It seems clear, from the statement, and in particular the line “The primary aim of the vaccination programme has always been to prevent hospitalisations and deaths…”, that the JCVI had been instructed ONLY to take into account the impact of vaccinating children and young people on hospitalisations and deaths.

Knowing how JCVI, and the people on the committee, work, I am sure that they know that the impact of Covid-19 on children and young people amounts to far more than just hospitalisations and deaths.  Children also stand to benefit directly from:

- Ending the pandemic and inevitable restrictions sooner;

- Avoiding the harms relating to the secondary cases (people infected by the children), especially if teachers, parents or carers are infected;

- Reducing the effects of Covid-19 (directly or through self-isolation etc) on loss of school;

- And, crucially, given the growing evidence of its severity and frequency, by preventing the long term consequences on the children and adolescents of “Long Covid”.  As Dr Tom Frieden in the USA tweeted: “The most certain way not to get long Covid is not to get Covid. The most certain way to not get Covid is to get vaccinated.”

It would appear that none of these issues have been considered in this guidance; and I strongly suspect that it because the government told them not to consider them.

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The Joint Committee on Vaccines and Immunisation (JCVI) has deliberated on an extremely complex issue and we are grateful for their expertise and the many hours that members of the committee have given to these difficult questions.  

We are very pleased that the Government has now accepted the advice of this expert group (which contains a number of paediatricians) – advice which was made available to Government some weeks ago.  

The JCVI advice reiterates what the evidence tells us – that most children are at minimal risk of being made seriously ill by COVID.  Having looked at the available national and international data, the Committee has weighed in the balance the benefit to children over 12 of being vaccinated, against the very small but important risk of potential side effects from the vaccine.  They have decided that for children who are otherwise healthy, the risk is not outweighed by the benefit.  

The Committee has, however, specified that some specific groups of children and young people aged 12 and over are at increased risk of hospitalisation from COVID and have recommended that these children be offered the Pfizer BioNTech vaccine, the only vaccine authorised by the MHRA for 12-17 year olds in the UK. Clarity and more detail about who exactly will be included in these groups is required as a matter of urgency both for families and also for paediatricians and primary care professionals who will inevitably be asked for advice from patients and their parents or carers.

The JCVI has also noted that some children and young people, although not in these at-risk groups, may wish to have the vaccine in order to protect household members who are immune-suppressed.  Provided they have proper information to make a decision, we believe children’s wishes to protect those with whom they live, should be listened to and respected.

It is extremely important that as many adults as possible are vaccinated and it is good to see the addition to the vaccination programme of those who will turn 18 in the next three months.  

Government and the NHS must move quickly to ensure that much needed guidance, information and resources are made available to professionals, patients, parents or carers, so that there is informed implementation of this next stage of the vaccination programme.

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We know that healthy young people have minimal risk of suffering severe health effects from COVID-19 infection.  The decision whether to provide COVID vaccines to young people under 18 is extremely complex with many health and social factors coming into play.  The JCVI comprises experts with many years of experience in these areas who will have carefully scrutinised the available data to assess the benefits and risks of different courses of action on the young people concerned.

They have concluded that young people aged 12-15 who have conditions that put them at high risk of complications from catching SARS-CoV-2 or those aged 12-17 who live with individuals who are immunosuppressed should be offered the Pfizer/BioNTech vaccine.  We know that these two groups of young people have been some of the most negatively impacted by the pandemic, particularly regarding concerns of the potentially severe health repercussions that catching the virus could entail.  The analysis carried out by the JCVI concluded that it was beneficial overall to provide these young people with added protection against infection via vaccination and this seems like a sensible course of action.

Similarly, the move to enable young people who are within 3 months of their 18th birthday to start their vaccine course seems a pragmatic one.  We know that lots of this cohort are due to leave home to attend university in September where they will mix with lots of new people and so it is a sensible precaution to provide them with maximum protection against COVID-19.

Many countries around the world are facing similar decisions on whether to vaccinate children and young people against COVID.  As the JCVI indicate, new data is emerging all the time around COVID vaccines so it’s important that this advice on young people and COVID vaccination is kept under review as more information becomes available.

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The guidance sets out a risk-benefit approach which is particularly important to consider given the lower risks of severe outcomes in children.  These risks are presented in the guidance as rates per population.  However it is important to note that these rates are appropriate to the context of the waves that have occurred to date.  If infections increase to the levels projected by modelling over the next 4 weeks, these rates will be increased significantly.  For example, at the peak of the winter wave there were approximately 60,000 cases per day.  If these levels double – as is projected – then this risk is doubled.  If it rises substantially more than this – as is plausible – then the risk increases further.  It is therefore important that this context is taken into account when considering the risk-benefit balance at an individual level.  The indirect effects that vaccines have in reducing exposure at a population level – and hence risk to an individual – should also be incorporated as is standard practice for other vaccine introductions.

The JCVI decision not to vaccinate teenagers in the UK has considered a range of evidence and of course a risk/benefit analysis to this age group.  In the document outlining the basis for this decision the amount of risk to children of this age from COVID19 is considered to be low, as is their contribution to community transmission.  On the other hand, the risk of myocarditis/pericarditis following vaccination with the Pfizer BNT162b2 vaccine is presented as relatively high.

Although it appears as a balanced report, the JCVI’s analysis is dismissive of the threats to children of severe disease, death and long-term COVD19 sequelae.  There are currently up to 30 children being admitted to hospital in the UK every day with severe COVID (see https://www.england.nhs.uk/statistics/statistical-work-areas/covid-19-hospital-activity/), it is likely that a small number of these children will die, as in previous waves.  In the USA more than 9 million teenagers are vaccinated with BNT162b2 with no vaccine attributable deaths reported and very low levels of severe side effects.  The impact of ‘long COVID’ in children is hard to currently quantify, but with high numbers of children now being hospitalised with the disease, many may suffer with long-term effects of this infection.  There may well be additional benefits to the mental health of teenagers, many of whom who want to be vaccinated to help them feel safer and more comfortable in social situations, with family, and at school.  Notwithstanding the benefits to the individual afforded by vaccination, there are additional societal benefits to vaccinating teenagers, including the possibility to keep more secondary schools open and fully functional this winter and in potentially reducing overall spread of the delta variant in the UK.  Overall, it is a gamble to delay vaccinating teenagers in the UK, and one that might not pay off well.

Vaccination of children is always a highly emotive issue; we all want to do our best to protect the next generation.  For the on-going COVID pandemic the question of whether or not to vaccinate the majority of 12-17 year olds is a complex balance between risks and benefits.  In this report JCVI has sought to balance the relatively low potential risks from the vaccine (in terms of the heart conditions, myocarditis and pericarditis) against the relatively low level of severe illness from COVID in healthy individuals within this age-group.  Balancing two sets of small, and therefore difficult to estimate numbers, is problematic.

There are some groups where the advantages of vaccination are clear, and here JCVI’s advice is in overwhelmingly favour of vaccination.  This includes:

- young people with underlying health conditions which means that they are more at risk of severe illness if they get infected with the SARS-CoV-2 virus; as such this is an extension of the scheme already in practise for vulnerable individuals age 16-17.

- young people living with an extremely vulnerable person, where the risks of them passing the infection to another member of their household could have serious consequences.

- and those about to turn 18 should also be offered the vaccine, to protect them as they enter the wider population or attend higher education.

For the remainder of the young people (aged 12-17) it was not felt that there was sufficient strength of evidence for vaccination to be recommended in terms of the health of those concerned.

Many questions still remain, and the document does an excellent job to spell these out in some detail.

We still don’t have a quantitative understanding of PIMS-TS in children, although current evidence would suggest it is rare; high levels of PIMS-TS would tip the balance in favour of vaccination.  A similar argument could be made about long-COVID, but again current studies indicate that long-COVID is relatively uncommon in children.  We could decide to vaccinate children in order to protect the rest of society, but this raises a range of ethical questions – and getting better vaccine uptake in those over 18 must be seen as a greater priority.

The document finishes with an open question, that is beyond the scope of JCVI and is essentially a question for society.  The COVID-19 outbreak has had a hugely detrimental impact on the education of all school-aged children.  Future educational impacts could be reduced by vaccination of those 12-18 year old, but it is unclear how this should be balanced against the (admittedly low and uncertain) risks of vaccination.

Given the lack of firm data, JCVI has been pragmatic — advising vaccination of those priority groups where it knows the vaccine will have a net positive benefit, but not mass vaccination in the face of considerable uncertainty.

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The decision to vaccinate children is complex and controversial.  This approach recommended by the JCVI is trying to address where vaccination is most likely to be of direct benefit to the child and to those around them.  For many patients with immunodeficiency or those on immunosuppression, who are less likely to respond to vaccination and have school age children or grandchildren, this will be welcome guidance.

JCVI have not addressed the wider benefit to society of vaccinating children to try and reduce infection rates and infection spread through the population.  It is likely that they felt the risks of wide spread vaccination outweighed the benefits in this case.

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The JCVI has recently recommended that only children at risk of severe disease or living with someone that is immunosuppressed should be offered the COVID-19 vaccine at present.  It is clear that prioritizing vaccination of children that are at risk of severe COVID-19 illness is critically important, however, the JCVI recommendation ignores the prevalence of long-term effects of COVID-19 illness in children.  According to ONS data, over 8% of children aged 12-16 that have been infected with COVID-19 have persistent symptoms for at least 12 weeks.  This prevalence increases with age, putting 17-18 year olds at even greater risk.  Long COVID is a debilitating illness that could have long term impacts on the health and wellbeing of children.  Recent clinical trial data showed high efficacy and low risks of adverse events following vaccination of 12-17 year olds with the Pfizer vaccine.  Thus, withholding the vaccine from 12-17 year olds puts many children at risk of long term disease, especially given the high rate of delta variant transmission in the UK and the current lifting of all restrictions.  The JCVI said that “until more safety data is available and has been evaluated, a precautionary approach is preferred.”  A precautionary approach is indeed preferred, but it should be guided by the best available data, which suggest that, at present, the risks of developing Long COVID in children are far greater than the risks of COVID-19 vaccination.

I am extremely disappointed by the decision of JCVI to not allow routine vaccinations in teenagers.  It is notable that the statement clearly states that the purpose of vaccinations is to prevent hospitalisations and deaths, rather than to interrupt transmission, which means that they appear untroubled by SARS-CoV2 infection in the under 18s.  It is great to hear that vulnerable teenagers will get the vaccine, as will children living with vulnerable adults, but in my view this doesn’t go anywhere near far enough.  It is also stated that JCVI consider the incidence of long COVID symptoms amongst children to be a minor issue compared to adults and that real world data on vaccine safety in children is lacking.

As stated in recent joint letters to the Lancet and BMJ, I am fundamentally against the widespread levels of infection that we are now seemingly tolerating as a result of government policy.  This applies very much to teens, and potentially younger children as well for the following reasons in my view:

1. Whilst it is obviously correct that children are far less likely to get seriously unwell and be hospitalised with COVID, this risk is nowhere near zero, and now that the majority of infections are in young people this may change.  Notably, something like 8-10% of hospital admissions on the JCVI dashboard are in under 18s.  A small percentage of a very large number is still a large number.

2. I am interested to know what data was used to calculate the risk of long COVID in children as most studies I have seen point to a rate just under that of adults.  Whilst there is clearly difficulty in defining the precise clinical composition of long COVID in both age groups, a lack of classification does not detract from the fact that this is, indeed, a very stark and harsh reality for a worrying number of families.  If cases continue to rise and are unabated, this will rise again.  The best way to tackle long COVID is surely to prevent the short version?  Charities such as #LongCovidKids should have been involved in these discussions.

3. The focus on preventing deaths and admissions rather than cases is a clear steer that JCVI do not consider attaining protective levels of population immunity via vaccination to be a priority.  By instead exposing children to natural infection, we do not only risk the associated danger, but we know the ensuing immunity is poor by comparison to vaccines, especially regarding VOCs.  Protective population levels of immunity alongside sensible precautions could indeed drastically limit community transmission in the future, but this alongside the relaxation of all restrictions today shows us this is now not the plan.  I despair for the clinically vulnerable who now must shield, again, and also for vulnerable parents who now may not be able to interact with their healthy children as a result of this decision.

4. Finally, I do not understand how safety concerns outweigh benefit.  The MHRA and other agencies have approved RNA vaccines for use in adolescents, but, critically, there is now ample real world date – millions of children – in the USA, Israel and elsewhere that have received these vaccines.  Of course we must consider the possibility of myocarditis etc., but both the danger and incidence of this appears extremely low.

5. Lastly, it would take just 6-7 million doses of vaccine, so about a fortnight to protect adolescents and ensure that the autumn did not get affected by school disruption.  This small number of doses will not deprive COVAX of anywhere near the number of doses required for e.g. a booster programme, and may also lessen the need for vulnerable groups to receive them the further towards population immunity we reach.

I genuinely hope that by keeping this under review we will see a reversal and ensure that children and their families can make a safer return to school in September.  Something we all want.

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The JCVI statement makes 3 changes to the current situation outlined in the green book:

1) Children and young people 12 and over who are household contacts of immunosuppressed people can received 2 doses of Pfizer vaccine.

2) Children and young people 12 and over who have Down’s syndrome, conditions resulting in immunosuppression, those with severe, profound or multiple learning disabilities or who are on the learning disability register.  There is no definition yet of the categories of immunosuppression to be included.  Without further specific clarification of what “conditions resulting in immunosuppression” means there will be confusion in both the clinical community and public.

3) Children and young people 12 and over with specific health conditions that puts them at risk of serious COVID-19 can be offered vaccine.

At this time, the JCVI statement explains that unspecified Government advisors are reviewing the evidence around specifically which children are at most risk of serious COVID-19.  Given what we know about COVID-19 in children, and the very few definitive risk factors for serious COVID-19 (even in children with some conditions considered at risk for other infections), the number of children to be offered vaccine is likely to be very small.

It will be very important for the Government, with other stakeholders including the NHS, the Royal College of Paediatrics and Child Health and the Royal College of General Practitioners, to provide absolute clarity on which children are to receive COVID-19 vaccine at this time.  For example, if children with the most severe asthma are to be included then it is critical that the degree of asthma treatment required as a marker of severity is also set out (and so on for all conditions).  Likewise a specific definition of what “conditions resulting in immunosuppression” actually means in practice needs to be provided.

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Offering a COVID vaccine to children based on their own vulnerability or that of someone they live with sounds like a sensible middle ground, especially given that COVID in the vast majority of children will be mild and also vaccine uptake in older people has been good.

I confess to being a tad confused by the JCVI recommendations, as the broad range of underlying conditions which increase risk for severe outcomes from COVID, and for which vaccination is recommended for 16-18 year olds, seem to have been omitted from the list of conditions for which vaccination of 12-15 year olds are recommended.  No clear explanation is given for this and as a consequence one might imagine lengthy discussions in GP surgeries between parents of children with brittle diabetes and renal disease and their GP advisor.  Perhaps JCVI might consider a fuller – preferably completely referenced – document for use by the folks at the sharp end of patient care.  The JCVI has emphasized hospitalisation and death as benefits overlooking the, apparently less serious but potentially significantly disabling, potential for post covid syndrome which, as the disease is now more prevalent in the young, may soon affect almost as many covid affected children as adults.  Given the impact on ability to concentrate associated with this illness the relative impact on schooling might be greater than days lost only to the acute illness.  JCVI has stated that it may revise these recommendations in future. It is interesting to note the (completely referenced) recommendations of the US Advisory Committee on Immunisation Practices published in the MMWR last week which recommended continued universal vaccination of 12-15 year olds, based on the same considerations.  I don’t myself follow why there is a positive risk benefit position for this age group in the US but a negative one in the UK, particularly as the US has been vaccinating 12-15 year olds for some time now and are therefore in a better position to have directly observed experience.

This report, which was leaked, should not come as much of a surprise.  The advice to immunise particularly vulnerable children is obvious but as the report indicates the advantages versus disadvantages for otherwise health teenagers is much more in balance.  As indicated in the report whether or not children should be offered vaccine has to rest on whether or not the vaccine provides benefit to those children being vaccinated (i.e. does giving the vaccine to a child make it less or more likely that that child suffers a health problem).  The decision about giving vaccine to children should not be made on whether or not it protects others in society.

One issue that was not included in this report is the issue of how many children have already recovered from infection and so already have a degree of immunity.  This is difficult to judge for most children but for the 16 and 17 year olds the ONS antibody survey produces estimates of the proportion of people in those age groups that are positive and so have already recovered from COVID and will have some degree of immunity.  Looking at the most recent report which covers the period up to the 20th June estimates of the daily proportion positive range from about 30% up to 90%.  So many children and possibly the majority will have some degree of immunity already.  Clearly this period was before the recent surge in infections and none of these will have had vaccine so protection rates will have increased.  At this stage of the pandemic it is essential that we have a better understanding of the prevalence of natural immunity in this age group when this decision is reassessed.  It would after all be inappropriate to immunise children with even a very small risk of adverse reactions if many are already immune.

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This is a worrying decision at a time when we are now relying on vaccination and personal responsibility, as opposed to mandated restrictions, to get us through the pandemic.  It runs contrary to vaccine programme in the US where the CDC recommends everyone 12 years and older to get vaccinated and the FDA have approved the vaccine as safe in this age group.  This acknowledges that while infected children mostly get mild symptoms, COVID-19 causes more deaths and hospitalisations in children compared to other viral diseases which have been deemed severe enough to warrant vaccination e.g. flu.  Vaccinating children will also protect them from developing long covid as well as help stem the spread of the virus in the population and thus the further generation of variants.  It is estimated that more than 8 million children over 12 have now been vaccinated in the US.  Around half of EU countries have also started to vaccinate the under 18s as have Singapore, Japan, Israel, China, Canada and the Philippines.  In the current situation where we in England are allowing mass infection and therefore depending on the development of herd immunity, this is a disturbing  approach that will only add more ‘fuel to the flame’ of rising infections, hospitalisations and long-term health problems.

The primary aim of the vaccination programme has always been to prevent hospitalisations and deaths.  Based on the fact that previously well children, if they do get COVID-19, are likely to have a very mild form of the disease, the health benefits of vaccinating them are small.

The benefits of reducing transmission to the wider population from children are also highly uncertain, especially as vaccine uptake is very high in older people who are at highest risk from serious COVID-19 infection.

We will keep this advice under review as more safety and effectiveness information becomes available.

Operationally, it is considered reasonable to allow a lead-in time to offer vaccination to children who are within 3 months of their 18th birthday to ensure good uptake in newly turned 18-year-olds.

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To recommend a vaccine for any population group there needs to be careful weighing up of the risks of the disease and benefits and risks of vaccinating.  Healthy young people and children, become seriously ill with COVID-19 extremely rarely, so there would be few direct benefits for them of vaccination but it would contribute to increasing population immunity.  There may be a stronger case for vaccinating those with existing serious health conditions.  Before recommending vaccination for all children and young people we therefore need to be very clear about of the safety of the vaccines in this group.  Although there is now good trial data and experience of vaccinating very large numbers of adults and the vaccines have been shown to be safe, we cannot automatically assume this applies to children.  More information is needed from trials and experience of using these vaccines in young people and children before the programme is rolled out further.

It is important to distinguish between MHRA regulatory approval (including emergency approval) and public health policy.  MHRA is responsible for assessing the safety and efficacy of the vaccines on the basis of the evidence submitted – including in children.  The Government is responsible for policy.

SARS-CoV-2 infects people of all ages, so it important to study systematically the safety and efficacy of vaccines across all age groups.  The standard approach in drug development is to conduct a paediatric program (following an approved paediatric investigation plan) once safety and efficacy have been established in adults.  Indeed following marketing authorisation in adults, a regulatory waiver (or deferral) is required to gain exemption from conducting such follow-on studies in children.  The development plan typically progresses through different age categories in a careful, stepwise manner, beginning with juveniles.  This approach is encouraged by the regulators to ensure that children are not excluded from realising the potential benefits from new drugs.

There is considerable debate around the benefits to children, versus the wider benefits to adults, of vaccinating children.  In this respect the risk risk/benefit in children needs to be quantified.  Conducting well-controlled studies in children provides the data that informs this debate and provides public health policy options, once and if regulatory approval results.  Undoubtedly some children will be more vulnerable than others to the effects of infection, so it is important to have experimental data to inform individual decision making and to provide options – recognising that vaccination is voluntary, not mandatory.

Fewer data are available on children and children have been shown to be less vulnerable to severe disease.  In this respect efficacy is predominately based on the immune response recorded in clinical trials, with the assumption that the immune response translates into clinical efficacy, as it does in adults.  This is a reasonable assumption.  Safety data generated from children is then evaluated in the context of the wider safety data available on the vaccine.  Standard pharmacovigilance processes will monitor the safety of any roll-out of vaccines in children, as has been the case in adults, and any safety signals will be promptly investigated.

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