No Covid vaccine yet for children as young as five, despite regulators saying it is safe

The mass vaccination of children as young as five will not yet go ahead, despite safety regulators giving the jab the green light.

The Joint Committee on Vaccination and Immunisation (JCVI) has said it wants more real-world evidence before recommending the jab, after it found that a million doses among five to 11-year-olds would prevent only two healthy children from requiring intensive care.

However, around 330,000 children with underlying health conditions in this age group will be offered two reduced doses of the Pfizer/BioNTech vaccine, eight weeks apart.

Included in this group are also children who are household contacts of people who are immunosuppressed.

On Wednesday, the Medicines and Healthcare products Regulatory Agency (MHRA) approved the jab as safe and effective for all children aged five and older, after concluding data showed a “positive benefit-risk profile”.

While the MHRA assesses whether the vaccine is safe and effective based on the evidence put before it, it is for the JCVI to decide whether it should be used in practice, given a wider range of real-world considerations.

Members are waiting for better data on the omicron wave more generally, as well as how well vaccines stand up to the variant. They are also awaiting real-world safety data from abroad about the rare risk of heart inflammation from the jab.

It comes after the European Medicines Agency approved the use of the Pfizer vaccine for children aged five to 11 in November.

The US has also approved the use of Covid jabs in children as young as five years old.

‘Mild’ side-effects

Dr June Raine, chief executive of the MHRA, said: “Parents and carers can be reassured that no new vaccine for children would have been approved unless the expected standards of safety, quality and effectiveness have been met."

“We have concluded that the Pfizer/BioNTech Covid-19 vaccine is safe and effective for five to 11-year-olds, with no new safety concerns identified. We have carefully considered all the available data and reached the decision that there is robust evidence to support a positive benefit risk for children in this age group.

“Our detailed review of all side-effect reports to date has found that the overwhelming majority relate to mild symptoms, such as a sore arm or a flu-like illness.

“We have in place a comprehensive safety surveillance strategy for monitoring the safety of all UK-approved Covid-19 vaccines and this includes children aged five to 11 years old.”

Wednesday’s approval is for a formulation, known as Comirnaty, specially designed for five to 11-year-olds. Children in that age group are given at a lower dose compared to individuals aged 12 and above - 10 micrograms compared with 30 micrograms.

The JCVI found that for every million doses given to five to 11-year-olds, 113 children with underlying health conditions would be spared admission to a paediatric intensive care unit.

Across all children of this age, the Pfizer jab is around 90 per cent effective at preventing symptomatic Covid, roughly the same as with adults.

Boosters for some older children

Separately, in response to the omicron threat, the JCVI has advised that booster vaccinations should be offered to those aged 16 to 17 years; children aged 12 to 15 who are in a clinical risk group or who are a household contact of someone who is immunosuppressed; and children aged 12 to 15 years who are severely immunocompromised and who have had a third primary dose.

The booster for these groups should be 30 micrograms of the Pfizer/BioNTech vaccine, given no sooner than three months after completion of the primary course.

Professor Wei Shen Lim, chairman, Covid-19 immunisation at the JCVI, said: “The majority of children aged five to 11 are at very low risk of serious illness due to Covid-19.

“However, some five to 11-year-olds have underlying health conditions that put them at higher risk, and we advise these children to be vaccinated in the first instance.

“For children and young people who have completed a primary course of vaccination, a booster dose will provide added protection against the omicron variant.”

Dr Camilla Kingdon, president of the Royal College of Paediatrics and Child Health, said: “As paediatricians, children are always at the centre of our care. It is therefore disappointing that the paediatric formulation of the vaccination is not yet available. 

“Nevertheless, we want to reassure parents, carers and the public that using a smaller dose of adult vaccine, or medicine, for children off-licence in the way described by the JCVI is not unusual. This is done by a qualified practitioner as they will have the right training and safeguards in place.”

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