Independent report

JCVI statement on COVID-19 vaccination of children aged 12 to 15 years: 3 September 2021

Published 3 September 2021

Introduction

Some COVID-19 vaccines available in the UK are currently authorised for use in those aged 12 years and over. The Joint Committee on Vaccination and Immunisation (JCVI) has previously advised an offer of first doses of Pfizer-BNT162b2 vaccine to all 16 to 17 year olds. People aged 16 and 17 years are moving towards adulthood, higher education and/or the workplace. Their social behaviour and social mixing patterns are different compared to children aged 12 to 15 years, and throughout the pandemic rates of infection have been consistently higher in 16 to 17 year olds compared to younger children. Those aged 16 to 17 years can also provide informed consent for their own vaccination.

JCVI has also previously offered advice regarding the vaccination of children aged 12 to 15 years with underlying health conditions (see Annex A below).

The current update relates to JCVI’s review of considerations for the vaccination of children aged 12 to 15 years who do not have underlying health conditions that put them at increased risk from COVID-19. A precautionary approach was agreed given the very low risk of serious disease in those aged 12 to 15 years without an underlying health condition that puts them at increased risk. Given this very low risk, considerations on the potential harms and benefits of vaccination are very finely balanced.

Considerations

The potential benefits of vaccination in children and young people were set out in the previous advice (JCVI statement on COVID-19 vaccination of children and young people aged 12 to 17 years: 4 August 2021). Key points of consideration include that admission rates in children with underlying co-morbidities were substantially higher than those in healthy children – evidence which prompted advice on vaccination of children aged 12 and over who are at clinical risk. The extent of any indirect benefits is highly uncertain given our current understanding of the impact of vaccination on transmission in the short and medium term. Understanding of the current and future role of schools on wider transmission, due to the previous use of non-pharmaceutical interventions, increases this uncertainty about the potential impact of vaccination.

On 26 August, 1 September and 2 September 2021, JCVI met, in collaboration with experts from overseas, to review updated evidence relating to the epidemiology of COVID-19 in the UK and safety data related to myocarditis following COVID-19 vaccination in the UK, US and Canada. There is increasingly robust evidence of an association between vaccination with mRNA COVID-19 vaccines and myocarditis. This is a very rare adverse event. Available data from the US and Canada indicate the reporting rate of myocarditis is higher following a second dose of mRNA vaccine, compared with the first dose. No association with prior SARS-CoV2 infection and myocarditis following vaccination has been identified.

The available data indicate that the clinical manifestations of myocarditis following vaccination are typically self-limiting and resolves within a short time. However, the clinical picture is atypical and the medium to long-term (months to years) prognosis, including the possibility of persistence of tissue damage resulting from inflammation, is currently uncertain as sufficient follow-up time has not yet occurred.

Advice

This advice is not based on assessments of vaccine availability, future supply or costs associated with delivery of a programme. When formulating advice in relation to childhood immunisations, JCVI has consistently held that the main focus of its decision should be the benefit to children and young people themselves, weighed against any potential harms from vaccination to children and young people. In providing its advice, JCVI also recognises that in relation to childhood immunisation programmes, the UK public places a higher relative value on safety compared to benefits.

The available evidence indicates that the individual health benefits from COVID-19 vaccination are small in those aged 12 to 15 years who do not have underlying health conditions which put them at risk of severe COVID-19. The potential risks from vaccination are also small, with reports of post-vaccination myocarditis being very rare, but potentially serious and still in the process of being described. Given the rarity of these events and the limited follow-up time of children and young people with post-vaccination myocarditis, substantial uncertainty remains regarding the health risks associated with these adverse events.

Overall, the committee is of the opinion that the benefits from vaccination are marginally greater than the potential known harms (tables 1 to 4) but acknowledges that there is considerable uncertainty regarding the magnitude of the potential harms. The margin of benefit, based primarily on a health perspective, is considered too small to support advice on a universal programme of vaccination of otherwise healthy 12 to 15-year-old children at this time. As longer-term data on potential adverse reactions accrue, greater certainty may allow for a reconsideration of the benefits and harms. Such data may not be available for several months.

JCVI has considered commentary from stakeholders on the benefits of vaccination on the operation of schools and the educational impact of the pandemic on children and young people. JCVI is constituted with expertise to allow consideration of the health benefits and risks of vaccination and it is not within its remit to incorporate in-depth considerations on wider societal impacts, including educational benefits. The government may wish to seek further views on the wider societal and educational impacts from the chief medical officers of the 4 nations, with representation from JCVI in these subsequent discussions. There is considerable uncertainty regarding the impact of vaccination in children and young people on peer-to-peer transmission and transmission in the wider (highly vaccinated) population. Estimates from modelling vary substantially, and the committee is of the view that any impact on transmission may be relatively small, given the lower effectiveness of the vaccine against infection with the Delta variant.

Delivery of a COVID-19 vaccine programme for children and young people is likely to be disruptive to education in the short term, particularly if school premises are used for vaccination and there is potential for a COVID-19 vaccine programme to impact on the efficiency of roll-out of the influenza programme. Adverse reactions to vaccination (such as fevers) may also lead to time away from education for some individuals.

Tables 1 to 4: risk-benefit assessment of COVID-19 vaccination in those aged 12 to 15 years who do not have underlying health conditions that increase the risk of serious COVID-19 disease

Table 1: prevented per million first vaccine doses

Paediatric intensive care unit (PICU)	Hospitalisations	Paediatric inflammatory multisystem syndrome temporally associated with SARS-COV2 infection (PIMS-TS)
2.39	87.01	15.31

Table 2: prevented per million second vaccine doses

PICU	Hospitalisations	PIMS-TS
0.16	5.74	12.67

Table 3: prevented per course

PICU	Hospitalisations	PIMS-TS
2.54	92.76	27.72

Table 4: myocarditis risk per million

First dose	Second dose
3 to 17	12 to 34

Annex A: JCVI advice on vaccination of children aged 12 to 15 years with underlying health conditions (31 August 2021)

JCVI has reviewed further UK data on hospital admissions, paediatric intensive care unit (PICU) admissions and deaths in children aged 12 to 15 years. For the vast majority of children aged 12 to 15 years, SARS-CoV2 infection is asymptomatic or mildly symptomatic, and is self-limiting. Of the very few children aged 12 to 15 years who develop more severe illness requiring hospital attendance, the majority have underlying health conditions.

In the latest analysis of UK data from the Royal College of Paediatrics and Child Health (RCPCH) together with the NHS England (NHSE) National Clinical Director for children and young people (see the ‘References’ section below), estimates of the incidence of PICU admission for children aged 12 to 15 years without underlying health conditions were 2 per million, compared to over 100 per million for those with underlying health conditions. These estimates are imprecise due to the small number of children requiring PICU admission over the course of the pandemic.

Previously, JCVI advised that children with severe neuro-disabilities, Down’s Syndrome, underlying conditions resulting in immunosuppression, profound and multiple learning disabilities (PMLD), severe learning disabilities or who are on the learning disability register, should be offered COVID-19 vaccination.

Following consideration of the updated data, JCVI advises that the offer of a course of COVID-19 vaccination should be expanded to include children aged 12 to 15 years with the following:

• haematological malignancy
• sickle cell disease
• type 1 diabetes
• congenital heart disease
• other health conditions as described below under ‘COVID-19 clinical risk groups for children aged 12 to 15 years’ (these health conditions reflect the basket of diagnoses used in the RCPCH and NHSE analyses mentioned above).

Asthma is one of the commonest underlying health conditions prevalent among children and young people. The RCPCH and NHSE analysis found that those with asthma, as a broad group, were not at particular risk from COVID-19. The British Thoracic Society, in collaboration with academic partners, have agreed a consensus view regarding which children and young people with poorly controlled asthma are at higher risk from COVID-19. These people with poorly controlled asthma should be offered a course of COVID-19 vaccination.

It is recognised that there are a number of less common conditions in children, often due to congenital or metabolic defects, where respiratory infections of any sort can result in severe illness. Clinical judgement would need to be applied in identifying these children, and they should be offered a course of COVID-19 vaccination as well.

A course of COVID-19 vaccination refers to a 2-dose primary schedule unless the individual is severely immunosuppressed when a 3-dose primary schedule is advised in accordance with the latest JCVI advice on third primary vaccine doses (see the green book, Chapter 14a).

COVID-19 clinical risk groups for children aged 12 to 15 years

Chronic respiratory disease:

Includes those with poorly controlled asthma that requires continuous or repeated use of systemic steroids or with previous exacerbations requiring hospital admission, cystic fibrosis, ciliary dyskinesias and bronchopulmonary dysplasia.

Chronic heart conditions:

Haemodynamically significant congenital and acquired heart disease, or milder heart disease with other co-morbidity.

Chronic conditions of the kidney, liver or digestive system:

Includes those associated with congenital malformations of the organs, metabolic disorders and neoplasms, and conditions such severe gastro-oesophageal reflux that may predispose to respiratory infection.

Chronic neurological disease:

Includes those with:

• neuro-disability and/or neuromuscular disease including cerebral palsy, autism, epilepsy and muscular dystrophy
• hereditary and degenerative disease of the nervous system or muscles, or other conditions associated with hypoventilation
• severe or profound and multiple learning disabilities (PMLD), Down’s syndrome, or those on the learning disability register
• neoplasm of the brain

Endocrine disorders:

Includes diabetes mellitus, Addison’s and hypopituitary syndrome.

Immunosuppression:

Immunosuppression due to disease or treatment, including:

• those undergoing chemotherapy or radiotherapy, solid organ transplant recipients, bone marrow or stem cell transplant recipients
• genetic disorders affecting the immune system (for example, deficiencies of IRAK-4 or NEMO, complement disorder, SCID)
• those with haematological malignancy, including leukaemia and lymphoma
• those receiving immunosuppressive or immunomodulating biological therapy
• those treated with or likely to be treated with high or moderate dose corticosteroids
• those receiving any dose of non-biological oral immune modulating drugs – for example, methotrexate, azathioprine, 6-mercaptopurine or mycophenolate
• those with auto-immune diseases who may require long term immunosuppressive treatments

Asplenia or dysfunction of the spleen:

Includes hereditary spherocytosis, homozygous sickle cell disease and thalassemia major.

Serious genetic abnormalities that affect a number of systems:

Includes mitochondrial disease and chromosomal abnormalities.

References

Deaths in Children and Young People in England following SARS-CoV-2 infection during the first pandemic year: a national study using linked mandatory child death reporting data. C Smith, D Odd, R Harwood, J Ward, M Linney, M Clark, D Hargreaves, SN Ladhani, E Draper, PJ Davis, SE Kenny, E Whittaker, K Luyt, RM Viner, LK Fraser. medRxiv 2021.07.07.21259779. doi: https://doi.org/10.1101/2021.07.07.21259779

Which children and young people are at higher risk of severe disease and death after SARS-CoV-2 infection: a systematic review and individual patient meta-analysis. R Harwood, H Yan, N Talawila Da Camara, C Smith, J Ward, C Tudur-Smith, M Linney, M Clark, E Whittaker, D Saatci, PJ Davis, K Luyt, ES Draper, S Kenny, L K Fraser, R.M Viner. medRxiv 2021.06.30.21259763. doi: https://doi.org/10.1101/2021.06.30.21259763

Risk factors for intensive care admission and death amongst children and young people admitted to hospital with COVID-19 and PIMS-TS in England during the first pandemic year. JL Ward, R Harwood, C Smith, S Kenny, M Clark, PJ Davis, ES Draper, D Hargreaves, S Ladhani, M Linney, K Luyt, S Turner, E Whittaker, L K Fraser, R.M Viner. medRxiv 2021.07.01.21259785; doi: https://doi.org/10.1101/2021.07.01.21259785

Some of the data considered by JCVI were unpublished analyses from the studies cited above.