Prioritising the vulnerable groups is a lower-risk strategy
Only if you don’t count the entire population being locked down as a risk.
Except we're not talking about a full lockdown until there's enough jabs for everyone, are we? Some restrictions, yes, but even before the vaccine is distributed the lockdowns in the UK have been a matter of weeks. If the government pulls its finger out of its arse and gets track and trace working properly then we'll be able to have fairly normal life while production and distribution ramp up. The other thing is if we know it's temporary the government can afford to pump more money in to keep people afloat and the economic pain can be reduced.
The most important thing is to end lockdown completely, not to tinker around the edges and keep some restrictions going for years to come.
Years? These vaccinations are going to be available by the new year and production will ramp up massively. I'd be astonished if it takes more than a year to get enough doses for the whole UK population. Even then, it's likely that partial distribution will start to reduce transmission far sooner. The goal is to save lives, stop the NHS collapsing and relieve the worst impacts of lockdown ASAP. If we have to keep 2m apart, and wear masks in shops and schools, until the end of 2021 but folk in care homes can see their loved ones by April then I think that's a fair trade off.
Keeping 2m apart is killing all kinds of places that just aren’t viable with the reduction in capacity that it requires. University staff, for instance, are having to double or even triple their workload because only a fraction of their students can fit in a lecture theatre at any given time, so each lecture is having to be delivered twice or more. Cinemas, restaurants, pubs, and all manner of sports clubs and tourist attractions are dying because they can’t fit enough people in to cover their costs.
Depends on the university and course. The course we give has the same number of lectures, and they're given online. As far as I'm aware all lectures are currently online, and the system seems to be working well for students (the staff are finding it harder to adapt to new technology and changes to the delivery this requires). The online laboratory work has been less successful with videos of PhD student demonstrators doing the experiment and then letting the students process the data. We're still working on the practicalities of online continuous assessment and examination ... ultimately when this is over there's almost certainly going to be a return to conventional exams for at least a part of assessment. It raises the question of whether the students needed to actually be in the same city (several aren't - one of our students is from Hong Kong and was unable to travel). There's no particular reason why ongoing social distancing will prevent most of university teaching - though, it would impact the social aspects of university - the same as pubs, restaurants etc
Keeping 2m apart is killing all kinds of places that just aren’t viable with the reduction in capacity that it requires. University staff, for instance, are having to double or even triple their workload because only a fraction of their students can fit in a lecture theatre at any given time, so each lecture is having to be delivered twice or more. Cinemas, restaurants, pubs, and all manner of sports clubs and tourist attractions are dying because they can’t fit enough people in to cover their costs.
None of which will be fixed by vaccinating a proportion of the less vulnerable before the most vulnerable.
Apropos epidemics in general. TV is running a short series on England's Bubonic plague outbreak in the 1600's. Bacterial rather than viral, and a bit of a confused approach to the 'why' it was happening (rats? miasma? touch? - lice and fleas, in seems). Once symptoms appeared hospitals refused to allow the afflicted in. And foreign ships were made to wait for a period of 40 days before docking and unloading or 'quarantined' as it became known. The general response was brutal isolation, locking affected people, with their families, into their homes and marking their house-doors with plague crosses and prayers; stationing watchmen to guard the door so no-one could leave. Until either cure or death occurred. Body collection was done at night ("Bring out your dead"), and the dead interred just as they were, uncoffined and unshrouded, into huge communal plague pits. All belongings of infested homes were recommended for burning.
The plague took about 70% of those affected. Began in London, so London began to empty of its population once the plague took a hold. Or rather those who could afford to leave London and live elsewhere moved away. Like King Charles II. Certificates of good health were required to move away. Samuel Pepys remained as his job focused on the naval London yards. In those days people didn't travel to the extent they do now, so it took a while for the plague to reach other parts of the country. Next episode: Eyam. The village that chose isolation for its whole population rather than spread the disease after villagers began to die, having contracted it. One of their safeguarding tactics apparently was outdoor church meetings where people could safely distance from each other. A practice that was also being used in London by various groups. The Lord Mayor even built himself a special gallery in his guildhall so he could stand high up and apart from petitioners coming to consult with him. It seemed to work. He died nearly thirty years later.
Keeping 2m apart is killing all kinds of places that just aren’t viable with the reduction in capacity that it requires. University staff, for instance, are having to double or even triple their workload because only a fraction of their students can fit in a lecture theatre at any given time, so each lecture is having to be delivered twice or more. Cinemas, restaurants, pubs, and all manner of sports clubs and tourist attractions are dying because they can’t fit enough people in to cover their costs.
None of which will be fixed by vaccinating a proportion of the less vulnerable before the most vulnerable.
It would allow anyone who wants to to go and do those things without having to keep such a distance from anyone else.
Somehow I don’t think finding enough people who will want to do them will be a problem.
There's no particular reason why ongoing social distancing will prevent most of university teaching - though, it would impact the social aspects of university - the same as pubs, restaurants etc
You mentioned labs - labs where the students don't actually get to perform the experiment are woefully inadequate from the point of view of educating the students. It's the best we can do at the moment, as well, but it's nowhere near as good as the real thing.
Discussion classes actually work quite well over zoom, IME. You're better off on zoom than you are having everyone spaced out in a large room - being able to look at everyone's face on zoom makes it a more intimate experience than shouting across a large room.
Interactive tutorials / office hours are much better in person - sure, you can hold your work up to the camera, or position a camera to look at your work, but it's much more difficult than in-person.
For my mind, traditional lectures work well recorded and viewed online. I know some people who like to do interactive lectures where all the students have clickers to choose answers. You can do that in your choice of Canvas / Blackboard / whatever, but I don't know how it compares to the in-person experience.
I think I'd prioritize grocery store workers and the like over either normal over-65s or students. People who work in that kind of essential supply chain job don't have a choice about whether to go out in public or not.
This appears to be the USA Today article Gramps49 was referring to. It describes a proposal from the (US) National Academy of Medicine; the actual decision has yet to be made by the CDC’s Advisory Committee on Immunization Practices.
I note that Phases 1 and 2 together account for about 50% of the population, and Phase 4 is only 5-15%.
Politicians should not make any public health policy decisions re vaccinations nor anything else. Business leaders shouldn't either. It has to be all medical and epidemiological. Full stop. Politicians and business leaders are idiots about public health with rare exception.
If you're wealthy, I've no doubt however that you can buy a vaccine for yourself when available. People are buying COVID testing independently, depending on jurisdiction, illegally. It's the same as everything else. It's merely about price.
Politicians should not make any public health policy decisions re vaccinations nor anything else. Business leaders shouldn't either. It has to be all medical and epidemiological. Full stop. Politicians and business leaders are idiots about public health with rare exception.
If you're wealthy, I've no doubt however that you can buy a vaccine for yourself when available. People are buying COVID testing independently, depending on jurisdiction, illegally. It's the same as everything else. It's merely about price.
I generally agree with you, except for discussions of medical ethics which sometimes need to be broader, when absolute values in medical ethics (first, do no harm) might need to be questioned. One should ask medical professionals to inform what the choices mean in such situations, but should not ask them to take decisions that compromise their ethical framework - that would be inflicting moral injury. Those are choices that our representatives should make on our behalf.
For example, the UK government eventually sanctioned challenge trialsfor vaccines. These trials were due to commence in January. These involve giving low risk volunteers a vaccination or placebo and then deliberately infecting them, to see if the vaccines are effective. This is ethically difficult, to say the least, when there is no fully effective treatment for those who develop a serious version of the illness. Yet there are thousands of willing, informed volunteers ready to do this.
Challenge trials could have been set up 3-6 months ago. They would have placed around 500 volunteers (expected UK trial numbers) at risk of serious illness and death. Actual deaths, with younger volunteers, are statistically unlikely to be above zero - but obviously, that is no guarantee... But it would have led to hundreds of thousands fewer deaths in the global population, through earlier vaccine rollout.
Keeping 2m apart is killing all kinds of places that just aren’t viable with the reduction in capacity that it requires. University staff, for instance, are having to double or even triple their workload because only a fraction of their students can fit in a lecture theatre at any given time, so each lecture is having to be delivered twice or more. Cinemas, restaurants, pubs, and all manner of sports clubs and tourist attractions are dying because they can’t fit enough people in to cover their costs.
None of which will be fixed by vaccinating a proportion of the less vulnerable before the most vulnerable.
It would allow anyone who wants to to go and do those things without having to keep such a distance from anyone else.
Somehow I don’t think finding enough people who will want to do them will be a problem.
Almost everyone would like to be free of the restrictions, so how do you decide who gets the vaccine first? Lottery?
The stated fundamental goal of the proposal is "Reduce severe morbidity and mortality and negative societal impact due to the transmission of SARS-CoV-2."
The report addresses the underlying reasons behind the ordering of people in the various phases on page 7:
The framework pursues that goal while mitigating health inequities, showing equal concern for all, being fair and transparent, and building on the best available evidence. Given the current state of the pandemic, the early phases of the committee’s proposed framework emphasize prevention of severe morbidity and mortality, particularly with regard to maintaining essential health and emergency services. The focus shifts toward reducing transmission in later phases. There are multiple reasons for this approach:
Death is an irreversible outcome. There are legitimate claims for many groups (e.g., schoolchildren, “non-essential” workers) to be in earlier phases as negative societal impact could occur if these groups are not prioritized. For example, there might be a substantial impact on the economy if a primarily transmission-focused strategy is not employed from the outset. However, the non-trivial effects of an economic downturn or an online semester can at least be partially reversed.
Preventing severe morbidity and mortality protects the health care system from being overwhelmed, contributing to the prevention of excess morbidity and mortality from other causes as well, with ripple effects on society and the economy.
For vaccination to materially reduce transmission requires vaccinating a critical mass of individuals, much greater than will be possible in the early phases of vaccine deployment.
The ongoing COVID-19 vaccine trials are not designed to estimate the impact of the vaccine candidates on transmission and evidence of the vaccines’ actual impact on transmission might not be available for some time after U.S. Food and Drug Administration approval.
While data on all aspects of COVID-19 are emerging, data on transmission risk groups (e.g., age, profession) are particularly limited.
Phizer formally applied for emergency approval in the USA today. There will be a public review of the data the first week in December. Distribution will begin by the third week in December. Moderna will also seek emergency approval within the next week.
According to US Today the distribution will be in phases:
Phase 1a will be first responders and hospital workers
Phase 1b will be elderly in nursing homes and people over 65 with two comorbid conditions,
Phase 2 will be anyone else over 65
Phase 3 will be college students and people in other institutions.
Phase 4 will be everyone else.
The hope will be everyone should have access to the vaccine by the summer.
Let me amend the list. Those younger than 65 with co-morbid conditions will be in phase 2.
Also, the FDA hearing on the vaccine will be on Dec. 10th according to the paper this morning.
Prioritising the vulnerable groups is a lower-risk strategy,
The problem is there is no perfectly practical* solution. Since this rushed process makes the first inoculated part of the primary test group, there is a strong case for it to be given to the strong first.That way, the most able to cope will find the side effects instead of the least able to cope.
Prioritising the vulnerable groups is a lower-risk strategy,
The problem is there is no perfectly practical* solution. Since this rushed process makes the first inoculated part of the primary test group, there is a strong case for it to be given to the strong first.That way, the most able to cope will find the side effects instead of the least able to cope.
*Apologies to Ms. Poppins
There will already have been 3 phases of clinical trials for all the deployed vaccines, and safety trials have been conducted to include older populations. The first set of therapeutic inoculations does not, in any way at all, constitute ‘the primary test group’.
Some data on side effects is already available here. Long story short - side effects may be more intense than some expect, but are not likely to be dangerous.
This link may be helpful. It lists all of the vaccine candidates around the world. Updated regularly. The 2 receiving press coverage currently are just ahead of a bunch of others. It's also worthy of note that there are multiple approaches to vaccine creation. The first or second vaccine may or may not be the best or right one. It's also quite possible that vaccine selection will vary depending on country, location of manufacturer, whether there's profiteering.
Prioritising the vulnerable groups is a lower-risk strategy,
The problem is there is no perfectly practical* solution. Since this rushed process makes the first inoculated part of the primary test group, there is a strong case for it to be given to the strong first.That way, the most able to cope will find the side effects instead of the least able to cope.
*Apologies to Ms. Poppins
There will already have been 3 phases of clinical trials for all the deployed vaccines, and safety trials have been conducted to include older populations. The first set of therapeutic inoculations does not, in any way at all, constitute ‘the primary test group’.
Some data on side effects is already available here. Long story short - side effects may be more intense than some expect, but are not likely to be dangerous.
A shortened time from will mean the testing phase will be abbreviated. The first inoculated will be part of the test group. This is always going to be true, but an accelerated time frame means it will be more so.
Prioritising the vulnerable groups is a lower-risk strategy,
The problem is there is no perfectly practical* solution. Since this rushed process makes the first inoculated part of the primary test group, there is a strong case for it to be given to the strong first.That way, the most able to cope will find the side effects instead of the least able to cope.
*Apologies to Ms. Poppins
There will already have been 3 phases of clinical trials for all the deployed vaccines, and safety trials have been conducted to include older populations. The first set of therapeutic inoculations does not, in any way at all, constitute ‘the primary test group’.
Some data on side effects is already available here. Long story short - side effects may be more intense than some expect, but are not likely to be dangerous.
A shortened time from will mean the testing phase will be abbreviated. The first inoculated will be part of the test group. This is always going to be true, but an accelerated time frame means it will be more so.
I am glad you agree that the primary test group are those in the formal trials (including a wide spectrum of ages), who were actually the first to be inoculated (rather than those who will be receiving the vaccine after (accelerated) approval). I also take it as read that you agree that the immediate side effects have already been established in those trials, as the report linked earlier shows.
While two or more vaccines will get emergency use authorizations, that does not mean they will have completed full permission. As I understand it, those that do get inoculated will get a rather extensive disclaimer sheet citing all probable complications with the vaccine(s). Two big unknowns are the safety of the vaccines and the long term effects of them. While anyone getting the emegency vaccine will not be in the third phase, those that are in the third phase will be followed for a while longer. But there will be a point at which the question will arise when can the control group (the group with the dummy vaccine) be allowed to get the real vaccine.
This is rather like when the Salk polio vaccine came out. It was given emergency use authorization before the third phase of the testing was completed.
In other news, Pfizer has begun a phase in which adolescents will be given the vaccine to test the effectiveness in them.
Prioritising the vulnerable groups is a lower-risk strategy,
The problem is there is no perfectly practical* solution. Since this rushed process makes the first inoculated part of the primary test group, there is a strong case for it to be given to the strong first.That way, the most able to cope will find the side effects instead of the least able to cope.
*Apologies to Ms. Poppins
There will already have been 3 phases of clinical trials for all the deployed vaccines, and safety trials have been conducted to include older populations. The first set of therapeutic inoculations does not, in any way at all, constitute ‘the primary test group’.
Some data on side effects is already available here. Long story short - side effects may be more intense than some expect, but are not likely to be dangerous.
A shortened time from will mean the testing phase will be abbreviated. The first inoculated will be part of the test group. This is always going to be true, but an accelerated time frame means it will be more so.
My husband and I are IN these two trials, and I assure you, the testing phase (in the sense of safety, which is what we have been discussing) has NOT been abbreviated. The first inoculated will be ... the first inoculated. They are NOT part of a test group at all, unless you want to stretch the English language to the point of breaking.
Stages one and two of both trials were the risky bits, where they were looking not only to see if it would work, but if it would do harm to participants. Stage three (which is the current trial for both) is designed to ascertain effectiveness in a large population, as well as to surface any rare side effects that might not turn up in a smaller trial. I am one of the 30,000 for Pfizer; my husband is one of the 30,000 for Moderna. We are the last test groups, UNLESS something really odd pops up that they decide to run a new trial for (for example, they discover that the vaccine accidentally cures tooth decay, hurray, hurray). Our trials are scheduled to run for two years, starting in September for both of us.
The first to be inoculated outside the trials will of course run the usual human risk of coming up with known side effects, unknown and vanishingly rare side effects, or oddities where for whatever reason, the vaccine just doesn't work for them (say, an immune system defect). That does not make them part of a test group or trial. It makes them ... recipients of a vaccine. Some of them may report adverse effects to a central agency, as is common for all vaccines. That still does not make them part of a test group or trial. They have not been registered, selected according to predetermined criteria, involved in a double-blind process, or carefully followed up on to the tune of weekly and sometimes daily in both our trials. They don't need to be. They are the people the current trials were held to benefit.
The next issue is when will we see the pandemic end. I think we will continue to see a phased approach to the ending based on the rate of transmission. It is really high now in most parts of the world; but, eventually, it will fall below the Rt of 1. I wonder how long that can take.
Oh, and the only "testing phase" that might be abbreviated is the third (general efficacy with large population out in the world at large) and it will NOT be abbreviated in such a way that safety corners are cut. In fact, it will not be abbreviated at all EXCEPT for those of us who received placebo. At the time when the vaccines become available to the non-trial public, we will each be contacted with the question, "Do you want to know whether you received the real thing or placebo, or not?" It's necessary under ethical rules to give us the choice.
At this point, we can either continue as trial subjects (say "no" and remain blinded) or say "yes," find out our status, and seek a dose of the vaccine on our own. That will of course make us useless for further study. I'm fairly sure from bodily (lack of) reactions that I got the placebo. Therefore I will say "Yes, please tell me," and when they confirm it was saline (ha!), I will say "thank you, I'm off to get the real thing" and they will close my individual case. I will be lost to the study.
As for my husband who almost certainly got the real thing, they may decide to keep him, regardless of whether he chooses to find out the truth or not. He is still useful to them as they continue to monitor for odd effects that may crop up in the future, how fast immunity wanes, and the like. So he probably won't be taken out of his stage three trial whether he unblinds or not.
But as you can see, that doesn't mean the current stage-three trials are going to be abbreviated. Mildly curtailed in size, no doubt. But then, that's the result of very, very good news. The purists may sigh a bit, but they don't expect us to lay down our lives for the sake of a perfectly complete 30,000 data set.
LC - since you're in a trial, perhaps you know (or can find out) the answer to this: under what conditions will the Phase 3 test be unblinded so that people in the control group can get the vaccine? It seems hard to imagine that they'd wait the full planned two years before giving participants a chance to be sure they were vaccinated.
There are some aspects of the trials which have been significantly shortened. They cut out the usual 2-3 years to decide that the disease in question is significant enough to start work on a vaccine. Then they truncated the usual process of reviewing the research proposals which can take a year before money becomes available, and the usual limits on funding weren't applied such that the research is conducted by two scientists and a technician who also have to manage roles on various departmental admin roles and supervise students.
Thanks, that's very interesting. I would guess that a lot of people in the control group will opt to drop out to get the vaccine. It will be useful to keep following the vaccinated people, though - they'll have a lot of data on them that won't be available for members of the general public that get the shots.
VI. CONSIDERATIONS FOR CONTINUING CLINICAL TRIALS FOLLOWING ISSUANCE OF AN EUA FOR A COVID-19 VACCINE
FDA does not consider availability of a COVID-19 vaccine under EUA, in and of itself, as grounds for stopping blinded follow-up in an ongoing clinical trial. An EUA request should include strategies that will be implemented to ensure that ongoing clinical trials of the vaccine are able to assess longterm safety and efficacy (including evaluating for vaccine-associated ERD as well as decreased effectiveness as immunity wanes over time) in sufficient numbers of subjects to support vaccine licensure. These strategies should address how ongoing trial(s) will handle loss of follow-up information for study participants who choose to withdraw from the study in order to receive the vaccine under an EUA.
High on the list would be preventing health services becoming overrun. If you have a heart attack and there is no bed/staff available due to Covid then you are in a pickle.
Several of my friends are health professionals and things are already very tight staffing - wise, due to the number who test positive and have to be off for two weeks.
Our trust is piloting the lateral assay tests, so we are being tested twice a week, with results in 30 min. This is good, in that it will reduce spread, but it also means they expect to have an increase in the number of asymptomatic staff identified and needing to isolate - with knock on staffing pressures as a result.
Yes, my son is tested twice a week and has been from the beginning.
He gets drafted in to the Covid ward when they are short of staff. It’s not ICU but about half of the patients do die because they’ve chosen not to go on ventilators with DNRs, so they just get palliative care. He sees at least one death each Covid shift. 😢
The most important thing is to end lockdown completely, not to tinker around the edges and keep some restrictions going for years to come.
I would think the most important thing is to stop people from dying but everybody has their priorities.
Preventing deaths isn’t the most important thing with anything else (otherwise we’d ban everything with any risk of death whatsoever), so why should it be with this virus?
The most important thing is to end lockdown completely, not to tinker around the edges and keep some restrictions going for years to come.
I would think the most important thing is to stop people from dying but everybody has their priorities.
Preventing deaths isn’t the most important thing with anything else (otherwise we’d ban everything with any risk of death whatsoever), so why should it be with this virus?
It's a better goal than making sure everybody gets to play all they want. Ironically the steps needed for both goals are roughly the same.
That's too black and white, in any case. We don't ban things, where there is a risk, we have safety measures. Hence, we don't ban driving, but we have seat belts and vehicle checks. I think some people used to argue for no restrictions at all on cars, but why?
Risk of any kind is made up of the interaction of hazard, exposure and vulnerability.
We have lots of very long term interventions to reduce the risk of premature death; seatbelts and laws against drink driving being those that most easily spring to mind.
Would help if we described this as a war or Covid ? Would people finally get that the hazards, exposures and vulnerabilities - and the costs an interventions are on the same scale ?
People seem prepared to close our borders to various nationalities, monster entire communities, accept laws limiting our civil liberties for decades, pass laws enabling actors of the state to use torture without fear of prosecution in response to less than 10,000 deaths from political violence in the U.K. over 50 years - but serious measures for less than a year to combat a new global disease that has killed over 50,000 people in this country in less than 12 months is somehow disproportionate ?
FWIW in his presidential address in March, Emmanuel Macron repeatedly told us "we are at war". I think it was effective at the time, but at this stage people are so weary and fed up that it wouldn't work any more.
I was speaking to an ITU nurse from the south of England this morning. Their occupancy levels are already at the peak level of earlier in the year “It’s not good,” she said, and the winter illnesses surge hasn’t really begun yet. And there’s a shortage of staff due to Covid (6-7%), and staff burnout.
Psychological injury for health care providers. With the clear problem that even when people gain symptom control and could return to *normal* work functioning, they can't return to looking after Covid patients.
Prioritising the vulnerable groups is a lower-risk strategy,
The problem is there is no perfectly practical* solution. Since this rushed process makes the first inoculated part of the primary test group, there is a strong case for it to be given to the strong first.That way, the most able to cope will find the side effects instead of the least able to cope.
*Apologies to Ms. Poppins
There will already have been 3 phases of clinical trials for all the deployed vaccines, and safety trials have been conducted to include older populations. The first set of therapeutic inoculations does not, in any way at all, constitute ‘the primary test group’.
Some data on side effects is already available here. Long story short - side effects may be more intense than some expect, but are not likely to be dangerous.
A shortened time from will mean the testing phase will be abbreviated. The first inoculated will be part of the test group. This is always going to be true, but an accelerated time frame means it will be more so.
I am glad you agree that the primary test group are those in the formal trials (including a wide spectrum of ages),
Actually, I do not. Technically, this is true. It would be true if the clinical trials had but one test subject. The point is that unless there is a sufficiently large group and a long enough time, the first to receive the product are effectively beta testers. This is true across many product fields.
It is a calculated and necessary risk in this case, but that doesn't change the basic mechanism.
Prioritising the vulnerable groups is a lower-risk strategy,
The problem is there is no perfectly practical* solution. Since this rushed process makes the first inoculated part of the primary test group, there is a strong case for it to be given to the strong first.That way, the most able to cope will find the side effects instead of the least able to cope.
*Apologies to Ms. Poppins
There will already have been 3 phases of clinical trials for all the deployed vaccines, and safety trials have been conducted to include older populations. The first set of therapeutic inoculations does not, in any way at all, constitute ‘the primary test group’.
Some data on side effects is already available here. Long story short - side effects may be more intense than some expect, but are not likely to be dangerous.
A shortened time from will mean the testing phase will be abbreviated. The first inoculated will be part of the test group. This is always going to be true, but an accelerated time frame means it will be more so.
My husband and I are IN these two trials, and I assure you, the testing phase (in the sense of safety, which is what we have been discussing) has NOT been abbreviated. The first inoculated will be ... the first inoculated. They are NOT part of a test group at all, unless you want to stretch the English language to the point of breaking.
Unless you have also participated in a normal time-frame development of a vaccine, you can only give only partial information here.
It is not unheard of for medication to be pulled after approval during normal development periods because they had unintentional effects.
Risk of any kind is made up of the interaction of hazard, exposure and vulnerability.
We have lots of very long term interventions to reduce the risk of premature death; seatbelts and laws against drink driving being those that most easily spring to mind.
But not banning driving altogether.
Would help if we described this as a war or Covid ? Would people finally get that the hazards, exposures and vulnerabilities - and the costs an interventions are on the same scale ?
It’s not a war. In war, a certain amount of deaths are accepted. And even during the blitz people were allowed to meet each other for support and companionship.
Risk of any kind is made up of the interaction of hazard, exposure and vulnerability.
We have lots of very long term interventions to reduce the risk of premature death; seatbelts and laws against drink driving being those that most easily spring to mind.
But not banning driving altogether.
Would help if we described this as a war or Covid ? Would people finally get that the hazards, exposures and vulnerabilities - and the costs an interventions are on the same scale ?
It’s not a war. In war, a certain amount of deaths are accepted. And even during the blitz people were allowed to meet each other for support and companionship.
The first does need debating (although it should be noted that we also had more deaths than the blitz so to some extent we already live in that world)
...
Regarding the second.
And even during a pandamic my kitchen light is on despite not even having net curtains there.
Prioritising the vulnerable groups is a lower-risk strategy,
The problem is there is no perfectly practical* solution. Since this rushed process makes the first inoculated part of the primary test group, there is a strong case for it to be given to the strong first.That way, the most able to cope will find the side effects instead of the least able to cope.
*Apologies to Ms. Poppins
There will already have been 3 phases of clinical trials for all the deployed vaccines, and safety trials have been conducted to include older populations. The first set of therapeutic inoculations does not, in any way at all, constitute ‘the primary test group’.
Some data on side effects is already available here. Long story short - side effects may be more intense than some expect, but are not likely to be dangerous.
A shortened time from will mean the testing phase will be abbreviated. The first inoculated will be part of the test group. This is always going to be true, but an accelerated time frame means it will be more so.
I am glad you agree that the primary test group are those in the formal trials (including a wide spectrum of ages),
Actually, I do not. Technically, this is true. It would be true if the clinical trials had but one test subject. The point is that unless there is a sufficiently large group and a long enough time, the first to receive the product are effectively beta testers. This is true across many product fields.
It is a calculated and necessary risk in this case, but that doesn't change the basic mechanism.
I see. You don’t agree it’s true, although you do agree it is true. Then you offer some opinions on product development.
Risk of any kind is made up of the interaction of hazard, exposure and vulnerability.
We have lots of very long term interventions to reduce the risk of premature death; seatbelts and laws against drink driving being those that most easily spring to mind.
But not banning driving altogether.
You've previously stated in this thread that anything short of removal of all restrictions is insufficient.
Right. During the Blitz certain activities led to life-endangerment; during Covid-19, other activities lead to life-endangerment. You really can't apply the one set of activities to the other crisis.
Comments
Except we're not talking about a full lockdown until there's enough jabs for everyone, are we? Some restrictions, yes, but even before the vaccine is distributed the lockdowns in the UK have been a matter of weeks. If the government pulls its finger out of its arse and gets track and trace working properly then we'll be able to have fairly normal life while production and distribution ramp up. The other thing is if we know it's temporary the government can afford to pump more money in to keep people afloat and the economic pain can be reduced.
Years? These vaccinations are going to be available by the new year and production will ramp up massively. I'd be astonished if it takes more than a year to get enough doses for the whole UK population. Even then, it's likely that partial distribution will start to reduce transmission far sooner. The goal is to save lives, stop the NHS collapsing and relieve the worst impacts of lockdown ASAP. If we have to keep 2m apart, and wear masks in shops and schools, until the end of 2021 but folk in care homes can see their loved ones by April then I think that's a fair trade off.
A possible alternative to a vaccine, for people without functioning immune systems, is entering its final stage of trials.
https://www.bbc.co.uk/news/health-55022288
None of which will be fixed by vaccinating a proportion of the less vulnerable before the most vulnerable.
The plague took about 70% of those affected. Began in London, so London began to empty of its population once the plague took a hold. Or rather those who could afford to leave London and live elsewhere moved away. Like King Charles II. Certificates of good health were required to move away. Samuel Pepys remained as his job focused on the naval London yards. In those days people didn't travel to the extent they do now, so it took a while for the plague to reach other parts of the country. Next episode: Eyam. The village that chose isolation for its whole population rather than spread the disease after villagers began to die, having contracted it. One of their safeguarding tactics apparently was outdoor church meetings where people could safely distance from each other. A practice that was also being used in London by various groups. The Lord Mayor even built himself a special gallery in his guildhall so he could stand high up and apart from petitioners coming to consult with him. It seemed to work. He died nearly thirty years later.
It would allow anyone who wants to to go and do those things without having to keep such a distance from anyone else.
Somehow I don’t think finding enough people who will want to do them will be a problem.
You mentioned labs - labs where the students don't actually get to perform the experiment are woefully inadequate from the point of view of educating the students. It's the best we can do at the moment, as well, but it's nowhere near as good as the real thing.
Discussion classes actually work quite well over zoom, IME. You're better off on zoom than you are having everyone spaced out in a large room - being able to look at everyone's face on zoom makes it a more intimate experience than shouting across a large room.
Interactive tutorials / office hours are much better in person - sure, you can hold your work up to the camera, or position a camera to look at your work, but it's much more difficult than in-person.
For my mind, traditional lectures work well recorded and viewed online. I know some people who like to do interactive lectures where all the students have clickers to choose answers. You can do that in your choice of Canvas / Blackboard / whatever, but I don't know how it compares to the in-person experience.
I think I'd prioritize grocery store workers and the like over either normal over-65s or students. People who work in that kind of essential supply chain job don't have a choice about whether to go out in public or not.
I note that Phases 1 and 2 together account for about 50% of the population, and Phase 4 is only 5-15%.
If you're wealthy, I've no doubt however that you can buy a vaccine for yourself when available. People are buying COVID testing independently, depending on jurisdiction, illegally. It's the same as everything else. It's merely about price.
I generally agree with you, except for discussions of medical ethics which sometimes need to be broader, when absolute values in medical ethics (first, do no harm) might need to be questioned. One should ask medical professionals to inform what the choices mean in such situations, but should not ask them to take decisions that compromise their ethical framework - that would be inflicting moral injury. Those are choices that our representatives should make on our behalf.
For example, the UK government eventually sanctioned challenge trials for vaccines. These trials were due to commence in January. These involve giving low risk volunteers a vaccination or placebo and then deliberately infecting them, to see if the vaccines are effective. This is ethically difficult, to say the least, when there is no fully effective treatment for those who develop a serious version of the illness. Yet there are thousands of willing, informed volunteers ready to do this.
Challenge trials could have been set up 3-6 months ago. They would have placed around 500 volunteers (expected UK trial numbers) at risk of serious illness and death. Actual deaths, with younger volunteers, are statistically unlikely to be above zero - but obviously, that is no guarantee... But it would have led to hundreds of thousands fewer deaths in the global population, through earlier vaccine rollout.
Almost everyone would like to be free of the restrictions, so how do you decide who gets the vaccine first? Lottery?
The stated fundamental goal of the proposal is "Reduce severe morbidity and mortality and negative societal impact due to the transmission of SARS-CoV-2."
The report addresses the underlying reasons behind the ordering of people in the various phases on page 7:
Let me amend the list. Those younger than 65 with co-morbid conditions will be in phase 2.
Also, the FDA hearing on the vaccine will be on Dec. 10th according to the paper this morning.
*Apologies to Ms. Poppins
There will already have been 3 phases of clinical trials for all the deployed vaccines, and safety trials have been conducted to include older populations. The first set of therapeutic inoculations does not, in any way at all, constitute ‘the primary test group’.
Some data on side effects is already available here. Long story short - side effects may be more intense than some expect, but are not likely to be dangerous.
Link: https://newsinteractives.cbc.ca/coronavirusvaccinetracker/
I am glad you agree that the primary test group are those in the formal trials (including a wide spectrum of ages), who were actually the first to be inoculated (rather than those who will be receiving the vaccine after (accelerated) approval). I also take it as read that you agree that the immediate side effects have already been established in those trials, as the report linked earlier shows.
This is rather like when the Salk polio vaccine came out. It was given emergency use authorization before the third phase of the testing was completed.
In other news, Pfizer has begun a phase in which adolescents will be given the vaccine to test the effectiveness in them.
My husband and I are IN these two trials, and I assure you, the testing phase (in the sense of safety, which is what we have been discussing) has NOT been abbreviated. The first inoculated will be ... the first inoculated. They are NOT part of a test group at all, unless you want to stretch the English language to the point of breaking.
Stages one and two of both trials were the risky bits, where they were looking not only to see if it would work, but if it would do harm to participants. Stage three (which is the current trial for both) is designed to ascertain effectiveness in a large population, as well as to surface any rare side effects that might not turn up in a smaller trial. I am one of the 30,000 for Pfizer; my husband is one of the 30,000 for Moderna. We are the last test groups, UNLESS something really odd pops up that they decide to run a new trial for (for example, they discover that the vaccine accidentally cures tooth decay, hurray, hurray). Our trials are scheduled to run for two years, starting in September for both of us.
The first to be inoculated outside the trials will of course run the usual human risk of coming up with known side effects, unknown and vanishingly rare side effects, or oddities where for whatever reason, the vaccine just doesn't work for them (say, an immune system defect). That does not make them part of a test group or trial. It makes them ... recipients of a vaccine. Some of them may report adverse effects to a central agency, as is common for all vaccines. That still does not make them part of a test group or trial. They have not been registered, selected according to predetermined criteria, involved in a double-blind process, or carefully followed up on to the tune of weekly and sometimes daily in both our trials. They don't need to be. They are the people the current trials were held to benefit.
At this point, we can either continue as trial subjects (say "no" and remain blinded) or say "yes," find out our status, and seek a dose of the vaccine on our own. That will of course make us useless for further study. I'm fairly sure from bodily (lack of) reactions that I got the placebo. Therefore I will say "Yes, please tell me," and when they confirm it was saline (ha!), I will say "thank you, I'm off to get the real thing" and they will close my individual case. I will be lost to the study.
As for my husband who almost certainly got the real thing, they may decide to keep him, regardless of whether he chooses to find out the truth or not. He is still useful to them as they continue to monitor for odd effects that may crop up in the future, how fast immunity wanes, and the like. So he probably won't be taken out of his stage three trial whether he unblinds or not.
But as you can see, that doesn't mean the current stage-three trials are going to be abbreviated. Mildly curtailed in size, no doubt. But then, that's the result of very, very good news. The purists may sigh a bit, but they don't expect us to lay down our lives for the sake of a perfectly complete 30,000 data set.
From the FDA's guidance on COVID-19 vaccine emergency use authorization:
I would think the most important thing is to stop people from dying but everybody has their priorities.
Several of my friends are health professionals and things are already very tight staffing - wise, due to the number who test positive and have to be off for two weeks.
He gets drafted in to the Covid ward when they are short of staff. It’s not ICU but about half of the patients do die because they’ve chosen not to go on ventilators with DNRs, so they just get palliative care. He sees at least one death each Covid shift. 😢
That gives it a human face. Thank you (I think) for sharing.
Preventing deaths isn’t the most important thing with anything else (otherwise we’d ban everything with any risk of death whatsoever), so why should it be with this virus?
It's a better goal than making sure everybody gets to play all they want. Ironically the steps needed for both goals are roughly the same.
We have lots of very long term interventions to reduce the risk of premature death; seatbelts and laws against drink driving being those that most easily spring to mind.
Would help if we described this as a war or Covid ? Would people finally get that the hazards, exposures and vulnerabilities - and the costs an interventions are on the same scale ?
People seem prepared to close our borders to various nationalities, monster entire communities, accept laws limiting our civil liberties for decades, pass laws enabling actors of the state to use torture without fear of prosecution in response to less than 10,000 deaths from political violence in the U.K. over 50 years - but serious measures for less than a year to combat a new global disease that has killed over 50,000 people in this country in less than 12 months is somehow disproportionate ?
It is a calculated and necessary risk in this case, but that doesn't change the basic mechanism.
It is not unheard of for medication to be pulled after approval during normal development periods because they had unintentional effects.
But not banning driving altogether.
It’s not a war. In war, a certain amount of deaths are accepted. And even during the blitz people were allowed to meet each other for support and companionship.
...
Regarding the second.
And even during a pandamic my kitchen light is on despite not even having net curtains there.
I see. You don’t agree it’s true, although you do agree it is true. Then you offer some opinions on product development.
Thank you for sharing.
You've previously stated in this thread that anything short of removal of all restrictions is insufficient.