We Used to Protect Children at All Costs, Now They're Big Pharma Fair Game
My lettter to ATAGI regarding the use of COVID-19 vaccines in children aged 5-11 years.
Earlier this year, as the Australian Technical Advisory Group on Immunisation (ATAGI) were considering the use of Pfizer’s paediatric vaccine in children aged 5-11 years, I wrote to the Chair, Associate Professor Nigel Crawford. I spoke about my concerns regarding mass COVID-19 vaccination of children in this age group, and also addressed the specific points detailed in the ‘ATAGI recommendations on the use of the paediatric Pfizer COVID-19 vaccine in children aged 5 to 11 years in Australia’ statement which was published on December 8th, 2021 (revised in February 2022).
Although I’m not really surprised I didn’t get a response given most letters I wrote regarding COVID-19 vaccines went unanswered, I still can’t quite believe that voicing serious concerns regarding the medication of children didn’t seem to warrant any reply from an organisation like ATAGI.
With Pfizer now seeking approval from the US Food and Drug Administration for use of their paediatric COVID-19 vaccine in babies and children six months to two years of age (apologies for the link to the flaming dumpster fire that is The Washington Post), and Australia’s Therapeutic Goods Administration (TGA) likely next, all the points in my letter about 5-11 year olds apply even more so to this younger group.
Given I wrote this letter five months ago and the field of COVID-19 vaccination is a rapidly shifting landscape, I’d like to make a couple of clarifications first:
1. When I mention that it may be useful to vaccinate children in at-risk groups rather than all children, I mean COVID-19 vaccination could be offered to these children and their families and they could reach their own, consensual decisions based on their specific situations, in consultation with their GPs who should in turn be free from any coercion or fear of inappropriate professional repercussions. I absolutely DO NOT support mandating the COVID-19 vaccination of at-risk children.
2. Once it became undeniable that COVID-19 vaccines do not stop infection or transmission, the messaging shifted to the purported meaningful reduction in serious illness and death. This was a bold claim from the outset, when applied to children (especially ones with no health issues). Over the last several months, emerging academic and real world data have caused further doubt on this claim, particularly when so many children have now been infected with and recovered from COVID-19. While the (actual and potential) risks of COVID-19 vaccination for a very small number of children may be outweighed by a (real or perceived) benefit, I do not believe this warrants the broad and indiscriminate use of COVID-19 vaccines in children (and certainly not babies).
Without further ado, my letter below (minimally edited for typographical errors):
Associate Professor Nigel Crawford
Chair – Australian Technical Advisory Group on Immunisation (ATAGI)
GPO Box 9848 – MDP 13
Canberra ACT 2601
9th January 2022
Re: Broad-scale Childhood COVID-19 Vaccination
Dear Associate Professor Crawford,
My name is Laine Jolly and I am an Australian Registered Nurse (RN) currently living in the Northern Territory. I have been an RN for nearly 14 years, during which time I have worked primarily in intensive care. I have completed post-graduate study in critical care nursing and counselling, and I have also spent substantial time working in aeromedical retrieval, organ donation and outpatient neurosurgery.
I am writing to you regarding alarm around the possibilities for childhood COVID-19 vaccination. The TGA have now approved a Pfizer vaccine for children 5-11 years old and ATAGI have recommended it for all children in this cohort, however I do not believe this approach is supported by the evidence in any way and to advise COVID-19 vaccination for all healthy children is likely to cause more harm than it prevents.
As the COVID-19 vaccine rollout began for Australian adults, we were (and continue to be) told repeatedly that the available vaccines are ‘safe and effective’ and ‘the benefits far outweigh the risks’. However the time since has shown us that COVID-19 vaccine efficacy wanes substantially over time and we are now seeing the requirement for boosters begin to emerge. If we accept the more recent messaging that the vaccines we currently have available do not stop infection and transmission but provide protection against hospitalisation and death, the obvious conclusion is that any benefit vaccination confers is enjoyed most significantly by the vaccinated person. This in turn supports the specific recommendation of COVID-19 vaccination for those people whose age, weight, co-morbidities and/or medical history puts them at an increased risk for poor outcome when exposed to COVID-19.
Given COVID-19 vaccination offers little absolute risk reduction in young, healthy people (and even less so in healthy children) pushing all children to receive the COVID-19 vaccine does not appear to substantially benefit them. COVID-19 vaccination also poses potential risks, some of which are now known and some which may have yet to be fully appreciated. There are also general concerns that the ATAGI recommendations may lead to further mandates which would see children required to be ‘fully’ vaccinated to attend school, sports and other community activities. As things currently stand, I believe such a situation is ethically indefensible. I note that included in your recommendations for COVID-19 vaccination of children 5-11 year of age you 'do not support restricting the activities of children in this age group who are not vaccinated or have only received one dose’, and I commend you for including this caveat. While vaccination could be justifiable, and potentially very wise for certain children with specific circumstances, vaccinating healthy children who are not at risk of harm from COVID-19 will result in nothing but increased risks of vaccine adverse events for marginal, if any, benefit.
I would like to continue by addressing the prominent points in your advice contained in the ‘ATAGI recommendations on the use of the paediatric Pfizer COVID-19 vaccine in children aged 5 to 11 years in Australia’ statement which was published on December 8th, 2021.
The direct benefits of vaccination for the child in preventing illness:
Pfizer paediatric trial shows vaccine reduced incidence of COVID-19 in 5-11year olds.
While the Pfizer trial showed a relative risk reduction of 90.7% in infection in trial participants aged 5-11 years old, there were no severe cases of COVID-19 in either the treatment or the placebo groups (which I acknowledge you have noted). While this shows promising results on the surface, on the basis of data gained from adult COVID-19 vaccination roll-outs in Australia and overseas, there is no reason to think this level of efficacy will be retained in children long-term. How many boosters will children be expected to take in the likely event of COVID-19 vaccine failure?
Young children are at an extremely low risk of serious illness and/or death from COVID-19. At the time of writing, the Australian Government statistics show that of 61,420 COVID-19 cases in children less than 10 years of age, there has been only one death. Those numbers suggest a risk of 0.0016% of death for a child in this age category. The next age category (10-19 years old), while inclusive of children older than 11 years, has a similar risk profile with two deaths from 86,842 cases (0.0023% chance of death). While these tiny numbers represent real children whose losses are absolutely tragic, they do not adjust for co-morbid risk factors meaning the risk of death in healthy children is likely even smaller. For this reason, we must be sure the risks of COVID-19 vaccination in children are exhaustively considered; something which the Pfizer study did not accomplish.
Pfizer paediatric COVID-19 vaccine is immunogenic.
The Pfizer study showed their paediatric COVID-19 vaccine induced immunogenicity in only 264 trial participants. The broader issues here do not relate to the efficacy of the Pfizer paediatric COVID-19 vaccine nor its ability to cause immunogenicity, rather they relate to immediate and long-term safety. Just because this vaccine has been shown to reduce infection (in a population at minimal risk from COVID-19), that does not mean it is necessary or safe.
Study done pre-Omicron.
As you correctly note, this Pfizer study was conducted before the Omicron COVID-19 variant was involved in the pandemic. Therefore efficacy of the Pfizer paediatric COVID-19 vaccine when Omicron is the variant in question is unknown. Based on the emerging real-world data for adult cases of COVID-19, it seems likely the 90.7% reduction in relative risk of infection with COVID-19 this Pfizer study reported, will not be achieved in its real-world application.
Risk of post-COVID Paediatric multisystem inflammatory syndrome temporally associated with SARS-CoV-2 (PIMS-TS; also known as multisystem inflammatory syndrome in children, MIS-C) with study (Payne, et al. (2021) claiming an incidence of 1 in 3,165 children).
Payne et al. (2021) contains limitations which are relevant to consideration of risk for children in developing MIS-C post COVID-19 infection, especially if quantifications of this risk are being used to justify the recommendation of COVID-19 vaccination for all children 5-11 years old. In particular, Payne et al. (2021) claim that there is a strong epidemiological and laboratory ‘association’ between MIS-C and COVID-19 infection, however the research they rely on (Abrams, et al. (2020)) included some children who did not have PCR or serological evidence of prior COVID-19 infection (but had a known exposure to COVID-19 prior to developing systemic inflammatory symptoms), suggesting the links drawn may not be causal. Abrams et al. (2021) also say that MIS-C is a ‘newly identified syndrome’ which requires further research in order to define a ‘universal case definition’. While I concede the inclusion of children who may not have laboratory confirmed evidence of recent COVID-19 infection, but who have a recent confirmed exposure to COVID-19 is prudent in the further research of MIS-C more broadly, I do not believe these cases should be used to inform paediatric COVID-19 vaccination policy. While it may be unlikely, in the event these cases did not experience a COVID-19 infection, it is possible that such presumed cases of MIS-C may in fact be different clinical entities entirely. This may seem like a pedantic point, yet it is one which must be considered if we are intent on actively pursuing the goal of vaccinating as many 5-11 year olds as possible against COVID-19 (an undertaking that will almost certainly not be risk-free).
In addition, Payne et al. (2021) suggest that while they have made the appropriate corrections for underreporting and/or under-recognition of total COVID-19 infections, they also acknowledge there are factors which contribute to underestimating the total number of cases (including asymptomatic infections), in which case the overall risk of MIS-C may actually be lower.
Despite these limitations, the findings of Payne et al. (2021) showed that of 248 cases (with no significant difference in males and females), there was a higher incidence in Hispanic, Black, Asian and Pacific Island children when compared to white children. As you would expect, the authors concluded that this is an area requiring further research to determine if children from different racial backgrounds have a higher or lower risk of MIS-C post COVID-19 infection when individual risk/benefit analyses are undertaken. This is an important consideration for children, their parents and their family doctors when considering whether or not COVID-19 vaccination is right for them. Payne et al. (2021) and their supporting research shows there are clear ethnic factors to risk which should be further considered and this suggests a targeted COVID-19 vaccination roll-out for children at a higher risk of poor outcome as a result of COVID-19 is a preferred approach, rather than insisting on a one-size-fits-all approach of simply mass-vaccinating all children aged 5-11 years.
Moreover, does paediatric COVID-19 vaccination definitively prevent the development of MIS-C in the event of COVID-19 vaccine failure (breakthrough infection)? This question must also be reasonably answered before advising all children 5-11 years old to receive the COVID-19 vaccine.
Risk of ‘post-COVID-19 condition’ or ‘long COVID’.
While there is emerging evidence of ‘long COVID’ in a small number of adults, this incidence and effects in children do not seem to be well documented. A cursory search does not reveal any significant research in this area. I note that you are aware of some evidence which shows when children do develop ‘long COVID’ it is shorter in duration and less severe than in adult cases.
Similarly to MIS-C, does paediatric COVID-19 vaccination definitively prevent ‘long COVID’ in the event of COVID-19 vaccine failure (breakthrough infection)? This is another question which must be answered before simply mass-vaccinating all children aged 5-11 years against COVID-19.
The indirect benefits of vaccination for the child, their family and for the broader community. (To realise some of these benefits, a large proportion of the 5-11 year age group would need to be vaccinated):
Reduced school closures and disruptions to extra-curricular and social activities due to public health measures.
Mass-vaccination of all children (in particular, all healthy children with no known risk factors for poor COVID-19 outcome), has nothing to do with this issue. Current public health measures are political in nature and can be stopped at any time irrespective of vaccinations in healthy children. To suggest such changes are the responsibility of children by being contingent upon their broad uptake of COVID-19 vaccination (especially in cases where their risk of adverse event related to COVID-19 vaccination is elevated) is totally unreasonable.
Reduced absenteeism and isolation of children and their families (which disproportionately impact vulnerable children including those with disabilities and chronic mental and physical conditions; those under financial hardship; Aboriginal and Torres Strait Islander children; migrant and refugee children; those in residential care; and those in remote areas).
This is not an argument to mass vaccinate all healthy children so much as an argument against harmful, political public health measures including school closures and remote learning, COVID-19 vaccine mandates applied to parents, lockdowns, vaccine passport-style restrictions, to name a few; all of which also disproportionately affect many of the above groups of children.
Absenteeism and isolation of children and their families are again caused by political public health measures, and have nothing to do with whether or not a large proportion of children aged 5-11 years have received a COVID-19 vaccination or not. Given the woeful efficacy of adult COVID-19 vaccinations over time, it would seem that vaccinating all children in the above age category may not cause any lasting reduction in the spread of COVID-19 anyway, and by extension on rates of absenteeism or isolation related to dynamic public health policy.
In addition, given this waning efficacy of COVID-19 vaccinations for adults (which is likely to also occur in the paediatric vaccine), children with disabilities, chronic health conditions and/or other high risk demographics will remain at risk from vaccinated individuals who also contract and transmit COVID-19. This is further evidence to suggest a targeted approach in paediatric COVID-19 vaccination of high risk children, as opposed to all children.
Reducing disruptions to usual activities has a positive effect (mental health issues in children during pandemic increased significantly compared to pre-pandemic).
This is a point on which we can agree, although I would again suggest that these disruptions are caused by public health measures which can be changed at any time and do not rely solely on the mass-vaccination of all healthy children against COVID-19.
At the population level, reduced transmission of SARS-CoV-2 among young children may lead to lower SARS-CoV-2 incidence in all age groups.
Subjecting young children to an invasive medical procedure with emerging short- to moderate-term adverse effects and unknown long-term adverse effects for the benefit of older members of society is unethical and morally reprehensible. It is not the burden of children aged 5-11 years to take on unknown risks to protect adults. Shame on us as adults and healthcare workers; this has never been the case in medicine previously. If this is the direction we are determined to take, I fear for our future generations’ mental and physical wellbeing.
I note you also say ‘may’ lead to lower SARS-CoV-2 incidence in all age groups, so you cannot even say this is likely). Mass vaccination of healthy children against COVID-19 in the pursuit of such an uncertain goal is absolutely unjustifiable.
Several published modelling studies suggest that a vaccination program for young children may have an impact on reducing COVID-19 hospitalisations, ICU admissions and deaths in the overall population.
Sadly, modelling is inherently unreliable as has been demonstrated many times in the past, and during the COVID-19 pandemic. I note you use the word ‘may’ again. Are you really willing to gamble with the lives of children in the hopes that this strategy may succeed? I would again argue that risking the health of children in this undertaking is ethically indefensible. Children are not responsible for maintaining the health of adults, especially when to do so involves a risk, however rare, to their own health.
Children aged 5-11 years who contract SARS-CoV-2 within a school setting have a high likelihood of transmitting to unvaccinated household contacts.
Given the government have made it virtually impossible for people to avoid being vaccinated (due to the various vaccine mandates and restrictions for the unvaccinated, coupled with the hamstringing of medical staff in providing exemptions), I do not see why there would be a significant risk of this issue given almost all household contacts of children will already be vaccinated themselves. If a household contact is unvaccinated, in the event they are an adult I would argue the burden of risk of COVID-19 vaccination (or infection while unvaccinated) should fall on the household contact. In the event the household contact is a high-risk child, that is another argument for targeted vaccination for high-risk children specifically, not all children.
Rationale for dosing interval:
Attempts to offset peak antibody production with risk of adverse event/s.
Frankly, most of this is guesswork. The recommendations are not in line with the manufacturer’s instructions and instead adopt the same interval as is used in some countries overseas. As we have seen with adults and booster doses, the advice seems to change according to the whims of politicians and health bureaucrats, rather than clear scientific evidence. Is this the sort of thing we can expect for children, too?
Risk of adverse events:
Pfizer study showed it was ‘well tolerated’ in 5-11 year olds.
The Pfizer paediatric COVID-19 vaccine study was inadequate for the assessment of possible safety issues in COVID-19 vaccination for children. The sample size was a mere 2186 children (which in itself is curious, given the likelihood of many addition families and children being willing to participate), which was not large enough to capture some of the adverse events seen in other age groups (for example myocarditis and pericarditis, which I note you do acknowledge). Interestingly, the same dose given to 2-5 year olds in ongoing Pfizer research caused a significant number of participants to experience severe fevers (Pfizer, 2021). Given the dosage is not adjusted according to body weight like almost every other paediatric medication, this adverse event could occur in children with smaller builds in the 5-11 year old cohort.
A small number of participants in earlier adult and adolescent pharmaceutical trials (including those who received a Pfizer vaccine) have testified in various political fora regarding the adverse effects they experienced and how their symptoms have been trivialized by Pfizer when documented in the official trial data (or they were removed from the trial altogether) (Johnson, et al., 2021).
A Pfizer whistleblower has also come forward to suggest that certain trial centres were involved in the falsification of data (Thacker, 2021). In addition, the whistleblower alleged researchers did not appropriately follow up adult participants who reported adverse events and therefore data may be compromised (Thacker, 2021). These points suggest how relying heavily on for-profit companies’ assessments of their own products (particularly in emergency or provisional approval scenarios and with liability waivers in the case of adverse events) could be dangerous.
Emerging research suggests that the incidence of some adverse events (in young men and boys in particular) is being grossly under-recognised and/or under-reported by healthcare professionals and/or regulatory bodies such as the CDC and the TGA. A recent preprint by Sharff and colleagues (2021) showed an incidence of myopericarditis in boys ages 12-17 post their second dose of mRNA-based COVID-19 vaccine of 1 in 2,652.
The assertion that most cases of myocarditis and/or pericarditis resolve within a several weeks and are therefore not serious adverse events is ridiculous. In all my years working in acute care, myocarditis (or pericarditis) was a remarkably rare but serious diagnosis. I fear COVID-19 vaccine-induced myocarditis and pericarditis are not as rare as we currently believe, nor are they a minor inconvenience as many health bureaucrats would have us believe. Heart problems of this nature can cause life-threatening and/or life-limiting events in the short or long-term. We will not be able to appreciate the true depth or breadth of this issue for many years.
The fact that you acknowledge that myocarditis (not related to COVID-19) is lower in children ages 5-11 years old than in adolescents suggests that COVID-19 vaccination could significantly increase a child’s risk of myocarditis when compared to their presumed risk had they not received COVID-19 vaccination.
Adequate supply of the paediatric Pfizer COVID-19 vaccine is expected to be available to vaccinate all 5-11-year-old children:
Adequate supply to cover 5-11 year old children.
This reasoning is either poorly worded or obtuse. Just because we have the supply to vaccinate children aged 5-11 years (and presumably increasingly younger children in the future), it does not mean we should vaccinate them.
With the issues I have raised here in mind, I implore you to carefully reconsider your recommendations regarding COVID-19 vaccines for all children, particularly those who do not have any significant risk factors for poor COVID-19 outcome. By simply making sweeping recommendations without any nuance you are not adequately ensuring appropriate boundaries for harm minimisation. Your recommendations have very little to do with benefits for the specific children in question and a lot more to do with misguided attempts to reduce risks of COVID-19 in the adult population, while enabling politicians in their continued creation and application of poor public health policy more broadly. I believe you are currently at risk of facilitating the harm of children who are otherwise at very little risk from COVID-19, the extent of which we will only truly realise in the years and decades ahead.
Yours sincerely,
Laine Jolly.
References
Abrams, J. Y., et al. (2021). Multisystem Inflammatory Syndrome in Children Associated with Severe Acute Respiratory Syndrome Coronavirus 2: A Systematic Review. https://doi.org/10.1016/j.jpeds.2020.08.003
Australian Government Department of Health; Coronavirus (COVID-19) Case Numbers and Statistics. https://www.health.gov.au/health-alerts/covid-19/case-numbers-and-statistics
Johnson, R., et al. (2021). Vaccine Mandates Expert Panel Highlights.
Payne, A.B., et al. (2021). Incidence of Multisystem Inflammatory Syndrome in Children Among US Persons Infected With SARS-CoV-2. JAMA. https://doi.org/10.1001/jamanetworkopen.2021.16420
Pfizer (December, 2021). Analyst and Investor Call to Discuss the First COVID-19 Comprehensive Approach: Pfizer-BioNTech Vaccine and Pfizer’s Novel Oral Antiviral Treatment Candidate. Slide 23. https://s28.q4cdn.com/781576035/files/doc_presentation/2021/12/17/COVID-Analyst-and-Investor-Call-deck_FINAL.pdf
Sharff, K. A., et al. (2021). Risk of Myopericarditis following COVID-19 mRNA vaccination in a Large Integrated Health System: A Comparison of Completeness and Timeliness of Two Methods (Preprint). https://doi.org/10.1101/2021.12.21.21268209
Thacker, P. D. (2021). Covid-19: Researcher blows the whistle on data integrity issues in Pfizer’s vaccine trial. BMJ Investigation. https://doi.org/10.1136/bmj.n2635
Adding to this letter now, I would highlight that the anecdotal incidence of ‘long COVID’ does not appear to have been significantly reduced as a result of mass COVID-19 vaccination and boosting. Therefore I do not believe this warrants the mass COVID-19 vaccination of children with a novel product with known and potentially unknown adverse effects. Similarly, a recent journal article suggests Multisystem Inflammatory Syndrome in Children (MIS-C) also occurs after COVID-19 vaccination, and despite concluding that rates post-infection are greater than rates post-vaccination, I think it’s clear we really don’t have a firm handle on what we’re dealing with here.
I hope with every fibre of my being that rationality prevails when the FDA deliver their decision regarding babies and children six months to two years, but given everything that has happened to date in this sorry excuse for a pandemic response, I won’t hold my breath.
I still can't decide what I'm most shocked and appalled by - the willingness of individuals like Crawford to sacrifice children (the vast majority of whom were never at any risk) by formulating these guidelines, the eagerness of doctors to enact them, or the enthusiasm of parents to inject a product with no long term safety data into their own children.