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The Joint Committee for Vaccination and Immunisation (JCVI) has updated its advice on vaccinations for children aged 5-11 and recommends a non-urgent offer of two 10 mcg doses of the Pfizer-BioNTech COVID-19 vaccine to those who are not in a clinical risk group.
Statement from the Royal College of Paediatrics and Child Health (RCPCH):
“We acknowledge the careful scrutiny the Joint Committee on Vaccines and Immunisation (JCVI) has given to the issue of assessing the health benefits and risks of healthy 5 to 11 year olds being offered the COVID-19 vaccine. It is important that this decision has been reached following expert consideration over time by the JCVI of all available evidence and information. JCVI has said going ahead with the vaccine will increase this age group’s protection against severe illness in advance of a potential future wave of COVID-19. We recognise that the JCVI has stated this is a one off pandemic response programme of vaccinations, and it will review its advice over the long term.
“It is a priority that 5-11 year olds who are deemed to be at risk of COVID infection or who are living with family members who are immunosuppressed, receive this vaccine. The COVID vaccine has been certified as safe by the Medicines Healthcare Regulation Agency (the MHRA), and we would encourage all those who are eligible to have the vaccine to consider doing so.
“Delivering a vaccination programme to 5-11 year olds will require careful planning in order to ensure a favourable experience for children. Finding child-friendly vaccination sites, staffed with appropriately trained professionals, will be important and should facilitate equal access to all children which is key to avoiding disadvantaging some families. Governments should develop information and materials that are parent-and-carer friendly, and suitable for children, to facilitate their decision making.
“Measles is much more infectious than COVID-19 and potentially a serious illness for children, especially the very young. We know uptake rates of the vaccine for Measles, Mumps, Rubella (MMR) as well as other routine vaccinations are decreasing, but these are potentially life saving. In the UK we are fortunate to have a very successful childhood immunisation programme which is highly effective. The COVID-19 vaccination must not displace others and Government must take action to ensure uptake of these routine vaccinations is increased.
“Governments across the UK will now be considering how to best deploy the vaccines and delivery operations must be tailored to meet the needs of this age group, while maintaining the routine vaccination schedule.”
Dr Brian Ferguson, Associate Professor of Immunology, University of Cambridge, said:
“In terms of risk/benefit analysis of the Pfizer vaccine given as two 10 mcg doses in children aged 5-11: The phase 2/3 trial data from this dose regimen reported an efficacy of >90% 5-to-11-year-old children (https://www.nejm.org/doi/full/10.1056/nejmoa2116298). In the same report the side effects were minimal and mostly mild. The main safety concern about this vaccine (BNT162b2) in young people has been myocarditis, reported to occur at a low level, mainly in young men and mainly following the second dose. This side effect has been tightly monitored in the USA during the vaccine rollout in 5-11 yer-olds. The CDC reported 12 incidents of myocarditis out of 8,674,378 doses of vaccine administered in Nov –Dec, 2021, a much lower rate of this side effect than reported for teenagers. All 12 of these cases were not severe and the individuals were all discharged from hospital. This vaccine therefore appears extremely safe in this age group, both from the clinical trials and from the real-world data from the rollout in the USA. At the same time the benefits of vaccination to the individual are multiple, including protection from severe disease, future variants and long covid, and to help reduce disruption to education. The protection from future variants is important, as is acknowledged by JCVI, since many children have now experienced Covid in primary schools this winter. We know that vaccination on top of prior infection generates an increased breadth of neutralising antibodies, which will very likely help to protect from future variants, should they arise and circulate in the UK. Giving parents the choice to vaccinate their child with this safe, effective vaccine is reasonable and many will be left wondering why it has not happened sooner.”
Dr James Doidge, Senior Statistician, Intensive Care National Audit & Research Centre (ICNARC); and Honorary Associate Professor, London School of Hygiene and Tropical Medicine, said:
“The evidence and modelling underpinning this advice from JCVI warrants scrutiny, especially because “it is estimated that over 85% of all children aged 5 to 11 will have had prior SARS-CoV-2 infection by the end of January 2022”. It is likely that UK children aged 5-11 are the first population anywhere in the world to be offered COVID-19 vaccination after attaining this level of prior infection. So what assumptions do the models make about this? Table 2 reveals that prior infection has been assumed to provide only 50-70% protection against “disease outcomes” (the disease outcomes specified are hospitalisation and ICU admission, presumably because the number of deaths caused by COVID-19 in children aged 5-11 are too low to model). Anyone following the research on infection-acquired immunity would immediately point out that this seems very low for protection against severe illness. As with the COVID-19 vaccines, the protection that prior infection provides against severe illness is much greater than the protection provided against symptomatic disease. Following the trail of footnotes reveals that, yes, the estimates relied on by JCVI are not for protection against severe illness but are in fact for protection against symptomatic disease with Omicron, and not for protection against severe disease [1]. With the exception of one discredited study [2], the level of protection provided by prior infection against severe disease has been universally estimated to be much closer to 100% [3,4,5] and to last for “several years” [3] and the emerging data from the Omicron wave indicates that this has changed little [6].
“The JCVI acknowledge that “should prior infection provide a high level of immunity against future severe COVID-19, the benefits from vaccination would be smaller, and vice versa.” Even in their worst-case scenario, the JCVI have assumed a level of protection afforded by prior infection against severe disease that is considerably lower than the available data suggests, which means that they have overestimated the benefits of vaccination. If the true level of protection provided by prior infection against severe disease were only 95%, then then JCVI would have overestimated the benefits for children with prior infection by a factor of 6x-10x. If the true level of protection provided by prior infection were 99%, then they will have overestimated by the benefits by 30x-50x. Even with large source of bias built in, the estimated benefits were small and “highly uncertain”, with 340,000 to 1.9 million doses required to prevent one ICU admission.
“Another revealing part of the modelling is the impact on schooling, which JCVI describe as “indeterminate”. A closer look at Figure 2 reveals that this “indeterminate” scenario is one assuming a “high incidence” and that the 5-day isolation rule is maintained. Even in this worst-case scenario, vaccinated pupils were estimated to require marginally more time off than their unvaccinated counterparts, because “in the United States… 8 to 10% of persons reported at least one day absent from school following vaccination”. From this we can confidently conclude that if the 5-day isolation rule is removed, as is intended to happen, then vaccination is likely to cause more days off school than it prevents.
“In summary, it is reasonable to expect vaccination to boost the immunity of people with prior infection, and so to offer some additional protection. The question is whether that additional protection outweighs the additional risks? The evidence provided by JCVI indicates a very poor job in weighing these risks in a population of children with low baseline risk and high levels of infection-acquired immunity.”
[1] https://doi.org/10.1101/2021.12.14.21267615
[2] https://brownstone.org/articles/a-review-and-autopsy-of-two-covid-immunity-studies/
[3] https://www.medrxiv.org/content/10.1101/2021.09.13.21263487
[4] https://www.medrxiv.org/content/10.1101/2021.08.24.21262415
[5] https://www.nejm.org/doi/full/10.1056/NEJMc2108120
[6] https://www.medrxiv.org/content/10.1101/2022.01.05.22268782v1 (follow-up to [5])
Dr Liz Whittaker, Senior Clinical Lecturer in Paediatric Infectious Diseases and Immunology, Imperial College London, said:
“I am glad to see this decision from JCVI, I think it is the right decision. I know that many have been impatient to get to this point, but as a parent and a paediatrician I am pleased that the JCVI has followed an evidence based approach rather than being swayed by public and other pressures. It is clear that they review the data regularly, only recommending vaccination once the benefits outweigh the risks. I hope this gives confidence to parents about all vaccines offered to our children and young people.”
Dr David Elliman, Consultant Paediatrician, Great Ormond Street Hospital, said:
“The JCVI has now released their recommendation and the reasons behind it. It is clear that the decision was a difficult one. Serious side effects of the vaccine are rare in this age group, although 10% of children have one or two days off school following vaccination. COVID-19 disease in children without underlying conditions is usually very mild, but if a child is known to be affected, the time they have to take off school is disruptive to their education and may cause problems with child care. JCVI acknowledges that vaccination of this age group is unlikely to have an effect on the current wave of Omicron infection. The benefits apply predominantly to any future waves of COVID-19. If there are future waves, but they are very mild the benefits are likely to be small, whereas, if a severe variant arises, there could be significant benefits.
“Importantly, any programme of COVID-19 vaccination, must not interfere with the routine childhood vaccination programme, where the benefit is clearer.”
(Comment from JCVI member; not a third-party comment) Prof Adam Finn, Professor of Paediatrics, University of Bristol, said:
“The JCVI recommendations published today set out in detail the information that underlines the non-urgent offer of COVID vaccination for healthy 5-11 year old children in the UK. The risks posed by COVID in this age group are low but they exist and parents may wish to reduce them by having their children immunised. The programme will not impact significantly on the current omicron wave in children but may reduce the risks children may face in a possible future wave of this or another variant. Common side effects such as fever, headaches and malaise do occur in some children following this vaccine but do not last more than a day or two in most cases. Nevertheless, they may result in some school absence. More serious side effects are reported in this age group but are extremely rare and are minimised by using a lower vaccine dose than in adults and a wide 12 week interval between the two doses. It will be important that the deployment of this part of the COVID vaccine programme does not result in children failing to receive doses of other important vaccines, for example against meningitis, cervical cancer and measles, in a timely way.”
(Comment from JCVI member; not a third-party comment) Prof Matt Keeling, Professor of Populations and Disease, University of Warwick, said:
“It’s great to see this statement made public, and I’m sure it will be a substantial relief to many parents. We now have a very good understanding of the risks from the mRNA vaccines, and therefore know that the risks to this age group – who receive a smaller dose – are minimal. However, given that Omicron is now in decline and many children will already be protected through infection the short-term benefits are also likely to be small – see https://www.medrxiv.org/content/10.1101/2022.02.04.22270361v1 for a detailed projection of potential benefits of vaccinating 5-11 year olds. COVID-19 remains primarily a disease of the elderly and vulnerable, therefore while the offer to vaccinate 5-11 year olds will be welcomed by many we should not expect it to have a large impact on the overall level of severe disease.
“The decision by JCVI therefore had to weigh the potential longer-term benefits of vaccinating 5-11 year olds – generating additional immunity against future variants – against the potential disruptions that a new vaccination program could have on other immunisations and on the educational system in general. The logistical problems of offering an additional vaccine to 5-11 year olds is considerable. It has recently been revealed that uptake of the MMR vaccine has dropped, and to young children measles is generally far more harmful than COVD-19 – so it is important that vaccination against COVID is not prioritised over other existing programmes.”
Declared interests
Dr Brian Ferguson: “I don’t have any interests to declare.”
Prof Adam Finn: “AF is a member of JCVI and also does vaccine policy advisory work for WHO. He is chief investigator of the Valneva and Sanofi COVID vaccine development programmes in the UK and investigator in other COVID vaccine trials and trials of other non-COVID vaccines. He leads research projects on vaccine preventable disease epidemiology funded by Pfizer. He receives no personal remuneration for any of this work and his sole source of income is his salary from the University of Bristol.”
Prof Matt Keeling: “Note that I’m a member of SPI-M and JCVI – but I’m speaking here in a personal capacity.”
None others received.