DEMYSTIFYING AND ENHANCING AWARENESS ON COVID-19 VACCINATION

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DEMYSTIFYING AND ENHANCING AWARENESS ON COVID-19 VACCINATION
ONLINE SEMINAR ON

DEMYSTIFYING AND ENHANCING AWARENESS
       ON COVID-19 VACCINATION

          BACKGROUND MATERIAL

             6TH FEBRUARY, 2021

              4.00 PM - 6.00 PM

                 Organised by

        WATERFALLS INSTITUTE OF
        TECHNOLOGY TRANSFER
              In Association with
        THE MADRAS CHAMBER OF
        COMMERCE & INDUSTRY

                     1
DEMYSTIFYING AND ENHANCING AWARENESS ON COVID-19 VACCINATION
ONLINE SEMINAR ON

DEMYSTIFYING AND ENHANCING AWARENESS
      ON COVID-19 VACCINATION

         BACKGROUND MATERIAL

            6TH FEBRUARY, 2021

              4.00 PM - 6.00 PM

                Organised by

      WATERFALLS INSTITUTE OF
      TECHNOLOGY TRANSFER
             In Association with
      THE MADRAS CHAMBER OF
      COMMERCE & INDUSTRY

             CONTENTS

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DEMYSTIFYING AND ENHANCING AWARENESS ON COVID-19 VACCINATION
INVITATION               …                    …             …                1

 PREFACE                  …                    …             …                2

1.   INTRODUCTION: COVID-19 & VACCINES                                       4
     1.1   About COVID-19                                                     4
     1.2   Executive Summary (Covid 19 Vaccine – Operational Guidelines)      5
     1.3   Introduction to Vaccines for Covid-19                              8
     1.4   Development of COVID-19 Vaccine                                    9
     1.5   COVID-19 vaccine development in India                             11
     1.6   Communication Strategy                                            11
     1.7   Contents of COVID-19 Vaccine(s) – Operations Guidelines           13
     1.8   Contents COVID-19 Vaccine(s) – Communication Strategy             15
     1.9   List of Awareness Material (Ministry of Health)                   17
2.   DEMYSTIFYING THE CONCEPTS ABOUT COVID-19 AND                            20
     VACCINATION
     2.1   India’s Vaccination Drive                                         20
     2.2   US COVID-19 Vaccination Program                                   21
     2.3   FAQ and Answers on Vaccines for Covid-19                          22
     2.4   Myths on Vaccines                                                 27
     2.5   WHO Conversation in Science                                       39
3.   VACCINE MANUFACTURING                                                   40
     3.1   Types of Covid-19 Vaccines                                        40
     3.2   Vaccine Manufacturing                                             44
     3.3   Indian Vaccine Development & Manufacturers                        47
     3.4   Emergency use Authorisation : Covid-19 Vaccine                    50
     3.5   Indian Vaccines: How the Globe Views It                           52
4.   INTELLECTUAL PROPERTY RIGHTS AND COVID 19 VACCINES                      54
     4.1   Patent Ownership of Covid-19 Vaccines                             54
     4.2   COVID-19 Patent Ban (South Africa/Indian)                         56
     4.3   Looking into Future of Patent Ban /Waiver                         58
     Annexure 4.1 :   A note on International development regarding Access   61
                      to Medicine to address the COVID-19
                        ( A note from Dr. K.S. Kardam)
5.   ABOUT THE SPEAKERS                                                      63

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DEMYSTIFYING AND ENHANCING AWARENESS ON COVID-19 VACCINATION
P R E F A C E

This background material is prepared for the online Seminar being planned
for 6th February, 2021, jointly organised by Waterfalls Institute of
Technology Transfer and Madras Chamber of Commerce and Industry. The
subject of the Seminar is “Demystifying and Enhancing Awareness on
Covid-19 Vaccination”. No doubt at all, the subject is rapidly evolving and
this material assembled in later part of January 2021 would be impacted by
newer information that would become available by the time the seminar
takes place in the first week of February 2021.

No originality whatsoever is implied by the Institute for the material
assembled here; all credit is in fact due to several agencies and
organisations for publishing very valuable information from time to time.
Material put out by only a few organisations are included here after being
abridged and edited in this backgrounder such as; the Ministry of Health
and Family Welfare of the Govt. of India, World Health Organisation,
Geneva Switzerland, leading Vaccine Manufactures, some medical centres
and few others; the reader is urged to refer to the original material of such
organisations to form a firm view on an issue, this backgrounder serving
only as an indication for further study and examination.

Chapter I. Introduction to Covid 19 and Vaccine is mainly from the
Website of the Ministry of Health and Family Welfare of the Govt. of India
under the “Resources” section, “Training Material” lists several links. Two of
them dealing with vaccines is picked up; they are (i) Covid 19 Vaccines:
operational guidelines uploaded on 28-12-2020. The Contents page and
Executive Summary is given in this Chapter; and (ii) Covid 19 Vaccines:
Communication strategy uploaded on 30-12-2020. The introduction and
Contents page is also extracted for presentation in this Chapter. This
chapter also gives a list of Awareness material on a wide range of topics by
the Ministry of Health and Family Welfare.

Chapter 2. contains material which will help to Demystify the concept about
Covid-19 and vaccination. Section 2.1 give a brief overview of India’s
vaccination drive, perhaps the largest in the history of the world. Section 2.2
similarly gives the US program on vaccination. In fact the largest impact of
Covid-19 in terms of persons infected are USA and India and as such their
vaccination program have many similar features with 2 vaccines in each
country. Section 2.3 provides answers to the frequently asked questions on
Vaccines for Covid-19. Section 2.4 provides explanations and clarifications
on many myths relating to Covid-19 vaccines and vaccination. It will be
seen that many items of myths relates to perception and misinformation in
USA; similar myths exists in India too, but here the correct information has
not yet been collected and clarified. Perhaps this could be done as India’s’
vaccination drive advances and the items reported in Phase I of the
Vaccination could be brought out; this would be of use in enhancing
awareness in the later phases of the vaccination program. Section 2.5 gives
a list of subject items (Episodes) covered in the WHO series in
“conversation in science”, which incidentally have cleared some myths and
provided clarification relating to covid-19.
                                      4
DEMYSTIFYING AND ENHANCING AWARENESS ON COVID-19 VACCINATION
The third Chapter is focussed on Vaccine Manufacture, which will be of
special interest to industry, showing how the recent advances in science is
impacting this segment of the Industry particularly to meet the demands in
the pandemic period. Section 3.1 provides an introduction to the different
types of Covid-19 vaccines, and Section 3.2 points out the problem in the
manufacturing vaccine to provide the large number of doses in an
affordable manner. Section 3.3 provides insights to the Indian Vaccine
development. Section 3.4 explains the process to obtain an Emergency use
approval (EUA). Section 3.5 points out the praise showered on India in
raising to the occasion in combating the pandemic and the success of the
“vaccine diplomacy”.

The Chapter 4 deals with the Intellectual property rights relating to vaccine
manufacture and it impacts on the availability and accessibility issues and
eventually leading to affordability. Section 4.1 points out the ownership
issues relating to Patents rights, reorganising the large investments made
by the pharmaceutical industrial giants and risks associated with such
investment. However, the large investments provided by the public (the
Government) is often ignored or forgotten.

Section 4.2 deals with a proposal moved at the WTO by India and South
Africa to temporarily ban the IPR on inventions relating to Covid-19
medicines and vaccines. Section 4.3 after an analysis of the proposal
peeps into the future as to what may happen.

An Annexure (4.1) to this Chapter is a note by Dr K S Kardam titled “A note
on International development regarding Access to Medicine to
address the COVID-19”

Chapter 5 is a short two page note giving a brief thumb nail sketch of the
speakers taking part in this Seminar.

In the Seminar ahead, our experts will throw more information to clarify the
issues and they will answer questions lingering in the minds of the
audience.

I wish to thank several of our experts in providing me information relating to
this backgrounder. Special thanks are also due to the Staff of Waterfalls
Institute of Technology Transfer and the Madras Chamber of Commerce
and Industry for their efforts in planning the Seminar.

Chennai                                                Dr.K.V. Swaminathan
03- February, 2021                                     (Founder Chairman)

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DEMYSTIFYING AND ENHANCING AWARENESS ON COVID-19 VACCINATION
1.   INTRODUCTION: COVID-19 & VACCINES

                                1.1 About COVID-19

       Coronavirus disease (COVID-19) is an infectious disease that has spread
rapidly throughout the world. In March 2020, the World Health Organization (WHO)
declared the COVID-19 outbreak a pandemic. The pandemic has severely impacted
health systems, economic and social progress throughout the world. From a few
thousand confirmed COVID-19 cases in January 2020, cases continue to grow
globally; as of 26 January 2021, there have been 100,280,252 confirmed cases of
COVID-19, including 21,49,387 deaths. (www.worldmeters.info/coronovirus)

       COVID-19 is caused by a newly discovered coronavirus now named as the
Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2). Coronaviruses
(CoV) are zoonotic, and are transmitted between animals and humans.
Coronaviruses cause diseases such as the Middle East Respiratory Syndrome
(MERS) and Severe Acute Respiratory Syndrome (SARS) and more mild illnesses
including the common cold. The most common signs of infection with COVID-19
include fever, dry cough, shortness of breath or difficulty in breathing, and tiredness
or fatigue. Most people (~80%) experience mild disease and recover without
requiring hospitalization. However, globally, around 20% of people who contract
COVID-19 become more seriously ill and have trouble in breathing. In more severe
cases, the infection can cause pneumonia, severe acute respiratory syndrome,
kidney failure and even lead to death.

       In India, 1,06,77,710 confirmed COVID-19 cases and over 1,53,624 deaths
have been reported as of 26th January 2021. While strong measures were adopted
and some progress was made in containing the spread through better public health
interventions, diagnostics and treatments, scientists across the world have
accelerated the process to develop a safe and effective vaccine that will break the
chain of transmission.

     The Ministry of Health and Family Welfare in their Website has provided
very valuable information concerning the theme of the Seminar planned for 6
February 2021. In particular two recent documents contains information about
vaccines and vaccination; (i) Loaded on 28- December 2020 is titled “Covid-19
Vaccines – Operational Guidelines; (ii) Loaded on 30 December 2020 is titled
“Covid-19: Communication Strategy”. Section 1.2 of this Backgrounder is the
Executive Summary of the first publication covering operational guidelines.
Section 1.7 and Section 1.8 gives the contents of these to publications.

    Table 1.4 gives details about the impact of Covid-19 on the world and 10
countries who had felt the impact severely, of which India ranks 2.

     The Ministry have also provided valuable awareness material in the website.
Section 1.9 gives a list of such awareness Material.

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DEMYSTIFYING AND ENHANCING AWARENESS ON COVID-19 VACCINATION
1.2 Executive Summary (Covid 19 Vaccine – Operational Guidelines)
       Coronavirus disease (COVID-19), is an infectious disease caused by a newly
discovered coronavirus (SARS-CoV-2), which has spread rapidly throughout the
world. In March 2020, the World Health Organization (WHO) declared the COVID-19
outbreak a pandemic. The pandemic has severely ravaged health systems, and
economic and social progress globally.

       In India, 96,06,810 confirmed COVID-19 cases and over 1,39,700 deaths
have been reported as of 4 December 2020. COVID-19 most commonly manifests
as fever, dry cough, shortness of breath and tiredness. Most people (~80%)
experience mild disease and recover without hospitalization, while around 20% may
become more seriously ill.

       While countries, including India, have taken strong measures to contain the
spread of COVID-19 through better diagnostics and treatment, vaccines will provide
a lasting solution by enhancing immunity and containing the disease spread. In
response to the pandemic, the vaccine development process has been fast-tracked.
Globally, over 274 candidate vaccines are in different stages of development as of 4
December 2020. The majority of vaccines in clinical evaluation as of 4 December
2020 will require a two dose schedule to be administered two, three or four weeks
apart, and is need to be administered through the intramuscular route.

         Anticipating that the COVID-19 vaccine may soon be available, the
Government of India (GoI) is preparing for its it to be introduced in the country so
that it can be expeditiously rolled out when available.
        One of the milestones in this direction has been the constitution of a National
Expert Group on Vaccine Administration for COVID-19 (NEGVAC). The NEGVAC
will guide all aspects of the COVID-19 vaccine introduction in India.
        High-level coordination at the national, state and district levels must be
established for effective cooperation and collaboration among the key departments.
19 ministries at national level, 23 departments at state/ district and numerous
developmental partners are involved in planning the COVID-19 vaccine introduction;
their roles have been described in these operational guidelines.

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DEMYSTIFYING AND ENHANCING AWARENESS ON COVID-19 VACCINATION
The Successful introduction of the COVID-19 vaccine will largely depend
upon the quality of training conducted for enumerators for beneficiary listing, health
functionaries for vaccination activities, social mobilizers for all mobilization activities
and communication training for all workers involved in the process of vaccination. As
demonstrated during recent experiences with pneumococcal conjugate vaccine
(PCV) introduction and polio supplementary immunization activities (SIAs) conducted
during the COVID-19 pandemic, national and state training of trainers (ToT) may be
successfully conducted on virtual platforms and cascaded to district and sub-district
levels using a mix of virtual and face-to-face training. The COVID-19 vaccine will be
introduced once all training is completed in the district/block/planning unit.

        COVID-19 vaccine will be offered first to healthcare workers, frontline workers
and population above 50 years of age, followed by population below 50 years of age
with associated comorbidities based on the evolving pandemic situation, and finally
to the remaining population based on the disease epidemiology and vaccine
availability. The priority group of above 50 years may be further subdivided into
those above 60 years of age and those between 50 to 60 years of age for the
phasing of roll out based on pandemic situation and vaccine availability. The latest
electoral roll for the Lok Sabha and Legislative Assembly election will be used to
identify the population aged 50 years or more.

       The COVID-19 Vaccine Intelligence Network (Co-WIN) system, a digital
platform will be used to track the enlisted beneficiaries for vaccination and COVID-19
vaccines on a real-time basis. At the vaccination site, only pre-registered
beneficiaries will be vaccinated per the prioritization, and there will be no provision
for on-the-spot registrations. Based on the numbers of registered beneficiaries and
the priority accorded, vaccination sessions will be planned with the following
considerations:

     •     One session for 100 beneficiaries;

     •     While most of the healthcare and frontline workers would be vaccinated at
           fixed session sites that may be government health facilities above PHCs
           or private health facilities identified by district administration, vaccination
           of other high-risk populations may require outreach session sites, and
           mobile sites/teams; and

          State/UT can identify specific days for vaccination;

          The entire vaccination process will be broadly similar to the election
           process.

          The vaccination team will consist of five members as follows:

              Vaccinator Officer–Doctors (MBBS/BDS), staff nurse, pharmacist,
               auxiliary nurse midwife (ANM), lady health visitor (LHV); anyone
               authorized to administer an injection may be considered as a potential
               vaccinator;

              Vaccination Officer 1: At least one person (Police, home guard, civil
               defense, national cadet corps (NCC), national service scheme (NSS),
               endr yuva kendra sangathan (NYKS) who will check the registration

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status of a beneficiary at the entry point and ensure the regulated
               entry to the vaccination session;
              Vaccination Officer 2: Is the verifier who will authenticate/verify the
               identification documents; and

              Vaccination Officer 3 & 4 are the two-support staff who will be
               responsible for crowd management and ensure 30 minutes of waiting
               time by beneficiary post-vaccination. Support staff will provide
               information, education and communication (IEC) messages and
               support to vaccinator as well as the vaccination team.

      Essential health services including existing routine immunization
sessions should not be impacted or interrupted.

       Vaccine safety need to be ensured during storage, transportation and delivery
of vaccine with sufficient police arrangements so that there are no leakages in the
delivery system.

Safety precautions, including infection prevention and control practices, safe
injection practices and waste disposal, will be followed during vaccination sessions.
As large population groups will be vaccinated over a short period with a new vaccine,
monitoring the safety of these vaccines will be critical. The existing adverse events
following immunization (AEFI) surveillance system will be utilized to monitor adverse
events and understand the safety profile of the vaccines. To ensure confidence in
the vaccine and the immunization programme during COVID-19 vaccine introduction,
states/UTs must rapidly detect and promptly respond to all AEFIs. The reporting of
AEFI through surveillance and action for events following vaccination (SAFEVAC)
has been integrated with Co-WIN software and every AEFI to be reported at the
district level and facilitate the referral mechanisms in case any AEFI needs to be put
in place.

       Requirements for management of the cold chain for COVID-19 vaccination
will vary depending on the type of COVID-19 vaccine, as different vaccines have
different storage temperature ranges. Cold chain assessments and gap analysis
have been completed, and there are plans in place for supplying additional cold
chain equipment where required. States/UTs must ensure adequate cold chain
storage capacity for the COVID-19 vaccine campaign. Cold chain handlers, and
vaccinators at all levels will be trained on procedures for vaccine and logistics
management as well as infection prevention and control precautions.

       Every effort is being made to ensure that everyone in the country has access
to timely, accurate and transparent information about the COVID-19 vaccine(s). This
requires a meticulous, structured, informative and clear communication strategy to
create adequate awareness, ensure accurate knowledge, generate and manage
adequate demand, facilitate eagerness and address vaccine hesitancy and
confidence, and mitigate for unintended situations (e.g. AEFI clusters, delay in
vaccine roll-out for certain population categories) to ensure the smooth introduction
and roll-out of COVID-19 vaccine(s). Key communication and demand generation
strategies include advocacy at national, state, district and sub-district levels; capacity
building, media engagement, social mobilization and partnership, community
engagement and empowerment is included at family and community levels. Key

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areas to be addressed in the communication plan includes information on COVID-19
vaccine, vaccine eagerness, vaccine hesitancy and COVID-19 appropriate behavior.

      A vaccination programme of this scale will require close monitoring and
supportive supervision at all levels to identify bottlenecks and challenges faced at the
ground level. Each step-in the vaccine introduction will be monitored. This includes:

     •     Tracking the progress of introduction activities – beneficiary
           registration training, vaccine logistics availability, and task forces. This will
           be supported by partners through tracking mechanisms;

     •     Readiness assessment before vaccine introduction – field visits and
           desk review of data at national and state levels;

     •     Concurrent monitoring of vaccination activities – daily evening
           meetings, standardized monitoring tools, mobile-based apps, real-time
           data from the planning unit to the national level; and

     •     Knowledge management – the best practices and innovations at all
           levels would be shared to improve the implementation in the next phase of
           scale-up.

                    1.3 Introduction to Vaccines for Covid-19

       The overarching goal is for COVID-19 vaccines to contribute significantly to
the equitable protection and promotion of human well-being among people globally.
Global equitable access to a vaccine, particularly protecting health care workers and
those most-at-risk is the only way to mitigate the public health and economic impact
of the pandemic and is the current priority. The vaccine is to be used in conjunction
with other control measures. In the longer term, the vaccine is intended to be used
for active immunization of people at-risk to prevent COVID-19. While countries,
including India, have taken strong measures to contain the spread of COVID-19
through better diagnostics and treatment, vaccines will provide a solution by
enhancing immunity and containing the disease spread.

       Scientists throughout the world have accelerated the process to develop safe
and effective COVID-19 vaccines. Vaccines aim to expose the body to an antigen
and provoke an immune response that can block or kill the virus if a person becomes
subsequently infected, without causing the disease. As part of the global efforts for
rapid development of a safe and effective COVID-19 vaccine, various scientific
techniques like the use of different viruses or viral parts10 are being developed. The
COVID-19 vaccines under development use one of the following techniques:

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11
Virus vaccines

       These vaccines use the virus itself in a weakened or inactivated form.
Vaccines against measles and polio (oral) are made in this manner. There are two
types of virus vaccines under development against coronavirus, weakened virus and
inactivated virus vaccines.

Viral-vector vaccines

       In the development of these vaccines, a virus (such as adenovirus or
measles), is genetically engineered to produce coronavirus proteins in the body, but
the virus is weakened and cannot cause disease. The two types of viral-vector
vaccines under development are replicating viral vector (can replicate within cells)
and non-replicating viral vector (cannot replicate within cells).

Nucleic-acid vaccines

     In these vaccines, nucleic acid (DNA or RNA) is inserted into human cells.
These human cells then produce copies of the virus protein which produces an
immune response. The two types of nucleic-acid vaccines under development are
DNA vaccine and RNA vaccine.

Protein-based vaccines

        These vaccines use virus protein fragments or protein shells which are
injected directly into the body. The two types of protein-based vaccines being
developed against the coronavirus are the protein subunit vaccines and virus-like
particle vaccines.

                           1.4 Development of COVID-19 Vaccine

       The Development of a vaccine is a time-consuming process that includes the
following phases:

Table.1.1. Phases of vaccine development

Phases of vaccine development/trial          Purpose

Pre-clinical                                 Vaccine development in laboratory
Phase 1 Clinical trial (8-10 participants)   For testing vaccine safety Phase

2 Clinical trial (50-100 participants)       For testing vaccine immunogenicity i.e.
                                             production of antibodies against virus

Phase 3 Clinical trial (30,000-50,000        For testing actual protection offered by the
participants)                                vaccine

       The vaccine development process has been fast-tracked and multiple
platforms are under development. Among those with the greatest potential for speed
are DNA and RNA-based platforms, followed by those for developing recombinant-
subunit vaccines. RNA and DNA vaccines can be made quickly because they require
no culture or fermentation, instead use synthetic processes.
                                             12
Per the tracker developed by the Vaccine Centre at the London School of
Hygiene and Tropical Medicine, a total of 274 candidate vaccines are in different
stages of development as of 4 December 2020, preclinical (215), phase I (25), phase
I/II (17), phase II (5), phase II/III (1), phase III (10) and licensed (1).

 Table 1.2: Progress on COVID-19 Vaccine Development (Source: Vaccine
            Centre of London School of hygiene and Tropical Medicine,
            accessed 4 December 2020).

Types of COVID-19 vaccines               Pre-       Phase   Phase   Phase   Phase    Phase   Licensed
                                         clinical   I       I/II    II      II/III   III
                 Live-attenuated         3          1
Virus Vaccine
                 Inactivated             11         1       2       1                4
                 Replicating viral vector 18        1       2       1
Viral vector
Vaccine          Non-replicating viral   26         6                                4
                 vector
                 DNA vaccine             16         2       5
Nucleic acid
vaccines         RNA vaccine             29         2       2       1                1       1
                 Protein subunit         64         9       5       2                1
Protein based
vaccine          Virus like particle     17                 1               1
Unknown          -                       31         3
      Total                              215        25      17      5       1        10      1

      With multiple COVID-19 vaccines under development, key characteristics
regarding dosage, storage requirements, efficacy, route of administration, etc.,
currently remain unknown. However, a recent landscape document by WHO details
51 vaccines in clinical evaluation. The landscape document, as of 2 December 2020,
indicates that most vaccines will require a two-dose schedule to be administered
two, three or four weeks apart, and will be administered through-the intramuscular IM
route.

Vaccine specifications

      In June 2020, the United Nations Children’s Fund (UNICEF) gathered
information on vaccine specifications from 26 vaccine developers and manufacturers
(10 manufacturing in China, 6 in India, 3 in the United States of America, 2 each in
Belgium, Russia and Japan, 1 each in France, South Korea, Switzerland and the
United Kingdom).

     From the results, which were made public on 31 August 2020, characteristics of
the COVID-19 vaccines under development from these 26 developers are:

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Of the four vaccines with preliminary efficacy data available as of 4 December
2020, all are intramuscular (IM) injections with 2-dose courses.

     •   The University of Oxford/AstraZeneca vaccine can be stored, transported
         and handled at +2o to 8oC.

     •   BioNTech/Fosun Pharma/Pfizer vaccine has a recommended temperature
         condition of -80oC and can be stored for five days at +2o to 8oC.

     •   The Moderna/NIAID vaccine remains stable at -20oC for up to six months
         and remains stable at +2o to 8oC for 30 days and the Gamaleya institute,
         Sputnik-V vaccine can be stored at +2o to 8 oC.

                  1.5 COVID-19 vaccine development in India

      There are 9 COVID-19 vaccine candidates in different phases of development
in India, of these 3 are in pre-clinical phase whereas 6 are under clinical trials.

     Table.1.3. Indian landscape of COVID-19 vaccines under development

                         1.6 Communication Strategy

      The communication strategy that supports the COVID-19 vaccines rollout in
India seeks to disseminate timely, accurate and transparent information about the
vaccine(s) to alleviate apprehensions about the vaccine, ensure its acceptance and
encourage uptake.

     The strategy will also serve to guide national, state and district level
communication activities, so that the information on the COVID-19 vaccines and
vaccination process reaches all people, across all states in the country.

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To support and encourage appropriate uptake of the vaccines by:

                                              Managing     and    mitigating any
                                              potential disappointment expressed
                                              by unmet demand for the vaccine or
                                              ‘eagerness’ amongst people.

                                              Addressing vaccine ‘hesitancy’ that
                                              could       arise      because      of
                                              apprehensions       around    vaccine
                                              safety, efficacy; and any other myths
                                              and misconceptions.

                                              Provide information on potential risks
                                              and mitigate unintended crisis (e.g.
                                              AEFI clusters, delay in vaccine
                                              rollout   for   certain   population
                                              categories) during the introduction
                                              and rollout.

           The strategy also seeks to build trust and enable greater confidence in
           the COVID-19 vaccine amongst all people by employing transparency in
           communication, while also managing any mis/disinformation and rumours
           around it.

Table 1.4        TOP 10 COUNTIRES IMPACTED BY COVID-19
                           (Numbers as of 01, February 2021)

No.    Country     Total Cases Total deaths    Recovered     Active     Per million
                                                             Cases      Population
                                                                        Cases         Deaths
1.    USA         26,767,229    452,279       16,403,843   9,911,107    80,590        1,362
2.    India       10,758,619    154,428       10,434,983   169,208      7,752         111
3.    Brazil      9,204,731     224,534       8,027,042    953,155      43,125        1,052
4.    Russia      3,868,087     73,619        3,318,173    476,295      26,499        504

5.    UK          3,817,176     106,158       1,673,936    2,037,082    56,057        1,559
6.    France      3,197,114     76,057        224,406      2,896,651    48,917        1,164
7.    Spain       2,830,478     58,319        N/A          N/A          60,525        1,247

8.    Italy       2,553,032     88,516        2,010,548    453,968      42,262        1,465
9.    Turkey      2,477,463     25,993        2,362,415    89,055       29,191        306
10.   Germany     2,225,659     57,777        1,935,600    232,282      26,514        688

 Total World      103,569,867 2,238,898       75,193,856   26,132,615   13,287.0      287.2

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(Source: https://www.worldometers.info/coronavirus/)

1.7 Contents of COVID-19 Vaccine(s) – Operations Guidelines

                        CONTENTS

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17
1.8 Contents COVID-19 Vaccine(s) – Communication Strategy

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-------------------

       19
Table 1.9      Awareness Material
                    (Ministry of Health & Family Welfare - GOI)

04.01.2021   Audio visual on Dr Guleria, Director, AIIMS sharing FAQs on COVID 19 vaccine rollout
             Episode 1/3        Episode 2/3       Episode 3/3
17.12.2020   FAQs on COVID 19 Vaccine for Healthcare providers and Frontline workers –
             English - Hindi
17.12.2020   FAQs on COVID 19 Vaccine for General Public - English - Hindi
12.10.2020   Encouraging youth to advocate against stigma and discrimination during COVID-19 -
             English
12.10.2020   Encouraging youth to advocate against stigma and discrimination during COVID-19 -
             Hindi
15.07.2020   Patients, their families and health care providers stand together to counter stigma
             and discrimination associated with COVID19
15.07.2020   A/V on 15 COVID Appropriate Behaviours - English
15.07.2020   A/V on 15 COVID Appropriate Behaviours - Hindi
03.07.2020   Hindi Video on supporting COVID recovered patients
03.07.2020   Hindi Video on COVID Appropriate Behaviours during COVID-19
03.07.2020   Hindi Video on extending support towards persons returning home during COVID-19
03.07.2020   Hindi Video on showing respect to healthcare workers
03.07.2020   Hindi Video on showing respect to sanitation workers
03.07.2020   Video on health care workers’ helping us fight the battle against COVID-19
03.07.2020   Heartfelt thanks to Corona Warriors
03.07.2020   Video on showing support for persons in quarantine / isolation
02.07.2020   A/V on thanking Corona Warriors
02.07.2020   Video on Home Isolation for very mild/ pre-symptomatic COVID-19 patients
22.06.2020   A/V on COVID Appropriate Behaviours
             (1/5), (2/5), (3/5), (4/5) & (5/5)
18.06.2020   An Illustrative Guide on COVID Appropriate Behaviours -English, Hindi
18.06.2020   A/V on "Quit using spit as it can increase the risk of spread of COVID-19" - (English)
18.06.2020   A/V on "Quit using spit as it can increase the risk of spread of COVID-19" - (Hindi)
16.06.2020   Guide to address stigma associated with COVID-19 - English
16.06.2020   Guide to address stigma associated with COVID-19 - Hindi
12.06.2020   Guidelines for Hotels on preventive measures to contain spread of COVID-19
12.06.2020   Guidelines for Offices on preventive measures to contain spread of COVID-19
12.06.2020   Guidelines for Religious Places on preventive measures to contain spread of COVID-19
12.06.2020   Guidelines for Restaurants on preventive measures to contain spread of COVID-19
12.06.2020   Guidelines for Shopping Malls on preventive measures to contain spread of COVID-19
08.06.2020   A/V on the need to address Stigma and Discrimination associated with COVID-19
08.06.2020   A/V on COVID Appropriate Behaviours - (English)
08.06.2020   A/V on COVID Appropriate Behaviours - (Hindi)
28.05.2020   RAP video to advocate no spitting

                                                  20
27.05.2020   Video on Caring and Sharing, the new normal
16.05.2020   NO Spitting in public places (Video)
15.05.2020   Guidelines for Home Isolation of very mild / pre-symptomatic COVID-19 cases
(Video)
05.05.2020   Thematic Bank of COVID19 Creatives
             1. What is Corona Virus and how does it transmits
             2. Handwashing
             3. COVID Appropriate Behaviours Pack 1.0
             4. COVID Appropriate Behaviours Pack 2.0
             5. Home Quarantine
             6. Myth Busters
             7. All India National Helpline 1075
             8. No Spitting
             9. Stigma and Discrimination
             10. Thank you COVID Warriors
29.04.2020   Awareness Material for front line workers of COVID-19 – Hindi
29.04.2020   Awareness Material for front line workers of COVID-19 – Punjabi
29.04.2020   Awareness Material for front line workers of COVID-19 - Bengali
29.04.2020   Awareness Material for front line workers of COVID-19 - Marathi
29.04.2020   Awareness Material for front line workers of COVID-19 - Telgu (Telangana)
29.04.2020   Awareness Material for front line workers of COVID-19 - Telgu (Andra Pradesh)
29.04.2020   Awareness Material for front line workers of COVID-19 - Malayalam
29.04.2020   Awareness Material for front line workers of COVID-19 - Kannada
29.04.2020   Awareness Material for front line workers of COVID-19 - Tripura
29.04.2020   Awareness Material for front line workers of COVID-19 - Tamil
29.04.2020   Awareness Material for front line workers of COVID-19 - Gujrati
29.04.2020   Awareness Material for front line workers of COVID-19 - Odia
20.04.2020   Audio Visual on Addressing Stigma Related to COVID-19
18.04.2020   Information for general public on use of necessary medicines for COVID19 (Poster)
18.04.2020   Information for general public on use of necessary medicines for COVID19 - Audio Visual
11.04.2020   Video on use of reusable face cover (English) - Part 1
11.04.2020   Video on use of reusable face cover (English) - Part 2
08.04.2020   Video on Salutations to Coronavirus Warriors - I
08.04.2020   Video on Salutations to Coronavirus Warriors - II
08.04.2020   Know how to use your own Homemade Reusable Face Cover
07.04.2020   Know how to use your own Homemade Reusable Face Cover
04.04.2020   Video on Lockdown - Staying Active at Home
02.04.2020   Aarogya Setu App for staying informed and alert against COVID19. Government
             initiative to develop a digital Bridge to fight against COVID_19. Download Today!
             Play Store APPIOS APP
31.03.2020   Handling Public Grievances pertaining to COVID-19 in M/o Health & Family Welfare
29.03.2020   Video from experts from AIIMS, New Delhi sharing basic steps on hand washing to
             fight against COVID-19 – English

                                               21
29.03.2020          Video from experts from AIIMS, New Delhi sharing basic steps on hand washing to
                    fight against COVID-19 - Hindi
29.03.2020          Video from experts from AIIMS Advising Stay Home Stay Safe – English
29.03.2020           Video from experts from AIIMS Advising “Stay Home Stay Safe” – Hindi
29.03.2020           Poster on Social distancing in a market place during COVID-19 English
29.03.2020           Poster on Social distancing in a market place during COVID-19 Hindi
28.03.2020           COVID-19 Health Service Providers Toolkit: General Health Facilities
                    1. A letter from HFM to the Health Administrators
                    2. Community leaflet
                    3. What is Novel Coronavirus?
                    4. Is your Healthcare facility ready to manage patients with COVID-19?
                    5. How to use the handrub?
                    6. When and How to wear mask?
                    7. Guidelines on the use of materials
28.03.2020          COVID-19 Health Service Providers Toolkit: Designated Hospitals
                    1. A letter from HFM to the Health Administrators
                    2. Community leaflet
                    3. What is Novel Coronavirus?
                    4. Is your Healthcare facility ready to manage patients with COVID-19?
                    5. How to protect all health workers at designated hospital?
                    6. What are my moments of hand hygiene?
                    7. How to manage Suspected or confirmed COVID-19 patients at designated hospital?
                    8. Guidelines on the use of materials
28.03.2020           COVID-19 Frontline Worker Toolkit in Englsih
                     1. Facilitator Guide
                     2. PPT with seven sessions including for Urban
                     3. A digital pocket book for front line workers
                     4. Training Protocols and guidelines
                     5. Training Plan template
28.03.2020           When to get tested for COVID-19 English
28.03.2020           When to get tested for COVID-19 Hindi
25.03.2020           Role of Frontline Workers in Prevention and Management of CORONA VIRUS- English
25.03.2020           Role of Frontline Workers in Prevention and Management of CORONA VIRUS - Hindi
23.03.2020           Posters for Safety measures against COVID-19 - English
23.03.2020           Posters for Safety measures against COVID-19 - Hindi
22.03.2020           KIDS, VAAYU & CORONA : Comic book for children to provide correct information
                     about COVID-19 - Part 2
19.03.2020           Posters for Indians traveling from abroad – English
19.03.2020           Posters for Indians traveling from abroad – Hindi
09.03.2020           KIDS, VAAYU & CORONA : Comic book for children to provide correct information
                     about COVID-19
06.03.2020           Do's and Don't Poster in English
06.03.2020           Do's and Don't Poster in Hindi
06.03.2020           Watch all COVID-19 management videos here
06.03.2020           TV and Radio Spots (English & Hindi) for COVID-19
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                                                                22
2.   DEMYSTIFYING THE CONCEPTS ABOUT COVID-19 AND VACCINATION

                           2.1 India’s Vaccination Drive
       India started the world's largest Covid-19 vaccination drive, inoculating 3 crore
people on priority. On 16 January, 2021- the first day of the drive - over 3 lakh
healthcare workers were to be administered the vaccine against Covid-19. (Actual
about 2.0 lakh were vaccinated).

      A total of 3,006 session sites across all states and union territories will be
virtually connected during the launch at 10.30 am by Prime Minister Narendra
Modi and around 100 beneficiaries will be vaccinated at each session site. As India
begins its journey into what the Health Ministry has called 'the beginning of the end”.

 (i) What are the Vaccines approved by India, and their prices?
     The vaccines Covishield, developed by the Serum Institute of India, and
     Covaxin from Bharat Biotech have been approved by the Indian government.
     These have already been delivered to all states and union territories. A dose of
     Covishield and CoVaxin may cost in the range of ₹200 to 295 in India. Serum
     Institute chief has also said that the jab may cost Rs.1,000 in the private
     market.
 (ii) Are there any side-effects to the Vaccines?
     The Health Ministry has cautioned about mild side effects following vaccination
     for both the vaccines. In case of Covishied, some mild adverse effects may
     occur like injection site tenderness, injection site pain, headache, fatigue,
     myalgia, malaise, pyrexia, chills and arthralgia and nausea. Some mild adverse
     effects in case of Covaxin include injection site pain, headache, fatigue, fever,
     body ache, abdominal pain, nausea and vomiting, dizziness-giddiness, tremor,
     sweating, cold, cough and injection site swelling. Paracetamol may be used to
     provide symptomatic relief from post vaccination adverse reactions.
(iii) Who is in the Priority Group ?
     Healthcare workers will receive the jab first because they are at high risk of
     contracting the infection. Next, come the frontline workers, the vaccination of
     whom will help in reducing the societal and economic impact by reducing
     COVID-19 mortalities. And lastly, persons over 50 years of age and persons
     under 50 years with comorbid conditions will be inoculated, due to there being
     high mortality in the category.
 (iv) What about the Co-win Application ?
     Co-WIN is an online platform designed by the Centre for monitoring COVID-19
     vaccine delivery. The Health Ministry has said it will form the foundation for the
     anti-coronavirus inoculation drive. The App is also designed to enable citizens
     to self-register for the vaccination process. However, that will take some time
     as the vaccination drive will start for frontline workers and other vulnerable
     citizens. The government had explained that the Co-WIN app comes with five
     modules, namely - Administrator module, Registration module, Vaccination
     module, Beneficiary Acknowledgement module, and Report module - to ensure
     smooth tracking and registration for COVID-19 vaccine in the country. The
     mobile app is also an upgraded version of the eVIN (Electronic Vaccine
     Intelligence Network) and it will be available to download for free via the Google
                                           23
Play Store and Apple App Store. The App may also launch on Jio phones that
     run on KaiOS.
                   2.2 US COVID-19 Vaccination Program
        (Information provided by the Centers for Disease Control and Prevention)

     Now that there are authorized and recommended vaccines to prevent COVID-
19 in the United States, here are 8 things one need to know about the new COVID-
19 Vaccination Program and COVID-19 vaccines. Vaccination started in US in
December 2020.

 (i) The safety of COVID-19 vaccines is a top priority.

     The U.S. vaccine safety system ensures that all vaccines are as safe as
     possible.

     CDC has developed a new tool, v-safe, as an additional layer of safety
     monitoring to increase our ability to rapidly detect any safety issues with
     COVID-19 vaccines. V-safe is a new smartphone-based, after-vaccination
     health checker for people who receive COVID-19 vaccines.

 (ii) COVID-19 vaccination will help protect one from getting COVID-19. Two
      doses are needed.

     Depending on the specific vaccine, a second shot 3-4 weeks after your first
     shot is needed to get the most protection the vaccine has to offer against this
     serious disease.

(iii) CDC is making recommendations for who should be offered COVID-19
      vaccine first when supplies are limited.

     To help guide decisions about how to distribute limited initial supplies of
     COVID-19 vaccine, CDC and the Advisory Committee on Immunization
     Practices have published recommendations for which groups should be
     vaccinated first.

(iv) There is currently a limited supply of COVID-19 vaccine in the United
     States, but supply will increase in the weeks and months to come.

     The goal is for everyone to be able to easily get vaccinated against COVID-19
     as soon as large enough quantities are available. Once vaccine is widely
     available, the plan is to have several thousand vaccination providers offering
     COVID-19 vaccines in doctors’ offices, retail pharmacies, hospitals, and
     federally qualified health centers.

 (v) After COVID-19 vaccination, one may have some side effects. This is a
     normal sign that the body is building protection.

     The side effects from COVID-19 vaccination may feel like flu and might even
     affect ability to do daily activities, but they should go away in a few days.

(vi) Can a COVID-19 vaccine make one sick with COVID-19?

                                          24
No. None of the COVID-19 vaccines contain the live virus that causes COVID-
    19 so a COVID-19 vaccine cannot make one sick with COVID-19.

(vii) The first COVID-19 vaccines are being used under Emergency Use
      Authorizations (EUA) from the U.S. Food and Drug Administration (FDA).
      Many other vaccines are still being developed and tested.
    If more COVID-19 vaccines are authorized or approved by FDA, the Advisory
    Committee on Immunization Practices (ACIP) will quickly hold public meetings
    to review all available data about each vaccine and make recommendations for
    their use in the United States.
    All ACIP-recommended vaccines will be included in the U.S. COVID-19
    Vaccination Program. CDC continues to work at all levels with partners,
    including healthcare associations, on a flexible COVID-19 vaccination program
    that can accommodate different vaccines and adapt to different scenarios.
    State, tribal, local, and territorial health departments have developed
    distribution plans to make sure all recommended vaccines are available to their
    communities.

(viii) COVID-19 vaccines are one of many important tools to help stop this
       pandemic.
    It’s important for everyone to continue using all the tools available to help stop
    this pandemic as we learn more about how COVID-19 vaccines work in real-
    world conditions. Cover your mouth and nose with a mask when around others,
    stay at least 6 feet away from others, avoid crowds, and wash your hands
    often.

               2.3 FAQ and Answers on Vaccines for Covid-19

 (i) How do vaccines work?

    Vaccines stimulate the human body’s own protective immune responses so
    that, if a person is infected with a pathogen, the immune system can quickly
    prevent the infection from spreading within the body and causing disease. In
    this way, vaccines mimic natural infection but without actually causing the
    person to become sick.

    For SARS-CoV-2, antibodies that bind to and block the spike protein on the
    virus’s surface are thought to be most important for protection from disease
    because the spike protein is what attaches to human cells, allowing the virus to
    enter the cells. Blocking this entrance prevents infection.

    Not all people who are infected with SARS-CoV-2 develop disease (Covid-19 is
    the disease caused by the virus SARS-CoV-2). These people have
    asymptomatic infection but can still transmit the virus to others. Most vaccines
    do not completely prevent infection but do prevent the infection from spreading
    within the body and from causing disease. Many vaccines can also prevent
    transmission, potentially leading to herd protection whereby unvaccinated
    people are protected from infection by the vaccinated people around them
    because they have less chance of exposure to the virus.

                                         25
(ii) What are the different types of vaccines in use or in development and why
     are there so many?
     Several different types of vaccines against SARS-CoV-2, the virus that causes
     the disease Covid-19, are in use or in development. Some are based on
     traditional methods for producing vaccines and others on newer methods. One
     of the more traditional ways of making a viral vaccine is to inactivate (kill) the
     virus with chemicals, such as is done with the flu vaccine, inactivated polio or
     hepatitis A vaccines, so that the virus can no longer multiply. Several
     inactivated SARS-CoV-2 vaccines are in development. Other vaccines are
     based on just a part of the bacteria or virus, typically one or more proteins, such
     as the vaccines for whooping cough (pertussis) and hepatitis B virus. For
     SARS-CoV-2 vaccines that focus on a part of the virus.

     Newer vaccine types include what are called viral vector vaccines, in which the
     SARS-CoV-2 gene for the spike protein is inserted into another harmless virus
     to deliver the gene to human cells where the spike protein is produced. The
     spike protein then stimulates immune responses. The most common viral
     vectors are adenoviruses, which typically cause common cold-like symptoms in
     people but are further weakened for vaccines so they cannot cause any
     disease at all. Several adenovirus vector vaccine for SARS-CoV-2 are in
     advanced clinical testing (phase 3 clinical trials), such as the vaccine produced
     by Johnson & Johnson that may be protective following a single dose.

     Finally, instead of using a viral vector, the gene for the spike protein can be
     used directly as a vaccine in the form of DNA or messenger RNA (mRNA).
     These are the most novel SARS-CoV-2 vaccines. Several mRNA vaccines are
     in advanced clinical testing.

     Many manufactures around the world are working on this global problem. This
     means that there will likely be multiple different types of SARS-CoV-2 vaccines
     and they may work differently in different people. Hopefully, some will work well
     in older adults and in people with underlying conditions that impair their immune
     system, as these groups are more likely to get sick and die from Covid-19.

(iii) How do we know if a vaccine is safe and effective?
      The safety and efficacy of a vaccine are determined through clinical trials.
      Clinical trials are studies that are typically conducted in three phases to assess
      the safety and efficacy of vaccines in increasingly larger numbers of volunteers.

     Phase 1 clinical trials assess the safety and dosage of a vaccine in a small
     number of people, typically a dozen to several dozen healthy volunteers.
     Whether a vaccine stimulates immune responses is often assessed in a phase
     1 study but this is better assessed in phase 2 studies, which typically involve
     hundreds of people including some special groups such as children, people
     with pre-existing conditions such as heart disease, and older adults. Vaccine
     safety is also assessed in phase 2 studies, in which adverse events not
     detected in phase 1 trials may be identified because a larger and more diverse
     group of people receive the vaccine. However, only in much larger phase 3
     clinical trials can it be demonstrated whether a vaccine is actually protective
     against disease and safety is more fully assessed.

                                           26
Phase 3 clinical trials often include thousands of volunteers, and for Covid-19
    vaccines involve tens of thousands (30,000 to 45,000 people in some of the
    phase 3 trials). In phase 3 trials, participants are randomized to receive either
    the viral vaccine or a placebo vaccine (sometimes a vaccine against another
    disease or a harmless substance like saline). Randomization is a process to
    determine who receives the vaccine and who receives the placebo without any
    bias, like flipping a coin. To further prevent any bias in interpreting the study
    data, participants and most of the investigators will not know if an individual
    received the vaccine or placebo. The participants are then followed to see how
    many in each group get the disease. If the vaccine is efficacious, many fewer
    people who received the viral vaccine will get the disease compared to those
    who received the placebo vaccine. It takes time for cases of disease to
    accumulate so that we can be confident there is a true difference between the
    two groups, and this is why these phase 3 trials often take a long time.
    Assessing safety is also a major goal of phase 3 trials, both short-term (e.g.,
    fever, tenderness, muscle aches) and long-term safety (e.g., autoimmune
    conditions or enhanced disease following infection).

    After a vaccine is approved and in more widespread use, it is critically important
    to continue to monitor for both safety and effectiveness. Some very rare side
    effects may only be detectable when large numbers of people have been
    vaccinated. Safety concerns that are discovered at this late stage could lead a
    licensed vaccine to be withdrawn from use, although this is very rare.

(iv) When will a vaccine be available ?

    Vaccines for SARS-CoV-2 will be available when they are demonstrated to be
    safe and efficacious in large phase 3 clinical trials, have been approved by
    regulatory authorities (the Food and Drug Administration in United States), and
    have been manufactured and distributed to places where people can be
    vaccinated.

    To demonstrate efficacy, sufficient differences in disease must be observed
    between those who received the viral vaccine and those who received the
    placebo or comparison vaccine in a phase 3 clinical trial. This depends on the
    likelihood of infection in places where the studies are conducted but can take
    from several months to years. Once sufficient data are available to be confident
    that the vaccine is efficacious, and no evidence of serious adverse events is
    identified, a rigorous and transparent approval process should take place.

    Manufacturing capacity has already been developed for some vaccines and
    vaccine distribution systems are being put in place. However, because of
    limited quantities of vaccine, some groups of people will be offered the vaccine
    first, likely health care workers, other essential personnel, and those most
    vulnerable to severe disease and death.

(v) How is the process for approving a vaccine moving so quickly ?

    Traditionally, it has taken many years to develop a vaccine, confirm its safety
    and efficacy, and manufacture the vaccine in sufficient quantities for public use.
    This timeline has been substantially shortened for SARS-CoV-2 vaccines in
    development. There are several ways this has been made possible. First, some
                                         27
clinical trials have combined phases 1 and 2 to assess safety and immune
     responses. Second, because of the high number of new cases of Covid-19 in
     many places, differences in disease risk between those who received the viral
     vaccine and those who received the placebo or comparison vaccine can be
     measured more quickly than in the absence of a pandemic. Third, the United
     States government and others heavily invested in building the manufacturing
     capacity to produce large numbers of vaccine doses before the findings of the
     phase 3 trials were available. Typically, vaccine manufacturers wait until the
     phase 3 trial is completed and shows safety and efficacy before making such a
     large investment in manufacturing capacity. None of these factors that
     contribute to the accelerated development of a vaccine for SARS-CoV-2 imply
     that safety, scientific or ethical integrity are compromised, or that short-cuts
     were made.

 (vi) What is an emergency use authorization?

     Drugs and vaccines have to be approved by the Food and Drug Administration
     (FDA) to ensure that only safe and effective products are available to the
     American public. In situations when there is good scientific reason to believe
     that a drug is safe and is likely to treat or prevent disease, the FDA may
     authorize its use even if definitive proof of the efficacy of the drug is not known,
     especially for diseases that cause high mortality.

     Emergency use authorizations were granted by the FDA Commissioner for
     chloroquine and hydroxychloroquine (later revoked) and for the use of
     convalescent plasma to treat hospitalized patients with Covid-19. Many are
     concerned that Emergency Use Authorization for a vaccine could be issued
     prematurely, before sufficient safety and efficacy data have been generated
     through phase 3 clinical trails.

     It is important to emphasize that the bar for ensuring safety of a vaccine is
     higher than for a therapeutic to treat an ill person. Vaccines are given to
     potentially millions of healthy people, unlike drugs for sick people, and loss of
     trust in a vaccine for SARS-CoV-2 could spill over into loss of trust in other
     vaccines, seriously jeopardizing public health.

(vii) How long will it take for the general public to be vaccinated after a
      vaccine is approved?
     It is not clear at this point in time when vaccines will be available, but a
     reasonable guess may be at least six months to one year after approval. The
     timeline depends on how rapidly vaccine doses can be produced and
     distributed. Importantly, the public will need to trust a vaccine and be willing to
     be vaccinated to have a public health impact. Building trust in a vaccine for
     SARS-CoV-2, particularly in communities with long-standing mistrust of the
     government and scientific experiments, is critical.

(viii) Should children get the vaccine?
     Children will not be a priority group for a vaccine early in vaccine deployment
     but will likely be eligible as vaccine availability improves. The major vaccine
     clinical trails are currently focussed on enrolling adults, and as they expand, the
     inclusion of children in vaccine clinical trials will produce data on safety and
                                           28
efficacy that can be applied to children. While children are less likely to
      develop severe disease and die from Covid-19, there are several reasons for
      ensuring that eventually there is a vaccine that is safe and effective for children.
      Although rare, some children may develop severe disease or die from Covid-
      19. Children have also developed a severe inflammatory syndrome, called
      multisystem inflammatory syndrome in children. Children may be important
      transmitters of SARS-CoV-2 and vaccinating them with a vaccine that reduces
      transmission could be important in controlling the pandemic. Finally, having a
      safe vaccine for children will build confidence towards opening up schools and
      learning centers for in-person educational processes.

(ix) How long will protection last following vaccination?
      We do not yet know how long protection lasts following vaccination but it will be
      critically important to measure long-term protection (at least two years) in the
      phase 3 trials and in other groups prioritized for early vaccination. We are still
      learning about the duration of protection following infection with SARS-CoV-2
      and it is too early to tell how long protection will last. There have already been
      cases where individuals have been shown to be infected twice but most often
      the second illness was mild or without any symptoms. This is what we would
      expect with an immune response that protects against disease but not infection.

      There are ways to potentially make protection following vaccination more
      durable than following natural infection, such as with an adjuvant, an ingredient
      used in some vaccines that helps create a stronger immune response, or with
      booster doses of vaccine. These strategies to enhance vaccines may be
      particularly important for vulnerable populations, such as the elderly and those
      with underlying diseases, who are at particular risk of severe Covid-19 but are
      also less likely to develop a protective immune response to a vaccine.

(x)   If I already had Covid-19, should I still get a vaccine?

      When people recover from some viral infections, such as measles or mumps,
      they are protected against reinfection and would not need to be vaccinated.
      However, for other diseases, such as pneumococcal pneumonia or influenza, it
      is important to be vaccinated (or revaccinated) despite having disease because
      the vaccine protects against several strains or types of the pathogen and thus
      can still be valuable. There is no evidence that there are significant differences
      in SARS-CoV-2 to warrant vaccination for this reason, but we do not yet know
      how long people are protected after having Covid-19 and so do not yet know if
      these people should be vaccinated. If protection only lasts for several months,
      vaccination could be of benefit.

(xi) Can someone get Covid-19 from the vaccine?

      No, it is not possible to get Covid-19 from vaccines. Vaccines against SARS-
      CoV-2 use inactivated virus, parts of the virus (e.g., the spike protein), or a
      gene from the virus. None of these can cause Covid-19.

(xii) Should I get the vaccine for influenza (flu shot)?

      Yes, it is very important to get the influenza vaccine, particularly this season
      when both influenza viruses and SARS-CoV-2 can infect people. We still do not
                                            29
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