The MHRA has given approval for a paediatric formulation of the Pfizer vaccination to be used for 5-11year olds at a 10 microgram dosage.
- The MHRA has said approval was given following a robust review of safety data that shows a positive benefit-risk profile for this vaccine to be used in this age group.
- The MHRA has highlighted its liaison with international regulators and public bodies, and carefully considered global data on use in 5-11 year olds. They noted these data demonstrate a favourable safety profile compared with that seen in other age groups. Over 5.5 million dosages of the vaccine in 5-11s have now been administered in the US alone.
- We understand the specific Paediatric formulation which easily enables administration of the 10 microgram dose for 5-11 year olds (known as orange cap) is not currently available in the UK and won’t be until late January 2022. The Adult/Adolescent formulation (known as purple cap) is available.
- The JCVI has advised that priority children within the 5-11 age range can receive a 10 microgram dose of the Adult formulation by diluting to achieve the correct dose. This will be off-licence use.
- Further information is available on the MHRA pages of the government’s website, and the statement from the JCVI.
Dr Camilla Kingdon, President of the Royal College of Paediatrics and Child Health (RCPCH) responded to the announcement:
Children aged 5-11 years who are deemed to be highly vulnerable to Covid-19, will be offered the Covid vaccination, in line with adults and teenagers. Rolling this out to the 5-11 year age group will provide a variety of operational challenges for the Covid vaccination programme which will need to be fully considered.
Their parents or carers will need to provide consent and this age group of 5-11 year olds can be practically more challenging to immunise than teenagers.
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.