Covid-19: Vulnerable children aged 12-15 will be offered Pfizer vaccine, UK announces
BMJ 2021; 374 doi: https://doi.org/10.1136/bmj.n1841 (Published 20 July 2021) Cite this as: BMJ 2021;374:n1841Read our latest coverage of the coronavirus pandemic
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Dear Editor
Dr English makes some interesting points, which appear to suggest childhood vaccination is a worthwhile option ?
If he has a grand child, and someone offered him a free bike for her, unused and of a new experimental design that has no medium or long term safety record, and the makers decline any compensation liability, would he accept the offer ? Or would he like time to consider ?
We need to remember that children beyond a certain age, not forgetting their parents, deserve the opportunity to help in deciding what is best for them, individually, based on an honest and comprehensive account of the risks and benefits that might accrue to any medical or surgical procedure.
That is, after all, the law of the land. (1).
To complicate matters further, we know next to nothing of medium nor long term side effects.
Dr English has been in favour of helping young people to decide what course to follow regarding (HPV) vaccination. (2).
Is such a confident, albeit well intentioned approach, ideal in present circumstances, when so many uncertainties prevail ?
1 https://www.supremecourt.uk/cases/docs/uksc-2013-0136-judgment.pdf
2 https://www.bmj.com/content/357/bmj.j2730/rr-0
Competing interests: No competing interests
Dear Editor
I read this with concern for those who are to be offered the product [1]. Only last year BMJ published an article about the seriousness of informed consent in a product with known risks [2]. Will we find children developing heart disease or even dying an acceptable collateral? We used to be told that vaccines were “safe and effective” or “the benefits far outweigh the risks” (a lottery for those who were in fact severely injured) but here we are apparently moving into territory where even net benefit is somewhat in the balance. There is no doubt about the government’s ability to play down the harms or vilify those who have doubts [3,4] and for this reason we need to be all the more careful.
[1] Elisabeth Mahase, ‘ Covid-19: Vulnerable children aged 12-15 will be offered Pfizer vaccine, UK announces’, BMJ 2021; 374 doi: https://doi.org/10.1136/bmj.n1841 (Published 20 July 2021)
[2] Peter Doshi, ‘WHO’s malaria vaccine study represents a “serious breach of international ethical standards”’, BMJ 2020; 368 doi: https://doi.org/10.1136/bmj.m734 (Published 26 February 2020)
[3] John Stone, ‘ Regarding the Use of the Term "Anti-Vaxxer", 27 August 2020, https://www.bmj.com/content/370/bmj.m3099/rr-5
[4] John Stone, ‘ Re: Social media has become the cancer of the society, destroying from within’, 23 February 2021, https://www.bmj.com/content/372/bmj.n272/rr-8
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
Britain has opted (wisely) against mass Covid vaccinations for all children and teenagers; plan to offer jabs to vulnerable 12 to 15-year-olds and those about to turn 18. Let’s explore the issue (COVID in children), available data, and most importantly the risk-benefit analysis, to conclude whether mass-vaccinations in children are indicated?
As of July 1, 2021, ~4 million children in the United States have been tested positive for COVID-19. (1) Only ~1% of those resulted in hospitalization (10-20 times less than in adults) and 70% of those children hospitalized had underlying comorbidities such as obesity (2). Case fatality rate in this group is also extremely low (0 - 0.03%; 100 times less than in elderly) (1).
Next we look at the risks associated with mass vaccinations which potentially include ~75 million children in the US alone. In the absence of long-term safety data, there is a potential for harm - both for known side effects as well as the long-term unknown and unintended consequences for children (given longer remaining lifespan) from COVID-19 vaccines. Besides local injection site reactions and systemic symptoms, the CDC has completed investigation of more serious side effects - myocarditis and pericarditis - now reported in over 1000 children and young adults and found a potential link (3); 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). Even if these reactions are rare, the absolute number of (healthy) children affected with this and other unknown side effects could potentially outnumber complications due to COVID-19 requiring hospitalizations.
Another important point to consider is possibility of unintended consequences related to differences in 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 CD8 T cell responses generated could be less-broadly protective against future variants (6).
Proponents of covid-19 vaccine in children argue that children transmit viruses to vulnerable older adults. Data to back this argument does not exists. More so, the Covid vaccination rates for elderly in the United States (and in western countries) is relatively very high (~85% has received one shot and 75% has received 2 shots) which should provide adequate protection from Covid infection and complications (7).
We must vaccinate our (and 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-COVID-immunization of healthy children. Informed consent should also be “truly informed” for those parents who wish to vaccinate their children (8), and we must use our wisdom; the marginal benefits of mass vaccination should be considered in the larger overall context of available resources and potential harm (9).
References:
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
From the JCVI statement, and in particular the line "The primary aim of the vaccination programme has always been to prevent hospitalisations and deaths…", it would appear 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 amount of time in school missed (directly or through self-isolation etc) as a consequence of Covid-19,
* Reducing the related harms from parents having to take time off work to care for children who do not attend school because they are "self-isolating";
* 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.
We need to see both JCVI's workings and the parameters they were giving for their considerations. Were they instructed by the government not to consider these issues?
Competing interests: Dr English is on the editorial board of Vaccines Today: an unpaid, voluntary, position.
Inviting the Adolescent aged 12-17 cohort for Covid-19 immunisation: The Need for some Patience.
Dear Editor
By reserving it for vulnerable children the UK is showing some restraint in rolling out Covid-19 vaccination in the adolescent group. (1) We can only approve of such prudence and fully agree with the previously published statements of Dominique Wilkinson et al. (2) In addition we have some more considerations in this discussion about study requirements and side effects, particularly still unknown long-term ones.
The Health Council of The Netherlands decided to start offering Covid-19 vaccine to vulnerable sections in the group 12-17 years (or vaccinating direct family/caregivers around if vaccination is contraindicated) remarkable swiftly after EMA’s (European Medicines Agency’s green light and the Minister of Health's advice of 9th June to do so. (3) On 29th June the RIVM (National Institute of Public Health and the Environment) decided to offer an mRNA vaccine to the complete age group. (4) Many countries such as Belgium, Denmark, Finland, Austria, Portugal only offer this to 16- and 17-year-olds. The Covid-19 pandemic emergency pushed the expeditiously developed vaccines unprecedently fast through several national approval processes. Priority was understandably given to the vulnerable in the population. The impact of Covid-19 on the health of young people was until recently not seen as a real issue and as a result they were left untouched in the immunisation strategy. Park et al. and others however already had reported that this group, without being ill, is to be considered having a major role in transmission to families and relatives. (5) They highlighted that household transmission of SARS-CoV-2 was high if the index patient was 10–19 years of age. The Comirnaty (Pfizer-BioNTech) and Spikevax (Moderna) vaccines are recently accepted by EMA for use from 12 years old.
Expected direct health benefits are prevention of MIS-C (Multisystem Inflammatory Syndrome in Children) and long Covid and indirect benefits less virus circulation in the age group 12–17-year-old. According to modelling by RIVM, this strategy will possibly also help to block a new wave. Expected side effects of the jab such as myocarditis, pericarditis are under review by EMA and others. According to some policymakers in the Netherlands, an additional benefit to expect from vaccinating this new adolescent group is a contribution to herd immunity as some older age cohorts see too many refusals. Parents and caregivers to 12–16 year olds are approaching Specialists in the fields of Travel Medicine, Infectious Diseases, Global Health and Tropical Medicine, seeking answers about the need and safety aspects of the proposed Sars-Cov-2 vaccines.
Until sufficient good trials with control groups are available, we tend to err on the side of caution in our recommendations. However, we do need to stay alert to the pathology displayed by increased virulence of the virus such as now with the delta and lambda variants, follow the data from genomic surveillance and respond quickly if needed as William Hanage and others advocate. (6) In analogy with vaccines such as Hepatitis A and B which have junior reduced doses that proved superior in antibody response to the full adult dose, trials with lower doses or already available vaccines which are “too weak” for adults could be set up in the 12-16 year old group. If adolescents get in contact at school or home with a Covid positive, we could offer testing them for Sars-Cov-2 IgG -antibodies. It would save 1 vaccine for each positive we find as ECDC (European Centre of Disease Control), RIVM and others consider the immune response with 1 vaccination in people with IgG antibodies equal to that after two vaccinations. (7)(8) This is written in the Dutch vaccination passport. Opponents of this strategy state that cost-benefit analysis was a reason not to include this in the guidelines. The price of IgG testing however can be less expensive than some popular Covid vaccines. In this way we could save vaccines and donate them to one of the countries with a Covid-vaccine score under 2 per 100 inhabitants as listed in One World data collection. (9) (10)
Expeditious global vaccine rollout to the vulnerable would be in everyone’s interest as it would avoid vaccine resistant mutant reservoirs.
1. Mahase E. Covid-19: Vulnerable children aged 12-15 will be offered Pfizer vaccine, UK announces. BMJ. 2021;374:n1841. Published 2021 Jul 20. doi:10.1136/bmj.n1841
2. Wilkinson D, Finlay I, Pollard AJ, Forsberg L, Skelton A. Should we delay covid-19 vaccination in children? BMJ. 2021;374:n1687. Published 2021 Jul 8. doi:10.1136/bmj.n1687
3. Vaccinatie van kinderen met een medisch risico en ringvaccinatie (Vaccination of children with a health risk and ring vaccination.) Health Council of the Netherlands 09-06-2021
https://www.gezondheidsraad.nl/documenten/adviezen/2021/06/09/vaccinatie...
4. Vaccinatie tegen COVID-19 beschikbaar stellen voor alle 12- tot en met 17-jarigen (Making COVID-19 vaccination available for all 12- to 17-year-old.) Health Council of the Netherlands 29-06-2021
https://www.gezondheidsraad.nl/actueel/nieuws/2021/06/29/vaccinatie-tege...
5. Park YJ, Choe YJ, Park O, et al. Contact Tracing during Coronavirus Disease Outbreak, South Korea, 2020. Emerg Infect Dis. 2020;26(10):2465-2468. doi:10.3201/eid2610.201315
6. Karin Feldsher. The danger of the Delta variant (interview with William Hanage) July 8, 2021
https://www.hsph.harvard.edu/news/features/the-danger-of-the-delta-variant/
7. Partial COVID-19 vaccination, vaccination following SARS-CoV-2 infection and heterologous vaccination schedule: summary of evidence. ECDC 20 July 2021; https://www.ecdc.europa.eu/sites/default/files/documents/Partial%20COVID...
8. Met één vaccin al beschermd na doorgemaakte Covid-infectie. (With one vaccine protected after having gone through Covid-infection) Dutch Central Government
04-06-2021
https://www.rijksoverheid.nl/actueel/nieuws/2021/06/04/met-een-vaccin-al...
9. Coronavirus (COVID-19) Vaccinations – Our World in Data, last accessed 25-07-2021 https://ourworldindata.org/covid-vaccinations?country=OWID_WRL
10. Ledford H. Should children get COVID vaccines? What the science says [published online ahead of print, 2021 Jul 20]. Nature. 2021;10.1038/d41586-021-01898-9. doi:10.1038/d41586-021-01898-9
Competing interests: No competing interests