COVID-19 vaccine surveillance strategy 04 June 2021

 
CONTINUE READING
COVID-19 vaccine
surveillance strategy
04 June 2021
Citation:
Public Health Scotland. COVID-19 vaccine surveillance strategy.
Edinburgh: PHS; June 2021.
Enhanced surveillance of COVID-19 vaccination programme in Scotland

Contents
Executive summary................................................................................................................. 2
Background............................................................................................................................. 3
Aims ........................................................................................................................................ 5
Vaccine coverage and uptake................................................................................................. 5
   Vaccine Management Tool.................................................................................................. 6
   Monitoring and reporting of vaccine uptake ........................................................................ 6
   Vaccine uptake rates are reported daily within the PHS daily dashboard. .......................... 6
Vaccine safety......................................................................................................................... 7
   Direct reporting from NHS Boards....................................................................................... 9
   Analyses of linked national clinical databases .................................................................... 9
   Signal verification and characterisation............................................................................. 10
   Signal evaluation ............................................................................................................... 10
Vaccine effectiveness ........................................................................................................... 10
Post-vaccine infections ......................................................................................................... 12
Sero-surveillance .................................................................................................................. 12
Enhanced surveillance.......................................................................................................... 15
   Primary and secondary care ............................................................................................. 15
   Vaccination of healthcare workers .................................................................................... 16
   Vaccination of teachers, people in prisons and people with diabetes ............................... 17
   SIREN study...................................................................................................................... 18
   COVID-19 in Pregnancy in Scotland (COPS) study .......................................................... 18
   Transmission ..................................................................................................................... 19
Vaccination programme evaluation....................................................................................... 19

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Enhanced surveillance of COVID-19 vaccination programme in Scotland

Executive summary
This document sets out the proposed protocol from Public Health Scotland (PHS) for
the post-licensure surveillance strategy for COVID-19 vaccinations in Scotland. This
is version 3 of our surveillance strategy and we will update this document regularly.

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Enhanced surveillance of COVID-19 vaccination programme in Scotland

Background
In late December 2019, the People’s Republic of China reported an outbreak of
pneumonia due to an unknown cause in Wuhan City, Hubei Province. In early
January 2020, the cause of the outbreak was identified as a new coronavirus,
SARS-CoV-2, which causes the disease COVID-19. There are a number of
coronaviruses that are transmitted from human-to-human which are not of public
health concern. However, COVID-19 can cause respiratory illness of varying
severity. On 30 January 2020 the World Health Organization declared that the
outbreak constitutes a Public Health Emergency of International Concern. Extensive
measures have been implemented across many countries to slow the spread of
COVID-19. Further information for the public on COVID-19 can be found on NHS
inform.

On 8 December 2020, a Coronavirus (COVID-19) vaccine developed by Pfizer
BioNTech was first used in the UK as part of national immunisation programmes.
The Oxford AstraZeneca vaccine was also approved for use in the national
programme, and rollout of this vaccine began on 4 January 2021. Roll out of a third
vaccine, Moderna, began on 7 April 2021. These vaccines have met strict standards
of safety, quality and effectiveness set out by the independent Medicines and
Healthcare products Regulatory Agency (MHRA). Further candidate vaccines
continue to be developed and are considered under the same processes.

The aim of the current vaccination programme is to protect those who are at most
risk from serious illness or death from COVID-19. The Joint Committee on
Vaccination and Immunisation (JCVI) consider the available epidemiological,
microbiological and clinical information on the impact of COVID-19 in the UK and
provide the Government with advice to support the development and ongoing
monitoring of the vaccine strategy.

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Enhanced surveillance of COVID-19 vaccination programme in Scotland

Phase 1 to 3 clinical trials have been undertaken by the vaccine manufacturers to
estimate the immunogenicity, safety and efficacy of the vaccine in clearly defined
populations against specific end points. These provide evidence on common
adverse reactions and the early efficacy of the vaccine against laboratory confirmed
disease within the study population. This has informed decision making on vaccine
choice and target groups for a national programme. Nevertheless, these studies are
undertaken in ideal delivery conditions, tend to exclude certain populations, such as
individuals with underlying medical conditions, and typically have a relatively short
follow-up period.

With vaccines now being offered to millions of people, comprehensive ‘real world’
post-implementation surveillance systems are being used to monitor delivery of the
vaccination programme and evaluate its impact on health. This involves using
existing disease surveillance systems and electronic health data, capturing
vaccination data and active follow-up of vaccinated individuals and cases of
COVID-19 within vaccine eligible cohorts. The JCVI has made recommendations on
the need to monitor the effectiveness and impact of vaccines against a broad range
of outcomes and the need to integrate monitoring of inequalities in uptake,
acceptability and outcomes in key underserved groups and across protected
characteristics as a core component of the post-implementation surveillance.

In order to maintain public and healthcare professionals’ confidence in the vaccine
and to ensure that surveillance systems are in place for long-term monitoring of the
programme, it is important that post-marketing surveillance is led by independent
public health agencies without association with vaccine manufacturers.

This document provides a high-level oversight of the post-implementation
surveillance strategy that PHS is implementing, in collaboration with the MHRA, NHS
Scotland, UK Public Health agencies and academic partners, to monitor and
evaluate the COVID-19 vaccination programme. The outcomes of this surveillance
are reported regularly on the PHS website.

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Enhanced surveillance of COVID-19 vaccination programme in Scotland

Aims
The aims of enhanced vaccine surveillance are to:

   •   monitor uptake and coverage of the vaccine in targeted populations and
       identify under-vaccinated groups

   •   rapidly detect and evaluate possible adverse events associated with
       vaccination

   •   estimate the effectiveness of the vaccine at preventing a spectrum of disease
       outcomes in different targeted populations, and against different viral variants,
       as well as the duration of any protective effect and prevention of transmission

   •   identify risk factors for and outcomes of vaccine effect and failure, including
       any impact on strain evolution

   •   monitor the overall impact of the vaccination programme on COVID-19 in the
       wider population including the indirect effect on groups not targeted by the
       vaccination programme

   •   monitor the impact of the vaccination programme on prevalence of antibodies
       against COVID-19 as an indicator of population level immunity, and to monitor
       antibody waning in the population

   •   monitor attitudes to vaccination and identify barriers to high vaccine uptake

   •   monitor inequalities in each of these outcome measures.

Vaccine coverage and uptake
Vaccine coverage is a key indicator of the performance of the immunisation delivery
system. Moreover, data on vaccine uptake are used to estimate the level of
susceptibility in the population and identify areas or populations at increased risk of
outbreaks. Identification of under-vaccinated groups can be used to adapt delivery of
the programme. Vaccination data at an individual and population level are also used
to support the analysis of vaccine effectiveness, impact and safety in eligible groups.

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Enhanced surveillance of COVID-19 vaccination programme in Scotland

Vaccine Management Tool
The COVID-19 vaccination programme is being delivered through a range of models
including hospital trusts, mass vaccination centres and primary care networks. A
Vaccine Management Tool (VMT) has been developed in order to monitor uptake of
vaccines and to collect information on individuals at the point of vaccination. Data
collected includes age, sex, location of vaccine delivery, individuals’ board of
residence, vaccine type, vaccine dose and eligibility for receiving the vaccine. Data
from the VMT feeds into the National Clinical Datastore (NCDS) in real ime with an
approximate 30-minute latency. The NCDS also contains separate feeds of data
which can be linked to the VMT data to provide more information on individuals
vaccinated. The VMT is the preferred method of data collection, with all services
being encouraged to use it, but it is not mandatory. GPs can use the existing
General Practice Information Technology (GPIT) systems to enter data. Vaccination
data from the GPIT systems is being integrated with the data from the VMT via the
NCDS. Similarly, data from the VMT is being fed back into GPIT systems to ensure
coordination of vaccination records.

Monitoring and reporting of vaccine uptake
Vaccine uptake rates are reported daily within the PHS daily dashboard.

The information presents number of people receiving COVID-19 vaccinations and
rates per population and provides a summary by:

   •   first dose and second dose

   •   vaccine type

   •   NHS board of residence

   •   local authority

   •   JCVI priority groups

   •   age group

   •   sex.

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Enhanced surveillance of COVID-19 vaccination programme in Scotland

In addition to the daily dashboard, PHS publishes a monthly report on equalities in
vaccination uptake, providing in-depth analysis of the ethnicity and deprivation of the
vaccine uptake rates.

Additionally, areas where there are lower uptake rates of vaccinations are identified
and shared with local vaccination leads to inform the delivery of the programme.

Vaccine safety
The COVID-19 vaccination programme involves vaccinating millions of people over a
short period of time using several newly developed vaccines. Clinical trials indicate
that these vaccines have few side effects, however rarer side effects may only
become apparent when these vaccines are introduced into the general population.
Detecting, investigating and responding to any potential risks associated with the
vaccination programme is critical to ensure the safety and credibility of the
vaccination programme, to ensure public trust in the programme, and to inform
changes to vaccination policy and to how the programme is delivered.

PHS is working closely with the MHRA and counterparts across England, Wales and
Northern Ireland to monitor and ensure the safety of the COVID-19 vaccination
programme. In the UK, vaccine safety is primarily the responsibility of the MHRA.
The MHRA runs the Yellow Card scheme, which facilitates real-time direct reporting
of suspected adverse events following COVID-19 vaccination (https://coronavirus-
yellowcard.mhra.gov.uk/). In addition to the Yellow Card scheme, the MHRA is
running the Vaccine Monitor, through which vaccinated individuals are followed up
over time to gather information on their experience following vaccination. People
presenting for vaccination in Scotland may register for the Vaccine Monitor here:
https://vaccinemonitor-yellowcard.mhra.gov.uk/

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Enhanced surveillance of COVID-19 vaccination programme in Scotland

As a supplement to this system, PHS has developed a vaccine safety surveillance
and response system for adverse events following COVID-19 vaccination, which
includes monitoring of adverse events reported directly to Health Boards, as well as
analyses of linked national clinical databases. This system covers both clinical
adverse events following vaccination, such as anaphylaxis, as well as adverse
events related to the delivery of the programme (hereafter known as programmatic
adverse events), such as cold chain failures or issues relating to dosage or the
administration of the vaccine. Programmatic adverse events are particularly
important given the scale and pace of the vaccination programme, and the fact that
the vaccination programme will employ novel approaches to vaccine delivery, such
as mass vaccination and drive-through clinics. PHS continues to develop and
strengthen the vaccine safety surveillance system as more data becomes available
with the expansion of the vaccination programme.

In addition to the investigations and monitoring described above, Public Health
Scotland is undertaking an ad hoc study (RADIOVACC) investigating Cerebral
Venous Thrombosis (CVT) in vaccinated individuals using the national Picture
Archiving Communications System (PACS) to identify all potential CVTs on
Computerized Tomography (CT) or Magnetic Resonance Imaging (MRI) scans in
Scotland since 1 December 2020. The study then links this data to the national
vaccination database to evaluate any potential association with a vaccine.

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Enhanced surveillance of COVID-19 vaccination programme in Scotland

Direct reporting from NHS Boards
Within Scotland, Health Board immunisation coordinators are requested to submit a
weekly report detailing all adverse events reported to the Health Board via the Board
management system (e.g. Datix) in the previous seven-day period. In addition,
immunisation coordinators may make an immediate report to PHS of more notable
adverse events that either provide important information for the delivery of the
programme, or that require an immediate public health response. These reports can
be made both within and out of office hours. Depending on the nature of the event,
PHS may escalate it to the Clinical Governance Group, which provides high-level
clinical oversight to the vaccination programme. The Clinical Governance Group may
provide expert advice on how to respond to an event, or may use the information to
inform decision making around the delivery of the programme.

Analyses of linked national clinical databases
Signal detection
PHS is conducting rapid cycle analyses of possible adverse events following
vaccination, by linking data on an individual’s vaccination status to health outcomes
to assess whether there is any increased rate or risk of these outcomes following
vaccination. This includes analyses of non-specific health outcomes such as A&E
attendances and all-cause emergency admissions, as well as analyses of
cause-specific hospital admissions for adverse events of special interest that could
be associated with vaccination, such as Bell’s palsy or narcolepsy. Analyses
investigate both the risk of these outcomes in vaccinated individuals following
vaccination, as well as changes to the rates when compared to historical baselines.

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Enhanced surveillance of COVID-19 vaccination programme in Scotland

Signal verification and characterisation
The detection of a signal does not necessarily mean that there is a safety concern
with the vaccination programme. In the event that a signal is detected, further
investigation will need to be conducted to verify whether it is real and to characterise
the signal. This may involve:

   1 Checking the quality and completeness of the data, including the
       completeness of recording of data on vaccination status, as missing data may
       bias the analyses.

   2 Investigating other potential sources of bias or confounding in the data.

   3 Characterising the cases by person, place and time.

   4 Conducting more in-depth investigation of cases, including analysing
       concurrent diagnoses.

   5 Investigating temporal or geographical clustering of cases.

   6 More in-depth medical record review of a sample of cases to confirm
       diagnoses and temporal associations with vaccination.

Signal evaluation
If a signal is verified as real, then further epidemiological investigations will be
required to assess causal associations with vaccination. These studies will be
designed as needed. It is likely that PHS will work closely with the MHRA, PHE and
other counterparts across the three nations on any such evaluations.

Vaccine effectiveness
Even with a highly effective vaccine, it is anticipated that some vaccinated individuals
will develop COVID-19. The first COVID-19 vaccines have been used in the UK as
early as December 2020. PHS is conducting analyses to estimate vaccine
effectiveness (VE) in preventing COVID-19 infection in Scotland.

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Enhanced surveillance of COVID-19 vaccination programme in Scotland

VE is the percent reduction in the frequency of COVID-19 among vaccinated people
compared to people not vaccinated, with adjustment for factors (confounders) that
are related to both COVID-19 illness and vaccination.

PHS is exploring three methods: (1) Screening Method, (2) Test Negative Case
Control (TNCC) and (3) cohort (EAVE II) to monitor and estimate COVID-19 VE
through data linkage using existing surveillance systems and registers. VE analyses
are primarily being conducted at population-wide level, however protocols to assess
VE in specific populations or cohorts are being developed for enhanced surveillance
of VE within these groups.

The programme aims to identify risk factors impacting vaccine effectiveness and
assess the impact of the move of the second dose to 12 weeks. The primary
objective is to estimate VE by vaccine type and by number of doses. The secondary
objectives aim to estimate VE by:

   •   infection (PCR/Seroconversion)

   •   demographic (e.g. age, sex, SIMD)

   •   other identifiable target cohorts (e.g. clinical risk group)

   •   time since vaccination (Vaccination status)

   •   severity (Hospitalisation, ICU admission, Mortality)

   •   transmission.

PHS shares the VE results regularly with JCVI. PHS is also conducting vaccine
effectiveness studies through a range of other approaches in collaboration with
academic and UK/European consortia. These work streams aim to evaluate vaccine
effectiveness as part of larger programmes conducting enhanced and sentinel
surveillance of COVID-19 within primary and secondary care, and at-risk cohorts
such as shielding groups, healthcare workers, care homes and teachers. Also see
the ‘Enhanced surveillance’ section for more details.

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Enhanced surveillance of COVID-19 vaccination programme in Scotland

Post-vaccine infections
Evidence from the vaccination trials indicate that the currently available vaccines
protect against severe COVID-19 disease (rather than preventing infection). Even
with the highly effective vaccines available, it is anticipated that some vaccinated
individuals may go on to develop serious outcomes of COVID-19. Understanding the
factors associated with post-vaccination infection is important in ensuring the
success of the vaccination programme.

PHS is identifying and investigating COVID-19 infections, hospitalisations or death
more than seven days post-second dose of COVID-19 vaccine through record
linkage to key national datasets. This information will be published periodically. PHS
is conducting surveillance to investigate potential programme delivery factors and
identify epidemiological features that could help understanding of the vaccine effect
and disease outcome to inform communication and programme delivery strategies.
Where appropriate serological testing and/or whole genome sequencing of
SARS-CoV-2 may be conducted to better understand factors associated with post
vaccination infections.

Sero-surveillance
The SARS-CoV-2 genome encodes four major structural proteins including the spike
(S) glycoprotein, envelope (E), membrane protein (M) and the nucleocapsid protein
(N). Most serological studies are based on assays which target either the N or S
proteins. PHS has been using a range of commercial assays targeting both the
N and S proteins for sero-surveillance activities to date. This currently includes the
Roche assay targeting N protein and the Diasorin and Euroimmun assays targeting
the S protein.

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Enhanced surveillance of COVID-19 vaccination programme in Scotland

Although the timing and sensitivity and specificity will vary by assay, typically an
antibody response to N and S following infection is detectable from the first week
from symptom onset and peaking at around 28 days. Given the delay between
natural infection and antibody response, seroprevalence studies measure infections
acquired at least three weeks earlier. While there is no agreed correlate of
protection, sero-surveillance provides valuable information on the proportion of the
population that has been exposed to SARS-CoV-2 and includes asymptomatic
infections that generally remain undetected using other surveillance systems.

All the currently proposed vaccines for use in the UK target the spike protein only
and therefore it is not expected that there will be an antibody response to the other
SARS-CoV-2 proteins, especially the N protein. Immunological responses following
vaccination appear to be strongly detected at 28–35 days following the first dose of
the vaccine. It is proposed that the differential antibody response to N and S can be
used to distinguish between antibody response to vaccine or to wild infection (Table
1) and therefore testing samples collected through the existing PHS
sero-surveillance programme by multiple assays is supporting the evaluation of the
vaccine programme.

These collections currently include:

   •   Primary care: Samples collected from patients (700 per week, aged 0 years
       and above) attending community healthcare settings for routine blood tests in
       11/14 NHS Boards since April 2020. Basic demographic information (age,
       sex, NHS Board) is routinely available on each samples. Additional
       demographic and clinical information including vaccine status will be available
       via data linkage.

   •   Scottish National Blood Transfusion Service (SNBTS): Adult blood donor
       samples (500 per week, aged 17 years and above) provided by SNBTS in
       12/14 NHS Boards since June 2020. Basic demographic information (age,
       sex, NHS Board) is routinely available on each samples. Additional
       demographic and clinical information including vaccine status will be available
       via data linkage.

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Enhanced surveillance of COVID-19 vaccination programme in Scotland

   •   Antenatal: Samples collected from the national Down’s syndrome screening
       programme offered to all pregnant women in Scotland (due to commence
       January 2021). Basic demographic information (age, sex, NHS Board) will be
       routinely available on each sample. Additional demographic and clinical
       information including vaccine status will be available via data linkage.

   •   Paediatric: Samples collected from children (aged
Enhanced surveillance of COVID-19 vaccination programme in Scotland

Enhanced surveillance
PHS is also conducting enhanced surveillance of COVID-19 vaccinations through a
range of other approaches, including enhanced and sentinel surveillance within
primary and secondary care, and at-risk cohorts.

Primary and secondary care
PHS is providing information about patients that, when linked to national vaccination
databases, may be used to inform estimates of vaccination uptake and effectiveness
against COVID-19 across Scotland.

In primary care, PHS will build on the existing community surveillance system to
estimate COVID-19 vaccine uptake, as well as effectiveness for individuals who
have had swabs taken within primary care and have laboratory confirmed infection.
These individuals comprise a wide sample of patients throughout Scotland with
symptoms compatible with COVID-19 who are referred for NHS clinical assessment,
either in person or over the telephone, through the current community assessment
arrangements. Enhanced surveillance information is provided by the patient and
comprises data on demographic characteristics, underlying conditions, symptoms
and the self-reported COVID-19 vaccination status, as well as test results. The
system will also link the patient’s community surveillance data to that held within the
national vaccine registry data. Data from this system also contributes to the EAVE-II
project, which tracks the COVID-19 across Scotland (5.4 million people), and the
I-MOVE-COVID-19 Consortium, which monitors vaccine effectiveness across
Europe.

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Enhanced surveillance of COVID-19 vaccination programme in Scotland

In secondary care, enhanced surveillance data are compiled for hospitalised patients
with laboratory confirmed COVID-19, using the RAPID dataset – a timely dataset
recording basic information on Scottish inpatients to which we can link laboratory test
results for COVID-19 and other respiratory pathogens. We also plan to undertake
enhanced surveillance for all Severe Acute Respiratory Infection (SARI) as a clinical
syndrome, based on routinely collected electronic variables (e.g. ICD-10 codes)
which are suggestive of a SARI presentation. As part of creating this proxy SARI
dataset, we will continue to link RAPID data to test results and intend to link to data
within the national vaccine registry. This data may then be used to calculate vaccine
effectiveness in preventing more severe outcomes in hospitalised proxy SARI
patients across Scotland. The gold standard for SARI surveillance is symptomatic
SARI as defined by the World Health Organization (WHO), an acute respiratory
infection with history of fever or measured fever of ≥ 38°C and cough with onset
within the last 10 days and requires hospitalisation. This kind of surveillance would
allow for international comparisons, however Scottish hospitals do not currently
routinely collect symptoms data. Therefore, in addition to the proxy SARI
surveillance, we plan to develop a pilot system for sentinel surveillance within select
hospitals, utilising innovative digital solutions for patient assessment and
management to collect symptoms data needed to identify SARI patients as defined
by the WHO in real-time. If successful, this could provide a timely means to assess
vaccine effectiveness and contribute data to the I-MOVE-COVID-19 Consortium.

Vaccination of healthcare workers
We will build on existing work – conducted in partnership with NHS Education
Scotland and with support from the representatives of some healthcare worker
groups – looking at the risk of COVID-19 (including hospitalisation, intensive care
unit admission and death) in healthcare workers and their households
(www.bmj.com/content/371/bmj.m3582) to examine vaccination of healthcare
workers.

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Enhanced surveillance of COVID-19 vaccination programme in Scotland

The healthcare worker project was based on linking NHS human resources data to a
mature case-control study run by Public Health Scotland on COVID-19. The study
brings together data on microbiological testing for COVID-19 as well as data on
drug-prescribing, intensive care admission and hospital admission. As such, the
case-control study contains data on different types of healthcare worker (e.g. patient
facing and non-patient facing and different occupational groups) and different
occupations (e.g. nursing, medical, allied health professionals) who are directly
employed by the NHS in Scotland as well as data on GPs (family doctors) who are
independent contractors. It also allows to identify household members of healthcare
workers who, like healthcare workers themselves, are at elevated risk of severe
COVID-19. When vaccination data are added into the Public Health Scotland
case-control study of COVID-19, this will allow us to rapidly evaluate rates of
vaccination, as well as real-world effectiveness and safety data, both for different
types of healthcare worker, and compared to the general population.

Vaccination of teachers, people in prisons and people with
diabetes
Similarly to healthcare workers, data on who in the Scottish population are teachers,
have diabetes or are in custody have been linked into the PHS case-control study of
COVID-19. By connecting vaccination status to this data, we will be able to examine
rates of vaccination, as well as real-world effectiveness and safety data for these
groups.

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Enhanced surveillance of COVID-19 vaccination programme in Scotland

SIREN study
Scotland is also participating in the UK-wide SIREN (SARS-CoV-2 Immunity &
REinfection EvaluatioN) study. This is a serological study testing health workers
which will provide information on immunity and prevalence of COVID-19 infection.
Every participant will complete a baseline and follow up survey (e.g. symptoms
associated with further confirmed infection), with PCR testing for SARS-CoV-2 every
two weeks and an antibody test every four weeks. The primary objective of the study
is to determine whether the presence of COVID-19 antibodies is associated with a
reduction in the subsequent risk of re-infection over the next year. The data will also
be used to estimate the prevalence of COVID-19 infection in healthcare workers by
region, using baseline testing at study entry and symptom history from 1 February
2020 to date of study entry and estimate cumulative incidence of new infections in
healthcare workers. A nested cohort study of Scottish healthcare workers in ten NHS
Boards in Scotland including (Dumfries & Galloway, Orkney, Shetland and Tayside
not included) may be used to estimate VE within this group.

COVID-19 in Pregnancy in Scotland (COPS) study
In partnership with the University of Edinburgh, Public Health Scotland is leading the
COVID-19 in Pregnancy in Scotland (COPS) study. This study aims to find out how
COVID-19 infection during pregnancy affects mothers and babies. COPS will help
address uncertainties about the effects of COVID-19 infection in pregnancy by
providing population-based information for the whole of Scotland on the incidence of,
and outcomes following, COVID-19 infection in pregnancy.

The JCVI currently recommends that COVID-19 vaccination may be offered to
pregnant women if they are at unavoidable high risk of exposure to infection, or at
high risk of severe infection due to underlying health conditions. In addition, women
in other risk groups may be vaccinated in the very early stages of pregnancy, before
they realised they were pregnant. The COPS study dataset will therefore also be
used to support evaluation of vaccine uptake, safety and effectiveness in pregnant
women.

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Enhanced surveillance of COVID-19 vaccination programme in Scotland

Transmission
Using the existing EAVE-II platform, and data which is held in PHS related to contact
tracing and households, the effects of vaccine on transmission will be monitored and
measured.

Vaccination programme evaluation
The evaluation of the COVID-19 vaccination programme aims to establish the extent
to which the extended flu and COVID-19 vaccination programmes were successfully
implemented and achieved their intended outcomes, as well as assessing the
scalability and replicability of the current programmes for future vaccination delivery.

In particular, we are exploring if, how, and why there are differences in vaccine
uptake by area, delivery model, eligible cohort and population group. This includes a
deeper understanding of DNAs (did not attend) to inform service delivery and
vaccine confidence work. We share emergent lessons with the programme to help
inform improvements to ongoing and future vaccination delivery, communications
and engagement.

The overarching evaluation questions are as follows:

   •   What are the different service delivery models for flu and COVID-19 in each
       eligible cohort and how does this vary by area (Health Board, Health and
       Social Care Partnership, urban/rural/island)?

   •   Which models are most effective (and cost-effective) at maximising uptake in
       different cohorts and population groups, and why?

   •   Which factors influenced uptake of the flu and COVID vaccinations?

   •   What lessons can be learned about implementing the different service
       delivery models for future vaccination programmes?

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Enhanced surveillance of COVID-19 vaccination programme in Scotland

PHS has developed a portfolio of five mixed-method studies to help us answer the
evaluation questions:

   •   Learning from the flu vaccination programme.

   •   Effectiveness and cost-effectiveness of the flu and COVID-19 vaccination
       programmes.

   •   Experiences of those planning and delivering the COVID-19 vaccination
       programme.

   •   Attitudes and experiences of eligible cohorts (and their representatives) of the
       COVID-19 vaccination programme.

   •   Synthesis and legacy implications.

We draw on learning from other parts of Public Health Scotland, and external
organisations including: other national boards, Scottish Government, local partners
(Health Boards, Local Authorities, the Third Sector, and academics. We have also
linked with some of these partners to facilitate knowledge exchange and proactively
address evidence gaps for example, by commissioning primary research, facilitating
workshops to inform research applications, and contributing to the design of topic
guides and surveys.

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Other formats of this publication are
available on request at:

        0131 314 5300

        phs.otherformats@phs.scot

Published by Public Health Scotland
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Edinburgh EH12 9EB
© Public Health Scotland 2021
All rights reserved.
Established on 1 April 2020,
Public Health Scotland is Scotland’s
national public agency for
improving and protecting the health
and wellbeing of Scotland’s people.
                                        0363 6/2021

www.publichealthscotland.scot
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