THE HSE’S COVID-19 registration portal has opened for parents and guardians to register children aged between 12 and 15.
Health officials are particularly encouraging the parents of children who are medically vulnerable to take the offer of a vaccine for their children, who may be at high risk of severe disease if infected with the coronavirus.
All parents are being asked to consider the research to date and the information provided by the health service and to discuss the vaccine with their children as they make a decision.
As part of The Journal’s Reader Q&A series, we asked readers what they wanted to know about this next stage of the roll-out.
Many of the questions related to potential side effects, some wanted to know about clinical trials, while others wanted to find out whether other countries are taking a similar approach.
People in this age group will all receive either the Pfizer (also known as Comirnaty) or Moderna (also known as Spikevax) Covid-19 vaccines.
Both of these vaccines are mRNA jabs. This means it contains a molecule called messenger RNA with instructions for producing a protein – the spine protein – naturally present in SARS-CoV-2, the virus that causes Covid-19.
The vaccine essentially teaches the body how to defend itself against SARS-CoV-2. It does not contain any SARS-CoV-2 virus.
These are both two-dose vaccines and people in this age cohort will still receive two jabs. The dosage will be the same as it is for adults.
In response to a query from The Journal, the HSE said:
The licenced dose of the mRNA (Pfizer and Moderna) Covid-19 vaccines is indicated for all those aged 12 years and older. This is the dose that was used in the clinical trials and has been shown to be safe and effective at reducing the risk of severe Covid-19 infection in those aged 12 years and older.
Experts have said a change in dosage may have to be considered for younger age groups – under the age of 12. For example in Israel, where the vaccine was approved for at-risk children aged 5-11 recently, the dose is 0.1 millilitres, three times less than the standard vaccine.
In may this year the European Medicines Agency approved the first Covid-19 vaccine for children aged 12-15 in the EU, the Pfizer vaccine.
This was based on a study involving 2,259 children aged 12 to 15. The trial showed an immune response that was comparable to that shown in the 16 to 25 age group. None of the children who received the vaccine developed Covid-19, compared to 16 who did develop Covid-19 after receiving a placebo.
The most common side effects included pain at the injection site, tiredness, headache, muscle and joint pain, chills and fever. These effects are usually mild or moderate and improve within a few days from the vaccination.
Then in July, the EMA approved the Moderna vaccine for this age cohort. This was based on a study of 3,732 children aged 12 to 17 years.
Again this study showed the jab produced a comparable antibody response in those aged 12-17 to that seen in young adults aged 18-25.
None of the children who received the vaccine developed Covid-19, compared with four who did after receiving the placebo.
The most common side effects included pain and swelling at the injection site, tiredness, headache, muscle and joint pain, enlarged lymph nodes, chills, nausea, vomiting and fever. These effects are usually mild or moderate and improve within a few days from the vaccination.
In both cases the EMA acknowledged that due to the limited number of children in the studies, the trials could not have detected rare side effects. However, despite this uncertainty it said it still considered that the benefits of the vaccines in children aged 12-15 outweigh the risks, particularly in children with conditions that increase their risk of severe Covid-19.
There have been some rare reports of heart conditions in younger people following Pfizer or Modern vaccines.
Myocarditis and pericarditis are inflammatory heart conditions. Symptoms often include breathlessness, a forceful heartbeat that may be irregular (palpitations), and chest pain.
According to the HSE’s information for parents: “Very rarely some children aged 12 or over develop inflammation of the heart (myocarditis) and the outer lining of the heart (pericarditis). The risk of myocarditis is higher in boys after their second dose.
“Data from the United States estimates that the risk of myocarditis in boys aged 12 to 17 is about 1 in 16,000. In girls of the same age, the risk is 1 in 100,000. This is after they got their second dose.”
According to a Harvard article published last month, around 1,000 cases of myocarditis and pericarditis had been reported following the administration of 300 million vaccinations in the US, with either a Pfizer or Moderna vaccine, usually occurring within days of receiving the vaccine.
The majority of these cases were mild and 79% of teens and young adults who experienced it had recovered, while others were still receiving treatment.
By the start of July, the US Centers for Disease Control and Prevention (CDC) had reported that for every million doses given, there had been 67 cases of heart inflammation in boys 12 to 17 (nine in girls of that age group), 56 in those aged 18 to 24 (six in girls), and 20 in males 25 to 29 (three in girls).
To date, around 42% of Americans aged 12-15 have received at least one dose of the vaccine.
Last month the European Medicines Agency’s safety committee PRAC recommended that myocardits and pericarditis be listed as new side effects in product information for both the Pfizer and Moderna vaccines.
The committee conducted an in-depth review of 145 cases of myocarditis in the European Economic Area (EEA) among people who received the Pfizer vaccine and 19 cases among people who received the Moderna vaccine.
PRAC also reviewed reports of 138 cases of pericarditis following the use of Pfizer and 19 cases following the use of Moderna. As of 31 May 2021, around 177 million doses of Pfizer and 20 million doses of Moderna had been given in the EEA.
In addition the PRAC also looked into cases received worldwide.
The committee concluded that the cases primarily occurred within 14 days after vaccination, more often after the second dose and in younger adult men.
In five cases that occurred in the EEA, people died. They were either of advanced age or had associated diseases, the EMA said.
The EMA stated that available data suggests that the course of myocarditis and pericarditis following vaccination is similar to the typical course of these conditions, usually improving with rest or treatment.
The HSE information for parents states:
Most people recover from myocarditis and pericarditis on their own but they may need treatment in hospital. We don’t yet know if there are any long-term problems because of these side effects.
At a recent health briefing, Dr Karina Butler, chair of the National Immunisation Advisory Committee (NIAC) said for those who have experienced this rare side effect “it has resolved and resolved quickly”.
“Some of those patients, in fact most of them would have ended up in an ICU because whenever you have something like that people will want to monitor you closes, but it has been self-limited, resolved quickly and those patients discharged from hospital,” she said.
Dr Butler said the overall risk to this age group is about the same as the risk of paediatric inflammatory multisystem syndrome, caused by Covid-19 infection in children, which can also cause inflammation of the heart.
The HSE in its information for parents has outlined the risk associated with Covid-19 infection, so parents can consider this as part of their decision-making.
Most children aged 12-15 who get Covid-19 have very mild symptoms or no symptoms.
However the HSE pointed out that children who do get Covid-19, regardless of symptoms, will have to self-isolate from other people to stop the spread of the virus. This means they will have to stay at home for at last 10 days from when they develop symptoms or test positive.
It is rare that Covid-19 causes serious illness, hospitalisation or death in children. Around one in 100,000 children who get Covid-19 have to go to hospital. The risk of needing intensive care treatment is very low.
Children with certain health conditions such as chronic lung disease or chronic neuroligical conditions are at higher risk of severe illness and are more likely to require hospitalisation.
“In extremely rare cases Covid-19 can cause a condition called multisystem inflammatory syndrome in children (MIS-C),” the HSE said.
“MIS-C is also known as paediatric inflammatory multisystem syndrome (PIMS). It causes pneumonia, inflammation of the heart and difficulty breathing. It can cause death.”
Around one in 20,000 children who have or previously have had Covid-19 develop this syndrome and it generally occurs in children who were previously healthy. Other symptoms include persistent fever, rash, hypotension/tachycardia, vomiting, diarrhoea and abdominal pain.
As of 28 June this year, the total number of MIS-C cases identified in the US was 4,196, with 37 associated deaths.
According to the latest available figures in Ireland, at least 32 children had been treated for this syndrome up to February this year.
The HSE said it is not yet known whether there is a risk of long-lasting side effects from Covid-19 infection in children. Some children have experienced what is known as ‘long-Covid’, but it is unclear how long these effects may last.
Experts have also pointed out that there are wider benefits of vaccinations, both for children, their loved ones and their communities.
At a recent health briefing, Dr Karina Butler, chair of the National Immunisation Advisory Committee (NIAC), said the pandemic had caused an increase in anxiety among younger people.
“Fear of mingling, feeling that adults are pulling away from them, disruption to their normal growth and development. Taking all of that the benefits of vaccination exceeded any risk associated with the vaccine for children,” she said.
She said NIAC strongly recommends that parents of children who might have an underlying condition should avail of the offer of a vaccine at their earliest opportunity.
“There may be parents where there might be, for example, a younger child who has an underlying condition or a vulnerable adult – someone maybe who’s immunocompromised – who might not respond as well to the vaccine that they want to protect within the household.”
Experts at John’s Hopkins Medicine, in an article on the topic, pointed out that children, like adults, can transmit the virus to others, even if they are not sick with Covid.
“The Covid-19 vaccine protects against this potential harm to the child and others, including family members and friends who may be susceptible.
Another reason to consider a Covid-19 vaccine for your child is to protect the health of the broader community. Each child or adult infected with the coronavirus provides a chance for the virus to mutate and create a variant that might prove more dangerous or resistant to the available vaccines and therapies.
“Fewer overall infections among the population means less chance of dangerous coronavirus variants.”
NIAC, in its consideration of whether to recommend vaccines for this cohort, conducted focus groups with children and adolescents in this cohort.
Dr Butler said they were struck by the maturity of those who participated in the groups:
“They weren’t so worried about the consequences of infection for them, because that is a rare event that they would end up in hospital or in an ICU, but they were concerned about everything else.
They were concerned about the fact that they might unwittingly pass it to someone else. They were concerned that their lives have been disrupted, they talked about wanting to get back to that life that they liked before Covid.
“They were concerned, they’ve been through a hard year and they saw it as the vaccine would have benefits for them.
“In terms of health, it will protect them, but that wasn’t a major concern. They wouldn’t pass it on to anyone – that was a concern that they voiced. Their life would be better again, both in terms of maybe reducing the amount of disruptions in terms of education and socialisation, and that they would be happier again, which was an interesting thought.”
Dr Karina Butler, chair of the National Immunisation Advisory Committee (NIAC) addressed this issue recently when she appeared on RTÉ’s Today with Claire Byrne.
She pointed out that the HPV and Covid vaccines are both inactivated vaccines (the meningitis vaccine is also an inactivated vaccine) and that there is “no interaction between the two”.
Dr Butler said it would be technically safe for a child to receive both the HPV vaccine and the Covid vaccine on the same day:
“I can give the reassurance that in terms of the HPV vaccine, which is an inactivated vaccine, and this vaccine, which is inactivated vaccine, actually they could even get them together on the same day,” she said.
“So, we have no concerns about there having to be any interval between them.”
Dr Butler added that parents can, of course, decide to wait for a period of time after another vaccine if they are more comfortable with that.
Countries in the EU that have also approved the use of a Covid-19 vaccine for children in this age cohort include:
In the UK, its Joint Committee on Vaccination and Immunisation (JCVI) also recommended vaccinating children aged 12-15, but only if they are at high risk of Covid due to certain illnesses or disabilities.
In France, almost 50% of children aged 12-17 have received their first dose, while almost 30% in Spain have received a first dose.
In Italy more than 40% of the 12-19 age cohort have received a first dose and 23% are fully vaccinated.
The United States began inoculating young adolescents in mid-May and around 42% have received at least one dose so far. Around 600,000 adolescents in the US received their first jab the week after it was authorised for those aged 12-15.
Canada also approved the use of the Pfizer vaccine in children aged 12-15 in early May.
In Israel, eligibility for the Covid vaccine was extended to those aged 12-15 in May. As mentioned above, Israel has also recently approved Covid jabs for at risk children aged 5-11.
They include children with brain, heart or lung problems, severe immunosuppression, sickle cell anaemia, pulmonary hypertension and severe obesity.
Since registration opened yesterday evening, parents of 12-15 year olds can either:
To register your child on the portal you’ll need:
If you do not have these things, you can call the Covid-19 helpline to register by phone instead.
If you register by phone, a parent or legal guardian will need to be at the appointment to give consent for the vaccine in person.
You need to register each child separately if you have more than one child in this cohort. If their appointments are on the same day, but at different times, you can bring them at the same time – you do not need to attend twice or more in one day.
If your child is due to turn 12 this year, you can register them for a vaccine after that.
The HSE’s information for parents states that “a parent or legal guardian will need to give consent for their child to get their vaccine”.
When asked by The Journal, the HSE clarified that consent is only required from one parent:
Consent of one parent or legal guardian is required for vaccination. However, it is important for parents to discuss with their family and their child to ensure that they are making a decision that is right for their family.
Parents who register their child through the online portal will receive a text message with a link to give their consent before the appointment. This will be sent to the number used to register.
A parent or legal guardian will need go to the appointment in person to give consent if they:
The child getting the vaccine will also be asked if they are happy to get the vaccine at their appointment.
Speaking to RTÉ’s News at One yesterday, Damien McCallion, National Director Covid Vaccination Programme, said parents are advised to discuss the vaccine with their children so there is an understanding of what it is.
“If the child is resistant of has any issues that would be dealt with appropriately either in the centre or, for example, we also have GPs participating and pharmacies, so they’ll be dealt with sensitively,” he said.
“If there are any issues with young children clearly we won’t be trying to force the vaccine on anyone. We’ll work with parents and with guardians.”
The HSE has said most children aged 12-15 will be vaccinated at a vaccination centre near their home, though some pharmacies and GP surgeries may also provide the service.
They will need to bring an adult to their appointment – children attending alone will not be vaccinated.
Where possible, the child’s parent should attend, but if the parent or guardian has given consent online before the appointment, another adult can attend.
If consent has not yet been given, the parent must accompany the child.
The HSE has said it will try to facilitate, where possible, appointments over weekends or later in the evening to take into account work and other responsibilities parents have.
Those attending should bring their appointment information, which will be in a text message on their phone. If possible, the child should bring a form of identification with their date of birth on it, such as a passport or their birth certificate.
If these are not available, other identification such as a Public Services Card or a school ID could be used.
And if the child does not have any identification, the adult accompanying them can confirm their identity and age.
The HSE has not indicated that priority will be given to high risk children, but said it expects the roll-out will move quickly. In a statement it told The Journal:
Due to the pace of the vaccination roll-out, it is anticipated that appointments will be offered quickly to all those aged 12-15 years in the community vaccination clinics. In addition to vaccination at the community vaccination clinics, vaccines will also be available with some GPs and pharmacies.
In terms of appointments, the HSE has said some children with additional needs may require more time for their appointment or a quiet time when there are fewer people. Parents can arrange one of these options by calling HSELive on 1800 700 700.
The HSE said children attending for their vaccine should wear something that makes it easy to get the jab in their upper arm. And they are advised to eat before arriving as there may be a wait at the vaccination centre.
The child should not attend if they:
Appointments can be rescheduled if this happens.
The government has said vaccinations for children will not be mandatory and a decision not to vaccinate a child will not result in their exclusion from education.
Speaking about the topic last month, Dr Karina Butler said health officials to not want to see “any discrimination or segregation between those who are vaccinated and those who are not vaccinated, if parents decide they want to defer, or to wait until there’s even more information if they need that.”
“We know that the schools, even without any vaccines in children – and we know through the last year – have done a superb job in terms of controlling the risks of spread of infection,” she said. “And now going back at least all of the adults in the setting will have been vaccinated, or at least had the offer to be vaccine.”
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