Tag: Vaccination

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

What is behind the low covid-19 vaccine take-up in some ethnic minorities?

The latest data from the Office for National Statistics confirms that ethnic minorities in England are considerably less likely to receive a covid-19 vaccine than their White counterparts. While 90.2% of those aged 70 years and over living in England had received at least one dose of vaccine by 11 March 2021, uptake rates were 58.8% and 68.7% in Black African and Black Caribbean groups, respectively. [2] This was followed by Bangladeshi (72.7%) and Pakistani (74.0%) populations, with the most pronounced differences seen in those living in the most deprived areas of England.

Vaccine take-up also varied by religious affiliation with Muslims (72.3%) and Buddhists (78.1%) having the lowest rates, despite Pfizer-BioNTech, AstraZeneca and Moderna confirming that their vaccines do not contain animal products, and despite endorsement of the vaccines by the British Islamic Medical Association, the Dalai Lama, the Hindu Council UK and the Board of Deputies of British Jews. Vaccination rates were also lower among disabled people (86.6%), who are more likely to live in poverty and account for a large proportion of covid-19 deaths. After accounting for geography, underlying health conditions and some socioeconomic inequalities, these stark differences in vaccine uptake persisted.

Despite the considerable obstacles, there is an opportunity to improve the historically low vaccine uptake rates in ethnic minorities. With new data continuing to emerge on the relationship between the AstraZeneca/Oxford vaccine and a very rare risk of specific types of blood clots, such as cerebral venous sinus thrombosis (sometimes associated with low platelet counts), the Medicines and Healthcare products Regulatory Agency (MHRA) and the European Medicines Agency (EMA) have stated, once again, on 7 April 2021 that the benefits of covid-19 vaccines considerably outweigh the possible risks. Some anti-vaccination advocacy groups may try to take advantage of this association to further their own agenda, but clinicians and public health specialists need to reaffirm the safety of covid-19 vaccination, and also the high risk of serious illness, long-term complications, and death in people who are not vaccinated.

Vaccine safety and effectiveness concerns are, however, not our only challenges; effective vaccine allocation strategies can alleviate other barriers, including vaccine-related access and convenience of appointments. Reaching communities, through culturally-sensitive communication, remains even more crucial in light of the Joint Committee on Vaccination and Immunisation resisting calls to prioritise ethnic minorities across the different phases of the vaccination programme or through larger allocations of vaccines to areas with the highest rates of covid-19.

The origins of vaccine hesitancy and vulnerability are rooted in everyday life, requiring intersectoral approaches and mitigation efforts from outside the health sector to transform the social determinants of health. The legacies and current practices of racial exclusion, disinvestment, discrimination, and violence that continue to enable health inequalities provide conditions for covid-19 to persist in ethnic minorities even when life-saving vaccines are available. A refusal to address the root causes of these ingrained societal inequalities may lead covid-19 to become, like many other infectious diseases, a “disease of poverty.” The recent government report, denying the reality and consequences of structural racism—despite overwhelming evidence—will make it extremely difficult to establish trust and overcome justifiable anger and mistrust in some ethnic minorities.

One of the core aims of health policy is maximising overall population health while achieving equitable health distributions. Tensions between efficiency and equity often lead to positive and negative impacts of health policies and interventions being distributed unequally within populations, as observed during the covid-19 response. For public health interventions to be considered effective, and not only efficient, those at highest risk must be targeted, protected, and supported, thereby ensuring that health outcomes are improved.

Social justice is the moral foundation of public health. However, the pandemic response demonstrates that it is not always central to government policy. Unless we mitigate the consequences of past and ongoing wrongs, and unless vulnerable populations feel seen, heard and advocated for, the low uptake rates seen across older people from ethnic minorities will become even more pronounced when the vaccination programme starts to target younger people, among whom vaccine hesitancy and distrust is highest.

Tasnime Osama, Honorary Clinical Research Fellow in Primary Care and Public Health, Department of Primary Care & Public Health, Imperial College London, London, UK

Mohammad S Razai, Academic Clinical Fellow in Primary Care, Population Health Research Institute, St George’s University of London, London, UK

Azeem Majeed, Professor of Primary Care and Public Health, Department of Primary Care & Public Health, Imperial College London, London, UK

This article was first published by BMJ Opinion.

Covid-19 vaccine passports: access, equity, and ethics

In an editorial published in the British Medical Journal, Tasnime Osama, Mohammad Razai and I discuss the practical and ethical issues in the implementation and use of vaccine passports, and the need to ensure they do not exacerbate current societal or health inequalities.

With millions of people receiving covid-19 vaccines globally, some countries have already started planning the implementation of “vaccine passports”—accessible certificates confirming covid-19 vaccination linked to the identity of the holder. The purpose of vaccine passports, governments argue, is to allow people to travel, attend large gatherings, access public venues, and return to work without compromising personal safety and public health. There remain, however, considerable practical and ethical challenges to their implementation.

Vaccine passports are not only permissible under international health regulations, they already exist. The World Health Organization endorses certificates confirming vaccination against yellow fever for entry into certain countries. Contrary to immunity passports, which may, perversely, incentivise infection, vaccine passports incentivise vaccination, an international public good with many positive benefits4 including individual and population immunity.

The public health principle of least infringement states that to achieve a public health goal, policy makers should implement the option that least impairs individual liberties. While lockdowns may be required, the continued restriction of the civil liberties of those who are immune and pose minimal risk of spreading infection may be unethical, as lack of freedom of movement is one of the most common adverse impacts of the pandemic on people’s lives. Additionally, vaccine passports could help prevent other health and socioeconomic harms caused by lockdowns, thereby accruing individual and collective health, economic, and social benefits.

For vaccine passport holders to demonstrate protection from illness and lack of infectiousness, however, more evidence about the long term effectiveness of different types of vaccines and the duration of protection they confer is required, particularly with the regular emergence of new variants. The AstraZeneca vaccine may reduce transmission by up to 67% while the Pfizer BioNTech vaccine is 85% effective in preventing asymptomatic and symptomatic infections after the second dose, 78 generating indirect benefits that extend to unvaccinated individuals through a reduction of SARS-CoV-2 circulation. Given that there are currently more than 200 vaccine trials underway, however, establishing the characteristics of each vaccine for the purpose of passport renewal would be challenging.

Vaccine passports need to be internationally standardised and must have verifiable credentials that safeguard against problems such as forgery and loss of privacy. WHO does not currently endorse covid-19 vaccine or immunity passports because of these concerns. It has, however, initiated a Smart Vaccination Certificate Working Group to establish key specifications and standards for effective and interoperable digital solutions for covid-19 vaccination.

Ethical concerns remain about the societal divide that these passports could cause. The Nuffield Council on Bioethics states that such passports could enable coercive and stigmatising workplaces, thereby compounding current structural disadvantages. Vaccine passports must be available and accessible to all to prevent exacerbating existing societal inequalities and worsening the health divide. Vaccines are scarce and access remains unequal, both globally and within countries. Covid-19 vaccines are also contraindicated in some people with serious health conditions and allergies. People facing vaccination access problems will be unable to obtain vaccine passports. Pregnant women are at an increased risk of severe covid-19 illness; however, as clinical trials did not include pregnant women, the uncertain risk of vaccination during pregnancy may also lead to understandable hesitancy in this group. Ethnic minorities are also more likely to be vaccine hesitant.

With most vaccine doses delivered in high income countries, WHO warned that the world is on the brink of a catastrophic moral failure. Because of vaccine nationalism and insufficient efforts to support globally coordinated access to covid-19 vaccines, nearly 25% of the world’s population may not have access to a vaccine until at least 2022. This will widen the global north-south divide and create a situation where people from high income countries are able to travel, but not those from low income countries.

As vaccine passports would probably be digital and require access to private medical records, there are important questions around internet access, costs of acquiring and maintaining the passports, privacy, and data protection that must be tackled. Many consider adequate internet access a fundamental human right; as large numbers of people do not have smartphones or stable internet connections, their exclusion breaches their rights to equality, particularly for those in low and middle income countries. Whether it is legal for workplaces, airlines, and entertainment and leisure venues to access vaccination data remains controversial, as this can perpetuate a form of elitism. Furthermore, ensuring that patient sensitive data are not used for other purposes is essential.

While the merits of vaccine passports may be undeniable, implementation will require ethical justifications and practical solutions that do not discriminate against the poor, the less technically literate, and people from low and middle income countries. Without mitigation strategies and alternative solutions, the hardships experienced by marginalised and vulnerable groups will be intensified through the perpetuation of discrimination. If they are to be rolled out, the benefits of vaccine passports should not be dispersed unequally, and societies globally must strive to ensure that they are available to all.

DOI: https://doi.org/10.1136/bmj.n861

This article was first published in the BMJ.

Questions and answers about Covid-19 vaccination in children

Why should children have the vaccine?

Children will usually have a mild or asymptomatic illness and are very unlikely to die if they contract Covid-19. But they can sometimes have a prolonged illness that can result in them being absent from school and which can also occasionally lead to serious long-term complications, such as Multisystem Inflammatory Syndrome. Children can also transmit infection to others at higher risk of serious illness and death, such as their parents and grandparents.

 

Will all under-18s get the jab or specific groups/age groups?

Covid-19 vaccines will only be made available to children once we have good evidence of their safety and efficacy, and they have been licensed for use in children in the UK by the MHRA. It’s likely that any vaccination programme for children will start with those old enough to attend secondary school (above the age of 11 years), with vaccinations for younger children starting later.

 

Will it be compulsory?

Childhood vaccinations are not compulsory in the UK and are only given with parental consent.

 

Does it have to be an injection?

All the Covid-19 vaccinations in use in the UK, or which are close to being approved, are given by injection. It will be sometime, perhaps years, before we have vaccines that can be given by other routes, such as the nasal influenza vaccine that is used in children.

 

Will babies get it when they get their other jabs?

The timing of vaccination will depend on the results of research studies and the conditions put in place by the MHRA and guidance from the JCVI. Hence, we cannot yet say if younger children will be able to get the vaccine at the same time as their other vaccinations. But if this was possible, this would make vaccination more straightforward for children, parents and the NHS.

 

Will children get it at school or elsewhere?

This has not been decided yet but if vaccines are given to school-age children, this would be easier to carry out in schools as we currently do for the influenza vaccine for children. However, the government may also decide to use the NHS Covid-19 vaccine centres because some vaccines – such as the Pfizer mRNA vaccine – are not very easy to transport.

 

Are children getting vaccines in other countries? What has happened?

There are trials underway in some countries, such as the USA and UK, to test the safety and efficacy of Covid-19 vaccines in children. Israel has started to use vaccines in 16-17 year olds. Some children aged 16-17 years old in the UK with serious medical problems are also being vaccinated. However, the use of Covid-19 vaccines in children is not yet widespread, even for older children.

 

Does it mean children who aren’t vaccinated won’t be able to travel abroad?

It’s likely that children will be excluded from the need to provide proof of vaccination to travel overseas as there are not yet any vaccines that are approved for use for them. They may though require a recent negative test for Covid-19 before they can travel. It’s also possible that some countries will change their rules once Covid-19 vaccination becomes common in children.

 

If every person in Britain is vaccinated, will Covid be eradicated?

Only one disease, smallpox, has been entirely eradicated through vaccination. Some people will refuse to be vaccinated and in those who are vaccinated, the vaccines are not 100% effective in preventing infection, although they are very effective at preventing serious illness and death. Hence, we will still see cases of Covid-19 in the UK but if we have very high vaccine uptake in our population, we are unlikely to see large outbreaks unless a new variant of virus appears that is resistant to current vaccines.

Covid-19 vaccine adverse events: balancing monitoring with confidence in vaccines

As the global covid-19 vaccine rollout continues, uncertainties regarding the association between thromboembolic events and the Oxford-AstraZeneca vaccine have dominated the news during March, leading 18 European countries to suspend its use whilst this association was investigated by the European Medicines Agency. This suspension of the vaccine will have serious implications for vaccine confidence in general and, in particular, for global vaccination programmes. It has already  heightened anxiety levels and affected vaccine uptake especially among vaccine-hesitant groups due to claims about side effects that are not supported by real world data or data from clinical trials.

Of all the covid-19 vaccines currently licensed or in development, the Oxford-AstraZeneca vaccine was considered the vaccination of choice by many countries because of its low cost and ease of storage compared to other vaccines. In the UK, more than 25 million people have had their first dose of covid-19 vaccine, comprising almost half of the adult population, with either the Oxford-AstraZeneca or Pfizer-BioNTech vaccines.

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has monitored the safety of both vaccines through the Yellow Card scheme—a mechanism of reporting any possible vaccine side effects known as adverse drug reactions (ADRs). However, these reports do not mean there is causal link between the use of a vaccine and side effects. Data up to 7 March shows an estimated 11.7 million first doses of Oxford-AstraZeneca and 10.9 million doses of Pfizer-BioNTech vaccines were administered in the UK, resulting in 35,325 and 61,304 reports of possible side effects for Pfizer and AstraZeneca vaccines respectively, indicating a very low rate of reported side effects. The overwhelming majority of reports consist of injection-site reactions and symptoms secondary to the normal immune response such as “flu-like” illness, headaches, chills, and fatigue. All these are in line with the findings from clinical trials and from side effects reported with other routinely used vaccines.

Reports of severe allergic reactions to the Pfizer (223 reports) and AstraZeneca (234 reports) vaccines have been very rare. Available MHRA data do not suggest that venous thromboembolism is caused by the AstraZeneca vaccine. To date, there have been five reports of cerebral venous sinus thrombosis to MHRA, a rare type of blood clot in the cerebral veins, with no causal association with the vaccine. The temporal association between vaccination and death in mostly elderly patients with health conditions have also been reported in about 500 cases. However, there is no evidence to support that vaccination caused these deaths.

While the investigations of a potential link between AstraZeneca vaccine and thromboembolic events continue, the MHRA, the World Health Organization (WHO) and the European Medicines Agency (EMA) have ruled out the causal link and stated that the population benefits far outweigh the risks, thereby reaffirming the safety of the vaccine that over 17 million people in the UK and EU have so far received. Around 30 cases of thromboembolic events have been reported amongst five million vaccinated people in EU; this rate remains lower than that observed in the general population.

Receiving a covid-19 vaccine is a landmark and memorable event for people and this coupled with a heightened sense of awareness following vaccination may lead to more cases being picked up. Moreover, there will be more presentations and over-diagnoses of thromboembolic events as expected following a highly publicised safety scare such as this.

While routine monitoring of vaccines to avoid potential harms is necessary, pausing or delaying vaccines must be evidence-based. The speculative commentary, generated by the media, will have serious and unintended consequences including an increase in vaccine hesitancy and even refusal; across Ireland, 30,000 vaccination appointments were cancelled during the week starting 15 March. Safety signals occur often with vaccines, with the majority representing false signals; although well-intentioned, the misapplied precautionary principle will undermine public trust, and heighten covid-19 risk through amplification of misinformation and disinformation campaigns of the “anti-vaxxer” movement. Vaccine-hesitant individuals are concerned about side effects and health-related long-term effects; these reports will make it very challenging to overcome these concerns at a time when covid-19 cases are still increasing across many European countries, requiring optimal uptake of vaccines to limit the impact of the covid-19 pandemic on populations.

The risks and trade-offs of suspending a life-saving vaccine must be carefully weighed especially during a pandemic; covid-19 itself is associated with blood clotting disorders. Historical precedents show that widely publicised safety scares have profound and long-lasting influence on vaccine confidence. [1] In 2017, the announcement that the dengue vaccine, Denvaxia, posed a risk to those who had not previously been exposed to the virus caused a drop in vaccine confidence in the Philippines and Indonesia. The safety controversy around the human papillomavirus vaccine in Japan caused one of the sharpest declines in vaccine uptake (from approximately 74% in those born in 1994-1998 to approximately 0.6% for those born in 2000). [2] The shock of this still reverberating today with Japan ranking among the lowest in vaccine confidence in a worldwide study. [1] A decline in vaccine uptake was also observed in Indonesia following warnings by the country’s faith leaders. [3]

Covid-19 vaccines are the single most effective way to prevent severe illness and death from the disease and accelerate the re-opening of society following non-pharmacological interventions such as lockdowns. Furthermore, vaccines are safe and have contributed to saving millions of lives. We call for monitoring of vaccine safety to occur out of the media limelight as sensationalist and exaggerated reporting will do irreparable damage to vaccine confidence. This includes suggestions by some media outlets that the actions taken by European countries were driven by political reasons. Sensationalist media reporting will lead to increased vaccine hesitancy, further loss of lives and derail efforts to end the current pandemic. Governments responses must be led by independent evidence through established public health and regulatory bodies such as the WHO, EMA and MHRA.

Mohammad S Razai, Academic Clinical Fellow in Primary Care, St George’s University of London. 

Tasnime Osama, Honorary Clinical Research Fellow, Department of Primary Care & Public Health, Imperial College London.

Azeem Majeed, Professor of Primary Care & Public Health, Department of Primary Care & Public Health, Imperial College London. 

This article was first published on BMJ Opinion

Questions and Answers about the AstraZeneca Covid-19 Vaccine

Should I really be worried about blood clots?

The AstraZeneca vaccine has been given to many millions of people across the world (over 10 million in the UK). A few of these people have suffered from blood clots after receiving the vaccine but no causal relationship has been found and the number of people affected is not above what we would expect in the general population in people who did not receive the vaccine.

How safe is the vaccine?

The clinical trials in which the vaccine was tested showed it was very safe, with a very low level of serious side effects and this has been confirmed subsequently in the wider use of the vaccine in the UK and elsewhere. The benefits of the vaccine far outweigh any risks. The clinical events that led to concerns about the vaccine are very rare with only a small number of episodes among the many millions of people who have received the vaccine.

Why are so many countries suspending it?

When a possible side effect is linked to a drug or vaccine, some countries will temporarily suspend use of the product until this has been investigated further. This does not mean that the vaccine is unsafe and we would expect further review of the data to confirm its safety.

Can I reduce the risk of a blood clot by taking an aspirin?

It’s probably not advisable to use aspirin in this way because no link between blood clots and the vaccine has been confirmed and there is a small risk of suffering a serious stomach bleed after taking aspirin.

What are the other possible side effects of the vaccine?

The most common side effects of the vaccine are pain and tenderness at the injection site, headache, tiredness, generalised muscle pain, shivering and a fever. These side effects usually resolve within a few days.

Does your age affect the likelihood of side effects? (For instance, do younger people feel worse because their immune systems are better?)

Side effects can occur at all ages but tend to be less common in older people. This is thought to be because the immune system gradually weakens with age, which also leaves older people more susceptible to infection.

Won’t I still be protected if I refuse the vaccine, because so many other people have had it?

It’s important that as many people as possible receive the vaccine. If a large number of people are not vaccinated, we will continue to see outbreaks of Covid-19, with some people suffering a serious infection that could result in hospital admission or death. The vaccine is not 100% effective and children are not currently being immunised, so there will be many people in the population who can still become infected.

What’s the down side of not having the vaccine?

If you don’t receive the vaccine, you are at much higher risk of contracting a Covid-19 infection. These infections can be serious, leading to long-term complications and death in many people. You may also infect others, including elderly relatives who may be at high-risk of serious illness. Furthermore, the more people who receive the vaccine, the more likely we are to an end to the pandemic and the lockdown measures it has led to.