Blog posts

Consent for covid-19 vaccination in children

Now that covid-19 vaccination of children in the UK is starting, it is essential that the legal basis of consent for a medical intervention in this group are well understood

A Court of Appeal ruling on 17 September 2021 overturned a previous High Court ruling, and decided that parental consent is not needed for children under 16 to take puberty blockers. This reaffirms, again, that the responsibility to consent to treatment depends on the ability of medical staff to decide on the capacity of under 16 year olds to consent to medical treatment.

The timing is auspicious. Just a few days before, the four UK Chief Medical Officers recommended that all healthy children aged 12-15 should be “offered” a single covid-19 vaccine, with a booster likely in the Spring 2022. Until now, the only children in this age group offered a vaccine have been those with certain medical conditions, or those living in a household with a clinically vulnerable adult. With a mass vaccine campaign for children now starting, the issue of consent for vaccines in this group has been headline news.

Reaching the decision about vaccinating 12-15 year olds in the UK has been an interesting process. The Joint Committee on Vaccination and Immunisation (JCVI) have deliberated, awaiting evolving evidence, and have scrutinised the data available purely on a risk benefit basis for the vaccine itself. The chief medical officers looked at wider effects to society, and given that modelling suggests that vaccination of 12-15 year olds can save so many lost days of school, infections and associated transmission, they recommended vaccination to the government, but leaving the final decision to politicians.

Now that covid-19 vaccination of children in the UK is starting, it is essential that the legal basis of consent for a medical intervention in this group are well understood by parents, carers, health professionals—and most importantly by children. Teenagers who are aged 16 or 17 are deemed under English law to be able to give their own consent for vaccination. But what about 12-15 year olds?

Ideally, for children who are aged 12-15, covid-19 vaccination would be given with the approval and support of their parents. This is likely to improve children’s confidence in covid-19 vaccines, and help ensure a high and rapid take-up of vaccination. With the vaccine programme due to start in schools before the end of September, parents are being sent out consent forms, along with NHS information leaflets. Explaining such a finely balanced decision in child friendly terms will be challenging. A survey by the UK Office for National Statistics reported that around 90% of parents were in favour of vaccinating children. Surveys also show good confidence in covid-19 vaccines among children and young adults (but usually at a lower level than among older people).

But despite high overall support for covid-19 vaccination, there will be families where children and parents may have very differing opinions about its risks and benefits. For example, some parents may be strongly opposed to covid-19 vaccination, but their child may have a different view. The opposite situation is also possible whereby the parents are in favour of vaccination but the child is opposed to vaccination.

In such circumstances, the NHS and the responsible clinicians have to decide if the child is competent to make their own decision about covid-19 vaccination. This is known as Gillick competence following a court case in the 1980s between Ms Victoria Gillick and the NHS about consent to treatment for children under 16. The court case eventually made its way to the House of Lords, which ruled that “As a matter of Law, the parental right to determine whether or not their minor child below the age of sixteen will have medical treatment terminates if and when the child achieves sufficient understanding and intelligence to understand fully what is proposed.” The ruling is valid in England and Wales.

Whether a child is Gillick competent is assessed using criteria such as the age of the child, their understanding of the treatment (both benefits and risks) and their ability to explain their views about the treatment. If deemed to be Gillick competent, the child can make their own decision about a medical intervention such as covid-19 vaccination.

There may also be situations in which two parents disagree about covid-19 vaccination. If the child is not Gillick competent, then a decision needs to be made about which parent’s views take priority. In a court case in 2020 where two parents disagreed about vaccination for their children, the Judge ruled that vaccination was in the best interests of the child because this is what the scientific evidence suggests. In the court case, the judge (Mr Justice MacDonald) deferred deciding about any future covid-19 vaccination because of the “early stage reached with respect to the covid-19 vaccination programme.” However, now that vaccination has been approved by the UK government and is supported by bodies such as Public Health England, it is highly likely that a court would rule in favour of covid-19 vaccination where two parents had opposing views.

None of these issues are new, and the current HPV vaccination programme has tested many of the issues surrounding vaccination in this age group already. However, the scale and speed of the covid-19 vaccination may be far more contentious—particularly given the finely balanced risk-benefit profile, the small risks of myocarditis, and the vaccine hesitancy already noted in younger people.

It is important that parents, teachers, and healthcare professionals understand the risk and benefits of covid-19 vaccination for children, so that we can support them in reaching an informed decision. We need to respect the ability of our children, whose lives and education have been so greatly affected and disrupted by the pandemic, to reach their own conclusions given the evidence available. Where there is a disagreement between a child and their parents or legal guardians regarding any medical treatment, healthcare professionals must feel confident in judging Gillick Competence and the issues surrounding capacity to give consent.

Azeem Majeed, Professor of Primary Care and Public Health, Imperial College London, London, UK, Twitter @Azeem_Majeed

Simon Hodes, GP Partner, Watford, UK, Twitter @DrSimonHodes

Stephen Marks, Consultant Paediatric Nephrologist, Great Ormond Street Hospital, London, UK

Competing Interests: We have read and understood the BMJ policy on declaration of interests. AM and SH are GPs and have supported the NHS covid-19 vaccination programme. We have no other competing interests.

Acknowledgements: AM is supported by the NIHR Applied Research Collaboration NW London. The views expressed are those of the authors and not necessarily those of the NHS, the NIHR or the Department of Health and Social Care.

This article was first published in BMJ Opinion.

GPs should not be made scapegoats for political failings

A recent article in the Daily Telegraph article asked “If the GPs went on strike, would anybody notice?” The article claimed that no one would notice if GPs went on strike and the author suggested that making all GPs salaried, forcing them to work longer hours, would help improve general practice for patients. The author quoted “a now retired GP in his 90s from Bristol who continued doing locum work until five years ago,” who apparently said, “Many GPs are using covid-19 as an excuse for not providing good clinical services. Being able to opt out of night/weekend cover and only working two or three days a week have caused the demise of general practice to the detriment of patients.”

As GPs we have worked throughout this pandemic often face-to-face in the most basic of personal protective equipment (PPE), and we were disheartened to read this piece.

GPs and their teams have played an essential role throughout the pandemic. GP teams in England alone deal with over 300 million contacts each year. General Practices have been running community hot covid clinics, and supporting NHS 111 and the Covid Clinical Assessment Service (CCAS). We are supporting 5.5 million patients on NHS waiting lists, who are often in severe pain and in need of extra support, as well as supporting about 1 million patients with the effects of long covid, and adapting to new ways of working enforced by a global pandemic. In addition, our teams have delivered the majority of covid vaccinations thus far. We are currently being asked to recall our most clinically vulnerable patients for their third covid booster vaccination. All this has been achieved despite the proportion of the NHS budget spent on NHS general practice and the number of GPs per person both declining in England in recent years.

We are already seeing that any small reduction in GP access causes rapid spill over into Emergency Departments, so just imagine if there were no GP service at all. The NHS would collapse. When GPs began to pull back from the covid-19 vaccination programme because of the mass vaccine sites taking over, for example, the rate of vaccination slowed—especially in the hardest to reach groups—and complaints increased from patients unable to access vaccine appointments.

If we look at prescriptions, GPs and their teams issue a vast number every year. If another part of the NHS tried to take on this work, an army of people would be needed—doctors, pharmacists, and administrative staff. Many higher risk medications need careful monitoring and regular review. Patients on most regular medication also require medication reviews, checks (e.g., blood tests, measuring blood pressure) to monitor safe prescribing and prevent drug interactions, and to deal with queries and frequent shortages and changes of medicines. The efficient systems that GPs have developed for prescribing means that they issue many prescriptions that would be given by hospital specialists in other countries.

Moreover, every patient seen in secondary care generates a letter, often with requests for GP teams to follow up patients, monitor their treatment, arrange blood tests, or prescribe.

The work of a GP can be incredibly rewarding as we build long term relationships with people over years, and there is strong evidence for the benefits of continuity of care (for both patients and the care provider).  GPs are true “generalists” and the uncertainty of undifferentiated illness is stressful, especially when working remotely. GPs in the UK work at a higher level of intensity than elsewhere in Europe. GPs in the UK have the shortest consultation times in Europe, and UK GPs tend to see more than twice the safe recommended number of patients per day.

BMA appointment data show huge increases in activity over the past 18 months. Yes, there are more telephone appointments and fewer face to face appointments, but this is the same in all sectors of society—and the same for both community and hospital care. It should come as no surprise, or make headline news, because remote working is in line with direct government policy and is there to protect both patients and staff from a highly infectious and potentially lethal virus. It is especially important to protect the many vulnerable individuals we look after in general practice, in a time when there are over 30,000 covid-19 cases reported daily in the UK.

Despite political promises for an additional 6000 additional GPs in England by 2024, there has been a reduction in numbers rather than an increase. While there is a clear link between ratios of family doctors and life expectancy, the number of patients per practice is now 22% higher than it was in 2015, and the GP workforce has not grown with this demand. As a result, there are now just 0.46 fully qualified GPs per 1000 patients in England, down from 0.52 in 2015, which, when added to growing demand from the rising number of people living with complex chronic illness and poverty along with an ageing population, means that primary care is in a desperate situation. GP turnover is higher in deprived areas further exacerbating health inequalities.

Demand on general practice is increasing, while at the same time general practices are struggling to recruit staff. The current deepening GP crisis that we are facing is having widespread effects on patient care nationwide. The current crisis long predated covid-19, but the pandemic has highlighted the large cracks in the NHS. GP teams should not be made scapegoats for the political failings, under-funding, and shortages of essential staff, which are the root cause of the issue.

General practice is often described as the “Bedrock of the NHS,” and the NHS Five Year NHS View states that “if General Practice Fails the NHS Fails.” We must be mindful of that, and instead of blaming GPs for the current crisis, look at what can be urgently done to alleviate the crisis.

Simon Hodes, GP partner in Watford, GP trainer, appraiser and LMC rep. Twitter: @DrSimonHodes

Frances Mair, Norie Miller professor of general practice. Twitter: @FrancesMair

Azeem Majeed, Professor of Primary Care and Public Health, Imperial College London, London, UK, Twitter @Azeem_Majeed

This article was first published in BMJ Opinion.

Covid infections are high in the UK – these are the reasons why

Covid-19 case numbers remain high in the UK. In this article, I discuss why this is and why vaccines are working as expected, and protecting us from serious illness and death.

What is a breakthrough infection?

No vaccine is 100% effective against preventing infection. An infection in a fully vaccinated person is sometimes described as a breakthrough infection because the infective agent has “broken through” the protection from infection provided by the vaccine.

How common is Covid-19 infection in fully vaccinated people?

Data from Public Health England show that the Covid-19 vaccines used in the UK reduce the risk of  infection by about 70-90% in people who are fully vaccinated, so vaccines prevent the majority of people who are vaccinated from becoming infected. However, some people who are fully vaccinated will still become infected. Over time, as the number of people in the population who are vaccinated increases, a greater proportion of infections will occur in vaccinated people. It is possible that the immunity from vaccination will weaken over time, with breakthrough infections therefore becoming more common, which is why the government is now considering giving booster doses of vaccine to some people.

How serious is Covid-19 infection in vaccinated people?

Research shows that vaccines are very effective in reducing the risk of serious illness from a Covid-19 infection, with around a 95% reduction in the risk of hospitalisation and death. However, some people who are vaccinated will still have a serious illness. As with infections in unvaccinated people, the risk of a serious illness is highest in the elderly and people with medical problems such as diabetes and obesity.

What makes a breakthrough infection more likely?

The more people you come into close contact with, the more likely you are to have a breakthrough infection. People whose work involves a lot of contact with other people, such as health professionals, will be at greater risk of a breakthrough infection. The risk of a breakthrough infection is also higher in people with weak immune systems because vaccines work less well for them. The risk of becoming infected with Covid-19 is highest in poorly-ventilated, crowded indoor spaces. To reduce your risk of infection, you should as far as possible, avoid these kinds of settings. A face mask can provide some protection from infection, particularly if you use a higher specification mask such as FFP2 mask.

How do new variants like delta effect the risk of infection?

The delta variant of the coronavirus that spread across the world in 2021, and which is now responsible for nearly all cases of Covid-19 in the UK, is more infectious than other variants. Vaccines will be a little less effective at preventing infection from the delta variant than the variants that were previously circulating in the UK. However, vaccines still remain very effective at preventing serious illness, hospitalisation and death, even against infections caused by the delta variant. So far, we have not yet come across a variant of the coronavirus against which vaccines are ineffective.

How well are vaccines working in the UK?

Vaccines are working very well in the UK. Around 81% of people aged 16 and over have been fully vaccinated. Public Health England estimates that around 24 million infections, 144,000 hospitalisations and 112,000 deaths have been prevented by vaccination. Without vaccines, the number of cases, hospitalisations and deaths in the UK would be much higher than now, requiring further Covid-19 restrictions and lockdowns to control the pandemic. It is vaccines that have allowed the government to relax these restrictions and let people to live more normally.

First published in the Daily Mirror.

Risk of Covid-19 in shielded and care home patients

Early in the Covid-19 pandemic, the elderly and people who were clinically extremely vulnerable were asked to shield to reduce their risks of Covid-19 infection and its complications. We evaluated the effectiveness of shielding in a study published recently in the journal BJGP Open.

We found that Covid-19 rates were much higher in the shielded group compared with non-shielded group (6.5% vs 1.8%). The increase in risk of infection in the shielded group persisted after adjustment for a wide range of factors in a Cox proportional hazards regression model.

We also found that Covid-19 rates were seven times higher in people living in care homes; and were also higher among people from ethnic minorities, those living in poorer areas, and in people with long-term medical conditions such as respiratory disease.

Our results suggest that shielding alone is not enough to protect clinically vulnerable people and that vaccination, along with suppressing community infection rates, remains the best way to protect these patients from the risk of serious illness and death from Covid-19.

Our results also refute suggestions that the UK could have avoided lockdowns by shielding vulnerable groups, whilst allowing society to otherwise function normally. This policy would probably have led to even higher infection, hospitalisation, and death rates in vulnerable people.

DOI: https://doi.org/10.3399/BJGPO.2021.0081

Having multiple sclerosis and depression is associated with an increased risk of early death

Depression is common in people with multiple sclerosis (MS), and a new study from our research group shows that people with both conditions are more likely to die over the next decade than people with just one or neither condition. The study was published in the September 2021, online issue of Neurology, the medical journal of the American Academy of Neurology. The study also found that people with MS and depression have an increased risk of developing vascular disease such as heart attack and stroke.

“These findings underscore the importance of identifying depression in people with MS as well as monitoring for other risk factors for heart disease and stroke,” said lead author Raffaele Palladino, MD, PhD, of Imperial College of London in the United Kingdom. “Future studies need to be conducted to look at whether treating depression in people with MS could reduce the risk of vascular disease as well as death over time.”

The study involved 12,251 people with MS and 72,572 people who did not have MS. We looked at medical records to see who developed vascular disease or died over a period of 10 years. At the start of the study, 21% of the people with MS had depression and 9% of the people without MS had depression.

We found that people with both MS and depression had a mortality rate from any cause of 10.3 per 100,000 person-years. Person-years take into account the number of people in a study as well as the amount of time spent in the study. The mortality rate for people with MS without depression was 10.6, for people who had depression without MS it was 3.6 and for people with neither condition it was 2.5.

Once we adjusted for other factors that could affect the risk of death such as smoking and diabetes, we found that people with both conditions were more than five times more likely to die during the next decade than people with neither condition. People with MS without depression were nearly four times more likely to die than people with neither condition and people with depression without MS were nearly twice as likely to die.

For the risk of vascular disease, the rate for people with both MS and depression was 2.4 cases per 100,000 person-years; 1.2 for people with MS without depression; 1.3 for people with depression without MS; and 0.7 for people with neither condition.

After adjusting for other factors, we found that people with both conditions were more than three times as likely to develop vascular disease as people with neither condition.

“When we looked at the risk of death, we found that the joint effect of MS plus depression equaled more than the effect for each individual factor alone — in other words, the two conditions had a synergistic effect,” Palladino said. “A total of 14% of the effect on mortality rate could be attributed to the interaction between these two conditions.”

Materials for this blog were provided by the American Academy of Neurology.

Journal Reference:

  1. Raffaele Palladino, Jeremy Chataway, Azeem Majeed, Ruth Ann Marrie. Interface of Multiple Sclerosis, Depression, Vascular Disease, and Mortality: A Population-Based Matched Cohort Study. Neurology, 2021; 10.1212/WNL.0000000000012610 DOI: 10.1212/WNL.0000000000012610

Impact of social restrictions during the COVID-19 pandemic on the physical activity levels of older adults

Physical inactivity adversely affects older adults, with more than 60% of those aged over 75 years not sufficiently physically active for good health as defined by meeting the WHO and UK guidelines. From March until June 2020 in the UK, a national ‘lockdown’ was implemented to reduce exposure to, and transmission of, COVID-19. Although applied to the whole population, adults aged over 70 years and those with underlying health conditions at higher risk of severe COVID-19 disease were asked to follow more stringent social distancing measures. These included remaining at home where possible; avoiding social mixing in the community; avoiding physically interacting with friends and family; and avoiding public transport.

In a paper published in the journal BMJ Open, we examined self-reported physical activity before and after the introduction of lockdown, as measured by metabolic equivalent of task (MET) minutes. Associations of physical activity with demographic, lifestyle and social factors, mood and frailty were also examined. The study population comprised adults enrolled in the Cognitive Health in Ageing Register for Investigational and Observational Trials cohort from general practitioner practices in North West London from April to July 2020. 6219 cognitively healthy adults aged 50–92 years completed the survey.

Mean physical activity was significantly lower following the introduction of lockdown from 3519 to 3185 MET min/week (p<0.001). After adjustment for confounders and pre-lockdown physical activity, lower levels of physical activity after the introduction of lockdown were found in those who were over 85 years old (640 (95% CI 246 to 1034) MET min/week less); were divorced or single (240 (95% CI 120 to 360) MET min/week less); living alone (277 (95% CI 152 to 402) MET min/week less); reported feeling lonely often (306 (95% CI 60 to 552) MET min/week less); and showed symptoms of depression (1007 (95% CI 612 to 1401) MET min/week less) compared with those aged 50–64 years, married, cohabiting and not reporting loneliness or depression, respectively.

We concluded that markers of social isolation, loneliness and depression were associated with lower physical activity  following the introduction of lockdown in the UK. Targeted interventions to increase physical activity in these groups are needed to limit adverse health outcomes from lower levels of exercise.

DOI: http://dx.doi.org/10.1136/bmjopen-2021-050680

Vaccinating healthcare workers against Covid-19

In an article published in the British Medical Journal, we discuss the topic of vaccinating healthcare workers against Covid-19. Our conclusion is that compulsion is unnecessary and inappropriate.

Parliament’s decision to make vaccination against covid-19 a condition of employment for care home workers has fuelled the debate around compulsory vaccination for healthcare workers, which may follow. Compulsory vaccination is not a panacea and may harm the safety of patients and healthcare workers, as well as affecting workload and wellbeing. It is a dilemma familiar to occupational health services in many NHS trusts.

Is there a vaccine hesitancy problem in UK healthcare for which mandatory vaccination is an appropriate solution? Data suggesting pockets of poor uptake of covid-19 vaccination among care home staff led the government to make vaccination compulsory, abandoning a targeted but voluntary approach. The government’s Scientific Advisory Group for Emergencies (SAGE) has not published a recommended minimum acceptable level of staff vaccination for healthcare settings, but over 80% of frontline healthcare workers in NHS trusts have now received two vaccine doses,4 reaching over 90% in some trusts. The level of risk posed by the remaining minority is unlikely to justify policy change at a national level.

Vaccination is already compulsory for staff working in healthcare settings in France and Italy. However, both countries have a history of compulsory vaccinations in response to substantial vaccine hesitancy and outbreaks of vaccine preventable infections such as measles. In Italy, legislation introducing compulsory childhood vaccinations was followed by a decrease in the incidence of measles and rubella. Nevertheless, this policy is under review and may be made more flexible depending on regional vaccine coverage.

The full text of the article is available in the BMJ.

DOI: https://doi.org/10.1136/bmj.n1975

How long does immunity from Covid-19 vaccination last?

In a letter published in the British Medical Journal, I discuss the topic of how we assess the long-term safety and efficacy of Covid-19 vaccination. Vaccines for COVID-19 were eagerly awaited; and their rapid development, testing, approval and implementation are a tremendous achievement by all: scientists, pharmaceutical companies, drugs regulators, politicians and healthcare professionals; and by the patients who have received them.[1] Early real-world data from vaccine recipients in England, Scotland and Israel show that vaccination provides a high level of protection from symptomatic COVID-19 infection and serious illness, along with a large reduction in the risk of hospital admissions and death.

However, because these vaccines are new, we do not yet have information on how long the immunity generated by COVID-19 vaccines will last; or on how well they will protect against new variants of SARS-CoV-2. Longitudinal data on ‘vaccine failures’, or re-infections can help guide national policies on how frequently booster doses of vaccines are needed to maintain a good level of immunity in the population, and on whether vaccines need modification to provide protection against new variants of SARS-CoV-2.[2]

The UK is well-placed to collect these data and to secure its timely evaluation and integration with information provided by its strong life sciences research industry, to guide public health decision making. We also have a National Health Service that has developed computerised medical records for use in general practices on a population of around 67 million people. These electronic medical records provide longitudinal data on people’s health and medical experiences and can be used to estimate the longer-term efficacy of Covid-19 vaccines.[3] This will provide a valuable resource, not just for guiding public health policy in the UK, but also for global health.

References

1. Majeed, A, Molokhia, M. Vaccinating the UK against COVID-19. BMJ 2020; 371: m4654–m4654.

2. Majeed A, Papaluca M, Molokhia M. Assessing the long-term safety and efficacy of COVID-19 vaccines. Journal of the Royal Society of Medicine. May 2021. doi:10.1177/01410768211013437

3. Hodes S, Majeed A. Building a sustainable infrastructure for covid-19 vaccinations long term BMJ 2021; 373 :n1578 doi:10.1136/bmj.n1578

What are the arguments in favour of reducing the gap between doses of the Pfizer Covid-19 vaccine to 3-4 weeks?

Early on during the pandemic, the UK government took the decision to give second doses of the Pfizer Covid-19 vaccine after 12 weeks rather than the recommended 3-4 weeks. It has now reduced the gap to 8 weeks and is considering reducing the gap to 3-4 weeks. What are the arguments in favour of reducing the gap between doses to 3-4 weeks?

1. Giving the two doses of the Pfizer vaccine 3-4 weeks apart is in line with the manufacturer’s guidance.

2. This is what most other countries using the Pfizer vaccine are doing.

3. Evidence from randomised controlled trials and subsequent evidence from real-world data provides strong evidence that two doses of Pfizer vaccine given 3-4 weeks apart provide excellent protection against severe disease and death

4. Data from Public Health England shows that two doses of vaccine provide much better protection against the delta variant than one dose. Hence, giving second doses after 3-4 weeks instead of after 8-12 weeks could help reduce the current ratee of infection in the UK

5. Many people are keen to get their second dose of Pfizer vaccine quickly because of concerns about other family members or to help them travel.

 

Why we should continue to wear face masks

The government’s chief medical officer says he will continue to wear a face mask when appropriate. We should follow his example. Covid-19 is an infection that is largely spread indoors – particularly in crowded, poorly ventilated areas – through inhaling droplets and aerosols produced by infected people when they cough, sneeze, sing, talk, or breathe. Face masks are a simple method of reducing the risk of infection – but only if they are worn by large numbers of people. The main function of a mask is to reduce the emission of droplets from infected people into the air. The droplets are captured by the mask and hence less virus enters the air. Much of the benefit of wearing face masks goes to other people but they can also benefit the wearer, particularly if a high-specification FFP2 mask is worn that filters out more particles and droplets when the wearer breathes in air.

Wearing face masks will reduce the spread of the coronavirus and help protect others. This is very important in settings where we are in contact with older and more vulnerable people – such as in supermarkets and on public transport. Wearing a mask has no major side effects, and does not change a person’s oxygen or carbon dioxide levels. Widespread wearing of face masks has been an important part of the pandemic control strategies of countries that have been more successful in containing the spread of Covid-19. Vaccines are essential and can protect us from developing a more serious illness. But we must maintain the use of other control measures, such as the use of face masks, until we are past the worst of the Covid-19 pandemic.