COVID-19 and trust

Trust in organisations during the COVID-19 pandemic

Preamble

The new coronavirus called the Severe Acute Respiratory Syndrome coronavirus-2 (SARS-CoV-2) causes the disease known as COVID-19.  Three vaccines have been authorised by the Medicines and Healthcare products Regulatory Agency (MHRA) for temporary supply in the UK (MHRA, 2021a; MHRA, 2021b; MHRA, 2021c).

These vaccines are –

BioNTech/Pfizer: COVID-19 mRNA Vaccine BNT162b2

Moderna: COVID-19 mRNA-1273 Vaccine nucleoside modified

Oxford/AstraZeneca: COVID-19 Vaccine ChAdOx1 viral vector DNA.

Informed consent is essential when a vaccine is offered to a person with mental capacity. In my opinion the decision by the UK government supported by various organisations to increase the interval between the first dose and the second/booster dose for these vaccines to 12 weeks is wrong and I am opposed to it.

Trust in an organisation is based on the three issues of ability, benevolence and integrity (Best et al., 2020; Mayer, 1995). As a consequence of some of their actions in relation to the COVID-19 pandemic, I have a low level of trust in the following organisations – the Joint Committee on Vaccination and Immunisation (JCVI), the Medicines and Healthcare products Regulatory Agency (MHRA), and Public Health England (PHE).

Commentary: The Evidence

When considering the research evidence about the vaccines in the context of the interval between the first dose and the second dose, a key indicator is the level of neutralising antibodies which in turn leads to a key outcome of efficacy which is defined as the ability of the vaccine to reduce the new cases of COVID-19 disease (BioNTech/Pfizer, 2020; Moderna, 2020; Voysey et al., 2020).

BioNTech/Pfizer: with this mRNA vaccine, neutralising antibodies were barely increased after the first dose of vaccine but they were significantly increased when the second dose was given at 21 days (BioNTech/Pfizer, 2020).  

After one dose the vaccine efficacy for BioNTech/Pfizer was 52.4% (95% Confidence Intervals 29.5%, 68.4%) (BioNTech/Pfizer 2020; Polack et al., 2020). 

In contrast after the second dose the vaccine efficacy was 95% (95% Confidence Intervals 90.3%, 97.6%) (BioNTech/Pfizer 2020; Polack et al., 2020). 

The MHRA have authorised the vaccine as a two dose regime with the second dose given at least 21 days after the first dose and the MHRA’s notes: “Individuals may not be maximally protected until at least 7 (sic) days after their second dose of the vaccine.” (MHRA, 2021a).

Moderna: with this mRNA vaccine, neutralising antibodies were increased after the first dose for 15 days but thereafter they were starting to plateau or decline in most patients. Once the second dose was given at 29 days the neutralising antibodies increased significantly (Widge et al., 2021).

After one dose the vaccine efficacy for Moderna was 80.2% (95% Confidence Intervals 55.2%, 92.5%) (Moderna, 2020).

In contrast after the second dose the vaccine efficacy was 94.1% (95% Confidence Intervals 89.3%, 96.8%) (Moderna, 2020).

The MHRA have authorised the vaccine as a two dose regime with the second dose given 28 days after the first dose (MHRA, 2021b).

There is no data to support extending the time interval between the first and second dose for the mRNA vaccines researched and manufactured by BioNTech/Pfizer and Moderna.

Oxford/AstraZeneca: with this viral vector vaccine, neutralising antibodies were increased by the second dose of vaccine at 28 days after the primary vaccination (Ramasamy et al., 2020).

After one dose the vaccine efficacy was 64.1% (95% Confidence Intervals 50.5%, 73.9%) (Voysey et al., 2020).

In contrast after the second dose the vaccine efficacy was 70.4% (95% Confidence Intervals 54.8%, 80.6%) (Voysey et al., 2020).

The MHRA have authorised the vaccine as a two dose regime with the second dose given between four and 12 weeks after the first dose (MHRA, 2021c).

The Oxford/AstraZeneca vaccine was researched in several trials which is the normal practice. However the timings and dosages of the primary and secondary vaccinations varied between the trials (Voysey et al., 2020) and there were also variations between standard doses and low doses which further complicate the analyses. 13% of the UK participants and 10% of the Brazil participants were aged 56 years or older hence overall 88% of participants were 55 years or younger (Voysey et al., 2020; Voysey et al., 2020, supplementary appendix).

For the Oxford/AstraZeneca viral vector vaccine the evidence for a longer interval than four weeks between the first and second dose is equivocal due particularly to the differences in dosing and scheduling during the trial (Griffin, 2021;  Iacobucci et al., 2021). Hence in my opinion increasing the interval beyond four weeks is stretching the evidence.

Commentary: Trust in Organisations

A high level of trust in an organisation is based on the three issues of ability, benevolence and integrity (Best et al., 2020; Mayer, 1995). Trust in an organisation’s ability centres on their competence and performance to do something. It is both task-specific and context-specific.

Benevolence is identified by the organisation wanting to do good to the trustor, that is, me, you, a member of the public. Integrity is about the wholeness of the organisation based on a set of principles that are acceptable to the trustor.

As regards the UK government, they fail on all three measures of ability, benevolence and integrity so I have no trust in them.

The UK government in collaboration with the JCVI and PHE have increased the interval between the first and second dose to 12 weeks and they argue that having many people partially vaccinated is better than a smaller number of people fully vaccinated (Department of Health and Social Care, 2020; Harnden et al., 2021). However their calculations of the benefits and harms are based on many assumptions and they have been challenged (Apple, 2021; Sewell et al., 2021). 

The UK government seem to be engaged in a competition to claim they are vaccinating more people than other countries; perhaps to distract from all their failures during the COVID-19 pandemic. The countries of the European Union have been slower to begin vaccinating their citizens but they are focussing on delivering two doses within the interval defined by the manufacturers and the World Health Organization (Sewell et al., 2021). By the measure of fully vaccinated citizens per capita, several countries including Germany and Italy are outperforming the UK (Henley, 2021).  

It is damaging to trust in the government to see the breach of contract towards the people who were in the first group of vaccinations and who gave informed consent on the basis that their second dose would be at the time shown by the research, that is, after 21 or 28 days.

It would be more truthful of the UK government to stop claiming how many people have had one dose of a SARS-CoV-2 vaccine and instead to be open that some people have been partially vaccinated which will cause:

– limited increases in their neutralising antibodies against the SARS-CoV-2

– limited reduction in their risk of acquiring the COVID-19 infection

– limited reduction in transmitting the virus to others.

The vaccine programme of two doses is based on research evidence and few people in the UK have had a full course of vaccination against the SARS-CoV-2. After one dose the efficacy is about 50 to 65% whereas after two doses the efficacy is more than 70% and possibly as high as 95% (Moderna, 2020; Polack et al., 2020; Voysey et al., 2020).

The effects of not following the research evidence on the efficacy of the vaccines will include:

– partially vaccinated people having a false sense of security and having less aversion to the risk of infection due to the poor messages from the government

– partially vaccinated people being at risk of infection for some eight weeks longer so the trends of new cases, hospital admissions, deaths, long-COVID-19, et alia, will be prolonged

– the development of vaccine resistant variants, also known as mutations, of the SARS-CoV-2 amongst partially vaccinated people and thereby resistance to the vaccines (Iacobucci, et al., 2021; Moore, 2021).

If the decision to ignore the research evidence was purely an action by the UK government then that would be damaging for trust. I find it much more damaging to trust to see the support for the UK government from the JCVI, the MHRA, and PHE hence I have a low level of trust in them. Their benevolence seems to me to be to do good for the UK government and their integrity seems to be based on the principles of helping the government implement its decisions. They could have the ability to analyse the evidence but their ability seems to be influenced by the context of their wish to help the government.

The Joint Committee on Vaccination and Immunisation (JCVI) have supported increasing the interval (Harnden et al., 2021; JCVI, 2021) which is convenient for the UK government and it seems a political decision has been made against the research evidence.

However the JCVI:

– have not provided the evidence for their decision to increase the interval (Harford, 2021)

– seem to have used precedents from viral vector vaccines but the precedents cannot be applied to mRNA vaccines because these vaccines are too novel to have established precedents (Bird, 2021)

– appear to have applied assumptions and modelling that is based on unpublished research data which needs to be peer reviewed (Robertson et al., 2021).

Public Health England (PHE) have supported increasing the interval (Harnden et al., 2021) but they are an executive agency of the Department of Health taking instructions from the UK government (Vize, 2020).  

PHE:

– have carried subset analyses and exploratory analyses of the results from the BioNTech/Pfizer and from the Oxford/AstraZeneca studies. The PHE analyses had wide confidence intervals for efficacy after one dose, for example, from 52% to 97%, and from 48% to 86% (Iacobucci, et al., 2021), which do not appear to justify their conclusions in support of increasing the interval

– have form when it comes to finding information to support the UK government, for example, counting a test for the SARS-CoV-2 that has been posted to a person as the same as a completed test sent to the laboratory

– also helped the government by stating that the first and second dose of a SARS-CoV-2 vaccine could reasonably be from different brands (PHE, 2021). Mixing brands is neither supported by the evidence nor by expert opinion (Mahase, 2021a).

The Medicines and Healthcare products Regulatory Agency (MHRA) have not changed their authorisation for the second dose of the BioNTech/Pfizer and Moderna vaccines but they have stated an interval of between four and 12 weeks for the

Oxford/AstraZeneca vaccine which is convenient for the UK government.

The MHRA:

– fast-tracked the authorisation of the Oxford/AstraZeneca vaccine and perhaps they over-looked the low percentage of people over 56 years and the mixture of doses and timings which are some of the reasons other countries in Europe are not authorising the Oxford/AstraZeneca vaccine for people over 65 years, for example, Austria, France, Germany, Poland, Sweden

– initially they did not authorise the use of the Innova lateral flow test for asymptomatic people in the community then they reversed their position which has divided expert opinion (Deeks, 2021; Kmietowicz, 2021) and it has not added to the credibility of the MHRA.

Conclusions

The actions by the UK government, the JCVI, the MHRA and PHE in relation to increasing the interval between the first and second doses have only limited support in the medical community (Mahase, 2021b). It is significant that the manufacturers, regulatory agencies and other relevant organizations have advised following the peer reviewed research evidence for the BioNTech/Pfizer and Moderna vaccines for the interval of 21 days and 28 days (Sewell et al., 2021) and not one other national government has extended the interval to 84 days. The World Health Organization have recommended a maximum of 42 days for the interval for the BioNTech/Pfizer vaccine (World Health Organization, 2021).

In the UK as a consequence of extending the interval, I expect there will be a reduction in the rate of decline in new cases of SARS-CoV-2 infection compared to other countries because partially vaccinated people will be at risk of infection for some eight weeks longer than if they had been fully vaccinated. In turn there will be a slower rate of decline in hospital admissions, deaths, long-COVID-19, et alia, and more prolonged lockdowns.

The UK organisations supporting the 12 week interval will partly blame the development of vaccine-resistant variants on the slowing of these rates which will be hypocritical when their actions contributed to the creation of the variants. 

Declarations

Informed consent is essential when a vaccine is offered to a person with mental capacity.

I am very keen to be vaccinated against the SARS-CoV-2 and if I have some choice then I would prefer to receive the BioNTech/Pfizer vaccine with the second dose at 21 days or the Moderna vaccine with the second dose at 28 days.

I have written elsewhere about my opposition to mandatory face coverings outdoors: http://www.iainrobbe.com/covid-19-and-face-coverings/

References

Apple, M. (2021). Response to: https://blogs.bmj.com/bmj/2021/01/08/maximising-the-benefit-of-the-uk-covid-19-vaccination-programme/

Best, S., et alia. (2020). https://www.tandfonline.com/doi/full/10.1080/20479700.2020.1862399

BioNTech/Pfizer. (2020). Briefing Document.  https://www.fda.gov/media/144246/download

Bird, S. (2021). https://www.sciencemediacentre.org/expert-comment-on-whether-giving-two-doses-of-covid-vaccine-separated-by-a-longer-period-is-sensible/

Deeks, J. (2021). https://blogs.bmj.com/bmj/2021/01/12/covid-19-government-must-urgently-rethink-lateral-flow-test-roll-out/

Department of Health and Social Care. (2020). https://www.gov.uk/government/news/statement-from-the-uk-chief-medical-officers-on-the-prioritisation-of-first-doses-of-covid-19-vaccines

Griffin, S. (2021). https://www.sciencemediacentre.org/expert-comment-on-whether-giving-two-doses-of-covid-vaccine-separated-by-a-longer-period-is-sensible/

Harford, T. (2021). Is “First Dose First” the Right Vaccination Strategy? Financial Times, January 9/10 2021.

Harnden, A., et alia. (2021). https://blogs.bmj.com/bmj/2021/01/08/maximising-the-benefit-of-the-uk-covid-19-vaccination-programme/

Henley, J. (2021). Merkel and Macron Lead Defence of EU’s Vaccination Strategy. Guardian, February 4th 2021. 

Iacobucci, G., et al. (2021). https://www.bmj.com/content/372/bmj.n18

JCVI. (2021). https://www.gov.uk/government/publications/prioritising-the-first-covid-19-vaccine-dose-jcvi-statement/optimising-the-covid-19-vaccination-programme-for-maximum-short-term-impact

Kmietowicz, Z. (2021) https://www.bmj.com/content/372/bmj.n81

Mahase, E. (2021a) https://www.bmj.com/content/372/bmj.n12

Mahase, E. (2021b) https://www.bmj.com/content/372/bmj.n226

Mayer, R.C., et alia (1995). An Integrative Model of Organisational Trust. The Academy of Management Review, 20(3), 709–734.

MHRA. (2021a). https://www.gov.uk/government/publications/regulatory-approval-of-pfizer-biontech-vaccine-for-covid-19/information-for-healthcare-professionals-on-pfizerbiontech-covid-19-vaccine

MHRA. (2021b). https://www.gov.uk/government/publications/regulatory-approval-of-covid-19-vaccine-moderna/information-for-healthcare-professionals-on-covid-19-vaccine-moderna

MHRA. (2021c). https://www.gov.uk/government/publications/regulatory-approval-of-covid-19-vaccine-astrazeneca/information-for-healthcare-professionals-on-covid-19-vaccine-astrazeneca

Moderna. (2020). Briefing Document. https://www.fda.gov/media/144434/download

Moore, J.P. (2021). https://blogs.bmj.com/bmj/2021/01/06/john-p-moore-how-do-you-take-your-vaccine-one-lump-or-two/

PHE. (2021). https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/955548/Greenbook_chapter_14a_v6.pdf

Polack, F.P., et alia. (2020). https://www.nejm.org/doi/full/10.1056/NEJMoa2034577

Ramasamy, M.N., et alia. (2020). https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(20)32466-1/fulltext

Robertson, J.F.R., et alia. (2021). https://blogs.bmj.com/bmj/2021/01/05/covid-19-vaccines-to-delay-or-not-to-delay-second-doses/

Sewell, H.F., et alia. (2021). https://blogs.bmj.com/bmj/2021/01/20/revisiting-the-uks-strategy-for-delaying-the-second-dose-of-the-pfizer-covid-19-vaccine/

Vize, R. (2020). https://www.bmj.com/content/371/bmj.m4476

Voysey, M., et alia. (2020). https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(20)32661-1/fulltext

Voysey, M., et alia. (2020). Supplementary Appendix. https://www.thelancet.com/cms/10.1016/S0140-6736(20)32661-1/attachment/75bff1ea-804f-4c66-adc1-2f7d0f9b4550/mmc1.pdf

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About Iain Robbe

I am a medical practitioner (MB, BS, 1980; MRCS, LRCP, 1980) registered with the General Medical Council of the United Kingdom. Due to the COVID-19 pandemic I have reactivated my licence to practise and I am providing telephone support to vulnerable elderly to assist them during the pandemic. I remain active as a Clinical Medical Educationist participating in a number of projects with the universities of St Mary’s and Dalhousie in Nova Scotia and Mount Allison in New Brunswick, inter alia, and separately with three of the veterinary schools in the UK. My focus is on teaching and research in professionalism, ethics, and communications, and particularly the influences of vernacular architecture on the creation of positive learning experiences in undergraduate and postgraduate medical education. I have the degree of Master in Public Health from the University of London (1985) and the degree of Master in Medical Education with distinction from the University of Wales (2001). The guiding principles in my practices are based on andragogy and humanism, and the prime ethical principle of autonomy for the individual and in population health.

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