by John Stone

The British government (Prime Minister Boris Johnson pictured) are running a public consultation with a view to cutting every corner and safe-guard in order to roll out a COVID vaccine campaign before Christmas (the British “warp-speed”). presumably with the Oxford/Astra-Zeneca product in mind. For anyone who wants to respond it ends this Friday (18 September). This is how I have responded to the on-line form.

Temporary authorisation of the supply of unlicensed products

The urgency of the situation in which such a decision needs to be taken is heavily in doubt. While the government has taken it upon itself to place restrictions on the public from which it would gladly be alleviated the hospitalisation and fatality rates for the virus have been in continuous decline since the spring - if indeed there is a continuing infection rate this presumably confers more certain immunity than any putative vaccine. None of the initial candidate products purports to offer strong immunity so it is hard to see even if there were any good reasons for the present restrictions that the introduction of these products would offer sufficient grounds for their removal. It is more likely that they would simply contribute to public confusion.

As I understand it the decision to distribute unlicensed vaccines (or licensed ones) will be taken by the JCVI. The JCVI is described as an “independent” body, but of what? The chair of the JCVI, Andrew Pollard, is lead developer of the Oxford/Astra Zeneca COVID-19 vaccine, which has been backed by the government to the tune of at least £100 million. In February 2014 Pollard chaired a meeting of the JCVI which recommended the Bexsero Men B vaccine to the schedule of which he was also lead developer, which became part of Conservative window-dressing at the 2015 election. Even if Pollard recuses himself the “independence” of any decision will be in doubt - apart from anything else at its February 2016 meeting the JCVI enjoyed the hospitality of Pollard’s research institution, the Martin School, and his Oxford College, St Cross. It is not reported that any members protested. Dissent at JCVI meetings had never been reported, indeed no votes ever seem to be recorded.

Should a decision be delayed beyond the end of the year it will come under the remit of the licensing authority, the MHRA. The MHRA is entirely funded by the industry for the licensing of medicines and biologicals, and also advised by Prof Pollard. In 2009 the MHRA - at the time of the swine flu scare - failed to detect an association between the GSK vaccine Pandemrix and the condition of narcolepsy, and remained uncontrite in BMJ correspondence as late as 2018. It is illusory at the present time to suppose the licensure in itself provides grounds for confidence. The government in fact has no existing processes to ensure confidence. The government also assumes that anything “authorised” will subsequently be “licensed” which further calls the independence of the process into question. What if it turned out to be not just “temporary”

Civil liability and immunity

The document maintains that it would be unfair to manufacturers to have to sustain liability, but it is not clear why it would be fair to the public who have already had incredible costs loaded on to them, whether any suit was against the manufacturer (to be reimbursed by the government) or against the government itself, the cost of which would then be passed to the public, if successful. Admittedly, in almost any circumstances the Legal Aid Agency will fail to support such litigation (a dramatic instance would be Vioxx), so it is somewhat theoretical: whatever happens the manufacturer makes a killing and there is little sanction on them to ensure safety, let alone that you will not catch the disease.

Ultimately, the government shelters legally behind the principle of informed consent which leaves the onus on the patient or their guardian, but needs to entail that it is genuinely informed (including all the risks and shortcomings of the product as is provided in the Montgomery ruling). It is further prejudicial if scorn and loathing are heaped on anyone who is not sure whether to comply (for instance the several derogatory comments made the Prime Minister about “anti-vaxxers”, or pronouncements by the WHO about the “vaccine hesitant” being a threat to global health) which is devoid of intellectual merit, quite outside the spirit of freedom of choice or the recommendations of the recent Cumberlege review, which considered instances where injured patients were subjected to bullying tactics. This fails to recognise the rights of the patient. It also undermines the rights of the patient if they are expected to be vaccinated to protect someone other than themselves. It is not only a dubious principle it may well be that it is in the interests of children, for example, to acquire natural immunity, particularly if the virulence of the disease retreats to the level of the common cold (which seems entirely likely).