Julian Savulescu’s Posts

Cross Post: There’s no Need to Pause Vaccine Rollouts When There’s a Safety Scare. Give the Public the Facts and Let Them Decide

Written By: Julian Savulescu, University of Oxford; Dominic Wilkinson, University of Oxford;

Jonathan Pugh, University of Oxford, and Margie Danchin, Murdoch Children’s Research Institute

This article is republished from The Conversation under a Creative Commons license. Read the original article.

 

When someone gets sick after receiving a vaccine, this might be a complication or coincidence. As the recent rollout out of the AstraZeneca vaccine in Europe shows, it can be very difficult to know how to respond.

For instance, reports of blood clots associated with the AstraZeneca vaccine led to several European countries suspending their vaccination programs recently, only to resume them once these clots were judged to be a coincidence. However, authorities couldn’t rule out increased rates of a rare brain blood clot associated with low levels of blood platelets.

There are also problems with the Pfizer and Moderna vaccines. By early February 2021, among the over 20 million people vaccinated in the United States, there have been 20 reported cases of immune thrombocytopenia, a blood disorder featuring a reduced number of platelets in the blood. Experts suspect this is probably a rare vaccine side-effect but argue vaccination should continue.

So what happens with the next safety scare, for these or other vaccines? We argue it’s best to give people the facts so they have the autonomy to make their own decisions. When governments pause vaccine rollouts while investigating apparent safety issues, this is paternalism, and can do more harm than good. Continue reading

Ethics, iBlastoids, and Brain Organoids: Time to Revise Antiquated Laws and Processes

Written by Julian Savulescu
Oxford Uehiro Centre for Practical Ethics and Wellcome Centre for Ethics, University of Oxford
Biomedical Ethics Research Group, Murdoch Children’s Research Institute

Jose Polo and his team at Monash University have successfully reprogrammed human adult cells (fibroblasts – skin cells) to form “iBlastoids”. These are structures which are like early human embryos. Normally when a sperm enters an egg, it produces a new cell, which divides, and these cells divide until a blastocyst is formed in the first week, consisting of 200-300 cells. In normal embryonic development, this would implant in the uterus. However, iBlastoids can’t do this as they lack the normal membrane that surrounds the blastocyst. They cannot by themselves form a fetus or baby.

They will be useful to study early human development and why so many embryos die soon after formation. They can be used to study mutations or the effect of toxins, perhaps developing treatments for infertility. So far, they have only been allowed to develop to the equivalent of a Day 11 Blastocyst. It is not clear whether they can produce the precursors to brain development:

“the developmental potential of iBlastoids as a model for primitive streak formation and gastrulation remains to be determined, and will require an international conversation on the applicability of the 14-day rule to iBlastoids.” (Excerpt from the team’s Nature article)

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Suspending The Astra-Zeneca Vaccine and The Ethics of Precaution

By Jonathan Pugh, Dominic Wilkinson, and Julian Savulescu

The authors are working on the UK Pandemic Ethics Accelerator project – @PandemicEthics_. This project was funded by the Arts and Humanities Research Council (AHRC) as part of UKRI’s Covid-19 funding.  All authors are affiliated to the University of Oxford.

 

Summary Points

  • Preliminary Reviews suggest that the number of thrombotic events in individuals who have received the Astra Zeneca vaccine is not greater than the number we would normally expect in this population.

 

  • It is crucial that we closely monitor these adverse events. The regulation of new medical interventions always requires us to manage uncertainty.

 

  • A precautionary approach to managing this uncertainty may be important for ensuring continued confidence in vaccination.

 

  • Regulators must weigh the potential risk suggested by these reports of adverse events following vaccination against the harm that suspension of the vaccine could have.
  • The harm of suspending the use of the Astra Zeneca vaccine depends on how many preventable deaths we can expect by suspending its use.

 

  • Amongst other things, this will depend on (i) how many people will be delayed in receiving a vaccine as a result (ii) the mortality risk of the people who would be prevented from receiving a vaccine, (iii) the prevalence of the virus at the time of the suspension, and (iv) the number of people who have received one dose of the Astra Zeneca vaccine, but not a second.

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What Is The Justification For Keeping Lockdown In Place? Two Questions For The UK Government

Written by Alberto Giubilini and Julian Savulescu

Oxford Uehiro Centre for Practical Ethics, University of Oxford

Given the success of the vaccine roll out in the UK and the higher than expected drop in COVID-19 deaths, it is legitimate to ask whether lockdown should continue to be the key strategy to contain the pandemic or whether the ‘roadmap’ announced by the UK Government should be adjusted. Because lockdown is a very exceptional measure, the burden of proof is on the Government to provide answers as to why the easing of lockdown is proceeding at the current pace and not faster. The impact of lockdown is devastating for the economy, mental health, and employment rates and the cost and benefits are in many cases very unevenly distributed. For instance, the young are at highest risk of redundancy, but benefit less from lockdown because COVID-19 pose a very low risk on them. There is a serious concern around the rise of referrals for mental health assistance for  children and teenager over the past year. If the lockdown is justified at this stage, the Government has the burden of proof of providing a strong justification for this.

Such justification might need to be updated with respect to the one offered when the roadmap was announced on 22 February. That justification was centred on the target of “keeping infections rates under control” as determined by 4 tests: successful vaccine deployment program; vaccines being successful at reducing hospitalizations and deaths in the vaccinated; infection rates not putting unsustainable pressure on the NHS; and the risk assessment not being significantly altered by new variants.

Even assuming those criteria are fair, the justification now needs to take into account the “very very impressive” and “spectacular” results of vaccine rollout, to quote a lead researcher from Public Health Scotland.  As we shall see below, there are reasons to think that the vaccines are producing better results than those expected by the Government and assumed by the modelling used to inform the roadmap. Plausibly also because of the vaccine roll out, the drop in COVID-19 deaths in the UK is now three weeks ahead of the estimates of the modelling that the Government has used to design its roadmap: while the modelling estimated that COVID-19 deaths would fall below 200 a day after mid-March, we reached that point on 25 February. The model suggested we would have as few as 150 deaths per day by 21 March, but we are at that point now.

In light of these data, the Government would need to justify using indiscriminate lockdowns to achieve something – protection of the vulnerable and the NHS – which data suggest is now achievable without overburdening the whole society (as lockdown is doing) and possibly even without burdening those who need protection the most (as selective shielding would do). Vaccines are offering a level of protection to the vulnerable (roughly 80-90% drops in hospitalizations and deaths) that, if it was achieved through measures like selective shielding, would plausibly justify considering selective shielding successful. But vaccines do this without the downsides of indiscriminate lockdown or of selective lockdown.

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Cross-Post: Self-experimentation with vaccines

By Jonathan Pugh, Dominic Wilkinson and Julian Savulescu.

This is a crosspost from the Journal of Medical Ethics Blog.

This is an output of the UKRI Pandemic Ethics Accelerator project.

 

A group of citizen scientists has launched a non-profit, non-commercial organisation named ‘RaDVaC’, which aims to rapidly develop, produce, and self-administer an intranasally delivered COVID-19 vaccine. As an open source project, a white paper detailing RaDVaC’s vaccine rationale, design, materials, protocols, and testing is freely available online. This information can be used by others to manufacture and self-administer their own vaccines, using commercially available materials and equipment.

Self-experimentation in science is not new; indeed, the initial development of some vaccines depended on self-experimentation. Historically, self-experimentation has led to valuable discoveries. Barry Marshall famously shared the Nobel Prize in 2005 for his work on the role of the bacterium Helicobacter pylori, and its role in gastritis –this research involved a self-experiment in 1984 that involved Marshall drinking a prepared mixture containing the bacteria, causing him to develop acute gastritis. This research, which shocked his colleagues at the time, eventually led to a fundamental change in the understanding of gastric ulcers, and they are now routinely treated with antibiotics. Today, self-experimentation is having something of a renaissance in the so-called bio-hacking community. But is self-experimentation to develop and test vaccinations ethical in the present pandemic? In this post we outline two arguments that might be invoked to defend such self-experimentation, and suggest that they are each subject to significant limitations. Continue reading

An Ethical Review of Hotel Quarantine Policies For International Arrivals

Written by:

Jonathan Pugh

Dominic Wilkinson

Julian Savulescu

 

This is an output of the UKRI Pandemic Ethics Accelerator project – it develops an earlier assessment of the English hotel quarantine policy, published by The Conversation)

 

The UK has announced that from 15th Feb, British and Irish nationals and others with residency rights travelling to England from ‘red list’ countries will have to quarantine in a government-sanctioned hotel for 10 days, at a personal cost of £1,750. Accommodation must be booked in advance, and individuals will be required to undergo two tests over the course of the quarantine period.

Failure to comply will carry strict penalties. Failing to quarantine in a designated hotel carries a fine of up to £10,000, and those who lie about visiting a red list country are liable to a 10-year prison sentence.

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Cross Post: Not Recommending AstraZeneca Vaccine For The Elderly Risks The Lives Of The Most Vulnerable

Jonathan Pugh, University of Oxford and Julian Savulescu, University of Oxford

Regulators in Europe are at odds over whether the Oxford/AstraZeneca vaccine should be given to the elderly. In the UK, the vaccine has been approved for use in adults aged 18 and up, but France, Germany, Sweden and Austria say the vaccine should be prioritised for those under the age of 65. Poland only recommends it for those younger than 60. Italy goes one step further and only recommends it for those 55 and younger.

It is only ethical to approve a vaccine if it is safe and effective. Crucially, the reluctance to approve the AstraZeneca vaccine in the elderly is grounded only in concerns about its efficacy.

The concern is not that there is data showing the vaccine to be ineffective in the elderly, it’s that there is not enough evidence to show that it is effective in this age group. The challenge is in how we manage the degree of uncertainty in the efficacy of the vaccine, given the available evidence. Continue reading

The Ethics of Age-Selective Restrictions for COVID-19 Control

Written by: Bridget Williams1,2, James Cameron3, James Trauer2, Ben Marais4, Romain Ragonnet2, Julian Savulescu1,3

Cross-posted with the Journal of Medical Ethics blog

One of the major controversies of the COVID-19 pandemic has been disagreement about whether age-selective measures should be introduced, with greater focus on preventing infection in older people but tolerance of some transmission amongst younger people. Some have advocated a path of focusing efforts on protecting those most vulnerable and tolerating transmission in younger people. Others have argued for minimising community transmission. This debate involves important empirical uncertainties; including the feasibility of effectively isolating older people and the consequences of allowing infection in a large number of younger people, as well as the feasibility and consequences of alternative measures such as strict border control and quarantine. It also raises ethical considerations, including whether introducing age-selective restrictions is unjust, and whether it is acceptable for a policy to tolerate foreseeable harms.

Here we address these ethical questions and suggest that, although the appropriateness of age-selective approaches requires further consideration of the empirical evidence, ethical concerns should not prevent its consideration as a policy option.

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Are Immunity Passports a Human Rights Issue?

Written by Julian Savulescu

A shorter version of this post appears in The Telegraph

Imagine you are about to board a plane (remember that…) Authorities have reason to believe you are carrying a loaded gun. They are entitled to detain you. But they are obliged to investigate whether you have a gun. And if you are not carrying a gun, they are obliged to free you and allow you to board your plane. To continue to detain you without just cause would be false imprisonment.

Having COVID is like carrying a loaded gun that can accidentally go off at any time. The main ground for restricting people’s liberty is if they risk harming other people. This is the justification for quarantine, isolation, lockdown and other coercive measures in the pandemic. But if they are not a risk to other people, they should be free.

The ‘loaded gun’ analogy fails to acknowledge that most who are infected are significantly less harmed than gunshot victims: most recover swiftly and fully. However, in a pandemic, there is a second reason to restrict liberty: to decrease the number who fall ill and “save the NHS”. A person becoming ill not only threatens to harm others who become infected, but also increases the strain on the NHS themselves.

While research on immunity and transmission is ongoing, typically, immunity (natural or via a vaccine) both protects the individual from getting ill and reduces transmission to others. The Federal Drug Administration in the US has admitted as much. A recent study by Public Health England showed natural infection confers similar immunity vaccination (the SIREN study). There are also reasons to believe natural immunity might reduce transmission (by specific antibodies in the airways, called IgA).

An immunity passport would record a past infection (or presence of antibodies) or vaccination. It could be a bracelet, an app on the phone, or a certificate. An immunity passport would constitute evidence that a person was no longer a threat to herself or others. Because people have a human right of freedom of movement, they should be released from current lockdown if they are known not to be threats. There is no ethical basis to imprison people who are not a threat.

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Ethical Considerations For The Second Phase Of Vaccine Prioritisation

By Jonathan Pugh and Julian Savulescu

 

As the first phase of vaccine distribution continues to proceed, a heated debate has begun about the second phase of vaccine prioritisation, particularly with respect to the question of whether certain occupations, such as teachers and police officers amongst others, should be prioritised in the second phase. Indeed, the health secretary has stated that the government will look “very carefully” at prioritising shop workers – as well as teachers and police officers – for COVID vaccines. In this article, we will discuss moral and scientific reasons for and against different prioritisation strategies.

The first phase of the UK’s Joint Committee on Vaccination and Immunisation (JCVI)’s guidance on vaccine prioritisation outlined 9 priority groups. Together, these groups accommodated all individuals over the age of 50, frontline health and social care workers, care home residents and carers, clinically extremely vulnerable individuals, and individuals with pre-existing health conditions that put them at higher risk of disease and mortality. These individuals represent 99% of preventable mortality from COVID-19. Prioritising these groups for vaccination will mean that the distribution of vaccines in a period of scarcity will save the greatest number of lives possible.

In their initial guidance, the JCVI also suggested that a key focus for the second phase of vaccination could be on further preventing hospitalisation, and that this may require prioritising those in certain occupations. However, they also note that the occupations that should be prioritised for vaccination are considered an issue of policy, rather than an issue that the JCVI should advise on.

We shall suggest that the input of the JCVI is absolutely crucial to making an informed and balanced policy decision on this matter. But what policy should be pursued? Here, we outline some of the ethical considerations that bear on this policy decision.

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