Covid-19 vaccines for children: hypothetical benefits to adults do not outweigh risks to children - The BMJ

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Covid-19 vaccines for children: hypothetical benefits to adults do not outweigh risks to children - The BMJ

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Covid-19 vaccines for children: hypothetical benefits to adults do not outweigh risks to children
July 13, 2021

Elia Abi-Jaoude, Department of Psychiatry, University of Toronto, ON, Canada
Peter Doshi, Department of Pharmaceutical Health Services Research, University of Maryland School of Pharmacy, Baltimore
Claudina Michal-Teitelbaum, Preventive Medicine, Independent Researcher, Lyon, France

As the majority of adults in multiple rich western countries have now received at least one dose of a covid-19 vaccine, the focus is turning to children. While there is wide recognition that children’s risk of severe covid-19 is low, many believe that mass vaccination of children may not just protect children from severe covid-19, but also prevent onward transmission, indirectly protecting vulnerable adults and helping end the pandemic. However, there are multiple assumptions that need to be examined when judging calls to vaccinate children against covid-19.

First, the disease in children is commonly mild, and serious sequelae remain rare. Despite “long covid” recently garnering increased attention, two large studies in children show that prolonged symptoms are uncommon and overall similar or milder in children testing positive for SARS-CoV-2 compared to those with symptoms from other respiratory viruses. The US Centre for Disease Control (CDC) estimates put the infection fatality rate from covid-19 among children 0 to 17 years old at 20 per 1,000,000. Hospitalization rates are also very low, and have likely been overestimated. Furthermore, a large proportion of children have already been infected with SARS-CoV-2. The CDC estimates 42% of US children aged 5 to 17 years have been infected by March 2021. Given that SARS-CoV-2 infection induces a robust immune response in the majority of individuals, the implication is that the risks covid-19 poses to the pediatric population may be even lower than generally appreciated.

In the clinical trial underlying the authorization of Pfizer-BioNTech’s mRNA vaccine in children aged 12 to 15, of the close to 1000 children who received placebo, 16 tested positive for covid-19, compared to none in the fully vaccinated group. Given this low incidence, the fact that covid-19 is generally asymptomatic or mild in children, and the high rate of adverse events in those vaccinated (e.g. in Pfizer’s trial of 12-15 year olds, 3 in 4 kids had fatigue and headaches, around half had chills and muscle pain, and around 1 in 4 to 5 had a fever and joint pain), a comparison of quality-adjusted life-years in the trial would very much favour the placebo group. Potential benefits from the vaccine, including protection of children against severe covid-19 or long covid, or covid-19 months in the future, could affect this balance, but such benefits were not shown in the trial and remain hypothetical.

Even if one assumes protection against severe covid-19, given its very low incidence in children, an extremely high number would need to be vaccinated in order to prevent one severe case. Meanwhile, a large number of children with very low risk for severe disease would be exposed to vaccine risks, known and unknown. Thus far, Pfizer’s mRNA vaccine has been judged by Israel’s government as likely linked to symptomatic myocarditis, with an estimated incidence between 1 in 3000 to 1 in 6000 in men ages 16 to 24. Furthermore, the long term effects of gene-based vaccines, which involve novel vaccine platforms, remain essentially unknown.

In terms of the risk of transmission of SARS-CoV-2 from children to adults, this is also low and decreasing, though not negligible. School teachers are more likely to get SARS-CoV-2 from other adults than they are from their students. The contribution of schools to community transmission has been consistently low across jurisdictions. In addition, considering estimates that 42% of those aged 5 to 17 years in the US are now post-covid, this should only lower the risk of transmission from children. Add to this the fact that most adults in rich western countries have received at least one dose of covid-19 vaccine—around 80% of UK adults now have SARS-CoV-2 antibodies, whether from past infection or from vaccination—and it seems the opportunities for children to be vectors of transmission to adults are dwindling.

Given all these considerations, the assertion that vaccinating children against SARS-CoV-2 will protect adults remains hypothetical. Even if we were to assume this protection does exist, the number of children that would need to be vaccinated to protect just one adult from a bout of severe covid-19—considering the low transmission rates, the high proportion of children already being post-covid, and most adults being vaccinated or post-covid—would be extraordinarily high. Moreover, this number would likely compare unfavourably to the number of children that would be harmed, including for rare serious events.

A separate, but crucial question is one of ethics. Should society be considering vaccinating children, subjecting them to any risk, not for the purpose of benefiting them but in order to protect adults? We believe the onus is on adults to protect themselves. In multiple jurisdictions around the world, the vast majority of adults, including those that are at high risk, have not been fully vaccinated against covid-19. If the goal is to protect adults, shouldn’t efforts be focused on ensuring adults are fully vaccinated rather than targeting children? Further, it is highly inequitable to be vaccinating very low risk children in wealthy countries while many vulnerable adults in low-income countries have not had any doses.

There is no need to rush to vaccinate children against covid-19—the vast majority stands little to benefit, and it is ethically dubious to pursue a hypothetical protection of adults while exposing children to harms, known and unknown. The risk/benefit consideration may be different in children at relatively higher risk of severe disease, such as those who are obese or immunocompromised. Otherwise, the focus should be on ensuring safe and effective vaccines are available for the adult populations which stand the most to benefit, especially those at high risk. In the meantime, there should be ongoing active evaluation of risks to youth, including research into risk factors for severe covid-19 and the impact of new variants, as well as ongoing evaluation of vaccine efficacy and safety. There should also be ongoing evaluation of the protection afforded by infection-induced immunity relative to vaccine-induced immunity, especially in youth.

See also: Should we delay covid-19 vaccination in children?

Elia Abi-Jaoude, Department of Psychiatry, University of Toronto, ON, Canada

Peter Doshi, Department of Pharmaceutical Health Services Research, University of Maryland School of Pharmacy, Baltimore

Claudina Michal-Teitelbaum, Preventive Medicine, Independent Researcher, Lyon, France

Competing interests: PD has received travel funds from the European Respiratory Society (2012) and Uppsala Monitoring Center (2018); grants from the FDA (through University of Maryland M-CERSI; 2020), Laura and John Arnold Foundation (2017-22), American Association of Colleges of Pharmacy (2015), Patient-Centered Outcomes Research Institute (2014-16), Cochrane Methods Innovations Fund (2016-18), and UK National Institute for Health Research (2011-14); was an unpaid IMEDS steering committee member at the Reagan-Udall Foundation for the FDA (2016-20), and is an editor at The BMJ. EAJ and CMT have no relevant financial conflicts of interest to declare. The views and opinions expressed here are those of the authors and do not necessarily reflect official policy or position of the University of Maryland or the University of Toronto.

Acknowledgment: The authors wish to thank Jennie Lavine for her comments on this article.

Not commissioned, peer reviewed.

Covid-19 vaccines for children: hypothetical benefits to adults do not outweigh risks to children - The BMJ
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335. That is how many children under 18 have died with a Covid diagnosis code in their record,

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The agency overcounts Covid hospitalizations and deaths and won’t consider if one shot is sufficient.

By Marty Makary
July 19, 2021 1:52 pm ET

A tremendous number of government and private policies affecting kids are based on one number: 335. That is how many children under 18 have died with a Covid diagnosis code in their record, according to the Centers for Disease Control and Prevention. Yet the CDC, which has 21,000 employees, hasn’t researched each death to find out whether Covid caused it or if it involved a pre-existing medical condition.

Without these data, the CDC Advisory Committee on Immunization Practices decided in May that the benefits of two-dose vaccination outweigh the risks for all kids 12 to 15. I’ve written hundreds of peer-reviewed medical studies, and I can think of no journal editor who would accept the claim that 335 deaths resulted from a virus without data to indicate if the virus was incidental or causal, and without an analysis of relevant risk factors such as obesity.

My research team at Johns Hopkins worked with the nonprofit FAIR Health to analyze approximately 48,000 children under 18 diagnosed with Covid in health-insurance data from April to August 2020. Our report found a mortality rate of zero among children without a pre-existing medical condition such as leukemia. If that trend holds, it has significant implications for healthy kids and whether they need two vaccine doses. The National Education Association has been debating whether to urge schools to require vaccination before returning to school in person. How can they or anyone debate the issue without the right data?

Meanwhile, we’ve already seen inflated Covid death numbers in the U.S. revised downward. Last month Alameda County, Calif., reduced its Covid death toll by 25% after state public-health officials insisted that deaths be attributed to Covid only if the virus was a direct or contributing factor.



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Covid-19: Vaccine plan for children based on criteria beyond medical benefit - The Irish Times

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Covid-19: Vaccine plan for children based on criteria beyond medical benefit
The Irish Times

Low risk inherent but jabs for 12-15 year olds deemed social and psychological boost
Sat, Aug 7, 2021, 04:34

Paul Cullen Health Editor


‘The primary benefits of vaccinating healthy 12-15 year olds will be normalisation of life, less disruption to educational and social activities, and reduced virus transmission to vulnerable household contacts,’ claims the National Immunisation Advisory Committee.
‘The primary benefits of vaccinating healthy 12-15 year olds will be normalisation of life, less disruption to educational and social activities, and reduced virus transmission to vulnerable household contacts,’ claims the National Immunisation Advisory Committee. Photograph: Kirsty O’Connor/PA

Of the many ethical dilemmas thrown up by the Covid-19 pandemic, few are greater than the question of vaccinating children.

For many families, this challenge comes centre-stage from next week, with the beginning of registration for 12-15 year olds for administration of the vaccine.
For children with underlying health conditions, there is a clear case for recommending the vaccine, as the risks of Covid-19 infection greatly exceed any posed by taking the vaccine.
But for the broad mass of healthy adolescents, the consideration of whether they should be given a new vaccine under emergency use authorisation, when their risk of serious illness from Covid-19 is minimal, is finely balanced.

This can be seen in the differing policy responses in different countries. France, Israel and Canada, for example, have gone down the route of universal vaccination from 12 years, while the UK and Norway are focusing on vaccinating vulnerable children.

Here, our experts in the National Immunisation Advisory Committee (Niac) have recommended that all those aged 12-15 years “should be offered” an mRNA vaccine (effectively Pfizer as it is the only vaccine authorised for this age group as of now).

In stronger language, children with underlying medical conditions, as well as those living with vulnerable siblings or adults, are being “strongly encouraged” to get vaccinated quickly.

Endorsing Niac’s recommendation to Government, chief medical officer Dr Tony Holohan repeated its wording, with the sole change of underlying the word “all” (12-15 year olds).

So while the wording is restrained, and Niac stresses that any decision by parents to accept, refuse or defer vaccination should be respected, the spirit of public policy clearly favours universal vaccination of this age group.

In the UK, the Joint Committee on Vaccination and Immunisation (JCVI) – the equivalent of Niac – advised against routine universal vaccination of children until more data becomes available.

Potential risks
“The health benefits in this population are small, and the benefits to the wider population are highly uncertain,” the JCVI concluded last month.

“At this time, JCVI is of the view that the health benefits of universal vaccination in children and young people below the age of 18 years do not outweigh the potential risks.”

As most people know by now, children are largely spared the ill-effects of Covid-19. Most infections are asymptomatic or mild. Hospitalisation rates are low and deaths rare.

In Ireland, a healthy child has a one in 100,000 risk of ending up in hospital due to Covid-19.

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Among all 12-15 year olds, there were 34 admissions in 2020 and 56 so far this year, and no deaths among this group. Fewer than five admissions to paediatric ICU have been linked to Covid-19.

At the start of the pandemic, there was concern over reports of a multisystem inflammatory condition in children, but treatment has improved as awareness of the condition has grown. Up to last February, 32 cases of this condition had been reported in Ireland, with all children recovering successfully.

In any case, as Niac acknowledges, it is not yet known whether vaccination will prevent this condition occurring. In the UK, the JCVI found the available data was insufficient to advise on vaccination to prevent it.

As for “long Covid”, the JCVI said the risk was “very low” while Niac spoke of “considerable uncertainty” around the risk.

Earlier this week, the first large-scale study on Covid and children found most recovered quickly from the disease. Just 1.8 per cent experienced symptoms for longer than eight weeks. Again, the impact of vaccines on long Covid is not yet known.

Well over four billion doses of Covid-19 vaccine have been administered worldwide since the end of 2020. The products developed have proved to be highly effective and safe. In Ireland, this and the high levels of trust in public health officials have seen our vaccine take-up soar to a very high level; almost 90 per cent of the adult population have had at least one dose.


Side-effects reported
Inevitably with such high numbers there have been reports of side-effects. One issue relates to very rare cases of myocarditis and pericarditis (heart-related inflammation) with a higher than expected rate reported in the US, predominantly among men aged 30 years and under. There, the highest reporting rate has been in males aged 12-17 years – more or less the current age-group being targeted for immunisation in Ireland.

According to Niac, most cases are self-limited and resolve with treatment of symptoms, though it adds that follow-up will be needed to determine whether there are longer-term effects.

“Data on the incidence of these events in children and young people are currently limited, and the longer-term health effects from the myocarditis events reported are not yet well-understood,” the JCVI concluded in the UK.

In Ireland, there have been 17 reports linked to myocarditis/pericarditis, but none among children. The youngest report concerned a patient aged 38.

In such a fast-moving situation, it is not possible to set out a detailed risk/benefit analysis for Covid-19 vaccines in children, though clearly the equation is evenly balanced.

Niac also took into account the indirect benefits of vaccination, particularly in light of the spread of the Delta variant. While not the primary drivers of transmission of the disease, in households or elsewhere, children do contribute to spread. Their vaccination, it is hoped, will reduce the amount of onward transmission.

In its decision, Niac cited a recent study which found that adults vaccinated with the Pfizer vaccine and who were later infected were up to 50 per cent less likely to transmit the virus in a household setting.

However, the US Centers for Disease Control has made the point recently that even fully vaccinated people can transmit the virus.

Niac based its decision in favour of vaccinating 12-15 year olds on criteria wider than indirect medical benefit. “In the unique circumstances of the pandemic, consideration regarding recommending Covid-19 vaccination to this age cohort must extend to include their physical, psychological and social wellbeing.”


‘Normalisation of life’
Universal vaccination of adolescents offers direct and indirect benefits, such as reducing the risk of severe disease, keeping schools open and “facilitating psychosocial development”, it found.

“The primary benefits of vaccinating healthy 12-15 year olds will be normalisation of life, less disruption to educational and social activities, and reduced virus transmission to vulnerable household contacts.”

These conclusions were reached after holding focus group meetings with parents and young people. “There was an expectation that vaccination might be a step toward getting life back to normal and might facilitate more freedoms in terms of school and social activities,” the research found.

Relying on unpublished focus group studies reporting a yearning for a return to normal life doesn’t feel like “following the science”. Yet this research appears to have tipped the balance in favour of universal vaccination of young people.

Niac has also argued that universal vaccination of young people may impede the development of new variants that could lead to the development of severe disease in adolescents.

Early vaccination of healthcare workers and other vulnerable adults in developing countries would probably do more to prevent the emergence of new variants than vaccinating low-risk children in Ireland and other wealthy nations.

The World Health Organisation has suggested a pause on booster vaccinations until supplies are provided to immunise 10 per cent of the world’s population. Others have questioned the morality of western countries racing to vaccinate entire populations when coverage is so scant elsewhere.

There is a good case for Ireland using up the doses it has to hand or has ordered, but the 700,000 doses we plan to buy from Romania are supplies that could be used to help poor countries with little or no protection against the Delta variant.

Beyond the binary decision whether to vaccinate or not, some parents may opt to wait and see.


Will the current surge of cases abate soon or continue to grow? Will the Delta variant be shown to be more dangerous than previous strains? Can the concerns about rare reports of side-effects among vaccinated young people be adequately addressed?

Few of the big questions can be answered definitively or permanently, when the data is evolving so quickly.

Covid-19: Vaccine plan for children based on criteria beyond medical benefit - The Irish Times
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Paradise to Hell - Kingdom of Tonga will introduce compulsory vaccination and punitive action against those who refuse

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meanwhile in the Pacific Islands The 'democratic' kingdom of Tonga....
the Tongan government has applied an emergency provision in the country's health legislation (Section 181 of the Public Health Act). The new Bill aims to impose a fine of 1,000 pa’anga (approximately USD 445), or imprisonment for six months, for anyone who refuses to be vaccinated. Parents will be held responsible if their children refuse to be vaccinated. I have not seen the Bill, but as the author states; “…to enforce inoculation of the public”, this must mean that the Bill also contains a provision that regulates arresting unwilling members of the public, hospitalization by force and finally vaccination by force, if necessary by applying restraints.

Paradise to Hell - Kingdom of Tonga will introduce compulsory vaccination and punitive action against those who refuse
https://www.rettsnorge.com/From
Wednesday, August 4, 2021 - 12:04
Tonga is set to introduce compulsory inoculation against coronavirus disease. A Bill to amend the Public Health Act to enforce inoculation of the public against COVID-19, was among seven Bills that government tabled into parliament yesterday, 3 August. The Bill was carried unanimously on its first reading and passed on to a Standing committee. Full details of the amendment have not been released to the public. From the House by Pesi Fonua

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Samoa max vaccinations start Aug 11 2021

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