DECLARATION

This is to declare that I,am PRASHANT MISHRA student of

MBA, 1ST semester, have personally worked on the MINI
PROJECT entitled “COVID19 VACCINE". The data
mentioned in this report were obtained during genuine work
done and collected by me. The data obtained from other
sources have been duly acknowledged. The result embodied in
this project has not been submitted to any other University or
Institute for the award of any degree.

Date NAME- PRASHANT

MISHRA

Place: Lucknow ( Roll No.)

 ACKNOWLEDGEMENT

Every work constitutes great deal of assistance and guidance

from the people concerned and this particular project is of no
exception.
A project of the nature is surely a result of tremendous support,
guidance, encouragement and help.
Wish to place on record my sincere gratitude to wish to place on
record my sincere gratitude to Dr. Smriti Srivastava (HOD
MBA Dept)
I thank her for constructive help and encouragement throughout
the project. Without his support and guidance taking this would
not have been possible.
Also, wish to acknowledge enthusiastic encouragement and
support extended to me by my family members.
At last, I would like to thank all the faculty of business
management to help me completing this project.
I am also thankful to my friends who provided me their constant
support and assistance.

NAME- PRASHANT MISHRA

( Roll No.)

MBA 1ST Semester

 PREFACE

For a Management student, Mini Project plays an important role

during the study. This project provides a corporate or real world
platform to learn practically. MBA degree without any Innovative
Project or ideas, experience is just like food without salt. So, Mini
Project provides a great learning experience about management
concepts and its applications.

This project was undertaken as a part of the curriculum of MBA

course, which is compulsory for each student to have the project in
any new ideas to the development of the student capabilities and
gain the knowledge. This exposure enables the mentor to learn
effective and efficient ways and means to solve the real problems
faced by the organization and also to understand its dynamics.
 INTRODUCTION
• Supporting countries to prepare for COVID-19
vaccine introduction:
To prepare all countries for COVID-19 vaccine introduction,
WHO, UNICEF, Gavi, and partners are working together at
the global and regional levels to (1) develop and
disseminate adaptable guidance, trainings, planning and
monitoring tools, and advocacy materials and to (2) provide
technical assistance and support to countries.
One of the initial resources developed is the COVID-19
VIRAT. This tool is intended to be used by Ministries of
Health, with support from WHO and UNICEF Country
Offices where relevant, to provide a roadmap for countries
to plan for COVID-19 introduction and a structure
framework for countries to self-monitor their readiness
progress against key milestones.
This COVID-19 VIRAT is ready for immediate use by all
countries. It may be slightly updated as more information
becomes available on the vaccine(s) and timelines for
delivery.
1. Planning and coordination:
→ Establish (or engage an existing committee) a National
Coordinating Committee (NCC) for COVID-19 vaccine
introduction with terms of reference, roles and
responsibilities and regular meetings.

→ Establish (or engage an existing working group) a

National Technical Working Group (NTWG) for COVID-19
vaccine introduction with terms of reference, roles and
responsibilities and regular meetings

2. Regulatory:
→ Confirm to WHO the existence of any expedited
regulatory pathway for approval of COVID-19 vaccines
(i.e. emergency use authorization, exceptional
approval/waiver mechanism based on
reliance/recognition, abbreviated procedure, fast track,
etc.). Timelines and maximum number of days should be
mentioned (expected timeline: maximum 15 working
days).

3. Prioritizing, Targeting and COVID-

19 Surveillance
→ Monitor progress of NITAG working groups on
COVID-19 vaccines and interim recommendations
focusing on prioritization and risk groups.
4. Service Delivery:
→ Update protocols for infection prevention and control
measures including adequate personal protection equipment
(PPE) to minimize exposure risk during immunization
sessions.

5. Training and Supervision:

→ Develop a training plan to prepare for COVID-19
vaccine introduction that includes key groups of
participants, content topic areas, key training partners
and training methods (in-person or virtual). WHO will
provide a template for guidance

6. Monitoring and Evaluation:

→ Develop or adapt existing surveillance and monitoring
framework with a set of recommended indicators
(coverage, acceptability, disease surveillance etc…) for
COVID-19 vaccine. Determine whether registration and
reporting will be individual or aggregate, and to what extent
existing tools and systems can be re-used.

7. Vaccine Cold Chain and Logistics:

→ Establish/strengthen the national logistics working
group with appropriate terms of reference and standard
operating procedures to coordinate COVID-19 vaccines
and ancillary products deployment.
8. Safety Surveillance:
→ Ensure that guidelines, documented procedures and
tools for planning and conducting vaccine
pharmacovigilance activities (i.e. AEFI reporting,
investigation, causality assessment, risk communication
and response) are available.
→ Assure competent and trained staff to perform vigilance
activities.

→ Expedite training the AEFI committee to review COVID-

19 Vaccine safety data (e.g., causality assessment of
serious AEFI, clusters of AEFI, emerging safety concerns
etc).

→ Identify provisions that require manufacturers to

implement risk management plans and collect and report
COVID-19 vaccine safety data to the NRA.
→ Plan active surveillance of specific COVID-19 vaccine
related adverse events. If this is not possible, develop
provisions that allow reliance on active surveillance data,
decisions, and information from other countries or
regional or international bodies.

9. Demand Generation and Communication:

→ Design a data-driven demand plan (includes advocacy,
communications, social mobilization, risk and safety
comms, community engagement, and training) to generate
confidence, acceptance and demand for COVID-19
vaccines. This must include a crisis communications
preparedness plan.
For information on COVID-19 vaccine development
and access, the following references are available:
COVID-19 Vaccine Research and Development: The 
Access to COVID-19 Tools (ACT) Accelerator is a global
collaboration accelerating the development, production,
and equitable access to safe and effective COVID-19
vaccines, treatments, and tests. Countries can see
progress updates on vaccine research and development 
here.

COVID-19 Vaccine Access: Countries can sign up to

receive COVID-19 vaccines through the ACT
Accelerator’s COVID-19 Vaccine (COVAX) Facility
The world is in the midst of a COVID-19 pandemic. As
WHO and partners work together on the response --
tracking the pandemic, advising on critical interventions,
distributing vital medical supplies to those in need--- they
are racing to develop and deploy safe and effective
vaccines. 

Vaccines save millions of lives each year. Vaccines work

by training and preparing the body’s natural defences ---
the immune system--- to recognize and fight off the
viruses and bacteria they target. If the body is exposed to
those disease-causing germs later, the body is
immediately ready to destroy them, preventing illness.
There are currently more than 60 COVID-19 vaccine
candidates in clinical development and over 170 in pre-
clinical development. WHO is working in collaboration with
scientists, business, and global health organizations
through the ACT Accelerator to speed up the pandemic
response. When a safe and effective vaccine is found,
COVAX (led by WHO, GAVI and CEPI) will facilitate the
equitable access and distribution of these vaccines to
protect people in all countries. People most at risk will be
prioritized. While we work towards rolling out a safe and
effective vaccine fairly, we must continue the essential
public health actions to suppress transmission and reduce
mortality.
 PROBLEM STATEMENT
• India's unusual Covid vaccine problem: Plenty of
shots, but few takers. Most of the world is struggling to
secure enough vaccines to inoculate their populations.
India has the opposite problem: Plenty of shots, but a
shortage of people willing to take them

• As India rolls out one of the world’s biggest inoculation

programs, some health-care and other frontline workers
are hesitating because of safety concerns over a vaccine
that has yet to complete phase III trials. As of Monday,
only about 56% of people eligible to get the shot have
stepped forward in a nation with the world’s second-
worst Covid-19 outbreak.

• Unless the inoculation rate significantly increases, India

will fall far short of its target of inoculating 300 million
people -- or about a quarter of the population -- by July.
That will setback global efforts to contain the virus and
snuff out optimism that a recovery is taking root in an
economy set for its biggest annual contraction in records
going back to 1952.
•“At least 40% of doctors here are unsure and want to
wait,” said Vinod Kumar, a resident doctor at the All India
Institute of Medical Sciences of Patna, in the eastern state
of Bihar. “Carrying out a vaccine trial on us when India is
short of doctors, health-care workers doesn’t make sense.”

• While vaccine hesitancy has surfaced in places like

Japan and Brazil, and China’s candidates have also faced
questions over data, the scale of the problem in India is by
far the biggest. The major difficulties facing places like the
U.S. and Europe are mostly due to scarce supplies rather
than vaccine acceptance, and some countries are turning
to New Delhi for help: India says it can produce 500
million shots per month for export, and countries such as
the U.K., Belgium and Saudi Arabia have sought to buy
them.
• India’s domestic vaccine program administers one of two
shots: the AstraZeneca Plc vaccine, manufactured by the
Serum Institute of India Ltd., or the Covaxin shot developed
by Bharat Biotech International Ltd., a private company
based in Hyderabad. India’s approval of the Bharat Biotech
shot, which was developed with government-backed
research groups, was met with widespread criticism from
scientists because of the lack of complete data.
•“Many in our institute aren’t comfortable with Covaxin
because we don’t know how effective it is,” said Adarsh
Pratap Singh, a member of the Resident Doctors
Association at the All India Institute of Medical Sciences in
New Delhi. “To build trust among people the government
must come out with the data, evidence of the trials, and
encourage free and fair discussions.”

•“Vaccine hesitancy among health workers should end -- I

am pleading on behalf of the government, that please adopt
it, because no one knows how this pandemic will take
shape in the future,” said V. K. Paul, a member of the
planning body Niti Aayog, noting that he’s taken the Covaxin
shot without any adverse effects.

•“These two vaccines are safe,” he said. “We have a

system to track it and if there is an unusual signal, it will be
responded to the way it should be.”
• As of Monday, India distributed about 2 million shots
nationwide. In Madhya Pradesh, the largest state in central
India, about 75% of enrolled people turned up for
vaccination on Jan. 21, while two days later in Bihar the
rate was much lower at 51.6%. On Jan. 19, about 55% of
those eligible were vaccinated in Rajasthan and 54% in the
southern state of Tamil Nadu, according to state
government data.
Statement on Human Challenge Studies
for COVID-19 Vaccine Development
•Two recent developments have brought renewed
publicity to proposals to conduct human challenge studies
to test COVID-19 vaccine candidates: an 
open letter from the organization 1DaySooner and media
reports that Adrian Hill’s Oxford University research group
is planning a challenge study, taking advantage of the
lack of regulatory oversight of human challenge
experiments in the United Kingdom.

•The open letter is addressed to Francis Collins, Director

of the US National Institutes of Health, and signed by
many eminent signatories including Nobel Laureates. It
offers three short paragraphs that attempt to explain how
challenge studies might accelerate the development of a
vaccine for COVID-19, before entering into a much
lengthier and more detailed discussion of how challenge
studies should be executed.
•This imbalance highlights the critical problem with
proposals for human challenge experiments: the
ethical justification for their conduct relies entirely on
the premise that they would speed the development of
a safe and effective COVID-19 vaccine. The evidence
supporting this premise is thin to non-existent.
 COMPANY PROFILE
PFIZER AND BIONTECH ACHIEVE FIRST
AUTHORIZATION IN THE WORLD FOR A VACCINE TO
COMBAT COVID-19
Wednesday, December 02, 2020 -
02:05am
U.K. regulator, MHRA, authorizes supply of COVID-19 mRNA
vaccine for emergency supply under Regulation 174; Companies
are ready to deliver the first doses to the U.K. immediately
First authorization for a COVID-19 vaccine represents a
breakthrough scientific achievement to help combat this
devastating pandemic
The companies previously signed an agreement to supply a total
of 40 million doses to the U.K. with delivery in 2020 and 2021
U.S. FDA and EU EMA decisions on authorization are expected in
December
NEW YORK & MAINZ, Germany--(BUSINESS WIRE)-- 
Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX)
announced today that the Medicines & Healthcare
Products Regulatory Agency (MHRA) in the U.K. has
granted a temporary authorization for emergency use
for their COVID-19 mRNA vaccine (BNT162b2), against
COVID-19. This constitutes the first Emergency Use
Authorization following a worldwide Phase 3 trial of a
vaccine to help fight the pandemic. Pfizer and BioNTech
are anticipating further regulatory decisions across the
globe in the coming days and weeks and are ready to
deliver vaccine doses following potential regulatory
authorizations or approvals. The distribution of the
vaccine in the U.K. will be prioritized according to the
populations identified in guidance from the Joint
Committee on Vaccination and Immunisation (JCVI).
“Today’s Emergency Use Authorization in the U.K. marks
a historic moment in the fight against COVID-19. This
authorization is a goal we have been working toward
since we first declared that science will win, and we
applaud the MHRA for their ability to conduct a careful
assessment and take timely action to help protect the
people of the U.K.,” said Albert Bourla, Chairman and
Chief Executive Officer, Pfizer. “As we anticipate further
authorizations and approvals, we are focused on moving
with the same level of urgency to safely supply a high-
quality vaccine around the world. With thousands of
people becoming infected, every day matters in the
collective race to end this devastating pandemic.”
“The Emergency Use Authorization in the U.K. will mark
the first time citizens outside of the trials will have the
opportunity to be immunized against COVID-19,” said
Ugur Sahin, M.D., CEO and Co-founder of BioNTech. “We
believe that the roll-out of the vaccination program in
the U.K. will reduce the number of people in the high-
risk population being hospitalized. Our aim is to bring a
safe and effective vaccine upon approval to the people
who need it. The data submitted to regulatory agencies
around the world are the result of a scientifically
rigorous and highly ethical research and development
program.”
Manufacturing and Delivery
Capabilities
Pfizer and BioNTech continue to work in collaboration with
governments and Ministries of Health around the world
that will distribute the vaccine, subject to country
authorization or approval, to help ensure it can reach
those most in need as quickly as possible. The companies
are leveraging leading vaccine manufacturing and
distribution capabilities to quickly scale, manufacture and
distribute large quantities of the vaccine at high quality,
complementing the mRNA manufacturing expertise of
BioNTech gained over almost a decade. Pfizer has a 171-
year track record of researching, developing,
manufacturing and delivering innovative medicines and
vaccines to patients in need. Pfizer and BioNTech are
confident in their ability to safely and effectively deliver the
vaccine to the people in the U.K. Based on current
projections, Pfizer’s and BioNTech’s combined
manufacturing network has the potential to supply globally
up to 50 million vaccine doses in 2020 and up to 1.3 billion
doses by the end of 2021 (subject to manufacturing
capacity and regulatory approval or authorization).
About Pfizer: Breakthroughs That Change
Patients’ Lives
At Pfizer, we apply science and our global resources to
bring therapies to people that extend and significantly
improve their lives. We strive to set the standard for
quality, safety and value in the discovery, development
and manufacture of health care products, including
innovative medicines and vaccines. Every day, Pfizer
colleagues work across developed and emerging
markets to advance wellness, prevention, treatments
and cures that challenge the most feared diseases of
our time. Consistent with our responsibility as one of
the world's premier innovative biopharmaceutical
companies, we collaborate with health care providers,
governments and local communities to support and
expand access to reliable, affordable health care
around the world. For more than 150 years, we have
worked to make a difference for all who rely on us. We
routinely post information that may be important to
investors on our website at www.Pfizer.com. In
addition, to learn more, please visit us on 
www.Pfizer.com and follow us on Twitter at @Pfizer
 and @Pfizer News, LinkedIn, YouTube and like us on
Facebook at Facebook.com/Pfizer.
Pfizer Disclosure Notice
The information contained in this release is as of
December 2, 2020. Pfizer assumes no obligation to
update forward-looking statements contained in this
release as the result of new information or future events
or developments.

This release contains forward-looking information about

Pfizer’s efforts to combat COVID-19, the collaboration
between BioNTech and Pfizer to develop a potential COVID-
19 vaccine, the BNT162 mRNA vaccine program and
modRNA candidate BNT162b2 (including qualitative
assessments of available data, potential benefits,
expectations for clinical trials, a temporary authorization for
emergency use in the U.K., regulatory submissions, including
a pending request for Emergency Use Authorization in the
U.S. and rolling submissions with the EMA and several other
regulatory agencies around the world, the anticipated timing
of regulatory submissions, regulatory approvals or
authorizations and anticipated manufacturing, distribution and
supply), that involves substantial risks and uncertainties that
could cause actual results to differ materially from those
expressed or implied by such statements. Risks and
uncertainties include, among other things, the uncertainties
inherent in research and development, including the ability to
meet anticipated clinical endpoints, commencement and/or
completion dates for clinical trials, regulatory submission
dates, regulatory approval dates and/or launch dates, as well
as risks associated with clinical data (including the Phase 3
data
COVAXINTM - India's First Indigenous COVID-19
Vaccine
COVAXINTM, India's indigenous COVID-
19 vaccine by Bharat Biotech is
developed in collaboration with the
Indian Council of Medical Research
(ICMR) - National Institute of Virology
(NIV).
The indigenous, inactivated vaccine is
developed and manufactured in Bharat
Biotech's BSL-3 (Bio-Safety Level 3) high
containment facility.

The vaccine is developed using Whole-Virion Inactivated

Vero Cell derived platform technology. Inactivated
vaccines do not replicate and are therefore unlikely to
revert and cause pathological effects. They contain dead
virus, incapable of infecting people but still able to instruct
the immune system to mount a defensive reaction against
an infection.

Why develop Inactivated Vaccine? Conventionally,

inactivated vaccines have been around for decades.
Numerous vaccines for diseases such as Seasonal
Influenza, Polio, Pertussis, Rabies, and Japanese
Encephalitis use the same technology to develop
inactivated vaccines with a safe track record of >300
million doses of supplies to date. It is the well-established,
and time-tested platform in the world of vaccine
technology.
Key Attributes:
COVAXINTM is included along with immune-potentiators,
also known as vaccine adjuvants, which are added to the
vaccine to increase and boost its immunogenicity.
It is a 2-dose vaccination regimen given 28 days apart.

It is a vaccine with no sub-zero storage, no reconstitution

requirement, and ready to use liquid presentation in
multi-dose vials, stable at 2-8oC.
Pre-clinical studies: Demonstrated strong immunogenicity
and protective efficacy in animal challenge studies
conducted in hamsters & non-human primates. For more
information about our animal study, please visit our blog
page on Non-Human Primates.

The vaccine received DCGI approval for Phase I & II

Human Clinical Trials in July, 2020.

A total of 375 subjects have been enrolled in the Phase 1

study and generated excellent safety data without any
reactogenicity. Vaccine-induced neutralizing antibody
titers were observed with two divergent SARS-CoV-2
strains. Percentage of all the side-effects combined was
only 15% in vaccine recipients. For further information,
visit our blog page on 
phase 1 study.
COVAXIN™ (BBV152) demonstrated acceptable safety
profile and high immune response, which induced T-
cell responses in Phase 1 study.

SALIENT FEATURES –
In a Phase 1 placebo-controlled, double-blinded clinical
trial, an inactivated SARS-CoV-2 vaccine (BBV152) was
evaluated in 375 subjects.
On day 28 (14 days after 2nd dose), all subjects who
received the vaccine intramuscularly had significantly
elevated Spike binding IgG antibodies and Neutralizing
Antibody titers.

The vaccine induced antibody responses reported, were

able to neutralize both homologous (vaccine virus strain)
and heterologous (divergent) SARS-CoV-2 strains.

A Th1 biased T-cell response was observed.

Local reactions and systemic events after immunization

were generally mild in nature and resolved transiently.
No serious (grade 3-4) adverse events were reported.
SUMMARY
BBV152 induced binding and neutralizing antibody
responses & with the inclusion of the Algel-IMDG
adjuvant, this is the first inactivated SARS-CoV-2 vaccine
that has been reported to induce a Th1-biased response.
Phase 2 trials are in analysis and phase 3 clinical trials are
underway.

Disclaimer: The provided study information is a preprint

publish and has not yet undergone peer review. The
findings are provisional and the conclusions/final results
may differ.
Phase 3 multi-centre trial: The first dose of vaccination
has been given to all the participants and presently,
second dose of either vaccine/placebo is being
administered.

Efficacy is estimated by the incidence of COVID-19 cases

accrual between the vaccine and the placebo group,
which will commence two weeks after the second dose.

The interim efficacy estimate will be generated by

the end of Feb, 2021.
COVAXINTM has been granted approval for emergency
restricted use in India by DCGI-CDSCO on Jan 03,
2021.
Global Acceptance of COVAXINTM:
Bharat biotech has been approached by several countries
across the world for the procurement of COVAXINTM.
Clinical trials in other countries to commence soon.
Supplies from government to government in the following
countries to take place:Mongolia, Myanmar, Sri Lanka,
Philippines, Bahrain, Oman, Maldives and Mauritius.
 REASEARCH OBJECTIVE
The third GAP approach acknowledged and encouraged
the research and development being undertaken by the
research community and the vaccine industry – to design
more potent and effective vaccines that are: (a) capable of
inducing protective responses after one dose, and/or (b)
induce broad-spectrum and long-lasting immunity against
both seasonal and pandemic influenza strains.

Develop more effective

influenza vaccines using new
technologies.
The ideal product profile is a
vaccine which:

is safe and highly protective, preferably in all target

groups, including infants, the elderly, pregnant women and
immunosuppressed individuals
is easily and inexpensively produced on a large scale
is effective - preferably with a low dose of antigen
is delivered, ideally, as a single dose
is thermostable; and
offers protection for a minimum duration of one year,
including protection against antigenically drifted viruses
Progress
WHO commissioned or prepared reviews on sustainable
production technology appropriate in developing countries
and related intellectual property rights.
Regular consultations were conducted to bring together vaccine
researchers and public health professionals to discuss pandemic
influenza prototype vaccines and vaccines that can potentially
induce broader spectrum and longer lasting immunity against
both seasonal and pandemic influenza strains. Significant
progress has been achieved with new vaccine formulations.

An internet-based database was established to provide

non-restricted information on clinical trials of candidate
pandemic influenza vaccines. This is updated and
complemented with data from technical meetings,
publications and direct contacts with manufacturers and
investigators in charge of clinical trials.
1. Development of an animal model and
accelerated development of a DNA vaccine
candidate
To develop a mouse model of SARS-CoV-2 infection.
This will not only enable us to evaluate the efficacy of the
vaccine; it will also facilitate in vivo research on SARS-CoV-2.

To evaluate the immunogenicity (ability to induce a specific

immune reaction) and efficacy (protection capability) of DNA-
based vaccine candidates.
DNA vaccination is a technique for protecting against disease by
injecting DNA encoding a specific antigen. The injected DNA
triggers a protective immunological response, for example the
production of antibodies against the antigen. DNA vaccines offer
potential advantages compared with conventional vaccines,
including the ability to induce a wider range of immune response
types. Two antigen candidates have already been designed,
based on the S (spike) protein of the virus, responsible for the
"crown" ("corona" in Latin) observed at the surface of
coronaviruses, after which they were named. 
2. Evolution of SARS-CoV-2 and the antibody
immune response in humans during infection
Aim: to understand the evolution of the SARS-CoV-2 viral
population in hosts during illness, in relation with the
infectivity of the virus and the establishment of the humoral
(antibody-based) immune response. This knowledge is
important to identify trends in disease progression and help
improve the treatment and post-treatment follow-up given to
patients. Detailed data on the evolution of the SARS-CoV-2
population in relation with disease progression, antiviral
treatment and viral shedding sites will also be useful in
evaluating links with disease severity and the potential failure
of antiviral treatments.

The aim is to elucidate the kinetics of SARS-CoV-2 shedding in

patients with Covid-19, depending on the severity of the
disease, age and existing comorbidities (shedding in upper
respiratory tracts – from the nose to the larynx – and lower
respiratory tracts – from the windpipe to the alveoli, or at non-
respiratory sites), and also to analyze the kinetics of the viral
load at respiratory and non-respiratory sites in confirmed cases
according to severity, age group and existing comorbidities. The
project also intends to determine the correlation between the
development of the viral load and infectivity, and to understand
the kinetics of introducing a neutralizing humoral response (the
body's production of antibodies to neutralize the virus).
3. Development of cell lines for research
Aim: to generate a line of specific cells that will serve as a basis
to improve characterization of the SARS-CoV-2 coronavirus.
The generated cell lines will be useful in facilitating the
isolation of clinical samples of coronavirus and in carrying out
high-throughput screening    

4.  A technique to identify key cellular factors

for SARS-CoV-2 infection
Aim: to carry out CRISPR/Cas9 tests to identify cellular
factors involved in infection with SARS-CoV-2 and antiviral
proteins that inhibit its replication. These approaches will
lead to the identification of key cellular factors that may
serve as virulence determinants and therapeutic targets.
This research particularly concerns lung cells, the main
targets of the virus. 

5. Building a collection of human biological

samples in France
Aim: to detect the presence of specific SARS-CoV-2 antibodies
in different populations, either those who traveled to China
in the weeks preceding the start of the outbreak, or those
with suspected infection with SARS-CoV-2. The aim is to
understand:
•When and how the virus was transmitted from animals to
humans
•When the virus began circulating in humans in France
•How long the infectious period lasts
•What percentage of patients experience few or no symptoms

To answer these questions, the scientists will carry out the first
seroepidemiological studies (detecting coronavirus antibodies in
patients) of SARS-CoV-2 infection, while also developing a
serological test. Samples will be taken:

- from subjects who traveled to China during the period from

August 1, 2019 to January 31, 2020 and who were not diagnosed
as infected with SARS-CoV-2 (CORSER-1);
- from suspected cases of SARS-CoV-2 infection that tested
negative for the virus with the RT-PCR assay on a respiratory
sample; contacts or individuals exposed to confirmed cases of
SARS-CoV-2 infection; or individuals who worked or stayed in a
hospital where confirmed cases of SARS-CoV-2 infection were
treated (CORSER-2).

6. Antibody profiling in recovering patients

and development of a serological test for an
epidemiological survey in individuals exposed
to SARS-CoV-2
Aim: to develop a test that can be used to carry out an initial
survey on the prevalence of antibodies in individuals exposed
to the SARS-CoV-2 coronavirus. The aim is to obtain a specific
serological test that can be used for high-throughput testing
for Covid-19 infection.

7. SARS-CoV-2 fusion, replication and host

responses
Aim: to use cell cultures and mouse models to analyze the
role of interferons and IFITMs (interferon-induced
transmembrane proteins) in the replication and pathology of
the SARS-CoV-2 virus.

8. Defective viral genomes (DVGs), potential

antiviral inhibitors of SARS-CoV-2 
Aim: to use a pipeline to identify the best DVG candidates
(molecules known to inhibit viral populations). The pipeline
has proven effective in several virus families such as the
MERS and murine (MHV) coronaviruses. The scientists
propose to use the same method for SARS-CoV-2 and to test
the five best DVG candidates on cell cultures. This could lead
to DVGs being brought to market as an antiviral treatment
for SARS-CoV-2.
DVGs are defective viral genomes capable of hijacking the
replication machinery of wild-type viruses and partially or totally
inhibiting viral populations. Thousands of different DVGs are
produced during infection by one of these viruses. The scientists
have developed a method to select those most likely to have anti
 SCOPE OF THE STUDY
Serum Institute of India to expand scope of
COVID-19 vaccine trials

Serum Institute of India, which is currently conducting

Phase 2 and 3 trials of the Oxford COVID-19 vaccine,
has sought approval to expand the scope of vaccine trials
in India.
The Pune-based vaccine maker has written to the drug
regulator to broaden the participant inclusion criteria to now
cover older individuals, people with health conditions,
those at high risk of Sars-Cov2 infection like household
contacts, and those who recovered from COVID-19
infection.

Broadening the inclusion criteria will align the Indian trials

of Covishield with that of the ongoing global trials and test
the vaccine for high-risk individuals and real-world
distribution scenarios.

The Subject Expert Committee responding to the proposal

submitted on October 6th recommended approval of the
amendments. It said, "After detailed deliberation, the
committee recommended for approval of the proposed
amendments subject to the condition that the inclusion &
exclusion criteria are same as that of AstraZeneca/Oxford
Trial with regard to the omission of history of COVID-19
disease in household contacts or history of COVID-19
infection or currently positive for SARS-CoV2 by RT-PCR,
as it is bridging study and the same should be submitted to
CDSCO."
COVID-19 vaccines are targeted for high-risk
populations, such as older individuals, those with co-
morbidities, healthcare workers, or household contacts
of COVID positive individuals. Hence, testing the
vaccine’s effectiveness in this group of people is crucial.
"There were certain cohorts in the current trial structure
which are restricted to people under 60 or 65 years, now
there will be no upper age limit. Senior citizens, who are
actually high risk and older people with co-morbidities will
be included and it makes it a fuller trial," said a senior
medical doctor with expertise in vaccine trials. He didn’t
wish to be named.

Besides, testing people for current or past exposure to

viruses before administering the vaccine is not possible
when the vaccine is rolled out to the general public.
"Hence, the vaccine needs to be one that can be
administered to any high-risk individual and we know
that it will work and is safe," explained the senior medical
doctor quoted above.
According to Serum Institute's trial protocols published on
the Clinical Trials Registry of India, people with a history of
laboratory-confirmed COVID-19 disease in household or
workplace contact, those who show IgG seropositivity to
SARS-CoV-2, those recovered or currently positive for
SARS-CoV-2 by RT-PCR test are all currently excluded
from the trial.

Serum Institute’s vaccine trials are part of Phase 3 global

trials being conducted by the University of
Oxford/AstraZeneca in more than 30,000 individuals.
Oxford’s trial global trials include adults aged 18 years or
over from diverse racial, ethnic, and geographic groups
who are healthy or have stable underlying medical
conditions, including those living with HIV, and who are
at increased risk of infection from the SARS-CoV-2 virus.
 RESEARCH METHODOLOGY
TYPES OF RESEARCH
The different types of COVID-19 vaccines
This article is part four in a series of explainers on vaccine
development and distribution.
Part one focused on how vaccines work to protect our bodies
from disease-carrying germs.
Part two focused on the ingredients in a vaccine and the three
clinical trial phases.
Part three focused on the steps from completing the clinical
trial phases through to distribution.
This document outlines the different types of vaccines.

As of December 2020, there are over 200 vaccine candidates

for COVID-19 being developed. Of these, at least 52
candidate vaccines are in human trials. There are several
others currently in phase I/II, which will enter phase III in the
coming months (for more information on the clinical trial
phases, see part three of our Vaccine Explained series).

Why are there so many vaccines in development?

Typically, many vaccine candidates will be evaluated
before any are found to be both safe and effective. For
example, of all the vaccines that are studied in the lab and
laboratory animals, roughly 7 out of every 100 will be
considered good enough to move into clinical trials in
humans. Of the vaccines that do make it to clinical trials,
just one in five is successful. Having lots of different
vaccines in development increases the chances that
there will be one or more successful vaccines that will be
shown to be safe and efficacious for the intended
prioritized populations.

The different types of vaccines

There are three main approaches to designing a vaccine.
Their differences lie in whether they use a whole virus or
bacterium; just the parts of the germ that triggers the
immune system; or just the genetic material that provides
the instructions for making specific proteins and not the
whole virus.
The whole-microbe approach
Inactivated vaccine
The first way to make a vaccine is to take the disease-
carrying virus or bacterium, or one very similar to it,
and inactivate or kill it using chemicals, heat or
radiation. This approach uses technology that’s been
proven to work in people – this is the way the flu and
polio vaccines are made – and vaccines can be
manufactured on a reasonable scale. 

Live-attenuated vaccine
A live-attenuated vaccine uses a living but weakened
version of the virus or one that’s very similar. The
measles, mumps and rubella (MMR) vaccine and the
chickenpox and shingles vaccine are examples of this
type of vaccine.
Viral vector vaccine
This type of vaccine uses a safe virus to deliver specific
sub-parts – called proteins – of the germ of interest so
that it can trigger an immune response without causing
disease. To do this, the instructions for making
particular parts of the pathogen of interest are inserted
into a safe virus. The safe virus then serves as a
platform or vector to deliver the protein into the body. 
The protein triggers the immune response. The Ebola
vaccine is a viral vector vaccine and this type can be
developed rapidly.

The subunit approach

 RESEARCH DESIGN
Coronavirus disease (COVID-19): Vaccine
research and development
WHO and its partners are committed to accelerating the
development of COVID-19 vaccines while maintaining
the highest standards on safety.
In the past, vaccines have been developed through a
series of steps that can take many years. Now, given the
urgent need for COVID-19 vaccines, unprecedented
financial investments and scientific collaborations are
changing how vaccines are developed. This means that
some of the steps in the research and development
process have been happening in parallel, while still
maintaining strict clinical and safety standards. For
example, some clinical trials are evaluating multiple
vaccines at the same time. However, this does not make
the studies any less rigorous.

What are human challenge studies? What is WHO’s view on thes

e studies?
In a regular vaccine study, one group of volunteers at risk
for a disease is given an experimental vaccine, and
another group is not; researchers monitor both groups
over time and compare outcomes to see if the vaccine is
safe and effective.
In a human challenge vaccine study, healthy volunteers are
given an experimental vaccine, and then deliberately
exposed to the organism causing the disease to see if the
vaccine works. Some scientists believe that this approach
could accelerate COVID-19 vaccine development, in part
because it would require far fewer volunteers than a typical
study.

However, there are important ethical considerations that

must be addressed – particularly for a new disease like
COVID-19, which we do not yet fully understand and are
still learning how to treat; it may be difficult for the medical
community and potential volunteers to properly estimate
the potential risks of participating in a COVID-19 human
challenge study. For more information, 
see this WHO publication on the ethics of COVID-19 huma
n challenge studies
. 
What are human challenge studies? What is WHO’s view on t
hese studies?

In a regular vaccine study, one group of volunteers at risk

for a disease is given an experimental vaccine, and
another group is not; researchers monitor both groups over
time and compare outcomes to see if the vaccine is safe
and effective.
In a human challenge vaccine study, healthy volunteers are
given an experimental vaccine, and then deliberately
exposed to the organism causing the disease to see if the
vaccine works. Some scientists believe that this approach
could accelerate COVID-19 vaccine development, in part
because it would require far fewer volunteers than a typical
study.

However, there are important ethical considerations that

must be addressed – particularly for a new disease like
COVID-19, which we do not yet fully understand and are
still learning how to treat; it may be difficult for the medical
community and potential volunteers to properly estimate
the potential risks of participating in a COVID-19 human
challenge study. For more information, 
see this WHO publication on the ethics of COVID-19 hum
an challenge studies
. 
Who should participate in clinical trials for COVID-19 vaccines?

Small (phase I) safety studies of COVID-19 vaccines

should enroll healthy adult volunteers. Larger (phase II
and III) studies should include volunteers that reflect the
populations for whom the vaccines are intended. This
means enrolling people from diverse geographic areas,
racial and ethnic backgrounds, genders, and ages, as well
as those with underlying health conditions that put them at
higher risk for COVID-19. Including these groups in clinical
trials is the only way to make sure that a vaccine will be
safe and effective for everyone who needs it. 
 SAMPLING DESIGN
1. Background and purpose
The urgent, worldwide need for a method of controlling
the spread of SARS-CoV-2 requires an accurate
evaluation of the sources of data on which the
estimation of the epidemic’s main parameters can be
based. Only in this way will we be able to monitor the
evolution of the epidemic over time while
simultaneously supporting decision makers in

evaluating the effects of the restrictive measures gradually

introduced to try and stop the spread and the time
required for the reduction and removal of these measures.
In general, this approach enables the production of future
forecasts of the evolution of the disease, and these
forecasts are the essential basis for achieving an effective
healthcare response. Indeed, while some degree of
uncertainty is inherent in any statistical model, the level of
inaccuracy in terms of monitoring the development of the
situation can and must be kept under control.
The objective of the proposed method is the definition of
an observational protocol for observing the SARS-CoV-2
epidemic over time and providing statistically unbiased
and efficient estimates of the sizes of the different
attributes of any population identified as a concern with
regard to the epidemic. Moreover, we aim to propose a
dynamic monitoring tool that can be suitably calibrated
both in the growth phase of the infection rate and in the
decline
However, apart from a few remarkable exceptions, until now,
the data that have been collected favour the examination of
cases in which the patients display symptoms. This situation
is described in statistics as “convenience sampling”, and no
sound probabilistic inference is possible under such a
sampling approach (Hansen et al., 1953). More precisely, in a
formal sample design, the choices of observations are
suggested by a precise mechanism based on the definition of
the inclusion probabilities of each unit (and, hence, by a
sound probabilistic inference method); in contrast, with a
convenience sampling, no probabilities of inclusion can be
calculated, thus giving rise to over- or underrepresentation of
the sample units.
In particular, several studies on COVID-19 diffusion have
clearly shown (e.g., Aguilar et al., 2020; Chugthai et al.,
2020; Li et al., 2020; Mizumoto et al., 2020a, 2020b and
Yelin et al., 2020) that the available data strongly
underestimate the number of infected people that they are
unable to capture, e.g., asymptomatic cases with an
obvious overestimation of the lethality rate6. On the other
hand, a broad data collection method using medical swabs
that is carried out on a voluntary basis does not constitute a
probabilistic sample either7. For instance, the practice of
systematically collecting observations from people in the
vicinity of supermarkets leads to an overinclusion of healthy
people in the sample and to a systematic exclusion of those
who (either because they are manifesting symptoms or
because they feel weak) have chosen to stay confined at
home.
However, it is of crucial importance for government and health
officials and for the general population to have a clear
understanding of the dynamics of an epidemic while it is in
progress so that the government can take appropriate
measures and guide individual behaviours. In such a situation,
it is essential to set up a data collection system that can
provide unbiased estimates and statistically valid comparisons
over time and across different geographic areas. For sampling
during an epidemic to be empirically relevant, any data
collection design must be technically specified, the properties
of the associated estimators have to be proved formally, and
the design has also to satisfy the following two conditions:

2. Data collection during an epidemic: a review

of strategies and experiences currently in
progress
In the emergency phase connected with the quick and
uncontrolled diffusion of COVID19, governments and
institutions in charge are fully aware that knowledge and
understanding of the dynamics at work represent the central
element for establishing how to intervene and in which
geographical areas intervention is most urgent.
In reviewing the approaches followed by various countries
until early April 2020, we can identify four strategies and
experiences in progress with regard to the estimation of the
disease phenomena in the entire population.
a) The first consists of massive test campaigns (regardless
of the presence of symptoms) carried out without following
a formal sampling design; these are essentially aimed at
intervening during outbreaks of the epidemic to identify
subjects who are infected but with no symptoms or only
slight symptoms. This was the strategy of South Korea and
Hong Kong, as well as of the United Arab Emirates,
Australia, Iceland, and the Veneto Region in Italy8. The big
limit of this approach is the impossibility of making statistical
inferences for the whole population based on the results.

b) The second possible strategy consists of diagnostic tests

through a probabilistic sample according to a planned design
for the estimation of the phenomena of interest with
predetermined precision levels. This approach is aimed at
estimating the effective amount of infections, including those
in the asymptomatic population. This approach was used in
the project performed by the Helmholtz Center for Research
on Infections in Germany; this project was based on testing
patients’ blood for antibodies to the Covid-19 pathogen and
involved over 100,000 individuals (Hackenbroch, 2020).
Similarly, in Romania, a random sample of 10,500 people
living in Bucharest has been planned to detect infected
persons by following the directions of the Matei Bals Institute
of Infectious Diseases in Bucharest (Romania-insider.com,
2020). Finally, a random selection of people who do not meet
the testing criteria will be observed at two Canberra locations
by the Australian Capital Territory (Abc, 2020). All these
sample surveys are cross-sectional and useful for measuring
the infection rate at a precise instant. However, they have
distinct characteristics from those of continuous panel-type
c) The third strategy consists of a specific massive web
survey collected from individuals and households that decide
to participate on a voluntary basis. Some 60,000 Israelis
completed the online daily survey developed by the
Weizmann Institute. The participants disclosed personal
details, such as their age, gender, address, general state of
health, isolation status and any symptoms they may have
been experiencing (Rossman et al., 2020). We observed
examples of the same strategy in Iceland, Estonia and other
countries. The results allow us to compare contagion and
testing experiences for people and households with different
socioeconomic characteristics. For strategy a), the
selfselection mechanism in the sampling process makes it
impossible to extend the results to the whole population

d) Another possible strategy is to use pre-existing sample

surveys and partially modify them to collect information
about the epidemic. Creating an EU ‘Corona Panel’, which
is a standardized European sample test to uncover the true
spread of the coronavirus, is indeed the proposal of the
Centre for European Policy Studies, as presented by Daniel
Gros (2020). The proposal refers, in particular, to the use of
the EU-wide sample of the
 SAMPLE SIZE
How small clinical trial sample sizes can offer
important findings
Scientists have been racing to develop COVID-19
vaccines that could reach millions, yet many of the
studies have surprisingly small sample sizes drawn from
the clinical trials. Does that matter?

Before a vaccine or drug is made available to the public it

normally needs to undergo clinical trials, some of which
involve tens of thousands of people. But, as we have seen
with interim results for some COVID-19 vaccines, often
only a small proportion, or sample, of these people
actually end up exposed to the virus. 

Moderna recently reported that its vaccine candidate had

an efficacy of 94.5% after phase 3 trials involving 30,000
volunteers began in July – yet only 95 people in the trial
have so far actually contracted COVID-19, and only five of
them had been vaccinated. Based on these results, the
company has said it will have 20 million doses by the end
of the year.
The Pfizer/BioNTech vaccine trial that made it through phase
3 trials with an efficacy of 95%, had 170 cases of COVID-19
(it’s worth noting that sample size is different to trial size,
which in this case is 43,000 participants). But though the
sample sizes may seem tiny, many important drugs or
vaccines have been found with similarly small sample sizes. 
FROM HIV TO EBOLA
Trials with a very small sample size might not seem to have
enough statistical “power” to be able to determine whether a
drug or vaccine is effective at treating or preventing disease.
Yet, for diseases that are either life-threatening (e.g. COVID-
19) or rare (certain cancers), trying to test a vaccine in larger
numbers of people than are needed to reach a decision on its
efficacy could be challenging and even unethical. A key
question on ethics is how efficacious the intervention will need
to be to make using it worthwhile. COVID-19 vaccine trials
were actually geared towards detecting a lower level of
efficacy because that would justify their use.

In 2015, when scientists were trying to find a vaccine to

stop the Ebola outbreak in West Africa from spreading, the
vaccine was declared 100% efficacious after 16 cases of
disease in a ring vaccination trial. Back in 1994, the drug
zidovudine, used to stop mother-to-child transmission of
HIV, was scaled-up based on a trial which was stopped
early after 53 cases of disease.
A key factor is that sample size is only meaningful in the
context of the efficacy of the intervention. The more
efficacious the intervention, the smaller the number of
clinical outcomes needed to demonstrate its efficacy. If all of
the negative outcomes are in the control group, the value of
the intervention becomes clear very quickly. 
 DATA COLLECTION METHODS

The current COVID-19 pandemic raises important questions about

opening, sharing and using data, and highlights the challenges
associated with data use. To address the ongoing need for data-
driven decision making, Open Data Watch has put together some
of the most helpful articles we’ve found, organized by the stages of
the data value chain: availability, openness, dissemination, and use
and uptake. These will be updated as new information becomes
available and new resources will be noted with each update by the
text *New*. The date of publication is listed beside each article;
however, dates are not shown for dashboards and data sources
that are dynamically updated. If you know of something more to
add, please contact us.

Vaccine distribution brings new data

challenges and opportunities
The world was greeted with a wave of positive results from
vaccine trials in November. With a vaccine in place, countries
can reach herd immunity and stop the spread of the virus.
Governments around the world are now dealing with the next
challenge, how to distribute and vaccinate their populations
and who should be vaccinated first? There are a huge number
of logistical challenges to this task and data will be critical to
solving it. For this new update of our COVID-19 resource page,
the ODW team has added 
a new section on vaccination data and resources to help solve
these challenges.
Availability
What data are available to understand the spread of COVID-19?
•In anticipation of the academic year, Alisha Morris, a theater
teacher in Kansas’ Olathe School District, 
developed a national database to track COVID-19 related sc
hool closings, quarantines, cases, and deaths
. (8/17/20)
•The Openpath Social Distancing Index provides 
real-time data on social distancing rates across US states.
•COVID-19-related imaging data and AI resources compiled
by Stanford University’s Center for Artificial Intelligence in
Medicine & Imaging.
•The Group on Earth Observations (GEO) has collated a 
list of resources from member organizations on earth observ
ation data to fight COVID-19
.
•The Center for Disease Control has released its 
first dataset on COVID-19 cases in children in the United Sta
tes
. (4/6/20)
•The United Nations Statistics Division, in partnership with
ESRI, 
launched a new COVID-19 data hub to disseminate COVID-
19 data that is interoperable with data on national platforms
.
•Data.World curated a collection of COVID-19 data sources.
•The World Bank curates a collection of COVID-19 datasets
 and a 
dashboard for understanding the COVID-19 pandemic throu
gh data
.
•The World Health Organization (WHO) provides daily status
 FINDINGS
Coronavirus Vaccine Progress
The FDA granted emergency use authorization to
Pfizer/BioNTech's COVID-19 vaccine for people 16 years of
age and older on Dece. 11, 2020. The push to distribute it to
all 50 states began the following day in operation that was
months in the making. A week later, the same authroizationb
was granted to a vaccine by Moderna.

The CDC has recommended that health care workers and

the elderly be the first to receive the vaccine. It could be
spring or even summer before enough of the vaccine can be
manufactured to help inoculate the general public.

Britain approved and began administering the same Pfizer

vaccine earlier the same week of the FDA approval. Two
people who received it had adverse allergic reactions, so at
present time, people who have a history of severe allergies
 are advised not to take it. It is also unclear what affect it
may have on pregnant women.

Both the Pfizer and Moderna vaccines have shown over

90% efficacy and require two doses which are administered
several weeks apart. China and Russia have both
developed their own vaccines which are being used in other
countries.
The Pfizer vaccine uses messenger RNA (mRNA). This is
what carries the instructions for making the “spike” protein
that lets the virus enter human cells. The mRNA vaccine
tells your immune cells to make the protein and act as if
they’ve already been infected with the coronavirus, giving
you some immunity against it.

Another vaccine candidate uses DNA that’s designed to

trigger an immune response to the virus.

Still another candidate uses the recombinant vesicular

stomatitis virus (rVSV) which was used to create the Ebola
vaccine.

Several vaccines have weakened versions of the

adenovirus, one of the viruses that causes the common
cold. It’s been combined with genes from the new
coronavirus’ spike protein to trigger your immune system
to fight it.

Yet other vaccines teach your immune system to target

the coronavirus by using versions of the spike protein or
the virus itself.

Some of the companies working on vaccines are also

looking for ways to ramp up production quickly when the
clinical trials find one that works safely. With more than 300
million people in the United States alone, mass vaccination
will be a joint effort among several companies and
government agencies.
This version of the coronavirus only surfaced in late 2019.
Normally developing a new vaccine for a new virus takes
years, but scientists were able to get a boost from research
on similar coronaviruses that cause severe acute
respiratory syndrome (SARS) and Middle East respiratory
syndrome (MERS).

Experts say this coronavirus could eventually turn out to be

seasonal, like colds and the flu. A vaccine would be vital to
helping control it.

What Does a COVID-19 Vaccine Do?

When you come into contact with viruses or bacteria, your
body’s immune system makes antibodies to fight them off.

A vaccine forces your immune system to make antibodies

against a specific disease, usually with a dead or
weakened form of the germs. Then, if you come into
contact with them again, your immune system knows what
to do. The vaccine gives you immunity, so you don’t get
sick or so your illness is much milder than it otherwise
would have been.

How Are Vaccines Developed?

The development of a vaccine against COVID-19 has
taken place in an unparalled pace. Usually such a process
takes years, but the scope of the pandemic triggered
round-the-clock work by thousands of researchers working
on over 100 different forms of the vaccine.
The development of a vaccine against COVID-19 has
taken place in an unparalled pace. Usually such a process
takes years, but the scope of the pandemic triggered
round-the-clock work by thousands of researchers working
on over 100 different forms of the vaccine.

Effectiveness and safety were key concerns and the Pfizer

vaccine approved in the U.S. for emergency use has been
found to have 95% efficacy after its second dose.

Before any vaccine can be used widely, it must go through

development and testing to make sure that it’s effective
against the virus or bacteria and that it doesn’t cause
other problems. The stages of development generally
follow this timeline:

•Exploratory stage. This is the start of lab research to find

something that can treat or prevent a disease. It often lasts
2 to 4 years.

•Pre-clinical stage. Scientists use lab tests and testing in

animals, such as mice or monkeys, to learn whether a
vaccine might work. This stage usually lasts 1 to 2 years.
Many potential vaccines don’t make it past this point. But if
the tests are successful and the FDA signs off, it’s on to
clinical testing.
•Clinical development. This is a three-phase process of
testing in humans. Phase I usually lasts 1 to 2 years and
involves fewer than 100 people. Phase II takes at least 2
years and includes several hundred people. Phase III
lasts 3 or 4 years and involves thousands of people.
Overall, the clinical trial process may stretch to 15 years
or more. About a third of vaccines make it from phase I
to final approval.

•Regulatory review and approval. Scientists with the

FDA and CDC go over the data from the clinical trials and
sign off.

•Manufacturing. The vaccine goes into production. The

FDA inspects the factory and approves drug labels.

•Quality control. Scientists and government agencies

keep tabs on the drug-making process and on people who
get the vaccine. They want to make sure it keeps working
safely.
SUGGESTION AND RECCOMENDATION
COVID-19 Vaccine Recommendations
When the Food and Drug Administration (FDA) authorizes or
approves a COVID-19 vaccine, the Advisory Committee on
Immunization Practices (ACIP) will quickly hold a public
meeting to review all available data about that vaccine (sign
up to receive email updates whenever 
ACIP’s Meeting Information is updated). Before making
recommendations, ACIP reviews all available clinical trial
information, including descriptions of:

•Who is receiving each vaccine (age, race, ethnicity, 

underlying medical conditions)

•How different groups respond to the vaccine

•Side effects of each vaccine

From these data, ACIP will then vote on whether to

recommend the vaccine. ACIP also votes on
recommendations for 
who should be offered COVID-19 vaccine first when supp
lies are limited
.
Ethical principles
ACIP identified four ethical principles to guide their decision-
making process when supply is limited:

•Maximize benefits and minimize harms — Respect and

care for people using the best available data to promote
public health and minimize death and severe illness.

•Mitigate health inequities — Reduce health disparities in

the burden of COVID-19 disease and death, and make sure
everyone has the opportunity to be as healthy as possible.

•Promote justice — Treat affected groups, populations,

and communities fairly. Remove unfair, unjust, and
avoidable barriers to COVID-19 vaccination.

•Promote transparency — Make a decision that is clear,

understandable, and open for review. Allow and seek public
participation in the creation and review of the decision
processes.

The Advisory Committee on Immunization Practices (ACIP)

 provides advice and guidance to the Director of the CDC
regarding use of vaccines and related agents for control of
vaccine-preventable diseases in the civilian population of
the United States. Recommendations made by the ACIP
are reviewed by the CDC Director and, if adopted, are
published as official CDC/HHS recommendations in the
Morbidity and Mortality Weekly Report (MMWR).
 CONCLUSION
There are hundreds of coronaviruses, most of which
circulate in animals. Only seven of these viruses infect
humans and four of them cause symptoms of the common
cold. But, three times in the last 20 years, a coronavirus
has jumped from animals to humans to cause severe
disease.

SARS, a beta coronavirus emerged in 2002 and was

controlled mainly by aggressive public health measures.
There have been no new cases since 2004. MERS
emerged in 2012, still exists in camels, and can infect
people who have close contact with them.

COVID-19, a new and sometimes deadly respiratory

illness that is believed to have originated in a live animal
market in China, has spread rapidly throughout that
country and the world.

The new coronavirus was first detected in Wuhan, China

in December 2019. Tens of thousands of people were
infected in China, with the virus spreading easily from
person-to-person in many parts of that country.
The novel coronavirus infections were at first associated
with travel from Wuhan, but the virus has now established
itself in 177 countries and territories around the world in a
rapidly expanding pandemic. Health officials in the United
States and around the world are working to contain the
spread of the virus through public health measures such
as social distancing, contact tracing, testing, quarantines
and travel restrictions. Scientists are working to find
medications to treat the disease and to develop a vaccine.

The World Health Organization declared the novel

coronavirus outbreak “a public health emergency of
international concern” on January 30. On March 11, 2020
after sustained spread of the disease outside of China, the
World Health Organization declared the COVID-19
epidemic a pandemic. Public health measures like ones
implemented in China and now around the world, will
hopefully blunt the spread of the virus while treatments
and a vaccine are developed to stop it.
 LIMITATION OF STUDY
The Public Must Be Aware of the COVID-19
Vaccine’s Limitations

There is euphoria following the pharmaceutical company

Pfizer’s press release  on November 9 that on a review of
preliminary results, its vaccine candidate was found to be
“more than 90% effective in preventing COVID-19” among
trial participants.
The announcement was widely criticised for being
misleading, while a number of other companies rushed to
announce that their trial results were due shortly.

Over this clamour of claims and counterclaims, scientists

have pointed out limitations in the way in which vaccine
candidates are being tested, which requires a more sober
appraisal. The urgent need for a vaccine against COVID-
19 may lead to the use of vaccines of limited value and
less than ideal information on their safety. The people
must understand these constraints. They must also be
assured that the vaccine will be rolled out with all the
necessary precautions for follow-ups and the investigation
of possible vaccine-related injuries

For some months now, we have been following the race

for a COVID-19 vaccine – the shot that will let us go
back to living a normal life. This has been marked by
dramatic flourishes.

One such was when the CEO of the Serum Institute of

India, Adar Poonawalla, announced the manufacture of
millions of doses of a number of vaccine candidates even
before trials had started, so that if an effective vaccine was
found, it would be available right away for distribution.
Some months later, he tweeted asking the Indian
government whether it was ready with Rs 80,000 crore so
that all Indians could get the vaccine in the next year. All
this, before the vaccine candidate has even been proven to
work.
Such reports built up to a drumroll on November 9 when
Pfizer issued a press release with the preliminary results
of its vaccine candidate, developed along with BioNTech.
The same day, WHO’s chief research officer tweeted:
“The shot that rang across the world – Pfizer’s and
BioNTech’s vaccine is the start of the end of the
pandemic.” Shortly after Pfizer’s stocks rose by 15%. And
interestingly, on the same day, its chief executive sold
62% of his stock at near-peak prices. The company also
announced that it would have enough data to apply for
emergency use authorisation in the US by the end of the
month.

This was not surprising – only more evidence of the high

financial stakes in the COVID-19 vaccine race. Indeed, a
good amount of the reporting on COVID-19 vaccines
consists of press releases with an eye on the market.

Now, we are given to understand that the vaccine is almost

upon us, and the discussion has become focused on logistical
issues, such as the need to store it at very low temperatures.
And since there will be limited supplies initially, we are called
upon to plan for who should get the vaccine on first.
 BIBLOGRAPHY
Workshop on Ensuring Access to Priority Medic
ines for Mothers and Children, Manila, Philippi
nes, 15 to 17 August 2011 : report
 
World Health Organization. Regional Office for
the Western Pacific (Manila : WHO Regional
Office for the Western Pacific, 2011)

Bibliography for COVID-19

REALM Project - OCLC/IMLS/Batelle - Collaboration to
conduct research on how long the COVID-19 virus
survives on various materials. (Added 7/20/20)

Round 1 Test Results - Hardback book cover, softback

book cover, plain paper pages inside a closed book,
plastic book cover, DVD case

Round 2 Test Results - Braille paper pages, glossy paper

pages, magazine pages, children's board book, archival
folders
The joint webinar with IMLS and CDC had the most specific
advice for libraries and librarians handling paper materials.
A summary and a recording of the session are available
here: 
https://www.imls.gov/webinars/mitigating-covid-19-when-ma
naging-paper-based-circulating-and-other-types-collections

In addition to stating that paper is not a material that will

keep a virus alive, David Berendes, an epidemiologist at the
CDC said that any survival was noted in ideal lab
conditions, not real world conditions. They recommend
good basic hygiene and quarantining books for a 24 hour
period before touching them. Also included in the summary
(and recording) are recommendations about having signage
inside the building and plenty of cleaning and disinfecting
supplies on hand.

CDC Guidance for Schools and Child Care Programs: 

https://www.cdc.gov/coronavirus/2019-ncov/community/sch
ools-childcare/index.html

The “At all times…” segment should be applicable to any

area that employees are in. This section states it is for
schools and childcare programs, but can be applied to any
public building. Community members and staff should be
encouraged to protect their personal health, and signs
detailing symptoms of COVID-19 should be posted in
public areas.
CDC How to Clean and Disinfect: 
https://www.cdc.gov/coronavirus/2019-ncov/community/disinfe
cting-building-facility.html

Covers the basics of how to clean various surfaces and what

cleaners work best. Has a printer friendly version that could
be printed out and hung in the library.
CDC Interim Recommendations for U.S. Community
Facilities with Suspected/Confirmed Coronavirus Disease
2019: 
https://www.cdc.gov/coronavirus/2019-ncov/community/or
ganizations/cleaning-disinfection.html
OSHA COVID-19 Resource page: 
https://www.osha.gov/SLTC/covid-19/controlprevention.ht
ml#health

General guidance for all workers and employers. Breaks

down information by work environment and outlines risk
to workers and employers. The Retail Workers section
seems most similar to libraries offering curbside service
and lists the exposure risk levels as Lower or Medium.
Outlines what steps to take for establishing protocols and
safe work practices.
 QUESTIONNAIRE
How do mRNA vaccines work?
People make mRNA all the time. In our cells, DNA in the
nucleus is used to make mRNA, which is sent to the
cytoplasm where it serves as a blueprint to make proteins.
Most of the time, the proteins that are produced are
needed to help our bodies function.
mRNA vaccines take advantage of this process by
introducing the mRNA for an important protein from the
virus that the vaccine is trying to protect against. In the
case of COVID-19, the important protein is the spike
protein of the SARS-CoV-2 virus. The mRNA that codes
for the SARS-CoV-2 spike protein is taken up by cells
called dendritic cells, which express the spike protein on
the cell surface, travel to a local lymph node, and
stimulate other cells of the immune system (B cells) to
make antibodies. These antibodies protect us, so that if
we are exposed to SARS-CoV-2 in the future, our immune
system is ready and we don’t get sick. (See more about
dendritic
cells and the adaptive immune system in this animation.)
Where can I get the vaccine?
Each state is creating their own plan for vaccine distribution.
While these plans are based on guidance from the CDC, each
is a bit different to accommodate the unique needs of their
populations as well as to account for the disease statistics in
their area, number of doses of vaccines they expect to receive
in the early days, etc. As such, we suggest checking your
state health department website as most of the states have
put their plans on their website. Some states also have
opportunities to sign up for text or email alerts to stay abreast
of COVID-19 vaccine distribution information.

What are the side effects of the mRNA

vaccine?
Side effects from both mRNA vaccines are caused as part of
the immune response to the vaccines. In some ways, the
more vigorous the immune response, the more common the
side effects.
The most common side effects from the mRNA vaccines are:
•Fatigue
•Headache
•Muscle aches
Side effects occurred during the first week after vaccination,
but were most likely one or two days after receipt of the
vaccine. Side effects were more frequent following the
second dose and more likely to be experienced by younger,
rather than older, recipients. Although most people will not
Can I take medicine for the side effects after I
get the vaccine?
The CDC has indicated that you can take anti-fever or anti-
inflammatory medications if necessary following COVID-19
vaccination, but it is important to know that doing so could
diminish the level of immunity that develops. This is true
anytime you take these types of medications, whether
following vaccination or to treat illness. Generally speaking,
the “symptoms” people experience following vaccination or
during illness, such as fever, redness, or fatigue, are caused
by your immune system responding. For example, fever is
your body turning up its “thermostat” to make the immune
system more efficient and the pathogen less efficient. For
these reasons, if you are not very uncomfortable, it is better
not to take these medications.

Some wonder how long they should wait after vaccination

before taking these types of medicines, so their immune
response is not affected. As a rule of thumb, the immune
response develops over a week or two after vaccination,
but the greatest chance of affecting your immune
response would be in the first few days after receipt of the
vaccine.