The rollout of the Covid vaccine has been speedy to say the least, with millions of jabs distributed in the UK so far. But one cohort missing from any vaccine conversations up until recently has been children.
The good news is that a number of trials have been ongoing in the background involving those under 18. One such trial with the Pfizer jab has found the vaccine is safe and strongly protective among children as young as 12.
In a study of 2,260 US volunteers aged 12 to 15 years old, preliminary data (which hasn’t yet been published) showed no cases of Covid-19 among fully vaccinated adolescents, compared with 18 among those given placebo shots. The company said the jab was 100% effective in this age group.
Another positive finding is that researchers also reported high levels of virus-fighting antibodies in this age group – higher than in studies of young adults. Children had side effects similar to young adults, Pfizer said, mainly pain, fever, chills and fatigue, particularly after the second dose.
The study will continue to track participants for two years for more information about long-term protection and safety, PA Media reports.
In the meantime, Pfizer and its German partner BioNTech plan to ask the US Food and Drug Administration and European regulators to allow emergency use of the vaccine starting at the age of 12. “We share the urgency to expand the use of our vaccine,” Pfizer chief executive Albert Bourla said in a statement.
All being well, it’s hoped this age group could start being vaccinated before the start of the next school year in the US. In the UK, it could mean a vaccine suitable for older kids is available come autumn.
Why are the available vaccines not given to children?
The vaccines currently issued in the UK are suitable for different age groups. The Pfizer/BioNTech vaccine is suitable for people aged 16 and over, while the AstraZeneca/Oxford vaccine and Moderna vaccines, which will be available in April, should be given to over-18s.
This is because the safety and efficacy of these vaccines in younger people and children have not yet been established.
The number one role of the vaccine is to prevent severe disease and death from Covid-19 – and the aim will be the same in any vaccine issued to children. There may also be an additional benefit of the vaccines reducing transmission.
As studies have found children have a reduced risk of experiencing either severe illness or death from Covid-19, they are considered a lower priority for the vaccine than the elderly or those with underlying conditions.
But children aren’t untouchable. Hundreds of children in the UK are struggling with long Covid months after becoming sick and, in rare instances, some children have developed a multi-system inflammatory syndrome linked to Covid-19 which can lead to organ damage.
Are trials in children underway?
With the Pfizer vaccine, trials have so far focused on those aged 12 to 15 years old. A spokesperson told HuffPost UK in February that moving below 12 years of age will require a new study and potentially a modified formulation or dosing schedule of the vaccine. This could mean a delay in getting a vaccine to younger kids.
In December, Moderna pressed go on its own trial of the vaccine in 12- to 17-year-olds, but in January, USA Today reported the company had been struggling to find enough teen volunteers for its trials. In February, the company enrolled 3,000 teens aged 12-17 years old in a study of the jab and is also launching a trial for 6,750 children aged between 6 months and 11 years old, C&EN reported.
Meanwhile Oxford/AstraZeneca has enrolled a trial assessing whether children and young adults aged 6-17 years old make a good immune response to its vaccine.
Trials are also ongoing in the UK to calibrate the correct dose for children and ensure the vaccine is safe. Professor Adam Finn, the deputy chairman of the joint committee on vaccination and immunisation, told the Today programme in January: “We are just starting studies right now, initially in teenagers and then in younger children with the existing vaccines.
“We need to know we’re giving the right dose to the younger children, we need to know that they’re safe, and that information needs to come in before we start using them.”
So when will vaccines be available for children?
Prof Finn said he believes we will see vaccines being used in children later in the year. England’s deputy chief medical officer, Professor Jonathan Van-Tam agrees the end of the year seems feasible.
“I believe most of the major manufacturers are starting to turn their attention to, ‘can we do some clinical trials to prove our vaccines are safe and effective in children’,” he told ITV News in February. “It is perfectly possible that we will have some licensed children’s vaccines for Covid-19 by the end of the year. It is perfectly possible, but not assured.”
In the meantime, the Medicines and Healthcare products Regulatory Agency (MHRA) confirmed to HuffPost UK that approved Covid-19 vaccines can currently be used off-label, meaning they can be given to children in exceptional circumstances.
MHRA chief executive Dr June Raine said a vaccine is likely to be permitted for children where the view of the prescriber is that “the patient’s health is likely to be in jeopardy unless the vaccine is administered”.
“This is standard practice and brings approved Covid-19 vaccine conditions in line with those of other medicines,” she said.