COVID-19 Vaccinations in Children: FOI release

Information requested

1.  A list of all vaccines for covid-19 available in UK but NOT approved for use by NHS Scotland  for children under 12 year of age
2.  A list of all vaccines for covid19 approved for use by NHS Scotland for children under 12 year  of age
3.  A quantitative risk assessment or similar detailed verification demonstrating that the vaccines  (if any) approved for use in children under 12 years of age are safe and effective and that the  risks associated with vaccination are clearly and substantially less than the risks associated with  covid-19 in that age group.

Response

The COVID-19 vaccines currently approved for use in the UK are:

• Moderna vaccine
• Oxford/AstraZeneca vaccine
• Pfizer/BioNTech vaccine
• Janssen vaccine (not currently available)
• Novavax vaccine (not currently available)
• Valneva vaccine (not currently available)

The only vaccine currently authorised for use in eligible children aged 5 to 11 years in the UK is the Comirnaty 10 micrograms/dose (COVID-19 mRNA vaccine, Pfizer/BioNTech). It should be offered in accordance with the recommendations in the Green Book: COVID-19 Greenbook chapter 14a (publishing.service.gov.uk) which states that, “A 10 microgram dose of Pfizer BioNTech vaccines formulated for children, has recently completed clinical trials and has now been approved by the Medicines and Healthcare products Regulatory Agency (MHRA) for use in children aged 5-11 years.”

JCVI announcement regarding a paediatric vaccine dose: JCVI update on advice for COVID-19 vaccination of children aged 5 to 11 - GOV.UK (www.gov.uk)

There are various forms of authorisation in the UK, which enable a prescription only medicine to be lawfully administered. Like the UK Health Security Agency, Public Health Scotland uses the word ‘licensed’ to refer to all of these, including the conditional marketing authorisation in place for Comirnaty 10 micrograms per dose for use in those aged 5-11 years. Further information regarding this can be found in the following link: Comirnaty 10 micrograms/dose concentrate for dispersion for injection Children 5 to 11 years COVID-19 mRNA Vaccine (nucleoside modified) - Summary of Product Characteristics (SmPC) - (emc) (medicines.org.uk).

The Scottish Government does not hold information on a risk assessment as it continues to be guided by the UK Joint Committee on Vaccination and Immunisation (JCVI) who provide expert independent advice on immunisations, clinical experts, and that of the MHRA as the medicines regulator to authorise all medicinal products, including vaccines, to be used in the UK. The authorisation of medicines for
supply, including vaccines, is a matter reserved to the UK Government, via the MHRA and is not devolved. Scotland only deploys COVID vaccines authorised for supply by the MHRA. Their advice and recommendations are based on careful review of the available published scientific evidence (including trials) as well as their considerations of unpublished data from trusted and reputable organisations. We have full confidence in the governance and recommendations made by these expert scientific and regulatory bodies, with long proven track records, and will continue to base our policy decisions on their advice.

It is the responsibility of the MHRA to ensure the safety, quality and efficacy of all UK medicines, including the COVID-19 vaccines, and they have robust surveillance systems in place, monitoring this on an on-going basis. Whilst all medicines, including vaccines, can have side effects, the available clinical data shows that serious adverse events and deaths are very rare with COVID vaccines and the risk benefit analysis remains overwhelmingly in favour of vaccination. The Scottish Government has full confidence in the procedures put in place by the MHRA in monitoring and investigating any significant suspected adverse incidents potentially involving COVID-19 vaccines.

Additional information regarding the approval of a paediatric dose of vaccine against COVID-19 is available here:

UK regulator approves use of Pfizer/BioNTech vaccine in 5 to 11-year olds - GOV.UK (www.gov.uk)

CMO Letter (scot.nhs.uk)

About FOI

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