The Medicines and Healthcare products Regulatory Agency (MHRA), working with law enforcement partners, seized more than 15.5 million doses of illegally traded medicines with a street value of more than £30 million during 2023.
his includes more than two million doses seized during Operation Pangea, the international initiative of global enforcement partners that targets the illegal internet trade in medical products.
Last year’s seizures included prescription-only anti-anxiety medicines, opioids and sleeping pills and falsified and unlicensed lifestyle products such as erectile dysfunction and hair loss medications, as well as a small number of aesthetic products such as Botox and semaglutide-containing ‘weight loss’ products.
Working with partners, the MHRA also disrupted more than 12,000 websites illegally selling medical products to the public and shut down almost 3,000 social media profiles during the year.
The MHRA works with many online marketplaces, social media platforms and technology providers, as well as a wide range of law enforcement agencies at home and abroad to investigate and remove potentially harmful medical products that are offered illegally to the public.
Support and advice provided by the MHRA to online marketplaces resulted in the successful removal of more than half a million unregulated prescription medicines, over-the-counter medicines and medical devices before they could even be offered for sale to the public.
Andy Morling, MHRA Deputy Director (Criminal Enforcement), said: Public safety is our number one priority. Our Criminal Enforcement Unit works hard to prevent, detect and investigate illegal activity involving medicines and medical devices, to protect people and defeat this harmful trade.
“This year, working with partners across public and private sectors, our efforts have led to more medicines seizures than ever, custodial sentences for offenders, the removal of criminal profits and considerable success in disrupting the trade online.
“We would urge everyone to think very carefully before buying medicines they see online and to take the necessary steps to assure themselves the seller is legitimate. Buying powerful medicines from illegitimate sellers poses a real and immediate danger to your health, as you have no idea what they might actually contain.
“If you suspect that you have seen illegal products being sold online, you can help us take action by reporting your concerns through our Yellow Card scheme.
The dangers of unlicensed medicines
If a medicine is unlicensed, it will not have been assessed by the MHRA for its safety, effectiveness or the quality of its manufacturing and distribution processes. Anyone buying such a product cannot be sure what it contains or whether it will cause them harm.
In the courts
The sale of medicines and medical devices is strictly controlled in the UK, with certain products only permitted for sale through registered pharmacies or supplied on prescription from a qualified healthcare professional.
Last year, six MHRA investigations resulted in significant custodial sentences for many of those convicted. These prosecutions followed detailed investigations, the seizure of millions of doses of medicines and the removal of hundreds of thousands of pounds of criminal profits.
MHRA safety advice when buying medicines online
Be careful when buying medicines online
Medicines are not ordinary consumer goods and their sale and supply is tightly controlled. Websites operating outside the legal supply chain may seem tempting, for example, offering a prescription medicine without a prescription. Not only are these sites breaking the law – they are putting your health at risk.
Criminals use a variety of techniques to sell medicines illegally online. Some are sold using websites designed to look like legitimate pharmacies or online retailers, while others might be advertised via online marketplaces or social media sites.
Visit the #FakeMeds website for tools and resources to help people purchase medicines or medical devices safely online.
Anyone who suspects that their product is fake is encouraged to report it directly to the Yellow Card scheme, through the website (https://yellowcard.mhra.gov.uk/) or by searching the Google Play or Apple App stores for MHRA Yellow Card.
Following a comprehensive scientific safety review of the latest available data on the safety of pholcodine, together with advice from the independent Commission on Human Medicines, it has been concluded that the potential risks outweigh the benefits for these products.
The Medicines and Healthcare products Regulatory Agency (MHRA) keeps the safety of medicines under review and acts where necessary to protect patients and the public.
Following a comprehensive scientific safety review of the latest available data on the safety of pholcodine, together with advice from the independent Commission on Human Medicines, it has been concluded that the potential risks outweigh the benefits for these products.
There is already a known link between pholcodine and an increased risk of the very rare event of a severe allergic reaction (anaphylaxis) to muscle relaxants (neuromuscular blocking agents) that are used during general anaesthesia in surgery. In September 2022 the findings of a new study further strengthened the evidence of this link, but the overall risk is very small.
The MHRA advises that pholcodine-containing cough and cold medicines are being removed from the UK market as a precautionary measure.
Dr Alison Cave, MHRA Chief Safety Officer said: “Safety is our top priority, and we keep the safety of medicines under continual review.
“Following a thorough scientific safety review of all the available evidence on pholcodine, together with advice from the independent Commission on Human Medicines, it has been recommended, as a precautionary measure, that these products should no longer be used.
“If you are taking a cough or cold medicine, check the packaging, label or patient information leaflet to see if pholcodine is a listed ingredient. If it is, and you have any questions, you can talk to your pharmacist who will suggest an alternative medicine.
“If you have an operation scheduled using general anaesthesia, tell your anaesthetist if you think you have used pholcodine, particularly in the past 12 months. The anaesthetist will be well placed to take this into account. Anaesthetists are highly trained in managing anaphylaxis.
“If you want more information or advice, please speak to your pharmacist.”
Following on from the previous advice on which vaccines should be used in this year’s autumn booster programme, the Joint Committee on Vaccination and Immunisation (JCVI) has updated its published advice to include an additional bivalent vaccine now approved by the Medicines and Healthcare products Regulatory Agency (MHRA).
Studies indicate the Pfizer-BioNTech bivalent vaccine produces a marginally higher immune response against some variants than the Pfizer-BioNTech mRNA Original ‘wild-type’ vaccine. The clinical relevance of these small differences is uncertain.
‘Bivalent’ vaccines have been developed by global manufacturers since the emergence and dominance of the Omicron variant. These vaccines are targeted against antigens (substances that induce an immune response) from 2 different COVID-19 strains, or variants.
All of the available booster vaccines offer very good protection against severe illness from COVID-19. As more vaccines continue to be developed, the committee will consider their use in the autumn programme.
Professor Wei Shen Lim, Chair of COVID-19 immunisation on the JCVI, said: “It is very encouraging that more vaccines continue to become available and we now have another option to add to the vaccines already advised for the autumn booster campaign.
“Winter is typically the time of greatest threat from respiratory infections. We strongly encourage everyone who is eligible to have their booster vaccine this autumn when it is offered. This is our best defence against becoming severely ill from COVID-19.”
Pfizer/BioNTech bivalent COVID-19 booster approved by UK medicines regulator
A second, “bivalent” vaccine was yesterday approved as a booster by the Medicines and Healthcare products Regulatory Agency (MHRA) after it was found to meet the UK regulator’s standards of safety, quality and effectiveness.
The updated booster vaccine made by Pfizer/BioNTech, targeting two coronavirus variants, has been approved for use in individuals aged 12 years and above. This decision has been endorsed by the Commission on Human Medicines, after a careful review of the evidence.
In each dose of the booster vaccine, ‘Comirnaty bivalent Original/Omicron’, half of the vaccine (15 micrograms) targets the original virus strain and the other half (15 micrograms) targets Omicron (BA.1).
The MHRA’s decision is based on data from a clinical trial which showed that a booster dose with the bivalent Pfizer/BioNTech vaccine triggers a strong immune response against both Omicron and the original strain. Safety monitoring showed that the side effects observed were the same as those seen for the original Pfizer/BioNTech booster dose and were typically mild and self-resolving, and no new serious safety concerns were identified.
Dr June Raine, MHRA Chief Executive said: I am pleased to announce that we now have a second approved vaccine for the UK Autumn booster programme. The clinical trial of the Pfizer/BioNTech bivalent vaccine showed a strong immune response against the Omicron BA.1 variant as well as the original strain.
“Bivalent vaccines are helping us to meet the challenge of an ever-evolving virus, to help protect people against COVID-19 variants.
“We have in place a comprehensive safety surveillance strategy for all UK-approved COVID-19 vaccines, and this will include the updated booster we approved today.”
Professor Sir Munir Pirmohamed, Chair of the Commission on Human Medicines said: “Following an independent review of the safety, quality and effectiveness of the vaccine, the Commission on Human Medicines and its COVID-19 Vaccines Expert Working Group supports the MHRA’s decision.
“As with any medicinal product, including vaccines, it is important to continually monitor effectiveness and safety when it is deployed, and we have the relevant processes and expertise in this country to do that.
“The Joint Committee on Vaccination and Immunisation (JCVI) will advise on how this vaccine should be offered as part of the deployment programme.”
Health and Social Care Secretary Sajid Javid yesterday accepted advice from the Joint Committee on Vaccination and Immunisation.
Health and Social Care Secretary Sajid Javid said: “Our independent medicines regulator, the MHRA, has approved Pfizer’s paediatric vaccine for children aged 5 to 11 following a thorough review of the safety and effectiveness.
“I have accepted the advice from the Joint Committee on Vaccination and Immunisation to offer vaccines to at-risk 5-11 year old children and extend the booster programme to at-risk 12-15s and all 16-17s.
“While our current and unrelenting focus is ensuring all eligible adults are offered a COVID-19 booster vaccine by the end of December because two doses do not provide enough protection against the Omicron variant, the NHS will prepare to offer vaccines to at-risk 5-11 year old children.
“We have secured supplies of the Pfizer/BioNTech paediatric vaccine which will start to arrive in the UK from mid-January.
“Vaccines are our best defence against this virus and our booster programme has accelerated rapidly, with almost 30 million doses administered and more than half of adults jabbed, securing vital protection.
“This is a national mission and we urge everybody to play their part by getting their vaccines and booster doses as soon as possible.”
Thousands of vulnerable NHS patients in hospital due to COVID-19 are set to benefit from a ground-breaking new antibody treatment, the UK government has announced.
Ronapreve, a combination of two monoclonal antibodies, will be targeted initially at those in hospital who have not mounted an antibody response against COVID-19.
This includes people who are immunocompromised, for example those with certain cancers or autoimmune diseases, and therefore have difficulty building up an antibody response to the virus, either through being exposed to COVID-19 or from vaccination.
The government has taken action to secure supply of the new therapeutic for NHS patients across the four nations, buying enough to treat eligible patients in hospital from next week. Guidance will shortly be going out to clinicians so they can begin prescribing the treatment as soon as possible.
Health and Social Care Secretary Sajid Javid said: “We have secured a brand new treatment for our most vulnerable patients in hospitals across the UK and I am thrilled it will be saving lives from as early as next week.
“The UK is leading the world in identifying and rolling out life-saving medicines, particularly for COVID-19, and we will continue our vital work to find the best treatments available to save lives and protect the NHS.”
Ronapreve is the first neutralising antibody medicine specifically designed to treat COVID-19 to be authorised by the Medicines and Healthcare products Regulatory Agency (MHRA) for use in the UK.
It will be used to treat patients without antibodies to SARS CoV-2 who are either aged 50 and over, or are aged 12 to 49 and are considered to be immunocompromised.
Antibody testing will first be used to determine whether patients are seronegative, meaning those who do not have an adequate existing antibody response, and will therefore receive the treatment. The treatment antibodies – casirivimab and imdevimab – will then be administered to patients through a drip and work by binding to the virus’ spike protein, stopping it from being able to infect the body’s cells.
The UK’s world-renowned vaccination programme also continues to provide protection to tens of millions of people across the country, and has so far saved 112,300 lives, prevented 230,800 hospitalisations and stopped over 24 million infections in England alone.
Since the beginning of the pandemic, the UK has proven itself to be a world-leader in identifying and rolling out effective treatments for COVID-19 – including the world’s first treatment dexamethasone, which has since saved at least 22,000 lives in the UK so far and an estimated million worldwide.
The NHS has also rolled out monoclonal immunomodulatory antibody treatments tocilizumab and sarilumab, following clinical trial results from the government-funded REMAP-CAP trial. The treatments were found to reduce the relative risk of death by 24%, when administered to patients within 24 hours of entering intensive care.
Earlier this year, the government also brought together a new Antivirals Taskforce to supercharge the search for new treatments for patients who are exposed to COVID-19 to stop the infection spreading and speed up recovery time.
The UK’s leading research infrastructure and life sciences sector makes it the ideal base for the brightest of global innovators to research and progress cutting-edge treatments for COVID-19 through the clinical trials process here in the UK.
Paul McManus, COVID-19 Lead at Roche Products Ltd, said: “Over the last 18 months, our goal has been to do everything we can to minimise the impact of the pandemic on those affected and the brilliant people who work tirelessly to treat and care for them.
“Ronapreve is the first dedicated medicine developed for COVID-19 to receive marketing authorisation from the MHRA, representing a significant milestone in how the NHS is able to fight this disease.
“This is just another step in our journey to overcome COVID-19, and we will continue to collaborate with partners to identify and investigate multiple options that may help different groups of patients.
“Together with Regeneron, we’re grateful for the collaboration of the vaccine taskforce and NHS England in helping to bring this important antibody cocktail to treat and prevent acute COVID-19 across the UK.”
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.”
JVCI advises politicians to seek further advice from CMOs
The four Chief Medical Officers will provide further advice on the COVID-19 vaccination of young people aged 12 to 15 with COVID-19 vaccines following the advice of the independent Joint Committee on Vaccination and Immunisation (JCVI).
The independent medicines regulator, the Medicines and Healthcare products Regulatory Agency (MHRA), has approved the Pfizer and Moderna vaccines for people aged 12 and over after they met strict standards of safety and effectiveness.
The JCVI has advised that the health benefits from vaccination are marginally greater than the potential known harms. It has advised the government to seek further input from the Chief Medical Officers on the wider impacts.
This includes the impact on schools and young people’s education, which has been disproportionately impacted by the pandemic.
UK health ministers from across the four nations have today written to the Chief Medical Officers to request they begin the process of assessing the broader impact of universal COVID-19 vaccination in this age group.
They will now convene experts and senior leaders in clinical and public health to consider the issue. They will then present their advice to ministers on whether a universal programme should be taken forward.
People aged 12 to 15 who are clinically vulnerable to COVID-19 or who live with adults who are at increased risk of serious illness from the virus are already eligible for a COVID-19 vaccine and are being contacted by the NHS, to be invited to come forward.
The JCVI has advised that this offer should be expanded to include more children aged 12 to 15, for example those with sickle cell disease or type 1 diabetes.
Health and Social Care Secretary Sajid Javid said: “Our COVID-19 vaccines have brought a wide range of benefits to the country, from saving lives and preventing hospitalisations, to helping stop infections and allowing children to return to school.
“I am grateful for the expert advice that I have received from the independent Joint Committee on Vaccination and Immunisation.
“People aged 12 to 15 who are clinically vulnerable to the virus have already been offered a COVID-19 vaccine, and today we’ll be expanding the offer to those with conditions such as sickle cell disease or type 1 diabetes to protect even more vulnerable children.
“Along with Health Ministers across the four nations, I have today written to the Chief Medical Officers to ask that they consider the vaccination of 12 to 15 year olds from a broader perspective, as suggested by the JCVI.
“We will then consider the advice from the Chief Medical Officers, building on the advice from the JCVI, before making a decision shortly.”
Scottish Health Minister Humza Yousaf said: “I want to thank the JCVI for today’s advice regarding vaccination for 12 -15 year olds.
“While the JCVI has agreed that the benefits marginally outweigh the risks they are not yet prepared to recommend universal vaccination of 12-15 year olds, however, they have suggested that Health Ministers may wish to ask their respective CMOs to explore the issue further, taking into consideration broader educational and societal impacts.
“Therefore, I have agreed with the other three UK Health Ministers to write a letter asking the four Chief Medical Officers to consider this latest guidance and explore whether there is additional evidence to suggest it would be beneficial to offer vaccination to all 12 – 15 year olds. We have asked for this further work to be conducted as soon as possible.
“A further update will be issued once these discussions have taken place. In the meantime, we will offer the vaccine to those children and young people currently recommended.
“The recent increase in cases of COVID-19 means it remains crucial that everyone who is offered a vaccination takes up the offer.”
Under 30s in the UK should be offered an alternative to Oxford-AstraZeneca vaccine
The benefits of vaccination continue to outweigh any risks but the MHRA advises careful consideration be given to people who are at higher risk of specific types of blood clots because of their medical condition.
The MHRA is not recommending age restrictions in COVID-19 Vaccine AstraZeneca vaccine use.
The MHRA’s scientific review of UK reports of extremely rare and unlikely to occur specific blood clots with lowered platelets has concluded that the evidence of a link with COVID-19 Vaccine AstraZeneca is stronger but more work is still needed.
By 31 March 20.2 million doses of the COVID-19 Vaccine AstraZeneca had been given in the UK meaning the overall risk of these blood clots is approximately 4 people in a million who receive the vaccine.
Anyone who did not have these side effects should come forward for their second dose when invited.
The data suggest there is a slightly higher incidence reported in the younger adult age groups and the MHRA advises that this evolving evidence should be taken into account when considering the use of the vaccine.
The MHRA is now issuing updated guidance for healthcare professionals on how to minimise risks, as well as further advice on symptoms for vaccine recipients to look out for 4 or more days after vaccination.
Vaccines are the best way to protect people from COVID-19 and have already saved thousands of lives. Everyone should continue to get their vaccination when asked to do so unless specifically advised otherwise.
"If you sail a massive liner across the Atlantic, it's not reasonable that you aren't going to have to make at least one course-correction during that voyage"
The Joint Committee on Vaccination and Immunisation (JCVI) have also published a statement (see below) following reports of an extremely rare adverse event after vaccination with the first dose of the AstraZeneca COVID-19 vaccine.
This includes information on the use of the vaccine in those under 30.
The MHRA has undertaken a thorough review into UK reports of a very rare and unlikely to occur specific type of blood clot in the brain, known as cerebral venous sinus thrombosis (CVST) occurring together with low levels of platelets (thrombocytopenia) following vaccination with the COVID-19 Vaccine AstraZeneca. It is also considering other blood clotting cases (thromboembolic events) alongside low platelet levels.
These reports have been analysed by the Government’s independent advisory body, the Commission on Human Medicines (CHM) and its COVID-19 Vaccines Benefit Risk Expert Working Group, which includes lay representatives and advice from leading haematologists.
Up to and including 31 March 2021, the MHRA had received 79 UK reports of blood clotting cases alongside low levels of platelets following the use of the COVID-19 Vaccine AstraZeneca:
44 of the 79 cases were of CVST with thrombocytopenia
35 of the 79 cases were of thrombosis in other major veins with thrombocytopenia
79 cases occurred in 51 women and 28 men, aged from 18 to 79 years. It should be noted that more women have been vaccinated with COVID-19 Vaccine AstraZeneca than men.
Sadly, 19 people have died out of the 79 cases – 13 females and 6 males. 11 out of the 19 people who died were under the age of 50, 3 of whom were under 30. 14 of these 19 cases were of CVST with thrombocytopenia and 5 were of thrombosis with thrombocytopenia.
All 79 cases occurred after a first dose of the vaccine.
This risk, based on reports up to and including 31 March, is slightly higher than the risk calculated from the reports published up to and including 24 March. However, likelihood of these blood clots occurring is still extremely rare.
As a precaution, administration of COVID-19 Vaccine AstraZeneca in people of any age who are at higher risk of blood clots because of their medical condition should be considered only if benefits from the protection from COVID-19 infection outweighs potential risks.
Anyone who experienced cerebral or other major blood clots occurring with low levels of platelets after their first vaccine dose of COVID-19 Vaccine AstraZeneca should not have their second dose. Anyone who did not have these side effects should come forward for their second dose when invited.
Pregnancy predisposes to thrombosis, therefore women should discuss with their healthcare professional whether the benefits of having the vaccine outweigh the risks for them.
The MHRA recently confirmed that the evidence to date does not suggest that the COVID-19 Vaccine AstraZeneca causes venous thromboembolism without a low platelet count.
It is important to note that this type of blood clot together with lowered platelets can rarely occur naturally in unvaccinated people as well as in people with COVID-19 disease.
While the MHRA continues to investigate these cases, as a precautionary measure, anyone who has symptoms four days or more after vaccination is advised to seek prompt medical advice, such as:
a new onset of severe or persistent headache, blurred vision, confusion or seizures
develop shortness of breath, chest pain, leg swelling or persistent abdominal pain,
unusual skin bruising or pinpoint round spots beyond the injection site
Dr June Raine, MHRA Chief Executive, said: “Over 37 million doses of vaccines against COVID-19 have now been administered in the UK, saving thousands of lives through the biggest vaccination programme that has ever taken place in the UK.
“No effective medicine or vaccine is without risk. We continually monitor safety during widespread use of any vaccine. This is to ensure vaccines are performing as expected, to identify any new side effects that may arise, and to ensure the benefits continue to outweigh the risks.
“The public’s safety is always at the forefront of our minds and we take every report of a suspected side effect very seriously indeed. We thoroughly analyse each and every report as we receive it and although the number of reports of CVST and other thromboembolic events has increased over the last week, so has the overall number of vaccinations administered, therefore these blood clots remain extremely rare and unlikely to occur.
“We ask anyone who suspects they have experienced a side effect linked with their COVID-19 vaccine to report it to the Coronavirus Yellow Card website.
“It is still vitally important that people come forward for their vaccination when invited to do so.”
Professor Sir Munir Pirmohamed, Chair of the Commission on Human Medicines, said: “The independent Commission on Human Medicines (CHM) and its COVID-19 Expert Working Group, together with leading haematologists, has conducted a rigorous scientific analysis of all available evidence regarding reports of thromboembolic events occurring together with low platelets and COVID-19 Vaccine AstraZeneca and usage of the vaccine in different age groups.
“We have a rich source of data – the best data there is – and the MHRA and CHM will continue to keep this under close observation. The public deserve nothing less.”
JCVI statement on use of the AstraZeneca COVID-19 vaccine: 7 April 2021
Since the start of the pandemic over 4 million COVID-19 infections have been confirmed in the UK causing more than 120,000 deaths. Over 30 million people have received their first dose of COVID-19 vaccine since the start of the programme, which Public Health England (PHE) estimate has prevented at least 6,000 deaths in the first 3 months of 2021. Analysis of infection data since the introduction of the COVID-19 vaccines in the UK demonstrates that vaccination is highly effective and substantially reduces the risk of infection and severe COVID-19 disease.
There have been reports of an extremely rare adverse event of concurrent thrombosis (blood clots) and thrombocytopenia (low platelet count) following vaccination with the first dose of AstraZeneca ChAdOx1 nCoV-19 vaccine (AZD1222).
There has been no signal for thrombosis/thrombocytopenia following receipt of other COVID-19 vaccines approved for use in the UK (Pfizer-BioNTech and Moderna).
Given the very low numbers of events reported overall, there is currently a high level of uncertainty in estimates of the incidence of this extremely rare adverse event by age group.
However, the available data do suggest there may be a trend for increasing incidence of this adverse event with decreasing age, with a slightly higher incidence reported in the younger adult age groups.
In contrast, the risks of severe disease associated with COVID-19 increases steeply with age, with the youngest adults at lowest risk.
There are currently no known risk factors for this extremely rare condition, which appears to be an idiosyncratic reaction on first exposure to the AstraZeneca COVID-19 vaccine.
Alternatives to the AstraZeneca COVID-19 vaccine currently approved for use in the UK include the Pfizer-BioNTech BNT162b2 and Moderna mRNA-1273 vaccines.
JCVI has weighed the relative balance of benefits and risks and advise that the benefits of prompt vaccination with the AstraZeneca COVID-19 vaccine far outweigh the risk of adverse events for individuals 30 years of age and over and those who have underlying health conditions which put them at higher risk of severe COVID-19 disease.
JCVI currently advises that it is preferable for adults aged <30 years without underlying health conditions that put them at higher risk of severe COVID-19 disease, to be offered an alternative COVID-19 vaccine, if available.
People may make an informed choice to receive the AstraZeneca COVID-19 vaccine to receive earlier protection.
There are some adults <30 without underlying health conditions who are in phase 1, who were prioritised due to an increased risk of exposure and/or to reduce the risk of passing the infection on to vulnerable individuals.
This includes health and social care workers, unpaid carers and household contacts of immunosuppressed individuals. Acting on a precautionary basis, if these persons are still unvaccinated, it is preferable for them to be offered an alternative COVID-19 vaccine, if available.
JCVI is currently finalising its advice on phase 2 of the programme, particularly for healthy people under 30 years of age, and this will be published in due course.
To date, there are no reports of the extremely rare thrombosis/thrombocytopenia events following receipt of the second dose of the AstraZeneca COVID-19 vaccine. All those who have received a first dose of the AstraZeneca COVID-19 vaccine should continue to be offered a second dose of AstraZeneca COVID-19 vaccine, irrespective of age. The second dose will be important for longer lasting protection against COVID-19.
JCVI advises that all individuals offered a COVID-19 vaccine should be fully informed about the benefits and risks of vaccination. This should include clear information on the extremely rare thrombosis/thrombocytopenia adverse event, how to monitor for symptoms that might be related to the adverse event, and what action should be taken by individuals and health professionals in the event of such symptoms arising.
PHE is preparing updated information for those being offered COVID-19 vaccines, and for health professionals, which will be available through the GOV.UK website.
UK’s independent regulator to evaluate latest data from Pfizer and BioNTech to ensure the quality, safety and effectiveness of the vaccine meets the standards required.
The UK has ordered 40 million vaccine doses from Pfizer/BioNTech – enough for up to a third of the population
Initial data shows the vaccine is 94% effective in protecting people over 65 years old from coronavirus and clinical trials have not reported any serious safety concerns
The UK Government has today (Monday 23 November) welcomed the Medicines and Healthcare products Regulatory Agency’s (MHRA) review of data from Pfizer/BioNTech to determine whether its vaccine meets robust standards of quality, safety, and effectiveness.
The companies have reported data that indicates their vaccine is 94% effective in protecting people over 65 years old from COVID-19, with trials suggesting it works equally well in people of all ages, races and ethnicities.
As the first country to pre-order the vaccine from Pfizer/BioNTech, the UK is expected to receive a total of 40 million doses by the end of 2021, enough to vaccinate up to a third of the population, with the majority of doses anticipated in the first half of next year.
The COVID-19 vaccine will only be authorised for supply by the UK’s independent regulator the MHRA if it meets strict standards of quality, safety, and effectiveness, and if they are satisfied the vaccine can be consistently manufactured.
Today marks the next step forward for the vaccine following the MHRA’s confirmation that it has received the necessary data to progress their review into whether the vaccine meets the required standards.
Despite encouraging data about this vaccine, people must continue to follow public health advice to keep themselves and their loved ones safe; regularly washing their hands, wearing a face mask and making space.
Health and Social Care Secretary Matt Hancock said: “The whole country will be cheered by the news that Pfizer/BioNTech have formally reported the data from their clinical trials for their vaccine to the regulator.
“This is another important step on the road to recovery. We must now allow the MHRA’s renowned teams of scientists and clinicians to make an independent assessment of whether it meets their robust standards of quality, safety, and effectiveness.
“If approval is granted, the NHS will be ready to deliver. The NHS has vast experience in delivering widespread vaccination programmes and an enormous amount of work has taken place to ensure we have the logistical expertise, transport and workforce to roll out a vaccine according to clinical priority, at the speed at which it can be manufactured.”
Business Secretary Alok Sharma said: “Today, we have renewed hope that we are on the brink of one of the most significant scientific discoveries of our time, as we reach the crucial last stage to finding a COVID-19 vaccine.
“While this news is a cause for celebration, we must make sure that this vaccine, like all new medicines, meets standards of quality, safety, and effectiveness. I urge the public to be patient while we wait for regulators to do a thorough assessment.
“Finding a vaccine is not going to end the pandemic overnight, but we are hopeful of being one step closer to defeating this terrible virus.”
Final deployment plans will depend on decisions by regulators but preparations have been underway for months and are in place to ensure that:
the NHS will be ready to begin vaccinating as soon as the first vaccine is approved and delivered to the UK
GPs have already been signed up to take part in the programme when an appropriate vaccine is ready
dozens of hospitals across the country will lead co-ordination on behalf of neighbouring hospitals, community trusts and local health groups in vaccinating staff and other priority groups
there will also be vaccinations sites across the country
The government has purchased 7 different types of vaccine in advance and procured 355 million doses. This includes 100 million doses of the vaccine being developed by AstraZeneca and the University of Oxford.
The UK government is working closely with the devolved administrations to ensure an aligned approach to COVID-19 vaccine deployment across the UK.
Chair of Vaccines Taskforce, Kate Bingham, said: “We are moving ever closer to having the means with which to help end this pandemic but we must wait for the outcome of the MHRA assessment before we will truly know if we have our first approved vaccine.
“Irrespective of the outcome, which we all hope will be positive, this is a tremendous day for science. It is testament to the Herculean efforts of the scientific and biopharmaceutical community and it makes me immensely proud.”
