Consultation outcome

Review of temporary provisions in the Human Medicines Regulations 2012 to support COVID-19 and influenza vaccination campaigns: equality impact assessment

Updated 25 January 2022

1. Introduction

The general equality duty that is set out in the Equality Act 2010 requires public authorities, in the exercise of their functions, to have due regard to the need to:

• eliminate unlawful discrimination, harassment and victimisation and other conduct prohibited by the Act

• advance equality of opportunity between people who share a protected characteristic and those who do not

• foster good relations between people who share a protected characteristic and those who do not

1.1 Equality impact assessment

When the Human Medicines Regulations 2012 (HMRs) were amended in October and December 2020 to facilitate the mass vaccination programmes for coronavirus (COVID-19) and influenza, a number of the amendments no longer have effect from 1 April onwards. This was either because they were exceptions to the ‘business as usual’ model which, under normal circumstances, we would not want to retain; or, because they were new and would require a review of the practical implications and safeguards following implementation. Given the experience arising from the pandemic, we needed to retain flexibility to deal with unknowns.

The Secretary of State for Health and Social Care, in conjunction with the Minister of Health in Northern Ireland in relation to Northern Ireland, has sought views via public consultation on proposals that support the influenza vaccination programme in the UK and the effective rollout of COVID-19 vaccines and any necessary subsequent booster vaccine doses by either extending or making permanent some of the current temporary provisions. The intention of doing this is to help give the NHS added flexibility to operate any necessary mass vaccination programmes for COVID-19 and influenza; some provisions may be extended permanently, whilst others may be extended for a further limited time period during which we will develop further experience of using the provisions in practice and understand more about the UK’s future vaccination requirements. The public consultation ran from 8 to 29 December 2021 and sought views in the light of the learning and experience that has taken place since the amendments were first made. 125 responses were submitted, and the full consultation document and government response are available online.

The provisions which will no longer have effect from 1 April 2022 onwards if we take no further action broadly concern:

• expanding the workforce to vaccinate the public and NHS and local authority staff

• making provision for sharing vaccine stocks between sites

• easing final preparation of COVID-19 vaccines

• supply of COVID-19 or influenza vaccines by a pharmacy beyond their registered premises

These provisions are intended to give flexibility to the NHS to deliver COVID-19 and influenza vaccines at a pace and scale required for mass vaccination across the UK. As such, it is expected that they will continue to reduce health inequalities by helping to make these vaccinations available and accessible for everyone.

1.2 The public sector equality duty

The Secretary of State must have regard to 3 specified matters (outlined below) when exercising functions. The public sector equality duty (‘PSED’) applies when decisions are taken under powers exercised within Great Britain. This is found in section 149 of the Equality Act 2010.

The department is committed to equal treatment and equality of opportunity, the need to reduce inequalities between different people by reference to particular protected characteristics with respect to the benefits that may be obtained by them from the health service. The PSED (also known as the ‘general duty’) is a key lever for ensuring that public bodies take into account equality impacts when conducting their day to day work in shaping policy and delivering services.

Section 149 Public sector equality duty:

(1) A public authority must, in the exercise of its functions, have due regard to the need to:

(a) eliminate discrimination, harassment, victimisation and any other conduct that is prohibited by or under this Act

(b) advance equality of opportunity between persons who share a relevant protected characteristic and persons who do not share it

(c) foster good relations between persons who share a relevant protected characteristic and persons who do not share it

(2) A person who is not a public authority but who exercises public functions must, in the exercise of those functions, have due regard to the matters mentioned in subsection (1), above

(3) Having due regard to the need to advance equality of opportunity between persons who share a relevant protected characteristic and persons who do not share it involves having due regard, in particular, to the need to:

(a) remove or minimise disadvantages suffered by persons who share a relevant protected characteristic that are connected to that characteristic

(b) take steps to meet the needs of persons who share a relevant protected characteristic that are different from the needs of persons who do not share it

(c) encourage persons who share a relevant protected characteristic to participate in public life or in any other activity in which participation by such persons is disproportionately low

(4) The steps involved in meeting the needs of disabled persons that are different from the needs of persons who are not disabled include, in particular, steps to take account of disabled persons’ disabilities

(5) Having due regard to the need to foster good relations between persons who share a relevant protected characteristic and persons who do not share it involves having due regard, in particular, to the need to:

(a) tackle prejudice

(b) promote understanding

(6) Compliance with the duties in this section may involve treating some persons more favourably than others; but that is not to be taken as permitting conduct that would otherwise be prohibited by or under this Act

(7) The relevant protected characteristics are:

• age

• disability

• gender reassignment

• pregnancy and maternity

• race

• religion or belief

• sex

• sexual orientation

(8) A reference to conduct that is prohibited by or under this Act includes a reference to:

(a) a breach of an equality clause or rule

(b) a breach of a non-discrimination rule

The PSED continues to apply to the decision-making process relating to the development, implementation and review of COVID-19 policies. There are no PSED exceptions for a public health emergency. The overarching policy objective of the proposals is to enable the continued deployment of safe and effective COVID-19 (including any necessary subsequent booster doses) and influenza vaccines to the pace and scale required both now and in the future.

We have considered whether the provisions set out above could constitute conduct prohibited by the Equality Act 2010. The provisions will apply to all persons irrespective of protected characteristic and will not constitute direct discrimination on that basis.

The regulatory proposals enable the NHS to carry out the mass vaccination programmes required for COVID-19 and influenza. They enable vaccination services to take place in new, non-conventional settings, to target areas where vaccinations are most needed, where there is low uptake or where there are clusters of infections. Pharmacies have used the flexibility to vaccinate away from their normal premises to good effect. Vaccinations have taken place in a wide number of places such as from mobile bus services, football stadiums, and church or village halls.

COVID-19 is mostly likely to have negative health impacts and outcomes for individuals from certain protected groups, such as the elderly, and in particular, older men, certain ethnic minority groups and others who have been classed as extremely clinically vulnerable. According to ONS data for the week ending 6 January 2022, the positivity rate continued to increase among those aged 50 years and over and was highest for those in school year 12 (8.98%) to those aged 24 years, and lowest in those aged 70 years and over (3.12%). However, hospital admission rates remain highest for those aged 75 years and over. Therefore, while younger people are more likely to get COVID-19, it is still the older population that are particularly vulnerable to severe illness and death, especially those who are unvaccinated.

A report on the health impacts of COVID-19 has highlighted the ways in which the virus has negatively impacted those with protected characteristics. The report states, ‘people in the most deprived socioeconomic groups have experienced greater adverse health impacts in almost all categories of harm for which we could consider deprivation.’ Regionally, Greater London experienced the greatest direct health impacts of COVID-19: it had the highest rate of deaths to April 2021 once population size and age were taken into account; it also had the greatest Quality Adjusted Life Year (QALY) losses from death and morbidity.

The success of the vaccination programme significantly mitigates the risk to all individuals, as well as those from more vulnerable groups. The COVID-19 vaccination programme has progressed so that to date over 136 million COVID-19 vaccines have been administered in the UK since the start of the campaign. Young people aged 12 to15 are now able to book their jabs through the National Booking Service. Vaccines provide an effective level of protection against the virus and provide over 90% protection against hospitalisation from the Delta variant (for those who have received both doses). The House of Commons and Science and Technology Committee and Health and Social Care Committee have published their report, Coronavirus: lessons learned to date, examining the initial UK response to the COVID-19 pandemic. It states, ‘in the UK alone, the successful deployment of effective vaccines has allowed, as at September 2021, a resumption of much of normal life, with incalculable benefits to people’s lives, livelihoods and to society.’

Every eligible adult in England aged 18 and over was given the chance to get a COVID-19 booster jab before the end of 2021. The booster dose will help extend the protection gained from the first 2 doses and give longer term protection. It will also help to reduce the risk of patients needing admission to hospital due to COVID-19 infection this winter. Data shows that the natural immunity provided by vaccines will wane over time, particularly for older adults and those more at risk from COVID-19. Recent studies suggest protection against death falls from 95% to 80% for the AstraZeneca vaccine after 6 months, and from 99% to 90% for the Pfizer vaccine.

A rapid increase in cases of the Omicron variant has led the government to significantly increase NHS vaccination capacity. This announcement suggests that vaccine efficacy against symptomatic infection is substantially reduced against Omicron with just 2 doses, but a third dose boosts protection back up to over 70%.

While uptake of the vaccine has been high overall, vaccine hesitancy has made an impact. Analysis of data from the Office for National Statistics survey has shown higher rates of vaccine hesitancy in adults from certain ethnic minority groups. The latest ONS analysis from August 2021 shows that black or black British adults had the highest rates of vaccine hesitancy (21%) compared with white adults (4%). The government continues to engage in a range of measures to increase uptake and in doing so reduce the risk to people from ethnic minority groups. Additionally, the continued roll out of the vaccine programme may to some extent reduce the risk to those not vaccinated, by limiting the overall transmission of the virus.

During 2020 to 2021, the influenza vaccination programme was extended, and more groups were eligible to receive influenza vaccine than in previous years. Although influenza activity was low during 2020 to 2021, influenza activity during 2021 to 2022 may be high. This is because the non-pharmaceutical interventions such as shielding and social distancing that were in place during 2020 to 2021 have now been lifted and more of the population may be susceptible to influenza this winter.

As there may be winter outbreaks of COVID-19, protecting those at high risk of influenza, who are also those most vulnerable to hospitalisation as a result of COVID-19, is vitally important. 2020 saw the roll out of the biggest NHS influenza vaccination programme ever, with the aim of offering protection to as many eligible people as possible during the COVID-19 pandemic. Despite the challenges due to the COVID-19 pandemic, at the end of February 2021 NHS services had vaccinated a record 80.9% of those aged 65 years and over in England. This is the highest uptake ever achieved for this group and exceeds the WHO uptake ambition of 75%. For frontline healthcare workers, 2 and 3 year olds, and at risk groups the highest ever recorded levels of influenza vaccine uptake were also achieved.

The use of the provisions under consideration here will help the continued rollout of the COVID-19 and influenza vaccination campaigns, with public health at the forefront of the policy development. The main aim is to get the vaccines to as many people as possible, safely and swiftly, in a way that causes no discrimination or inequality.

We conducted a public consultation from 8 to 29 December 2021 regarding amending the HMRs. 125 responses were submitted, and the full consultation document and government response are available online.

1.3 Secretary of States duties under the National Health Service Act 2006

The National Health Service Act 2006 (NHSA) contains a number of overarching duties on the Secretary of State for Health which apply to every action undertaken in relation to the NHS and public health. The following duties appear to be engaged in relation to the proposals being analysed in this Equality Assessment. These are:

a) the Duty to continue to promote a comprehensive health service in England (section 1)

b) the Duty as to improvement in quality of services (section 1A)

c) the Duty as to reducing inequalities (section 1C)

1.4 Duty to continue the promotion in England of a comprehensive health service (section 1)

This Duty requires the Secretary of State to continue the promotion in England of a comprehensive health service designed to secure improvement -

a) in the physical and mental health of the people of England, and

b) in the prevention, diagnosis and treatment of physical and mental illness 

1.5 Duty as to improvement in quality of services (section 1A)

The Secretary of State must exercise the functions of the Secretary of State in relation to the health service with a view to securing the continuous improvement in the quality of services provided to individuals for or in connection with:

a) the prevention, diagnosis or treatment of illness

b) the protection or improvement of public health

In discharging this duty, the Secretary of State must act with a view to securing continuous improvement in outcomes, and in particular those outcomes which show the effectiveness or safety of the services, and the quality of the experience undergone by patients.

1.6 Duty as to reducing inequalities (section 1C)

In exercising functions in relation to the health service, the Secretary of State must have regard to the need to reduce inequalities between the people of England with respect to the benefits that they can obtain from the health service. 

It is important to emphasise that this duty is separate from the PSED duty and is about a need to reduce inequalities that may or may not be based on protected characteristics. Socio-economic impacts need therefore to be considered in terms of other socio-economic factors such as income, social deprivation and rural isolation. 

The particular legislative provisions are set to expire on 1 April 2022 and if they lapse without amending, some NHS vaccination activities would need to cease. If they inadvertently continued to operate, they may be doing so unlawfully. It is our aim to ensure that vaccines are made available to ensure public health at a scale that promotes accessibility.

Reducing health inequalities in vaccine uptake is important and cuts across several socio-economic indicators, including social deprivation. It is important that vaccine availability does not impact on these factors. In making the proposed amendments, the vaccination campaigns can continue at pace.

We have considered the various impacts of the proposals on various groups of people in this analysis. Socio-economic issues are dealt with below.

2. Analysis of impacts

Several societal benefits may arise to different groups as a result of making these amendments, including:

• a higher level of vaccination across the UK population, particularly in harder to reach locations or where vaccine uptake has been slow

• reduced likelihood of COVID-19 and influenza infections and clusters, where NHS services can act rapidly to offer the vaccine to people most at risk

• reduced rate of COVID-19 and influenza transmission in the community, in turn putting less pressure on health care services

• ensure the availability of vaccines for health and care staff, by expanding the workforce able to give the vaccination in occupational health settings

Our PSED analysis indicates that enabling the NHS to organise and prepare influenza and COVID-19 vaccination campaigns at pace and scale required could impact positively on certain groups with protected characteristics. Analysis is based on various datasets published in response to the vaccination campaigns.

3. Disability – attitudinal, physical, and social barriers for both visible and hidden disability

The House of Commons and Science and Technology Committee and Health and Social Care Committee have published their report, Coronavirus: lessons learned to date, examining the initial UK response to the COVID-19 pandemic. It states: ‘the impact of the pandemic has also been disproportionately severe for individuals with learning disabilities, both in terms of their mortality rate due to the virus itself and the impact of non-pharmaceutical interventions such as lockdown and shielding.’ The death rate from COVID-19 among adults is higher than the general population, and it is even more disproportionate amongst young adults with learning disabilities.

Initial research suggests that people with learning disabilities entered the pandemic from a position of heightened vulnerability because of existing comorbidities. Public Health England analysis highlighted that people with learning disabilities already have higher death rates from respiratory infection than the population as a whole, as well as higher rates of diabetes and obesity, both of which are risk factors for COVID-19. There have also been issues of accessing health care and having access to an accompanying family member or carer whilst doing so. Lockdowns and lack of social support was also very damaging to the wellbeing of some people with learning disabilities.

The provisions under consideration enable the NHS to provide services specifically designed to encourage people with learning disabilities to get the vaccine. Whilst some provisions are aimed at scale, there is also the benefit of targeting smaller, more bespoke requirements. For example, a COVID-19 sensory vaccination clinic aimed at helping young people with learning disabilities conquer their fear of needles has been set up within the South West London Clinical Commissioning Group (CCG).

4. Sex

According to the Office for National Statistics data, there was an almost 18% difference in the total number of COVID-19-related deaths for men (63,700) and women (53,300), between March 2020 and January 2021 in England and Wales. In the early stages of the pandemic, the difference was even more pronounced. The difference narrowed as the pandemic went on, but then grew to a peak in January 2021.

A consistently greater number of women than men have been furloughed because of the COVID-19 pandemic. It was also the case that women reported higher anxiety, depression and loneliness than men between March 2020 to January 2021.

The provisions under consideration would apply to all people regardless of their sex and help to ensure the availability of vaccines across the UK.

5. Sexual orientation

There is no data on the prevalence of vaccine hesitancy by sexual orientation. However, one in 7 LGBT people (14%) say that they have avoided treatment for fear of discrimination on the grounds of sexual orientation. Further, one in 5 (19%) of LGBT people have not disclosed their sexual orientation to any healthcare professional when seeking health care. The policy provisions under consideration may have an impact on them as they may be less likely to already be vaccinated or may face additional access barriers to vaccination. Given that individuals are not required to disclose their sexual orientation to healthcare professionals, it remains a challenge to determine the full impact of the policy.

However, as the overriding policy ambition is to increase availability, access and flexibility of vaccine programmes, it is likely to beneficially impact LGBT people.

6. Race

It has been known from fairly early in the pandemic that all other ethnic minority groups combined were disproportionately impacted by COVID-19. Office for National Statistics data on COVID-19 deaths by ethnicity shows that compared to the white British population people from all other ethnic groups combined had higher death rates during the first and second waves of COVID-19. Adjusting for location, measures of disadvantage, occupation, living arrangements and pre-existing health conditions accounted for a large proportion of the excess COVID-19 mortality risk in most ethnic minority groups; however, most black and South Asian groups remained at higher risk than white British people in the second wave even after adjustments.

Evidence suggests that certain minority ethnic groups may be more hesitant about vaccinations more generally, for example seasonal influenza and pneumococcal vaccines. Population-based analysis of previous routine vaccination uptake shows consistent reduced vaccination uptake in black African and black Caribbean groups (50%) compared to white groups (70%). The latest data from ONS states that black or black British adults had the highest rates of vaccine hesitancy (21%) compared with white British adults (4%).

Factors influencing vaccine hesitancy must not be trivialised. The government has taken a multi-channel approach to encouraging vaccine uptake in ethnic minority communities. Initiatives have included (but not limited to) i) working with specialist agencies to hold a series of roundtables for ethnic minority healthcare professionals, religious and community leaders to act as ambassadors within their communities, ii) the development of editorial content.

This policy may indirectly help to improve vaccine uptake amongst ethnic minority groups. The provisions enable the NHS to target where the vaccine is needed most and then deliver it in ways outside of the norm. REACT-2 data suggests that black adults are still least likely to get the COVID-19 vaccine and OpenSAFELY analysis has found that vaccine uptake is lower in black and South Asian over 80s. Primary care data analysed by QResearch indicates that, in the case of several viruses, black African and black Caribbean groups are less likely to be vaccinated compared with white groups; over-65s from the black Caribbean population are half as likely to have had the influenza vaccine, compared with over-65s from the white group. Recent survey data from the UK Household Longitudinal study shows that black groups are the most likely not to be vaccinated, the next group being the combined Pakistani and Bangladeshi group.

An example of how the NHS has sought to address this using the flexibilities offered by the provisions under consideration, is that the NHS in Leicester organised a mobile clinic and a pop-up clinic in a mosque, in partnership with the Somali Health Association, which resulted in 750 vaccinations in one day. Furthermore, it was found that 40% would not have gone somewhere else if the service hadn’t been available in that community.

7. Age

The provisions under consideration here are likely to have a positive impact on older people, given that increased age is a risk factor for poorer outcomes of infection. Since 1 October 2020, the mortality rate was highest among those aged over 80 (annualised rate of 1,967 per 100,000 population per year).

Recent ONS data show that levels of COVID-19 vaccine hesitancy in the general population are higher in younger people – 5% in those 18-21 years, and 9% in those aged 22-25 compared with 4% in the general population. This may possibly be because they feel themselves to be at lower risk of death or adverse outcomes from infection, but it is also noted that hesitancy has decreased slightly in the younger categories.

The provisions under consideration will help to give the NHS flexibility to provide outreach vaccination services that can target both younger and older age groups.

8. Gender reassignment

There is no evidence that this group experiences high levels of vaccine hesitancy. However, there are reports that persons with this protected characteristic face some issues when accessing healthcare, including fear of discrimination and experiences of healthcare staff lacking understanding of specific transgender health needs. Factors such as these can deter transgender people from accessing medical treatment. As a result, they may be less likely to be registered with a GP, or less likely to respond to communication inviting them to have the vaccine.

These provisions support mitigation of these access barriers to the vaccine, which ensure vaccination is consistently offered through various programmes and outreach projects.

9. Religion or belief

Recent ONS data shows that in England, people identifying as Muslim, Hindu, Sikh, or Jewish had higher age-standardised mortality rates (ASMRs) for deaths involving coronavirus (COVID-19) than those identifying as Christian in the period 24 January 2020 to 28 February 2021. The findings show that the patterns of excess COVID-19 mortality risk by religious group have changed over the course of the pandemic; after adjustments, the Hindu population and Muslim men were disproportionately affected throughout the pandemic; for other religious groups, the excess risk relative to the Christian group was only observed in the first wave (Jewish and Buddhist men) or second wave (Sikh men and women and Muslim women).

Further data also indicates that COVID-19 vaccine hesitancy was higher for adults identifying Muslim (14%) or ‘other’ (14%) as their religion, when compared with adults who identify as Christian (4%). There was no statistically significant difference when compared with other religious groups. A number of people may be opposed to vaccination in principle due to their beliefs, either religious or non-religious. These beliefs may encompass safety concerns, scepticism about vaccine efficacy, germ theory denialism, lack of trust in conventional medicine, a belief that immunity acquired through disease is superior to vaccine-acquired immunity, belief in conspiracy theories or other factors.

The provisions under consideration here allow the NHS to address these issues with its vaccination campaign. For example, a mosque in Pennine Lancashire was turned into a pop-up vaccination clinic to target ‘at-risk’ groups who had been hesitant to come forward for their vaccine. This example shows how the provisions can help to protect the most vulnerable people at a local level and by enabling flexible delivery mechanisms that best meet their needs and so remove barriers to accessing vaccines.

10. Pregnancy and maternity

In April 2021, the Joint Committee on Vaccination and Immunisation (JCVI) updated their advice on vaccination during pregnancy to state that pregnant women should be offered the COVID-19 vaccine at the same time as people of the same age or risk group. The JCVI has also recommended that the vaccines can be received whilst breastfeeding, in line with recommendations from the USA and the World Health Organization.

The provisions under consideration will have a beneficial impact on pregnant or breastfeeding women by increasing the NHS’s ability to deliver vaccination programmes where they are needed most. For example, the NHS has arranged for the vaccine to be available to expectant mums at a number of convenient local locations, including at some antenatal clinics.

11. Marriage and civil partnerships

There is no current evidence that these provisions to enable the influenza and COVID-19 vaccination campaigns in the UK will have a greater or lesser impact depending on marital and partnership status.

12. The family test

The family test was designed to complement the existing work of Departments to consider the 3 aims of the PSED.

Applying the family test when developing policy and complying with the PSED should lead to better overall outcomes for people. The test seeks to ensure that during the development of policy, particular attention is paid to its impact on supporting strong families and relationships:

1. Couple relationships (including same sex couples) including marriage, civil partnership, co-habitation and couples not living together

2. Relationships in lone parent families, including relation between the parent and children with a non-resident parent, and with extended family

3. Parent and step-parent to child relationships

4. Relationship with foster children and adopted children

5. Sibling relationships

6. Children’s relationships with their grandparents

7. Relatives or friends looking after children unable to live with their parents

8. Extended families, particularly where they are playing a role in raising children or caring for older or disabled family members

The 5 Family Test questions are:

1. What kind of impact might the policy have on family formation?

2. What kind of impact will the policy have on families going through key transitions such as becoming parents, getting married, fostering or adopting, bereavement, redundancy, new caring responsibilities or the onset of a long-term condition?

3. What impacts will the policy have on all family members’ ability to play a full role in family life, including with respect to parenting and other caring responsibilities?

4. How does the policy impact families before, during and after couple separation?

5. How does the policy impact those families most at risk of deterioration of relationship quality and breakdown?

We do not anticipate any direct impacts on families as a result of amending the HMRs. However, there may be indirect benefits for families associated with mass vaccination campaigns that continue to allow close to pre-pandemic life to continue. Vaccines have proven to be the first and best line of defence against the COVID-19 pandemic and for the prevention of seasonal influenza. This may maintain normal (pre-pandemic) life and mean that couple and family formation may be easier and allow all family members to play a full role in family life.

It seems likely that families going through key transitions may be aided by the continued rollout of vaccination programmes. For example, during the height of the pandemic, couples were unable to get married and families were unable to mourn the loss of a relative in a usual way; when gatherings were allowed, social distancing measures limited those able to attend.

For couples becoming parents, similar positive effects are likely to be enjoyed as easements were made to social distancing and infection control measures in place before and at the birth (such as limiting partner attendance at appointments).

There are likely to be benefits for new parents from being able to spend time with family and friends, play a full role in family life or provide care, whilst no longer needing to adhere to social distancing measures.

13. Engagement and involvement

This work was subject to the requirements of the cross-government Code of Practice on Consultation.

Alongside the 125 formal consultation responses that DHSC received and analysed through this exercise, the department also held initial conversations with external stakeholders to determine their views on how the provisions have been used and the direction they should take from 1 April 2022. We received responses to our informal consultation from NHS England and NHS Improvement, the Medicines and Healthcare products Regulatory Agency, the Devolved Administrations and some of the professional bodies such as the Faculty of Occupational Medicine and the Association of the British Pharmaceutical Industry.

The responses were mainly positive and reflective of a service that had used the flexibilities under consideration to help to deliver a mass vaccination campaign for COVID-19 and influenza. Stakeholders were also generally keen to see the provisions retained. The following quotes are important here:

Pop-up and roving vaccination models have been and continue to be used within the COVID-19 vaccination programme – these need to be retained for outreach activity to ensure the vaccine is as accessible as possible.

Our local community pharmacy has run a mini vaccination centre (incredibly flexibly and successfully) and also supported on outreach sessions in reduce inequalities in uptake.

The statistics from the formal consultation were reviewed by analysts from the COVID-19 and Health Protection Analysis team within DHSC.

In the formal consultation, we asked ‘Do you think the proposals risk impacting people differently with reference to their [or could impact adversely on any of the] protected characteristics covered by the Public Sector Equality Duty set out in section 149 of the Equality Act 2010 or by section 75 of the Northern Ireland Act 1998?’ 44% of respondents stated yes, 25% no and 31% I don’t know. The majority of respondents who stated that they were NHS, health service delivery or social care professionals disagreed, with 57% stating no and 14% yes. One respondent (an organisation) commented in favour of the proposals:

If anything, this will promote diversity in healthcare delivery.

Of the 44% who responded yes, very limited, relevant evidence was provided to support their responses to the consultation question. The comments were generally about their views on the COVID-19 pandemic, vaccines or the government itself, for example:

As a Christian I do not want a treatment that has been designed using foetal cells. I am fearful these genuinely held concerns will be overlooked.

Every single one of us has been equally impacted by the past 2 years and Agenda 2030 is particularly AED at getting rural populations off their land so yes they will be affected massively.

14. Summary of analysis

In summary, the effects of this policy are a significant part of the UK’s COVID-19 and influenza vaccination programme as well as an intrinsic part of the NHS’s response to targeting areas of low vaccine uptake or areas of high infection. The effects are more pronounced when considered from a perspective of not having these provisions. The NHS would not have been able to deliver such a successful campaign, reaching all areas of need, without them.

The NHS has used the full range of options available to them under the HMRs so that they can match available vaccinator staff with public demand and vaccine availability. The NHS has been able to safely vaccinate staff and deliver the vaccine campaigns and to do so with minimal disruption to normal GP and hospital services using these provisions.

In light of the intention for all health and care workers to be COVID-19 vaccinated as a condition of deployment, the provisions allowing for an expanded workforce within occupational health schemes will prove beneficial. The provisions will have a positive impact on service users in healthcare settings and care homes. These are predominantly vulnerable individuals who may face a higher risk from COVID-19 infection than the wider population. This policy will mean that more staff can be vaccinated, safely and at pace, providing them with greater levels of protection against COVID-19 infection.

In the case of disability, and pregnancy and maternity, the impacts are centred on access to the vaccine. For disabled people with learning disabilities, access barriers could be mitigated by offering the vaccine through multiple routes.

Young people may be significantly affected by this policy due to higher levels of vaccine hesitancy. This impact could be mitigated by using the provisions under consideration here to improve accessibility and outreach projects.

People from ethnic minorities and adherents to certain religions and beliefs, are likely to be significantly impacted by this policy. This is because there appears to be higher levels of vaccine hesitancy in these groups. It is key therefore to carry out work relating to culturally, religiously, and linguistically suitable and effective communications to improve voluntary vaccine uptake. These provisions help to increase levels of accessibility and ways in which the vaccine is offered to those who need it most.

The analysis conducted here is based on evidence gathered through the consultation process, as well as historical data and evidence from the COVID-19 pandemic so far. As set out, there are multiple groups with protected characteristics who may benefit from these policies because they enable increased access to vaccines, for example in locations beyond the normal GP or pharmacy practice. The benefits to the population as a whole will be compounded for groups such as older and vulnerable people who face a high risk of serious complications from COVID-19.

15. Health inequalities

In exercising functions in relation to the health service, the Secretary of State must have regard to the need to reduce inequalities between the people of England with respect to the benefits that they can obtain from the health service.

Health inequalities are unfair and avoidable differences in health across the population, and between different groups within society. They lead to poorer outcomes, shorter, unhealthier lives, and additional burdens on the NHS.

16. Socio-economic groups and deprivation

People who live in deprived areas have higher rates of COVID-19 diagnosis and death than those living in less deprived areas. According to ONS data, in England, the age-standardised mortality rate for deaths involving COVID-19 in the most deprived areas in July 2020 was 3.1 deaths per 100,000 population; as seen in previous months, this was more than double the mortality rate in the least deprived areas (1.4 deaths per 100,000 population). Poor outcomes from COVID-19 infection in deprived areas remain, even after adjusting for age, sex, region, and ethnicity.

Adults living in the most deprived areas of England (based on the Index of Multiple Deprivation) were more likely to report vaccine hesitancy (8%) than adults living in the least deprived areas (2%). Adults who were unemployed (12%) were more likely to report vaccine hesitancy than those who were in employment (4%) or retired (1%).

The NHS has sought to address this with its COVID-19 vaccination programme, by offering the COVID-19 vaccine to people most at risk from coronavirus. For example, East Brighton in Sussex is one of the 10% most deprived areas in the UK and data suggests that there is lower uptake in East Brighton compared to most of the city. The NHS worked with local stakeholders to better understand why there was a lower than average take up of vaccinations in this area and found a key barrier is travelling to the vaccination centres. Prominent locations were agreed, and communication routes were discussed to promote a roving bus or ambulance model. The provisions under consideration here helped to make this model possible and thus have a positive impact on people who live in deprived areas.

The importance of the influenza vaccine has also been highlighted. In 2020 to 2021, published monthly data included a breakdown by ethnic group for the first time. This was included in Seasonal flu vaccine uptake in GP patients: winter 2020 to 2021 and will continue in 2021 to 2022. Other inequalities work led by the UK Health Security Agency will continue to monitor and enhance the tools available and will include data on Index of Multiple Deprivation (IMD) which can be used to provide the best measure of relative deprivation as a snapshot in time (see Appendix I). We need to ensure those who are living in the most deprived areas, from ethnic minority and other underserved communities, have equitable uptake compared to the population as a whole. It will therefore require high quality, dedicated and interculturally competent engagement with local communities, employers, faith and advocacy groups. Providers are expected to ensure they have robust plans in place for tackling health inequalities for all underserved groups to ensure equality of access.

GP practices and school-based providers must actively invite 100% of eligible individuals (for example, by letter, email, phone call, text) and ensure uptake is as high as possible. The benefits of influenza vaccination among all eligible groups should be communicated and vaccination made as accessible as possible. The provisions under consideration here will help to give the NHS flexibility to deliver mass vaccination campaigns safely and at the pace required.

17. Geography

Mortality rates from COVID-19 were high in urban areas such as London. Data from ONS shows that, in the first wave of the pandemic between 1 March and 17 April 2020, London local authorities had the highest COVID-19 mortality rates in England, allowing for the age distribution of the population.

Throughout 2021, ONS data has found a widespread fall in vaccine hesitancy. Falls tended to be greatest in areas with the highest initial vaccine hesitancy rates such as London (11% to 7%), including Inner London East (13% to 7%), Outer London West and North West (12% to 7%); and Wales (9% to 4%), including West Wales and The Valleys (11% to 5%).

Ethnicity interacts with geographical location and deprivation, and ethnic minority groups are more likely to live in urban, overcrowded, and more deprived communities. This policy could protect those living in areas with highest levels of mortality, specifically urban areas, by increasing accessibility and ease of vaccination.

Accessibility to vaccines can also be a problem for rural communities. The provisions under consideration enable the NHS to deliver vaccination services to those communities that are harder to reach. For example, NHS Lanarkshire is working with colleagues in the Scottish Ambulance Service to bring a drop-in mobile vaccination unit to rural areas of Lanarkshire, Scotland. The bus offers COVID-19 and influenza vaccinations and no appointments are required.

18. Inclusion health and vulnerable groups

Socially excluded populations, including populations such as homeless people, white Gypsy, Roma and Irish Traveller ethnic groups, people in contact with the justice system, migrants and sex workers, tend to have the poorest health outcomes, putting them at the extreme end of the gradient of health inequalities. This is a consequence of being exposed to multiple, overlapping risk factors, such as facing barriers in access to services, stigma and discrimination.

These provisions have been used by the NHS to reach out to homeless people and make it easier for them to get the COVID-19 vaccination. This has included vaccinating people in interim accommodation such as former student residences and existing hostels. In another example, to vaccinate the ‘harder to reach’ group of people rough sleeping in the city, a community engagement vehicle from Hampshire Fire & Rescue Service was used to provide the vaccination service. In this way, the provisions have had a positive impact on vulnerable groups such as homeless people.