MOLECULAR BIOLOGY AND DIAGNOSTICS based on the weight of the patient (weight = LIVE ATTENUATED (LAV) SUBUNIT (PURIFIED

LIVE ATTENUATED (LAV) SUBUNIT (PURIFIED ANTIGEN)

TOPIC 5: VACCINE STUDIES how much post-prophylactic rabies vaccine ▪ Acellular pertussis (aP)
▪ Tuberculosis (BCG)
Lecturer: Dr. Alessandra Kamille P. Mallari, MD, DPSP they are given) ▪ Haemophilus influenzae type B
▪ Oral polio vaccine (OPV)
o it is not 1 vial per 1 person, you may not use (Hib)
Currently, in the timeline of our pandemic, vaccines have been a hot topic ▪ Measles
the entire bottle ▪ Pneumococcal (PCV-7, PCV-10,
lately. As we all know, we have started vaccinating medical health workers ▪ Rotavirus
▪ include a variety of substances (Thiomersal, PCV-13)
and the rest of the frontliners in the Philippines. ▪ Yellow fever
Formaldehyde, or phenol derivatives) ▪ Hepatitis B (HepB)
VACCINES 101 INACTIVATED (KILLED ANTIGEN) TOXOID (INACTIVATED TOXINS)
World Health Organizations HOW DOES VACCINE WORK?
▪ Whole-cell pertussis (wP) ▪ Tetanus toxoid (TT)
▪ Vaccination is one of the great public health achievements of human Vaccines contain the same antigens that are found on the pathogen that ▪ Inactivated polio virus (IPV) ▪ Diphtheria toxoid
history. causes the associated disease. But, exposure to the antigen in the vaccine is mRNA VIRAL VECTOR VACCINE
▪ Vaccines used in national immunization programmes (NIPs) are controlled. By priming the immune system through vaccination, when the
considered safe and effective when used correctly. vaccinated individual is later exposed to the life pathogen in the *descriptions for the types of vaccines are found on the last page*
▪ Vaccines are, however, not risk-free and adverse events will occasionally environment, the immune system can destroy them before they can cause
ROUTE OF ADMINISTRATION
occur following vaccination. Public trust in vaccine safety is key to the disease.
success of vaccination programmes.
The goal of all vaccines is to elicit an immune response against an antigen so
WHY ARE VACCINES SO SPECIAL? that when the individual is again exposed to the antigen, a much stronger
▪ Vaccines promote health: unlike many other health interventions, they secondary immune response will result.
help healthy people stay healthy, removing a major obstacle to human
Vaccines produce a natural infection with less complications. You have the
development.
immunity in the center. When you have a natural infection, this infection will
▪ Vaccines have an expansive reach: they protect individuals, communities,
trigger an immune system response by which the vaccine produces a long-
and entire populations (the eradication of smallpox is a case in point).
o one good example is the eradication of smallpox in the 1980-1990s due term protection immunity that would normally follow recovery from
to the development of vaccines naturally occurring infections. Basically, you are just priming yourself to
▪ Vaccines have rapid impact: the impact of most vaccines on communities produce antibodies against a particular substance that you have not been
exposed with or you have not been developed antibodies for.
and populations is almost immediate.
o example: between 200 and 2008, vaccinations has reduced the global What is advantageous here is that vaccination causes less adverse disease or INTRAMUSCULAR (IM) INJECTION SUBCUTANEOUS (SC) INJECTION
deaths of measles by 78% (from 750,000 down to 164,000 deaths per the vaccinee does not endure the illness and there is a lower risk of adverse ▪ most common
year) reaction that greatly outweighs the risk of complications by natural ▪ administers the vaccine into the
▪ Vaccines save lives and costs: recently, a panel of distinguished administers the vaccine into the
infection. muscle mass
economists put expanded immunization coverage for children in fourth subcutaneous layer above the
▪ vaccines containing adjuvants
place on a list of 30 cost-effective ways of advancing global welfare. muscle and below the skin
should be injected IM to reduce
WHAT ARE THE COMPONENTS OF VACCINES? adverse local effects
INTRADERMAL (ID) INJECTION ORAL/INTRANASAL SPRAY
INGREDIENTS THAT PROVIDE IMMUNITY ▪ administers the vaccine in the vaccine makes immunization
ANTIGENS ADJUVANTS topmost layer of the skin easier by eliminating the need for
▪ are the components derived ▪ vaccine adjuvants accelerate, ▪ BSG is the only vaccine with a needle and syringe (e.g Polio
from the structure of disease- enhance, and prolong the this route vaccine given to babies)
causing organisms, which are immune responses triggered by
recognized as “foreign” by the antigens: the vaccine components HOW ARE VACCINES BEING DEVELOPED?
immune system and trigger a that elicit pathogen-specific
protective immune response to immune responses
the vaccine ▪ most common example adjuvant
TYPES OF VACCINES
▪ the types of vaccines are used in vaccines is aluminum
dependent on what kind of which contain most of our Vaccine manufacturers strive to develop vaccines that: Research Development → Pre-Clinical → Phase 1 → Phase 2 → Phase 3 →
antigen that particular vaccine vaccines ▪ are effective in preventing or reducing severity of infectious disease Submission to FDA → Phase 4
is being used ▪ provide durable, long-term protection against the disease
What does EUA mean? Emergency Use Authorization
▪ achieve immunity with a minimal number of doses
INGREDIENTS THAT PROLONG SHELF LIFE AND KEEPS THEM SAFE ▪ provide the maximum number of antigens that confer the broadest SHORT RECAP
PRESERVATIVES STABILIZERS protection against infection Vaccines work by mimicking the body’s immune system to build up defense
▪ are added to multidose vaccines to prevent ▪ used to help the ▪ cause no or mild adverse events against infectious bacteria or virus without causing disease. So, the parts of
bacterial and fungal growth vaccine maintain ▪ are stable at extremes of storage conditions over a prolonged period of the infectious organism that the immune system recognizes are foreign the
o for example: rabies vaccine its effectiveness time body and are called antigens.
o the most prophylactic rabies vaccine is a during storage ▪ are available for general use through mass production
multidose vial: one container can be used by ▪ are affordable to populations at risk for infectious disease
different people because in most prophylactic
There is a balance that must be strived in the development of vaccines. The
rabies vaccination, the computation there is
table shows the types of vaccines that are currently used.
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 IT STARTS IN THE LAB 3b PHASE 2 Clinical Trial SEEKING APPROVAL
1 RESEARCH AND DISCOVERY STAGE ▪ tested on more people, where various dosages are tested on 100’s of 4 SUBMISSION TO THE FDA
▪ scientists develop a rationale for vaccine - how the infectious organism people with typically varying health statuses and from different the vaccine company will seek the approval of the FDA
causes disease demographic groups, in randomized-controlled studies when seeking FDA approval, this is when you hear “FDA Approved”
o Do they need the vaccine? How infectious/deadly is the organism? o in this phase, the goal here is that they are now finding what is the ▪ permission to distribute and market a vaccine in the US (Doc got data
▪ research to test their idea for a vaccine candidate: sometimes this correct dosage of that particular vaccine where they can obtain a from the US FDA, that’s why it’s US instead of PH)
testing occurs in animals very good immune response ▪ evaluates data to determine whether the safety and the effectiveness
▪ when findings are thought to have practical application, the research o they are grouped in 200’s: Group A is given 1 ml, then Group B is of the vaccine has been demonstrated and whether the manufacturing
moves forward given 2 mL facility information is complete
o in this stage, they will think of an organism, and ask the following o both of these groups also will have different dosing, different o by then, FDA will now decide whether the analysis of the benefits
main questions: “Do we need a vaccine for this?” or “How often do timing, how many days or how many weeks they will give the and risks for the intended population who will receive the vaccine
this come about in the community?” or “How transmissible is it?” second dose, or do you even need a second dose? (main function ▪ once everything is okay, FDA approves license for use
or “How deadly is this?” of Phase 2) MONITORING SAFETY AND EFFECTIVENESS
o like in basic research, you always start with your research question ▪ provide additional safety information: common short term-side 5 PHASE 4
RESEARCH MOVES FORWARD effects and risks include control groups ▪ ongoing surveillance of vaccines after FDA-approval to identify
2 PRE-CLINICAL o since you are testing it on a larger scale, more people would be uncommon adverse events or long-term complications
▪ before a vaccine can be tested in people, a company or researcher exposed so you have a good idea now what are the common side o although Phase 1-3 are studied in certain individuals, some of them
performs additional laboratory research and testing in animals to effects (e.g. pain, fever, allergies, and any other risks) might not develop adverse reactions/events
obtain information about how the vaccine works and whether it’s o will also include CONTROL GROUPS: groups wherein you will give ▪ PHASE 4 Studies: when FDA require post-marketing studies to further
likely to be safe and work well in humans them a placebo vaccine, they will take the vaccine but technically assess known or potential serious risks
o usually, animal testing happens during this stage you’re not giving anything to them but instead, it’s just water ▪ Lot Release
TESTING THE VACCINE IN PEOPLE 3c PHASE 3 Clinical Trial o a mechanism which provides FDA with real-time system to
when the company/researcher is ready to begin studies in humans they: ▪ where the vaccine is administered to thousands of people to generate continuously monitor product quality
▪ they compile the results & other information -- assessment of information on effectiveness and additional safety data o manufacturers are not permitted to distribute a specific lot of
preclinical data ▪ include additional information about immune responses and vaccine until the FDA releases it
o they compile results of their laboratory and other pre-clinical compare: 1 who receive the vaccine and 2 in negative control groups ⇥ It is important that when you see drugs, reagents, or vaccines,
testing (e.g. placebo) there should be a LOT number. This is because when the FDA
▪ assessment on the product itself; quality and safety & the technology ▪ provide additional information regarding the vaccine’s safety, approves that LOT number that means that batch that was made
to manufacture particularly less common side effects is safe to use as sometimes, it might not be consistent when
o also compiling information pertaining to the manufacturing o kind of similar to Phase 2 but this will be more focused on manufacturing these products.
technology and quality of vaccine information on its effectiveness and additional safety data ⇥ if a serious/adverse event happens to a particular batch/LOT
o these are submitted to the Food and Drug Administration in the ASSESSMENT OF MANUFACTURING number, they can recall that entire LOT number simultaneously
form of an Investigational New Drug Application if it has passed the Phase 1-3 Clinical Trials, the research is now submitted (they can easily identify which ones are bad if ever one will be
o FDA will evaluate or assess the data that they are given--whether to FDA and they will also be assessing pertaining to the manufacturing of bad)
these are conducted according to good laboratory practices and will the vaccine & the facility where it is made EMERGENCY USE AUTHORIZATION
also conduct assessment of the product if it is safe (What is the ▪ vaccine manufacturing is complex ▪ WHAT: vaccine development may be atypical or expedited
technology that manufactured it?) and is it reasonably safe to move ▪ LOT: process of making the candidate vaccine in Phase 3 studies in o governments, organizations, or other pharmaceutical companies
forward in testing people batches (helps ramp up production) coalesce together to develop a strategy for prioritizing and
▪ studies conducted in people are known as the CLINICAL o when they create or manufacture vaccines, they will group it in LOT speeding development of vaccines or treatments
DEVELOPMENT STAGE—or the stage called “CLINICAL TRIALS” numbers, it helps the manufacturer ramp up the commercial scale ▪ WHEN: public health emergencies - pandemic
▪ in Clinical Trials, it is divided into 4 stages-- this is where we start now ▪ FDA requires data to support manufacturing processes, facilities, o recognizing the urgent need for a safe and effective vaccine after it
to give the vaccine to individuals (this covers 3 phases) characterization and lot-to-lot consistency utilizes its various authorities and expertise to facilitate the
▪ the phases of the studies may progress sequentially, but it is also not expenditures, development and availability of safe and effective
uncommon for the phases of development to overlap vaccines.
3a PHASE 1 Clinical Trial ▪ FDA will undertake a comprehensive evaluation of this information
▪ emphasis during this phase is on safety and generally includes about submitted by a vaccine manufacturer
20-100 volunteers who haven’t been exposed to the disease being o they must also determine that the known and potential benefits
studied and who are generally otherwise healthy outweigh the known and potential risks of the vaccine
▪ determine whether there are adverse reactions with increasing doses ▪ EUA request for a COVD-19 vaccine can be submitted to FDA based on
and, if possible, to gain early information about how well the vaccine a final analysis of a Phase 3 clinical efficacy trial or an interim analysis
works to induce an immune response in people of such trial (e.g. an analysis performed before the planned end of the
o technically, in the first stage, the main role of the researcher or the trial once the data have met the pre-specified success criteria for the
investigator is to know if the vaccine is safe study’s primary efficacy endpoint)
o in order to know what happens when you give them to an o unlike the usual process, vaccine to be approved by the FDA in cases
individual: whether it will cause an adverse reaction or not of EUA (to expedite processes), what they did is they usually overlap
o that’s why they are given to a small & healthy population, without (clinical trials 1 and 2 both happen at the same time) and when the
a disease

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 manufacturer releases an interim analysis of the Phase 3 trial, they SARS-CoV-2 VIRUS AND ITS VACCINE Fortunately, we already have a head start on the first phase of vaccine
can go ahead and give emergency use authorization development: research. SARS-CoV-2 has been extensively studied during the
Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2)
⇥ licensing, manufacturing, and other paperwork details are start of the pandemic. When they identified the virus, they started
▪ causes coronavirus disease 2019 (COVID-19)
skipped as long as clinical trials deem the vaccine safe, EUA may researching immediately for vaccine development. These are the companies
▪ positive-sense single stranded RNA virus
be approved by FDA that currently have clinical trials underway:
▪ zoonotic origin: genetically similar to bat coronavirus (suggesting it
⇨ EUA applicable only during times of crises or pandemic
emerged from a bat-borne virus)
⇨ vaccines cannot be marketed/sold for commercial purposes
▪ how it spreads: respiratory droplets produced by coughs and sneezes
⇨ guidelines should be followed for the usage
▪ R0 estimate around 5.7
SAFETY OF VACCINES GRANTED EUA o one infected individual can infect about 5-6 individuals at a time
▪ must include all safety data accumulated from Phase 1 and 2 studies o trivia time/add on info about R0:
with expectation that Phase 3 data will include a follow-up of at least ⇥ R0, pronounced “R naught,” is a mathematical term that indicates
2 months how contagious an infectious disease is
o e.g. Pfizer was granted EUA in the middle of Phase 3 clinical trial ⇥ is also referred to as the reproduction number
▪ after completion of the vaccine regimen, FDA will include phase 3 ⇥ as an infection is transmitted to new people, it reproduces itself
safety database of >3,000 recipients ⇥ R0 tells you the average number of people who will contract a
▪ also a requirement for EUA contagious disease from one person with that disease
o evaluation of the chemistry, manufacturing, and control ⇥ it specifically applies to a population of people who were previously
information for the vaccine free of infection and haven’t been vaccinated
⇥ for example, if a disease has an R0 of 18, a person who has the
HOW ARE THESE MANAGED IN A SHORT PERIOD OF TIME? disease will transmit it to an average of 18 other people
▪ Adaptive Trial Designs are developed: ⇨ that replication will continue if no one has been vaccinated
o these clinical study designs aim to expedite clinical trial decisions against the disease or is already immune to it in their community
based on preliminary results derived from earlier trials and in some ▪ enters cells: angiotensin converting enzyme 2 (ACE 2)
cases, from the same trial (dinali’an/rushed)
o using this approach can facilitate efficient clinical development
o the goal of these designs is to reduce the size and duration of the
trial and demonstrate an effect if one exists
o performed with close attention to statistical rigor STRUCTURAL
COMPONENT OF
DEVELOPMENT IN THE COVID-19 VACCINE
SARS-COV:
▪ 50-200 nm in dm ▪ dozens of vaccines are starting clinical trials and use the experimental
mRNA and DNA technology which provides the body with instructions on
to produce its own antibodies against the virus
▪ the vaccine development process typically takes a decade long
o Varicella = 28 years
o Rotavirus and Human papillomavirus = 15 years
o SARS-CoV-2 = 18 months
image from NY times

4 STRUCTURAL PROTEINS (lol semen mnemonic)

important because these are the antigens identified and being tested in your
RT-PCR testing
descriptions of the image: spike protein (which is outside): responsible for attachment
▪ in phase 1, there is academic research S
and fuse with the membrane of the host cell (S1/S2)
▪ since COVID-19 has been well studied, the academic research has been E envelope protein
skipped (there is no discussion whether we need the vaccine or not M membrane protein
since we are currently in the pandemic) N nucleocapsid protein: holds the RNA genome
▪ to reduce the time, the clinical trials are combined while building the
manufacturing factory so by the time that they finish the Phase 3
clinical trial, they are ready to mass produce the vaccine
▪ in contrast to a normal development where factories are built when
clinical trials are completed and approved
▪ based on FDA, there are thousands of vaccine research being
submitted but only 10% are accepted for human consumption

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 WHAT ARE THE VACCINES CURRENTLY AVAILABLE? ▪ Indication: This product is suitable for clinically healthy people aged Pfizer-BioNTech COVID-19 Vaccine General Information (CDC)
in our country that are being used or to be used 18 to 59 years susceptible to the virus. Vaccination of this product ▪ Vaccine: Pfizer-BioNTech COVID-19 Vaccine
▪ EUA is different for each country stimulates the body to induce immunity against SARS-CoV-2 virus for ▪ Diluent: 0.9% Sodium Chloride (normal saline, preservative free)
o In the US there are only 3: Pfizer, Moderna, and Jannsen the prevention of disease caused by SARS-CoV-2 virus. This product is (that's why it only lasts 10 days because it is preservative free, the
o PH: Sinovac, AstraZeneca, and Pfizer not recommended for use on healthcare works with exposure to advantage is that it does not contain any chemicals, but the downside
COVID-19 Patients. is that it should be consumed immediately)
SARS-CoV-2 VACCINE (VERO CELL), INACTIVATED [CORONAVAC] PFIZER-BIONTECH COVID-19 VACCINE ▪ Discard vial when there is not enough vaccine to obtain a complete
NAME: CoronaVac ▪ Name: BNT162b2 dose. Do not combine residual vaccine from multiple vials to obtain a
COMPANY: SINOVAC ▪ Generic Tozinameran Brand: Comirnaty dose.
EFFICACY: 50% in Brazil and 91.4 in Turkey ▪ Company: Pfizer-BioNTech ▪ Vaccine must be mixed with diluent before administration
▪ type of vaccine: killed virus ▪ mRNA Vaccine ▪ Multidose Vial: 6 doses per vial
o grew coronavirus: monkey kidney cells + beta-propiolactone ▪ Dosing 2, 0.3ml doses 21 days apart ▪ Dosage: 0.3ml
(disables/kills the coronaviruses) = inactivation of the virus ▪ Storage: -70°C ± 10°C for up to 10 days unopened. ▪ Age Indication: 16 years of age and older
o adjuvant added: aluminum-based compounds The pFizer vaccine uses the previously discussed mRNA vaccine where in ▪ Schedule: 2 dose series separated by 21 days
▪ since it is dead/killed, it can be injected in the arm without risking genetic material that are self read (??) to make protein is injected directly ▪ A series started with Pfizer-BioNTech COVID-19 Vaccine should be
COVID into the body. This mRNA will be translated inside our cells, and our cells completed with this product
o once inside the body, some of the inactivated viruses are are taught to produce spike protein antigens. It will be then presented ▪ Administer: Intramuscular injection (IM) in the deltoid muscle.
swallowed up by the immune system and an immune response will outside the cell and will be able to identify or recognize the spike protein PH FDA RECOMMENDATIONS:
be printed (?) antigen found in COVID-19. That’s how they develop their immune ▪ Each vial must be diluted with 1.8 ml of sterile 0.9% chloride injection,
response. To protect the mRNA they are covered in a lipid molecule. USP prior to the use to reconstitute the vaccine. The dosing regimen
Because of their fragility, the mRNA molecule will quickly fall apart at is two doses of 0.3ml each. Second dose should be given after three
room temperature. Pfizer vaccines are the most pernicious?? vaccine. weeks from the first dose only to prevent COVID-19 in individuals ages
The reason why 3rd World Countries are having trouble procuring this 16 and older.
vaccine is because it's very unstable. They would need an ultra-low ▪ Preliminary data suggest high vaccine efficacy in preventing COVID-19
freezer of about negative 80C for them to store their vaccines and once following receipt of two doses of mRNA COVID-19 vaccine (pfizer-
they are acquired, they must be given directly. The problem here is bioNtech: 95,0% (95% CL: 90.3%, 97.6%); Moderna 94.1% (95% CL:
because of the temperature in the Philippines, it might compromise the 89.3%, 96.8%)
effectiveness of the vaccine. It is too warm for the vaccine. Emergency Use Authorization (EUA) for Pfizer-BioNTech COVID-19
Vaccine Suspension for IM injection
This applies to the application for the issuance of Emergency Use
authorization for Pfizer-BioNTech COVID-19 Vaccine Suspension for IM
injection.
▪ Product Name: Pfizer-BioNTech COVID-19 Vaccine (BNT162b2)
▪ Dosage Strength and Form: 30 mcg suspension for Intramuscular
Injection
▪ Pharmacologic Category: Vaccine
PH FDA RECOMMENDATIONS ▪ Storage: Prior to dilution, store at -80C to -60c
▪ used only to prevent COVID-19 in clinically healthy individuals ages 18
▪ Packaging: 15 and 195 multiple dose vials (after dilution each vial
to 59 years
contains 6 doses of 0.3mL
▪ does not support the use of SARS-CoV-2 Vaccine (Vero Cell),
inactivated CoronaVac on health care workers exposed to COVID-19
▪ Manufacturer: Pfizer Manufacturing Belgium NV- Puurs, Belgium,
Phjarmacia and Upjohn Company ::C. Kalamazoo, Michigan, USA
patients as it has a low efficacy of 50.4% in this group
▪ 0.5ml (600SU) of inactivated SARS-CoV-2 inactivated antigen ▪ Indication: For active immunization for the prevention of COVID - 19
▪ 2nd dose given after 4 weeks caused by SARS-COV-2 in individuals 16 years of age and older
COVID-19 VACCINE {ChAdOx1-S [recombinant])
Emergency Use authorization (EUA) for SARS-CoV-2 vaccine (Vero Cell) (COVID-19 VACCINE ASTRAZENECA)
inactivated (Corona Vac), Sinovac Life Sciences Co. Ltd
▪ Name: ChAdOx1 nCoV-19 or AZD 1222
The details of the SARS-CoV-2 vaccine (Vero Cell) (these are monkey ▪ Generic: Tozinameran Brand: Comirnaty
kidney cells) Inactivated (Corna Vac) are as follows ▪ Company: AstraZeneca
▪ Product Name: SARS-CoV-2 vaccine (Vero Cell) Inactivated (Corna Vac) ▪ Vector Based vaccine that uses Modified
▪ Dosage Strength and Form: 600SU/0.5mL suspension for injection Chimpanzee adenovirus (ChAdOx1)
(IM) ▪ Dosing: 2, 0.5mL between 4 - 12 weeks
▪ Pharmacological category: Vaccine (more stable than the Pfizer)
▪ Storage: Store at 2 to 8C. Protect from light. Do not freeze ▪ Storage: at least six months when refrigerated at 38 to 46°F (2-8°C)
▪ Shelf Life: 6 months
▪ Packaging: Vial (box of 40’s) What happens here is that adenoviruses are commonly found viruses
▪ Manufacturer: Sinovac Life Sciences Co,. Ltd. that cause flu and cold-like symptoms. What the astraZeneca did is that

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they used a modified version of the Chimpanzee adenovirus called ▪ Company: Moderna
(ChAdOx1). It can enter the cell but cannot replicate inside the cell. After ▪ Efficacy 94.1%
the vaccine is injected into the arm of the person, the adenovirus will ▪ Dosing Information:
latch on to the surface of the cell and the cell will engulf it. Once the o Multidose vial: 10 doses per vial
adenovirus is inside the cell, it releases the DNA that is stored, and the o Dosage: 0.5ml
DNA virus will push itself to store the DNA into the nucleus. The ▪ Do not mix with a diluent, discard vial
adenovirus is engineered in such a way that it cannot make copies of when there is not enough vaccine to
itself (it cannot reproduce). But the gene for the coronavirus spike obtain complete dose. Do not
protein can be readily read by the cell and copied into a molecule called combine residual vaccine from multiple vials to obtain a dose.
your mRNA. It is similar with Pfizer that it uses the mRNA, it’s just ▪ Age indication:
AstraZeneca uses an organism as the carrier (adenovirus). o 18 years of age and older
▪ Schedule:
o 2 dose series separated by 28 days
o a series started with COVID 19 vaccine Moderna should be
completed with this product
▪ Administration: IM injection in the deltoid muscle.

VACCINE TRACKER OVERVIEW

GENETIC VACCINES

PH FDA RECOMMENDATIONS
▪ used only to prevent COVID-19 in individuals ages 18 and older
▪ consists of two separate doses of 0.5ml each
▪ the second dose should administered between 4 and 12 weeks after
the first Dose JANSSEN COVID-19 VACCINE (JOHNSON & JOHNSON)
Emergency Use Authorization for COVID-19 Vaccine (ChAdOx1) S1 ▪ Name: JNJ-78436735 or Ad26.COV2.S (this is a vaccine based on the
Recombinant Vaccine (ChAdOx1-S [recombinant]) (COVID-19 Vaccine virus’ genetic instruction to build a spike protein) (somewhat the same
AstraZeneca) as Pfizer)
▪ This applies to the application issuance of Emergency Use ▪ Company: Jansse by Johnson and Johnson
Authorization (EUA) for COVID-19 Vaccine (ChAdOx1) S1 Recombinant ▪ Efficacy: up to 74%
Vaccine (ChAdOx1=Sl(recombinant) (COVID-19 Vaccine AstraZeneca. ▪ DNA based vaccine. Its advantage against RNA based vaccine is that
The details of the COVID-19 Vaccine AstraZeneca are as follows DNA is not as fragile as RNA and can be refrigerated up to 3 months at
2-8°C (ref temp.) (this is the difficulty with Moderna and Pfizer VIRAL VECTOR VACCINES
▪ Product Name: COVID-19 Vaccine (ChAdOx1) S1 Recombinant Vaccine
(ChAdOx1-S [recombinant]) (COVID-19 Vaccine AstraZeneca) products because they must be stored at ultra-low freezers which may
▪ Dosage Strength and form: 0.5ml Solution for Injection (IM) not be available in certain communities)
▪ Pharmacologic Category: Vaccine ▪ Given as a single dose
▪ Storage: Store in a refrigerator 2 to 8 degrees C. Do not freeze, Keep ▪ Dosing Information
vials in outer carton to protect from light o Multidose Vial: 5 doses per vial
▪ Packaging: 5ml of Solution in a 10-dose vial (clear type 1 glass) with o Dosage: 0.5mL
stopper (elastomeric with aluminum overseal) with a plastic flip off o Do not mix with a diluent
cap. Packs of 10 vials. 4ml of solution in an 8-dose vial (clear type 1 o Discard vial when there is not enough vaccine to obtain a complete
glass) with stopper (elastomeric with aluminum overseal) with a dose. Do not combine residual vaccine from multiple vials to obtain
plastic flip off cap. Packs of 10 vials. a dose
▪ Manufacturer: Catalent Anagi S.R.L Anagi (FR) Italy ▪ Age Indicators: 18 years old and older
▪ Indication: For active immunization of individuals greater than or ▪ Schedule: Single dose
equal 1o 18 years old for the prevention of coronavirus disease 2019 ▪ Administration: Intramuscular injection in the deltoid muscle
(COVID 19)
MODERNA COVID-19 VACCINE
▪ Name: mRNA-1273 (similar to Pfizer) (stable up to 6 months when
shipped and stored at negative 20°C) (more stable than Pfizer because
it contains a stabilizer and a preservative) (Pfizer, Moderna, and Jansse
are the only FDA approved?? [she cut in the middle])

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 PROTEIN BASED VACCINES CONSIDERATIONS FOR VACCINATION OF PEOPLE WITH CERTAIN
UNDERLYING MEDICAL CONDITIONS
Any current authorized COVID 19 vaccine can be administered to people
with underlying medical conditions who have no contraindications to
vaccination.
CONTRAINDICATIONS
CDC considers a history of the following to be a contraindications to
vaccination with covid 19 vaccines
▪ Severe allergic reaction (anaphylaxis) after a previous dose or to a
component of the COVID 19 vaccine.
▪ Immediate allergic reaction of any severity toa previous dose or known
diagnosed allergy to a component of the vaccine.
KILLED OR LIVE ATTENUATED

FAQs ON SARS-CoV-2 VACCINE

Interim clinical considerations for the use of COVID 19 vaccines currently
authorized in the United States
INTERCHANGEABILITY OF COVID-19 VACCINE PRODUCTS
▪ Any current authorized COVID-19 vaccine can be used when indicated.
ACIP does not state a product preference. However Covid 19 vaccines are
not interchangeable
▪ mRNA COVID-19 Vaccines (PFizer and Moderna)
▪ The safety and efficacy of a mixed product series have not been
evaluated. Both doses of the series should be completed with the same
product.
COADMINISTRATION OF OTHER VACCINES
None of the currently authorized COVID 19 vaccines are live virus vaccines.
Because data are lacking on the safety and efficacy of COVID 19 vaccines
administered simultaneously with other vaccines, the vaccine series should
routinely be administered alone with a minimum interval of 14 days before
or other administration of any other vaccine.
PEOPLE WITH PRIOR OR CURRENT SARS COV 2 INFECTION
Data from clinical trials indicate that the currently authorized COVID19
vaccines can be given safely to people with evidence of a prior SARS COV 2
infection.
VACCINATING PEOPLE WITH A KNOWN COVID 19 EXPOSURE OR DURING
COVID 19 OUTBREAKS
COVID 19 vaccines are not currently recommended for outbreak
management or post exposure prophylaxis to prevent SARS COV 2 infection
in a person with a known exposure because the median incubation of COVID
19 is 4 to 5 days. It is unlikely that a dose of COVID 18 vaccine would provide
an adequate immune response with the incubation period for effective post
exposure prophylaxis.

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HANNAH P., & PATRICK Y.
AIRAH M.
 LIVE ATTENUATED (LAV) INACTIVATED (KILLED ANTIGEN) SUBUNIT (PURIFIED ANTIGEN) TOXOID (INACTIVATED TOXINS)
▪ derived from disease-causing pathogens which have been ▪ made from microorganisms that
PROTEIN-
weakened under lab conditions have been killed through physical POLYSACCHARIDE CONJUGATE
BASED
▪ they will grow inside, but will cause no/very little disease or chemical processes. These
▪ these are live pathogens that are weakened in the laboratory cannot cause disease ▪ SAFEST VACCINE
▪ technically, it is almost as if saying we’re saying that the main ▪ has an excellent stability profile ▪ do not contain live components
pathogen is given to you so that you will develop an immune because they have no life v ▪ they contain only the antigenic parts of the
response components and have no risk of pathogen, which are necessary to elicit a “MOST EASY TO DEAL WITH”
▪ amongst all of the types of vaccines, this is the one that has the most introducing disease (safer and protective immune response vaccine
DESCRIPTION excellent immune response more stable than the live ▪ e.g. in a certain bacteria, you have to know what
o since you are giving a live pathogen into the body so that you will attenuated vaccines) is the antigenic portion of that pathogen (e.g.
develop an antibody for this, however, it is less safe compared to ▪ this type of vaccines are the surface antigen)
inactivated vaccines vaccines that are usually free ▪ the surface antigen will be extracted and will be
doses and most of them require the one that will be used in the vaccine formation
booster doses in the future ▪ similar with killed vaccines, they have an excellent
stability profile (have no live components, no risk
of inducing the disease, and is safer and more
stable than the live attenuated vaccines)
▪ stimulate excellent immune response, pathogens provide continual ▪ since the pathogen is already ▪ antigenic properties of the various potential ▪ based on the toxin produced
antigenic stimulation-sufficient memory cell production killed, it may not always induce an subunits of a pathogen must be examined in detail by certain bacteria: the toxin
▪ live microorganisms provide continual antigenic stimulation, giving immune response and the to determine which particular combination will invades the bloodstream and
sufficient time for memory cell production response may not be long lived produce an effective immune response but they is responsible for symptoms of
▪ attenuated pathogens are capable of replicating within host cells ▪ several doses may be required to are the safest amongst all of the vaccines the disease
▪ excellent immune response evoke an immune response ▪ it is very specific to a certain antigenic component ▪ usually, this is the type of
▪ may not always induce an immune ▪ once a response is elicited, there is no guarantee vaccine that requires an
response at first dose that an immunological memory will be formed in adjuvant
▪ response may not be long-lived, a correct manner ▪ to increase the immune
requiring several doses of vaccine o it is not 100% sure that in the next infection, response, the toxoid is
▪ LESS STRONG IMMUNE that surface antigen that we extracted from the absorbed to aluminum or
IMMUNE
RESPONSE COMPARED TO LIVE vaccine will be present in the pathogen since calcium salts, which serves as
RESPONSE
VACCINES sometimes, in certain organisms, one may be adjuvants (adjuvants boost the
absent from that specific specie (this doesn’t immune response of the
have a surface antigen), hence, the vaccine is individual) and may also
not effective against the said pathogen require several doses
▪ must determine which combination of antigenic ▪ may require several doses and
properties will produce an effective immune usually need an adjuvant
response with the correct pathway ▪ NOT HIGHLY IMMUNOGENIC
▪ a response may be elicited, but with no guarantee
that memory will form for future responses
▪ LESS STRONG IMMUNE RESPONSE COMPARED
to LAVs
▪ since live attenuated vaccines (LAVs) contain living organisms, there ▪ no risk of inducing disease, they do ▪ do not contain live components and are ▪ cannot cause the disease
is a degree of unpredictability raising some safety and stability not contain live components considered as very safe ▪ no possibility of reversion to
concerns ▪ more stable ▪ have no live components, no risk of inducing the virulence
▪ attenuated pathogens can revert to original form and cause disease ▪ have no live components, no risk disease ▪ stable, as they are less
▪ potential harm to individuals with compromised immune systems of inducing the disease ▪ safer and more stable than LAVs susceptible to changes in
(e.g. HIV) ▪ safer and more stable than LAVs ▪ EXCELLENT STABILITY PROFILE temperature, humidity and
▪ sustained infection (BCG-local lymphadenitis) ▪ EXCELLENT STABILITY PROFILE light
SAFETY AND
▪ contamination of tissue culture ▪ vaccine cannot cause disease
STABILITY
▪ immunization errors (Reconstitution, cold chain) it prevents
o a very unstable product since these are live pathogens ▪ very rare local and systemic
o the storage is very strict here: usually they are in freezing reactions
temperatures and freezing-thawing cycle is generally not ▪ usually stable and long lasting
recommended (once they are thawed, they must be given) ▪ EXCELLENT STABILITY
▪ usually not given in pregnancy PROFILE
▪ less safe compared to inactivated vaccines

AIRAH M.
 mRNA VIRAL VECTOR VACCINE (very recent vaccine)
mRNA vaccine is a very new technology and has been in development in early 2019 before SARS-CoV-2 hit. ▪ uses a safe virus to deliver the genetic code (DNA) of SARS-CoV-2 spike protein into the human cells to
mRna vaccine was initially developed for Ebola virus and is actually undergoing clinical trials using this type make protein
of technique as vaccines for Ebola virus. However, this has been superseded by the pandemic and mRNA ▪ JNJ-7843672 uses a human adenovirus to deliver the code for the SARS-CoV-2 spike protein
vaccine is one of the technology or types of vaccine that is on the market and is currently available as vaccines ▪ AZD1222 uses a non-replicating chimpanzee adenovirus to deliver the code for a SARS-CoV-2 spike protein
for SARS CoV-2. (used in MERS-COV)
▪ messenger (mRNA) is introduced to the cells providing the cells readable instructions on how to make WHAT DOES IT DO?
SARS-CoV-2 spike protein A purified spike protein is injected into
▪ this mRNA component is protected by lipid nanoparticles deliver mRNA to the cell’s cytoplasm a host or carrier virus and this carrier
▪ mRNA from the COVID-19 vaccine never enters the nucleus of the cell - the mRNA does not alter or interact virus carrying the DNA or the genetic
with the DNA. These are eventually degraded inside the cell. code of a particular antigen that you
WHAT IS mRNA? want your body want to recognize is
▪ It uses a molecular technique wherein the mRNA is introduced in contained. So, you give this virus to the
the cells. Providing readable (???) instructions on how to make a individual and then once it is absorbed,
SARS-CoV-2 protein. So technically, you are introducing an mRNA it will then infect or attach itself to a cell
component into the cell. So, this mRNA is protected by lipid and from there, the spike protein gene
nanoparticles which deliver mRNA to the cell's cytoplasm. Once is purified and then adenoviral is
they enter the cell, protein translation will ensue inside the cell injected, then body produces spike
and antibodies for that particular spike protein will be developed protein and finally the immune system
by the cell. produces the antibody. So, if you think
▪ ANALOGY on how vaccines work: So the vaccine contains a code, about it, it is similar to the live
and that code will be absorbed to your cell and then your cell will attenuated vaccine except that in live attenuated vaccine, the pathogen itself that is injected is the one that
read that code. Then it will produce the antibodies. you want your body to identify. In the Viral Vector Vaccine, it is using a different virus to carry the genetic
code so that once it attaches itself to the immune cells, it will inject that genetic code and then the immune
SARS-CoV-2 SPIKE PROTEIN
cells will read that genetic code – thus, producing the antibodies.
▪ the antibodies that are coded in the mRNA
▪ protein found outside of the SARS-CoV 2 virus WHAT ARE THE POSSIBLE COMPLICATIONS?
Adenovirus is actually a causative agent of the seasonal/common flu. So that is why, the safety issue for this
IS IT SAFE? is that this type of vaccine actually produces more adverse reactions than any other type of virus because
▪ based on their initial findings, it is safe you are technically injecting yourself with a human adenovirus or an adenovirus that causes flu. So, usually
▪ the mRNA does not alter or interact with the DNA because they patients that are given this type of vaccine are reported to produce full length symptoms (e.g. fever and
are limited, thus, they remain outside of the cell and they are cough) but when the patient recovers from it, there is an abundant production of antibodies. Take note that
eventually degraded or broken down in the cytoplasm the adenovirus given is modified so that they won’t replicate inside the body.

AIRAH M.