By Dr James Low Senior Consultant, Geriatric Medicine Director, GeriCare

1. 1
COVID-19 vaccinations-
An Update
Dr James Low
Senior Consultant, Geriatric Medicine
Director, GeriCare
8 February 2021

2. 2
• Overview of COVID-19 outbreak in Singapore
• COVID-19 vaccination programme in Singapore
• Types of COVID-19 vaccines
• Pfizer-BioNTech vaccine
• COVID-19 vaccination in the ILTC Setting
• Q & A
Outline

3. 3
Data source: https://co.vid19.sg/singapore/
Overview of COVID-19 outbreak

4. 4
Data source: https://co.vid19.sg/singapore/
Dashboard of COVID-19 virus outbreak in Singapore
21 January 2020 to 23 January 2021
Overview of COVID-19 outbreak

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COVID-19 Vaccination Strategy
Why introduce the COVID-19 vaccination programme in Singapore?
Risk of serious, life-threatening
disease and death from COVID-19
infection, especially in the elderly
and other vulnerable groups
(e.g. persons with comorbidities)
• Prevent the disease
• Minimise the risk of spread
• Prevent large clusters
• Prevent the healthcare systems
from being overwhelmed
• Protect those not medically
eligible to be vaccinated (e.g.,
immunocompromised, children)

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Who are the prioritized groups, and what is the rationale for prioritization?
Healthcare
workers
COVID-19
frontline
workers
Vulnerable
(elderly/chronic
medical
conditions)
a. Sustain healthcare and COVID-19 response systems
b. Reduce morbidity and mortality among those at greatest risk
c. Protect those at increased risk due to their living or working conditions
(e.g. settings with the potential for rapid transmission and large outbreaks)
d. Maintain the function of society as a whole with a view to maximise benefits &
minimise harms.

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COVID-19 Vaccine Landscape
As of 2 Dec 2020 (WHO):
• 51 vaccine candidates in clinical evaluation
• 163 in preclinical evaluation
An accelerated development timeline for vaccines against COVID-19 was possible
given the following:
Significant
investment &
dedication of
resources
Global partnerships:
organisations,
governments,
researchers &
manufacturers
Given the pandemic
situation, recruitment
for and conduct of
clinical trials could be
done quickly.
Different phases of clinical
trials have been performed
concurrently, allowing for
sufficient data to be
produced in a shorter time.
Safety, scientific or ethical integrity have not been compromised, and no short-cuts have been made,

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Pre-clinical Phase 1 Phase 2 Phase 3
Regulatory
review &
market
approval
Post -
marketing
surveillance
Phase 4
• Selection of
new compound
• Animal studies
• Trial in small
group(<100)
of healthy
volunteers
• Identify
serious side
effects
• Size the
required dose
• Trial in several
hundreds
• Identify common
side effects
• Observe immune
response
(i.e. efficacy)
• Trial in thousands
• Identify additional
side effects
• Compare safety &
efficacy against
placebo
• Evaluate safety,
quality &
efficacy data
• Review if
benefits
outweigh
risks prior to
approval
• Continued
monitoring
for real world
effectiveness
• Identify rare side
effects
Traditional paradigm: At least 10 years for entire process
Vaccine development timelines
Pandemic paradigm: Compressed and parallel development phases, and early authorisation for
emergency use
Pre-clinical Phase 1 Phase 3
Phase 4
Post-use
surveillance
Phase 2
Emergency
use
authorisation

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Types of vaccines
Some candidates use vaccine platforms that are well-established, while others use
newer/novel technologies
S/N Vaccine type Description
1 Inactivated
(e.g. Sinovac)
Made from whole or part of dead bacteria or viruses that are incapable
of causing illness but can mount an immune response (e.g. flu vaccine).
2 Protein subunit
(e.g. Novavax )
A type of inactivated vaccine. Presents an antigen (i.e. protein) to the
immune system without the whole virus or bacteria, using a specific,
isolated protein of the pathogen (e.g. hepatitis B)
3 Viral vector
(e.g. JnJ , Oxford
AZ)
Delivers one or more antigens encoded into an unrelated, modified live
virus which acts as a ‘carrier’. Upon delivery to cells, antigens are
expressed, and the host is able to induce immune responses against the
target pathogen.
4 RNA
(e.g. Pfizer BioNTech,
Moderna
A messenger RNA (mRNA) sequence is coded for a disease
specific antigen and delivered to human cells. Once there, it can be used
for production of antigen within the cell. This will lead to an immunogenic
response.

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RNA(e.g. Pfizer-BioNTech)
• Messenger RNA (mRNA) stays in the cell
cytoplasm, making protein to trigger an
immune response that protects against
COVID infection
• mRNA does not enter the nucleus of the cell,
and does not affect a person’s genetic
material (which is DNA)
• mRNA breaks down in 48 hours
• mRNA vaccines don’t contain any live virus &
cannot cause COVID

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Are mRNA vaccines safe?
• To date, there have been no increase in the rates of major serious adverse effects
(Phase 3 studies)
• Have involved over 30,000 and 40,000 people in the two separate studies (i.e. Moderna
& Pfizer-BioNTech); the Pfizer-BioNTech has been authorised by the US FDA and
regulatory authorities in the UK and Canada.
• Manufacturers will continue to monitor safety and efficacy for 1-2 years.
Are mRNA vaccines a form of genetic modification?
• They are not a form of genetic modification.
• mRNA vaccine is in a form that is unable to be converted back to DNA.
• There is no possibility that the COVID-19 mRNA will interfere with or modify human
DNA.

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Current Frontrunners
Company Technology Development Stage Safety and Efficacy Data
Pfizer
BioNTech
RNA • Phase 3 primary endpoint reached
• To date, other than Singapore, the UK MHRA,
Health Canada and US FDA have authorised
its use
• Regulatory submission to Australia TGA
• Phase 3 analysis showed 95% efficacy in
reducing symptomatic COVID 19 disease
• Efficacy consistent across age groups 16
years & above
• Well tolerated*, mostly mild to moderate
side effects which were self limiting
• Grade 3 adverse events generally low;
4.2% fatigue, 2.4% headache in vaccinated
persons
*Persons with a history of anaphylaxis should
not receive the
vaccine.
Moderna RNA • Phase 3 primary endpoint reached
• Regulatory submission to the US FDA,
UK MHRA, EMA and Swissmedic
• Phase 3 analysis showed 94.5% efficacy
• Well tolerated; 9.7% fatigue, 8.9%
myalgia, 5.2% arthralgia,
4.5% headache
Sinovac Inactivated
virus
• Phase 3 trials in Brazil, Turkey, Indonesia • Phase 1/2 trials showed >90%
seroconversion
• Prelim Phase 3 data shows vaccine
appears safe, no serious adverse events
On 14 Dec 2020, the Health Sciences Authority authorised Pfizer BioNTech’s COVID 19 vaccine for pandemic use in
Singapore, for persons aged 16 years and above. Vaccination of pregnant women, children under 16 and
immunocompromised persons will be deferred until more data for these groups.

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Pfizer-BioNTechCOVID-19 Vaccine
• mRNA vaccine encoding for the spike protein, formulated with a lipid nanoparticle
(LNPs)
• Vaccination induces antibodies that block entry of SARS-CoV-2 virus into cells,
and prevent infection
• Vaccine efficacy 95% for COVID cases by 7 days after Dose #2.
21,720 vaccine 8 cases 1 severe
21,728 placebo 162 cases 3 severe
• Singapore’s HSA issued interim authorization under the Pandemic Special
Access Route (PSAR) on 14 December 2020, for use in persons ≥ 16 years of
age.
• EC19V recommends that the Pfizer vaccine be given on a voluntary basis, to
persons ≥ 16 years’ old, starting with the groups who are at higher risk of infection,
or severe COVID.

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Vaccine Administration
• 2 doses, given IM, 3 weeks apart @ Day 0, 21
• Early 2nd dose: Considered valid from Day 17, no earlier
• Late 2nd dose: If > Day 21, give at earliest opportunity.
No need to re-start vaccination or repeat doses.
• Vaccine recipients should be counselled about importance of
completing both doses in the series.
• Both doses are necessary for full protection, and for long-lasting
protection. 1 dose is not valid vaccination.

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• COVID vaccines should be administered alone with a minimum interval of 14 days
before/after any other vaccines.
• No available data for safety or efficacy of the vaccine given simultaneously with other
vaccines.
• If inadvertently given within 14 days of another vaccine, no need to repeat doses for
either vaccine.
Co-Administration with Other Vaccines
• No data on interchangeability of Pfizer with other COVID vaccines. Both doses should
be completed with the same vaccine brand.
• If 2 doses of different mRNA vaccines are inadvertently given, no additional doses are
recommended.
Interchangeability

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Prior COVID-19 infection
Testing before or after vaccination not needed
• Persons with prior COVID-19 infection are likely to be protected for at least the first 3
months after infection, and possibly longer.
• Prior COVID-19 infection is NOT a contraindication to getting vaccinated. COVID-19
vaccination is not required nor recommended for individuals known to have had prior
COVID-19 infection
• There is no need to test vaccine recipients by PCR or serology before giving COVID-19
vaccination.
• There is no recommendation to test serology after vaccination.
• Vaccinated persons who develop ARI’s later on should be tested for COVID-19,
following public health policy.

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Pregnancy, Conception, Lactation
• EC19V currently recommends against COVID-19 vaccination of pregnant women,
based on current risk/benefit situation.
• There is no data on safety of COVID-19 or mRNA vaccines in pregnancy.
• For females planning pregnancy, recommend deferring conception until at least
1 month after Dose #2.
• If becomes pregnant before Dose #2, recommend deferring Dose #2 until after
delivery, unless community transmission risk is high enough to vaccinate during
pregnancy.
• If breastfeeding, COVID-19 vaccination is allowed. Recommend suspending
breastfeeding for 5 to 7 days after vaccination.

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Pregnancy & Immunocompromised Persons
EC19V Guidance –as of Dec 2020
RECOMMEND
VACCINATION
ALLOW VACCINATION RECOMMEND AGAINST
VACCINATION FOR NOW
Planning conception (defer
till > 1 month after Dose #2)
Breastfeeding (advise to
suspend for 7 days)
Pregnant, or becomes
pregnant before Dose #2
HIV with CD4 ≥ 200 HIV with CD4 < 200
Transplant (after 3 months) Transplant (solid organ or
stem cell within 3 months)
Cancer (in remission,
history of cancer)
Active cancer (including
untreated or palliative)
Completed cancer
treatment; on hormonal
therapy
On cancer treatment
(chemo, immune or
radiation therapy)
Older age Older age AND
immunosuppression
Medical conditions
(eg.DM, HTN, obesity)
Medical conditions AND
immunosuppression

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Anaphylaxis
• History of anaphylaxis to first dose of COVID-19 vaccine (or vaccine components)
• Prior anaphylaxis or severe allergy (difficulty breathing, face/throat/ eye/lip
swelling, fast heartbeat, bad rash all over the body, dizziness) .
Resourcing for Vaccine Administration
• Doctors on-site not required but must have access to E-kit and adrenaline, and
nurses trained to respond.
• Patients should be observed for 30 minutes post-vaccination.
Injection risks
• Vaccines must be given IM, not SC.
• Patients with anti-coagulation, anti-platelet agents, bleeding disorders, low platelets
(>50,000) can be vaccinated.
• Counsel about hematoma risk, hold firm pressure x 5 minutes.
Contraindications & Precautions

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84%
63%
55%
38%
32%
24%
14%
10%
0.30%
Pain at injection site
Tiredness
Headache
Muscle pain
Chills
Joint pain
Fever
Injection site
swelling/redness
Lymphadenopathy
About the Pfizer-BioNTechCOVID-19 Vaccine
What are the risks of the vaccine?
Vaccinated persons may experience mild to moderate pain at the injection site, fatigue and headache,
which usually resolve in 1 to 3 days. (an immune response)

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Meds & Supplies for Managing Anaphylaxis
Adrenaline vial, pre-filled syringe or auto-injection
H1 anti-histamine (e.g. diphenhydramine)
Blood pressure cuff
Stethoscope
Must have at vaccination sites !
Have emergency drugs and a Doctor on site during
vaccination to respond if any serious adverse events
occur, and a space for staff to gather/wait for post
vaccination monitoring (for up to 30 minutes)
In Situ Vaccination Good to have on- site:
• Pulse oximeter
• Oxygen
• Bronchodilator (e,g. albuterol)
• H2 antihistamine (e.g.
famotidine)
• IV fluids
• Intubation kit
• CPR mask

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• Protection is not immediate; full efficacy is 1-2 weeks after 2nd dose
• Vaccine is 95% effective, and no data on sterilizing immunity
• If fever or respiratory symptoms, test as per prevailing protocol.
• COVID vaccination will not affect PCR and antigen tests.
• Antibodies to spike protein will be positive after COVID vaccination.
• To evaluate for infection in a vaccinated individual, serology must test for IgM/IgG to
nucleocapsid (N-protein)
N+/S+  virus immunity
N-/S+  vaccine immunity
Vaccinated Persons & Public Health

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Post- vaccination monitoring
• Research studies will be conducted to better understand
the impact of the COVID-19 vaccination, including the durability and
sterilising immunity.
• Hence, vaccinated persons may be recruited for such studies.
• HSA will actively monitor the adverse events associated with the
COVID-19 vaccines in the local population to safeguard public health.
Public health measures post-vaccination
Safe distancing, mask wearing and good hand hygiene, should continue to be
practiced until more clinical data on vaccine’s ability to induce sterilising immunity in
preventing infection are known.

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Can vaccinated persons get infected with COVID-19?
Are they less able to transmit the disease?
95%
effective
In preventing
symptomatic
disease
5%
breakthrough
in vaccinated
persons
No data to show if vaccination will prevent onward transmission of infection.
Phase 3 trial data
Studies are still ongoing on the extent and duration of immunity provided by the vaccines.

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Broad Guiding Principles for COVID-19 Vaccination in the
ILTC Setting
While vaccination is voluntary, it is strongly encouraged to be vaccinated
early in this current period of low transmission. It will also take time to complete
the full course of vaccination and to develop immunity.
Free of charge to all Singaporeans and long- term residents, including staff on
long term work permits. Goal is to have enough by 2021-Q3.
As a general principle, all staff (whether client facing or not, and including
outsourced vendors) should be vaccinated.
Vaccinations may be conducted on site at ILTC premises with suitable medical
personnel and storage facilities.
Examples of ILTC settings: Community Hospitals, Nursing Homes, Senior Care
Centres, Active Ageing Hubs, Home Care providers, Renal Dialysis Centres

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Acknowledgements
• Ministry of Health
• Expert Committee on COVID-19 Vaccination (EC19V)
• Agency for Integrated Care (AIC)

27. 27
Q & A