Coronavirus (COVID-19) - vaccine: letter from the Cabinet Secretary for Health and Sport on the approval of the AstraZeneca Vaccine

In line with my commitment to update you on progress on the COVID-19 vaccination programme and further to my letter sent on the 23 December.  I am delighted to inform you of the news that the Medicines and Healthcare products Regulatory Agency (MHRA) has today authorised the AstraZeneca (Oxford) vaccine for supply across the UK. 

The MHRA authorisation includes conditions that the AstraZeneca (Oxford) vaccine should be administered in 2 doses, the second dose to be given between 4 and 12 weeks after the first.   The vaccine is logistically more straightforward to transport and store (although it still requires a cold chain of 2-8 degrees C) and I am anticipating delivery of a larger overall volume of vaccine compared with the Pfizer vaccine, which will enable us to progress through the Joint Committee on Vaccination and Immunisation (JCVI) priority list more quickly.  I have attached a copy of the vaccination prioritisation list in Annex A of this letter, it can also be accessed on the NHS Inform website - Who will be offered the coronavirus (COVID-19) vaccine | NHS inform.  

We will begin to administer the AstraZeneca (Oxford) vaccine from 4 January 2021 firstly in the settings in which we have already been delivering COVID vaccination, expanding out into additional community settings, from 11 January 2021.  Of course if it is possible to expand into community settings earlier than 11 January we will certainly do so.  Vaccinations will continue to focus initially on the first priority groups as set by the Joint Committee on Vaccination and Immunisation (JCVI) – residents in a care home for older adults and their carers, people over the age of 80 years and frontline health and social care workers.

The COVID vaccination programme will then continue be rolled out to the rest of the population in sequence based on the JCVI’s priority list, starting with people aged 75 to 79 years of age, followed next by 70-74-year-olds alongside those who are clinically extremely vulnerable.  

The AstraZeneca Vaccine was produced in collaboration with the University of Oxford, with the Universities of Glasgow and Edinburgh playing a key role in conducting Scotland-based clinical trials.

Pfizer/BioNTech Vaccine

The MHRA has also now clarified that, for the Pfizer/BioNTech vaccine, the interval between doses is to be a minimum of 3 weeks. The JCVI has further advised that the Pfizer/BioNTech vaccine second dose should be given between 3 and 12 weeks after the first dose. The data provided to the JCVI demonstrates that while overall efficacy is optimised when a second dose is administered, however, a single dose does offer considerable protection, in the short term.   For both vaccines the second dose completes the course and is important for longer term protection.

The JCVI has subsequently recommended that as many people on the JCVI priority list as possible should sequentially be offered a first vaccine dose as the initial priority.

The four UK Chief Medical Officers agree with the JCVI that, at this stage of the pandemic, prioritising the first doses of vaccine for as many people as possible on the JCVI priority list (whilst ensuring that all receive a second dose within 12 weeks of the first) will protect the greatest number of at risk people overall in the shortest possible time and will have the greatest impact on reducing mortality, severe disease and hospitalisations from COVID and in protecting the NHS and equivalent health services.

Operationally this will mean that second doses of both vaccines will now be administered towards the end of the recommended vaccine dosing schedules of up to 12 weeks. This will maximise the number of people getting a first dose of the vaccine quickly and therefore receiving more rapid initial protection.

That means that appointments for the second dose of vaccine scheduled before the 4th January 2021 should go ahead but scheduled on and after 4 of January 2021 should be rescheduled to fall into line with the CMOs’ agreed approach of 12 weeks from the first dose.

From 30 December 2020 all people receiving their first dose should be informed that they will receive their second dose in 12 weeks time.

Pregnant and Breastfeeding Mothers

The JCVI has also amended its previous highly precautionary advice on Covid-19 vaccines and pregnancy or breastfeeding. The UK Chief Medical Officers also agree with this advice.  Vaccination with either the Pfizer or AstraZeneca vaccines in pregnancy should be considered where the risk of exposure to COVID infection is high and cannot be avoided, or where the person has underlying conditions that place her at very high risk of serious complications of Covid-19. 

Those who are trying to become pregnant do not need to avoid pregnancy after vaccination, and those who are breastfeeding may be offered vaccination with either vaccine following consideration of the clinical need.

Collecting Data

We are also continuing to enhance our digital infrastructure.  Our Vaccine Management Tool was successfully launched in all NHS Boards on 8 December and is collecting critical clinical information at the point of vaccination.  The data collected by this tool helps us to ensure that vaccination data is included in clinical records, it records when someone is due their second dose of the vaccine, and it will also, over time, collect data that enables us to identify segments of our population who would benefit from additional targeted vaccine information and encouragement and for us to take action to address this.

Alongside this, we are building a national scheduling tool which will support the scheduling of further cohorts. This is being developed at pace and is on track for delivery by the end of January.

Data from the Vaccination Management Tool (Vax App) shows there were  2,311 registered vaccinators as at 23 December although not all of them are currently required, and not all of them may be able to be immediately deployed.  We also know that more than 4,000 individuals have attended national training events focused on delivery of the Pfizer vaccine.  If the AstraZeneca vaccine becomes available in early January and given our aspiration to conclude vaccination of those on the JCVI priority list in the spring, we have modelled a likely workforce requirement of c. 1400 vaccinators, with support staff adding an additional requirement of 800.

Communication Activity

We are working with Health Boards to communicate the updated information about the AstraZeneca (Oxford and Pfizer BioNTech vaccines, and the adjustments to JCVI and MHRA advice about timing of second doses. This includes any required updates to the materials below:

Materials for staff

Separate communications toolkits for health care workers and social care workers to be vaccinated have been available since the start of the programme in early December but will be updated to reflect the new advice.  These toolkits are similar to those available for other immunisation programmes such as flu and will include staff posters, leaflets, emails and social media content to help understand the importance of receiving the vaccine as a health or social care worker.

Materials for care homes

Consent packs will be sent to care homes, including a letter, a leaflet, and consent form and post-immunisation card for each resident.

Materials for the public

Those aged 80 years and over will be invited to attend in due course for vaccination via letter and accompanying leaflet.   Other population groups will be invited in due course as we reach that cohort on the JCVI priority list groups. 

This will be in addition to a national, local and sectoral public information campaign including a national door drop during week commencing 4 January.

I previously mentioned in the letter to you last week that there are a number of ways you can signpost your constituents to further information on the COVID-19 vaccination programme. These include NHS Inform Coronavirus (COVID-19) vaccine | NHS inform, and the National Advice line is fully operational and accepting calls with language translation and BSL support fully in place on 0800 030 8013.

It is important to remember that we will call people forward for vaccination in accordance with the JCVI advice on clinical prioritisation and it is crucial to reassure those who may be anxious that we will be in contact with those who are eligible to be vaccinated as the programme proceeds.  It is not necessary for people to make proactive contact.    

Furthermore, I am pleased with the pace of vaccination programme that is underway and from 8 December to 27 December 2020, 92,188 individuals received their first dose of COVID-19 vaccination.

I hope that you find this information helpful and I will be providing a further update to parliament on the COVID-19 vaccination programme in the New Year.

Jeane Freeman

ANNEX A

Prioritisation

As vaccine supply increases, we will work our way through the priority list set by the JCVI with the aim of completing this by the end of spring 2021.

1. residents in a care home for older adults and their carers
2. all those 80 years of age and over and frontline health and social care workers
3. all those 75 years of age and over
4. all those 70 years of age and over and clinically extremely vulnerable individuals
5. all those 65 years of age and over
6. all individuals aged 16 years to 64 years with underlying health conditions which put them at higher risk of serious disease and mortality
7. all those 60 years of age and over
8. all those 55 years of age and over
9. all those 50 years of age and over

The JCVI estimate that, taken together, these groups represent around 99% of preventable mortality from COVID-19.

JCVI advises that implementation of the COVID-19 vaccine programme should aim to achieve high vaccine uptake. implementation should also involve flexibility in vaccine deployment at a local level with due attention to:

• mitigating health inequalities, such as might occur in relation to access to healthcare and ethnicity;
• vaccine product storage, transport and administration constraints;
• exceptional individualised circumstances;
• availability of suitable approved vaccines, for example for specific age cohorts.

The JCVI acknowledges that operational considerations, such as minimising wastage, may require a flexible approach, where decisions are taken in consultation with national or local public health experts.

The JCVI advise that frontline health and social care workers at high risk of acquiring infection, at high individual risk of developing serious disease, or at risk of transmitting infection to multiple vulnerable persons or other staff in a healthcare environment, are considered of higher priority for vaccination than those at lower risk.

iBased on the JCVI priority list and the guidance in the Green Book (COVID-19 Greenbook Chapter 14a (publishing.service.gov.uk)) I will be advising Health Boards to prioritise the following cohorts.

 

JCVI Priority	Group
1	Residents and workers in care homes for older people. Residents and those working in long-stay residential and nursing care homes or other long-stay care facilities for older adults where rapid spread is likely to follow introduction of infection and cause high morbidity and mortality. This includes non-clinical ancillary staff who may have social contact with resident but are not directly involved in patient care, such as cleaners and kitchen staff.
2	All those 80 years of age and over Starting for logistical reasons with long-term hospital inpatients who are over 80.
2	Patient facing, frontline healthcare workers. Staff who have frequent face-to-face clinical contact with patients and who are directly involved in patient care in either secondary or primary care/community settings. This includes doctors, dentists, midwives and nurses, vaccinators, paramedics and ambulance drivers, pharmacists, optometrists, occupational therapists, physiotherapists, radiographers and any associated support staff of independent contractors. It should include those working in public, private, third sector and non-standard healthcare settings such as hospices, and community-based mental health or addiction services. It should include Healthcare Improvement Scotland inspectors who are required to visit premises. Temporary staff, including those working in the COVID-19 vaccination programme, students, trainees and volunteers who are working with patients must also be included.
2	Non-clinical but patient facing staff in secondary or primary care/community healthcare settings. This includes non-clinical ancillary staff who may have social contact with patients but are not directly involved in patient care. This group includes receptionists, ward clerks, porters and cleaners.
2	Laboratory and pathology staff Hospital-based laboratory and mortuary staff who frequently handle SARS-CoV-2 or collect or handle potentially infected specimens, including respiratory, gastrointestinal and blood specimens should be eligible as they may also have social contact with patients. This may also include cleaners, porters, secretaries and receptionists in laboratories. Frontline funeral operatives and mortuary technicians / embalmers are both at risk of exposure and likely to spend a considerable amount of time in care homes and hospital settings where they may also expose multiple patients. However, not included here are staff working in non-hospital-based laboratory and those academic or commercial research laboratories who handle clinical specimens or potentially infected samples as they will be able to use effective protective equipment in their work and should be at low risk of exposure.
2	Social care staff directly involved in the care of their service users and others involved directly in delivering social care such that they and vulnerable patients/clients are at increased risk of exposure This includes, for example, workers in residential care for adults and children, supported housing, and also personal assistants and social workers who have face-to-face contact in the course of their duties including child, adult, mental health officer duties and public protection. It should include Care Inspectorate staff who are required to visit care homes and other registered services. Young people age 16-18 years, who are employed in, studying or in training for health and social care work should be offered vaccination alongside their colleagues if a suitable vaccine is available.
3	all those 75 years of age and over
4	all those 70 years of age and over and clinically extremely vulnerable individuals
5	all those 65 years of age and over
6	all individuals aged 16 years to 64 years with underlying health conditions which put them at higher risk of serious disease and mortality
6	Unpaid carers, including all adult carers and young carers aged 16 to 18
7	all those 60 years of age and over
8	all those 55 years of age and over
9	all those 50 years of age and over

 

Letter to Presiding Officer and MSPs on the approval of the AstraZeneca Vaccine

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