COVID-19 VACCINES - Alameda County ...
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2/22/2021
COVID-19 VACCINES
SETH GOMEZ
PHARMD, BCPP
FEBRUARY 22ND, 2021
SENIOR PHARMACIST
ALAMEDA COUNTY HEALTH
CARE FOR THE HOMELESS
COVIDACHCH@acgov.org
seth.gomez2@acgov.org
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OVERVIEW:
▪ Regulatory Process
▪ mRNA Vaccine Technology
▪ Clinical Trial Information
▪ Common Questions and Concerns
▪ Conversational Tips
▪ Supportive Materials
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WHY WE ARE HERE:
You are the most accessible and trusted partners for our
unhoused neighbors
Can positively influence vaccination decisions of peers, patients,
friends, and family
Together we can provide consistent and accurate information
about the COVID-19 vaccines
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Vaccine No. Doses Largest Completed Efficacy Evidence Peer-Reviewed
Needed for Trial Publications
full (No. of participants)
protection
Pfizer/BioNTech 2 > 43, 000 95% Strong Published
Moderna 2 >30, 000 94.5% Strong Published
Johnson & 1* > 43, 000 72% (U.S.) Strong Press Release
Johnson 66% (Overall) (Full data set
58% (SA) expected soon)
* Ongoing study to assess 2 doses
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FDA- EMERGENCY USE AUTHORIZATION
Two (2) vaccines have received FDA Emergency Use Authorizations (EUAs):
Pfizer/BioNTech
Moderna
Both are mRNA vaccines with a 2-dose schedule.
Both vaccines are ~95% effective at preventing symptomatic COVID-19
disease
One (1) vaccine will likely receive EUA on 2/26/21
Johnson & Johnson/Janssen
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VACCINE DEVELOPMENT PROCESS
Non-Human Approval
Testing Applications
Real-world
Research and Studies
Human Studies
Discovery Stage
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THE MRNA COVID-19 VACCINES ARE THE FIRST TO
COME TO MARKET, BUT NOT THE FIRST STUDIED.
2017-2020
Rabies1, Influenza2, Cytomegalovirus3, Zika4
No urgency to bring them to market
Knowledge gained helped jump start the development of the
COVID-19 vaccine
Sources: 1. Alberer, M. Lancet 2017; 2. Feldman, R. Vaccine 2019
3. Moderna Press Release Jan 2020; 4. Moderna Press Release April 2020
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COVID-19 VACCINE DEVELOPMENT
A surplus of volunteers signed up for the COVID-19 vaccine
Feels like we trials allowing the studies to move quickly through phases 1-3.
Collection of all the needed safety and efficacy data at record
Started Here started here speeds. FAST BUT NOT RUSHED.
Normally the recruitment of study subjects takes a lot of
effort and slows down the process.
Real-world
Research and Studies
Human Studies
Discovery Stage
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MAKING THE MRNA VACCINE
Simple ingredients that help stabilize the vaccine:
- sugars, salts, and fats
- No egg proteins or animal tissues
- No latex
- No tracking device or chip
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WHAT IS MRNA?
“Messenger” RNA is normal
Provides instructions to make proteins that are
involved in nearly every body function
The instruction encoded in mRNA is unique to
each protein
Once proteins are made, the mRNA is broken
down to its basic building blocks
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COVID-19 MRNA VACCINES
Teach our bodies to make a harmless protein (Spike Protein)
unique to the virus that causes COVID-19
No other proteins or parts of the virus are made
No live virus, no real infection
The mRNA never enters the protective bubble (nucleus) where
DNA lives
The mRNA is broken down quickly after the proteins are made
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THE IMMUNE SYSTEM BECOMES ACTIVATED ONCE
THE BODY MAKES THE “SPIKE PROTEIN”
The body produces the spike protein which sets off an
alarm in the body
The immune system begins to recognize the protein
Makes anti-bodies
Fights off the protein thinking it is an infection or invader
Stores everything it learned about the Spike Protein until
the alarm is triggered again in the future
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WHAT WE LEARNED SO FAR…
Key messages:
mRNA vaccines were made fast but not rushed → Scientist had a jump start with
years of experience with mRNA technology
No corners were skipped → all clinical trials for safety and efficacy were
performed and with high quality
mRNA is familiar to our bodies
mRNA vaccine ingredients include small amount of fats, sugars, and salts
mRNA vaccines will not interfere with your DNA
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MRNA COVID-19
CLINICAL TRIAL
INFORMATION
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RACIAL & ETHNIC REPRESENTATION
Race/Ethnicity % % %
U.S. Population Moderna Study Pfizer Study
White 75 79.2 82.9
Black or African 14.2 10.2 9.2
American
Asian 6.8 4.6 4.3
More than one race 3.4 2.1 2.3
American Indian/Alaskan 1.7 0.8 0.5
Native
Hawaiian or Pacific 0.4 0.2 0.2
Islander
Hispanic or Latinx 18.4 20.5 28
Other 5.5 2.1 -
Unknown - 0.9 0.6
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STUDY PARTICIPANT HEALTH STATUS
Moderna:
47% either with a high risk condition or >65 years
Pfizer:
56% either with a high risk condition or >65 years
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SAFETY OF COVID-19 VACCINES
ESTIMATES OF LOCAL SIDE EFFECTS
Moderna 1st dose Moderna 2nd dose Pfizer 1st dose Pfizer 2nd dose
Any Local Side >75% >80% >75% >70%
Effect
Pain >75% >80% >75% >70%
Redness 2-3% 8-9% 5% 6%
Swelling 6-7% 10-13% 6% 7%
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SAFETY OF COVID-19 VACCINES
SYSTEMIC SIDE EFFECTS
Moderna 1st dose Moderna 2nd dose Pfizer 1st dose Pfizer 2nd dose
Any Systemic >75% >80% >75% >70%
Effect
Fever >75% >80% 3% 10-13%
Fatigue 35-40% 60-70% 35-45% 50-60%
Headache 30-35% 50-60% 25-40% 40-50%
Chills 5-10% 35-45% 6-12% 23-35%
Vomiting 5-10% 15-20% 1-2% 1-2%
Muscle aches 20-25% 50-60% 15-20% 30-40%
Joint aches 15-20% 40-45% 9-11% 15-22%
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SAFETY OF COVID-19 VACCINES
Severe allergic reactions have been reported (2/22/2021
EFFICACY OF THE COVID-19 MRNA VACCINES
94.5+% efficacious at preventing symptomatic disease (mild-severe)
>90% efficacious for people with high risk conditions or >65 years
Trends towards preventing asymptomatic disease but
need more time to study true impact
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J+J VACCINE
CLINICAL TRIAL
(>40,000 STUDY PARTICIPANTS)
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J+J COVID-19 VACCINE
Likely to be approved for 18+
Also delivers genetic material so that our bodies produce a
protein unique to the virus that causes COVID-19
The genetic material does not change a person’s DNA make-up.
Sources: Johnson & Johnson Press Release Jan 2021
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FULL STUDY DETAILS NOT AVAILABLE
3 continents (>40Kpeople overall; ~19K people from U.S.)
Overall: 34% over age 60; 41% with high risk conditions
U.S.:15% Hispanic/latinx,13% Black/African American, 6% Asian
72% effective at preventing moderate-severe disease (still VERY good for
a vaccine)
85% at preventing severe disease overall
Protection against the South Africa Variant
Sources: Johnson & Johnson Press Release Jan 2021
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WHAT WE HAVE LEARNED SO FAR…
Trials were large with thousands of people
Quality of trials were strong
The racial and ethnic demographics closely align with U.S. demographics
Half the participants in studies were people who were “high risk”
Side effects should be expected and are temporary
Vaccines are safe and the FDA will continue to monitor
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ARE VACCINES EFFECTIVE FOR THE VARIANTS?
Studies are ongoing but the evidence suggest YES
We can stop new variants from forming if
everyone gets the vaccine
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WILL THE VACCINE MAKE ME TEST POSITIVE
FOR COVID-19?
No. The vaccine will not affect the results of antigen tests that look for active
COVID-19 infection.
REMEMBER: The vaccine does not prevent the virus from entering the body, so at
any time after receiving a dose of the vaccine you are exposed to the real virus, you
could test positive for an active infection. If this happens, the benefit of being fully
vaccinated is that you will not have severe illness or need to go to the hospital.
The vaccine’s protection against symptomatic disease increases with time after the
1st and 2nd dose. Full protection occurs 2 weeks after the 2nd dose.
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I ALREADY HAD COVID-19. DO I STILL NEED THE
VACCINE?
Yes. The vaccine is recommended for people who have
already been sick with COVID-19. Experts do not yet know
how long you are protected from natural immunity after
recovering from COVID-19 and it is possible that you can
be infected again.
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HOW LONG DOES IMMUNITY LAST AFTER
RECEIVING A COVID-19 VACCINE?
The studies stopped measuring immunity after 3 months.
However, the type of immune response triggered after full
vaccination suggests long term (years) is likely.
Still, scientist are studying the benefits of a booster shot,
especially to target new variants.
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WHAT HAPPENS IF I MISS MY 2ND DOSE OR GET
IT LATE?
If a 2nd dose is missed, then your immune response will not be as
robust against the virus that causes COVID-19. Get your 2nd dose as
soon as possible.
The CDC recommends getting the 2nd dose of Moderna’s COVID-19
within 4-6 weeks from the 1st dose. This is based on how the vaccine
was administer in the study. However, if you get it later than 6 weeks,
it’s not likely to be any less effective but should still be administered
as soon as possible to get the full protection.
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SHOULD I STOP WEARING MASKS AFTER
GETTING THE COVID-19 VACCINE?
Not yet. It is not clear yet if people who receive COVID-19
vaccines can still carry and pass the virus to others. It is strongly
recommended to keep wearing masks, stay 6ft apart from others,
and to wash your hands frequently.
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COVID-19 VACCINES & PREGNANCY OR BREASTFEEDING MOMS
▪ Neither Pfizer nor Moderna included pregnant women at the start of their
studies.
▪ FDA is reviewing the research data on women who became pregnant during
the studies as one of their ongoing safety evaluations.
▪ Experts overwhelmingly agree that pregnant and breastfeeding women should
receive the vaccine when no other contraindications are present.
▪ There are no reasons to believe that the vaccine would cause infertility.
▪ Pregnant/breastfeeding registries are under development for additional safety
monitoring.
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UNDERSTANDING VACCINE LOGISTICS
Vaccine doses are in limited supply
Vaccines are fragile and must be handled with care
All doses have to be used within a few hours of opening a
vial
We expect to have zero waste
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ELEMENTS OF EFFECTIVE VACCINE CONVERSATIONS
1. Start from a place of empathy and understanding
2. Assume everyone wants to be vaccinated but
may have questions
3. Give your strong recommendation
4. Address misinformation by sharing key facts
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ELEMENTS OF EFFECTIVE VACCINE CONVERSATIONS
5. Listen, Listen, Listen and respond to questions
6. Proactively explain side effects
Side effects may be confused with COVID-19 symptoms
Emphasize that side effects go away quickly
2nd dose is still needed even if unpleasant side effects
occurred after the 1st dose
7. Keep the doors open
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MATERIALS PROVIDED:
FLYERS & POSTERS
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MATERIALS PROVIDED:
EDUCATIONAL MATERIAL FOR STAFF & CLIENTS
Plus Vaccine Fact Sheet & Immunization Registry Disclosure
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MATERIALS PROVIDED:
ADDITIONAL EDUCATIONAL MATERIAL FOR STAFF
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MATERIALS PROVIDED:
REGARDING EVENT PREPARATION AND LOGISTICS
EVENT FLYER Event Operational Considerations Action item Checklist
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CONSENT FORMS
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202/22/2021
THANK YOU!
SETH.GOMEZ2@ACGOV.ORG
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