COVID-19 VACCINATION STRATEGY IN SPAIN
KEY POINTS

This document is under permanent revision according to the evolution and new information
available on the infection by the novel coronavirus (SARS-CoV-2).

1

1  Introduction
The COVID-19 pandemic is causing enormous human and economic costs in Spain and
the world. Having an effective and safe vaccine available in the short term, which can
be  used  for  the  population  at  large,  will  help  to  reduce  the  number  of  cases,
hospitalizations and deaths by COVID-19 and will help us to gradually return to normal.

The  development  of  such  a  vaccine,  its  acquisition  and  administration  is  an
unprecedented  challenge  to  the  world.  For  this  reason,  the  European  Commission
presented  a  strategy  to  speed  up  the  development,  manufacture  and  deployment  of
vaccines against COVID-191. The EU vaccine strategy aims to ensure the availability of
quality,  safe  and  effective  vaccines  in  the  European  Union  (EU)  as  well  as  an  equal,
rapid  and  equitable  access  to  the  available  doses  by  all  Member  States  and  their
citizens.  This  strategy  ensures  that  the  entire  purchase  and  distribution  process  is
conducted  transparently  and  with  equal  standards  of  vaccine  safety  and  efficacy
among  all  Member  States.  Joint  action  at  EU  level  is  the  safest,  fastest  and  most
efficient way to achieve these goals.

The Spanish Agency for Medicines and Healthcare Products (AEMPS) represents Spain
in  the  body  that  makes  decisions  about  every  advance  purchase  process.  This  body
monitors the development of vaccines and ensures transparency and good governance
in the process of purchase and distribution. Within this framework, advance purchase
agreements  for  vaccines  have  already  been  signed  with  five  pharmaceutical
companies:
AstraZeneca/Oxford,
Sanofi-GSK,
Johnson
&
Johnson/Janssen,
Pfizer/BioNTech  and  Curevac.  Negotiations  continue  with  Moderna/Lonza  and
Novavax. This is a broad portfolio of vaccines that will ensure that, if the authorization
is granted, Europe and Spain will gradually have the necessary doses, at the same time,
and for the entire population, so as to face this unprecedented situation.

The  effort  that  the  world's  scientific  community  is  making  to  achieve  a  safe  and
effective vaccine is unparalleled by any other before, and citizens should be aware that
the vaccines that will eventually be used in the EU against COVID-19 will have the same
levels of safety as any of those commonly used.

1 https://eur-lex.europa.eu/legal-content/ES/TXT/?qid=1597339415327&uri=CELEX:52020DC0245
3

On  October  15,  2020,  the  European  Commission  published  a  Communication  on  the
preparation  of  COVID-19  vaccination  strategies  and  vaccine  deployment2  which
identifies key elements to be considered within national vaccination strategies.

This European Commission document and the recommendations of other international
bodies  have  been  taken  into  account  for  drawing  up  of  the  Vaccination  Strategy  for
Spain34.  The  main  objective  of  the  vaccination  strategy  is  to  reduce  COVID-19
morbidity  and  mortality  by  vaccinating  the  population  at  large.  Bearing  in  mind  that
the availability of vaccines will be progressive, it is necessary to establish the main lines
that  this  vaccination  strategy  must  follow,  as  well  as  the  prioritization  of  different
population groups.

The  COVID-19  Vaccination  Strategy  in  Spain  has  been  devised  with  the  information
available at this moment and aims to be a live, agile and flexible document, which will
be updated as knowledge increases on the results of the clinical trials being carried out
with  candidate  vaccines,  on  the  information  related  to  the  logistics,  storage  and
administration  requirements  of  the  vaccines  close  to  authorization,  and  on  details
about the immunity generated after the disease.

This  is  a  country-wide  strategy,  which  is  driven  by  an  ethical  framework  based  on
equity,  with  a  solid  technical  base  which  will  be  coordinated  on  the  basis  of  the
common  European  framework,  and  it  is  born  with  the  conviction  that  better
acceptability results can be achieved if the vaccine is voluntary.

It  should  be  noted  that  Spain  has  a  great  deal  of  experience  in  logistics,  distribution
and  vaccination,  both  in  systematic  vaccination  and  in  specific  campaigns.  Indeed,  in
the current flu vaccination campaign, in the context of a pandemic, vaccination levels
have significantly increased in all territories.

2 https://ec.europa.eu/health/sites/health/files/vaccination/docs/2020_strategies_deployment_en.pdf
3 https://www.ecdc.europa.eu/sites/default/files/documents/Key-aspects-regarding-
introduction-and-prioritisation-of-COVID-19-vaccination.pdf
4 https://www.who.int/publications/i/item/WHO-2019-nCoV-Vaccine_deployment-2020.1

4

At the same time, lessons learned from the past 2009 influenza pandemic showed the
importance  of  having  an  international  regulatory  framework  that  would  strengthen
global  surveillance  and  response  capacity,  the  inclusion  of  vaccines  and  antivirals  in
preparedness  and  response  plans,  or  the  development  of  stronger  information
systems.  This  experience  ensures  that  the  COVID-19  Vaccination  Strategy  can  be
successfully implemented.

The current document describes the main lines for establishing a COVID-19 Vaccination
Strategy in Spain with the current knowledge, including the aspects described below.
2  Objectives of the strategy

The  global  objective  of  the  COVID-19  vaccination  strategy  in  Spain  is  to  reduce  the
morbidity and mortality caused by this disease, protecting the most vulnerable groups
through vaccination in a context of progressive vaccine availability.

There are four operational objectives:
1.  To  establish  an  order  of  priority  of  the  population  groups  to  be  vaccinated,
taking into account scientific, ethical, legal and economic criteria, in a  context
of  progressive  availability  of  vaccine  doses.  It  is  necessary  to  prioritize  the
protection of the most vulnerable groups and those for which our legal system
has assumed a specific and reinforced duty of protection.
2.  To  arrange  the  fundamental  aspects  related  to  logistics,  distribution  and
administration  of  the  vaccines  that  will  be  available  for  Spain  in  the  coming
months.
3.  To  establish  the  priority  lines  for  the  monitoring  and  evaluation  of  the
vaccination, including the coverage, safety and effectiveness of the vaccines, as
well  as  their  impact  on  the  epidemiology  of  COVID-19,  which  will  allow  the
strategy to be assessed and adjusted in order to achieve the maximum benefit
for the population.
4.  To  arrange  the  key  aspects  for  the  development  of  a  communication  strategy
aimed at health personnel and the general population, which will give access to
adequate  and  truthful  information,  increasing  the  population’s  trust  in  the
process  of  authorization  and  use  of  the  vaccine(s),  and  ultimately  achieving
high coverage.

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The  main  objective  of  the  COVID-19  vaccination  strategy  in  Spain  is  to  reduce  the
morbidity  and  mortality  caused  by  this  disease  through  vaccination  against  COVID-
19,  in  a  context  of  progressive  availability  of  doses,  and  protecting  the  most
vulnerable groups

3  Governance of the strategy

The preparation of the COVID-19 Vaccination Strategy in Spain is a mandate from the
plenary session of the Inter-territorial Council of the National Health System (CISNS), a
collegiate health body in which the health councilors of the autonomous communities
and cities and the Minister of Health participate.
On  9  September  the  CISNS  plenary  session  approved  a  declaration  of  Coordinated
Actions in the field of Public Health which agreed:
•  The implementation of a common vaccination strategy for all territories, drawn
up jointly taking into account the opinion of experts in bioethics and scientific
societies, approved by the CISNS plenary session.
•  The  provision  by  the  Autonomous  Communities  of  the  equipment,  resources
and materials necessary for the administration of the vaccines provided by the
Ministry of Health.
•  The creation of a COVID-19 State Vaccination Register by the Ministry of Health
in collaboration with the autonomous communities and cities, which will be fed
with  information  from  the  vaccine  registers  and  information  systems,  or  any
other system with information of interest on the autonomous communities and
cities.
To  this  end,  a  COVID-19  Vaccination  Technical  Working  Group  (GTV)  was  created,
depending  on  the  CISNS  Programme  and  Registry  of  Vaccinations  Report  (or
Vaccination  Committee),  coordinated  by  the  Ministry  of  Health,  and  which  includes
eight members of the Committee itself, specialists from scientific societies,  experts in
bioethics,  sociology  and  methodology,  as  well  as  experts  from  the  Carlos  III  Health
Institute,  the  Spanish  Agency  for  Medicines  and  Healthcare  Products  (AEMPS),  the
Health  Alerts  and  Emergencies  Coordination  Centre  (CCAES)  and  the  Ministry's
Occupational Health and Vaccination Programmes areas.
The GTV has elaborated a document of Basis for the Strategy of COVID 19 Vaccination
in Spain, validated by the Programme and Registry of Vaccinations Committee.

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The  CISNS  Vaccine  Committee  and  the  GTV  are  the  technical  bodies  that  will  review
and  update  the  Basis  of  the  Strategy  as  new  knowledge  on  the  characteristics  and
availability of vaccines and the implementation of the Strategy advance.

In addition, with the aim of supporting inter-sectoral coordination and promoting the
effective  planning  and  implementation  of  the  Vaccination  Strategy  in  the  various
priority groups, an inter-ministerial advisory group will be set up with the participation
of technical teams from the  Second Vice-Presidency and the Ministry of Social Rights
and  2030  Agenda,  the  Ministries  of  Territorial  Policy  and  the  Civil  Service,  Defense,
Home  Affairs,  Inclusion,  Social  Security  and  Migration,  Labour  and  Social  Economy,
Education  and  Vocational  Training,  Industry,  Trade  and  Tourism  and  Agriculture,
Fisheries and Food.

The  Ministry  of  Health  will  acquire  the  corresponding  doses  for  Spain  within  the
framework  of  the  European  strategy.  Once  the  availability  of  doses  authorized  and
purchased by the Ministry of Health is known, the final prioritization of the vaccination
of  certain  population  groups  and  the  allocation  of  doses  to  each  of  the  Autonomous
Communities will be agreed upon in the plenary session of the CISNS, after discussion
in  the  Vaccines  Committee  and  the  Public  Health  Commission.  The  vaccines  will  be
administered free of charge through the National Health System (SNS).

•  The COVID-19 Vaccination Strategy in Spain is based on the recommendations
of  the  COVID-19  Vaccination  Technical  Working  Group  and  the  Vaccine
Committee,  and  will  be  coordinated  by  the  Inter-territorial  Council  of  the
National Health System (CISNS).
•  The vaccines will be administered free of charge through the NHS.
4   Development and availability of vaccines
Finding  a  safe  and  effective  vaccine  is  a  key  element  of  the  exit  strategy  from  the
pandemic.  That  is  why  an  unprecedented  collective  effort  is  underway  involving
countries, institutions, researchers and companies around the world to make vaccines
available at short notice.
7

Sixty-six  days  after  the  sequencing  of  the  SARS-CoV-2  genome,  a  human  was  first
injected with a candidate vaccine against the pandemic virus5.
At  present,  more  than  250  different  COVID-19  vaccine  candidates6  are  being
developed  worldwide,  based  on  different  technological  platforms,  ranging  from  the
most  common  (inactivated  viruses  or  purified  protein  sub-units  of  viruses),  those
based on more recent technologies and for which vaccines are already commercialized
(replicative  and  non-replicative  viral  vectors),  but  also  very  new  platforms  that  have
never been commercialized until now (DNA and mRNA).
The  Spanish  government  is  also  promoting  research  and  production  of  vaccines,
providing  resources  for  the  development  of  projects  and  programmes  through  the
Carlos III Health Institute and the Spanish National Research Council (CSIC). There are
currently 11 candidate vaccine projects.
The development of any vaccine  covers different phases. Initially, an exploratory and
pre-clinical phase is developed with studies on laboratory animals. Then, clinical trials
in humans phase I, II and III are initiated to determine the optimal dose, explore initial
safety  and  characterize  the  efficacy  and  safety  profile.  Finally,  data  are  evaluated  by
the drug agencies, so that only if they prove to be effective and safe do the agencies
grant  marketing  authorization  and  pharmacovigilance  activities  begin,  which  are
maintained throughout the life cycle of the drug.
It is not yet known which of the more than 250 candidate projects will successfully go
through pre-clinical and clinical studies until approval, nor when these vaccines will be
available in sufficient quantities to allow their use  in the population at large. For this
reason,  work  is  underway  at  the  European  level  on  a  broad  portfolio  that  includes
vaccines  from  all  platforms,  thus  maximizing  the  chances  of  having  an  effective  and
safe  vaccine  as  soon  as  it  becomes  available  and  is  authorized  by  the  competent
authorities.
The  criteria  for  including  vaccines  in  the  portfolio  include  the  solvency  of  the  clinical
development  project  and  the  consequent  probability  of  being  assessed  for
authorization  and  commercialization,  the  capacity  and  solvency  of  the  company  to
manufacture it in a significant quantity, that can be produced in European territory or,
for  example,  have  the  possibility  of  distributing  vaccines  as  soon  as  they  are
authorized.

5 Callaway E. The race for coronavirus vaccine. Nature. April 2020. 580 no. 7805: 576-577. Available at:
https://doi.org/10.1038/d41586-020-01221-y [accessed 10 November 2020]
6 https://vac-lshtm.shinyapps.io/ncov_vaccine_landscape/
8

At  the  moment,  there  are  eleven  vaccines  on  different  platforms  that  have  already
started phase III of the clinical trials. Of these, five7 are in the European portfolio.
Table 1 lists the main characteristics and current state of development of the COVID-
19 vaccines that are part of the European Vaccine Strategy.
Table 1: Summary of European SARS-CoV-2 vaccine candidates and current status of development (results published
in peer review or preprint as of November 2020), subject to change.
Pharmaceutical
Platform
Schedule   Dose
Clinical Stage
companies
Oxford/
Non-replicating
2 doses:
0.5ml
Phase III: UK,
Astra-Zeneca
chimpanzee adenovirus
0-28 days   dose
Brazil,
that carries the protein S
IM
South Africa, USA,
among others.

BioN-Tech/
mRNA encoding S protein
2 doses:
0.3ml
Phase III: USA,
Pfizer
encapsulated in lipid
0-21 days   dose
Brazil, Argentine,
nanoparticles
IM
among others.
J&J/Janssen
Non replicating Ad26
1-28
0.5ml
Phase III: USA,
vector carrying S proteing  doses:
dose
Argentine, Brazil,
0-56 days   IM
Philippines, Spain,
among others.
Sanofi/GSK
Protein S purified with
2 doses:
0.5ml
Phase I/II: USA.
the adjuvant AS03
0-28 days
dose
Phase III
IM
scheduled for
December
Moderna
RNA encoding S protein
2 doses:
0.5ml
Phase III: USA.
encapsulated in lipid
0-28 days
dose
particles
IM
Novavax
S-protein nanoparticle
2 doses:
0.5ml
Phase III: UK.
with Matrix-M1 saponin
0-21 days
dose
as an adjuvant
IM
Curevac
mRNA encoding a
2 doses:
0.6ml
Phase I: Belgium
stabilized form of S-
0-28 days
dose
and Germany,
protein encapsulated in
IM
amongst others.
lipid nanoparticles
Phase II: Peru,
Panama, among
others.

7 BioNTech/Pfizer, Moderna/Lonza, Johnson&Johnson/Janssen, Astra-Zeneca/Oxford y Novavax.
8 J&J/Janssen está llevando a cabo un gran ensayo fase III en Estados Unidos con una sola dosis (que en
principio será la dosis seleccionada para la autorización inicial) y otro gran ensayo fase III multinacional
con la misma vacuna, pero a dos dosis.

9

Within the framework of  the European  Vaccine Strategy, which provides for advance
purchase  agreements,  four  contracts  have  already  been  signed:  with  Astra-Zeneca  /
Oxford, Sanofi / GSK, J & J / Janssen and Pfizer / BioNTech. In addition, there is already
an agreement with CureVac and the contract will be signed shortly, other agreements
are still being negotiated with Moderna / Lonza and Novavax. If all the agreements are
completed,  the  EU  will  have  secured,  should  vaccines  be  licensed,  around  1.4  billion
doses  (or  immunizations  for  around  800  million  people)  available  from  various
manufacturers for the EU population, but also outside of it.

Advance Purchase Agreements within the European Vaccine Strategy reserve or grant
Member States the right to purchase a specified number of doses of vaccination at a
price stipulated at the time the vaccine in question is available. All Member States will
have access to COVID-19 vaccines at the same time and according to the size of their
population.

For a vaccine to be available to the population, it must be previously authorized by the
European  Commission  after  a  positive  scientific  and  technical  opinion  from  the
Committee for Medicinal Products for Human Use of the European Medicines Agency
(EMA) and based on the usual criteria with which the quality, safety and efficacy of the
drugs  are  guaranteed.  The  authorization  granted  in  this  way  is  identical  and  valid
throughout the EU.

The  time  frame  for  the  development  of  a  vaccine  is  shortened  for  several  reasons.
First,  because  the  companies  develop  the  vaccine  by  performing  several  phases  in
parallel that would normally be carried out sequentially. Secondly, because companies
begin  to  manufacture  "at  risk"  –supported  by  advance  payments  of  purchase
agreements– so that they can have doses from the very moment they are authorized.
Finally,  because  to  speed  up  the  evaluation  process  in  a  health  emergency  situation
like this, the EMA has launched the rolling review process, whereby its Committee for
Medicinal Products for Human Use reviews the data as soon as they are available, in a
ongoing review that enables applications for authorisation to be quickly assessed while
ensuring  sound  scientific  advice.  In  this  way,  the  vaccine  evaluation  process  is
accelerated  to  a  great  extend  without  compromising  the  safety  requirements  for  its
authorization at any time.

Citizens should know that the vaccines that will ultimately be used to get immunized
against COVID-19 will have the same levels of safety as any other that are commonly
used. And that the levels of effectiveness will comply with the standards required for
its use to be authorized.We are relying on more teams and more resources. And all the
initiatives underway to obtain vaccines are undergoing the same procedures followed
by all the vaccines authorized so far.
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Based  on  all  established  reviews,  some  vaccine  manufacturers  have  announced  that
the first deliveries of vaccine doses to EU Member States would be available possibly
before  the  end  of  2020,  provided  the vaccines  have  a  marketing  authorisation  in  the
EU .

In  addition,  to  facilitate  early  access  to  the  vaccine,  aspects  such  as  the  labeling  of
medicines or actions at the national level have also been simplified to the maximum,
so that when a vaccine is authorized by the European Commission, the Spanish Agency
for Medicines and Medical Products (AEMPS) will grant the national code immediately
so that the vaccination can begin.
Table 2 summarizes the status of negotiations with the different companies, for which
marketing  authorization  is  being  requested  in  the  EU  and  for  which  early  availability
may be possible or a sufficient number of vaccine doses could be available to initiate a
nationwide vaccination campaign for priority groups.

Table 2: Status of the negotiations and approval schedule expected to November 2020, subject to change.

Pharmaceutical  EU agreement
Total  number  Number
of  Expected
company
of doses
doses
for  approval
Spain
schedule
Oxford/
Contract  signed  300M  (+100M  31,555,469
Rolling  review
Astra-Zeneca
in August 2020
optional)
doses
ininitiated
October 2020
Sanofi/GSK
Contract  signed  300M
It
will
be  2021
September  2020
decided  when
(acquisition
phase  I  /  II
right)
ends
BioN-Tech/
Contract  signed  200 M (+100 M  20.873.941
Rolling  review
Pfizer
in
November  optional)
doses
ininitiated
2020
October 2020
J&J/Janssen
Contract  signed  200 M (+200 M  Pending*
2021
in
November  optional)
2020
Curevac
Contract  signed  225 M (+180 M  Pending*
2021
in October 2020
optional)
Moderna
Very  advanced  80M
(+80M  Pending*
Rolling  review
negotiation
optional)
ininitiated
October 2020
Novavax
Ongoing
-
-
2021
negotiation
*Spain represents 10.57% of the population of the EU without the countries of the European Economic Area (EEA)
and 10.44% including the EEA countries (Norway, Iceland and Liechtenstein).

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• Countries, institutions, researchers and companies around the world are making
an unprecedented effort to develop a safe and effective vaccine in a short period of
time.
• If the agreements are completed, the EU will have secured 1,400 M doses or 800
M of immunizations and all Member States will have access to it at the same time to
a quantity according to its population.
• Citizens should know that the vaccines that will ultimately be used to immunize
against COVID-19 will have the same levels of security as any of those commonly
used.
5  Prioritization of vaccination
The objective of the vaccination of the population is to prevent the disease and reduce
its severity and mortality, in addition to  reducing the impact of the  pandemic on the
health  care  system  and  the  economy,  especially  by  protecting  those  groups  with
greater vulnerability.
Given that the first vaccines against COVID-19 will be available in limited quantity, and
will increase progressively, three stages have been identified according to availability
at any particular time:

o  First stage. Initial and very limited supply of vaccine doses.
o  Second stage. Progressive increase in the availability of vaccines  will alow to
increase the number of people to be vaccinated.
o  Third stage. Increase in the number of doses and vaccines available to cover all
priority groups.

Due  to  the  gradual  availability  of  vaccine  doses,  it  is  necessary  to  prioritize  the
population groups to be vaccinated in each of the stages set out. To this end, an ethical
framework has been established where prevail, in this order, principles of equality and
dignity of rights, necessity, equity, protection of disabilities and minors, social benefit
and  reciprocity.  In  addition,  the  following  more  procedural  principles  have  also  been
taken into account: participation, transparency and accountability.
The  evaluation  of  the  different  population  groups  is  based  on  this  framework,  also
taking  into  account  the  applicable  legal  regulations  and  international
recommendations.

To  set  out  the  prioritization  of  the  groups  to  be  vaccinated  in  each  of  the  stages,  an
evaluation  has  been  carried  out  based  on  the  following  criteria:  risk  of  severe
morbidity  and  mortality,  exposure,  socioeconomic  impact  and  transmission,  in
addition to feasibility and acceptance.
Based  on  this  evaluation,  the  following  group  prioritization  has  been  established  for
the first stage:
12

1. Residents and health and social care personnel in care homes for the elderly and the
disabled.
2. Front-line health personnel.
3. Other health and social health personnel.
4.  Dependent  people  with  disabilities  who  require  intensive  support  measures  (non-
institutionalized highly dependents).

Once  the  availability  of  one  or  more  of  the  authorized  and  acquired  vaccines  by  the
Ministry of Health is known, the final prioritization of vaccination to certain population
groups will be agreed in the Plenary of the CISNS, after discussion in the Presentation
of Vaccines and Vaccination Registry and in the Public Health Commission,


• Due to the gradual availability of vaccine doses, it is necessary to prioritize the
population groups to be vaccinated based on to an established ethical framework
and risk criteria.
• The Plenary of the CISNS will agree on the final prioritization of vaccination of the
various groups of population.

6  Logistics, distribution and administration

The vaccination program against COVID-19 entails several critical points different from
the  usual  vaccination  programs.  These  have  to  do  with  the  requirement  of
extraordinary  cold  conditions  in  the  transport  and  storage  of  some  vaccines,  their
distribution  in  multi-dose  vials  that  require  planning  of  appointments  to  avoid  dose
loss,  the  possible  coincidence  of  use  of  different  vaccines  with  different  formats  and
specific handling instructions and that to  complete vaccination coverage may require
one  or  two  doses,  the  need  to  maintain  physical  distance  and  preventive  measures
during  the  process  (for  which  the  experience  during  the  influenza  vaccination
campaign  serves  as  a  reference),  the  special  characteristics  of  the  Immunization
Registry  or  the  need  to  consider  possible  vaccination  sites  in  addition  to  the  usual
ones.

To  facilitate  the  correct  functioning  of  the  vaccination  process,  it  is  therefore
paramount to ensure that the storage, distribution and administration of each vaccine
are  carried  out  in  optimal  conditions  that  guarantee  the  quality  of  the  vaccines
throughout  the  process.  The  COVID-19  Vaccination  Technical  Working  Group  has
evaluated the fundamental aspects to take into account from the authorization of the
use of vaccines to their administration, as outlined in Figure 1:

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Gráfico:

A. Financing, Authorization
authorization for use of vaccines; labeling FT; Contract, Financing; Allocation and traceability

B. Reception, Storage, Distribution, Control
Reception,  storage  and  distribution;  Different  logistics  depending  on  the  vaccine;  Distribution  points
Autonomous Communities (type of vaccines); Registration/Traceability (stock, dose availability)

C. Information, Training
Continuous  information;  Administration;  Different  vaccines;  Protocols,  guides,  instructions  (training
platform); Vaccination card

D. Communication, Coordination
Manufacturers; Ministry of Health; AEMPS; Autonomous Communities
The  Ministry  of  Health  is  working  with  the  autonomous  communities  on  different
alternatives of vaccination centers, taking into account the experience of Primary Care.
As information on the availability of vaccines becomes available, it will be necessary to
update  the  processes  and  establish  where,  who  and  how  the  vaccination  will  be
carried out.

Vaccine  distribution  will  require  full  collaboration  and  coordination  between  public
institutions,  authorized  distributors  and  pharmaceutical  companies  so  that  supply
chain logistics are carried out in an efficient and orderly manner in a process validated
at  all  times  by  the  Ministry  of  Health.  To  this  end,  protocols  will  be  developed  to
control  the  traceability  of  distribution,  assign  process  managers  and  define  clear
communication flows.

The  administration  of  the  vaccines  will  be  carried  out  initially  with  confirmed
appointment  to  avoid  the  waste  of  doses  and  following  the  safety  protocols.  The
vaccine  doses  administered  will  be  included  in  the  registration  systems  and  the  date
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and  data  of  the  vaccine  received  will  be  included  in  the  clinical  history  of  the
vaccinated person.

All vaccinated persons shall receive adequate information on the vaccine administered
and  a  vaccination  card,  or  similar,  which  shall  state  the  type  of  vaccine  administered
and the lot number, date of vaccination and date for the administration of the second
dose, if applicable, as well as how to proceed with any suspected adverse reaction.

- The logistic, distribution and administration processes of the vaccines against COVID-
19 are complex and associate several critical points that are being technically prepared
in advance of the arrival of the first vaccines.

-  The  distribution  of  the  vaccines  will  require  full  collaboration  and  coordination
between public institutions and pharmaceutical companies so that the logistics of the
supply chain are carried out in an efficient and orderly manner in a process validated at
all times by the Ministry of Health.


7   Monitoring and Evaluation

Adequate records to ensure that vaccination data is properly collected and to assist in
surveillance  and  follow-up  activities  are  essential  for  monitoring  the  vaccination
strategy.

The National Health System's COVID-19 Vaccination Registry aims to keep track of the
doses  and  types  of  COVID-19  vaccines  administered  to  different  population  groups.
This  registry  will  be  used  to  calculate  the  vaccination  coverage  achieved  and  will
include the entire target population that is being prioritized.

The  Ministry  of  Health  is  working  with  the  Autonomous  Communities  on  the
standardized  and  structured  confluence  of  information  systems  and  regional  records
into a single registry that will house COVID-19 vaccination data for the entire country
and will be interoperable with other registries implemented during the pandemic.

The  Spanish  Pharmacovigilance  System,  coordinated  by  the  AEMPS,  has  developed  a
specific  Plan  for  the  safety  surveillance  of  COVID-19  vaccines  that  will  continuously
analyze the reports of suspected adverse reactions made by both health professionals
and the vaccinated citizens themselves, sharing information with the rest of European
agencies and the WHO.

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The  Strategy  contemplates  the  development  of  different  studies  of  vaccine
effectiveness  in  the  vaccinated  population  that  complement  the  data  of  the  studies
carried  out  by  the  pharmaceutical  companies,  as  well  as  studies  of  the  effect  of  the
introduction of the vaccine on the epidemic wave.

Spain  will  participate  together  with  seven  countries  in  the  European  project  ACCESS
coordinated by the European Medicines Agency on coverage, effectiveness and safety
of vaccines through the BIFAB Program, a computerized database of the clinical history
of Primary Care for pharmacoepidemiological research.

The Strategy also foresees studies of the acceptability of vaccination and processes of
continuous  evaluation  of  the  Strategy  that  allow monitoring  and  dynamic  adaptation
of the same.

• - The Strategy foresees different tools and studies that will allow monitoring and
evaluation of the coverage, safety and effectiveness of the vaccines.
• The Spanish Pharmacovigilance System, coordinated by the AEMPS, has developed
a specific Plan for the safety surveillance of COVID-19 vaccines that will continuously
analyze the reports of suspected adverse reactions made by both health
professionals and the vaccinated citizens themselves, sharing information with the
rest of the European agencies and the WHO.
8  Communication

The development of a communication strategy must contribute to effective, equitable,
and  ethically  sound  access  to  vaccination,  and  be  developed  with  full  respect  for
transparency,  as  the  fundamental  axis  of  all  public  decisions  and  policies,  especially
those  adopted  in  the  field  of  public  health,  as  set forth  in  the  General  Law  on  Public
Health.

It is considered a facilitator of these objectives that the  communication is carried out
preferably  by  technical  personnel  and  that  it  is  focused  on  the  transmission  of  the
criterion  of  solidarity,  that  is,  to  inform  that  the  vaccination  will  be  prioritized  to  the
population  that  needs  it  the  most,  taking  into  account  the  safety  of  the  vaccines.
Health personnel play a fundamental role in informing the public.

In short, it is a matter of generating a high level of confidence that will translate into
better coverage.

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This  communication  strategy  will  be  governed  by  the  application  of  the  following
principles:

- Veracity:  information  based  on  available  scientific  evidence  on  the  benefits  and
risks of vaccination.
- Transparency:  truthful  information  shall  be  provided  at  all  times  in  a  clear  and
accessible manner that also includes uncertainties.
- Participation: the doubts of the population and health personnel will be heard in
order to direct the communication strategy to respond to existing needs.
- Equity:  messages  will  be  adapted  to  the  audience  to  ensure  that  it  is  accessible.
Specific attention will be given to people with disabilities.
- Evaluation: information will be periodically re-evaluated.


The communication strategy will create a framework of truthfulness, transparency and
trust with differentiated objectives for health personnel and the general population.

1.Healthcare  personnel  must  be  informed  about  the  development,  authorization,
procurement  procedures,  distribution  and  use  of  COVID-19  vaccines  at  the  different
stages  of  availability  of  the  vaccines,  establishing  synergies  with  key  actors  in  the
vaccination  and  transmission  of  accurate  information  (participation  of  professional
associations). The following objectives have been established:

a) To ensure confidence in the evaluation, authorization and surveillance process after
the  administration  of  the  vaccines  (continuous  evaluation  in  the  benefit-risk
relationship).
b) To help understand the difference between the usual vaccine authorization process
and  the  one  used  in  the  current  situation  by  the  regulatory  agencies  (EMA  and
AEMPS).
c) Raise awareness of the need to prioritize vaccination as a criterion of solidarity and
in line with the safety and efficacy data of the vaccines.
d)  Raise  awareness  on  the  deontological  commitment  towards  vaccines,  so  that  they
transmit to the population the example of protecting their health to protect others.
e)  Remember  the  importance  of  reporting  adverse  events  that  may  occur  after
vaccination.

2. The general population should be informed about the development, authorization,
distribution  and  use  of  COVID-19  vaccines,  with  the  participation  of  population
associations (patient associations):

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a)  Communicate  about  the  process  of  evaluation,  authorization  of  the  vaccines  and
continuous surveillance after their authorization, as well as answering questions.
b) Explain the reasons for prioritization as a criterion of solidarity
c) Inform about the scientific evidence of the vaccines, their history and the scientific
characteristics of the vaccines to be distributed.
d) Inform about the adverse reactions of the vaccines identified before and after their
authorization. In this sense, to have data on the adverse reactions that occur in other
vaccines.

- The development of a communication strategy should contribute to the effective and
equitable  access  to  the  vaccination,  complying  with  ethical  principles  and  developed
with full respect to transparency. - The general objective of the strategy is to generate
a  high  level  of  trust  that  translates  into  better  coverage,  and  for  this  purpose  health
personnel play a fundamental role.




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