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UK regulator approves new formulation of Pfizer-BioNTech Covid-19 vaccine for under 12s


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UK regulator has approved a new age-appropriate formulation of the Pfizer BioNTech Covid-19 vaccine for use in children aged 5 to 11 years old.

The new paediatric formulation of Covid vaccine meets the required safety, quality and effectiveness standards, the Medicines and Healthcare products Regulatory Agency (MHRA) announced on Wednesday (December 22).

Dr June Raine, MHRA chief executive said that parents and carers can be reassured that this approval has been given after robust review of safety data.

These data showed a favourable safety profile for use in 5-11-year olds compared with that seen in other age groups, the regulator said.

Raine said: “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 5 to 11 years old.”

The specially designed formulation for 5-11 year olds will be given at a lower dose compared to that used for individuals aged 12 and above.

JCVI’s advice

In its updated advice the Joint Committee on Vaccination and Immunisation (JCVI) said that children aged 5 to 11, who are in a clinical risk group or are a household contact of someone immunosuppressed, should be offered a primary course of vaccination.

The committee has recommended two 10-microgram doses of the Pfizer-BioNTech Covid-19 vaccine, with an interval of eight weeks between the two doses.

JCVI will issue a broader advice on vaccination for other 5 to 11 year olds on a later date.


The committee has also advised that booster vaccinations should be offered to persons aged:

  • 16 to 17 years
  • 12 to 15 who are in a clinical risk group or who are a household contact of someone who is immunosuppressed
  • 12 to 15 years who are severely immunocompromised and who have had a third primary dose.


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