By Covid-19 vaccine approved for primary school children
A new age-appropriate formula of the Pfizer Covid-19 vaccine for vulnerable 5-11 year-olds has been approved by the UK regulator.
The Medicines and Healthcare products Regulatory Agency (MHRA) approved a new formula of the Pfizer vaccine which will be given at a smaller dose and only to those eligible.
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 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.”
Primary school children, who are given the vaccine, will be given a dose which is a third of the size of the one given to those aged 12 and above (10 micrograms compared with 30 micrograms).
The Joint Committee on Vaccination and Immunisation (JCVI) is advising that only children who are themselves vulnerable, or who live with clinically vulnerable parents should be offered the vaccine.
There are currently 330,000 children in the UK who are classed as clinically vulnerable, meaning they would be eligible to take this vaccine.
In coming to the decision to approve this vaccine, the MHRA delegated with international health bodies and studies data from other countries.
Over 5.5 million doses of the vaccine have been administered to 5-11 year-olds in the USA alone.
