COVID-19 IMUNISATION Cordell Health resource for employers and employees 8 March 2021
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Cordell Health resource for employers and employees 8 March 2021 COVID-19 IMUNISATION Immunisation/vaccination – how vaccines work We use the term vaccination and immunisation interchangeably. The first immunisation against infectious disease was introduced by Dr Edward Jenner in 17961. This was called a vaccine, because the name of this way to immunise people against serious disease is derived from the Latin vacca, for cow. Dr Jenner observed that milkmaids who previously caught cowpox did not catch smallpox, although he did not know at the time that both these conditions were caused by a similar virus. The current Covid 19 vaccines target the spike protein that coats the outside of the virus. These spike proteins assist the virus to enter the host cells in people who are infected, binding to receptors in the host cell called ACE2 receptors. The immunisations mimic natural infection, which stimulates antibodies to neutralise the ability of the spike protein to enter human cells and therefore stopping the virus entering the host cell and reproducing itself using the human cell’s own genetic material2. Purpose of immunisation Vaccines are the most effective way to prevent infectious disease3. The Covid 19 vaccination programme is prioritised to protect those people who are at the highest risk of serious illness or death through catching Covid 194. Over this last year the international evidence shows that more than 95% of those who have died in the pandemic have been over the age of 505, or had underlying health conditions that we know give rise to susceptibilities to Covid 19. So the vaccine is given to protect them, rather than other people. It is however hoped that high levels of immunisation may lead to so- called “herd immunity”. This is how immunisation programmes such as whooping cough or measles, mumps and rubella (MMR) vaccines work. 1 WHO at: https://www.who.int/news-room/feature-stories/detail/smallpox- vaccines#:~:text=The%20smallpox%20vaccine%2C%20introduced%20by,protected%20against%20inoculated%20vari ola%20virus. 2 Green Book Chapter 14a page 5 at: https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/961287/Gr eenbook_chapter_14a_v7_12Feb2021.pdf 3 NHS information on vaccination at: https://www.nhs.uk/conditions/vaccinations/why-vaccination-is-safe-and- important/ 4 UK Government COVID-19 vaccination programme at: https://www.gov.uk/government/collections/covid-19- vaccination-programme 5 ARRP article at: https://www.aarp.org/health/conditions-treatments/info-2020/coronavirus-deaths-older- adults.html Cordell Health © 8 Mar 2021 v 3
Types of COVID-19 vaccine The international effort to produce Covid 19 vaccines has been an outstanding achievement. There are currently three vaccines approved by the UK national regulator, the Medicines and Healthcare products Regulator Agency (MHRA)6. They are of principally two types, with different mode of action. The Pfizer BioNTech and Moderna vaccines include genetic material that attaches to the virus RNA, this being called messenger RNA, which then makes the human host translate this code to make the target spike protein. Once the host cell has produced small amounts of this protein, this then stimulates the immune response without the human cell having been infected by the virus itself. The Oxford/AstraZeneca vaccine delivers the spike protein genetic sequence itself using another type of virus that cannot infect humans, which again generates the host response. None of these vaccines are live vaccines, in contrast to live vaccines such as MMR or oral polio vaccine, which are live attenuated vaccines; altered so that they are not harmful. How effective are the COVID-19 vaccines? All currently approved vaccines within the UK have been shown to be highly effective. Soon after these were introduced it became clear that these vaccines were effective even with just one dose, although it is necessary to have a second dose in order to provide more long lasting protection. As at 8 Mar 2021, more than 21 million people in the UK have had their first dose of a COVID vaccination, and over a million have had the second dose7. Analysis of the impact of vaccination by Public Health England as at 22 Feb 20218, and using data from the SIREN study9, demonstrates that one dose reduces the risk of catching infection by more than 70%, rising to 85% after the second dose. This level of protection also suggests the vaccine may also help to interrupt virus transmission. The decision was made to delay the second dose of these vaccines until 12 weeks after the first in order to immunise as many people as possible in the shortest time10. Experience so far is therefore that a high level of protection is provided against severe disease even after only one dose. 6 Further information at: https://www.gov.uk/government/publications/regulatory-approval-of-covid-19- vaccine-moderna/information-for-healthcare-professionals-on-covid-19-vaccine-moderna 7 UK vaccine update statistics at: https://coronavirus.data.gov.uk/details/vaccinations 8 PHE monitoring of the effectiveness of COVID-19 vaccination at: https://www.gov.uk/government/publications/phe-monitoring-of-the-effectiveness-of-covid-19-vaccination 9 Report on SIREN Study at: https://papers.ssrn.com/sol3/papers.cfm?abstract_id=3790399 10 Information on delaying the second dose as at: 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 Cordell Health © 8 Mar 2021 v 3
How effective are the COVID-19 vaccines against new variants? Unlike live vaccines, the effectiveness of the immune response to vaccines that are not live vaccines wanes over time and so boosters will be needed if there is ongoing circulation of the virus globally. It is also the case that as coronaviruses naturally evolve over time, much like influenza, and so it is likely that annual vaccination will be needed with updated vaccine depending on circulating variants. The vaccines will be adjusted so that they remain maximally effective. We expect booster vaccines will be modified from laboratory analysis of the impact on the immune response to emerging variants. The Pfizer BioNTech and Moderna vaccines are highly flexible for adjustment, and the Oxford AstraZeneca vaccine is similarly being developed for adjustment in the Autumn of 202111. MHRA have already announced the process for approval of adjusted and new vaccines as they are developed12, as agreed with other regulators internationally forming the ACCESS Consortium13. How safe are the COVID-19 vaccines? Some employees we have had referred to us have expressed concerns over being vaccinated, most of them over the safety of these vaccines in view of the rapid development that we have seen. People can be reassured that there have been no shortcuts in the assessment of these vaccines, and they would not have been approved for use by the regulator (MHRA) if there was any doubt in regard to their safety. As with all medicines, rare side effects might emerge only later, but so far, with as of the date of this brief over 21 million people in the UK having been given the immunisation, the observed side effects have been those that might be expected in other vaccinations14. These typically affect about one in 10 people for both vaccines that have been used so far, and include having a sore arm, feeling tired, headache, feeling achy or feeling sick. These typically settle in a short time15. 11 New vaccines partnership working to rapidly respond to new virus variants at: https://www.gov.uk/government/news/new-vaccines-partnership-to-rapidly-respond-to-new-virus-variants 12 Announcement of MHRA and other regulators’ approach to approval of modified vaccines dated 4 Mar 2021 at: https://www.gov.uk/government/news/modified-covid-19-vaccines-for-variants-to-be-fast-tracked-says-mhra- and-other-regulators 13 ACCESS Consortium guidance on strain changes in authorised COVID-19 vaccines at: https://www.gov.uk/government/publications/access-consortium-guidance-on-strain-changes-in-authorised- covid-19-vaccines 14 Details of side effects reported may be found at the regularly published summary of Yellow Card reporting at: https://www.gov.uk/government/publications/coronavirus-covid-19-vaccine-adverse-reactions/coronavirus- vaccine-summary-of-yellow-card-reporting 15 Further detail may be found at: https://www.nhs.uk/conditions/coronavirus-covid-19/coronavirus- vaccination/coronavirus-vaccine/ Cordell Health © 8 Mar 2021 v 3
There has been misinformation on vaccines16, and incorrect advice, such not to have the vaccine if you have allergies, for example to penicillin. Allergies are not contraindications, unless the person has a specific allergy to a component of the vaccine. Full details are in the “Green Book” on immunisation17. COVID-19 vaccination is not usually recommended at present for women who are pregnant. However, this is because testing of the vaccine was not undertaken on pregnant women, or those breast feeding. However, there is no known risk associated with giving inactivated, recombinant viral or bacterial vaccines or toxoids during pregnancy, or whilst breast-feeding, which includes all COVID-19 vaccines in use. At present vaccination is advised for those women whose health condition would place them at a greater vulnerability to COVID-19, such as older age, diabetes and heart disease. There is also no known risk associated with giving non-live vaccines whilst breastfeeding. JCVI advises that breastfeeding women may be offered vaccination with the Pfizer BioNTech, Moderna and AstraZeneca COVID-19 vaccines. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for immunisation against COVID-19, and the woman should be informed about the absence of safety data for the vaccine in breastfeeding women18. When can people get it? Advice on priority has been given to the UK Government by the Joint Committee on Vaccination and Immunisation (JCVI), the imperative to protect as many people as possible, in accordance with their vulnerability. The most important determination of vulnerability is age, and this is why the oldest have been immunised first, and age groups have been designated as the framework for prioritisation from then on. As of the date of this brief (8 Mar 2021), those over 60 and those with conditions that make them vulnerable, or clinically extremely vulnerable, have had immunisation offered, and the penultimate group in Phase 1 of the roll-out, those aged 56 to 59, are now being offered immunisations19. 16 Loomba, S., de Figueiredo, A., Piatek, S.J. et al. Measuring the impact of COVID-19 vaccine misinformation on vaccination intent in the UK and USA. Nat Hum Behav (2021). https://doi.org/10.1038/s41562-021-01056-1 17 The “Green Book” Chapter 14a describes in detail the vaccines, side effects, contraindications and precautions at: https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/955548/Gr eenbook_chapter_14a_v6.pdf 18 Guidance note for pregnant and breastfeeding women on vaccination while pregnant and while breastfeeding at: https://www.gov.uk/government/publications/covid-19-vaccination-women-of-childbearing-age-currently- pregnant-planning-a-pregnancy-or-breastfeeding/covid-19-vaccination-a-guide-for-women-of-childbearing-age- pregnant-planning-a-pregnancy-or-breastfeeding 19 NHS announcement on invitations for immunisation at: https://www.england.nhs.uk/2021/03/56-59/ Cordell Health © 8 Mar 2021 v 3
There had been calls for some occupational groups, such as teachers and police officers, to be the first groups to be immunised in Phase 220, i.e. after all those aged 50 and over, and those adults who are considered clinically vulnerable or clinically extremely vulnerable. In their statement, JCVI have advised21 that there is evidence that some occupations have an increased risk of morbidity due to COVID-19, and that males aged 40 to 49 years are more likely to be employed in these occupations. However, a mass vaccination strategy centred specifically on occupational groups would be more complex to deliver and may slow down vaccine delivery, leaving some individuals unvaccinated for longer. JCVI have advised that vaccination during Phase 2 be age- based proceeding in the order of all aged 40 to 49, then 30 to 39, and then 18 to 29, and not occupation based. JCVI advise that those at increased risk on account of their occupation, male sex, obesity or ethnic background are likely to be vaccinated most rapidly by a simple vaccine strategy22. Do people have to have it? It is a basic principle that vaccination is voluntary and requires consent23. As set out in the “Green Book”24, the primary purpose of vaccinating health and care staff is to protect these workers at higher risk of exposure. We have had calls with care home staff who about these vaccinations. The aim of these calls has been to provide information on the nature of immunisation, and to get across the message that the aim of immunisation is to protect the individual, although it is likely that once people are immunised that this would protect vulnerable people they look after. It is the case that in healthcare certain immunisations are required for those in a patient facing role25, but at the present time, we would consider it unlikely that the Government would make it mandatory for people in certain occupations to be immunised against COVID-19. 20 The Independent 26 Feb 2021 at: https://www.independent.co.uk/news/uk/home-news/covid-vaccine- priority-teachers-police-b1808118.html 21 JCVI report on immunisation priorities for the second phase at: https://www.gov.uk/government/publications/priority-groups-for-phase-2-of-the-coronavirus-covid-19- vaccination-programme-advice-from-the-jcvi/jcvi-interim-statement-on-phase-2-of-the-covid-19-vaccination- programme 22 COVID-19 vaccine allocation by occupation in those under than 50 years of age: considerations for prioritisation and allocation at: https://www.gov.uk/government/publications/priority-groups-for-phase-2-of- the-coronavirus-covid-19-vaccination-programme-advice-from-the-jcvi/annex-a-covid-19-vaccine-allocation-by- occupation-in-those-under-than-50-years-of-age-considerations-for-prioritisation-and-allocation 23 Faculty of Occupational Medicine guidance on ethics and testing and vaccination at: https://www.fom.ac.uk/newsflash/covid-19-guidance-on-vaccination-and-testing 24 Green Book Ch 14a: https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/955548/Gr eenbook_chapter_14a_v6.pdf 25 The “Green Book” Chapter 12 Immunisation of healthcare workers at: https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/147882/Gr een-Book-Chapter-12.pdf Cordell Health © 8 Mar 2021 v 3
If employers are considering making immunisation a condition of employment, for example in care homes, this will need to account for anti-discrimination legislation. For example, there is a concern that uptake of COVID-19 vaccination among certain BAME groups has been less than the general population26. Also, at present, vaccination is not routinely offered to pregnant women unless they have conditions that may make them more vulnerable (for example heart disease, or diabetes)27. It may be that other nations may require visitors to their countries to demonstrate that they have been vaccinated. It is a requirement for travellers to certain countries to have evidence of yellow fever vaccination. However, in our view it may be considered discriminatory in the UK for people to generally be required to demonstrate vaccination to access services or other aspects of daily life. What does being vaccinated mean for individuals’ vulnerability, and the need to keep to risk management controls at work? We should emphasise that no vaccine is 100% effective, and although those who have been vaccinated are likely to have a high degree of protection, this cannot be guaranteed. Therefore at present those who are considered to have an increased level of vulnerability should continue to have the risk mitigation measures in place in line with the advice we have given when undertaking individual health risk assessments. This situation may change, based on the effectiveness of immunisation, but there may still be some people who may not be fully protected from immunisation. This would principally be those who have health conditions that reduce the effectiveness of their immune system. We should be happy to advise on those people where there may be some doubt about their ability to mount an immune response once they have had their Covid immunisation, on a case-by-case basis on referral. Furthermore, being vaccinated does not necessarily reduce the likelihood that the individual may spread the disease onto others. It may be for example that the individual is protected against serious disease themselves, and may not have symptoms, but may still be infective to others. Therefore, it is essential that until notified otherwise in Government guidance, employers and employees must continue to follow the rules in place within the community, and risk management controls in the workplace, whether they have been vaccinated or not, or whether they have previously had COVID-19. 26 Covid-19 vaccine hesitancy among ethnic minority groups. BMJ 2021; 372 doi: https://doi.org/10.1136/bmj.n513 (Published 26 February 2021). 27 Guidance note for pregnant and breastfeeding women on vaccination while pregnant and while breastfeeding at: https://www.gov.uk/government/publications/covid-19-vaccination-women-of-childbearing-age-currently- pregnant-planning-a-pregnancy-or-breastfeeding/covid-19-vaccination-a-guide-for-women-of-childbearing-age- pregnant-planning-a-pregnancy-or-breastfeeding Cordell Health © 8 Mar 2021 v 3
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