Covid-19 NLE Updates

TRUTHS
MYTHS
CONTROVERSIES
FLORENCE B. GRAGEDA, MD
OUTLINE OF PRESENTATION
 What is the COVID-19 disease?
 Pathophysiology of COVID-19 ?
 Clinical Manifestations
 Medical Management
 Nursing Management
 How are vaccines made?
 Differentiation of vaccines and efficacy
 What is Herd immunity?
 Frequently asked questions
EPIDEMIOLOGY: TIME LINE
November 9, 2019 :
PATIENT 0 in Wuhan, China

January 30, 2020 :

WHO declared “ Public Emergency of International Concern”

March 11, 2020 :

WHO declared Pandemic

March 27, 2020 :

US surpassed China in number of confirmed cases

March 27, 2020 :

number of cases worldwide: HALF A MILLION

December 14, 2020 :

UK report: new variant of SARS-CoV-2
greater transmissibilitiy
BACKGROUND
December 18, 2020 :
South AFRICA report: another SARS-CoV-2 variant
Initial studies suggest a High viral load

January 9, 2021 :
JAPAN: SARS-COV-2 variant detected in four travelers from Brazil
Initial studies suggest a High viral load

January 9, 2021 :
number of cases worldwide: 95 M
number of deaths : 2 M

January 19, 2021 :

number of cases PHILIPPINES: 27, 857 ( 5.5 % )
number of death IN THE PHILIPPINES: 9, 978 ( 1.98% )
BACKGROUND
January 19, 2021 :
number of cases worldwide: 95 M
number of deaths : 2 M

January 20, 2021 :

number of cases PHILIPPINES: 27, 857 ( 5.5 % )
number of death IN THE PHILIPPINES: 9, 978 ( 1.98% )

April 25, 2021 : 12:24 am

number of cases WORLDWIDE: 145,672,293
number of death IN THE WORLDWIDE: 3,087,046

April 25, 2021 : 12:24 am

number of cases PHILIPPINES: 989,380
number of death IN THE PHILIPPINES: 16, 674
 THE
CORONAVIRUS
CORONAVIRUSES
= family of viruses causing
illness from the common
cold to severe critical
illness
Severe Acute Respiratory Syndrome-2 (SARS-COV-2)
= COVID-19
= new ( novel ) strain of coronavirus
= not previously identified in humans

Middle East Respiratory Syndrome (MERS-CoV)

= 2012
Severe Acute Respiratory Syndrome (SARS-CoV)
= 2003
= both were also originally called “novel coronaviruses”

 Zoonotic
= passed between animals and people
ORIGIN of COVID-19
 bats or pangolins
 transmitted to humans directly
or through an intermediate
host
 source location: large live
animal market in Wuhan, Hubei
Province
 human – to – human spread
EPIDEMIOLOGY
 EPIDEMIOLOGY OF DISEASE TRANSMISSION

 R
= replication rate of the disease

 R naught ( R0)
= the inherent transmissibility of an infectious agent
 EPIDEMIOLOGY OF DISEASE TRANSMISSION
 What determines the replication rate?
• Unique biological characteristics of pathogen
• % of population susceptible ( without immunity )
• Mode of transmission (i.e. respiratory droplet, airborne)
• Serial interval
– amount of time between successive cases in a chain of
transmission
• Healthcare responses
– how soon and how well you isolate ill patients and quarantine of
contacts, restrict travel, and use of PPE in healthcare settings

FOR DISEASE TRANSMISSION TO BE STOPEED, R MUST BE <1.

 EPIDEMIOLOGY OF DISEASE TRANSMISSION


 INCUBATION PERIOD :
= 2 – 14 DAYS
= symptoms usually begin around 5th day
 Severe Acute Respiratory Syndrome-2
(SARS-COV-2)
 VIRAL MUTATIONS

 viruses naturally mutate over time

 severity of mutation depends on the change in virus’ genetic

material

 some results in the production of a different protein during

replication
 Severe Acute Respiratory Syndrome-2
(SARS-COV-2)
 VIRAL MUTATIONS
 Notable variants reported ( as of January 15, 2021 ) WHO:

 D614G ( > infectivity & transmission )

 VOC 202012/01 (UK variant; > transmission )
 501Y.V2 ( South Africa variant; > viral load )
 B.1.1.28 ( 12 mutations; Brazil variant; travelers
arrived in Japan )
 Severe Acute Respiratory Syndrome-2
(SARS-COV-2)
 VIRAL MUTATIONS
 Variants of concern: UP Philippine Genome Center (PGC)
March 10, 2021

 B.1.1.7 ( UK variant )
 B.1.351 ( South Africa variant; > viral load )
 P.1 ( 17 mutations; Brazil variant *)
PATHOPHYSIOLOGY
How Do COVID-19 Works ?
• Bump on the surface of
the virus
• About 75 spike proteins
 January 10, 2020
 complete
viral genome
sequence
released

Critical for
development of;
vaccines,
treatments
prevention multiple variants
causing COVID-19
 Key Components of the
adaptive immune response to
SARS-CoV-2
 CYTOKINE

 small soluble molecules acting as messengers for immune system

 produced by side variety of immune cells
 Neutrophils
 Basophils
 Eosinophils • Change activity of cell
 Mast cells • alter function of proteins
 Dendritic cells • change expression of certain genes
 Monocytes
 Macrophages
 B cells
 T cells
 CYTOKINE STORM

 Structural groups of cytokines:

 Interleukins (IL) 1-35
 key role in immune response
 Produced by leucocytes --> leucocytes
 Proinflammatory
 IL 1alpha, IL beta, IL 6 and IL-8
 Anti-inflammatory
 IL-4, IL-10, IL-13
 CYTOKINE STORM

 Structural groups of cytokines:

 Tumor Necrosis Factor (TNF)
 19 known
 mast cells, Macrophages, T cells
 immune cell activation
 differentiation, growth, death
 TNFa
 major proinflammatory cell
 potent activation of cytotoxic T cells
 viral disease and cytokine storm
 Blockage  autoimmune disease
 CYTOKINE STORM

 Structural groups of cytokines:

 Interferons (IFN)
 20 known
 Type I: IFN alpha and beta
 Produced by many cells to infection (Hep C)
 Type II:
 Role in immune responses
 Inc phagocytosis of macrophages
 ANTIVIRAL ROLE
 Colony Stimulating Factors (CSF)
 act on stem cells in bone marrow to stimulate growth and
differentiation
 CYTOKINE STORM in COVID-19

 Immune response is more than it should be!

 Infection

 Immune response to fight pathogen

 Dysregulated immune response

 2 weeks after infection

 Increase more
 CYTOKINE STORM in COVID-19

 Immune response is more than it should be!

 Deadly uncontrolled local and systemic inflammatory response

 Inc proinflammatory cytokine and many WBC

 Not sure of cause ?

 CYTOKINE STORM in COVID-19

 PROGRESSION
CORONAVIRUS

binds to ACE2 receptors

enters the alveoli

attacks the Type 2 alveolar cells

Inflammatory response

T cells, B cells, CYTOKINES storm

 CYTOKINE STORM in COVID-19

 PROGRESSION
vasodilation, edema

Inc extravascular pressure

Systemically
Dec tissue perfusion
SIRS
Endothelial dysfunction

Plasma proteins accumulate

TNFa & IL-6

Major contributors to cytokine storm
 CYTOKINE STORM in COVID-19

 PROGRESSION
acute lung injury

ARDS

May resolve

FIBROSIS

Long term dysfunction

•SURVEILANCE
 SURVEILANCE DEFINITIONS

• CONTACT
• defined by the WHO Global Surveillance for COVID-19 disease
interim guidance (as of March 20, 2020) is a person who
experienced any one of the following exposures during the 2 days
before and the 14 days after the onset of symptoms of a probable
or confirmed case:
1. Face-to-face contact with a probable or confirmed case within 1 meter
and for more than 15 minutes;
2. Direct physical contact with a probable or confirmed case;
3. Direct care for a patient with probable or confirmed COVID-19 disease
without using proper PPE; OR
4. Other situations as indicated by local risk assessments

Note: For confirmed asymptomatic cases, the period of contact is measured

as the 2 days before
 WHO Case Definitions for Surveillance
• SUSPECT CASE
• A. All SARI cases where NO other etiology fully explains the clinical presentation.
• b. ILI cases with any one of the following:
• i. With no other etiology that fully explains the clinical presentation AND a
history of travel to or residence in an area that reported local transmission of
COVID-19 disease during the 14 days prior to symptom onset OR
• ii. With contact? to a confirmed or probable case of COVID-19 disease during
the 14 days prior to the onset of symptoms
• c. Individuals with fever or cough or shortness of breath or other respiratory
signs or symptoms fulfilling any one of the following conditions:
• i. Aged 60 years and above
• ii. With a comorbidity
• iii. Assessed as having a high-risk pregnancy
• iv. Health worker
 WHO Case Definitions for Surveillance
• PROBABLE CASE
• a suspect case who fulfills anyone of the following listed below.
• a. Suspect case whom testing for COVID-19 is inconclusive
• b. Suspect who underwent testing for COVID-19 but not
conducted in a national or subnational reference laboratory or
officially accredited laboratory for COVID-19 confirmatory
testing
• c. Suspect case for whom testing could not be performed for
any reason
 SURVEILANCE DEFINITIONS

• CONFIRMED CASE
• any individual, irrespective of presence or absence of clinical signs
and symptoms, who was laboratory-confirmed for COVID-19 in a
test conducted at the national reference laboratory, a subnational
reference laboratory, and/or officially accredited laboratory testing
facility.
• (+) RT-PCR test
 INFECTION PROTECTION CONTROL (IPC)
• DEATH DUE TO COVID

• a death resulting from a clinically compatible illness in a probable

or confirmed COVID-19 case, unless there is a clear alternative
cause of death that cannot be related to COVID-19 disease such as
trauma or car accident.

• There should be no period of complete recovery between the

illness and death.
 CLINICAL
MANIFESTATIONS
 Most common symptoms
 Fever ( 83% - 99 %% )
 Cough ( 59% - 92 % )
 Shortness of breath ( 31% - 40 % )

 Other symptoms
 Anosmia
 Ageusia
 Feeling tired
 Headache
 Myalgias
 sore throat
 nasal congestion
 diarrhea
 CLINICAL SPECTRUM of sars-cOv-2 INFECTION

 Symptomatic or Presymptomatic Infection:

 test positive for SARS-CoV-2 using a virologic test (i.e., a nucleic
acid amplification test [NAAT] or an
 antigen test but who have no symptoms that are consistent with
COVID-19.

 Mild Illness:
 fever, * cough, sore throat, malaise,
 Headache. * muscle pain, nausea, vomiting, diarrhea,
 Ageusia * anosmia
 do not have shortness of breath, dyspnea, or abnormal chest
imaging.
 Managed at home or ambulatory care
 CLINICAL SPECTRUM of sars-cOv-2 INFECTION

 Moderate Illness:
 evidence of lower respiratory disease during clinical assessment
 imaging
 oxygen saturation (SpO2) ≥94% on room air at sea level
 If bacterial pneumonia or sepsis is suspected,
 Emperic antibitiotic treatment
 Close monitoring
 CLINICAL SPECTRUM of sars-cOv-2 INFECTION

 Severe Illness:
• SpO2 <94% on room air at sea level
• a ratio of arterial partial pressure of oxygen to fraction of inspired
oxygen (PaO2/FiO2) <300 mm Hg
• RR >30 breaths/min
• lung infiltrates >50%.
• Rapid clinical deterioration
• O2 using a nasal cannula or high-flow oxygen devise
 CLINICAL SPECTRUM of sars-cOv-2 INFECTION

 Critical Illness:
 Respiratory failure
 Septic shock
 MODS
 Patients with comorbidities;
 higher risk of progressing to severe COVID-19
 65 years or older
 cardiovascular disease
 chronic lung disease
 sickle cell disease
 Diabetes
 cancer
 CLINICAL SPECTRUM of sars-cOv-2 INFECTION

 Patients with comorbidities;

 Obesity
 chronic kidney disease
 being pregnant
 being a cigarette smoker
 being a recipient of transplant or immunosuppressive therapy.1

 Health care providers should monitor such patients closely until

clinical recovery is achieved.
• DIAGNOSIS
 C-Xray
 CT Scan
 ground glass opacities, peripheral,
asymmetrical and posterior distribution
in early infection without pleural effusion

 ECG
 Ferritin
 Male: 12-300, Female: 10-150
 inflammation: 1,000
 inc in inflammation
 early marker in CS in covid-19 patients
 CLINICAL DIAGNOSIS
 Laboratory tests:
 CBC with differential
 Metabolic profile
 SGPT/SGOT
 BUN/Creatinine
 inflammatory markers
 C-reactive protein (CRP)
 D-dimer
 ferritin
 DIAGNOSIS
 CRP
 produced by the liver in response to IL-6
 marker of inflammation
 rapid rise  risk for CS
 D-dimer
 coagulation system is active during critical illness
 levels associated with proinflammatory cytokine cascade
 Normal: < 500
 associated with inc risk for multi organ failure and death
 Elevation  3-4x  inc mortality
THERAPEUTIC MANAGEMENT of
OUTPATIENT ADULTS with
COVID-19
COVID-19 TREATMENT GUIDELINES
US-NIH, UPDATED RECOMMENDATIONS
APRIL 21, 2021
 THERAPEUTIC MANAGEMENT of ADULTS with COVID-19

 No therapy has been proven to be beneficial in OP with

mild to moderate COVID-19 who are at high risk for
disease progression
 Pathogenesis:
 Early: replication of SARS-CoV-2.
 Later: a dysregulated immune/inflammatory response
to SARS-CoV-2 that leads to tissue damage.
 Therapeutics:
 Early: Antiviral therapies
 Later: immunosuppressive/anti-inflammatory therapies
 THERAPEUTIC MANAGEMENT of ADULTS with COVID-19

 COVID-19 Treatment Guideline Panel

 Supportive care
 Reduce the risk of SARS-CoV-2 transmission
 Isolating patient
 Advise when to contact a HCP or in-person evaluation (AIII)

 Symptomatic management to OP with COVID-19

 Telehealth before receiving in-person care
 Triage
 Patients with dyspnea : in-person evaluation by a HCP and
followed closely for worsening respiratory status (AIII)
 Specific Therapy for Outpatients With Mild to Moderate COVID-19

 COVID-19 Treatment Guideline Panel

 Management plan based on patient’s;
 Vital signs
 Physical exam findings
 Risk factors for progression to severe illness
 Availability of health care resources (AIII)

 Rating of Recommendations: A = Strong; B = Moderate; C = Optional

Rating of Evidence: I = One or more randomized trials without major limitations;
IIa = Other randomized trials or subgroup analyses of randomized trials; IIb =
Nonrandomized trials or observational cohort studies; III = Expert opinion
 Specific Therapy for Outpatients With Mild to Moderate COVID-19

 Anit-SARS-CoV-2 Monoclonal Antibodies

 amlanivimab 700 mg plus etesevimab 1,400 mg (AIIa); or
 Casirivimab 1,200 mg plus imdevimab 1,200 mg (AIIa).

 The Panel recommends against the usepf;

 Chloroquine or Hydroxychloroquine with orwithout
 Azithromycin (AI).
 There are insufficient data for the Panel to recommend either for or
against the use of other agents for the treatment of outpatients with
COVID-19.
 Specific Therapy for Outpatients With Mild to Moderate COVID-19

 The Panel recommends against the use of;

 dexamethasone or other systemic glucocorticoids in
outpatients in the absence of another indication (AIII).

 There is currently a lack of safety and efficacy data on the use of

these agents in outpatients with COVID-19, and systemic
glucocorticoids may cause harm in these patients.
 Specific Therapy for Outpatients With Mild to Moderate COVID-19

 The Panel recommends against the use of;

 antibacterial therapy (e.g., azithromycin, doxycycline) in the
absence of another indication (AIII).

 Health care providers should provide information about ongoing clinical

trials of investigational therapies to eligible outpatients with COVID-19
so they can make informed decisions about participating in clinical
trials (AIII).
 Specific Therapy for INPATIENT COVID-19

 REMDESIVIR
 an antiviral agent
 only drug that is approved by the FDA for the treatment of COVID-
19
 recommended for use in hospitalized patients who require
supplemental oxygen.
 not routinely recommended for patients who require mechanical
ventilation due to the lack of data showing benefit at this advanced
stage of the disease.3-6
 Specific Therapy for INPATIENT COVID-19

 DEXAMETHASONE
 A corticosteroid
 found to improve survival in hospitalized patients who require
supplemental oxygen
 with the greatest benefit observed in patients who require
mechanical ventilation.

 Therefore, the use of dexamethasone is strongly recommended in this

setting.7-10
 Specific Therapy for INPATIENT COVID-19

 TOCILIZUMAB
 recombinant humanized anti-interleukin-6 receptor monoclonal
antibody
 Added to dexamethasone therapy
 found to improve survival among patients who were exhibiting
rapid respiratory decompensation due to COVID-19.11,12
 •NURSING
MANAGEMENT
and
INFECTION
PROTECTION CONTROL
 INFECTION PROTECTION CONTROL (IPC)

• Hand washing:
• Use at least one of the following, for at least 20 seconds
• Soap and water
• Sing Happy Birthday twice ~ 20 seconds
• Alcohol-based hand rub (at least 60% alcohol) for at least 30
seconds
• If these are not readily available, 0.05% chlorine solutions from
diluted bleach can be used.
• Always wash hands with soap and water and do not use alcohol-
based hand rub when hands are clearly soiled.
 INFECTION PROTECTION CONTROL (IPC)

 Standard precautions for patients

involve WHO’s 5 moments for hand
hygiene

 Before touching a patient

 Before any clean or aseptic
procedure is performed
 After exposure to body fluids
 After touching a patient
 After touching a patient’s
surroundings
INFECTION PROTECTION CONTROL (IPC)
 INFECTION PROTECTION CONTROL (IPC)
• Reusing PPEs in case of low supply.
• Gowns
• Can be washed with hot water and detergent for re-use.
• Store used gowns in a closed container in patient rooms.
• Staff handling dirty gowns should wear PPE.
• Gloves
• Disposable gloves preferred.
• Masks
• Masks can be reused up to 2-3 days or longer. Avoid touching the
mask when you have it on. Apply and remove by touching only the
straps.
• After removal, masks can be stored in a labeled bag for re-use.
• Eye-protection
• Eye protection such as goggles or face shields can be re-used. Clean
after each use by using disinfectant wipes and store in a labelled
bag.
 INFECTION PROTECTION CONTROL (IPC)

• Respiratory hygiene
• Cover their nose and mouth with a tissue or upper sleeve when
coughing or sneezing.
• Wash hands after coughing and sneezing.
• If upper respiratory symptoms are present, face masks should be
provided to patients while they are in waiting or public areas.
• Perform hand hygiene after any contact with respiratory
secretions.
• Avoid touching eyes, nose, or mouth.
 CARE OF CRITICALLY ILL ADULT
PATIENTS with COVID-19

1. CDC: Interim Infection Prevention and Control Recommendations for Healthcare Personnel During the
COVID-19 Pandemic
2. COVID-19 TREATMENT GUIDELINES, US-NIH, UPDATED RECOMMENDATIONS, APRIL 21, 2021
3. Aerosol-Generating Procedures and Patients with Suspected or Confirmed COVID-19, Minessota
Department of HealthApril 21, 2021
 PRONING
• Any COVID‐19 patient with respiratory embarrassment severe
enough to be admitted to the hospital should be considered for
rotation and proning.
• Care must be taken to not disrupt the flow of oxygen during patient
rotation, but we recommend proning regardless of oxygenation
modality.
• Typical protocols include;
• 30–120 minutes in prone position
• 30–120 minutes in left lateral decubitus, right lateral decubitus,
and upright sitting position.
• Positioning is guided by patient wishes–salutary effects are generally
noticed within 5–10 minutes in a new position;
• do not maintain a position that does not improve the patient’s
breathing and comfort.
 OXYGEN THERAPY
• If you recognize signs of worsening respiratory distress or
severe hypoxemic respiratory failure, you will need to
intervene beyond providing supplemental oxygen.
• face mask with reservoir bag at flow rates of 10-15 L/min.
• minimum flow required to maintain bag inflation.
• Hypoxemic respiratory failure in ARDS commonly results
from intrapulmonary ventilation-perfusion mismatch or
shunt and usually requires mechanical ventilation.
 OXYGEN THERAPY
• High-flow nasal oxygen (HFNO) or non-invasive ventilation
(NIV):
= Should only be used in select patients.
 CARE OF CRITICALLY ILL ADULT PATIENTS with COVID-19

• Aerosol-generating procedures (AGP)

= avoid or minimize
= open suctioning of airway secretions
= sputum induction
= CPR
= ET intubation and extubation
= Noninvasive positive pressure ventilation (NIPPV)
* BiPAP, CIPAP
= Bronchoscopy
= Manual ventilation

1. Aerosol-Generating Procedures and Patients with Suspected or Confirmed COVID-19, April 21, 2021
2. CDC: Interim Infection Prevention and Control Recommendations for Healthcare Personnel During the COVID-19 Pandemic
 CARE OF CRITICALLY ILL ADULT PATIENTS with CPVID-19

• Aerosol-generating procedures (AGP)

= minimize or avoid
= limited data;
nebulization
high-flow O2 delivery
tracheostomy
nasal endoscopy or endoscopic sinus surgery
transphenoidal surgeries
NG or nasojejunal tube placement
 CARE OF CRITICALLY ILL ADULT PATIENTS with CPVID-19

• Aerosol-generating procedures (AGP)

= minimize or avoid

• Rationale:
= generate higher concentrations of infectious
respiratory aerosols than coughing, sneezing, talking
or breathing
= put HCP increase risk for exposure to SARS-CoV-2
and infection
= should be performed in airborne infection
isolation rooms (AIIR) if available
 CARE OF CRITICALLY ILL ADULT PATIENTS with CPVID-19

• Infection Control

• For health care workers who are performing aerosol-generating

procedures on patients with COVID-19
• N95 respirator (or equivalent or higher-level respirator)
• PPE
• (AIII)
• Minimize the use of aerosol-generating procedures on ICU
patients with COVID-19
• Minimize any necessary aerosol-generating procedures in a
negative-pressure room, also known as an airborne infection
isolation room, when available
• (AIII)
 CARE OF CRITICALLY ILL ADULT PATIENTS with CPVID-19
• Infection Control

• For health care workers who are providing usual care for
nonventilated patients with COVID-19,
• N95 respirator
• or equivalent or higher-level respirator
• PPE
• surgical mask
• (AIIa)
 CARE OF CRITICALLY ILL ADULT PATIENTS with COVID-19

• Infection Control

• For health care workers who are performing non-aerosol-

generating procedures on closed-circuit mechanical
ventilation,
• N95 respirator (or equivalent or higher-level respirator)
• PPE
• Rationale:
= because ventilator circuits may become disrupted.
unexpectedly (BIII).
 CARE OF CRITICALLY ILL ADULT PATIENTS with CPVID-19

• Infection Control:

• The Panel recommends that ET intubation in patients with COVID-

19 be performed by health care providers with extensive airway
management experience, if possible (AIII).

• The Panel recommends that intubation be performed using video

laryngoscopy, if possible (CIIa).
 CARE OF CRITICALLY ILL ADULT PATIENTS with CPVID-19

• Hemodynamics:
 SHOCK
 dynamic parameters
 skin temperature
 capillary refilling time, and/or
 lactate levels over static parameters to assess fluid
responsiveness
 (BIIa)
 COVID-19 and SHOCK
 Initial resuscitation: ALBUMIN
 Vasopressor of Choice: NOREPINEPHRINE or EPINEPHRINE
 CONTACT TRACING
• involves contact identification, contact listing, contact follow-up.
• a person who was exposed during the 2 days before and the 14
days after the onset of symptoms of a probable or confirmed
cases.
• Face to face contact with a probable or confirmed case within 1
meter and for more than 15 minutes.
• Direct physical contact with a probable or confirmed case.
• Direct care for a patient with a probable or confirmed COVID-19
disease without using proper PPE.
• WHO recommends follow up for all contact.
•HOW DO WE QUARANTINE
or ISOLATE ?
• QUARANTINE
• separates and restricts the movement of people who were
exposed to a contagious disease to see if they become sick
• ISOLATION
• Separates sick people with a contagious disease from people
who are not sick
 ISOLATION and QUARANTINE

CASE 1 :
QUARANTINE PERIOD of a
CoVid – 19 NEGATIVE PATIENT
 ISOLATION and QUARANTINE

CASE 2 :
QUARANTINE PERIOD OF CLOSE
CONTACT OF POSITIVE PATIENT
ISOLATION and QUARANTINE

CASE 3 :
SYMPTOMATIC
POSITIVE PATIENT
ISOLATION and QUARANTINE

CASE 4 :
ASYMPTOMATIC POSITIVE
PATIENT
•VACCINES
 CLINICAL TRIALS
Vaccines have to go through rigorous testing and scrutiny to ensure
safety, because they’re given to healthy people to prevent them
from getting sick

Holds true, even with the urgency to develop a potential vaccine

for COVID-10
 Clinical Trial
• Pre-clinical trial :
• How will this vaccine work?
• Research-intensive stage
• Goal: find natural or synthetic Antigen that triggers
the same reaction an actual virus or bacteria would
• Testing done on animals
• Length: up to 4 years
 Clinical Trial
• Phase I:
• Is it safe ?
• “first in human”
• Testing done of Healthy Male Subjects
• Number of volunteers: 20 - 100
• Goal: Safety of the vaccine
• Safety ?
• response of the immune system ?
• Route ?
• Duration: 1 week – several months
 Clinical Trial
• Phase 2:
• Is it Safe and how will the immune system react?
• Testing done on patients with the disease
• Goal: effective dosages and safety
• Dose
• Side effects
• Risk factors
• Participants: several hundred
• Duration: up to 2 years
 Clinical Trial
• Phase III:
• How effective is the vaccine?
• Goal: safety, side effects and potential effectiveness
• Larger clinical trial from around the world with the disease
being studied
• Dosing
• Patient population
• Safe
• effective
• Participants: several hundred to three thousands
• Duration: 1 – 4 years
 Clinical Trial
• Phase IV:
• “open-label studies”
• Goal: Long term clinical studies to better understand risk and
potential benefits over time
• Participants: several thousands people
• Duration: over a year
PRINCIPLE ?
 CLINICAL PRECLINICAL PHASE 1 PHASE 2 PHASE 3 PHASE 4
TRIAL:
How will this work? Is it safe, and Is it safe, and How effective is the Can I buy it now in
what’s the right what’s the right vaccine? the pharmacy?
dose? dose?

GOAL • find a natural or • Safety • Effective dose • Side effects and • Long term
synthetic ANTIGEN 1. safe? and safety potential clinical studies
that can trigger an 2. response of 1. dose ? effectiveness to better
immune response immune 2. side effects? 3. 1. ID dose 2. understand
the same as a virus system? risk factors? ID population. risk and
or bacteria would 3. route? 3. safety. potential
4. side effects benefits over
time
PARTICIPANTS • animals • healthy (male) • Patients with the • Patients at risk of • Patients at risk
subjects disease being getting disease of getting the
studied disease

• 20 - 100 • Several hundreds • Several HUNDRED • Several

to THOUSANDS THOUSANDS

LENGTH OF • years • 1 week – several • Up to 2 years 1 – 4 years Over year

TIME months
COVID-19 vaccine,
hesitancy is real !
 “Being first”
 “Safety”
 “How long will the protection last?
 “What is Emergency Use Authorization (EUA)?
How Do COVID-19 vaccine Works ?
• Bump on the surface of
the virus
• About 75 spike proteins
PRINCIPLE ?
Three Types of Vaccines
 Efficacy ?

 Goal: not to prevent covid-19 that will kill

you

 If you get covid-19, you will only get colds

 not hospitalization, not intubation

 Differences of Vaccines
 Non-Replicating:
• Astra
• Jansen
• Sinovac
• Sinopharm
• Sputnik V
• Novavax

 Messenger RNA (mRNA):

• Moderna
• Pfizer
 Differences of Vaccines
 Non-Replicating: • Fixed number of proteins are introduced
• Astra ( 100 proteins )
• Jansen
• Sinovac • 100 antibodies will be produced
• Sinopharm
• Sputnik V
• Novavax
 Differences of Vaccines
 Messenger RNA (mRNA):
• Moderna
• Pfizer

• sends message to cells

• produce spike proteins

• 100 mRNA  immune system  10,000

spike proteins  10,000 antibodies will be
produced
 What is non-replicating doing ?
 Non-Replicating: • Fixed number of proteins are introduced
• Astra
• Jansen 100 antibodies will be produced
• Sinovac
• Sinopharm
• Sputnik V
• Novavax
• not make proteins ( vial )
• Less antibody produced
• Interaction between proteins and
antibodies are less
 What is mRNA doing ?
 Messenger RNA (mRNA) • mRNA
• Moderna • sends message to cells  produce spike
• Pfizer proteins
• 100 mRNA  immune system  10,000
spike proteins  10,000 antibodies will be
produced

• make proteins  work

• make antibodies  work
• proteins and antibodies interact  energy is
required
 History of Allergy ?
 Non-Replicating: • mRNA
• Astra • sends message to cells  produce spike
• Jansen proteins
• Sinovac • 100 mRNA  immune system  10,000
• Sinopharm spike proteins  10,000 antibodies will be
• Sputnik V produced
• Novavax

• allergy
 Elderly and history of disease ?
 Non-Replicating: • mRNA
• Astra • sends message to cells  produce spike
• Jansen proteins
• Sinovac • 100 mRNA  immune system  10,000
• Sinopharm spike proteins  10,000 antibodies will be
produced
• Sputnik V
• Novavax
• make proteins  more work
• make antibodies  more work
• proteins and antibodies interact  more
energy is required
 Elderly and history of disease ?
 Non-Replicating: • Non-replicating
• Astra • Fixed number of proteins are introduced
• Jansen
• Sinovac 100 antibodies will be produced
• Sinopharm
• Sputnik V
• Novavax

• less workload to body

 What brand of covid vaccine is the best
and good for me ?

 The BEST vaccine is the one that is available.

 You should get any COVID-19 vaccine that is available when

you are eligible.

 Do not wait for a specific brand. All currently authorized and

recommended COVID-19 vaccines are safe and effective.

 Better to have protection NOW than none at all.

 Are COVID-19 vaccines safe?

• The COVID-19 vaccine are granted with EMERGENCY

USE AUTHORIZATION by the Food and Drug
Administration (FDA) are considered safe and effective
based on the evidence to date.
 How does the COVID-19 vaccine work in
our body ?
• The COVID-19 vaccine will help to produce antibodies to help
fight the coronavirus.
 Are there risks when given the COVID-vaccine?

• Serious problems from vaccination can happen but are RARE.

• Anyone who will receive the vaccine will be properly evaluated

and closely monitored by health professionals to further minimize
any risk.
What are the common signs and symptoms
after receiving the COVID-19 vaccine??

 Usual signs and symptoms:

 pain and tenderness in injection site
 fever
 headache
 body pains
 What to do if you experienced this?
 Apply cold compress on the affected area
 May take paracetamol
 Exercise affected limb
 Drink plenty of water
 Take some rest
 Who can receive the covid-19 vaccine?
Anyone who is 18 years old and above ( 16 for Pfizer )
even if with the following disease:
 Hypertension
 Diabetes
 Heart problem
 Cancer
 Kidney disease
 Asthma
 Pregnant and lactating women are part of a group
recommended to receive the COVID_19 vaccine. There
are currently limited data on its safety
 Talk to healthcare provider for an informed decision
 Who can receive the covid-19 vaccine?

 Initially Sinovac was recommended only for ages 18-59 years old.
However, the newest guideline includes now the 60 and above
individuals.
What are the contraindications to getting
the COVID-19 vaccine?

 The only absolute contraindication is a known

hypersensitivity to the vaccine components

 Allergy to the first dose

Can the vaccine by administered for persons with a
history of COVID-19 disease?
 Vaccination is recommended for a person with a
history of COVID-19. People who currently has COVID-
19, should be deferred until fully recovered and has met
the criteria to discontinue isolation.

 Those who were exposed to COVID-19 individuals

should finish their14-day quarantine before receiving
the vaccine.
 How long will the vaccine work?

 We still do not have information about the durability of

protection of the virus.

 Initial studies by Pfizer reported that we may need a

booster dose and just like the flu vaccine, may need an
annual shot. More studies are underway.
 Can I get other vaccines at the same time
with COVID-19 ?

 At this time, there is limited data on the safety and

efficacy of COVID-19 vaccine with the other vaccines.

The vaccine series should be routinely administered

alone, with minimum of 14 days before or after the
COVID-19 vaccine.
 How effective are the vaccines available ?

 Different vaccine brands reported a range of

effectivity against mild symptomatic COVID

 100 % effective against severe COVID

 Vaccine Roll out in the Philippines

 As of April 12, 2021, DOH reported that the

Philippines has vaccinated over a million individuals
belonging to the top three priority groups ---
health workers, senior citizens and persons with
comorbidities
 What is HERD IMMUNITY ?

 indirect protection from an infectious disease that

happens when a population is immune either through
vaccination or immunity developed through previous
infection

 not everyone can be vaccinated in 1 reason or

another
 What is HERD IMMUNITY ?

virus can’t infect someone who is not vaccinated

because it can’t find the person

 NO way will the virus can get through the 70% who
are vaccinated or protected to the 30 % who are not
vaccinated

 70 % of the people around me is vaccinated

• FREQUENTLY ASKED
QUESTIONS
 If I complete the 2 doses of vaccine, what are
the chances that I will still get COVID ?

 Individuals may still get infected but with only mild

symptoms and can be cured at home

 100% sure that I will not get severe covid and will not be
hospitalized, much less, will be intubated
 What are the common side effects after
getting a COVID vaccine?
 fever
 pain
 redness
 swelling in the arm where you received the shot
 tiredness
 headache
 muscle pain
 chill
 nausea
 What about the issue of blood clot in
AstraZeneca ?
 Initially, it was withdrawn but eventually recalled
back.
 Only 37 reported blood clotting out of 17 million
who were vaccinated in UK and Europe
Mahase E. COVID-19:
European Medicines Agency, COVID-19
WHO says rollout of AstraZeneca vaccine
Vaccine AstraZeneca: benefits still outweigh
should continue
the risks despite possible link to rare blood
clots with low blood platelets.
BMJ 2021; 372:n728 doi:10.1136/bmj.n728
16 Mar 2021: https://www.ema.Europa.eu/en
 What are the benefits of getting
vaccinated?
 control and reduce spread of the virus

 reduce chances of getting hospitalized

 reduce mortality or death from COVID 19

 Once I am vaccinated, is it okay not to
wear face masks and shields ?

 NO

 protection against COVID-19 sets in about 2-3

weeks after completing the 2 doses
 If I am pregnant, can I get a COVID-19
vaccine?

 delay until after the 1st trimester

 limited data on the safety of COVID vaccines in

pregnant people
 Pregnant women can’t get COVID-19
vaccine?
 Memorandum 2021-0175
“Pregnant and lactating women who belong
to priority groups may be vaccinated. However
pregnant women in their first trimester will not
be given a vaccine
 If I am breastfeeding, can I get a COVID-
19 vaccine?

 lactating women may choose to be vaccinated

 If I want to get pregnant in the future, can
I get a COVID-19 vaccine?

 you may receive a COVID-19 vaccine when one

is available

 currently, no evidence that any vaccines,

including may harm humans
 I am a Covid 10 Survivor, when can I get
vaccinated?

 Department Memorandum 2021-0175 , (April 15,

2021)
“All vaccine recipients who contracted COVID-19
may be vaccinated after recovery or completion of
treatment, whether for 1st or 2nd dose, without
restarting the vaccine dose schedule.”
https://doh.gov.ph/press-release/DOH-ISSUES-ADDITIONAL-VACCINATION-GUIDELINES
 Should I still get tested after recovery or
14-day quarantine ?

 Recovered patients can continue to have SARS-CoV-2

RNA detected in their upper respiratory specimens for
up to 12 weeks after symptom onset. (31,33,34)
 How long will the covid vaccine protect us ?

 no definite data yet

 like other coronavirus causing common colds, 8
months to 1 year
 vaccination MAY BE once a year at most 2 years
 Why are children not vaccinated ?

 there are still no clinical trial on this age group

 if 70% of the population is vaccinated, children

can be protected
 Can I take IVERMECTIN to prevent from
being infected with Covic-19 ?
 Ivermectin was first developed in the late
1970’s as an antiparasitic drug

 Ivermectin was used to bring healing to the

countries to quell rising cases of river blindness

https://www.pna.gov.ph/articles/1136876 IVERMECTIN
 Can I take IVERMECTIN to prevent from
being infected with Covic-19 ?
 In a widely cited 2020 paper, a group of scientists
led by Australian Leon Caly of the Royal Melbourne
Hospital said that the antiparasitic Ivermectin is
effective in reducing SARS-CoV-2 in vitro.
o Done on a TEST TUBE
o “ further investigation for its possible benefits to
humans.”
Caly, L., Druce, J.D., Catton, M.G., Jans, D.A. & Wagstaff, K.M. The FDA‐approved drug ivermectin inhibits the
replication of SARS‐CoV‐2 in vitro. Antiviral Res. 178, 104787 (2020)
 Can I take IVERMECTIN to prevent from
being infected with Covic-19 ?
 Healthcare Professionals Alliance Against COVID-19
(HPAAC) said there are “73 ongoing clinical trials on its
use” and that they “expect more data and evidence on its
effectiveness in the next several weeks”.

 Yes, Ivermectin is very promising, but we still have to wait

for a few more weeks to ensure that it’s safe for treating or
preventing COVID-19.
 Some camps are already using IVERMECTIN to
prevent from being infected with Covic-19 ?
 That does not imply that it is already safe to take.

 Past studies attesting to its safety were done using dosages that
are insufficient for antiviral activity.

o In a 2020 paper, a group led by Dr. Virginia Schmith of North

Carolina-based pharmaceutical consulting firm Nuventra
Pharma Sciences said that the current US FDA-approved dose
for Ivermectin is not enough for use versus COVID-19.
Schmith VD, Zhou J, Lohmer LR. The approved dose of ivermectin alone is not the ideal dose for the treatment of
COVID. Clin Pharmacol. 2020. https://doi.org/10.1002/cpt.1889.
 Some camps are already using IVERMECTIN to
prevent from being infected with Covic-19 ?
This means that, if used against COVID-19, doctors will likely have
to prescribe higher doses

 Dosage levels that are still not proven to be safe.

 Specifically, Dr. Edsel Salvana of the UP National Institutes of

Health, citing a 2018 paper[3], said “at the doses required for
possible antiviral activity, [Ivermectin] can cause brain damage”.

Chandler R. E. Serious neurological adverse events after ivermectin-do they occur beyond the indication of
onchocerciasis? Am J Trop Med Hyg 98, 382–388. 10.4269/ajtmh.17-0042 (2018)
 Some camps are already using IVERMECTIN to
prevent from being infected with Covic-19 ?
Completed studies show that Ivermectin is safe up to a certain dose,
but that dose was designed for use of Ivermectin as an
antiparasitic.

 A higher dose is needed if we will use Ivermectin as an antiviral,

i.e. anti-COVID.

 Taking too much Ivermectin can cause brain damage.

 Too low a dose Ivermectin is useless and may even cause

resistance.
 Can I take IVERMECTIN to prevent from
infecting Covic-19 ?
Press release from company Merck, who manufactures Ivermectin:

• “Company scientists continue to carefully examine the findings

of all available and emerging studies of Ivermectin for the
treatment of Covid-19 for evidence of efficacy and safety. It is
important to note that, to-date, our analysis has identified:
o No scientific bases for a potential therapeutic effect against
Covid-19 from pre-clinical studies.
o No meaningful evidence for clinical activity or clinical
efficacy in patients with Covic-19 disease and
o A concerning lack of safety data in the majority of studies
 Can I take IVERMECTIN to prevent from
infecting Covic-19 ?
 Press release from company Merck, who manufactures
Ivermectin:

• “ We do not believe that the data available support the

safety and efficacy of ivermectin beyond the doses and
populations indicated in the regulatory agency-approved
prescribing information.”
Can I take IVERMECTIN to prevent from
infecting Covic-19 ?
 How much Ivermectin is enough and how
much is too much ?

 We have to wait for more data

 Guys, let’s wait a bit more.

 After all, good things come to those who wait.