Should the UK vaccinate children and adolescents against covid-19?
BMJ 2021; 374 doi: https://doi.org/10.1136/bmj.n1866 (Published 23 July 2021) Cite this as: BMJ 2021;374:n1866Read our latest coverage of the coronavirus pandemic
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Dear Editor
It is to be hoped, for the sake of our children that the MHRA before approving the Pfizer-BioNTech’s covid-19 vaccine for use in children aged over 12 years have honoured the undertaking they gave following the swine flu pandemic
“In preparation for any future pandemic we will ensure that mechanisms are developed to obtain real-time data on age and risk group-stratified vaccine uptake within the UK. Such data are a critical element to the “observed versus expected” analyses. They were not readily available in a timely manner during the pandemic and, had a serious safety issue emerged, the MHRA may not have been in a position fully to assess the risk this posed. Fortunately this was not an issue on this occasion.”(1)
A serious safety issue did emerge with a significant number of children and young people developing narcolepsy and cataplexy following administration of the Pandemrix vaccine. The fact that the MHRA recognised that they might not have been in a position to fully assess a risk had a serious safety issue emerged during the vaccination campaign must be deeply upsetting to the victims and their families. It is disingenuous for the MHRA in a somewhat celebratory note to conclude that the failing “was not an issue” during the swine flu vaccination campaign when so many children and young people suffered lasting disabilities, something that was only detected far too late in the day.
Can the MHRA reassure us that lessons have been learned, changes have been implemented and were something similar to occur today, it would be quickly detected and remedial action taken immediately?
The decision to “speed up” the use of swine flu vaccines by including children was said to have been taken following an assessment of the risks and benefits with material from an NHS website stating that most experts “would” agree that the benefits of vaccinating children for swine flu outweighed the “very small risk of narcolepsy”
“A decision was taken to speed up use of the vaccine and, as always, this was a judgement that carefully weighed up the risks and the benefits. Most experts would agree that the benefits of vaccinating children against H1N1 swine flu outweighed the very small risk of narcolepsy.”(2)
Since the MHRA admitted that they may not have been in a position to fully assess the risk a vaccine induced "serious safety issue" might pose during the swine flu pandemic, how could anyone accurately quantify the risk and conclude that the benefits of vaccinating children with swine flu vaccine outweighed the “very small” risk of narcolepsy?.
With hindsight some might still argue that statistically the benefits far outweighed the risks for most of us but try telling that to those who suffer today and every day with narcolepsy and cataplexy because of Pandemrix vaccine.
Can we be confident in view of the Pandemrix fiasco and the seemingly endless stream of highly critical reports on the workings of the MHRA, (Cumberlege Report) that all the fancy rhetoric will be set aside and adverse reaction reports whether “observed” or “expected” will be taken very seriously for what they are and acted upon immediately.
(1)
1 MHRA CONTRIBUTION TO THE H1N1 ... - GOV.UK
https://assets.publishing.service.gov.uk › file › me...
(2) https://www.nicswell.co.uk/health-news/swine-flu-jab-narcolepsy-risk-is-...
“Content supplied by the NHS website nhs.uk
Competing interests: No competing interests
Dear Editor
Britain is a (wise) outlier when it comes to the issue of vaccination for children and teenagers; the plan to offer jabs only to vulnerable 12 to 15-year-olds and those about to turn 18 harmonizes with known data. Let’s explore the issue (COVID in children), the available data, and most importantly a risk-benefit analysis of whether mass vaccination of all children is indicated.
As of July 1, 2021, ~4 million children in the United States have tested positive for COVID-19. (1) Only ~1% of those resulted in hospitalization (0.1 - .05 x that for adults) and 70% of those children hospitalized had underlying comorbidities such as obesity (2). The case fatality rate in this group is also extremely low (0 - 0.03%, 0.01 x that for the elderly) (1).
Next consider the risks associated with mass vaccination, which potentially includes ~75 million children in the US alone. In the absence of long-term safety data, there is a potential for harm - both from known side-effects as well as potential unknown long-term consequences of COVID-19 vaccines. Myocarditis and pericarditis have been reported in over 1000 children and young adults, with a potential link to the vaccine (3), and the US FDA has issued a warning for the same (4). Europe's drug regulator has also found a possible link between heart inflammation and mRNA COVID-19 vaccines (5). There is no published data to suggest that the vaccine has caused myocarditis/pericarditis in older adults. Even if these reactions are rare, the absolute number of (healthy) children affected with this and other unknown side-effects could potentially outnumber complications of COVID-19 infection itself.
There is another important point to consider. Are there unintended consequences related to differences between vaccine-induced and infection-induced immunity? There is a possibility that antibody responses due to mRNA vaccines against SARS-CoV-2 might be similar to that of natural infection, but it is also possible (and arguably more likely) that vaccine-related resistance will lead to less protection than that induced by infection; the CD8 T cell responses generated by vaccination could be less broadly protective against future variants (6). As the risks of serious consequences from infection decrease, the benefits from infection may increase. Adults clearly should be vaccinated, but this balance may change for children.
Proponents of covid-19 vaccine in children argue that children can transmit viruses to vulnerable older adults. Data to back this argument do not exist. Also, the Covid vaccination rates for elderly in the United States (and in western countries) is relatively high (~85 % have received one shot and 75% have received 2 shots). This should provide adequate protection from from severe Covid-related complications (7).
We must vaccinate the global vulnerable population (older individuals with risk factors and children with co-morbidities). However, utmost caution should be applied before embarking on any public policy suggesting/mandating mass immunization of healthy children. Informed consent should also be “truly informed” for those parents who wish to have their children vaccinated (8), and we must use our wisdom; the marginal benefits of mass vaccination should be considered in the larger overall contexts both of available resources and of potential harm (9).
1. American Academy of Pediatrics. Children and COVID-19: state-level data report. Updated 7/1/2021
https://services.aap.org/en/pages/2019-novel-coronavirus-covid-19-infect...
2. Hospitalization of Adolescents Aged 12–17 Years with Laboratory-Confirmed COVID-19 — COVID-NET, 14 States, March 1, 2020–April 24, 2021 | MMWR (cdc.gov)
3. Myocarditis and Pericarditis Following mRNA COVID-19 Vaccination. https://www.cdc.gov/coronavirus/2019-ncov/vaccines/safety/myocarditis.html
4. https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19...
5. https://www.reuters.com/business/healthcare-pharmaceuticals/eu-regulator...
6. Ivanova EN et al. Discrete immune response signature to SARS-CoV-2 mRNA vaccination versus infection.
7. https://covid.cdc.gov/covid-data-tracker/#vaccinations
8. Emanuel EJ, Boyle CW. Assessment of Length and Readability of Informed Consent Documents for COVID-19 Vaccine Trials. JAMA Netw Open 2021
9. Think Twice Before Giving the COVID Vax to Healthy Kids | MedPage Today
Competing interests: No competing interests
Dear Editor
If we are calculating net benefit to vulnerable people [1] we have come a long way perhaps from basic medical principles [2] and I wonder moreover whether these risks will be made clear to the parents of the children and the children themselves [3]. Is there even sufficient knowledge at the moment to be able to offer members of the public a rational choice? And if it goes wrong for individuals will the JCVI accept responsibility?
Indeed, supposing we are undergoing a revolution in human values [4] I am not sure it is for the better.
[1] Sonia Saxena, Helen Skirrow, Kate Wighton, ‘Should the UK vaccinate children and adolescents against covid-19?’, BMJ 2021; 374 doi: https://doi.org/10.1136/bmj.n1866 (Published 23 July 2021)
[2] John Stone, ‘Re: Covid-19: Vulnerable children aged 12-15 will be offered Pfizer vaccine, UK announces’, 21 July 2021, https://www.bmj.com/content/374/bmj.n1841/rr-1
[3] Noel Thomas, ‘Re: Covid-19: Vulnerable children aged 12-15 will be offered Pfizer vaccine, UK announces’ 21 July 2021, https://www.bmj.com/content/374/bmj.n1841/rr-2
[4] Peter Lloyd-Sherlock,Martin McKee, Leon Geffen, ‘Re: Should the UK vaccinate children and adolescents against covid-19?’, 25 July 2021, https://www.bmj.com/content/374/bmj.n1866/rr
Competing interests: AgeofAutism.com, an on-line daily journal, concerns itself with the potential environmental sources for the proliferation of autism, neurological impairment, immune dysfunction and chronic disease. I receive no payment as UK Editor. I also moderate comments for the on-line journal ‘The Defender’ for which I am paid. I am also a member of the UK Medical Freedom Alliance
Dear Editor,
The authors of this paper invite adolescents to be involved in decision making and indeed that is a very appropriate plan. However, it is vital that they are also furnished with full information on which to base their opinions.
Statements such as 'Regulatory agencies globally say vaccine benefits outweigh infection risks' is making a huge assumption. Of note, our own MHRA said exactly that, but did so without referring to any data beyond that supplied by Pfizer from their trials involving only 1131 vaccinated children [1]. The JCVI[2], looking also at real world data, have come to a very different conclusion.
The authors also state that 'A few vaccinated adolescents in the US and Israel have experienced heart inflammation'. In Israel 148 people developed myocarditis, the incidence within 30 days of the second dose of Pfizer rising to 1 in 41,731 but stating in the report that this was much more common in young men aged 16-25 where estimates of 1 in 6000 have been given[3]. Similarly, reports to the CDC[4] have suggested incidence several times higher than background rates. Of the 323 cases reported by the CDC for 16-29 year-olds, 9 were still in hospital with 2 in ICU. The longer term effects for the many who appear to have made a good recovery are not yet known. Several young people are known to have died of cardiac events within 7 days of vaccination. [5]
Given that the issue of safety is still unresolved within the medical community and with many as yet unanswered questions, would it really be right to ask adolescents to decide to take a vaccine for the benefit of older members of society? Vaccination, like mask-wearing, seems to have been linked to being a good citizen, to which of course we would normally wish young people to aspire. Peer pressure and the threat of vaccine passports as the route to a full adult life, both combine to seriously undermine the concept of fully informed consent, free of any inducement or coercion. Any communications with children and families must be truly open and honest. The RCPCH research charter would be an excellent starting point [6].
Dr Rosamond A K Jones (retired consultant paediatrician, member of Health Advisory & Recovery Team)
References:
1. https://assets.publishing.service.gov.uk/government/uploads/system/uploa...
2. https://www.gov.uk/government/publications/covid-19-vaccination-of-child...
3. https://www.jpost.com/health-science/covid-health-ministry-finds-some-my...
4. https://www.cdc.gov/vaccines/acip/meetings/downloads/slides-2021-06/03-C...
5.https://vaers.hhs.gov/data/datasets.html
6. https://www.rcpch.ac.uk/resources/research-charter-infants-childrens-you...
Competing interests: HART is a group of highly qualified UK doctors, scientists, economists, psychologists and other academic experts. We came together over shared concerns about policy and guidance recommendations relating to the COVID-19 pandemic. We continue to be concerned about the lack of open scientific debate in mainstream media and the worrying trend of censorship and harassment of those who question the narrative. Science without question is dogma.
This response was reposted at the request of the authors (Lloyd-Sherlock and colleagues) on 29 July 2021.
Dear Editor
Why UK government COVID-19 expert panels don’t understand older people’s health.
In response to the BMJ editorial on “Should the UK vaccinate children and adolescents against covid-19?”, we would like to develop the point that younger people’s concerns have not been understood by UK government advisory panels. It should not be assumed that these panels have been well-informed about the needs of other groups, including older people.
By the time the first cases of COVID-19 were being reported in the United Kingdom, it was already clear from other countries that deaths would be heavily concentrated among older people. It would therefore seem logical that people with expertise in geriatrics and gerontology would be brought into the government’s advisory structures. They were not.
Excluding people with relevant expertise mattered. John Edmunds, a modeller on SAGE, reflecting on the situation in care homes, commented that “I don’t think we had such good general situational awareness…. We were missing that” [1].
The absence of experts in older people’s health in government expert panels appears to reflect limited interest in this age group and has allowed some panel members to argue that avoiding COVID-19 deaths among older people should be a low policy priority. For example, in March 2020 Professor Robert Dingwall, of the UK government’s Joint Committee on Vaccination and Immunisation and of NERVTAG, wrote: “A wise person would, of course, prefer to die later rather than sooner, but they might also consider that some deaths are easier to bear than others… we should acknowledge that many frail old people might see Covid-19 infection as a relatively peaceful end compared with, say, several years of dementia or some cancers” [2]. He goes on to note that “pneumonia was described as ‘the old man’s friend’ in the days before antibiotics”. This may be true, but surely such views should be relegated to the history books?
The UK Prime Minister seemingly shared this view when he reportedly said “the people who are dying are essentially all over 80 and we can’t kill the economy just because of people dying over 80” [3]. His words justify concerns raised by the Director General of the World Health Organisation: “There is a disturbing narrative in some countries that it’s OK if older people die. It’s not OK… Those most at risk of severe disease and death from COVID-19, including health workers and older people, must come first. And they must come first everywhere” [4].
On 23 July 2021 Professor Dingwall announced he would no longer be needed to serve on any UK government COVID-19 scientific panels [6]. We urge the UK government to fill these vacancies with appropriate expertise, and urge advisers and policy-makers to renounce ageist mind-sets and the language of gerontocide.
Peter Lloyd-Sherlock, Martin McKee and Leon Geffen
References.
1 https://inews.co.uk/news/health/coronavirus-latest-sage-professor-care-h...
2 https://archive.is/2021.07.20-065902/https:/www.sciencemediacentre.org/e...
3 https://www.bbc.co.uk/news/uk-politics-57854811
4 https://twitter.com/DrTedros/status/1358084910569975810
5 https://twitter.com/rwjdingwall/status/1418591502561947651
Competing interests: No competing interests
What does informed consent entail for a 12 year-old?
Dear Editor
As we speed towards these products being recommended for children can we ascertain what the conditions for informed consent will be [1,2,3]?
Will parents and children (of presumed Gillick competence) be told for instance that the benefits for them may not outweigh the risks, that they may get inflammation of the heart which will be painful, possibly life changing and sometimes fatal? Will they be told that they are free to refuse without personal consequences?
[1] Jay Ilangaratne, ‘ Re: New guidance from the GMC: what constitutes meaningful dialogue?’, 3 November 2020, https://www.bmj.com/content/371/bmj.m3933/rr-8
[2] para.89 to 92 in Montgomery v Lanarkshire Health Board [2015], https://www.bailii.org/uk/cases/UKSC/2015/11.html
[3] John Stone , ‘ nformed Consent and the Government's Legal Position’, 16 November 2020, https://www.bmj.com/content/371/bmj.m3933/rr-14
Competing interests: AgeofAutism.com, an on-line daily journal, concerns itself with the potential environmental sources for the proliferation of autism, neurological impairment, immune dysfunction and chronic disease. I receive no payment as UK Editor. I also moderate comments for the on-line journal ‘The Defender’ for which I am paid. I am also a member of the UK Medical Freedom Alliance