11th August 2022
Your ref DE-1411619
Dear Mr X,
Thank you for your detailed reply on behalf of the Secretary of State, but unfortunately it totally fails to address the concerns outlined in our recent letter.
You start with a statement ‘Vaccines are now safer than ever before’. Can you explain if that is the case, why the MHRA Yellow Cards and the American VAERS system are receiving adverse event reports from Covid-19 vaccines higher than for all previous vaccines over the last 20 years?
You have quoted reports from the MHRA in June 2021 and the JCVI and the CMOs in September 2021 but what we are asking is for the current data to be reviewed in light of the much milder omicron and the loss of efficacy of the vaccines against the current variants.
There may have been a marginal benefit in September 2021 but that risk benefit ratio no longer applies.
It is of note that Denmark have recently ceased all vaccination of healthy under 18s and the director of their national board of health has acknowledged that vaccinating children achieved nothing. Meanwhile data from Iceland have also shown that serious vaccine adverse events greatly exceeded severe COVID-19 infection in children.
Last week for the first time, the regular MHRA yellow cards report included 6 vaccine-associated deaths of children (see table 11).
It is very unwise to rely on advice from a narrow group of medical advisers who may find it difficult to acknowledge a previous error of judgement.
Thank you for urgently addressing the need to take a fresh look. The latest estimates are that 99% of 5-14-year-olds have already had SARS-CoV-2 infection so have no realistic benefit from these vaccines, only potential harms.
Dr Rosamond Jones, Convenor Children’s Covid Vaccines Advisory Committee
On behalf of 100 health professional and scientists (names supplied)
Our original letter sent to Stephen Barclay on 6th July is linked here
The reply we had received is shown below.
9th August 2022 Our ref: DE-1411619
Dear Dr Jones,
Thank you for your correspondence of 12 July to Steve Barclay about vaccination against COVID-19 for children. I have been asked to reply.
I understand your concerns.
Vaccines are now safer than ever before. Any vaccine must first go through the usual rigorous testing and development process and meet strict standards of safety, quality and effectiveness before it can be deployed. Each COVID-19 vaccine has been assessed by teams of scientists and clinicians on a case-by-case basis and is only authorised once it has met the robust standards set by the Medicines and Healthcare products Regulatory Agency (MHRA). There are extensive checks and balances required by law at every stage of the development of a vaccine. The data looked at includes all the results from laboratory studies, clinical trials, manufacturing, and quality controls and testing of the product. The public should be very confident that all tests were completed to the very highest standards.
On 4 June 2021, the MHRA authorised the use of the Pfizer/BioNTech vaccine in those aged 12 to 15. The MHRA undertook a comprehensive review of the clinical trial data and concluded that the Pfizer/BioNTech vaccine was safe and effective in this age group and that the benefits of this vaccine outweigh any risk. No new side effects were identified and the safety data in children was comparable with that seen in young adults. As with young adults, the majority of adverse events were mild to moderate and relating to reactogenicity, such as a sore arm or tiredness.
On 22 December, the MHRA authorised use of the Pfizer/BioNTech paediatric vaccine for use in those aged 5 to 11, again reporting that following a comprehensive review of the clinical trial data it had concluded that the vaccine was safe and effective for this age group, with no new safety concerns identified. The MHRA’s detailed review of all side-effect reports to date has found that the overwhelming majority relate to mild symptoms, such as a sore arm or a flu-like illness.
The MHRA has in place a comprehensive safety surveillance strategy for monitoring the safety of all UK-approved COVID-19 vaccines. The MHRA closely monitors the safety of COVID-19 vaccine exposures in individuals aged under 18, including Yellow Card reports for COVID-19 vaccines. The Yellow Card scheme is a mechanism by which anybody can voluntarily report any suspected adverse reactions or side effects to a vaccine. It is very important to note that a Yellow Card report does not necessarily mean that the vaccine caused that reaction or event.
The Joint Committee on Vaccination and Immunisation (JCVI) is the independent body, made up of scientific and clinical experts, that advises the Government on which vaccines the UK should use and provides advice on prioritisation at a population level.
Since the beginning of the pandemic, the Government has been guided by the latest clinical and scientific evidence and advice from the JCVI and our Chief Medical Officers (CMOs) to reduce COVID-19 mortality and protect health and social care staff and systems.
When formulating advice in relation to childhood immunisations, the JCVI has consistently held that the main focus of its considerations should be the potential benefits and harms of vaccination to children and young people themselves. The benefits and risks from COVID-19 vaccination in children and young people are finely balanced, largely because the risks associated with infection are very low.
On 3 September, the JCVI advised that, while there is a marginal benefit to universally vaccinating 12 to 15-year-olds, the Government should consider taking further advice from the CMOs of the UK’s four nations to enable a fuller consideration of the potential benefits of vaccination, including the educational impacts.
As suggested by the JCVI, the UK CMOs then looked at these wider public health benefits and risks of universal COVID-19 vaccination in this age group. Of these, the most important was the impact on education. The UK CMOs also considered the impact on mental health and operational issues such as any possible negative impact on other vaccine programmes, noting the importance of other routine immunisations of children and young people, and the imminent commencement of the annual flu vaccine programme.
The UK CMOs consider education one of the most important drivers of improved public health and mental health. Evidence from clinical public health colleagues consistently makes clear the massive impact that disrupted face-to-face education has had on the welfare and mental health of many children and young people. The negative impact has been especially great in areas of relative deprivation particularly badly affected by COVID-19.
Overall, the view of the UK CMOs is that the additional likely benefits of reducing educational disruption, and the consequent reduction in public health harm, on balance provide sufficient extra advantage in addition to the marginal advantage at an individual level identified by the JCVI to recommend in favour of vaccinating this group. They therefore recommended on public health grounds that the Government extends the offer of universal vaccination with a first dose of the Pfizer/BioNTech COVID-19 vaccine to all children and young people aged 12 to 15 not already covered by existing JCVI advice. The Government has accepted this advice.
Universal vaccination of 12 to 15-year-olds with a first dose began on 20 September, reflecting the Government’s ongoing commitment to protect young people from catching COVID-19, and minimising any disruption to their education.
In response to the Omicron variant, on 29 November the Government accepted advice from the JCVI that all young people aged 12 to 15 should be offered a second dose of the Pfizer/BioNTech vaccine at a minimum of 12 weeks from the first dose.
On 16 February, the JCVI advised a non-urgent offer of two 10 microgram doses of the Pfizer/BioNTech COVID-19 vaccine to children aged 5 to 11 who are not in a clinical risk group.
Vaccination of children aged 5 to 11 years who are not in a clinical risk group is not expected to have an impact on the current wave of Omicron infection. The potential benefits from vaccination will apply mainly to any future wave of infection, and the intention of this offer is to increase the immunity of vaccinated individuals against severe COVID-19 in advance of a potential future wave. A future wave may or may not cause more severe infection than the currently dominant variant. The more severe a future wave, the greater the likely benefits from vaccination.
This advice on the offer of vaccination to children aged 5 to 11 is considered by the JCVI as a one-off pandemic response programme. As the COVID-19 pandemic moves further towards endemicity in the UK, the JCVI will review whether, in the longer term, an offer of vaccination to this, and other, paediatric age groups continues to be advised.
Under-16s are not automatically presumed to be legally competent to make decisions about their healthcare and, therefore, whether they should be given the COVID-19 vaccine. However, under-16s will be competent to give valid consent to a particular intervention if they have sufficient understanding and intelligence to understand fully what is proposed, known as ‘Gillick competence’. A child below the age of 12 is unlikely to be found Gillick competent for vaccination.
If a child is not competent to give consent for themselves, consent should be sought from a person with parental responsibility.
In all instances, the offer of vaccination must be accompanied by appropriate information to enable children, and those with parental responsibility, to provide informed consent prior to vaccination.
Teams responsible for the implementation and deployment of COVID-19 vaccination for children aged 5 to 11 should be appropriately trained and confident regarding the information relevant to their vaccination.
I hope this reply is helpful.
XX, Ministerial Correspondence and Public Enquiries, Department of Health and Social Care