A Bioethical Dilemma in the UK Vaccine Rollout

Oops:

The government and NHS England has ruled that GPs must move the second dose of the vaccine to 12 weeks after the first, instead of the originally planned three-week gap.

And from Monday, January 11 they were informed that they had to postpone any second dose vaccines they had originally booked within the timeframe.

Since December 15, 2,000 people in Tameside and Glossop received their second dose before the change in policy.

Dr Alan Dow, who works at in Cottage Lane Surgery in Glossop told a meeting of the primary care committee that some GPs feel they have been put in an ‘impossible position’ by the new national mandate.

“The breaking of the consent for the three week promise was a big thing,” he said.

“I personally told people that face to face as I vaccinated them on the day and then suddenly we can’t do it. That’s a big thing in general practice actually, breaking consent with our patients.

“It is close to moral injury, if not actually. I already think we’re out on a limb in terms of evidence.”

Moral injury is defined as the profound psychological distress which results from actions, or the lack of them, which violate one’s moral or ethical code.

Dr Dow added that he could understand the position of the medical chiefs to delay the second dose, but did not know how much that took into account ‘breaking consent which has been the model of personal care in the NHS for 70 plus years’.

The Pfizer vaccine has only been validated for its original 2 dose protocol (with that specific timing). We do not know how a 4x increase in the spacing affects the protection afforded by the vaccine. Perhaps you end up with the same protection (≈90%). Perhaps it’s a bit better. Perhaps it’s a lot worse! (There’s evidence of some protection from a single dose, but we probably only have data from three weeks after.) Lots of things could happen. We haven’t studied it so we don’t know. We don’t, as far as I know, have a great theoretical model that would help us make an educated guess.

Thus, a bunch of people are being subjected to an experimental treatment. It’s likely to be safe (i.e., the risks from the treatment itself are low…thought that’s more theoretical; mRNA clears in a few weeks; exposure to vaccine levels of spike protein don’t trigger cytokine storms; thus, from a safety perspective, get as many shots as you like). But we don’t know how effective it is and we won’t know until we see how many people in the new arm of the experiment contract severe COVID.

This would be fine…if the people involved gave informed consent in advance. They, of course, did not give such consent. The GPs told their patients they were going to get a certain treatment and then had to tell them they were going to get an untested alternative instead.

Ordinarily, this is no dilemma. It’s straight up wrong. Oh sure, if the second doses were destroyed or contaminated, etc., it would be unfortunate but not a wrongdoing in the simple scenarios. If only some were, then we’d have an allocation problem. Of course, assuming stocks can be replenished we could always have an interrupted treatment and then do the full treatment when possible.

But there is a dilemma! The UK is in the midst of a very bad outbreak with the whole country experiencing high rates of infection. The whole healthcare system is near the breaking point.

Things will get worse before getting better due to the time lag between exposure and manifestation of illness as well as the lack of transmission control and asymptomatic spreaders. Some people who will get sick are already infected. Some people who will get sick in the current trajectory are not yet infected. If we can get some of the second group at least one dose of the vaccine it could perhaps half the number of that second group getting hospitalised for COVID.

From a bioethics instruction perspective this is a pedogogically well structure dilemma. In first framing, you have deontological considerations (lack of consent) in tension with utilitarian ones (saving lives). If you poke at little further you have consequentialist issues buttressing the deontological ones (some of the people who relied on the normal course might get seriously ill; the “moral injury” is also a factor). There’s a lot of potential second order effects.

I wish it were a hypothetical instead of this grim reality.

I don’t envy any of the decision makers.

Ideally, everyone would eventually get the normal two dose protocol (for a total of three doses). It’d be best if everyone who’s received a dose got a choice whether to finish their treatment or postpone it, but it would depend a bit on the numbers. I think doing a one does, then delayed two dose is better than an off label 2 dose (unless we get excellent results from wide spaced 2 dose trials).

The damage to doctor/patient relations needs addressing as well. The government so routinely squanders everything, it’s hard to know the marginal effect of this overall, but there are directly relations that need restitution as well.

Update: Hmm:

For the Pfizer vaccine, the impact of stretching out the two doses hasn’t been tested in clinical trials. Pfizer cautioned that its trial only investigated giving two doses 21 days apart – far less than 12 weeks. But evidence increasingly suggests that spacing out doses of the AstraZeneca/Oxford vaccine may be more effective at protecting people.

The main risk is that people’s level of immunity falls before they receive their second dose, putting them at risk of Covid-19 – although this risk would still be lower than if they’d received no vaccine, and would be boosted when they eventually received their second shot.

However, a consensus statement by the British Society for Immunologists said that delaying the booster dose by eight or nine weeks was unlikely make much difference in the longer term.

Hmmmmm (following the AZ link):

Evidence now suggests that spacing out doses of the AstraZeneca/Oxford vaccine may be more effective at protecting people. Clinical trials revealed the efficacy of the vaccine was substantially higher, at 90%, in a subgroup of people who received half a dose followed by a full dose, rather than two full doses, which had an efficacy of 62%.

But Prof Wei Shen Lim, the chair of the Covid-19 immunisation group of the JCVI, told MPs further analysis by AstraZeneca showed the improved protection came from spacing out the doses.

“People who had the half dose then full dose were those who were vaccinated at a longer time interval, roughly six to 12 weeks, and what they’ve seen in their data is that people who have the second dose later probably have a three times higher antibody level than those who were vaccinated earlier. So if anything, it suggests that increasing the dose interval is beneficial,” he said.

Sir Mene Pangalos, the executive vice-president of biopharmaceuticals research and development at AstraZeneca, told the committee the first vaccine shot was more protective over time.

“What we’re seeing with our data so far is that as you go to the eight- to 12-week interval, you actually increase vaccine efficacy. People are protected enough with the first dose, to around 70%, but we see that within that eight- to 12-week interval is actually the sweet spot,” he said.

Again, I’ve not delved, but this reporting is worrisome. It is suggestive of motivated reasoning.

The brutal fact is that AstraZeneca and Oxford botched their trial. They didn’t do what they said they would do by accident. Maybe this will be a happy accident, but now you have, “Oh it’s the half dose, no, Oh it’s the spacing, no, oh, maybe it’s not the booster”. That’s not good!

It doesn’t mean that they are wrong but it’s all rather untrustworthy.