The following statement has been prepared by a retired UK Consultant Paediatrician and shared in original form with the author’s knowledge and consent for general use.
This is a statement prepared for a parent objecting to the proposed vaccination of their child.
1. At the beginning of the COVID-19 vaccine roll-out, high-risk groups were clearly prioritized, and it was stated by the Chief Scientific Officer, Sir Patrick Vallance, that vaccination of the over 50s and those with specified co-morbidities, would give protection to the groups who have accounted for 98% of the deaths in the first wave.
2. However, once these cohorts had been offered two doses, the roll-out started moving to younger and younger age groups with no clear reassessment of the risk/benefit balance. It has been clear from the beginning of the pandemic that SARS-CoV-2 infection is generally very mild in children, the majority of whom are either completely asymptomatic or have symptoms of a normal cough or cold. Severe illness leading to hospitalisation is uncommon and of the small number of children who have died, the majority have had serious underlying chronic conditions, this group of children already being eligible for vaccination on compassionate grounds prior to the MHRA authorisation. Estimates for deaths of otherwise healthy children have been as low as 1 in 2 million. Even long-covid, a concern for adults, is much milder and shorter-lived in children. Given the very low clinical impact of COVID-19, the risk of adverse events plays a much bigger part in ascertaining the benefit-risk balance, particularly coupled with the complete lack of any long-term safety data for the novel mRNA gene-based technology involved.
3. Aware that Pfizer had applied to the MHRA (Medicines Health Regulatory Authority) for an Emergency Use Authorisation, a wide group of senior doctors and scientists wrote an open letter to Dr June Raine on 17th May 2020. They expressed their concerns and listed the many reasons for delaying the decision to vaccinate children, at least until after the adult trials were all completed. This was a long letter with a more detailed document with full references. They outlined not only the extremely low risk to children from COVID but also the lack of evidence for children as a major driver of the pandemic. Potential and known adverse events were detailed. They also outline the legal position for use of experimental therapies in terms of the need for fully informed consent, freely given.
4. On 4th June 2021 the MHRA granted an Emergency Use Authorisation for Pfizer BioNTech for children aged 12-15. It is clear from the Public Assessment Report that they had only considered the data provided to them by Pfizer and that they had not done a review of the real-world data appearing from countries already vaccinating this age group in terms of risk of adverse events. The extremely small size of the Pfizer children’s trial (only 1,131 children were vaccinated) and short follow-up period (2 months) are completely different from the normal size and time frame for vaccine development. Thus, the statement by Dr June Raine that the vaccine was ‘safe and effective for children was extremely misleading.
5. Despite the authorisation, the vaccine roll-out nevertheless did not go ahead at that time since the JCVI advised in July that the benefit/risk balance did not support vaccinating healthy under 18s. By August, they changed their advice for 16-17-year-olds but only recommended a single dose in acknowledgement of the increasing risk of myocarditis with subsequent doses, but still reiterated their advice against vaccinating healthy 12-15s. The minutes of the JCVI meeting highlight their concerns about potential adverse events.
6. By this time more reports from abroad revealed that the concerns were justified, especially regarding the growing number of boys suffering from myocarditis post-vaccination in Israel and in the US. The JCVI specifically requested more time so that those children in the US with abnormal cardiac MRI scans following post-vaccination myocarditis could be properly followed up to check for complete resolution.
7. In September, the JCVI again ruled out routine vaccination of 12-15-year-olds on health grounds, but the decision was passed to the Chief Medical Officers who advised to go ahead, not on the grounds of their physical health but on the grounds of reduced disruption to schooling. The programme was started in mid-September, using a single dose. This has more recently been extended to include a second dose but with no new safety data published.
8. Adverse event monitoring via the UK Yellow Card system and the American Vaccine Adverse Events Reporting System (VAERS) have both shown a large signal of adverse events reports including fatalities which have been much higher than with other vaccines and certain serious side effects have been particularly prominent, namely: excess blood clots, myocarditis, and neurological conditions including Bell’s palsy and Transverse Myelitis. These four conditions have all been added to side effects warnings in the drug information leaflets.
9. Myocarditis in particular, affects young people much more frequently than older adults. Israeli data (personal communication) is shown in Appendix 3. Recent reports from Hong Kong have shown a myocarditis risk of 1 in 2680 for boys aged 12-17 after the Pfizer second dose and they have moved to a single dose programme.
10. All-cause mortality: There has been a significant increase in all-cause deaths in males aged 15-19 years between May to December 2021 compared to the 5-year average 2015-2019. The Office of National Statistics have agreed in court1 that this rise is statistically significant, but they have refused a Freedom of Information request on grounds of breach of confidentiality. They confirmed that they have the data, and they will analyse it when more reliable data becomes available. One would expect that this data would be analysed prospectively when a new drug was rolled out at speed, especially one involving totally novel technology.
11. Lack of long-term safety data with new mRNA technology: of necessity, since the vaccines were only produced and trialled within the space of one year, there is no long-term safety data. Animal studies have also been very much reduced and full toxicology on the various components has not been published. Pfizer’s own biodistribution studies in rats and mice have shown that the lipid nanoparticles are concentrated in the testes and ovaries, raising concerns for use of these agents in young people of childbearing years. There are also significant concerns about potential effects on immune function and hence on the risk of antibody disease enhancement and possibly on autoimmune diseases and cancer risks.
12. Reduced severity of the new omicron variant: it is now clear from UK data and also from other countries that the omicron variant is much milder than the data and this has also been shown for children, so calculations used by the JCVI to inform their benefit-risk analysis would show a lower possibility of benefit.
13. Vaccine efficacy for omicron: Moreover, it is clear that omicron has a significant escape from the vaccines, with positive cases occurring at a higher rate in the vaccinated than unvaccinated. Vaccinated adults have been recalled for booster doses and in Israel now for a 4th dose. Indeed, in Israel despite 4 doses of vaccine, they have the highest case rate in the world and currently deaths are higher than in any previous wave. The CEO of Pfizer announced recently that two doses of Pfizer BioNTech have no efficacy against omicron which is the variant accounting for 95% of cases in England.
14. Protection by naturally acquired immunity: Israel initially omitted those with prior infection from their vaccination programme. Comparison over time showed those protected by prior infection had a 13-fold lower risk of infection than those protected by vaccination, with vaccine protection waning within six months. Numerous other papers have confirmed that naturally acquired immunity is broader and more robust. The latest UK data shows no additional protection provided by vaccination with prior infection compared to prior infection alone.
15. Vaccination after the prior infection has been shown to have a higher incidence of side effects. There are also concerns about antibody-dependent enhancement (ADE).
16. Gillick competence & informed consent: Gillick competence requires a thorough assessment by a trained health professional. They need to have explained fully all aspects of having a particular treatment and also of not having the said treatment. Originally introduced regarding contraceptive advice for under 16s, it can also be applied in other situations, though would rarely be used under the age of 14 years. Regardless of Gillick’s competence, the process of obtaining informed consent requires the person to be given all the relevant information and also consent must be freely given with no coercion or inducement of any kind. One problem regarding consent is that much misleading information has been given out in schools, on the importance of vaccination against killer illnesses such as smallpox and polio and implying and also information suggesting that getting a Covid vaccination will help protect your family and friends. Against this background, a degree of peer pressure and dismissal of concerns as ‘anti-vax’ has made proper informed consent illusory.
17. Summary: As can be seen from the above, the risks from SARS-CoV-2 infection to a child aged 12 are extremely low, such that the JCVI repeatedly stated that routine vaccination was inappropriate. With omicron, the risks are even lower, such that even any marginal benefit for vaccinating healthy children has now disappeared. The current vaccines have very poor efficacy against the circulating variant. Any child who has already had COVID-19 will have strong natural immunity and vaccination offers no additional benefit. Where reinfections have taken place, they have generally been much milder than the first infection (or simply test-positives) and over time the pandemic is resolving to the point where SARS-CoV-2 will be a seasonal endemic virus. Since the vaccination programme began, more evidence has come to light over potential side effects which can be life-threatening. It is also now clear that the vaccines cannot prevent infection or transmission and that their effect is short-lived. Many countries including the UK are removing restrictions and/or vaccine passports.
1 In the matter of The Queen (on the application of AB and CD, by their mother and Litigation Friend EF) v The Secretary of State for Health and Social Care and The Joint Committee Vaccination and Immunisation, CO-3001-2021, a non-party application was made for provision by the ONS of disclosure of information
