COVID-19 VACCINES

1. COVID-19 vaccines
Prof.Amal Sayed
IPC Director
CUH

3. Vaccine prospects
The COVID-19 candidates, like all vaccines, essentially
aim to instruct the immune system to mount a
defense, which is sometimes stronger than what
would be provided through natural
infection and comes with fewer health consequences.

4. COVID-19 vaccine types in development
Candidates in Clinical Phases I-III

5. Vaccines Development
To do so, traditional vaccines use
the whole coronavirus, but in a
killed or weakened state.
Others use only part of the virus—
whether a protein or a fragment.
Some transfer the instructions for
coronavirus proteins into an unrelated
virus that is unlikely or even incapable of
causing disease.
Finally, cutting-edge vaccines under
development rely on deploying pieces of the
coronavirus’s genetic material, enabling our
cells to temporarily make coronavirus proteins
needed to stimulate our immune systems.

6. COVID-19 vaccine types in development

7. There are more vaccine candidates
simultaneously in the pipeline for COVID-19
than ever before for an infectious disease.
All of them are trying to achieve the
same thing – immunity to the virus,
and some might also be able to stop
transmission.
They do so by stimulating an
immune response to an antigen,
a molecule found on the virus.
In the case of COVID-19, the antigen
is typically the characteristic spike
protein found on the surface of the
virus, which it normally uses to help
it invade human cells.

8. THE FOUR MAIN TYPES OF
COVID-19 VACCINE
There are four categories of vaccines in
clinical trials:
WHOLE VIRUS
PROTEIN
SUBUNIT
VIRAL
VECTOR
NUCLEIC ACID
(RNA AND
DNA)
Some of them try to smuggle the antigen
into the body, others use the body’s own
cells to make the viral antigen.

9. Whole viruses
vaccines
Many conventional vaccines
use whole viruses to trigger
an immune response.
There are two main
approaches.
Live attenuated vaccines
use a weakened form of
the virus that can still
replicate without causing
illness.
Inactivated vaccines use viruses
whose genetic material has been
destroyed so they cannot
replicate, but can still trigger an
immune response.

11. Knocked-out
whole virus
Uses a non-infectious form of the coronavirus that can
no longer cause full-blown disease but can still provoke
an immune response.
The virus can either be fully inactivated or weakened.
These modes are considered the most classic ways to
make vaccines.

12. Both types use well-established technology and
pathways for regulatory approval, but live
attenuated ones may risk causing disease in
people with weak immune systems and often
require careful cold storage, making their use
more challenging in low-resource countries.
Inactivated virus vaccines can be given
to people with compromised immune
systems but might also need cold
storage.

13. Whole virus vaccines
Both are tried and tested vaccination strategies, which form the basis of many
existing vaccines – including those for yellow fever and measles (live attenuated
vaccines), or seasonal influenza and hepatitis A (inactivated vaccines). Bacterial
attenuated vaccines also exist, such as the BCG vaccine for tuberculosis
Live attenuated vaccines use a weakened
form of the virus, which can still grow and
replicate, but does not cause illness.
Inactivated vaccines contain viruses
whose genetic material has been
destroyed by heat, chemicals or radiation
so they cannot infect cells and replicate,
but can still trigger an immune response.

14. ADVANTAGES AND DISADVANTAGES OF
LIVE ATTENUATED VACCINES

15. ADVANTAGES AND DISADVANTAGES OF INACTIVATED
VIRUS VACCINES

16. HOW DO WHOLE VIRUS VACCINES TRIGGER IMMUNITY?
Both live attenuated and inactivated vaccines contain the whole or
part of the disease-causing pathogen, but the type of immunity they
trigger is slightly different.
*Live attenuated vaccines are derived from viruses that
have been weakened under laboratory conditions, so that
when injected they will infect cells and replicate but cause
no or only very mild disease.
*They may be unsuitable for people with compromised
immune systems (e.g. those with HIV) and pregnant
women though, because even a weakened virus may
trigger disease in these individuals.

17. live attenuated vaccines
Because these vaccines are simply weakened
versions of natural pathogens, the immune
system responds as it would to any other
cellular invader, mobilizing a range of defenses
against it, including killer T cells (which identify
and destroy infected cells), helper T cells (which
support antibody production) and antibody-
producing B cells (which target pathogens
lurking elsewhere in the body, e.g. the blood).
This immune response continues until
the virus is cleared from the body,
meaning there is plenty of time for
memory cells against the virus to
develop.
Because of this, live attenuated vaccines
can trigger an immune response which is
almost as good as being exposed to the
wild virus, but without falling ill.

18. Inactivated virus vaccines
Inactivated virus vaccines also contain the disease-
causing virus, or parts of it, but their genetic material
has been destroyed.
For this reason, they are considered safer and more
stable than live attenuated vaccines, and they can be
given to people with compromised immune systems.
Even though their genetic material has been destroyed,
inactivated viruses usually contain many proteins which the
immune system can react to. But because they cannot infect
cells, inactivated vaccines only stimulate antibody-mediated
responses, and this response may be weaker and less long-
lived.
To overcome this problem, inactivated vaccines are often
given alongside adjuvants (agents that stimulate the
immune system) and booster doses may be required.

19. Protein subunits vaccines
Subunit vaccines use pieces of the
pathogen - often fragments of protein -
to trigger an immune response.
Doing so minimizes the risk of side
effects, but it also means the immune
response may be weaker.
This is why they often require adjuvants,
to help boost the immune response.
An example of an existing subunit
vaccine is the hepatitis B vaccine.

20. Protein: These vaccines are typically made from
coronavirus proteins, which can be synthesized
or brewed in labs like beer.
Some versions involve coating a carrier—such as
nanoparticles—with proteins to better aid delivery
and uptake by cells.

21. Protein subunits vaccines
Protein subunit vaccines are
considered very safe.
There are several types:
Protein subunit vaccines contain
specific isolated proteins from viral
or bacterial pathogens.
Polysaccharide vaccines contain
chains of sugar molecules
(polysaccharides) found in the cell
walls of some bacteria.
Conjugate subunit vaccines bind a
polysaccharide chain to a carrier
protein to try and boost the
immune response.
Only protein subunit vaccines
are being developed against the
virus that causes COVID-19.

22. ADVANTAGES AND DISADVANTAGES OF PROTEIN SUBUNIT
VACCINES

23. HOW DO SUBUNIT VACCINES TRIGGER IMMUNITY?
Subunit vaccines contain
fragments of protein and/or
polysaccharide from the
pathogen, which have been
carefully studied to identify
which combinations of these
molecules are likely to
produce a strong and
effective immune response.
By restricting the immune
system’s access to the pathogen
in this way, the risk of side
effects is minimized.
Such vaccines are also relatively
cheap and easy to produce, and
more stable than those
containing whole viruses or
bacteria.

25. Nucleic acid vaccines
Nucleic acid vaccines use genetic material – either RNA or DNA – to provide cells with the
instructions to make the antigen.
In the case of COVID-19, this is usually the viral spike protein.
Once this genetic material gets into human cells, it uses our cells' protein factories to make the
antigen that will trigger an immune response.
The advantages of such vaccines are that they are easy to make, and cheap.
Since the antigen is produced inside our own cells and in large quantities, the immune reaction
should be strong.
A downside, however, is that so far, no DNA or RNA vaccines have been licensed for human use,
which may cause more hurdles with regulatory approval.
In addition, RNA vaccines need to be kept at ultra-cold temperatures, -70C or lower, which could
prove challenging for countries that don’t have specialized cold storage equipment, particularly
low- and middle-income countries.

26. Nucleic acid vaccines
Nucleic acid vaccines use genetic
material from a disease-causing
virus or bacterium (a pathogen) to
stimulate an immune response
against it.
Depending on the vaccine, the genetic
material could be DNA or RNA; in both
cases it provides the instructions for
making a specific protein from the
pathogen, which the immune system will
recognize as foreign (an antigen).
Once inserted into host cells, this
genetic material is read by the cell’s
own protein-making machinery and
used to manufacture antigens, which
then trigger an immune response.

27. TYPES OF VACCINES
Nucleic acid: Relies on injecting
snippets of a virus’s genetic
material, either DNA or messenger
RNA (mRNA), into human cells.
It spurs the production of viral
proteins that mimic features of the
coronavirus, training the immune
system to recognize its presence.

28. ADVANTAGES AND DISADVANTAGES OF NUCLEIC ACID
VACCINES

29. HOW DO NUCLEIC ACID VACCINES TRIGGER IMMUNITY?
Once the DNA or RNA is inside the
cell and it starts producing antigens,
these are then displayed on its
surface, where they can be
detected by the immune system,
triggering a response.
This response includes killer T cells,
which seek out and destroy infected
cells, as well as antibody-producing
B cells and helper T cells which
support antibody production.

32. Viral vector vaccines
Viral vector vaccines also work by giving cells genetic instructions to produce antigens.
But they differ from nucleic acid vaccines in that they use a harmless virus, different from
the one the vaccine is targeting, to deliver these instructions into the cell.
One type of virus that has often been used as a vector is adenovirus, which causes the
common cold.
As with nucleic acid vaccines, our own cellular machinery is hijacked to produce the antigen
from those instructions, in order to trigger an immune response.
Viral vector vaccines can mimic natural viral infection and should therefore trigger a strong
immune response.
However, since there is a chance that many people may have already been exposed to the
viruses being used as vectors, some may be immune to it, making the vaccine less effective.

33. Viral vector-based
Viral vector-based vaccines differ from most conventional vaccines in that
they don’t actually contain antigens, but rather use the body’s own cells to
produce them.
They do this by using a modified virus (the vector) to deliver genetic code for
antigen, in the case of COVID-19 spike proteins found on the surface of the
virus, into human cells.
By infecting cells and instructing them to make large amounts of antigen,
which then trigger an immune response, the vaccine mimics what happens
during natural infection with certain pathogens - especially viruses.
This has the advantage of triggering a strong cellular immune response by T
cells as well the production of antibodies by B cells. An example of a viral
vector vaccine is the rVSV-ZEBOV vaccine against Ebola.

34. ADVANTAGES AND DISADVANTAGES OF VIRAL VECTOR-BASED VACCINES

35. HOW DO VIRAL VECTOR VACCINES TRIGGER IMMUNITY?
Once injected into the body, these vaccine viruses begin infecting
our cells and inserting their genetic material – including the antigen
gene – into the cells’ nuclei.
Human cells manufacture the antigen
as if it were one of their own proteins
and this is presented on their surface
alongside many other proteins.
When the immune cells detect the
foreign antigen, they mount an immune
response against it.

36. Viral vector
One type involves introducing a
piece of DNA from SARS-CoV-2 into
another unrelated germ—for
example, an adenovirus, which
typically causes the common cold.
When this modified
adenovirus is injected into
humans, the hope is that it
will instruct cells to make
coronavirus proteins and will
trigger an immune response.

37. According to the World Health Organization (WHO), there are currently more than 100 COVID-
19 vaccine candidates under development, with a number of these in the human trial phase.
However, there are only five companies that have given preliminary data about
how effective their vaccines could be to fight against coronavirus. These five
companies include :
Pfizer
BioNTech
Moderna Inc
Oxford University-
AstraZeneca Plc,
Gamaleya Research Institute of
Epidemiology and
Microbiology.

38. COVID-19
vaccines
Chinese officials have authorized use
of Sinopharm’s COVID-19 vaccine just
a day after the company announced it
is 79-percent effective.
China plans to vaccinate 50 million
people by mid-February, despite a
lack of published evidence about the
safety and efficacy of its available
vaccines.
Argentina regulators approved the
AstraZeneca-Oxford vaccine.

39. Vaccines record time
COVID-19 vaccines have reached consumers in record time. Though the process can typically
take 10 to 15 years, the U.S. Food and Drug Administration has granted emergency authorization
to vaccines made by Pfizer and Moderna in less than a year.
Before now, the fastest-ever vaccine—for mumps—took four years to develop in the 1960s.
Yet even after a vaccine is authorized or fully licensed, it faces potential roadblocks when it comes
to scaling up production and distribution, which also includes deciding which populations should
get it first—and at what cost.

40. First doses Vaccines
Recipients
The Centers for Disease Control and
Prevention(CDC) have recommended that
health-care personnel and long-term care
residents receive the first doses.
The agency is also proposing that the
next in line should be people age 75
or older, and frontline workers.

41. Vaccines Distributions
Several efforts are underway to help produce and distribute the
vaccines more quickly, including the U.S. government’s Operation Warp
Speed initiative, which has pledged $10 billion and aims to develop and
deliver 300 million doses of a safe, effective coronavirus vaccine by
January 2021.
The World Health Organization is also coordinating global efforts to
develop a vaccine, with an eye toward delivering two billion doses by
the end of 2021.

42. VACCINES
PRODUCTION PHASES

44. Clinical trial process
More than 60 vaccines are still
going through a three-stage
clinical trial process that’s
required before they are sent to
regulatory agencies for approval.
Given the urgent need, some
vaccine developers have
compressed the clinical process
for SARS-CoV-2 by running trial
phases simultaneously.

45. VACCINE CLINICAL TRIAL PROCESS
Phase one(I)
Checks the safety of a vaccine and
determines whether it triggers an
immune response in a small group of
healthy humans.

46. Phase two(II)
Widens the testing pool to
include groups of people who
may have the disease or be
more likely to catch it, to gauge
the vaccine’s effectiveness.

47. Phase three(III)
Expands the pool up to the
thousands to make sure the vaccine
is safe and effective among a wider
array of people, given that immune
response can vary by age, ethnicity,
or by underlying health conditions.

48. Vaccine rollout and safety
Here’s a look at the prospects that have
reached phase three and beyond—
including a quick primer on how they
work and where they stand.
As of December 26, the U.S. has
administered 1.9 million COVID-19
vaccine doses and distributed 9.5 million
doses of the two authorized vaccines
made byPfizer-BioNTech and Moderna.

50. Pfizer/BioNtech vaccine
Pfizer and German start-up BioNTech announced their
vaccine has the ability to prevent more than 90 per cent
of people from getting COVID-19.
The drug manufacturers have concluded phase-3 study of their
mRNA-based COVID-19 vaccine candidate BNT162b2, and have
requested the US Food and Drug Administration (FDA) for
Emergency Use Authorization (EUA) of the vaccine.
The Pfizer-BioNTech vaccine requires storage at about -70
degrees Celsius, which requires specialized freezers.
•Type: mRNA
•Doses: 2, 28 Days Apart
•Storage: -70 degrees Celsius

51. Clinical trials status
Clinical trials status: On November 18, Pfizer and
BioNTech announced the conclusion of their phase three
trials. The companies stated that they’ve met their primary
goals.
The analysis found the candidate to be 95 percent
effective in preventing mild cases of COVID-19—and 94
percent effective in adults over 65 years old—with no
serious safety concerns.
Preliminary results of phase one/two data
showed the vaccine produces antibodies and T-
cell responses specific to the SARS-CoV-2 protein.

52. Pfizer
• Name: BNT162b2
• Who: One of the world’s
largest pharmaceutical
companies, based in New
York, in collaboration with
German biotech company
BioNTech.
• What: A nucleic-acid
vaccine that requires two
doses taken 21-28 days
apart.
• Latest news: On
December 27, the
European Union began its
immunization campaign,
administering the Pfizer
vaccine to health-care
workers and nursing
home residents
throughout its member
states.

53. Approval status: The FDA granted emergency approval to this vaccine on
December 11, a day after an advisory panel decided that the benefits of
the candidate outweigh the risks for anyone over the age of 16.
The vaccine has also been granted emergency approval in Canada
and conditional approval in the European Union.
Distribution: The first vaccinations in the U.S. were administered to
health-care workers at a medical center in Queens, New York.
The CDC has recommended that health-care personnel and long-term care
residents receive the first doses, but the ultimate rollout will depend on
state decision-making.

54. Priority For
Vaccinations
Prioritize vaccinations for the most vulnerable populations, including nursing home
residents, health-care workers, older adults, and those with underlying health conditions.
- Globally, Pfizer expects to be able to produce up to 1.3 billion doses by the end of 2021.
- However, questions have been raised over the vaccine’s storage, which requires ultra-cold
freezers set at minus 70 degrees Celsius).

55. Efficacy and safety
Efficacy and safety:
The New England Journal of
Medicine published the results
of Pfizer’s phase three study,
showing the vaccine was safe
and 95-percent effective in
protecting against COVID-19 in
people 16 and older.
The FDA has also published an
analysis saying that the Pfizer
vaccine is safe and offers
strong protection against
COVID-19 within 10 days of
the first dose, regardless of
the recipient’s race, weight,
or age.
On December 15, a day after the
U.S. launched its immunization
campaign, a health-care worker
in Alaska was hospitalized for a
severe allergic
reaction. According to the New
York Times, the worker had no
history of allergies, and the
reaction subsided after she was
treated with epinephrine.

57. Moderna Inc
Another company that used the same approach of m-RNA to
develop a vaccine against coronavirus has claimed that its vaccine is
95 per cent effective.
Moderna Inc's vaccine uses the same approach of injecting part of
the virus's genetic code in order to provoke an immune response.
Moderna's vaccine candidate mRNA-1273 can be stored at - 20
degrees Celsius for up to six months and can be kept in a standard
fridge for up to a month.
Type: mRNA
Doses: 2, 28 Days Apart

58. Moderna Therapeutics
Name: mRNA-1273
Who: A Massachusetts-based biotech company, in
collaboration with the National Institutes of Health.
What: A nucleic-acid vaccine that requires two doses, four
weeks apart.
Latest news: Canada has approved Moderna’s COVID-19 vaccine for
use in people 18 years or older. The vaccine’s rollout is expected to
begin within 48 hours of the announcement.
Approval status: On December 18, the FDA granted emergency
approval to Moderna’s COVID-19 vaccine, a day after an advisory
panel decided that the benefits of the vaccine outweigh the risks, such
as the mild side effects reported in their clinical trial.
Distribution: It is the second vaccine to receive emergency
authorization in the U.S., joining Pfizer’s candidate, which was
approved a week earlier.

59. Efficacy and safety
Efficacy and safety
The FDA has also published an analysis of the phase
three study of Moderna’s vaccine.
It confirms the company’s claims that its candidate is 94.1-percent
effective in preventing mild cases of COVID-19 and 100-percent
effective at preventing severe cases after taking two doses.
Moderna announced on December 22 that it plans to test how well its vaccine works
against the new variant of the virus that’s been found in the U.K.

60. Clinical trials status
Moderna announced on December
17 that it is launching clinical trials
to evaluate the vaccine’s safety
in children and people with cancer;
it will also establish a “pregnancy
registry” to track the vaccine’s
safety in people who are pregnant.
The company started the third
phase of its clinical trials in July.
Preliminary findings from its phase
one trials showed that healthy
subjects—including elderly
patients—produced coronavirus
antibodies and a reaction from T
cells, another part of the human
immune response.

62. Oxford University/AstraZeneca vaccine
British-Swedish pharmaceutical firm AstraZeneca has announced three kinds of data
about the efficacy of its vaccine.
Interim data suggested 70 per cent protection but the researchers say the figure may
be as high as 90 per cent by tweaking the dose.
According to AstraZeneca and Oxford University, their vaccine candidate AZD1222 was
90 per cent effective when the first dose was halved and a standard second dose was
administered.
However, it showed the efficacy of 62 per cent when two full doses were administered
to volunteers in 28 days part.
Type: Adenovirus-based
Doses: 2, 28 Days Apart

63. AstraZeneca.
Name: ChAdOx1 nCoV-19
Who: The U.K. university, in collaboration with the biopharmaceutical company
AstraZeneca.
What: A viral vector vaccine.
Latest news: On December 30, the British government announced that it has authorized use of the
AstraZeneca-Oxford vaccine. The U.K. also announced changes to its vaccine delivery plan: With COVID-
19 infections rapidly spreading, the country will now prioritize delivering the first dose of either vaccine
to as many at-risk people as possible, based on data provided to and released by health regulators.

66. Gamaleya Research Institute of Epidemiology and Microbiology
Russia became the first country in the world to register a coronavirus vaccine, called Sputnik V in August.
The vaccine was registered on 11 August 2020 by the Russian Ministry of Health.
The vaccine was approved for distribution in Russia, despite having been tested only in a small number of people
in early-stage clinical trials that lasted two months.
The institute published phase 1 and 2 results in September but the pivotal phase-3 results are yet to be
published.
Earlier this month, the institute announced that the vaccine candidate showed 91.4 percent efficacy.
Russian Direct Investment Fund (RDIF) has partnered with Indian pharmaceutical company Hetero to produce
over 100 million Sputnik V doses in India per year.
The production is expected to begin in 2021.
Storage: -18 degree Celsius

67. Efficacy and safety
Efficacy and safety
On November 11—two days after Pfizer’s announcement
of its interim results—Gamaleya reported that an interim
analysis of its phase three trial found 92 percent efficacy of
the Sputnik vaccine.
In September, a study of the institute’s phase one/two
trials published in the Lancet showed the vaccine
produced antibodies and a reaction from T cells.

68. Gamaleya National Center of Epidemiology and Microbiology
Name: Sputnik V
Who: A Russian research institution, in partnership with the state-run Russian
Direct Investment Fund.
What: A viral vector vaccine that uses two strains of adenovirus and requires
a second injection after 21 days to boost the immune response.
Latest news: On December 11, the Gamaleya Institute and biopharmaceutical company
AstraZeneca announced they will work together to study the possibility of combining Gamaleya’s Sputnik
vaccine with the candidate that AstraZeneca has developed with the University of Oxford. Since both
candidates use the same adenovirus, researchers will investigate whether combining them will improve
efficacy. Clinical trials are expected to begin by the end of the month.
Approval status: In August, Russia cleared the Sputnik V vaccine for widespread use and claimed
it as the first registered COVID-19 vaccine on the market—before the vaccine’s phase three trials
had begun and despite the lack of published evidence at the time. In late December, Belarus and
Argentina granted approval and began vaccination campaigns with the Sputnik V vaccine.

70. Sino pharm
• Name: None
• Who: China’s state-run pharmaceutical company, in
collaboration with the Wuhan Institute of Biological
Products.
• What: Two inactivated SARS-CoV-2 vaccines.
• Latest news: On December 31, China approved one of
Sinopharm’s vaccine candidates for use, a day after the
company announced results of its phase three study
showing the vaccine to be 79-percent effective in
preventing COVID-19.
• The company did not provide any data backing up its claim.
Authorities in the country have set a goal to vaccinate 50
million people by Lunar New Year in mid-February,
despite the lack of evidence that their available vaccines
are safe and effective. Chinese officials have said the
vaccine will be free for Chinese citizens, and that they will
prioritize immunizations for high-risk groups such as the
elderly and people with underlying conditions.
Sino
pharm

71. Approval status: Bahrain and the United Arab
Emirates have both approved one of Sinopharm’s
vaccines for general use.
China has also approved one of the company’s vaccines for
general use and another for limited use.

72. China began to innoculate medical
workers and other high-risk groups
with the Sinopharm trial vaccines in
July, making it the first experimental
vaccine available to civilians beyond
clinical volunteers
Efficacy and safety: In its approval of the
Sinopharm vaccine, the UAE said that an
interim analysis of the phase three study
showed the candidate is 86-percent
effective in preventing COVID-19 with no
serious safety concerns. UAE
officials claimed the vaccine is 100-
percent effective in preventing moderate
and severe cases of the disease, however
no data has been released from the study.

73. *Preliminary findings from two randomized trials, published in the Journal
of the American Medical Association, have shown the vaccine can trigger an
antibody response with no serious adverse effects.
*The study did not measure T cell-mediated immune responses.
*These results are significant, though, as they are the first published data
from human clinical trials for a COVID-19 vaccine that uses a whole,
inactivated virus.

75. Sinovac
Name: CoronaVac
Who: A Chinese
biopharmaceutical
company, in
collaboration with
Brazilian research
center Butantan.
What: An inactivated
vaccine.
Latest
news: expected to
grant emergency use
authorization to the
vaccine by the end of
January and roll out
its immunization
campaign shortly
afterward.

76. Approval status: Approved for limited use in China.
Efficacy and safety: On November 17, preliminary results from Sinovac’s early trials
reported that the vaccine was safe but produced only a moderate immune response,
with lower levels of antibodies compared to those in patients who have recovered
from COVID-19.
Preliminary results in macaque monkeys, published in Science, revealed that the
vaccine produced antibodies that neutralized 10 strains of SARS-CoV-2.
Clinical trials status: CoronaVac entered phase three trials in July,

78. Name: COVAXIN
Who: An Indian biotechnology company, in collaboration with the Indian
Council of Medical Research and the National Institute of Virology.
What: An inactivated vaccine, which requires two doses that are administered
28 days apart.
Latest news: On November 16, Bharat Biotech announced it has begun phase three
trials involving 26,000 participants at more than 25 centers across India.
Approval status: Not approved for use.
Efficacy and safety: Results posted online in September but not yet peer reviewed show that the
vaccine produced antibodies in monkeys.
Bharat Biotech Executive Director Sai Prasad also told Reuters in October that preliminary results from
early vaccine trials found more than 90 percent of human participants developed antibodies.

80. Name: NVX-CoV2373
Who: A biotechnology company based in Gaithersburg, Maryland.
What: A protein vaccine that involves a nanoparticle carrier to better aid delivery and uptake by cells.
The vaccine is administered in two doses, 21 days apart.
Latest news: On December 28, Novavax announced the launch of its phase three study in the U.S. and
Mexico, which will evaluate the safety and efficacy of its vaccine in up to 30,000 adults. The
announcement comes a month after Novavax said it had completed enrollment in its phase three trial
in the U.K., and that it expects to have interim data available in the first quarter of 2021.
Approval status: Not approved for use.
Efficacy and safety: On September 2, a study of the company’s phase one trial published in the New
England Journal of Medicine found that the vaccine was safe and produced coronavirus antibodies at a
higher level than is seen among those who have recovered from COVID-19.
It also stimulated T cells, another arm of the human immune response.

82. Name: JNJ-78436735
Who: One of the world’s largest multinational
corporations, based in New Jersey, specializing in
healthcare and pharmaceutical products.
What: An vector vaccine.
Latest news: On November 15, Johnson &
Johnson launched a second phase three
trial to study the safety and efficacy of a two-
dose regimen of its vaccine candidate in up
to 30,000 volunteers worldwide. The study
intends to assess whether a second dose of
the vaccine will offer longer protection.

83. Approval status: Not
approved for use.
Efficacy and safety: On
October 12, Johnson &
Johnson announced that it
paused phase three trials for
an independent safety review
due to an unexplained illness
in a participant.
The company didn’t provide
any details, in part to protect
the patient’s privacy, but said
that illnesses and accidents
are expected in large clinical
studies.

84. In July, a study published
in Nature showed that the vaccine
elicited neutralizing antibodies in
monkeys and provided “complete
or near-complete” protection with
just one dose.
Clinical trials status: On September 23,
Johnson & Johnson announced the
launch of its phase three “ENSEMBLE”
trial to evaluate the safety of the
vaccine—and how well it works—among
up to 60,000 adults from a variety of
countries. The trial will include
“significant representation” from older
populations and those with underlying
conditions that make them more
susceptible to COVID-19.
The company announced on
December 17 that the trial is fully
enrolled with 45,000 participants;
it expects to have interim data
available by the end of January.

86. Name: Bacillus Calmette-Guerin BRACE trial
Who: The largest child health research institute in Australia, in
collaboration with the University of Melbourne.
What: For nearly a hundred years, the Bacillus Calmette-
Guerin (BCG) vaccine has been used to prevent
tuberculosis by exposing patients to a small dose of live
bacteria.
Evidence has emerged over the years that this vaccine
may boost the immune system and help the body fight off
other diseases as well.

87. Latest news: In October, the U.K. launched a study of the BCG
vaccine that is part of the Australian-led trials. The study is
seeking to recruit 1,000 frontline health-care workers to test
the vaccine’s effectiveness against COVID-19.
Clinical trials status: In April, researchers from the Murdoch
Children’s Research Institute began a series of randomized
controlled trials that will test whether BCG might work on the
coronavirus as well. They aim to recruit 10,000 healthcare
workers in the study. As of April 12, however, the World
Health Organization says there is no evidence that the BCG
vaccine protects people against infection with the coronavirus.
Approval status: Not approved for use.

89. Name: Ad5-nCoV
Who: A Chinese biopharmaceutical company.
What: A viral vector vaccine.
Latest news: Indonesia has ordered 20 million doses of CanSino’s vaccine; Mexico is in
talks to receive up to 35 million doses.
Approval status: Though the company was still technically in phase two of its trial, on June 25,
CanSino became the first company to receive limited approval to use its vaccine in people.
The Chinese government has approved the vaccine for military use only, for a period of
one year.

90. Efficacy and safety: Preliminary results from
phase two trials, published in The Lancet,
have shown that the vaccine produces
“significant immune responses in the majority
of recipients after a single immunisation.”
There were no serious adverse reactions
documented.
Clinical trials status: On December 21,
CanSino announced that it has recruited more
than 20,000 participants for its phase three
trials in Pakistan, Russia, Mexico, and Chile.
On August 15, Russian biopharmaceutical
company Petrovax announced it had launched
the first phase three clinical trial of Ad5-nCoV.

96. Vector Institute
Name: EpiVacCorona Who: A Russian biotechnology institute.
What: A protein vaccine, namely it uses
small fragments of viral antigens called
peptides to produce an immune
response.
Latest news: In November,
Russia launched mass trials of its
EpiVacCorona vaccine; the trials will
innoculate 150 people over the age of 60
and 3,000 volunteers over the age of 18.

97. The CDC has also released the first data on the COVID-19 vaccines
from its Vaccine Adverse Event Reporting System, which collects
reports of allergic reactions and other adverse events from health-
care providers, vaccine manufacturers, and the public.

98. It will do so by delaying administration
of the second dose of the AstraZeneca-
Oxford drug; originally intended to be
administered a few weeks after the first
dose, patients will instead receive the
second dose within 12 weeks.
A similar rule was issued for the Pfizer-BioNTech
vaccine—its two doses were previously split over
three weeks—but regulators didn’t provide similar
data to back the new regimen. Overall, the U.K. still
recommends that recipients receive two doses of
either vaccine for maximum benefit. Rollout of the
AstraZeneca-Oxford vaccine will begin on January 4.
Argentina announced a similar approval the same
day as the U.K.

101. Prof.Amal Sayed
IPC DIRECTOR CAIRO UNIVERSITY
HOSPITAL