New treatment options will see people in the early stages of illness from COVID-19 who are at higher risk of complications access new antiviral treatments.
Antiviral medicines for the treatment of COVID-19 will be evaluated through a new national study called PANORAMIC, run by the University of Oxford. The UK-wide study will prioritise those at greater risk of being severely ill if they test positive for COVID-19. Eligibility for the study is therefore limited to those who meet certain criteria.
The study, starting today, is open to people aged 50 and above, or 18-49 with certain underlying health conditions which make them more vulnerable to COVID-19. They must also have started to experience COVID-19 symptoms within the past five days and have recorded a positive PCR test.
In addition to the study, all people considered as extremely high risk of becoming severely ill with COVID-19, and who have tested positive, will be able to access a monoclonal antibody or, if not appropriate, an antiviral treatment, from 16 December.
In the coming weeks letters will be sent to those eligible with further information. Details on who is eligible can also be found on NHS Inform, and – from 16 December – a dedicated contact number will be available for each health board to provide further information on how to get access to the medicines.
These treatments are in addition to vaccinations which still remain the best way to protect everyone.
Scotland’s Chief Medical Officer Dr Gregor Smith said: “This University of Oxford study will test whether new antiviral treatments for COVID-19 can help people in the early stages of the illness recover faster and therefore reduce the number of people being admitted to hospital.
“The results from the national study will give us a clearer understanding on how antivirals work in the UK population, which will allow the NHS to better plan how to make COVID-19 antivirals available for those who would benefit from them the most. We will provide further detail on plans for wider availability of antivirals in due course.
“I would encourage people in Scotland to take part if they are eligible. You may be contacted about taking part by a health care professional if you have a positive PCR result, or you can register yourself via the Oxford University website www.panoramictrial.org.
“The treatment is tablets taken orally as soon as possible after getting a COVID-19 infection to stop the illness from getting worse.
“Antiviral treatments are in addition to COVID-19 vaccinations – including boosters – and not a replacement. We hope they will help reduce the severity of illness in people who may fall ill even if they have been vaccinated.
“It remains clear that getting vaccinated is the single most effective step that anyone can take to protect themselves from the most severe disease caused by COVID-19. Anyone who has not yet received their first or second COVID-19 vaccination can check their nearest open access centre on NHS Inform or phone the national vaccination helpline on 0800 030 8013.”
Further details on the University of Oxford trial and what is involved in taking part is available at www.panoramictrial.org.
Move follows unanimous advice to ministers from the four UK Chief Medical Officers
Parental consent will be sought prior to vaccination
People aged 12 to 15 in England will be offered one dose of the Pfizer/BioNTech COVID-19 vaccine, following advice from the four UK Chief Medical Officers (CMOs), the Health and Social Care Secretary has announced. The Scottish Government is expected to make an announcement later today.
In line with the recommendation of the independent Joint Committee on Vaccination and Immunisation (JCVI), the government sought the views of the four UK CMOs on the wider issues that are relevant to the health of children.
The UK Government has accepted the advice of the four UK CMOs and the NHS is preparing to deliver a schools-based vaccination programme, which is the successful model used for vaccinations including for HPV and Diphtheria, Tetanus and Polio (DTP), supported by GPs and community pharmacies. Invitations for vaccination will begin next week.
Parental, guardian or carer consent will be sought by vaccination healthcare staff prior to vaccination in line with existing school vaccination programmes.
Healthy school-aged children aged 12 to 15 will primarily receive their COVID-19 vaccination in their school with alternative provision for those who are home schooled, in secure services or specialist mental health settings.
Health and Social Care Secretary, Sajid Javid said: “I have accepted the recommendation from the Chief Medical Officers to expand vaccination to those aged 12 to 15 – protecting young people from catching COVID-19, reducing transmission in schools and keeping pupils in the classroom.
“I am very grateful for the expert advice I have received from the Joint Committee on Vaccination and Immunisation and UK Chief Medical Officers.
“Our outstanding NHS stands ready to move forward with rolling out the vaccine to this group with the same sense of urgency we’ve had at every point in our vaccination programme.”
THE CHIEF MEDICAL OFFICERS’ LETTER READS:
To: Sajid Javid MP, Secretary of State for Health and Social Care, HM Government Eluned Morgan AS/MS, Minister for Health and Social Services, Welsh Government Humza Yousaf MSP, Cabinet Secretary for Health and Social Care, Scottish Government Robin Swann MLA, Minister of Health Northern Ireland Executive
13 September 2021
Dear Secretary of State, Cabinet Secretary and ministers,
Universal vaccination of children and young people aged 12 to 15 years against COVID-19
Background
The Joint Committee on Vaccination and Immunisation (JCVI) in their advice to you on 2 September 2021 on this subject said: ‘Overall, the committee is of the opinion that the benefits from vaccination are marginally greater than the potential known harms… but acknowledges that there is considerable uncertainty regarding the magnitude of the potential harms.
The margin of benefit, based primarily on a health perspective, is considered too small to support advice on a universal programme of vaccination of otherwise healthy 12 to 15-year-old children at this time…. JCVI is constituted with expertise to allow consideration of the health benefits and risks of vaccination and it is not within its remit to incorporate in-depth considerations on wider societal impacts, including educational benefits. The government may wish to seek further views on the wider societal and educational impacts from the Chief Medical Officers of the 4 nations, with representation from JCVI in these subsequent discussions.‘
You accepted this recommendation from JCVI, and wrote to us on 2 September 2021 stating “We agree with the approach suggested by JCVI, and so we are writing to request that you take forward work (drawing on experts as you see fit) to consider the matter from a broader perspective, as suggested by the JCVI.”
In doing so we have been fortunate to have been informed by the independent expertise of leaders of the clinical and public health profession from across the UK. This has included Presidents and Chairs or their representative of:
Royal College of Paediatrics and Child Health
Royal College of General Practice
Royal College of Psychiatry
Faculty of Public Health
Academy of Medical Royal Colleges representing all the other Royal Colleges and Faculties
Association of Directors of Public Health
Regional Directors of Public Health
national public health specialists
experts in data and modelling
We are very grateful to them for taking considerable time and effort to consult their own colleagues in all 4 nations at short notice to get a comprehensive view of the balance of informed medical opinion and experience across the UK.
The UK’s independent regulator of medicines and vaccines the Medicines and Healthcare products Regulatory Agency (MHRA) is in law the appropriate body to determine whether, based on risk-benefit grounds, a vaccine is safe and effective to use and so grant a licence. They have done so for children and young people aged over 12 years for two vaccines against COVID-19, those manufactured by Pfizer and Moderna. Their assessment is that benefits exceed risks on an individual basis. We take their independent opinion as read. The MHRA position on mRNA vaccines is similar to the relevant regulatory approvals granted in the same age groups in multiple other jurisdictions including but not limited to the USA, the European Union, and Canada.
The independent JCVI is the proper body to give advice on how to deploy a vaccine which has a prior favourable risk-benefit decision and authorisation from MHRA including whether it has a sufficiently large benefit to be worth deploying on a larger, population scale. Like MHRA they consider the benefits of vaccination in this age group exceed the risks (i.e. it is better to be vaccinated than not vaccinated in this age group).
They balanced the risk of COVID-19 against the risks of vaccination, including myocarditis. When forming its advice, the JCVI considered vaccine use according to clinical risk groups, thus identifying different groups according to their potential to benefit from vaccination.
For 12 to 15 year olds who do not have underlying health conditions that place them at higher risk from severe COVID-19, the JCVI considered that the size of both the risk and the benefit are at an individual level very small, and the overall advantage for vaccination, whilst present, is therefore not sufficiently large to recommend universal vaccination on their usual criteria.
They deemed the extent to which vaccination might mitigate the impacts of COVID-19 on education was beyond the usual remit of the JCVI. They recognised however that given the substantial scale of the impact of COVID-19 on all children and young people, which goes beyond normal clinical benefit and risk, wider issues could, exceptionally, be relevant hence their suggestion to consult UK CMOs.
The JCVI have already recommended that children and young people aged 12 to 17 with specific underlying health conditions, and children and young people who are aged 12 years and over who are household contacts of persons who are immunocompromised are offered two doses of a vaccine, normally Pfizer BioNTech BNT162b2. They have recommended all young people 16 to 17 are offered an initial first dose of vaccine.
The UK has benefited from having data from the USA, Canada and Israel, which have already offered vaccines universally to children and young people aged 12 to 15.
The UK CMOs start from the position that the MHRA and JCVI set out on individual benefit-risk calculations for this age group, and have not revisited this. We accept that at an individual level benefit exceeds risk but this advantage is small, and we have taken the JCVI figures as the UK current position on this question.
The Chair of the JCVI Prof. Lim has been a member of our group to ensure that there is no duplication of effort or conflict between the views of UK CMOs and the JCVI. We have been fortunate to have been joined also by the lead Deputy Chief Medical Officers for vaccines Prof. Van Tam (England), Prof. Steedman (Scotland) and Dr. Chada (Northern Ireland) and the DHSC Chief Scientific Adviser, Prof. Chappell. The final advice is that of the Chief Medical Officers, but informed by independent senior clinical and public health input from across the UK.
UK CMOs have decided in their ToR that we will only consider benefits and disbenefits to those aged 12 to 15 from vaccinating this age group, including indirect benefits. Whilst there may be benefits to other age groups, these have not been considered in our advice below.
Issues of vaccine supply were not factors considered in decision making.
The UK CMOs are aware of the extensive range of non-clinical views but this UK CMOs advice is purely clinical and public health derived and has not taken issues outside their clinical and public health remit into account. There is a subsequent political process where wider societal issues may be considered by ministers in deciding how they respond to this advice.
Advice
All drugs, vaccines and surgical procedures have both risks and benefits. If the risks exceed benefits the drug, vaccine or procedure should not be advised, and a drug or vaccine will not be authorised by MHRA. If benefits exceed risks then medical practitioners may advise the drug or vaccine, but the strength of their advice will depend on the degree of benefit over risk.
At an individual level, the view of the MHRA, the JCVI and international regulators is that there is an advantage to someone aged 12 to 15 of being vaccinated over being unvaccinated. The COVID-19 Delta variant is highly infectious and very common, so the great majority of the unvaccinated will get COVID-19. In those aged 12 to 15, COVID-19 rarely, but occasionally, leads to serious illness, hospitalisation and even less commonly death. The risks of vaccination (mainly myocarditis) are also very rare. The absolute advantage to being vaccinated in this age group is therefore small (‘marginal’) in the view of the JCVI. On its own the view of the JCVI is that this advantage, whilst present, is insufficient to justify a universal offer in this age group. Accepting this advice, UK CMOs looked at wider public health benefits and risks of universal vaccination in this age group to determine if this shifts the risk-benefit either way.
Of these, the most important in this age group was impact on education. UK CMOs also considered impact on mental health and operational issues such as any possible negative impact on other vaccine programmes, noting that influenza vaccination and other immunisations of children and young people are well-established, important, and that the annual flu vaccine deployment programme commences imminently.
The UK CMOs, in common with the clinical and wider public health community, consider education one of the most important drivers of improved public health and mental health, and have laid this out in their advice to parents and teachers in a previous joint statement. Evidence from clinical and public health colleagues, general practice, child health and mental health consistently makes clear the massive impact that absent, or disrupted, face-to-face education has had on the welfare and mental health of many children and young people. This is despite remarkable efforts by parents and teachers to maintain education in the face of disruption.
The negative impact has been especially great in areas of relative deprivation which have been particularly badly affected by COVID-19. The effects of missed or disrupted education are even more apparent and enduring in these areas. The effects of disrupted education, or uncertainty, on mental health are well recognised. There can be lifelong effects on health if extended disruption to education leads to reduced life chances.
Whilst full closures of schools due to lockdowns is much less likely to be necessary in the next stages of the COVID-19 epidemic, UK CMOs expect the epidemic to continue to be prolonged and unpredictable. Local surges of infection, including in schools, should be anticipated for some time. Where they occur, they are likely to be disruptive.
Every effort should be taken to minimise school disruption in policy decisions and local actions. Vaccination, if deployed, should only be seen as an adjunct to other actions to maintain children and young people in secondary school and minimise further education disruption and therefore medium and longer term public health harm.
On balance however, UK CMOs judge that it is likely vaccination will help reduce transmission of COVID-19 in schools which are attended by children and young people aged 12 to 15 years. COVID-19 is a disease which can be very effectively transmitted by mass spreading events, especially with Delta variant. Having a significant proportion of pupils vaccinated is likely to reduce the probability of such events which are likely to cause local outbreaks in, or associated with, schools. They will also reduce the chance an individual child gets COVID-19. This means vaccination is likely to reduce (but not eliminate) education disruption.
Set against this there are operational risks that COVID-19 vaccination could interfere with other, important, vaccination programmes in schools including flu vaccines.
Overall however the view of the UK CMOs is that the additional likely benefits of reducing educational disruption, and the consequent reduction in public health harm from educational disruption, 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 recommend on public health grounds that ministers extend the offer of universal vaccination with a first dose of Pfizer-BioNTech COVID-19 vaccine to all children and young people aged 12 to 15 not already covered by existing JCVI advice.
If ministers accept this advice, UK CMOs would want the JCVI to give a view on whether, and what, second doses to give to children and young people aged 12 to 15 once more data on second doses in this age group has accrued internationally. This will not be before the spring term.
In recommending this to ministers, UK CMOs recognise that the overwhelming benefits of vaccination for adults, where risk-benefit is very strongly in favour of vaccination for almost all groups, are not as clear-cut for children and young people aged 12 to 15. Children, young people and their parents will need to understand potential benefits, potential side effects and the balance between them.
If ministers accept this advice, issues of consent need to take this much more balanced risk-benefit into account. UK CMOs recommend that the Royal Colleges and other professional groups are consulted in how best to 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.
If ministers accept this advice, it is essential that children and young people aged 12 to 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. Individual choice should be respected.
Chief Medical Officer for England Prof. Christopher Whitty
Chief Medical Officer for Northern Ireland Sir Michael McBride
Chief Medical Officer for Scotland Dr. Gregor Smith
Chief Medical Officer for Wales Dr. Frank Atherton
Over four in five adults across the UK have received both COVID-19 vaccine doses, with over half of all 16 and 17 year olds coming forward for their first jab.
However COVID numbers continue to rise across the UK. 28,856 new cases were reported yesterday, with 4241 of these in Scotland. The daily Scottish figure is likely to be considerably higher due to an IT problem.
Responding to the advice from the Chief Medical Officers regarding the vaccination of all 12-15 year olds, Bruce Adamson, the Children and Young People’s Commissioner Scotland, said: “We welcome the advice to offer the vaccine to children between the age of 12 and 15. It is important to give them that choice.
“Children and young people have a right to the best possible health, that’s not just about protection from the Covid virus itself, but also the impact on their mental health due to isolation and other factors. The pandemic has impacted their right to education, their right to play, their right to see wider family and friends which is so essential to their development. Their education has been disrupted with two long periods of school closures.
“It is important that children are supported to make informed decisions about their own health. Children of this age group have told me over the last few months that they are in favour of having the choice to be vaccinated. That is not to say that all of them had made a decision about whether they would get a vaccine, but they wanted the option to be available to them. Of course, there have been some children who are concerned about vaccination, or who told me about parental concerns. It is important that there is no stigma attached to the choices that children make about vaccination.
“It is essential that this advice is communicated directly to 12 to 15 year olds in a child-friendly way so they can understand why they are now being offered the vaccine, and can have any questions they might have answered in a way they can understand. Children have the right to access appropriate information on decisions affecting them.
“Parents and carers will play an important role in supporting the decision-making around whether a child chooses to get vaccinated so it is important that they have all of the necessary information to support that choice.”
“By far the best course of action for you and your baby is to get both doses of the vaccine”
Scotland’s Chief Medical Officer is urging pregnant women to get the coronavirus (COVID-19) vaccine to protect them and their baby.
Following a recent study showing evidence of increased hospitalisations, Dr Gregor Smith is encouraging all expectant mothers to discuss the vaccine with their healthcare professionals so they can make a fully informed choice.
The UK Obstetric Service (UKOSS) published research last month which showed the number of pregnant women being admitted to hospital with COVID-19 across the UK is increasing, with many experiencing acute symptoms.
The report also suggests the Delta variant is associated with an increased risk of severe illness among hospitalised pregnant women.
Dr Smith said: “Firstly I want to thank all our healthcare staff for everything they are doing across Scotland not just in relation to the wider vaccination programme but also for their efforts to ensure good outcomes for women, families and babies during the pandemic.
“We have written to heath boards and GPs to ensure they are aware of all the latest evidence-based advice and guidance to enable them to fully discuss the very clear positive benefits of the vaccine with their patients.
“Recent data shows the number of pregnant women being admitted to hospital with COVID-19 has risen, and that is concerning. Evidence suggests that the Delta variant may be associated with an increased risk of severe illness among hospitalised pregnant women.
“We want all pregnant women to have the information they need to make an informed choice, so if you have any concerns or questions, please speak to your midwife, GP, or go along to a drop-in clinic. By far the best course of action for you and your baby is to get both doses of the vaccine.”
Appealfor those who missed vaccine appointments to come forward
Anyone who was part of vaccine priority groups 1-9 and missed their original appointment is being asked to come forward to arrange their vaccination.
This includes everyone 50 or over, adults on the shielding list, anyone with underlying health conditions, and unpaid carers.
Invitations have been issued to everyone aged 40 or over, with 30-39-year olds starting to be invited now. In the specific areas of Glasgow affected by the current outbreak, all 18-39 year olds are being invited with older age groups first.
Anyone who believes they should have had a letter by now with details of either their first or second dose should call the national helpline or fill out the missing appointments form on the NHS Inform site.
The system for handling missed appointments has recently been streamlined in order to speed up the process.
More than three million people – two thirds of the adult population – have now received their first dose. However, in response to the new variant currently circulating in parts of the UK, and in line with updated JCVI advice, second doses which are not already scheduled, are being brought forward from 12 weeks to eight weeks across Scotland where supply allows.
Chief Medical Officer Dr Gregor Smith said: “Our vaccination programme has been extremely successful, and we’ve seen very high uptake rates across all age groups. However, we know that there will inevitably be a small number of people who, for a variety of reasons, may not have taken up their original appointment.
“Our message to you is clear – it is not too late, and you are still welcome. Please contact us to make an appointment today.
“It continues to be vitally important that everyone takes up the opportunity to get both doses of their vaccination when their opportunity arrives. I want to emphasise that the second dose offers greater and longer lasting protection, and should not be missed.
“Vaccination is crucial in protecting ourselves, our families and communities and helping us on the path back to normality.
“Anyone who missed their original appointment, or thinks they may have been missed, should contact the Vaccination Helpline on 0800 013 8013 or fill out the missing appointment form on the NHS Inform website. They can also help you find other ways to get your coronavirus vaccination if you are unable to leave your home for your appointment on medical grounds.
“People who have been vaccinated should still continue to get tested and engage with contact tracing teams if they are a contact of a positive case. While the latest evidence suggests vaccines provide a high level of protection, they don’t yet provide a guarantee that you can’t still get the virus or pass it on to others around you.”
