of booster vaccines is “a big operation”.
“I believe it is being done as quickly as possible,” said Prof Horgan. She said the benefits of boosters were being seen already.
Meanwhile, the trade union Siptu called on the Government to reduce capacity on public transport amid a surge in Covid-19 numbers.
"We can't have overcrowded buses and not expect to have overcrowded hospitals as well due to higher infection rates," Siptu transport organiser John Murphy told Newstalk Breakfast.
The trade union wrote to Minister for Transport Eamon Ryan on Wednesday urging the Government to reduce passenger capacity from 100 per cent. The union represents 4,500 staff who work on all forms of public transport. – Additional reporting: PA