8 April 2021

Child vaccine trials paused
The trial of the Oxford-AstraZeneca Covid vaccine in children has been paused while a possible link with blood clots in adults is investigated. Given that the phase 3 adult vaccine trials to establish long-term safety data are on-going and are not due to conclude until late 2022/early 2023, the question remains why were trials in children ever started? The risks to children from COVID-19 remain extremely low and any suggestion that children should be vaccinated to protect adults is ethically highly questionable.

HART’s position remains that it is unnecessary, unethical and should be strongly discouraged until long-term safety data in adults are complete. HART would also remind regulators, the media and politicians that these are experimental vaccines, without full regulatory approval but issued under emergency waivers. It is vital that data is collected and rigorous scrutiny of vaccine effects is completed and letters such as this one in The BMJ must surely be followed up as a matter of urgency. (The letter was since removed by the Editors and replaced with the following warning: “Important editorial notice for readers: This rapid response has been removed as it was being used to spread misinformation and was attributed in a misleading way on certain websites and social media. The Editor, 12/04/2021.”)

Vaccine certification
Boris Johnson has confirmed that the government is investigating the use of ‘Covid status certificates’ which could be introduced in May. HART’s position has not changed on this topic. HART strongly contends that any vaccine certification or passport is highly coercive, threatening the loss of livelihood and the loss of freedom of movement, violates informed consent and instead represents unwarranted and considerable duress. It is welcome news that the Liberal Democrats and Labour are poised to vote against such measures in Parliament. Many businesses have also joined the wave of opposition, most notably the UK Cinema Association. Over the weekend, Michael Gove asked readers of The Daily Telegraph to share their views on the issue. Over 8,000 comments were forthcoming with the overwhelming majority strongly against the idea. As is argued by this article in The Critic, we must not remove the rights of the individual to assess risk and prioritise the quality of their own life.

Do we need the vaccine to protect others?
Putting aside the obvious breach of moral standards that domestic vaccine passports represent, how sound is the logic of the scheme? The premise of the idea, which has been welcomed by certain members of the press and public, is that the healthy population needs to be vaccinated in order to protect the vulnerable, who have themselves been vaccinated. The bottom line is, if an unvaccinated person poses a threat to a vaccinated person, then the vaccine does not work.

Fortunately, this is not true; the vaccine’s efficacy is undeniable. It is being reported that the AZ vaccine is 94% effective at preventing severe illness after just a single dose. With over 5 million people now fully-vaccinated, the most clinically vulnerable members of society are even less likely to die as a result of exposure to SARS-CoV-2. Vaccine passports are a redundant concept.

For context, a 65-year-old male with Type 2 diabetes has a 0.2% chance of hospitalisation from Covid (according to the QCovid risk assessment). Vaccination reduces this 0.2% risk by 94% to 0.01%.

Accounting for the fact that these figures were based on the prevalence of SARS-CoV-2 in the spring 2020 peak, and test positivity rates in England are now just 4% of that level, we should correct the risk to take this into account. The vaccinated 65-year-old now has a hospitalisation risk of 0.0004%.

The vaccine is reported to reduce transmissions by 70%, which seems like a high number on paper. However, once you have taken into account the low chance of a vaccinated person contracting the disease, we are talking about applying a 70% reduction to a starting risk of 0.0004% (roughly 1 in 250,000).

Given the efficacy of the vaccine and the huge uptake of the vaccine in the healthy population, the chance of a vaccinated person dying as a result of contact with an unvaccinated person is close to zero. We are risking widespread social division in order to alleviate a risk that barely exists.

SAGE modelling – approach with caution
On Monday 6 April, SAGE published their latest forecast, predicting spikes, surges and epidemic peaks if we venture from our homes in June. They say that ‘while the vaccines prevent the vast majority of people from falling ill and dying from coronavirus, they are not good enough to see all curbs lifted without a big epidemic.’

This shift in strategy has also been noted in tweets from Health Secretary Matt Hancock who on 3 April said: “The vaccine is our route to normal”. But just two days later on 5 April, he tweeted: “Reclaiming our lost freedoms and getting back to normal hinges on us all getting tested regularly.”

The SAGE model in question ignores real world data. Why should the UK, with one of the biggest vaccination roll-outs and high disease incidence over the past year expect ‘epidemic’ proportions of this disease, particularly when it did not occur last summer when fewer people in the population had been exposed to the virus and none had been vaccinated? This seems even more unlikely with the news that we will pass the herd immunity threshold next week. We also note in the same article that the Government is unhappy with the ‘pessimistic tone set by models produced by SPI-M’ and is asking other groups to critique the work. We look forward to reading these critiques and will be publishing our own in due course.

Value for money?
Boris Johnson has announced a further rollout for mass-testing the entire population as part of his return to normal. Twice weekly nose and throat swabs are far from ‘normal’ and certainly not scientifically valid or cost effective. Indeed the proposal for 10 million Lateral Flow tests at £10 per kit will cost £200 million per week.

By the government’s own calculation of 0.3% false positives, that will generate 60,000 false positives per week. These will all require tracing and offering a confirmatory PCR test at £100 each adding a further £6 million to the bill. Then NHS Test and Trace, already struggling with its current work-load, will be required to contact not only these 60,000 people but their 600,000 or more contacts. At present, deaths from COVID-19 are at a low level with a total of 227 deaths in the 7-days to 31 March. Even assuming that all these deaths were preventable, then this proposal would cost £907,489 per life saved, with no account of the staffing costs of the scheme.

NICE guidance for public health measures, define £20,000 per quality-adjusted life year (QALY) as cost effective. So for £206 million to be cost effective, it assumes those whose deaths were prevented still had an average of 45 years of quality life ahead of them (unlikely given the average age of COVID-19 deaths is 82.4). This money could provide proper care for those who are symptomatic and yet not self-isolating fully, while still leaving well over £200 million pounds to be spent on dealing with cancer waiting lists, mental health, a struggling economy or even a new communication strategy of hope.

Asthma remedy may reduce hospitalisation by 90%
One of the successes of the UK’s pandemic response has been mobilising the NHS to run clinical trials of new treatments for COVID-19 as part of the “RECOVERY” trial. It is through this trial that the benefits of a cheap, and widely available steroid drug, dexamethasone, when given to the seriously ill in hospital were discovered, and it seems likely that thousands of people’s lives have been saved worldwide as a result.

A group in Oxford, observing the benefits of dexamethasone reported above, and also noticing that asthma patients taking inhaled steroids seemed (surprisingly) to be under-represented as COVID-19 inpatients, embarked on a trial of budesonide – a cheap, widely available drug taken via inhaler by millions of asthma patients – started within 7 days of the onset of symptoms. 146 patients were recruited and half received budesonide.

As reported here, the results are impressive – the steroid inhaler reduced the relative risk of requiring urgent care or hospitalisation by 90% over the 28-day study period. The paper for the trial can be found here and is, according to the author, soon to be published in the Lancet Respiratory Medicine Journal.

Given that these results were published 2 months ago, it seems surprising that this trial has not attracted more interest, since many would quite rightly regard a safe, cheap and widely available treatment that could be given in early disease to prevent progression and the need for hospitalisation as a “game-changer”, with the potential to alter our entire attitude to COVID-19 management. For example, it could recalibrate the risk-benefit ratio of vaccination, especially relevant this week with the news of the clotting problems related to the AstraZeneca vaccine being confirmed by several authorities.

Texas back to normal
Followers of social media will have seen astonishing video clips of the jam-packed Texas Rangers stadium hosting a baseball game on Monday. Horrified observers in states maintaining restrictions (albeit lighter than those in the UK) argued that this will lead to massive spikes in infections.

But, they claimed the same when Texas State Governor Abbot ended the mask mandate and business restrictions over a month ago.

Did a disaster come to pass? No, in fact, over the past month Texas has seen substantial and sustained declines in cases, hospitalisations and deaths. This is despite only 16% of Texans being fully vaccinated even now (this was at 6.7% on 1 March). The state Governor has now announced a ban on vaccine passports in common with Florida, and the White House has also ruled them out at a Federal level, stating that “citizens’ privacy and rights should be protected”.

Masks in the classroom
The Prime Minister did not even mention children in Monday’s press conference on the road map, despite the promised review of face coverings in class introduced on 8 March. It took a tweet from the Department of Education yesterday to announce that this measure was to continue, with no risk-assessment provided. This is now 10 weeks of increased restrictions on school children despite the continuing fall in hospitalisations and deaths and the almost complete rollout of the vaccination programme to the top 9 risk categories. What does this say about how our society values its children?

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