May 6, 2021
The UK Government and Health Officials are planning to give school children aged 12 and over the experimental Pfizer Covid vaccine at the start of the 21/22 school year. But they won’t stop there. Not long after they will attempt to roll this out to children as young as 6-months-old. This is madness.
It is madness because children do not need an experimental Covid vaccine because they are virtually at zero risk of contracting Covid-19, and even if they do, their chances of developing serious disease and dying is so low that the number is negligible.
According to official NHS data from March 2020 through to the 31st March 2021 just 40 Covid-19 deaths were recorded in those aged 0 – 19. But 32 of those were in children / teenagers who had serious underlying conditions. Just 8 allegedly died of Covid-19 alone in twelve months. But we cannot even be sure the number is that high due to the fact deaths are recorded as Covid just because the person has received a positive test for Covid-19 within 28 days of their death. They could have died due to a head injury and be recorded as a Covid death if they had received a positive test within the 28 days prior.
Yet for some sinister and unexplained reason the authorities are desperate to get the Covid jab into the arms of children. It’s sinister because none of the Covid jabs are licensed. They are currently under emergency authorisation.
In October the government made changes to the Human Medicines Regulations 2012 to allow the MHRA to grant temporary authorisation of a Covid-19 vaccine without needing to wait for the EMA.
A temporary use authorisation is valid for one year only and requires the pharmaceutical companies to complete specific obligations, such as ongoing or new studies. Once comprehensive data on the product have been obtained, standard marketing authorisation can be granted. This means that the manufacturer of the vaccine cannot be held liable for any injury or death that occurs due to their vaccine, unless it was due to a quality control issue.
Why are they only under emergency use authorisation? Because none of the Covid jabs have concluded phase three trials.
The Pfizer phase three trial is not due to complete until April 6th 2023.
Whilst the AstraZeneca phase three trial is due to complete slightly earlier on February 14th 2023.
But what does this mean? Well 2023 at the time of writing is up to two years away. This means that the current worldwide Covid vaccine roll-out can be described as the largest human experiment ever conducted in history. Anybody who takes this vaccine, which is only temporarily authorised for emergency use is essentially a guinea pig, or a lab rat taking part in a trial.
There’s also the fact that all the Covid vaccines being used in the UK are types of vaccine that have never been authorised for use in humans before.
The Pfizer and Moderna jabs allegedly work by delivering mRNA, which Pfizer and Moderna tell us is the genetic code for the spike protein found on the surface of the alleged SARS-CoV-2 virus, to a human cell inside a lipid membrane. Once the mRNA is inside the cell, the same machinery that is used to make our own proteins can make the spike protein. This then causes the immune system to act and initiate an immune response.
Many people are under the illusion that the AstraZeneca vaccine is a traditional vaccine – “It’s no different to the flu jab”, we hear them say time and time again. They couldn’t be more wrong. The AstraZeneca vaccine is a viral vector vaccine, and like the mRNA vaccines they have never been authorised for human use on a mass scale before.
The genetic information inside a viral vectored vaccine like AstraZeneca’s is DNA rather than RNA. This DNA is a short linear piece of double stranded DNA which contains the viral genes along with the gene for the spike protein. The viral vector first infects the cell and then delivers this DNA to the cell nucleus. The cell can then transcribes the viral genes (DNA) into mRNA using the same RNA polymerase it uses for our own genes. After transcription, the mRNA gets tagged so it can leave the nucleus and be made into spike protein by the cell machinery.
Considering the fact that children are at virtually zero risk of contracting Covid it would be madness to give them an unlicensed, emergency approved, experimental vaccine of which not one single person on this planet has any idea of what the long term consequences of having it are. Because there is no data to tell us.
But there is data on the short term consequences in the form of the MHRA Yellow Card scheme in which people who have suffered an adverse reaction to the Covid vaccine can report it to the MHRA. The 13th update which includes data inputted up to the 21st April 2021 shows that there the reported adverse reactions to both the AstraZeneca and Pfizer vaccine include –
- 7,699 cardiac disorders,
- 10,633 eye disorders including blindness,
- A terrifying 152,273 nervous system disorders including brain damage, seizure, paralysis & stroke
- and 1,047 unnecessary deaths
That is just a snapshot as there had in fact been 722,732 reported adverse reactions to the Pfizer and AstraZeneca jabs as of the 21st April 2021. The scary thing is the MHRA say that only 1-10% of adverse reactions are actually reported. So the true number could be anywhere from 7 million to 70 million adverse reactions to the Covid-19 jabs.
Do you honestly think these numbers justify giving the jabs to children?
Well unfortunately the authorities seem to think so as health officials are drawing up plans to offer the Pfizer vaccine to secondary school pupils from September. ‘Core planning scenario’ documents compiled by NHS officials include the offer of a single dose to children aged 12 and over when the new school year starts.
And apparently education leaders would be willing to help facilitate a vaccine roll-out at schools around the country, according to Geoff Barton, general secretary of the Association of School and College Leaders (ASCL), the largest union for secondary school heads.
He explained that vaccinating children at school could result in higher take-up because pupils would not want to feel socially isolated by refusing to have the jab.
“The peer pressure of seeing that your friends are lining up to do it is likely to make the overall numbers taking up the vaccine higher,”.
Somebody should maybe tell Geoff Barton that what he just described is known as coercion.
The choice is yours whether or not you will allow your child to receive a dose of an experimental vaccine which neither prevents the recipient from catching Covid-19 or spread Covid-19. They only thing that these vaccines allegedly do is reduce the risk of hospitalisation and / or death. Which is why it makes no sense for any single child to have the jab, as they are already virtually at zero risk of hospitalisation and / or death according to official NHS data.
‘First they came for the elderly, and I did not speak out because I was not old.
Then they came for the disabled, and I did not speak out because I was not disabled.
Then they came for pregnant women, and I did not speak out because I was not pregnant.
But then they came for my children because I did not speak out for those before them.‘
Covid vaccines for children should not get emergency use authorization
May 7, 2021
Emergency use authorization for mass child vaccination presents a different balance of risks and benefits than it did for adults, say Wesley Pegden, Vinay Prasad, and Stefan Baral
The rapid development of highly effective covid-19 vaccines is a triumph of science and, with equitable implementation strategies, represents humanity’s path out of this pandemic. To expedite deployment in the United States, the US Food and Drug Administration (FDA) provided three covid-19 vaccines with emergency use authorization while they concurrently went through the traditional review process. Pfizer has asked the FDA to amend the existing emergency use authorization for its vaccine to allow eligibility for children aged 12 to 15. Further clinical trials of covid-19 vaccines, including for younger children, are underway. Unlike for adults, however, the likelihood of severe outcomes or death associated with covid-19 infection is very low for children, undermining the appropriateness of an emergency use authorization for child covid-19 vaccines.
Emergency use authorization in the US requires that an intervention address a serious or life threatening condition, and for known and potential benefits of the intervention to be balanced against the known and potential harms. The emergency use authorizations for covid-19 vaccines were implemented at the height of the second wave in the US, enabling around 100 million American adults, who would otherwise be at significant risk of severe outcomes or death from covid-19 infection, to be vaccinated on an accelerated time frame.
Significant adverse events to vaccines are sometimes detected during wider distribution; for example, such events were investigated for the Johnson & Johnson covid-19 vaccine. But phase III trials of covid-19 vaccines in adults have demonstrated reductions in both infections and severe disease, and even if one reasoned conservatively from data on infections alone, these trials showed a large benefit for adult populations that convincingly offset the potential for harms from any side effects rare enough to be missed in phase III trials. Collectively, covid-19 vaccination in adults met emergency use authorization criteria given the positive balance of risks and benefits at the individual level.
Trials for covid-19 vaccines are also underway for children as young as 6 months. These trials are not powered to measure decreases in severe covid-19 infections, due to their rarity in this age group. Instead, these trials are examining safety, the immune response, and, as a secondary outcome, the impact on the incidence of covid-19 infections. As for adults, these trials are not designed to assess rare or delayed adverse events. Unlike for adults, the rarity of severe covid-19 outcomes for children means that trials cannot demonstrate that the balance of the benefits of vaccination against the potential adverse effects are favorable to the children themselves. In short, given the rarity of severe clinical courses and limited clarity of risks, the criteria for emergency use authorization do not appear to be met for children.
Emergency use authorizations for child vaccinations can make sense for children for whom the benefits are greatest, and thus for whom it is clearest that the benefits outweigh any unknown harms. In the near term, emergency use authorizations should be considered for children at genuinely high risk of serious complications from infection. It is also worth considering whether emergency use could be authorized for children whom especially concerned caregivers are sheltering from school or social interactions. The small risk posed to children by covid-19 does not merit restrictions on any regular child activities in a context where adults are protected by vaccines, but individual children who find their lives curtailed in this way may obtain significant benefits from vaccination.
One might hope to achieve population level benefits with broader child vaccination for covid-19, even while the relative benefits and risks for children themselves remain unclear, but this is inconsistent with the conditions for emergency use authorization. Fortunately, covid-19 vaccines have shown very high effectiveness across the adult population, and future trajectories of hospitalizations and deaths will largely be determined by vaccination rates in adults.
In 1976, the vaccination campaign in anticipation of a deadly swine flu (H1N1) epidemic inoculated 45 million Americans before being derailed by very rare cases of Guillain-Barré syndrome. That year saw less flu-related morbidity and mortality than scientists and politicians had expected when they began the vaccine campaign, and these few hundred adverse events cast a long shadow on American vaccination programs, affecting attitudes towards influenza vaccines for years to come. This highlights an important tradeoff when accelerating approval of pharmaceutical interventions in the context of an emergency. Specifically, that the risk of rare adverse events remains and, if the benefit achieved by an intervention is insufficient, any serious, yet rare, adverse effects can prove to be the lasting legacy of a regulatory decision.
For adults, the benefits of covid-19 vaccination are enormous, while for children they are relatively minor. Rare side effects from adult covid-19 vaccination are unlikely to lead to future vaccine hesitancy whose public health impact could be comparable to the benefits of the adult covid-19 vaccination program itself. But accelerated mass child vaccination under emergency use authorization—perhaps even spurred by school mandates and “vaccine passports”—presents a different balance of risks and benefits. The possibility that rare adverse events could emerge as the more durable public health legacy of an emergency use authorization for child covid-19 vaccines is much greater.
Even in the likely scenario that no significant adverse events materialize, we may still pay a price for the pursuit of emergency use authorizations for covid-19 vaccines in children. Controversy surrounding mass child vaccination under emergency use authorizations could feed vaccine hesitancy in the United States at a time when public attitudes towards vaccination are critical. A wide rollout of child covid-19 vaccines should follow the standard regulatory process as for most children, unlike adults, covid-19 vaccination is not addressing an emergency.
Wesley Pegden is an associate professor in the Department of Mathematical Sciences at Carnegie Mellon University. He tweets @WesPegden
Vinay Prasad is a practicing hematologist-oncologist and an associate professor in the Department of Medicine and the Department of Epidemiology and Biostatistics at University of California, San Francisco. He tweets @VPrasadMDMPH
Stefan Baral is a physician epidemiologist and an associate professor in the Department of Epidemiology at the Johns Hopkins School of Public Health. He tweets @SDBaral
Competing interests: The authors have read and understood BMJ policy on declaration of interests and declare the following interests: VP discloses research funding from Arnold Ventures; royalties from Johns Hopkins Press, Medscape, and MedPage; consulting fees from UnitedHealthcare; speaking fees from Evicore and New Century Health; and Patreon backers for Plenary Session podcast.
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