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A lower dose Covid vaccine has been approved for use in vulnerable children aged five to 11-years-old in the UK by drugs regulator the Medicines and Healthcare products Regulatory Agency (MHRA).
A new formulation of the Pfizer BioNTech COVID-19 vaccine at 10 micrograms rather than 30 micrograms given to over 12s, has been especially designed for children and met the MHRA’s required safety, quality and effectiveness standards, they drugs regulator announced today.
Dr June Raine, MHRA Chief Executive 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 5 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 5 to 11 years old.”
As with other age groups, the vaccine is given as two injections in the upper arm.
Following the approval of the jab for children, the Joint Committee on Vaccination and Immunisation (JCVI) said it should be given to those that are clinically vulnerable, or those who are a household contact of someone who is immunosuppressed.
They have suggested an interval of eight weeks between the first and second doses.
They are also recommending booster vaccines for those age 12 to 17 years old, three months after their first course of jabs, at the usual adult dosage.
In the USA, over 5.5 million dosages of the vaccine for 5-11 year olds has already been administered. However there is no move at the moment to recommend the vaccine for all five to 11-year-olds in the UK. Despite the MHRA licensing the vaccine for use in all children today, the recommendation from the JCVI advisory body is that it is for the clinically vulnerable only.
The BBC reported that Professor Wei Shen Lim, from the JCVI said: “Some 5 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.”
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