The Covid vaccine roll-out for healthy 12-15 year-olds is due to begin this week, but scientists remain concerned about the likely side effects. Some teachers tell me their schools still aren’t fully aware of the role they are supposed to play – “I can see it becoming a minefield”, said one teacher at a school in Yorkshire – and there seems to be some confusion among parents about the power they hold. Can they withhold their consent for the vaccination of their children or not?
Parents will be sent consent forms but only, it seems, as a formality since children who are deemed ‘competent’ (the assessment of which contains no set of defined questions) will be able to overrule the decisions of their parents anyway. This is of a piece with the Government’s decision to push ahead with its roll-out despite being told by the Joint Committee on Vaccination and Immunisation (JCVI) that “there is considerable uncertainty regarding the magnitude of the potential harms” of Covid vaccination in healthy teenagers and that – given the small risk Covid poses to healthy 12-15 year-olds – the “margin of benefit… is considered too small”.
The JCVI is “generous” in its assessment, according to an executive at a pharmaceutical company writing for the Daily Sceptic. (He, by the way, believes vaccines are among the “three greatest medical innovations”, so could hardly be labelled “anti-vax”!) Responding to the data, he says there is a “serious enough” risk of children developing myocarditis after vaccination (inflammation of the heart muscle, the long-term consequences of which aren’t fully understood) whereas the benefits of vaccination are “not well quantified” by the JCVI. The body also fails to properly consider the risk of other conditions following vaccination.
Professor Adam Finn sums up the situation by saying the vaccination of children would not – in normal times – have been approved because of the possible risks. He believes that parents are justified in waiting to allow their children to get ‘jabbed’ until these risks are better understood. But therein lies the problem. What – if anything – can parents do to delay the vaccination of their children?
These – undoubtedly – aren’t normal times. If they were, the Covid vaccine would not have been approved for healthy children until it had been fully investigated, says Professor Adam Finn. He adds that parents are justified in waiting until more is understood about the risks of vaccinating children before getting their teenagers ‘jabbed’. The Timeshas the story.
Professor Finn, a member of the Joint Committee on Vaccination and Immunisation, says that in normal times, the vaccine would not have been recommended for widespread use in children until the long-term consequences of rare side effects had been fully investigated.
Parents are justified in waiting until the risks are clearer before getting their teenagers vaccinated and the NHS needs to spell out the uncertainty over long-term effects better, he argues on this page.
He fears that if some children eventually suffer lifelong health risks without being told of known concerns, trust in other vaccination programmes and wider Government health advice will be undermined. …
Given the huge uncertainty over the extent of the risks, Finn, professor of paediatrics at the University of Bristol, is concerned that parents and children have not fully understood the concerns that gave the JCVI pause and led to months of agonising over whether children should be offered the jab.
Finn insists that doctors need to be transparent about the “extremely uncommon” risks. He says that expert disagreement over possible side effects “cannot be an argument to downplay important information or to present the evidence as clearly pointing only in one direction when it doesn’t”.
An NHS leaflet to be given to children says only that “most people [suffering heart inflammation] recovered and felt better following rest and simple treatments”.
Writing with Guido Pieles, the consultant cardiologist who advised the JCVI, Finn explains that U.S. cardiologists are seeing signs of scarring in the hearts of otherwise healthy teenagers who suffer rare post-vaccine inflammation.
While they say that it is “perfectly possible that these changes will resolve completely over time”, they warn that such scarring is known to carry a risk of “life-threatening arrhythmias or sudden cardiac arrest”.
As coronavirus vaccines are so new, it is not yet known if the same serious long-term dangers will result. However Finn and Pieles said that “in normal times a rare, new and poorly understood process of this kind would be painstakingly studied over a longer period before any decisions were made”.
Given the pandemic, they acknowledge that many believe “we currently don’t have the luxury of time for more evidence”, making it much harder to issue authoritative advice.
Finn and Pieles suggest that parents consider waiting six months or so until the longer-term consequences of heart changes start to become clear, saying: “This is not a decision that needs to be rushed, and choosing to wait for more evidence is perfectly legitimate.”
The Declaration of Geneva of the World Medical Association binds the physician with the words, “The health of my patient will be my first consideration,” and the International Code of Medical Ethics declares that, “A physician shall act in the patient’s best interest when providing medical care.”
From the General Principles in the Declaration of Helsinki.
Let me start with a couple of confessions.
My first confession is that I work in the pharmaceutical industry and have done so for far more years than I’d like to admit (a Big Pharma Shill as one BTL commentator so kindly put it!). My second confession is that I’m a big fan of vaccination. I believe that clean water, vaccinations, and antibiotics are the three greatest medical innovations and together have probably saved more lives than all other medicines put together. But that said, I’m a supporter of vaccinations in the same way that I’m a proponent of any medical treatment… when it is the right treatment for the right person at the right time.
So, with those confessions off my chest, you can see that when I say that I believe that the proposed vaccination of healthy 12-15 year-olds against COVID-19 is morally, clinically and ethically wrong I am doing so from the perspective of a boringly mainstream industrial scientist and someone firmly on the inside of the large pharma Evil Empire.
Like many things in life, medical treatments come with some level of risk to the person receiving them and these risks need to be balanced against the benefit to this person. The balance of benefit and risk for a treatment can be a very individual affair and it is one of the skills of the doctor to make this judgement for their patient. In my world, understanding the balance of benefit/risk for new medicines is one of the main aims of drug development and the aim of good quality clinical trials is to try and fairly demonstrate that the benefits of a new treatment outweigh the risks to the patients who will be receiving it.
Benefit/risk can be quite nuanced, but in the case of vaccinating 12-15 year-olds against SARS-CoV-2, it is very clear. You can read the JCVI’s statement on COVID-19 yourself and form your own judgement based on the figures which are presented in the report, which I have reproduced below.
First, the benefits. There are approximately 3,200,000 12-15 year-olds in the U.K. and so we can convert the figures from the tables which are presented as X/million in the JCVI report into a number of cases based on this population. From Table One, one vaccination dose is predicted to prevent seven children ending up in the paediatric ICU, 278 hospitalisations and 49 cases of paediatric inflammatory multisystem syndrome temporally associated with SARS-CoV-2 infection (PIMS-TS). You can straight away see from Table Two that there is almost no additional benefit to a second dose which means that after two doses (Table Three), we only prevent eight kids ending up in the paediatric ICU, 296 hospitalisations and 88 cases of PIMS-TS.
It is unclear if these benefits are accumulative or over-lapping, i.e., are the ICU patients in addition to non-ICU hospitalisations and are the PIMS-TS patients counted separately or do some end up in hospital? I suspect there is some double-counting here. Also, the long-term outcomes of the hospitalisations and PIMS-TS cases are not discussed and so we don’t really know how many of the prevented outcomes would result in long-term problems for the children involved if they weren’t prevented. Clearly, the ICU cases are serious, but what about the other hospitalisations? Do these range from day-cases to long-term, more serious stays? The “T” in PIMS-TS is “temporally” so does this suggest that this syndrome resolves and, as unpleasant as it might be, is not life-threatening? Also, the word “syndrome” means that it encompasses a huge range of symptoms and so, one assumes, comes in a range of severities. Overall, these benefits are not well quantified in this summary document but taken at face value it does appear that there is some rationale to vaccinating 12-15 year-old children to avoid serious COVID-19 related illness.
But that’s just one side of the equation. What about the risks? Or more specifically, what about the risk, because the JCVI seems to have only really focused on the risk of myocarditis… but to be honest, they don’t really need to go much beyond this.
The risk of developing vaccine-induced myocarditis (inflammation of the heart muscle) (Table Four) ranges from approximately one in 330,000 to one in 60,000 following one dose rising to one in 83,000 to one in 30,000 after two doses. So, again assuming there are about 3.2 million 12-15 year-olds in the U.K. and we vaccinated all of them, we could expect between 9-54 cases of vaccine-induced myocarditis following one dose and between 38-108 cases if we double vaccinated. Serious enough in itself but compound by the fact, as highlighted by the JCVI, that we don’t know what, if any, the long-term consequences are for the children who develop myocarditis after vaccination.
No wonder the JCVI wasn’t supportive. To say that the benefit/risk is marginally positive is to be generous. Even for one vaccine dose the lower estimates of vaccine-induced myocarditis exceed the predicted reduction in the number of severe hospitalisations (CPU cases) and generating potentially long-term cardiac issues in healthy children to avoid a small number of serious COVID-19 cases in this cohort seems to go against the principle of “first do no harm”. For two doses it’s much worse because we gain almost no additional benefit but more than double the risk of adverse cardiac events. And this is only considering this one adverse event and ignoring all the other potentially serious safety problems.
Under normal circumstances, there is no way this would be approved as a treatment for this group. Yet here we are with the U.K. Government about to embark on the vaccination of 12-15 year-olds.
Something that is often glossed over as some kind of “detail” by those strongly advocating immunising as many people as possible against SARS-CoV-2 is that these are not approved medicines but are being used under emergency legislation. This means they are experimental treatments, not because they have never been trialled but because they haven’t completed the normal suite of clinical studies that are required for a vaccine to be authorised for use as a medicine in normal clinical practice. For their use in children, we also need to remember that youngsters are not just small adults but have their own unique physiology and so we can’t assume that adult results are relevant. Paediatric drug development is not a simple case of scaling down the adult dose but requires a whole host of dedicated studies and specific assessments. Which means that for the paediatric use of these vaccines the prior clinical data on their safety and efficacy is extremely limited despite millions of adults receiving the vaccine.
The bottom line is that, until approved, these vaccinations will remain experimental treatments, and far from this being a “detail” it means that ethically and clinically we should treat them as medicines in development and not as established drugs.
Experimental treatments are developed within the framework of good clinical practice or GCP. Within the U.K. and Europe, GCP is described in the nattily titled document “ICH E6 (R2) Good Clinical Practice”. This document defines the roles and responsibilities needed to develop a new medicine and is not just a guide to best practice but sets out some of the legal frameworks that anyone developing drugs here must adhere to. I’m not intending to describe ICH E6 (R2) in any detail but have provided a link for those interested in learning more about what goes into a clinical trial… or perhaps suffering from insomnia. What I want to highlight is that GCP is underpinned by some core ethical principles, explicitly those described in the Declaration of Helsinki which itself is founded upon the principles in the Nuremberg Code.
So, when we consider the use of the current COVID-19 vaccinations, it is the principles of GCP that I believe should be guiding us. Principles that the vaccination of children against SARS-CoV-2 ignore.
The Nuremberg Code was developed by the war crimes tribunal after the Second World War and put down 10 standards to which physicians must conform when experimenting on human subjects. It is this code that articulates the core requirement of voluntary informed consent. Informed consent isn’t some nice-to-have, but a fundamental human right that enshrines the rights of an individual to control what happens to their own body. It is also a right that has been undermined through the use of rewards and coercion in order to achieve a perceived societal benefit from COVID-19 vaccination. In fact, as I have discussed in a previous article, the destruction of informed consent is the logical consequence of assuming that society has some rights to decide which medical procedures are in the best interest of the population and once we do decide that this is ok, we start down a rocky road to a very unpleasant destination.
The Declaration of Helsinki was adopted by the World Medical Association in 1964 and builds on the Nuremberg Code to develop a set of ethical principles for medical research involving human subjects. I’ve started this article with the first of the General Principles in the Declaration which essentially asserts that it is the heath and best interests of the patient that must be the paramount consideration for a physician. Just like the Nuremberg Code, the Declaration of Helsinki focuses on the individual patient’s rights and how, regardless of the broader aims and benefits of the medical research, it is unethical to do this research if the individual’s rights are broken. And, like the Nuremberg Code, the rights described in the Declaration of Helsinki are just as open to erosion and destruction as soon as we start to consider potential societal needs over and above those of the individual.
In the Declaration of Helsinki, there is a section dealing with “Vulnerable Groups and Individuals” into which 12-15 year-old children would clearly fall. This states:
Medical research with a vulnerable group is only justified if the research is responsive to the health needs or priorities of this group and the research cannot be carried out in a non-vulnerable group. In addition, this group should stand to benefit from the knowledge, practices or interventions that result from the research.
It is explicit from this principle that the vulnerable group must be the main beneficiaries of the treatment and so any justification of vaccinating children to help protect others outside of this group destroys this principle and so is unethical. As described above, in the JCVI’s assessment there are some potential benefits associated with COVID-19 vaccination to 12-15 year-olds, but are they a health need or a priority? The loss of a young life is a tragedy and so avoiding this loss, if possible, would seem sensible but we cannot forget the risks of the treatment in our drive to achieve this benefit. A point that the Declaration of Helsinki makes clear in its section on “Risks, Burdens and Benefits”:
Physicians may not be involved in a research study involving human subjects unless they are confident that the risks have been adequately assessed and can be satisfactorily managed. (My emphasis.)
And this is the key reason why vaccinating healthy 12-15 year-olds is so emphatically wrong.
When it comes to the vaccine-induced safety risks, such as myocarditis, we do not have enough data to adequately assess what they mean for this vulnerable group and, as a result, we do not know how to satisfactorily manage them. This was the point the JCVI was making when raising concerns about the long-term risks. I must also emphasise again; children are not small adults and for 12-15 year-olds with hormones racing and puberty in full swing we cannot necessarily transfer any knowledge or assessment of risks from the adult population to this group. It may be that the risks are short-term, manageable, and acceptable and so the balance of benefit/risk is okay… but the fact is we simply do not know, and finding out by immunising 100,000s of children in uncontrolled circumstances is no way to discover the truth. One cannot ignore these risks just because “they are very rare”, especially when the significant benefits may also be “very rare”.
This is a clear case of where the precautionary principle should be applied and where we should assume the worse outcomes and manage the situation accordingly. Here, we’d assume there will be long-term issues associated with vaccine-induced myocarditis, put in place a routine monitoring plan for those who have already suffered this adverse event to ensure they remain healthy and detect any issues as soon as we can, and not vaccinate anyone else in this group until we understand what, if any, long-term issues there may be. It is ironic to me that the precautionary principle has been wielded by the Government and their advisors to justify a whole host of unproven interventions during the COVID-19 pandemic (think masks, think lockdown), but it appears that when it gets in the way of a desired policy implementation it is something that can just be forgotten. As Groucho Marx once said: “Those are my principles, and if you don’t like them… well, I have others.”
I can perhaps understand politicians not being au fait with the details of ICH E6 (R2), but they should be aware that with experimental treatments like the COVID-19 vaccinations, they are in effect the sponsors of a massive real-world clinical trial:
[The sponsor is] An individual, company, institution, or organisation which takes responsibility for the initiation, management, and/or financing of a clinical trial.(ICH E6 (R2), Section 1.54)
As sponsors, the Government and politicians are ultimately responsible and accountable for what happens to people taking this experimental treatment. Even trying to make 12-15 year-old children somehow legally competent to make the decision about being vaccinated does not abrogate them of their responsibilities. So I’d suggest that they familiarise themselves with the principles in the Declaration of Helsinki and the Nuremberg Code and read about GCP, because you never know but perhaps at some future point a competent authority could come knocking on the door.
The ignorance of politicians is one thing, but ignorance of these frameworks and their ethical principles cannot be an excuse used by senior clinicians who are recommending using partially tested treatment on youngsters. Inventing additional benefits not directly related to treatment, such as positive impacts on mental health, to try and justify the use of these vaccinations might help them sleep at night but doesn’t change anything. They are still, in my opinion, breaking ethical and professional principles… principles which they swore to uphold. Unfortunately, it wouldn’t be the first time that doctors have given a political decision a veneer of medical respectability. History will be the judge.
What can we do? Probably not a lot. If the Government and their senior advisors are going to ignore the clear recommendations of their own experts, then individuals outside of these circles have no chance. Perhaps, send your MP a copy of the JCVI’s assessment and point out that the precautionary principle means that vaccinating children where there is a clear, poorly understood safety finding is unethical and immoral, irrespective of how rare the finding might be. Send them the Declaration of Helsinki and point out that they are ultimately responsible for what happens in these vaccination campaigns and to reflect on which side of the ethical argument they want to be on. Probably a futile endeavour, but at least they might understand that they are no longer “following the science” and hiding behind the recommendations of a group of politically connected senior doctors and academics is not going to wash their hands of any issues that arise with this policy. Ultimately though, COVID-19 vaccination of our children will now go ahead and although some parents and children will refuse the jab, I suspect many more won’t and so the only thing really left to do is to pray that the Government and their advisors turn out to be right… right that vaccinating 12-15 year-olds is actually in their best interests and that any vaccine-induced adverse events are rare, transient and do not have any long-term consequences. The alternative is one I shudder to contemplate.
George Santayana is a pseudonym. The author is an executive at a pharmaceutical company.
Parents who are considering demonstrating against the vaccination of their healthy teenage children outside their local school’s gates may have to think twice, with headteachers having been told to call the police if ‘anti-vaxxers’ plan protests near their sites. The Telegraphhas the story.
The U.K. Health Security Agency has now issued guidance to headteachers who believe protests could be held outside their school over participation in the vaccination programme, advising them to contact police to help manage the situation.
The agency said it was aware some schools had received campaign letters and emails with “misinformation” about the vaccine programme, after ministers confirmed the roll-out.
Three million 12 to 15 year-olds across the U.K. will be eligible, and the programme is expected to be delivered primarily within schools.
In new guidance, the agency said it knew of schools seeking advice on how to handle protests, and suggested they get in touch with the School Aged Immunisation Service (SAIS) team at the “first opportunity” to understand “what security planning they have in place”.
“In the event of a protest or disruptive activity outside a school, or if schools know a protest is planned, they should alert the SAIS provider, local authority and police contacts to discuss the best way to manage the situation,” the guidance added.
Heads and teachers have also been advised “not to engage directly” with misinformation campaigns about the vaccine, but should “acknowledge receipt of concerns” and “refer to the latest scientific guidance on the issue” if necessary.
It comes as NHS England said its objective was to vaccinate children as “quickly as is safe and practical, with the majority of school visits completed and vaccinations administered before October half term”.
Any child who hasn’t received their dose within those five weeks should have the date of their vaccination confirmed, a letter sent on Wednesday to providers stated.
The programme should be ready to start administering jabs “no later” than Wednesday September 22nd, it added.
It is understood that the Department of Health and Social care is also drawing resources which will be issued to local authorities and schools imminently on how to handle potential protests.
Dr. Nikki Kanani, GP and Deputy Director of the Covid vaccination programme, said: “It is completely unacceptable for anyone involved in administering the Covid vaccine to be subjected to verbal abuse or violence, and we will be working with local partners to ensure that children, teachers and vaccinators are safe while carrying out these life-saving vaccinations.”
NHS England is expected to advise SAIS teams to follow that guidance, which is likely to reflect similar instructions issued earlier in the year on how to deal with violence, threats and abuse at vaccination sites.
Chief Medical Officer Chris Whitty should resign for approving the vaccination of all healthy teenagers against Covid “without good clinical reason”, according to Marcus Fysh MP. The Independenthas the story.
A row broke out on Monday after the government announced 12 to 15 year-olds will be offered one Pfizer jab from next week, following a decision made by the chief medical officers (CMO) of each of the U.K.’s four nations…
Responding to the move in a tweet on Monday night Marcus Fysh, the Conservative MP for Yeovil, claimed Prof Whitty “does not deserve the confidence of the country” as he called for him to step down.
Speaking in the House of Commons earlier, Mr. Fysh said he had “grave concerns about this policy and the fact that the CMOs have made their decision on the basis of the educational impact rather than the health of the children at clinical level”.
In a previous ruling the JCVI, which looks at vaccinations from a purely clinical perspective, concluded that the virus presents a very low risk for children and therefore an inoculation programme would offer only minor benefits.
The CMOs, who had come under significant political and media pressure to approve the roll-out, told a Downing Street press conference on Monday that there were other benefits, including reducing the disruption to the school term.
Professor Whitty told the news conference it had been a “difficult decision” but CMOs would not be recommending the jabs “unless we felt that benefit exceeded risk”.
Three million eligible teenagers will be offered a first dose as early as next week as part of in-school vaccination services.
Stop Press: Appearing on talkRADIO later on Tuesday, Marcus said the vaccination of healthy children is “an appalling decision [that’s] not based on medical need or clinical need”.
They’ve come up with the idea, because the JCVI didn’t think it was warranted, that somehow children’s mental health is a clinical need for this vaccination. Well, I’m sorry [but] we need to lead children to a better place of understanding they are not at risk if they are worried about getting Covid. It just is not something that is going to be dangerous for them. I just don’t buy that for a second and I think it’s an outrageous way that the medical advice has been manipulated.
Just days after it led the public into believing that plans for vaccine passports were off the table, the Government has announced that they will be introduced – along with mask mandates and potentially another full lockdown – if booster jabs and vaccines for healthy teenagers fail to keep Covid infections down this winter. Laying out its new plans, the Government said it is “committed to taking whatever action is necessary to protect the NHS”. MailOnlinehas the story.
Fronting a press conference alongside Chris Whitty and Patrick Vallance, the Prime Minister insisted that the U.K. was “incomparably” better placed to deal with the disease this year.
He said he hoped the situation could be kept stable with more jabs and the public behaving sensibly – although ministers have made clear another lockdown cannot be completely ruled out.
Professor Whitty gave a more downbeat assessment saying that infections were “high” relative to last year, and the NHS was under “extreme pressure” even though vaccines were helping significantly.
Meanwhile, Sir Patrick seemed to send a thinly-veiled message to Mr. Johnson by saying that when it comes to measures to stem cases the lesson was “you have to go earlier than you want to, you have to go harder than you want to”. …
Earlier, Sajid Javid was heckled by Tories admitting that ministers can only give Britons the “best possible chance” of avoiding brutal curbs.
In a statement to MPs, he stressed that vaccines can help “build defences’ against the disease, with boosters for the over-50s and jabs for under-16s starting next week.
But Mr Javid was hit with howls of rage from Conservatives in the Commons as he said the blueprint includes the ‘Plan B’ of making masks compulsory “in certain settings”, more working from home and social distancing if the NHS is under threat.
Vaccine passports will be kept “in reserve” and could be introduced in England with a week’s notice, even though they will not go ahead from next month as originally intended. …
The Winter Plan document lays out the details of ‘Plan A’ and ‘Plan B’. But although it does not go into detail about other contingencies, it states that further steps cannot be ruled out.
“While the Government expects that, with strong engagement from the public and businesses, these contingency measures should be sufficient to reverse a resurgence in autumn or winter, the nature of the virus means it is not possible to give guarantees,” the document says.
“The Government remains committed to taking whatever action is necessary to protect the NHS from being overwhelmed but more harmful economic and social restrictions would only be considered as a last resort.”
The U.K.’s four Chief Medical Officers have advised that all healthy teenagers should be vaccinated against Covid, while admitting that “in those aged 12-15, [the virus] rarely, but occasionally, leads to serious illness, hospitalisation and even less commonly death”. The decision will trigger the launching by the Government of a vaccine roll-out for 12-15 year-olds, despite ministers being warned by the JCVI of the risk of side effects. The Telegraphhas the story.
Professor Chris Whitty and his counterparts in Wales, Scotland and Northern Ireland said the benefits of vaccinating young people and reducing transmission of the virus outweighed potential costs of side effects for children and disruption to school timetables.
They also recommended that ministers “present the risk-benefit decisions in a way that is accessible to children and young people, as well as their parents”.
“A child-centred approach to communication and deployment of the vaccine should be the primary objective,” they said.
Boris Johnson, Professor Chris Whitty and Sir Patrick Vallance, the Chief Scientific Adviser, will give a press conference on Tuesday in which the Prime Minister is expected to announce he has accepted his chief medical officers’ advice and the rollout for 12 to 15 year-olds will begin.
A similar roll-out for children aged 16 and over is already running.
In a letter to Sajid Javid, the Health Secretary, and other health ministers in devolved parts of the U.K., the medical officers warned that “in those aged 12-15, Covid rarely, but occasionally, leads to serious illness, hospitalisation and even less commonly death”.
“The risks of vaccination (mainly myocarditis) are also very rare,” they said. …
They… warned that individual choice to receive the vaccine or not should be respected.
“It is essential that children and young people aged 12-15 and their parents are supported in their decisions, whatever decisions they take, and are not stigmatised either for accepting, or not accepting, the vaccination offer,” they said, adding that information on the jabs should be communicated in a “child-centred” way.
The Government may have rolledback on vaccine passports and a few other measures today but it seems determined to push ahead with the vaccination of healthy children against Covid. Following reports that Chris Whitty will advise the ‘jabbing’ of 12-15 year-olds to benefit their mental health, it has emerged that the roll-out could begin as soon as September 22nd. The Observerhas the story.
It is believed that vaccinations for children will begin on September 22nd. NHS leaders are understood to have been briefed on the plans after schools were told to be ready to introduce the programme.
The move follows the conclusion of a review by the chief medical officers (CMOs) of all four nations, led by Chris Whitty.
When asked to confirm the plan, a Department of Health source said ministers had not received final advice from the CMOs and did not want to prejudge them.
Last week, the Joint Committee on Vaccination and Immunisation (JCVI) said children would receive only marginal health benefits from a mass vaccination campaign but did not consider the potential benefits to children’s education.
Some Tory MPs had said they would oppose vaccinations for children without definite medical and scientific evidence in favour and a green light from the CMOs.
Not content with the ‘jabbing’ of children over the age of 12 with their Covid vaccine, Pfizer and BioNTech are now preparing to seek approval from U.S. and European medicines agencies for their vaccine in 5-11 year-olds. MailOnlinehas the story.
Dr. Özlem Türeci, Chief Physician for BioNTech, told German news site Der Spiegel that the companies are set to shortly release results from their study in kids under age 12 and will ask for the shot to be approved for emergency use authorization by the U.S. Food and Drug Administration (FDA) and other agencies.
“In the coming weeks, we will present the results of our study on the 5-11 year-olds worldwide to the authorities and apply for approval of the vaccine for this age group,'”Türeci said.
She added that the vaccine formula is the same as that approved for adolescents and adults, but that the dose size is smaller.
Currently, the Pfizer vaccine is only approved for children aged 12 and older in both the U.S. and the European Union.
Parents and doctors have been debating about whether or not to inoculate children because they make up 0.1% of all Covid deaths in the U.S.
A few hours after the new from Pfizer and BioNTech, the FDA said that clinical trial data submitted by vaccine manufacturers must include a monitoring period of at least two months after the final dose to ensure safety. …
Around 4,500 younger kids have been enrolled at nearly 100 clinical trial sites in 26 U.S. states, Finland, Poland and Spain. …
If the vaccine is proven to be safe and effective, the trial will be unblinded at the six-month follow-up, meaning those who received [a] placebo will be allowed to get the inoculation.
Trials for kids as young as six months to four years old are still in early stages and will expand once the researchers can determine safety.
After months and months of recommending lockdown policies that damaged the mental health, education and social development of young people, Chris Whitty is now set to recommend that children aged 12 and over should be vaccinated against Covid “to benefit their mental health, education and social development”, according to the Times.
The Chief Medical Officer for England is set to conclude a review of medical evidence early next week, with ministers promising that the first younger teenagers will be jabbed within five working days. …
Whitty and his counterparts in Scotland, Wales and Northern Ireland are finalising a review into the wider benefits of child vaccination after the Joint Committee on Vaccination and Immunisation gave them responsibility for making a decision. [Or, rather, after the Government chose to ignore the JCVI.]
The committee concluded last week that although the benefits of vaccinating healthy children aged 12 to 15 slightly outweighed the risk, the balance in favour was too small to justify mass immunisation on health grounds alone. They said Whitty should be tasked with considering the broader benefits to children and his review has been holding discussions this week.
The Times understands that talks with senior doctors and other experts reached the conclusion that vaccination should go ahead.
The desire to stop children taking time off school sick, and to help them avoid worrying about the pandemic and learning to get on with their peer group were together judged to tip the balance in favour of vaccination.
Sources close to Whitty stressed that he was still holding discussions and was yet to finalise his recommendations, but the backing of his top advisers means that vaccination of children is in effect agreed.