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

 
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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.

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The vaccine is not a vaccine!

It is also unproven, and consequences down the track are unknkwn but it wont be for the good of peoples health.

NZ and Australia are becoming a laughing stock with tginking that the virus can be eradicated.

They are totally delarious, and the consequences of locking people up is far worse than the virus which is only a middle of the road virus.

God help us when there  is actually a bad one.

As for vaccinating youth, totally careless without knowing the consequences and could cause reproductive problems in the future.

Watch this space we are in big trouble with a government that has no idea on anything unfortunately 

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Thomass why do you think it is funny???

You stated in the media that the Delta Variant is dangerous!!!!!!

Where is your evidence that it is dangerous without a single death from it apart from the many suicides due to financial reasons!!!

You get plenty of media coverage when you want it by going to the media!

Brodie does not seek media attention and does not require  it, but you are way off by preaching the benefit of a vaccine that is not a bloody vaccine and that it is dangerous!!!!!

Lockdown is going to kill business in Auckland as the ruler is not going to let you open to trade for many many weeks, and she does not care!!!

Edited by Brodie
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Rapid Response:

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...

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Covid Scotland: Vaccinating children to protect adults 'won't work'

Professor Eleanor Riley also said it was 'tricky' at this stage to know who, if anyone, really required booster vaccinations

Professor Eleanor Riley also said it was 'tricky' at this stage to know who, if anyone, really required booster vaccinations

 
 

ROUTINE vaccination of healthy children and teenagers against Covid is of little benefit to them and would not protect adults from the virus, according to a top infectious disease expert.

Eleanor Riley, professor of immunology and infectious disease at Edinburgh University, said such a policy would only make sense if it completely stopped the spread of the virus - something that is no longer possible with the Delta variant.

Speaking on the BBC Sunday Show, Prof Riley said: "It's quite clear now that the vaccines we have are very very good at preventing people ending up seriously ill in hospital with Covid, but they're not so good at preventing infection and transmission with the Delta variant of the virus.

 

"And so even if we vaccinated everybody in the country, the virus would continue to circulate albeit at lower levels that otherwise, so we have to be very clear about what we are trying to do.

"I think the argument that vaccinating children is to protect their teachers, their parents, their grandparents, I think we can probably put that to one side now because we know that even if the kids are vaccinated they are still potentially able to transmit the virus.

 

"If we want to protect people we have to protect them by vaccinating them but not by relying on somebody else to be vaccinated, so the question then is who really needs a vaccine and for children under the age of 16 the evidence is that not many of them are going to benefit hugely from being vaccinated in terms of getting sick with Covid. Some will, but many won't."

READ MORE: Why Delta variant has left herd immunity mathematically impossible

Both the Pfizer and AstraZeneca vaccines cut the risk of being hospitalised with Covid by more than 90%, but they are less effective at preventing symptomatic infections caused by the Delta variant than they were against the previously dominant Alpha (Kent) strain.

In the case of the Pfizer vaccine, efficacy is around 83% against Delta compared to 92% for Alpha; for AstraZeneca it is estimated at 61% against Delta compared to 81% against Alpha.

 
 

Prof Riley added that it was also not yet clear who should be given booster jags despite the rollout being expected to get underway in September.

Although antibody levels in the blood fade months after vaccination, other elements of the immune system - such as T cells and memory cells - can still offer protection, and scientists do not know what threshold of antibody protection is needed to fight off the virus.

READ MORE: When, and how, will it be safe to end physical distancing in the NHS?

Prof Riley said: "If you started off with 100 times more antibodies than you needed then if your antibodies drop by 50 per cent that probably doesn't make any material difference to whether you're going to get infected, pass the infection on to somebody else, or get sick. "We don't yet know what that level of antibody is that people need to maintain in order to remain protected and prevent them transmitting.

"It's a slightly tricky time because by the time we figure out the people who do need a booster we could be in a winter wave of Covid - probably not a very severe wave, but probably a little bit more virus than there is around at the moment."

READ MORE: 'Tragic' that disinformation is putting people off vaccine, says GP

It comes as the latest figures continue to show an increase in Covid cases in Scotland, with 9,329 infections confirmed over the past seven days - up by 12 per cent compared to the previous week.

More than four million adults in Scotland have now had a first vaccine dose, taking coverage to 90.2%, with 77.4% of adults now fully vaccinated.

The UK Government is under pressure to reveal what contingency plans are in place to deal with a future Covid variant that evades current vaccines, amid warnings from its scientific advisers that such an outcome could set the battle against the pandemic back a year or more.

Recent papers produced by the government’s Scientific Advisory Group for Emergencies (Sage) have suggested that the evolution somewhere in the world of a variant that evades vaccines is a “realistic possibility”.

Dr Marc Baguelin, from Imperial College’s Covid-19 response team and a member of the government’s SPI-M modelling group, told the Guardian: “It is unlikely that such a new virus evades entirely all immunity from past infection or vaccines.

“Some immunity should remain at least for the most severe outcomes such as death or hospitalisation. We would most likely be able to update the current vaccines to include the emerging strain.

“But doing so would take months and means that we might need to reimpose restrictions if there were a significant public health risk."

 
 
 
 
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The Pzifer vaccine is still under FDA EUA for under 16's.  Yet NZ has as good as approved it.

Based on what data?

I've seen the data presented to the FDA by Pzifer and it has no data past mid-March this year.  In terms of the efficacy data NONE of those that were infected either vaccinated with Pzifer or the placebo were infected with the Delta variant.  That is none of the trial data covers ANY Delta variant infection.

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1,600 people in the UK have died from covid-19 vaccine related issues.  97 died before the Swine Flu vaccine was withdrawn.  The following figures are at a level that is way above that vaccine.

This is an updated report published on August 26, 2021, detailing MHRA Yellow Card Reporting up to August 18:

 • Pfizer – 21.3million people, 37.9million doses. Yellow Card reporting rate, one in 199 impacted. 

• AstraZeneca – 24.8million people, 48.7million doses. Yellow Card reporting rate, one in 108 impacted. 

• Moderna – 1.4million people, 2.1million doses. Yellow Card reporting rate, one in 100 impacted. 

Overall, one in 135 people experience a Yellow Card Adverse Event from the 47.5million injected (20.7million men, women and children remain not injected in UK).  

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  • 2 weeks later...

Boys more at risk from Pfizer jab side-effect than Covid, suggests study

US researchers say teenagers are more likely to get vaccine-related myocarditis than end up in hospital with Covid

 

St Thomas' Hospital with an ambulance outside A&E deptThe findings appear to justify UK’s cautious approach to vaccinating teenagers against Covid. Photograph: Ilya Dmitryachev/TASS

 
Ian Sample Science editor

 

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Healthy boys may be more likely to be admitted to hospital with a rare side-effect of the Pfizer/BioNTech Covid vaccine that causes inflammation of the heart than with Covid itself, US researchers claim.

Their analysis of medical data suggests that boys aged 12 to 15, with no underlying medical conditions, are four to six times more likely to be diagnosed with vaccine-related myocarditis than ending up in hospital with Covid over a four-month period.

 

Most children who experienced the rare side-effect had symptoms within days of the second shot of Pfizer/BioNTech vaccine, though a similar side-effect is seen with the Moderna jab. About 86% of the boys affected required some hospital care, the authors said.

Saul Faust, professor of paediatric immunology and infectious diseases at the University of Southampton, who was not involved in the work, said the findings appeared to justify the cautious approach taken on teenage vaccines by the UK’s Joint Committee on Vaccines and Immunisation.

The JCVI did not recommend vaccinating healthy 12 to 15-year-olds, but referred the matter to the UK’s chief medical officers who are expected to make a final decision next week. Children aged 12 to 15 who are particularly vulnerable to Covid, or who live with an at-risk person, are eligible for the shots.

In the latest study, which has yet to be peer reviewed, Dr Tracy Høeg at the University of California and colleagues analysed adverse reactions to Covid vaccines in US children aged 12 to 17 during the first six months of 2021. They estimate the rate of myocarditis after two shots of Pfizer/BioNTech vaccine to be 162.2 cases per million for healthy boys aged 12 to 15 and 94 cases per million for healthy boys aged 16 to 17. The equivalent rates for girls were 13.4 and 13 cases per million, respectively. At current US infection rates, the risk of a healthy adolescent being taken to hospital with Covid in the next 120 days is about 44 per million, they said.

How reliable the data is and whether similar numbers could be seen in the UK if healthy 12 to 15-year-olds are vaccinated are unclear: vaccine reactions are recorded differently in the US and shots are given at longer time intervals in the UK. According to the UK medicines regulator, the rate of myocarditis after Covid vaccination is only six per million shots of Pfizer/BioNTech.

So far, UK children have not been admitted to hospital for Covid in large numbers and may not be at great risk of long Covid. While the recent Clock study found that up to 14% of children who caught Covid may still have symptoms 15 weeks later, levels of fatigue appear similar to those in children who have not caught the virus. This suggests that children may be spared some of the most debilitating problems seen in adult long Covid.

The overwhelming majority of myocarditis appears after the second dose of vaccine, so offering single shots could protect children while reducing their risk of the side effect even further.

“While myocarditis after vaccination is exceptionally rare, we may be able to change the first or second doses or combine vaccines differently to avoid the risk at all, once we understand the physiology better,” said Prof Faust. “On balance, there is no urgency to immunise children from a medical perspective, although if schools are unable to maintain education for the vast majority at all times, the overall balance could shift. If my two teenage children are offered the vaccine by the NHS my GP wife and I will have no hesitation in allowing them to receive the vaccine.”

Prof Adam Finn, a member of JCVI at the University of Bristol, said: “I stand by the JCVI advice, which is not to go ahead at this time with vaccinating healthy 12 to 15-year-olds on health outcome risk-benefit grounds given the current uncertainty – as there is a small but plausible risk that rare harms could turn out to outweigh modest benefits.”

The MHRA said it has been closely monitoring all available data on the potential risk of myocarditis and pericarditis following Covid-19 vaccination. “We have concluded that the Covid-19 vaccines made by Pfizer/BioNTech and Moderna may be linked with a small increase in the risk of these very rare conditions. The cases tended to be mild and the vast majority recovered with simple treatment and rest,” they added.

The spokesperson said the latest study had been considered by the government’s independent advisory body, the Covid-19 vaccines benefit risk expert working group, which found that the interpretation of the findings was limited by the fact that the study did not take into account differences in treatment practices when comparing hospitalisation rates between Covid-19 infections and myocarditis and pericarditis presenting post-vaccination, and there was no assessment of severity and duration of illness after admission.

“Safety monitoring strategies are in place for individuals under 18 years, including monitoring myocarditis and pericarditis occurring post-vaccination and the long term outcomes with these events. The MHRA continues to keep the safety of Covid-19 vaccines under close and continual review,” the spokesperson added.

 This article was amended on 12 September 2021 to add feedback from the MHRA

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zaRH8733yQeMYKv8tVb0cDJ3NJcjJntKEFefS7bI

Care of Children - Act and Reform NZ

 

PRESS RELEASE

Contact: Doug Graham

Email: press-media@cocaar.nz (we will respond within 15 minutes to any legitimate media enquiries).

 

FOR IMMEDIATE RELEASE 

14 September 2021

 

Vaccinating Not At Risk Under 16s Without Parental Consent Is Not Justified 

The UK and USA have not fully approved the Pzifer vaccine for children - why has NZ? 

The New Zealand Government has pushed ahead with the mass vaccination of children aged 12 to 16 when the UK Joint Committee on Vaccination and Immunisation (JCVI) has recommended not to.  The JCVI which makes recommendations to the UK Government has stated “that the health benefits from vaccination are marginally greater than the potential known harms. However, the margin of benefit is considered too small to support universal vaccination of healthy 12 to 15 year olds at this time1”.  Even the recent FDA full approval of the Pzifer vaccine did not include under 16 year olds because of “insufficient data.”  What safety and efficacy data does NZ’s vaccine approval authorities e.g. the COVID-19 Vaccine Technical Advisory Group (CV TAG) and Medsafe have that the JCVI and FDA doesn’t?

 

It is understandable that the JCVI has not recommended vaccinating under 16’s as there has been only limited blinded randomised control trials beyond Phase 1 for any vaccine for this cohort.  Nor has there been sufficient longitudinal studies over time that would allay any long term safety concerns.  That uncertainty alongside the low risk of serious illness to healthy children from catching Covid-19 does not warrant mass vaccinating children. There is already evidence of serious adverse effects from Covid-19 vaccination in children in the short term hence the JCVI recommendation.

 

As the JCVI said in their 3 September 2021 press release 1 - “When deciding on childhood immunisations, the JCVI has consistently maintained that the main focus should be the benefits to children themselves, balanced against any potential harms to them from vaccination.

 

As longer-term data on potential adverse reactions accumulates, greater certainty may allow for a reconsideration of the benefits and harms. This data may not be available for several months.” 

 

The JCVI made specific mention of “There is evidence of an association between mRNA COVID-19 vaccines and myocarditis. This is an extremely rare adverse event. The medium- to long-term effects are unknown and long-term follow-up is being conducted”.  Recent studies show that the JCVI caution may be warranted2 .

 

Further given the lack of published data supporting the decisions of the MOH, CV TAG or Medsafe it is impossible to give informed consent either as a parent or a child.  It is inconceivable that a 12 year old child in the absence of parental consent can fully understand the risks and benefits of the Covid-19 vaccine.  Yet a 12 year old in New Zealand can by themselves now make an appointment online for a vaccination and if deemed “mature enough to make an informed decision” can be vaccinated without parental consent or knowledge.  If the Government is to continue to actively promote and encourage children to be vaccinated then they need to publish the safety and efficacy data for widespread examination.  They also need to state what liability the Government will accept in the event that adverse effects occur in the long term.

 

Doug Graham, spokesperson for the children’s advocacy group COCAAR said “The Government needs to openly and transparently publish the data on which the decision to vaccinate children under 16 was made.  As it stands it appears that the only motivation for doing so is to try and attain a higher vaccination rate at the expense of the long term safety of children.”  

 

“Without this information parents can’t be expected to make an informed consent to vaccinate their children and if they can’t, then it is ludicrous to suggest that a 12 year old child can unilaterally do so”, said Mr Graham.  “Further the Government should be focussing its campaign on vaccinating adults and children who have underlying health issues, not healthy children who are not at risk from serious Covid-19 illness.”  

 

Mr Graham also said, “The NZ Government should make a clear and unequivocal policy announcement regarding what liability they will cover for any serious health issues that may arise in the future that are connected to the current mass vaccination of children.”

 

In summary the Government does not have sufficient long term safety and efficacy data for the Pzifer vaccine to approve the mass vaccination of children under 16 years of age.  Subsequently vaccination of this cohort should stop until such data is freely available or at the very least children under 16 should not be allowed to be vaccinated without parental consent.  If the Government remains committed to this course of action it should publicly state what level of long term liability they will fund having accepted this liability on behalf of the vaccine manufacturer Pzifer.


 

References:

1https://www.gov.uk/government/news/jcvi-issues-updated-advice-on-covid-19-vaccination-of-children-aged-12-to-15

2https://www.medrxiv.org/content/10.1101/2021.08.30.21262866v1
Research paper indicates that the risk of cardiac myocarditis from mRNA vaccines is higher amongst 12-15 yr old boys than from Covid-19.

 

#ENDS

 

Word Count =  773

About COCAAR
COCAAR has been created to:

  • advocate and achieve REAL change to all the legislation and the rules that govern the Family Court process in New Zealand;

  • to provide support and assistance to those who need to use the Family Justice process;

  • advocate for the rights of children and their parents.


 

Contact Name 

Spokesperson:  Doug Graham

Please contact via email in the first instance.  We will respond within 15 minutes and phone back if phone numbers are provided.

doug@cocaar.nz
press-media@cocaar.nz


 

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  • 2 weeks later...

I’m double jabbed but talking to my son yesterday, he’s anti vaxing. He said he’s not getting his kids done as well.  According to his research girls can have fertility problems with the jab. I stopped conversation with him on it then.

I suspect his wife may get them done when he’s out of town. I hope so.

 

 

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1 hour ago, Honestjohn said:

I’m double jabbed but talking to my son yesterday, he’s anti vaxing. He said he’s not getting his kids done as well.  According to his research girls can have fertility problems with the jab. I stopped conversation with him on it then.

I suspect his wife may get them done when he’s out of town. I hope so.

Why vaccinate them if they are not at risk from Covid-19?  Especially when the medium to long term risk to children is unknown.

The latest data shows that for children there is more risk from the vaccination than Covid-19.

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10 minutes ago, Chief Stipe said:

Why vaccinate them if they are not at risk from Covid-19?  Especially when the medium to long term risk to children is unknown.

The latest data shows that for children there is more risk from the vaccination than Covid-19.

I know, I got done because I’m in my 60s, and need to get back to Europe, I will leave my son to his research and I will see what happens, my sons pretty intelligent, but reads a lot into stuff on the puta. 

 

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  • 3 weeks later...

It seems they want to inject the kids with this saviour shot to make them infertile for the human race to skip a generation. It will help with decreasing the population, I'm starting to wonder if every shot is the same or some are placebos abit like a lottery. Some will die some will have long term complications and some will have no problems at all. Covid has killed no more than what the seasonal flu does if it's killed anyone at all. This is just the beginning to the new world order. 

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4 hours ago, Nostradamus said:

It seems they want to inject the kids with this saviour shot to make them infertile for the human race to skip a generation. It will help with decreasing the population, I'm starting to wonder if every shot is the same or some are placebos abit like a lottery. Some will die some will have long term complications and some will have no problems at all. Covid has killed no more than what the seasonal flu does if it's killed anyone at all. This is just the beginning to the new world order. 

 

That was my sons argument, remember thalidomide?

hj

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Breaking: FDA Panel Endorses Pfizer Shots for 5- to 11-Year-Olds, Experts Say Vaccine for Kids Is ‘Unnecessary, Premature and Will Do More Harm Than Good’

The U.S. Food and Drug Administration’s advisory panel today voted to recommend the agency allow Pfizer to amend its Emergency Use Authorization for its COVID vaccine for children 5 through 11 years old, despite a host of objections from scientists and physicians.

 
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The U.S. Food and Drug Administration’s (FDA) advisory committee today endorsed Pfizer’s COVID vaccine for children ages 5 to 11, despite strong objections raised during the meeting by multiple scientists and physicians.

The vote passed with 17 supporting it and one abstention.

Before the shots can be rolled out, the FDA will have to formally authorize the vaccine, and the Centers for Disease Control and Prevention (CDC) must also weigh in with its own recommendations — but the Biden administration’s announcement last week that it has already ordered 68 million doses of the pediatric vaccine suggests Pfizer’s request will sail through.

During today’s meeting, the Vaccines and Related Biological Products Committee (VRBPAC) heard evidence from Pfizer and regulators, and listened to concerns from numerous experts.

According to the FDA website, as of Oct. 25, the agency had received 139,470 comments from the public prior to today’s meeting — a number federal officials described as strikingly high.

As he opened the meeting, Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research (CBER), said, “I want to acknowledge the fact that there are strong feelings that have clearly been expressed by members of the public both for and against” authorization.

Marks stressed the only question before the experts was whether shots should be allowed, not whether to mandate them, the New York Times reported.

The dose for younger children would be one-third the strength given to people 12 and older, with two shots given three weeks apart.

Based on CDC data presented during the meeting, among children 5 to <12 years of age, there have been approximately 1.8 million confirmed and reported COVID cases since the beginning of the pandemic, and only 143 COVID-related deaths in the U.S. through Oct. 14.

In this same age group, there were 8,622 COVID-related hospitalizations through Sept 18.

“This translates to cumulative incidence rates of approximately 6,000 and 30 per 100,000 for confirmed COVID cases and COVID-related hospitalizations, respectively, among children 5 to <12 years of age,” Pfizer’s application said.

Children with underlying medical conditions, such as asthma, diabetes and obesity, made up two-thirds of severe COVID cases.

Pfizer provided safety data on two study cohorts of children ages 5 to 11, both of roughly equal size. The first group was followed only for about two months, the second for only two-and-a-half weeks.

The two-month cohort included 2,268 children ages 5 to 11. Of the 2,268 children, 1,518 received the vaccine and 750 received a placebo. Each received two shots spaced three weeks apart.

Pfizer’s study found its vaccine was about 91% effective against symptomatic COVID in children, based on 16 cases of COVID in the placebo group and three cases in the vaccinated group over the brief follow-up period.

Most side effects occurred within a couple of days and included pain at the injection site, fatigue, headache, muscle pains and chills, Pfizer said.

According to Pfizer, the number of participants in the current clinical development program was “too small to detect any potential risks of myocarditis associated with vaccination.”

Long-term safety of Pfizer’s COVID-19 vaccine “to evaluate long-term sequelae of post-vaccination myocarditis/pericarditis” in participants 5 to <12 years of age will not be studied until after the vaccine is authorized for children,” Pfizer’s application noted.

Pfizer data insufficient, kids’ risk of vaccine injury greater than COVID risk, experts say

Experts raised concerns over the lack of safety and efficacy data presented by Pfizer for use of its COVID vaccine in younger children, and they pointed to increasing safety signals based on reports to the Vaccine Adverse Event Reporting System (VAERS).

They also questioned the need to vaccinate children — whose risk of dying from COVID is “almost nil” — at all.

According to Dr. Meryl Nass, member of the Children’s Health Defense Scientific Advisory Panel, Pfizer once again did not use all of the children who participated in the trial in their safety study.

“Three thousand children received Pfizer’s COVID vaccine, but only 750 children were selectively included in the company’s safety analysis,” Nass said. “Studies in the 5-11 age group are essentially the same as the 12-15 group — in other words, equally brief and unsatisfying, with inadequate safety data and efficacy data, with no strong support for why this type of immuno-bridging analysis is sufficient.”

Nass said, “All serious adverse events were considered unrelated to the vaccine.”

During the meeting and in its FDA application, Pfizer argued children should be vaccinated to prevent SARS-CoV-2 transmission, yet the company did not assess asymptomatic transmission.

Dr. Ofer Levy, a VRBPAC member, asked for evidence that Pfizer’s vaccine prevents transmission.

Dr. William Gruber, senior vice president of Pfizer Vaccine Clinical Research and Development, said they did not assess whether the vaccine prevents transmission, but said there is evidence the vaccine prevents transmission in adults.

When questioned further, Gruber was unable to cite specific evidence to back his assertion.

Steve Kirsch, founder of the COVID-19 Early Treatment Fund, asked the panel how they could do a risk-benefit analysis with Pfizer’s COVID vaccine if they did not know the CDC’s VAERS under-reporting factor (URF).

Kirsch asked:

“How can you do a risk-benefit of analysis of COVID vaccines if you don’t know the URF? This is extremely, extremely important. You have been assuming it has been one. It is not one. Using a URF of 41, which is calculated using CDC methodology, we find over 300,000 excess deaths in VAERS. If the vaccine didn’t kill these people, what did?”

“How many Americans have to die before you pull the plug?” Kirsch asked.

Kirsch also questioned the panel on why Maddie de Garay’s severe adverse reaction to the Pfizer vaccine, which left her paralyzed, was not reported by the company to the FDA.

Dr. Jessica Rose, viral immunologist and biologist, told the panel EUA of biological agents requires the existence of an emergency and the nonexistence of alternate treatment.

“There is no emergency and COVID-19 is exceedingly treatable,” Rose said.

In a peer-reviewed study co-authored by Rose, myocarditis rates were significantly higher in people 13 to 23 years old within eight weeks of the COVID vaccine rollout.

In 12- to15-year-olds, Rose said, reported cases of myocarditis were 19 times higher than background rates.

“In an act of censorship, this paper has been temporarily removed and it has now been killed without criticism of the work,” Rose said, noting the timing of the removal was strange.

Rose said tens of thousands of reports have been submitted to VAERS for children ages 0 to 18.

Rose explained:

“In this age group, 60 children have died — 23 of them were less than 2 years old. It is disturbing to note that “product administered to patient of inappropriate age was filed 5,510 times in this age group. Two children were inappropriately injected, presumably by a trained medical professional, and subsequently died.”

Dr. Josh Guetzkow, a senior lecturer at the Hebrew University of Jerusalem, said expanding the EUA to children is unnecessary, premature and will do more harm than good.

Guetzkow said there is no emergency for children, especially healthy ones whose risk of severe illness and death is “almost nil.”

VTBPAC

Guetzkow said kids with pre-existing conditions and prior COVID infections were not included in Pfizer’s study, so including them in the EUA is negligence.

“Pfizer’s trial is woefully underpowered to detect specific safety concerns, such as myocarditis, just like the adolescent study was, and if they weren’t able to detect an unexpected safety concern there, they wouldn’t be able to here,” Guetzkow said.

Guetzkow said:

“In Pfizer’s study, only .5% of controls were dropped due to important protocol violations, versus 3% in the treatment group. The odds of that happening by chance are 1 in 10,000. This deviation is poorly explained with no ITT analysis. The study is not double-blind and may be subject to bias. Most VSD safety monitoring programs have not reported results, why not wait?”

Guetzkow said, “from CDC reports, we can expect that for every 18 child hospitalizations prevented, at least 43 will end up in the hospital for all causes following vaccination,” yet, the “FDA’s risk-benefit analysis only counts myocarditis hospitalization.”

“Why ignore the V-safe data, and shouldn’t FDA verify Pfizer’s efficacy and immunobridging analysis first?” he asked.

Guetzkow said VAERS shows alarming safety signals, which cannot be attributed to increased vaccination, simulated reporting or COVID infections.

“We calculated the ratio of adverse events reported per million Pfizer vaccinations to reports per million flu vaccinations among teenagers to see what to expect in children. Serious events are reported 51% more often for Pfizer, deaths 47 times, life-threatening conditions 49 times,” Guetzkow said.

Guetzkow asked the panel to look at the data on COVID vaccines compared to flu vaccines. Pointing to the data on reproductive organs, Guetzkow asked, “why would we expect children to take these risks to protect adults?”

There are more than 900 types of adverse events reported after Pfizer vaccination that have never been reported after flu vaccines, including 11 cases of multisystem-inflammatory syndrome (MS-C) that occurred without previous history of COVID infection, Guetzkow said.

He added that if the panel was considering authorizing Pfizer’s COVID vaccine to prevent MS-C — as Pfizer’s application suggested as one of the reasons they should — the panel should reconsider.

During another part of the meeting, Julia Barnes-Weise, director of the Global Healthcare Innovation Alliance Accelerator, said pharmaceutical companies have concerns.

“One of them is, especially for a not-yet-approved vaccine, that they could be held liable for any injury that that vaccine seems to have caused,” Barnes-Weise said.

In a preliminary analysis last week, FDA reviewers said protection would “clearly outweigh” the risk of a very rare side effect in almost all scenarios of the pandemic, PBS News Hour reported.

Children’s Health Defense (CHD) said yesterday it would take legal action against the FDA if it granted EUA for the Pfizer-BioNTech vaccine for children 5- to 11- years old.

In a letter signed by Robert F. Kennedy, Jr., CHD chairman and chief legal counsel, and Nass, Kennedy and Nass wrote:

“CHD will seek to hold you accountable for recklessly endangering this population with a product that has little efficacy but which may put them, without warning, at risk of many adverse health consequences, including heart damage, stroke, and other thrombotic events and reproductive harms.”

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We will kill 117 kids to save one child from dying from COVID in the 5 to 11 age range - by Steve Kirsch - Steve Kirsch's newsletter
prince3
Sun 28/11/2021 9:39 PM
 
 
 
 
https://stevekirsch.substack.com/p/we-will-kill-117-kids-to-save-one
https%3A%2F%2Fbucketeer-e05bbc84-baa3-43
Dr. Toby Rogers writes a popular substack looking at risk benefit issues. His credentials are described here.. In a recent article that I hope everyone will read or at least skim, he concluded: “So, to put it simply, the Biden administration plan would kill 5,248 children via Pfizer mRNA shots in order to save 45 children from dying of coronavirus. For every one child saved by the shot ...
stevekirsch.substack.com
Make what you will, but I believe this has merit.
 
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