Mass vaccination of children as young as five delayed, 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, finding that only two healthy children would be prevented from needing intensive care for every million doses dispensed.

However, around 330,000 children with underlying health conditions will be offered two reduced doses of the Pfizer BioNTech vaccine, spaced eight weeks apart. Included in this group are also children who are a household contact 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 the data showed a “positive benefit-risk profile”.

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, the 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.”

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Today’s approval is for a formulation, known as Comirnaty, specially designed for five- to 11-year-olds and given at a lower dose compared with that used in 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.

Further advice regarding Covid vaccination for other five to 11-year-olds will be issued in due course after consideration of additional data, and on the omicron variant more broadly.

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.

Prof Wei Shen Lim, the chairman, Covid-19 immunisation, 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.”

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