Coronavirus (COVID-19) domestic vaccine certification: business and regulatory impact assessment

Introduction

This BRIA considers the impacts for businesses and consumers of laying the Regulations under the Coronavirus Act 2020 to expand the domestic use of Covid Vaccine Certification (referred to as ‘Certification’ hereafter) to include a negative lateral flow device (LFD) or polymerase chain reaction (PCR) test result taken within 24 hours prior to the event.

Policy proposal

Covid Status Certification will require certain premises and settings to ensure that there is a reasonable system in operation for establishing that all people in the premises can demonstrate that they are fully vaccinated, they have received a negative test result (LFD or PCR), or they are exempt and to refuse access to or remove anyone who is neither fully vaccinated, nor has received a negative test result, nor is exempt. "Fully vaccinated" means that a person has completed a full course of a Medicines and Healthcare products Regulatory Agency (MHRA) authorised vaccine, with the final dose having been received 14 days before the date on which they seek to enter the premises or event. A negative test result means that a person has received a negative LFD or PCR test in the last 24 hours.

Initially, the scheme did not include a negative test result as an alternative to proof of vaccination as we did not consider that it would be appropriate and believed it could undermine one of the policy aims of the scheme: to increase vaccine uptake. Based on the latest evidence, and a balance of harms, the Covid Certification scheme will include the option of providing a negative test, instead of proof of vaccination. This means that individuals can provide either proof of vaccination or record of a negative test to gain entry to the settings in scope.

This change makes it possible for more people to make use of the scheme, such as those who are not yet fully vaccinated. It also means that individuals who received a vaccine not recognised by the MHRA or have experienced difficulty accessing their vaccination record, will be able to attend venues covered by the scheme. We hope that the inclusion of testing will encourage the greater use of regular lateral flow testing and will still support us to achieve our policy objective of reducing the risk of transmission of Coronavirus.

The scheme will apply in the following higher risk settings:

• late night premises with music, which serve alcohol after midnight and have a designated place for dancing for customers
• indoor events (unseated) planned for 500 or more people at any one time
• outdoor events (unseated) planned for 4,000 or more people at any one time
• any event planned for 10,000 or more people at any one time

The following will not qualify as events for the purposes of the scheme:

• a funeral, marriage ceremony, civil partnership registration, or a reception or gathering which relates to a funeral, marriage ceremony or civil partnership registration
• a mass participation event such as a marathon, triathlon or charity walk
• an event designated by the Scottish Ministers as a flagship event according to criteria, and in a list published by the Scottish Ministers
• a drive-in event
• an organised picket
• a protest or demonstration
• a public or street market
• an illuminated trail
• a work or business conference (not including any peripheral reception or function outside the core hours of the conference, whether or not alcohol is served)
• a business or trade event which is not open to the public for leisure purposes
• communal religious worship
• an un-ticketed event held at an outdoor public place with no fixed entry points

Ministers have been clear that certification will not be a requirement for public services or other settings that many people have no option but to attend public transport, health services and education.

The following people will be exempt:

• under 18s
• people who can be neither vaccinated or tested for medical reasons
• people taking part (or who have taken part) in vaccine trials
• the person responsible for the premises
• workers and volunteers at the premises or event
• emergency services responders and regulators carrying out their work

The regulations will require the persons responsible for a setting to ensure there is a reasonable system in operation for checking that people seeking to enter the premises are fully vaccinated, can provide record of a negative test result (either LFD or PCR), or are exempt, and to have in place a compliance plan for the system.

The amendments to the scheme will come into force on 6 December. Ministers must review the Health Protection (Coronavirus) (Requirements) (Scotland) Regulations 2021 (which include Certification) at least every 3 weeks to assess whether any requirement in the regulations is still necessary to prevent, protect against or provide a public health response to the incidence or spread of infection in Scotland. We will continue to assess whether any less intrusive measures could be introduced to achieve the same combination of policy objectives in respect of the higher risk sectors concerned; if so, the policy will be immediately reviewed.

Sectoral Guidance is published on the Scottish Government website here. Guidance for the wider public is published on the Scottish Government website here.

Policy Objectives

In line with our strategic intent to 'suppress the virus to a level consistent with alleviating its harms while we recover and rebuild for a better future', the policy objectives of Covid Vaccine Certification from 6 December are to:

• Reduce the risk of transmission of Coronavirus, by ensuring that specified indoor public spaces where transmission risks are higher are used only by those who are vaccinated or can provide a record of a negative test within the previous 24 hours (or exempt): vaccination or a negative test within the previous 24 hours reduces (but does not entirely eliminate) the risk of being infected, the risk of serious illness and death if infected, and the risk of infecting others;
• Reduce the risk of serious illness and death thereby alleviating current and future pressure on the National Health Service, by reducing transmission in specified settings where transmission risks are higher;
• Reduce the risk of settings specified in the scheme being required to operate under more restrictive protections, or to close, by ensuring that the risk of transmission in these settings is reduced; and
• Increase the protection enjoyed by those using settings covered by the scheme and their contacts, by incentivising those using the settings to take up the vaccine and/or to test regularly and self-isolate if positive.

An evidence paper summarising the range of evidence available on Vaccine Certification schemes was published here. A follow up evidence paper which sets out the evidence published on Certification since the original paper surrounding certification, including information on vaccination and testing, has been published here. Consistent with our approach throughout the pandemic, the paper adopts a four harms approach covering the direct health harms of Covid-19, the indirect health harms, the social and the economic harms. Evidence is drawn from clinical and scientific literature, from public opinion and from international experience. This impact assessment should also be considered alongside the latest State of the Epidemic report.

Public health rationale

The COVID-19 epidemic continues to pose considerable challenges, with new case rates currently averaging around 3,000 per day, an increase from October. COVID-19 related acute hospital admissions have fluctuated over the past month but have recently started to decrease. Case rates and age standardised hospital admissions are considerably lower in vaccinated vs unvaccinated individuals. Modelling indicates uncertainty over hospital occupancy and intensive care in the next four weeks. Hospitals are currently at, or very close to, capacity and have been in this position for many weeks now with several Health Boards operating within an environment of unprecedented pressure and heightened risk plus a requirement for military support. This is likely to be driven by Covid-19 cases and delayed discharges but also may reflect that patients with higher acuity are now requiring admission.

As we prepare for winter, our primary and secondary health and social care services are facing arguably the most significant and increasing pressures and demands in the history of the NHS. The winter period will also pose significant challenges of increased transmission and related pressure on the National Health Service. We remain of the view that action is therefore needed across all sectors to ensure adherence to baseline measures. Drawing on the evidence so far available, we consider that Covid Status Certification has a vital role to play as one such measure.

While no vaccine is 100% effective at preventing infection, disease and transmission, and they do not completely break the link between a high volume of positive cases and serious pressure on healthcare services, they are our best route out of the pandemic. Vaccines help prevent transmission of the virus as vaccinated people are less likely to become infected and ill than unvaccinated people (and only infected people can transmit the virus). The UK Vaccine Effectiveness Expert Panel (VEEP) is a group of scientific and analytical specialists from academia and government in the UK who provide a consensus view on vaccine effectiveness, split by variant, vaccine and dose. They have published estimates for vaccine effectiveness based on an assessment of the evidence at the time of writing and as new evidence or data emerges, SAGE will update its advice. A summary published on 24^th September can be found here.

More analysis can be found in a number of large studies including EAVE-II (Early Pandemic Evaluation and Enhanced Surveillance of Covid-19) in Scotland^[1], Real-time Assessment of Community Transmission (REACT-1) in England^[2] and the Office for National Statistics (ONS) Covid-19 Infection Survey ONS study.^[3] Therefore, we have strong evidence that vaccines are effective at preventing disease, hospitalisations and deaths. In September 2021, COVID-19 cases increased and surpassed the peak that was seen in early July 2021 but have since declined and remained steady through October and November. The rate of increase in cases was less among fully vaccinated individuals compared to partially or unvaccinated individual. As of 25 November, 82.4% of the eligible population (12+) were fully vaccinated, and in the week 13-19 November 38.6% of positive cases were in unvaccinated individuals. However, effectiveness decreases over time for both Pfizer-BioNTech and Oxford-AstraZeneca vaccines due to waning immunity.^[4] In the week 13-19^th November in an age-standardised population, individuals were 3.3 times more likely to be in hospital with COVID-19 if they were unvaccinated compared to individuals that had received two or more doses of vaccine.^[5]

Vaccine uptake has progressed extremely well in the Scottish adult population with approximately 79% of 18 to 29 year olds and 77% of 16 to 17 year olds having received the first dose of the vaccine as of 24 November. Around 96% of people aged 40 and over have received two doses, but uptake of a second dose remains lower in people in their 30s (77.9%) and the 18-29 age group (69.4%) as of 24 November. Vaccine uptake has slightly increased since the scheme was announced, although it is not possible to directly attribute rises to the introduction of Certification. The proportion of those aged 12+ with a first dose rose from 86.0% to 90.5%. The proportion of those aged 12+ with a second dose rose from 77.6% to 82.2%.^[6]

Two main testing methods exist for detection of SARS-CoV-2: LFDs (lateral flow tests or devices) or PCR. PCR is the recommended testing method if you have COVID-19 symptoms while LFDs are recommended only for people who do not have symptoms^[7]. PCR is a highly sensitive and specific technique to detect SARS-CoV-2 and is a recommended diagnostic testing method by the WHO^[8]. Specificity and sensitivity levels of >95% have been reported by SAGE for PCR testing^[9].

LFD testing is effective at identifying people with the virus when they are at their most infectious and have high viral loads^[10]. A peer-reviewed study on sensitivity of the LFDs carried out by the University College London found that LFDs are more than 80% effective at detecting any level of COVID-19 infection and, therefore, can be an effective tool in reducing transmission^[11]. Another study showed that LFDs are 95% effective and 89.1% specific at detecting COVID-19 when used at the onset of symptoms^[12].

SAGE endorsed the benefits that rapid antigen testing could have on reducing transmission when discussing the UK Government Plan B options; "Other measures are available which, if introduced, could also make Plan B (or more stringent measures) less likely (and could potentially offer better efficiency or effectiveness) for example encouraging wider use of rapid antigen testing in workplaces and the community, and ensuring self-isolation of those who test positive by providing sufficient support"^[13].

It is recommended to test twice weekly^[14], which will almost always identify Covid during early stages of infection and thus significantly reduce disease transmission^[15].

The optimal testing strategy in order to gain access to a high risk setting would be to take the test as close as practically possible to the time of entry. LFDs are less sensitive than PCR but have the advantage of providing rapid results, and SAGE has endorsed the benefits that rapid antigen testing (such as LFDs) could have on reducing transmission.

Higher-risk settings tend to have the following characteristics: close proximity with people from other households; settings where individuals stay for prolonged periods of time; high frequency of contacts; confined shared environments, and poor ventilation.^[fn][fn] Settings identified by SPI-B as high risk include public transport; places of worship; restaurants, shops, malls and markets; parties; cinemas; theatres; planes; large family gatherings; religious, cultural, sporting and political events; crowds; pubs and clubs; restaurants and cafes; hotels, cruise ships, hospitals and care homes^[16]

By restricting access to customers who are fully vaccinated or who can provide a record of a negative test, it is less likely that infection will take place in these settings, and it is less likely that infections within them will lead to illness. Consequently, we can reduce the risk of transmission of the virus and help reduce pressure on health services, while also allowing settings to operate as an alternative to closure or more restrictive measures. As such, we consider Certification, as part of a package of measures such as improved ventilation, to be a necessary and proportionate public health measure.

NHS Scotland Covid App and Paper Certificate

On 30 September we launched the NHS Scotland Covid Status App (the "App") for international use. This contains two unique QR codes, one for each dose of the vaccine. This product has been designed for use for international travel and so it is necessary to include full name, date of birth and details of vaccination to meet EU standards. This version of App can be used to demonstrate vaccine status in the settings in scope.

On 20 October, the NHS Scotland Covid Check App, which is used by venues to check QR codes, was updated so that when an international QR code is scanned for domestic purposes only, a green tick or 'Certificate not valid' representing someone's vaccination status is displayed, rather than a person's name, date of birth and vaccination details.

In order to further minimise data display, on 21 October, the Covid Status App was updated to include a domestic page. This option simply shows the person's name and a QR code. When the QR code is scanned by the NHS Scotland Covid Check App it shows either a green tick or 'Certificate not valid' representing someone's vaccination status. The domestic App has functionality to hide or display a person's name. The Privacy Notice can be found on NHS Inform: Personal information we process, How we use your data, Your Rights.

The latest PHS report^[17], published on Wednesday 17 November, showed that the Covid Status App has been downloaded over 1.7 million times up to midnight on 20 November and we continue to monitor user activity. Up to midnight on 20 November, more than 1.27 million PDFs have been downloaded since QR codes were introduced on 3 Sept, with over 516,000 printed versions issued.

For those who do not have digital access or would prefer a paper copy, a record of vaccination can still be requested by phoning the Covid-19 Status Helpline on 0808 196 8565. The paper record of vaccination will then be posted to the address that is held on the National Vaccination Service System (NVSS).

When registering an account on the App the user needs to verify their identity. This is for privacy protection as health data is special category data and protected by GDPR and human rights legislation (Article 8 right to respect for private and family life) and so additional safeguards and security measures are required to verify a person's identity before they are given access to their health records. The App uses biometric verification software following an options appraisal process which, at that point in time, did not identify another feasible option that met secure authentication requirements. Alternative routes to prove vaccination status, that did not require using the NHS Scotland COVID Status App, were already established (people can download a PDF or request a paper Certificate).

This means users are asked to scan a photo of their passport or driving licence and then to take a live photo of themselves. The software then uses their live photo to compare likeness with the photo in their ID and confirm their identity. There is manual verification for the small number of cases which fail the automatic process. For the limited number of cases where a person's identity cannot be verified in the App, individuals can call the Covid-19 Status Helpline, or use NHS Inform to request a paper Certificate, which will be posted to them. Additional forms of ID are being added to those that can be used already with biometric processing to ensure that inequalities in access are reduced. Further exploratory work on alternative (non-biometric) identity verification routes is underway.

Many countries accept negative PCR tests or recovery status as an alternative to vaccination, and we expect both of these functions, alongside booster vaccines, to be available in the NHS Scotland Covid Status App for international use only by mid- December. Further development work will need to be undertaken to extend this for domestic use. Further information, such as LFD negative test status, will be added in a future release of the App. In the meantime, customers can display an SMS (text) or email which records they have received a negative test. There is no QR code within SMS or emails and so they do not need to be scanned by the NHS Scotland Covid Check App. Venues will instead perform a visual check and no data will be retained. Individuals can get an SMS or email by registering the result of their LFD test on the GOV.UK website here.

The testing option requires people to have access to a standard mobile phone. This does not need to be a 'smart phone' and any mobile phone that can receive text messages or has access to email is sufficient. Test results can be displayed on a mobile phone, tablet or other device, or a paper copy can be printed. In Scotland, it is estimated that 88% of households had internet access in 2019, however this varied by household net income and deprivation. The proportion of internet users reporting that they access the internet using a smartphone increased from 81 per cent in 2018 to 86 per cent in 2019^[18].

Exemptions

There are medical exemptions for domestic Certification for the very limited number of people who can neither be safely vaccinated or tested. In the vast majority of cases, a successful route to safe vaccination or testing can be found. Local vaccination centres can help to answer questions about the vaccine and can advise what arrangements may be put in place to enable safe vaccination. In the rare cases where that support does not lead to vaccination, an exemption is offered to the individual which can be used for international use only. If the individual cannot be tested either, they will be advised to obtain proof of evidence from their primary or secondary care clinician in the form of a letter. This evidence will then be assessed by a Scottish Government clinician who will work with the Resolver Group to provide the necessary support on a case-by-case basis to determine whether the individual is also exempt from testing.

For more information on exemptions see the NHS Inform website here, call the Covid-19 Status Helpline or visit your local vaccination centre. Medically exempt individuals are provided with paper Certificates which have enhanced security features. Medical exemptions cannot be displayed on the international section of the App due to EU specifications. They are under consideration for a future release of the domestic section of the App. We continue to engage across the four nations to ensure that work around exemptions is taken forward collectively.

All clinical trial participants have received a letter from their Principal Investigator which can be used for proof of their trial status. Clinical trials participants are encouraged to undertake testing and provide a record of a negative test, as they may have received a placebo dose.

While children are exempt from the requirement to prove vaccine status for domestic purposes, 12- 17 year olds who have been vaccinated may choose to download a PDF via NHS Inform, or they may choose to request a paper Certificate by calling the Covid-19 Status Helpline.

The paper Certificates are in English. Information about what information the Certificates contain can be requested in other languages and alternative formats including Easy Read, audio and Braille. Information can be found on NHS Inform here, or when people request their Certificate.

For more information on the Covid Status Certificate see the Scottish Government website here.