Tag: Vaccination

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

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.

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.

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.

 

Questions and answers about Covid-19 vaccination in children

Countries globally are considering the implementation of Covid-19 vaccination programmes for children. In this article for the Daily Mirror, Matt Roper and I answer some of the common questions from parents about Covid-19 vaccination for children. 

I’m worried about vaccinating my child – how safe is it?

Clinical trials of Covid-19 vaccines in children aged 12-15 years in the UK and USA confirm that the vaccines are very safe. The rate of side effects in children in these studies was similar to that seen in young adults. As in young adults, most side effects were mild to moderate, such as a sore arm or tiredness.

Will children need two jabs like adults?

Children will need two doses of vaccine because this provides much better protection against serious illness than one dose of vaccine.

How likely is it they will suffer from side effects?

The most common side effects in children aged 12 to 15 years of age are pain at the injection site (> 90%), tiredness and headache (> 70%), muscle pains and chills (> 40%), joint pains and a high temperature (> 20%).

Is there anything I can do to offset any side effects?

Following the vaccination, paracetamol can help provide some relief from side effects such as muscle pain and headache. The side effects are generally transient and will resolve within a few days.

We’ve been told Covid doesn’t affect children as severely as adults, so why do we need to vaccinate them?

Although hospitalisation and death are rare in children following a Covid-19 infection, children can still sometimes have a prolonged illness and can also develop complications such as Multisystem Inflammatory Syndrome or other types of “Long-Covid”. Vaccination of children also helps to protect older members of the family, such as parents and grandparents, and teachers.

Is Long Covid a concern in relation to children, and will the vaccine help there?

Long Covid can occur in children. At present, we don’t yet know if vaccination will protect against Long Covid but we hope that if vaccines reduce the risk of symptomatic infection and serious illness, they will also reduce the risk of the long-term complications of Covid-19.

Will they need regular boosters later on?

Because the virus that causes Covid-19 is continually mutating, it is likely that booster doses of vaccine will be needed for both adults and children. For protection against current strains, it is possible that immunity may gradually weaken over time and this would be another reason for providing booster doses.

If they don’t get their jab, do we think they might be exposed to more risky variants in the future?

The vaccines do protect against serious illness even for the newer, more risker variants such as the delta variant. Children who are not vaccinated will be at higher risk of a serious illness if they are exposed to a new variant of the coronavirus in the future.

Building a sustainable infrastructure for Covid-19 vaccination

By mid-June 2021, the UK had administered over 70 million doses of covid-19 vaccines; with the majority (estimated around 75%) delivered by primary care-led vaccination sites. Since the start of the vaccine programme in December 2020, the UK has offered a variety of locations for covid-19 vaccination; GP led sites, mass vaccine sites, community pharmacies, and hospitals. The rollout of covid-19 vaccination is a major and much needed success for the NHS, and there are many positive lessons to be learned and taken forwards. However, we must not be complacent. We are still in the midst of a global pandemic, with covid-19 rife in many countries; and with new, more infectious variants of SARS-CoV-2 continually emerging. It is essential for the UK to maintain its vaccination momentum, as well as consider extending the vaccination programme to older children; and being prepared to offer booster doses to adults if these are required to maintain immunity. We must also focus on vaccine hesitancy, which is a major global health risk in its own right.

General practices in the UK are very experienced at mass vaccination programmes; being largely responsible for administering seasonal flu vaccines with support from community pharmacy sites. In 2020, the cohorts offered flu vaccines were extended to include household members of high risk patients, and all people aged 50-64. The same extended groups will be targeted for a flu vaccine next winter. General practices are embedded in their communities, are local and trusted, have health compliant regulated premises, rigorous cold storage systems, resuscitation equipment on site, hold full electronic patient records, and have long standing knowledge of their patients. For all these reasons, when the covid-19 vaccines became available, it was primary care teams nationwide who were able to quickly step forward and deliver the majority of vaccinations.

The initial cohort for the covid vaccination programme—people aged 80 and over—were not easily reached by email or text messages, are sometimes not technically literate, and many needed phone calls to book their vaccination appointments. The amount of time and effort this took was considerable and it is a credit to overstretched primary care teams nationwide (with special praise for practice managers, receptionists, care co-ordinators, link workers, nurses, volunteers and other support staff) that our most vulnerable patients, including nursing home, housebound and clinically extremely vulnerable patients received their initial injections so quickly and efficiently.

As we moved to the “lower risk” cohorts, the range of vaccine sites quickly expanded, and without any consultation central recalls were sent out, resulting in many unnecessary queries, much confusion, and unnecessary travel for patients. The logistics around the storage and handling of the mRNA Pfizer BioNTech vaccine precluded the use of community pharmacy sites, but the Oxford AstraZeneca (like seasonal flu vaccine) has been widely administered in community sites. The more recent changes by the MHRA allowing up to 31 days storage in a vaccine fridge for the Pfizer vaccine has the potential to further expand the range of suitable sites for its use.

In England, GPs have been working in primary care networks (PCNs) since July 2019, representing groups of practices typically covering 30,000-50,000 patients. Primary care networks are ideally placed to offer population based health services including covid-19 vaccination. Some primary care networks have offered covid-19 vaccinations in house by reorganising their services, while others have worked with other primary care networks to use large sites such as sports centres, entertainment venues, and village halls. Many primary care networks have also offered “pop up clinics”—for example in homeless shelters, community centres, places of worship and hostels—with great success, to increase uptake in marginalised groups who are typically at higher risk of infection, serious illness, and complications from covid-19; and thereby help to reduce health inequalities.

There has been great commitment from both the existing primary care workforce and volunteers to deliver the covid-19 vaccination programme, with many retired staff coming back to help, primary care staff being redeployed, and volunteers acting in roles such as marshals, data entry clerks and car park wardens. In addition to all the administrative workload in booking appointments, there are huge numbers of queries from patients about their vaccines both before and after the event. This hidden work is also being carried out, unfunded, and largely unrecognised, by primary care teams. Each time there is a change in policy by the government or a health scare in the media, primary care teams are inundated with calls, and this workload and its importance in ensuring the continued high uptake of covid-19 vaccines needs to be recognised by the government.

The UK government has recently announced that they may offer a covid-19 booster in the Autumn 2021 and, with new variants emerging, this is likely to be a key health policy to protect the NHS over the winter. Hence, now is the right time to appraise the various options for vaccine delivery. Having a mixed range of sites able to offer mass vaccination in theory should speed up the process, but it has been clear throughout the vaccination programme that the limiting factor is actually vaccine supply, not capacity to vaccinate.

We recommend that NHS England publish data on the respective costs of delivering vaccines via primary care networks (general practice sites) versus mass vaccine centres. Any such calculations must include set up costs, running costs, and also explain where the clinical staff are coming from—knowing that staff shortages are already running at over 10% across the NHS. The work in dealing with queries from patients also needs to be factored into this evaluation—this is currently largely being directed at primary care teams, who are often left to deal with the most complex patients. We would also request an official breakdown of the percentage of vaccines given in each setting thus far, so that there is full transparency and also an appreciation for the huge efforts made by GP teams nationwide.

By using primary care sites for the vaccination programme, there is the potential to invest in and strengthen our infrastructure for local healthcare delivery, which will assist in the covid-19 NHS recovery plans, and leave a legacy for the future. By contrast, there is a risk that mass vaccine sites—like the Nightingale hospitals—will eventually be dismantled. Policy makers need to carefully evaluate the use of mass vaccine sites versus GP led sites, along with the desire of patients to receive their care closer to home and in a familiar setting. However, there must be adequate resources attached for this work, so that routine care and timely access to other primary care services is not compromised by delivering the covid-19 vaccination programme.

We know that many GP teams are at breaking point, and must be fully supported if they are expected to provide mass covid-19 vaccination in addition to their core work. Investment in primary care led vaccination sites, supported by local pharmacies, is likely to be the most cost-effective option for ongoing mass vaccination, as well as being the option that is preferred by most patients. It is essential therefore for the government and NHS managers to work with primary care teams, giving them the resources needed to put in place a sustainable, long-term infrastructure for vaccine delivery.

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

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

Competing Interests: None declared

This article was first published by BMJ Opinion.

Covid-19 vaccination hesitancy

The rollout of Covid-19 vaccination is well underway, with more than 700 million doses given worldwide as of April 2021. Vaccination is highly effective at reducing severe illness and death from Covid-19. Vaccines for Covid-19 are also safe, with extremely low risks of severe adverse events. A major threat to the impact of vaccination in preventing disease and death from Covid-19 is low uptake of vaccines. In article published in the British Medical Journal, we give on overview of vaccine hesitancy and some approaches that clinicians and policymakers can adopt at the individual and community levels to help people make informed decisions about Covid-19 vaccination.

The World Health Organization defines vaccine hesitancy as a “delay in acceptance or refusal of safe vaccines despite availability of vaccine services.” It is caused by complex, context specific factors that vary across time, place, and different vaccines, and is influenced by issues such as complacency, convenience, confidence, and sociodemographic contexts. Vaccine hesitancy may also be related to misinformation and conspiracy theories which are often spread online, including through social media. In addition, structural factors such as health inequalities, socioeconomic disadvantages, systemic racism, and barriers to access are key drivers of low confidence in vaccines and poor uptake. The term vaccine hesitancy, although widely used, may not adequately convey these wider determinants that influence decisions to delay or refuse vaccination.

DOI: https://doi.org/10.1136/bmj.n1138

Questions and answers about Covid-19 vaccination

1. I’d rather wait to see if vaccines really are safe. What’s wrong with that?

Covid-19 vaccines were tested extensively before they went into general use. The data from this research and subsequent data from their widespread use in the UK and other countries in many millions of people show that all the vaccines are very safe and that serious side effects are very rare. If you delay getting vaccinated, you are at risk of getting infected and also put at the risk the people you are in contact with.

 

2. Other people need a vaccine more than me. Isn’t it OK to let others have theirs first?

People are prioritised for vaccination based on factors such as age and medical history. When you receive your invitation to be vaccinated, you are being called for vaccination at the right time for you and are not disadvantaging anyone else.

 

3. Aren’t people dying from blood clots because of the vaccine?

Reports of serious blood clots are very rare, with typically only a few cases per million doses of vaccine administered.

 

4. I don’t trust the government, so why should I trust a vaccine they’re trying to get us to have?

Covid-19 vaccines were tested rigorously before they were used in the general population. No short cuts were taken in this testing. The safety of the vaccines continues to be assessed continually.

 

5. The odds of me dying from Covid are so low I’d rather take the risk of not being vaccinated.

Many people who survived a Covid-19 infection have been left with long-term complications such as heart and lung damage. Vaccination reduces the risks of you suffering a serious illness, and also helps protect more vulnerable people such as your elderly relatives and older work colleagues.

 

6. Haven’t lots of people died after having their first Covid shot?

Reports of people dying after their first Covid-19 vaccine are very rare. In most cases, death was due to natural causes and not linked to their vaccination.

 

7. I’m suffer from a lot of allergies, so I’m worried I’ll have a serious reaction to the jab too.

Many millions of people who suffer from allergies have safely received a Covid-19 vaccination.

 

8. Can the Covid vaccine affect fertility?

Covid-19 vaccines do not affect fertility.

 

9. BAME communities have been treated badly in the past by health authorities. Why should we trust them now?

BAME communities are at much higher risk of serious illness and death from Covid-19. Vaccines will protect them from these risks. BAME organisations and health professionals have advised the members of their communities to get vaccinated when they are invited, so it is not only health authorities that are recommending the vaccines.

 

10. Are vaccines halal?

Covid-19 vaccines have been confirmed to be halal and acceptable for use in Muslims by religious scholars across the world. No Muslim country has refused to use Covid-19 vaccines.

 

11. I’ve seen videos where doctors say vaccines are dangerous and even change your DNA. Why should I believe another doctor who says it is safe and not those who have concerns?

Vaccines are safe and do not change your DNA. Extensive research has confirmed the safety of the vaccines.

 

12. This vaccine was developed in record time. I’m worried they cut corners to get it out in such a rush.

Vaccines were developed and tested in record time because of advances in medical technology in recent years and because bureaucratic obstacles to setting up research trials were minimised. No corners were cut in the development and testing processes.

 

13. You might seem OK after having your vaccine, but who knows how it might affect your health in several years’ time?

We now have evidence from many millions of people that vaccines substantially reduce the risks of serious illness and death. Ongoing research has shown the vaccines are safe and highly effective. The risks from Covid-19 infection in contrast are immediate and serious.

 

14. I’ve already had Covid so I don’t think I need a vaccine. Won’t I already have immunity?

Natural immunity to Covid-19 can wear off and people can sometimes suffer a second infection. A vaccine boosts your immune response and gives you additional protection from infection.

 

15. I’ve heard that vaccines can cause autism. What’s the truth?

There is no link between vaccines and autism.

 

16. I don’t want the dangerous chemicals in vaccines like formaldehyde, mercury and aluminium getting in to my body.

Vaccines are extensively tested to prove that the chemicals in them are safe.

 

17. Wasn’t the Spanish Flu vaccine responsible for 50 million deaths?

The deaths from Spanish Flu were caused by a virus, not by a vaccine.

Assessing the long-term safety and efficacy of COVID-19 vaccines

In an article published in the Journal of the Royal Society of Medicine, myself, Professor Marisa Papaluca and Dr Mariam Molokhia discuss how health systems can assess the long-term safety and efficacy of COVID-19 vaccines. 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.

Because these vaccines are new, we lack long-term data on their safety and efficacy. In surveys of people who define themselves as ‘vaccine hesitant’, this lack of long-term data is one of the main reasons given for their beliefs. Hence, providing this information is a public health priority and could help reassure vaccine-hesitant people that receiving a COVID-19 vaccine is the right choice for them. Emerging data from the UK and elsewhere are confirming the benefits of COVID-19 vaccines and this is one of the factors that is leading to a reduction in vaccine hesitancy in the UK population.

As long-term data on the safety and efficacy build globally, these can address many of the concerns that vaccine-hesitant people have about COVID-19 vaccines, thereby creating a positive environment that encourages higher uptake of vaccination. These data will also guide national public health policies, such as how frequently to provide booster doses of vaccine and whether limits should be placed on the use of a specific vaccine.

Vaccination remains the best way to control the COVID-19 pandemic, and countries globally should work together to generate the information needed to provide long-term data on safety and outcomes. Because of the very rare nature of some side effects, this will require international collaboration so that data from countries can be pooled to allow more precise estimates of risk to be calculated. This will include using data from low- and middle-income countries once vaccination programmes are established there, as well as from marginalised groups in higher-income countries, to ensure that the data are fully representative of the global population.

DOI: https://doi.org/10.1177/01410768211013437