COVID VACCINE

WHERE ARE WE?

PRESENTER: MADHU RAUNIYAR

MODERATER: DR. MUKESH BHATTA
 Current global situation
• 32,429,965 confirmed cases
• 985,823 deaths
Situation by WHO region
 Situation In India and Nepal
•  India:  
5,903,932 confirmed cases of COVID-19
with 93,379 deaths.

• Nepal
72000 confirmed cases, 475 deaths and 53013
recovered.
 When will a COVID-19 vaccine be ready?

• Lengthy and expensive process

• Developing a vaccine more rapidly as a response to the COVID-19
outbreak requires a different approach and has been estimated to take
around 12 to 18 months.

This includes:
• A rapid start of development by using novel platforms like mRNA
and DNA, that use synthetic processes that are faster than
traditional platforms that recreate the virus

• Vaccine development steps that are executed in parallel, e.g.

initial trials in humans (phase 1 clinical trials) may proceed in
parallel with animal studies
 Challenges
• Limited experience with novel mRNA and DNA platforms with some
uncertainty these platforms will work

• Financial risks

• Where and when to start clinical trials during the COVID-19 outbreak may
be hard to predict

• Ensure not to overburden countries when several candidate vaccines are

ready for human efficacy trials

• Placebo-controlled trials might be perceived to be unacceptable during the

COVID-19 outbreak
 Estimated cost?

• ?Somewhere between $ 4 to $40 per

dose.
 Addressing the challenges
• Vaccine development through traditional platforms must continue
to make sure that more tried and tested platforms are included
even though the initial development phase of these traditional
platforms takes longer

• Coalition for epidemic preparedness innovation (CEPI) supports:

o vaccine development and raises funds for vaccine candidates from
phase 2 trials on
o development of new platform technologies
o the creation of a global network to ensure equitable vaccine
distribution
 Difference between Traditional Vaccine Development
and Development Using a Pandemic Paradigm.

N Lurie et al. N Engl J Med 2020;382:1969-1973.

 The Vaccine Testing Process

• PRECLINICAL TESTING: A new vaccine is tested on cells and then

given it to animals such as mice or monkeys to see if it produces an
immune response.

• PHASE 1 SAFETY TRIALS: The vaccine is given to a small number of

people to test safety and dosage as well as to confirm that it
stimulates the immune system.

• PHASE 2 EXPANDED TRIALS: The vaccine is given to hundreds of

people split into groups, such as children and the elderly, to see if
the vaccine acts differently in them. These trials further test the
vaccine’s safety and ability to stimulate the immune system.
• PHASE 3 EFFICACY TRIALS: The vaccine is given to thousands of
people and wait to see how many become infected, compared with
volunteers who received a placebo. These trials can determine if
the vaccine protects against the coronavirus.

• EARLY OR LIMITED APPROVAL: China and Russia have approved

vaccines without waiting for the results of Phase 3 trials.
• APPROVAL: Regulators in each country review the trial results and
decide whether to approve the vaccine or not. During a pandemic, a
vaccine may receive emergency use authorization before getting
formal approval. Once a vaccine is licensed, researchers continue to
monitor people who receive it to make sure it’s safe and effective.

• COMBINED PHASES: To accelerate vaccine development is to

combine phases. Some coronavirus vaccines are now in Phase 1/2
trials, for example, in which they are tested for the first time on
hundreds of people.
 Vaccine prioritization for WHO Phase IIb/III
clinical trial

• Safety profile: 25 points

• Potential for efficacy : 25 points
• Vaccine stability : 10 points
• Vaccine implementation: 15 points
• Vaccine availability : 25 points
 COVID 19 vaccine
According to The New York Times
Coronavirus 19 vaccine tracker(updated on 25th september)
 Genetic Vaccines
Vaccines that deliver one or more of the coronavirus’s own genes
into our cells to provoke an immune response.
Phase 3
• MODERA/NIH: mRNA based

Phase 2 and 3
• BioNTech with Pfizer, based in New York, and the Chinese drug
maker Fosun Pharma: mRNA based

Phase 2
• Indian vaccine-maker Zydus Cadila : DNA-based
• CureVAc: mRNA based
Phase 1 and 2
Imperial College London : self amplifying RNA vaccine
Osaka University/ AnGes/ Takara Bio : mRNA

Phase 1
Inovio, Genexine  : DNA-based

Preclinical:
 Sanofi with Translate Bio: mRNA
 Viral Vector Vaccines

• Vaccines that contain viruses engineered to carry coronavirus

genes. Some viral vector vaccines enter cells and cause them to
make viral proteins. Other viral vectors slowly replicate, carrying
coronavirus proteins on their surface.

Phase 3
• CanSino Biological Inc./Beijing Institute of Biotechnology
• Gamaleya Research Institute
• Johnson & Johnson

Phase 2 Phase 3
• University of Oxford/AstraZeneca
 Viral Vector Vaccines

Phase 1
• ReiThera/LEUKOCARE/Univercells
• Institute Pasteur/Themis/Univ. of Pittsburg CVR/Merck Sharp
& Dohme
• Beijing Wantai Biological Pharmacy/ Xiamen University
• Vaxart

Preclinical
• IAVI/Merck
 Protein-Based Vaccines

• Vaccines that contain coronavirus proteins but no genetic material.

Some vaccines contain whole proteins, and some contain fragments
of them. Some pack many of these molecules on nanoparticles.
Phase 3
• Novavax
• Anhui Zhifei Longcom Biopharmaceutical/Institute of Microbiology,
Chinese Academy of Sciences

Phase 1 and 2
•  Finlay Vaccine Institute
• Sanofi Pasteur/GSK
• SpyBiotech/Serum Institute of India
Phase 1
• Clover Biopharmaceuticals Inc./GSK/Dynavax
• Vaxine
• Medigen Vaccine Biologics Corporation/NIAID/Dynav
• COVAXX

Preclinical
• Univ. of Pittsburgh
• Baylor College of Medicine
Inactivated or Attenuated Coronavirus Vaccines
• Vaccines created from weakened coronaviruses or coronaviruses that have been killed with
chemicals.

Phase 3
• Sinovac Biotech: CoronaVac
• Wuhan Institute of Biological Products/Sinopharm
• Beijing Institute of Biological Products/Sinopharm

Phase 1 and 2
• Bharat Biotech : Covaxin

Phase 1
Research Institute for Biological Safety Problems

Preclinical: Washington University; Western University

 Repurposed Vaccines
• Vaccines already in use for other diseases that may also
protect against Covid-19.

Murdoch Children’s Research Institute in Australia

is conducting a Phase 3 trial called the BRACE to see if BCG
vaccine partly protects against the coronavirus.
 Vaccines in phase 3 trial
COVID-19 Vaccine Type of Number Timing Route of
Vaccine platform candidate of doses of doses Administration
developer/man vaccine
ufacturer

University of Non- ChAdOx1-S 1 IM

Oxford/ Replicating
AstraZeneca Viral Vector

CanSino Non- Adenovirus 1 IM

Biological Replicating Type 5
Inc./Beijing Viral Vector Vector
Institute of
Biotechnology
Gamaleya Non- Adeno- 2 0,21 IM
Research Replicating based days
Institute Viral Vector (rAd26-
S+rAd5-S)
COVID-19 Vaccine Type of Number Timing Route of
Vaccine platform candidate of doses of doses Administration
developer/man vaccine
ufacturer

Janssen Non- Ad26COVS1 2 0,56 IM

Pharmaceutical Replicating days
Companies Viral Vector

Sinovac Inactivated Inactivated 2 0, 14 IM

days
Wuhan Institute Inactivated Inactivated 2 0, 21 IM
of Biological days
Products/Sinoph
arm
COVID-19 Vaccine Type of Number Timing Route of
Vaccine platform candidate of doses of doses Administration
developer/man vaccine
ufacturer

Beijing Institute Inactivated Inactivated 2 0, 21 IM

of Biological days
Products/Sinoph
arm
RNA LNP- 2 0, 28 IM
Moderna/NIAID encapsulate days
d mRNA
BioNTech/Fosun RNA 3 LNP-mRNA 2 0, 28 IM
Pharma/Pfizer daysIM
 Non injectable vaccines

COVID-19 Vaccine Vaccine Type of Number Timing of Route of Clinical

developer/manuf platform candidate of doses doses Administra stage
acturer vaccine tion

Inovio DNA DNA plasmid 2 0, 28 days ID Phase 2

Pharmaceuticals/ vaccine with
International electroporation
Vaccine Institute

University Hospital Protein SARS-CoV-2 1 SC Phase 1

Tuebingen Subunit HLA-DR
peptides

Cadila Healthcare DNA DNA plasmid 3 0, 28, 56 ID Phase

Limited vaccine days 1/2

Vaxart Non- Ad5 adjuvanted 2 0, 28 days Oral Phase 1

Replicatin Oral Vaccine
g Viral platform
Vector
 Vaccines approved

• CanSino Biologics with  Academy of Military Medical Sciences:

vaccine based on an adenovirus; Ad5

• Chinese military approved the vaccine on June 25 for a year as a

“specially needed drug”

• In August, CanSino : Phase 3 trials in a number of countries,

including Saudi Arabia, Pakistan and Russia.
• Sinovac Biotech : an inactivated vaccine; CoronaVac

• In June: Phase 1/2 trials on 743 volunteers found no severe adverse

effects and produced an immune response

• Chinese government gave the Sinovac vaccine an emergency

approval for limited use in July
Sinopharm put into clinical tests 2 vaccines by
• Beijing Institute of Biological Products.
They launched Phase 3 trials in the United Arab Emirates in July, and
in Peru and Morocco the following month

• Wuhan Institute of Biological Products

They launched Phase 3 trials in the United Arab Emirates
and Argentina

The government gave Sinopharm approval to inject hundreds of

thousands of people with its two experimental vaccines. On Sept.
14, the U.A.E. gave emergency approval for Sinopharm’s vaccine to
use on health care workers
Pool party in Wuhan post covid;? Herd
immunity? Mass vaccination achieved
• Gamaleya Research Institute, part of Russia’s Ministry of Health:
clinical trials in June ; Gam-Covid-Vac.

• Combination of two adenoviruses, Ad5 and Ad26, both engineered

with a coronavirus gene.

• On Aug. 11, Russian health care regulator approved the vaccine,

renamed Sputnik V, before Phase 3 trials had begun. 
 The Russian vaccine for COVID-19

• On Aug 11, 2020, Russia approved a vaccine.

• The vaccine, which is based on two adenovirus

vectors, was developed by the Gamaleya
National Center of Epidemiology and
Microbiology (Moscow, Russia).
 The Russian vaccine for COVID-19
• At the time of approval, the vaccine had not
even started phase 3 trials, nor had any results
on the earlier stage trials been published.

• Since then, the phase 1/2 results have been

published in The Lancet. The vaccine induced
a strong immune response in all 76
participants.
 The Russian vaccine for COVID-19
• The Russian vaccine is named Sputnik V, after
the Soviet-era space programme.
• One person to have received it is the
president's daughter.
•  Mass production began in September, 2020
• United Arab Emirates, Saudi Arabia, the
Philippines, and possibly India or Brazil, will
join the clinical trials of Sputnik V locally
 WHO updates
• According to WHO, 169 COVID-19 vaccine candidates under
development, with 26 of these in the human trial phase.

• 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.
 The Access to COVID-19 Tools (ACT)
Accelerator
• Global collaboration to accelerate development, production, and
equitable access to COVID-19 tests, treatments, and vaccines.

• Brings together governments, scientists, businesses, civil society,

and philanthropists and global health organizations (the Bill &
Melinda Gates Foundation,  CEPI, FIND,  Gavi, The Global Fund, 
Unitaid, Wellcome, the WHO, and the World Bank).

• The ACT-Accelerator is organized into four pillars of work:

diagnostics, treatment, vaccines and health system strengthening
 WHAT IS COVAX?
• COVAX is one of four pillars of the Access to COVID-19 Tools (ACT)
Accelerator, which was launched in April by the World Health
Organization (WHO), the European Commission and France in response to
this pandemic.

• Coordinated by Gavi, the Vaccine Alliance, the Coalition for Epidemic

Preparedness Innovations (CEPI) and the WHO

• Aim : providing innovative and equitable access to COVID-19 vaccines.

• Acts as a platform that will support the research, development and

manufacturing of a wide range of COVID-19 vaccine candidates, and
negotiate their pricing.
Can Nepal afford to buy COVID Vaccine?
• Yes: with donor aid

• No: on its own.

• Total budget for the current fiscal year: 1474.64

billion NPR.

• Health sector: 90.69 billion= 6.14% (previous fiscal

year: 68.78 billion)
Thank you