Mandatory covid-19 vaccination for care home workers

Dear Editors

I can understand the perceptive of people like Pamela Laurie (ref 1), some of whom may have loved ones who require specialised and individualised personal care which their own family and friends are physically or socially unable to provide, hence their placement in an aged care home.

And almost uniformly the family and friends expect a very high level of care in these facilities.

And for some reason they may not have ever questioned the remuneration of those aged care workers who looked after their loved one, including that fact that many of them have wages just barely above the minimum wage in the UK (in fact most are just 5% or less above the minimum wage).

Many of them are in it because of shift flexibility, love of the work with the home residents, limited labour skills beyond personal care.

The issues faced by aged care workers are similar across the UK, the US, Australia and other countries.

It is not unexpected that many have more than one paid job (ref 2), the second (or third) jobs involving care giving in another home or unskilled/low skill positions like cleaning or retail; and this was prevalent pre-COVID. Furthermore, the new requirement during this pandemic, that aged care workers are not allowed to work in more than one facility, significantly reduced the hours available to these workers to work.

Their working conditions are now made harder with the introduction of mandatory COVID-19 vaccination in many countries. There is a real concern that there will be an exodus of experienced workers who do care and connect with the home residents; sure, there will be a ready supply of workers to replace them, those who are less skilled/experienced and may not share the passion and dedication people want.

Those who exit these aged care homes would simply walk into other similarly lowly paid unskilled work, including commercial cleaning and supermarket retail which is experiencing a boom during the pandemic.

While those who subcontract the personal care of their loved ones to the state may rightly expect the highest level of standards, the mandatory vaccination of home staff may be the final straw for the much under-valued and overworked aged care workforce.

Coming to your nearest aged care home: a stream of anonymous, unskilled, less passionate replacements who are there to tick the boxes and biding their time until something better comes along.

Be careful what you wish for.

References
1. https://www.bmj.com/content/374/bmj.n1684/rr-9
2. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7267626/

Dear Editor,

We read with great interest the editorial by Hayes & Pollock [1] on mandatory COVID-19 vaccination for care home workers in England, with the concrete prospect of extending this obligation to all heath care workers (HCWs) of the latter country [1].

Mandatory COVID-19 vaccination for HCWs has been recently approved also in France and Greece [2]. Nonetheless, Italy was the first European country to enforce COVID-19 vaccinations for HCWs [3]. According to law decree by 1st April 2021 [4], Italy's HCWs declining to receive the COVID-19 vaccine will face the prospect of being re-assigned duties not entailing patient contact or even be subject to implementation of a work suspension without salary for as much as a year [3]. The nationwide number of HCWs rejecting COVID-19 vaccines in Italy is estimated to be around 46,000 [5], with a higher proportion in Southern regions (10-15%) than in the North of the country (6-10%) [3]. On the other hand, hesitancy against COVID-19 vaccines among HCWs in Italy is estimated to range between 7-25%, not different from other European countries like Spain (22%) or Greece (21.5%) and lower than France (19-32%) [6]. In a recent survey conducted among 2,768 HCWs of France, Belgium and Quebec, almost 30% disagreed with getting the COVID-19 vaccines [6].

It is worth mentioning that the World Health Organization is sceptical of the value of mandatory anti-COVID-19 vaccination for HCWs: “Given current rates (and concerns) of health worker “burn-out” as a result of the pandemic and the potential consequence of an inadequately resourced health workforce, mandatory vaccination policies that require unvaccinated health workers to stay at home or require vaccination as a condition of employment or hospital privileges might have significant negative consequences for already overburdened health systems. Policies that require unvaccinated health workers to be transferred to settings where the risk is lower might have similar consequences, as they might remove critical health workers from settings that badly need health human resources, such as congregate living settings where care is provided to older adults. Additionally, it may be difficult to distinguish high and low-risk settings where there is widespread community transmission of SARS-CoV-2” [15].

Phase 3 clinical trials were designed to measure the efficacy of vaccines to avert symptomatic COVID-19 [8-10], not to draw conclusions on prevention of SARS-CoV-2 infection and transmission [11]. However, an observational study using national surveillance data of Israel following the respective nationwide vaccination campaign using mRNA BNT162b2 vaccine (Comirnaty) of Pfizer-BioNTech, compared asymptomatic cases of laboratory-confirmed SARS-CoV-2 infections among two groups: fully vaccinated individuals (defined as those for whom 7 days elapsed since receiving the second dose of Comirnaty) and unvaccinated individuals (who had not received any doses of the vaccine). The overall incidence rate per 100,000 person-days was 1.2 in the former and 40.9 in the latter. Vaccine efficacy (VE), adjusted for age group (16–24, 25–34, 35–44, 45–54, 55–64, 65–74, 75–84, and ≥85 years), sex and calendar week of vaccine administration, was 93.8% (95%CI: 93.3; 94.2) in the above Israeli study [12].

The rising number of COVID-19 cases due to Delta variant worldwide has questioned the efficacy of COVID-19 vaccines against the latter as well as the forthcoming SARS-CoV-2 strains, prompting countries to re-introduce face masks and restrictions to travellers arriving from high-risk zones [13]. Further studies are therefore needed to confirm the magnitude of protection conferred by various COVID-19 vaccines
against asymptomatic SARS-CoV-2 infection.

A recent study estimated the efficacy of Comirnaty among HCWs of the Local Health Unit (LHU) N.2 of Treviso (North-eastern Italy) [14]. A total of 6,423 HCWs were included in the latter study from 27th December 2020 up to 24th March 2021, after exclusion of 1,285 (13.0%) HCWs infected with SARS-CoV-2 before the start of the vaccination campaign. The study reported an overall incidence of SARS-CoV-2 infection of 0.27 person-days at 21+ days following the first dose of Comirnaty, and 0.02 person-days after the second dose. The adjusted VE in preventing SARS-CoV-2 infection was 85.4% at 21+ days after one dose of Comirnaty, increasing up to 95% at 7+ days since the second dose. Furthermore, the latter Italian study reported that “All the included HCWs were screened approximately every 8 days and at any other time if presenting symptoms consistent with COVID-19”  where the word “approximately” implies a loose testing schedule, possibly underestimating the true incidence of SARS-CoV-2 infection, which is asymptomatic in more than 50% cases [15]. As acknowledged by the authors, the estimate of SARS-CoV-2 infection in the above Italian study was biased by several factors [14]:
• vaccinated people may have less rigorously adhered to testing, based on the belief they were protected, thus leading to an overestimate of VE;
• asymptomatic infections may have been missed by first-line antigenic tests;
• estimate of VE was impossible for much short follow up intervals (i.e. 21 days since the administration of the first vaccine dose, before receiving the second dose);
• the impact of SARS-CoV-2 variants could not be taken into account, since this information was not available.

A new study should therefore accurately investigate the incidence of SARS-CoV-2 infection among vaccinated and unvaccinated HCWs. Since the estimated average proportion of unvaccinated HSWs is reportedly low a multicentric study would be required.

A reliable estimate of SARS-CoV-2 infection among unvaccinated individuals (whatsoever direction) may have a major influence on the current hesitancy rate against Covid-19 vaccinations.

REFERENCES

1. Hayes L, Pollock AM. Mandatory covid-19 vaccination for care home workers. BMJ 2021;374:n1684

2. Wise J. Covid-19: France and Greece make vaccination mandatory for healthcare workers. BMJ 2021;374:n1797.

3. Official Gazette of the Italian Republic. Law Decree N. 44 – 1st April 2021. Available from: https://www.gazzettaufficiale.it/eli/id/2021/04/01/21G00056/sg (last accessed on 16th July 2021).

4. Paterlini M. Covid-19: Italy makes vaccination mandatory for healthcare workers. BMJ 2021; 373: n905.

5. Quotidiano Sanita'. No vax. Sono quasi 46 mila i sanitari italiani non vaccinati. E ora scatteranno le sospensioni. Available from: https://www.quotidianosanita.it/governo-e-parlamento/articolo.php?artico... (last accessed on 18th July 2021).

6. Biswas N, Mustapha T, Khubchandani J, Price JH. The Nature and Extent of COVID-19 Vaccination Hesitancy in Healthcare Workers. Journal of Community Health (2021).

7. World Health Organization. COVID-19 and mandatory vaccination: Ethical considerations and caveats. Available from: https://www.who.int/publications/i/item/WHO-2019-nCoV-Policy-brief-Manda... (last accessed on 12nd July 2021).

8. Polack FP, Thomas SJ, Kitchin N, et al. Safety and efficacy of the BNT162b2 mRNA Covid-19 vaccine. N Engl J Med 2020; 383:2603-2615.

9. Baden LR, El Sahly HM, Essink B, et al. Efficacy and safety of the mRNA-1273 SARS-CoV-2 vaccine. N Engl J Med 2021; 384:403-416.

10. Voysey M, Ann S, Clemens C, Madhi SA et al. Safety and efficacy of the ChAdOx1 nCoV-19 vaccine (AZD1222) against SARS-CoV-2: an interim analysis of four randomised controlled trials in Brazil, South Africa, and the UK. The Lancet, 2021; 397, (10269): 72-74.

11. Olliaro P, Torreele E, Vaillant M. COVID-19 vaccine efficacy and effectiveness—the elephant (not) in the room. Lancet Microbe. 2021 Apr 20. doi: 10.1016/S2666-5247(21)00069-0.

12. Haas EJ, Angulo FJ, McLaughlin JM, Anis E, R Singer S, Khan F, Brooks N, Smaja M, Mircus G, Pan K, Southern J, Swerdlow DL, Jodar L, Levy Y, Alroy-Preis S. Impact and effectiveness of mRNA BNT162b2 vaccine against SARS-CoV-2 infections and COVID-19 cases, hospitalisations, and deaths following a nationwide vaccination campaign in Israel: an observational study using national surveillance data. Lancet. 2021; 397, 10287: P1819-1829.

13. Washington Post (2021). Spread of delta variant prompts new restrictions worldwide. Available from: https://www.washingtonpost.com/world/2021/06/28/coronavirus-latest-updates/ (last access on 18th July 2021).

14. Fabiani M, Ramigni M, Gobbetto V, Mateo-Urdiales A, Pezzotti P, Piovesan C. Effectiveness of the Comirnaty (BNT162b2, BioNTech/ Pfizer) vaccine in preventing SARS-CoV-2 infection among healthcare workers, Treviso province, Veneto region, Italy, 27 December 2020 to 24 March 2021. Euro Surveill. 2021; 26(17): pii=2100420.

15. World Health Organization. Report of the WHO-China joint mission on coronavirus disease 2019 (COVID-19), 2020. Available: https://www. who. int/ publications-detail/report-of-the-who-china-jointmission-oncoronavirus- disease-2019-(covid-19) [Last accessed on 16th July 2021].

Dear Editor

A mandate enforcing Covid 19 vaccination on care home workers would not only create an ethical dilemma for the administrator with regard to the GMC guidance on consent but would surely also be in violation of what is required under UK law.

Care home workers in undergoing a medical intervention are surely entitled in law to the same rights and freedoms as everyone else when it comes to giving informed consent in that it needs to be freely and voluntarily given without coercion or duress.

I have had personal experience of the huge contribution care home staff made in caring for their residents during the pandemic. I have seen the voluntary contributions and many extras they have provided often with great personal sacrifice in doing so. Despite this they have endured negative publicity during the pandemic which although not directed at the workers themselves, must have been very difficult to endure in trying circumstances where they were giving their best.

And now we are expecting them to give up their autonomy and make one further sacrifice in accepting mandatory vaccination.

A French Journal has recently published a preliminary legal judgement on mandatory vaccines arguing in summary that “French law technically bans the Covid vaccines without informed consent because they are experimental.” (1)

Where does UK sit on informed consent and vaccines with temporary authorisations? Might the UK end up at odds with other countries if they persist with the mandatory vaccination of care home workers?

Previously in the case of Solomakhin v. Ukraine it was determined that……………

“Compulsory vaccination – as an involuntary medical treatment – amounts to an interference with the right to respect for one’s private life, which includes a person’s physical and psychological integrity, as guaranteed by Article 8 § 1” (2)

The enormity of what care home workers will be sacrificing in having to accept mandatory vaccination should not be underestimated.

One further observation I have made of the care home setting (long before the onset of the pandemic) was the difficulty they often have in recruiting staff something which might worsen significantly if they are subjected to mandatory vaccination.

I respect the fact that had I lost a loved one to Coronavirus in a care home setting I might view this differently and I endorse residents rights to be cared for in a safe environment but might it not be possible to increase vaccination rates by other means before introducing draconian measures such as mandatory vaccination?

The predicament for the vaccine administrators cannot be underestimated either.

The ethical duty in the concept of consent and medical treatment requires the administrator of a medical treatment to abide by the Greek Hippocratic Oath to“…use treatment to help the sick according to my ability and judgment, but never with a view to injury and wrong-doing” (3)

In the rare event that a care home worker suffered a serious adverse event following administration of a vaccine with a temporary authorisation where would that leave the administrator given that consent would not have been freely given?

Failure to correctly obtain informed consent for a medical intervention in cases where the patient suffers a resultant injury have been litigated by the courts many times over with heavy penalties for those found guilty and compensatory awards for the victims.

Surely mandatory vaccination should be a very last resort after all other possible means of increasing vaccination rates have been exhausted.

(1) Why the covid vaccines are illegal without informed consent. Conservative Woman 2021 July 11.

(2) https://hudoc.echr.coe.int/fre#{%22itemid%22:[%22001-109565%22]}
CASE OF SOLOMAKHIN v. UKRAINE (Application no. 24429/03)

(3) Informed Consent David C. Miller, MD, MA1 , and Clark C. Smith, MD, MPH2 on behalf of the Spine Intervention Society’s Patient Safety Committee

Dear Editor

I agree with the authors' points, but am concerned that they may be dismissed by non-clinicians who may not be held to the same ethical or professional standards.

What may also be worth noting is that forcing vaccines on people doesn't work. People who really don't want vaccines find a way to avoid having them, and vaccine acceptance is best done through clear information, honest communication of risks and calm countering of anti-vaccine propaganda, however wacky it may be. Vaccination rates are highest when this is done, and is the best way to get the greatest number of jabs into the greatest number of arms.

A further concern is that forcing vaccination on people risks fertilising seeds of hesitancy and doubt which we are trying to counter. What matters is what works, and as the Faculty of Occupational Medicine notes (1), there are many ways to positively encourage people to get vaccinated without turning them off this set of jabs or indeed the ones that will inevitably follow.

(1) https://www.fom.ac.uk/wp-content/uploads/COVID-19-Guidance-on-Vaccinatio...