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1

2021-2022 Pfizer (12 years and older), Moderna (12 years and older),

Janssen and NovavaxCOVID-19 Immunization Orientation

Presented by

Provincial Population & Public Health

Provincial CDC Immunization Team

July 19, 2022

2 To provide clinical information related to COVID-19 disease and immunization oNOTE: always use the online resources for up-to-date information oNOTE: Pfizer 5 to 11 years formulation and Moderna 6 to

11 years COVID-19 vaccines are discussed in separate

presentations available on the AHS Health Professional

Immunization Information webpage

Operational questions will NOT be addressed during this presentation (i.e., scheduling, vaccine distribution specifics)

Objective

3 For more detailed information it is important to refer to additional program resources such as: AHS COVID-19 Health Professional Immunization Information oInsitefor AHS employees or External sitefor non-AHS employees AHS Immunization Program Standards Manual (IPSM) Vaccine Biological pages are located at oInsitefor AHS employees or External sitefor non-AHS employees

COVID-19 Vaccine Product Monographs

AHS Vaccine Storage and Handling Standardand e-learning modules* Alberta Health Adverse Events Following Immunization (AEFI) Policy Site specific reporting requirements and data collection guidelines

Introduction

4

Coronaviruses are a large family of viruses.

oSome coronaviruses cause respiratory illness in people, ranging from a mild common cold to severe pneumonia. oOther coronaviruses cause illness in animals only. Rarely animal coronaviruses can infect people and these can spread from person to person through close contact. COVID-19 is the disease caused by SARS-CoV-2 coronavirus, a new virus that was first recognized in 2019. as it was not previously identified in humans. Due to it being a novel virus there was no herd immunity and there were no specific treatments when it emerged. COVID-19 poses a serious risk to public health and the healthcare system.

What is COVID-19?

5

What are COVID-19 Variant Strains?

Mutations in the COVID-19 virus over time are expected, and can cause variant strains of COVID-19 to emerge. Variant strains of COVID-19 have been identified in the United Kingdom, South Africa, Brazil, India and Peru, and have since been identified in many other countries around the world. These strains are known as variants of concern, as they have been shown to spread more easily than other COVID-19 strains. Studies are ongoing to determine the effectiveness of the currently authorized vaccines against these variants. 6

How is COVID-19 Spread?

The virus is spread mainly from person-to-person through coughing or sneezing (droplet spread). oThe droplets are propelled about 3 feet through the air People may also become infected by touching an object or a surface that has the COVID-19 virus on it and then touching their mouth, eyes or nose. Median incubation period is estimated at 5-6 days from exposure to onset. Most people (97.5%) develop symptoms within 11.5 days. 7

COVID-19 Infectivity

People infected with COVID-19 can spread the disease to others while they have symptoms and sometimes before they know they are ill. A person may be infectious for two days before showing symptoms.

Some people can be infected but have no symptoms.

oThese individuals can spread the virus to others This is important information for those caring for others, such as parents and all health care workers. 8

COVID-19 Signs and Symptoms

Commonfever, new cough or

worsening chronic cough, sore throat, runny nose.

Additionalstuffy nose, painful

swallowing, headache, chills, muscle/joint aches, fatigue or severe exhaustion, GI symptoms, loss of sense of smell or taste, conjunctivitis. 9

How Serious is COVID-19?

COVID-19 disease can lead to severe outcomes. Individuals who are infected may need to be hospitalized, admitted to the ICU or may die from the disease. Some individuals are at higher risk of developing complications from

COVID-19 disease, including:

oSeniors oAdults with existing chronic health conditions 10

Treatment of COVID-19

Treatment will vary depending on severity of disease. Some Albertans will be able to stay home and manage symptoms with comfort measures such as: rest analgesics fluids time antiviral medication monoclonal antibodies Other Albertans will require care in an acute care facility, perhaps in an ICU. 11

Universal COVID-19 Immunization Program

Alberta Health (AH) has made COVID-19 vaccine available to: All Albertans (5 years of age and older) at no charge. More information on the COVID-19 vaccine program can be found on the Alberta Health website. 12

COVID-19 Vaccines Available in Alberta

Viral Vector-based

oJanssen (Johnson & Johnson) mRNA oPfizer (Comirnaty) 12 years and older Ultra Frozen Vaccine oPfizer (Comirnaty) 5-11 Years Formulation Ultra Frozen Vaccine oModerna (SpikeVax) Frozen Vaccine

Recombinant Protein Subunit

oNovavax(Nuvaxovid) 13

What are Viral Vector COVID-19 Vaccines?

JanssenCOVID-19 vaccine is based on viral vector platforms using modified adenovirus virus to carry genes that encode SARS-CoV-2 spike proteins into the host cells. The vector virus is a type of adenovirus that has been modified to carry COVID-19 genes and to prevent replication. oThese modifications are intended to prevent the viral vector from causing disease. (i.e., they are non-replicating). Once inside the cell, the SARS-CoV-2 (or COVID-19) spike protein genes are transcribed into mRNA in the nucleus and translated into proteins in the cytosol of the cell. 14 Pfizer 5 to 11 years, 12 years and olderand Moderna COVID-19 vaccines use the messenger RNA (mRNA) manufacturing platform. mRNA (messenger ribonucleic acid) vaccines contain the genetic instructions for making the COVID-19 spike protein. This protein is found on the surface of the virus that causes COVID-19. When a person is given the vaccine, their cells will read the genetic instructions like a recipe and produce the spike protein. After the protein piece is made, the cell breaks down the instructions and gets rid of them. The cell then displays the protein piece on its surface. Our immune building an immune response and making antibodies. mRNA vaccines do not affect, interact with or alter your DNA in any way.

What are mRNA COVID-19 Vaccines?

15

What are Recombinant Protein COVID-19 Vaccines?

NovavaxNuvaxovid consists of a purified full-length SARS-CoV-2 recombinant spike (S) protein nanoparticle administered as a co- formulation with the adjuvant Matrix-M. Matrix-M is a novel saponin-based adjuvant that facilitates activation of the cells of the innate immune system, which enhances the magnitude of the S protein-specific immune response. Matrix-M has been used in NovavaxNuvaxovid clinical trials and in pre-licensure studies targeting other pathogens, but has not previously been used in any licensed vaccine.

National Advisory Council on Immunization, Recommendations on the use of NovavaxNuvaxovid COVID-19 vaccine, 17

February 2022

16

Vaccine Storage and Handling Principles

Protection of COVID-19 vaccine potency and stability is important Vaccines not kept in proper conditions may become ineffective The public trusts that the vaccine they receive will be effective COVID-19 vaccines are sensitive products and variances from the recommended handling may cause wastage due to: oCold chain excursions oRough handling causing vaccine to be jostled oUse of vaccine beyond time limits / expiry 17

Every immunizer must:

Understand cold chain excursions and the implications of them Identify the key staff members at the clinic responsible for vaccine management Understand the specific vaccine storage and handling recommendations for each product Understand how to monitor and interpret min/max thermometer readings Understand the actions required when a cold chain excursion is identified (quarantine product and notify clinic lead) Review AHS Vaccine Storage and Handling webpage (see next slide)

Vaccine Storage and Handling Principles

18

Vaccine Storage and Handling Principles

19

Janssen COVID-19 Vaccine

Dosage/Route0.5 mL / IM (deltoid or vastuslateralis)

PackagingMulti-dose vial 5 doses per vial

DiluentNo

EligibilityAs perindication

Indication

Janssen vaccine may be considered for individuals 18 years of age and older

oA complete series with an mRNA COVID-19 vaccine is preferentially recommended for individuals in the authorized

age group without contraindications to the vaccine. oShould not be used to complete an mRNA or AstraZeneca COVID-19 vaccine series. Individuals with an incomplete primary series and a contraindication to currently available COVID-19 vaccines can receive Janssen COVID-19 vaccine respecting the recommendedinterval from the previous dose of COVID-19 vaccine.

Composition

Recombinant, replication-incompetent adenovirus type 26 (Ad26) vectored vaccine encoding the SARS-CoV-2 Spike (S)

protein.

No adjuvants or preservatives

Schedule

Primary series is one dose

A single booster dose of Janssen COVID-19 vaccine may be administered to individuals who have previously received a

complete primary series (1 dose) of Janssen vaccine. Booster dose is given at least 2 calendar months after the last dose of the primary series.

Individuals who received a primary series of Janssen COVID-19 vaccine (one dose) and a first booster dose of any other

Health Canada approved COVID-19 vaccine are not eligible for another booster dose of Janssen.

Janssen Vaccine Summary

20

Janssen Vaccine Storage

JanssenVaccineStorage temperaturesand time limits

Pre-puncture storage:

Storeat -25°to -15°C until expiry date

Store at +2°to +8°C for 11 months, not exceeding the original expiry date

May be stored up to +25°C for up to 12 hours

(At room temperature it will take approx. 4 hours to thaw a 10 vial carton, an individual vial will take approx. 1 hour to thaw. At +2°to +8°C it will take approx.13 hours to thaw a 10 vial carton, an individual vial will take approx. 2 hours to thaw)

Post-puncture storage:

+2°C to +8°C for 6 hours OR +8°C to +25°C for 3 hours

Post-puncture

usage limit: Punctured vials (first dose is withdrawn) can be stored at +2°C to +8°C for up to 6 hours or at room temperature (up to +25°C) for 3 hours. Discard if not used within this time. Check puncture date/time and storage timelimitsprior to administration

DO NOT REFREEZE ONCEIN THAWING STATE

PROTECT FROM LIGHT

21

Janssen VaccineReactions

CommonUncommonRare

Pain, redness, warmth, and

swelling at injection site

Fever, chills

Fatigue

Headache, myalgia, arthralgia

Nausea

Rash

Muscle weakness

Feeling weak

Arm/leg pain

Malaise

Dizziness

Anaphylaxis

Urticaria

Seizures

Vertigo

Tinnitus

Vomiting/diarrhea

Paresthesiaand hypoesthesia

Lymphadenopathy

Thrombosis with thrombocytopenia syndrome

(TTS)

Venous Thromboembolism (VTE)

Immune Thrombocytopenia (ITP)

Capillary Leak syndrome

Guillain-Barre syndrome

Asthenia

Transversemyelitis (TM)

Unexplained bleeding

As with any immunization, unexpected or unusual side effects can occur. Refer to product monograph for more detailed information. 22

Janssen Vaccine Efficacy & Effectiveness

It is recommended that individuals who received only the single dose Janssen COVID-19 vaccine be offered an additional dose of mRNA vaccine as a booster dose at least 5 calendar months after the single dose. Given a lower vaccine effectiveness, an additional dose of mRNA vaccine is recommended to provide better protection. This does not apply to individuals who received any dose of mRNA vaccine previously. Other booster dose indications may still apply. Note: The Janssen vaccine is currently licensed as a one dose vaccine series with one booster dose at least 2 calendar months after the first. Individuals are considered fully-immunized 14 days following the immunization at this time. However, there is a possibility that in the future individuals who received one dose of the Janssen vaccine may need an additional dose to be considered fully- immunized. 23
A combination of thrombosis and thrombocytopenia, in some cases accompanied by bleeding, has been observed very rarely in the U.S. following immunization with Janssen COVID-19 Vaccine. This includes severe cases presenting as venous thrombosis, including unusual sites such as cerebral venous sinus thrombosis, mesenteric vein thrombosis, as well as arterial thrombosis, concomitant with thrombocytopenia. As of September 29, 2021, approximately 15 million doses of Janssen vaccine were administered in the U.S and the Vaccine Adverse Event Reporting System (VAERS), the national vaccine safety monitoring system, had received 47 reports of thrombosis with thrombocytopenia syndrome (TTS) after Janssen COVID-19 immunization. The rate has been highest in females aged 18 to 49 years and some cases have been fatal. The majority of cases occurred within three weeks following immunization.

Viral Vector COVID-19 Vaccine Rare Events

24
A causal relationship with the vaccine is considered plausible, but the exact mechanism by which the Janssen vaccine triggers these very rare but serious events is still under investigation. No specific risk factors have been identified at this time. Health Canada has assessed the available data on the reported events and has determined that the benefit of Janssen COVID-19 vaccine outweigh the risk of thrombosis and thrombocytopenia. Health Canada has worked with Janssen Inc. to update the Product Monograph for Janssen COVID-19 vaccine to include this new safety information to inform Canadians of the possible side effects and to provide information about the signs and symptoms and when to seek prompt medical attention following immunization. Healthcare professionals should be alert to the signs and symptoms of thromboembolism and/or thrombocytopenia and be aware of TTS including how to diagnose and treat the condition.

Viral Vector COVID-19 Vaccine Rare Events

25

Severe headache that does not go

away

Confusion or seizure

Difficulty moving part(s) of the body

Newblurry vision that does not go

away

Difficulty speaking

Shortness of breath

Chest pain

Severeabdominal pain

New severe swelling, pain or colour

change of an arm or leg

Unusual bruising or spontaneous

bleeding Those immunized should be instructed to seek immediate medical attention if they develop symptoms of thromboembolism and/or thrombocytopenia between days 4 and 28 following receipt of the

Janssen vaccine such as:

Viral Vector COVID-19 Vaccine Rare Events

26
Cases of Immune Thrombocytopenia (ITP) have been reported very rarely within the first four weeks after receiving Janssen COVID-19 vaccine and that include serious cases with very low platelet counts. If an individual has a history of ITP, healthcare professionals should consider the risk of developing low platelet levels prior to administering the vaccine. In individuals with a history of ITP, it is recommended to monitor platelet levels following immunization with the Janssen COVID-

19 vaccine.

Cases of Venous thromboembolism (VTE) have also been observed rarely following immunization with Janssen COVID-19 vaccine. The risk of VTE should be considered for individuals with increased risk factors for thromboembolism (blood clots).

Viral Vector COVID-19 Vaccine Rare Events

27

Pfizer 12 years and older mRNA

Effectiveness

Vaccine Effectiveness Against Omicron

Infection:

55% effective at protecting against infection at least two weeks

after the second dose

59% effective at protecting against infection at least two weeks

following the third dose

Hospitalization:

75% effective at preventing hospitalization at least two weeks after

the second dose

92% effective at preventing hospitalization at least two weeks after

the third dose 28
Pfizer 12 years and older mRNA COVID-19 Vaccine Summary

Pfizer 12 years and older COVID-19 Ultra Frozen

Dosage/Route0.3 mL (30mcg)/ IM (deltoid or vastuslateralis)

PackagingMulti-dose: 2 mL vial (6 doses)

DiluentYes (Purple Cap), No (Gray Cap)

Eligibility

A complete series with an mRNA COVID-19 vaccine is preferentially recommended for individuals in the authorized age group without contraindications to the vaccine. Pfizer 12 years and older-BioNTechCOVID-19 vaccine is preferentially recommended for individuals 12

years up to and including 29 years of age due to a lower risk of myocarditis with the Pfizer 12 years and

older-BioNTechvaccine compared to Moderna COVID-19 vaccine in this age group The Pfizer-BioNTechCOVID-19 vaccine may be recommended preferentially in those 18 years up to and

including 29 years of age as a booster dose, as there is limited information about the risk of myocarditis

following booster dose with the Moderna COVID-19 vaccine at this time and lower reported rates of myocarditis following immunization with Pfizer BioNTech(30 mcg) COVID-19 vaccine compared to Moderna (100 mcg) COVID-19 vaccine used in primary series.

IndicationAlbertans 12 years of age and older

Ingredients

mRNA (new technology) nucleoside-modified mRNA (modRNA) platform formulated in lipid nanoparticles (LNPs) no adjuvants or preservatives

Schedule

Primaryseries: 2 doses

Optimal spacing between dose 1 and dose 2 is 8 weeks

Minimum interval:19 days

First Booster dose: indicated for individuals 12 years of age and older, see Biological page Second Booster dose: indicated for individuals 18 years of age and older, see Biological page 29

Pfizer 12 years and older mRNA

COVID-19 Vaccine Reactions

CommonUncommonRare

Pain, rednessor swelling at

injection site

Chills, fever

Fatigue

Headache, myalgia, arthralgia

Nausea

Vomiting

Diarrhea

Lymphadenopathy

Feeling unwell

Arm pain

Asthenia, lethargy

Decreased appetite

Hyperhydrosis

Night sweats

Allergic reactions

Anaphylaxis

Myocarditis/Pericarditis

As with any immunization, unexpected or unusual side effects can occur. Refer to product monograph for more detailed information. 30

Pfizer 12 years and older mRNA

COVID-19 Vaccine Storage

Pfizer 12 years and older

COVID-19

Ultra Frozen

Storage temperaturesand

time limits -Purple Cap

Storage temperaturesand

time limits -Gray Cap

Primary storage: ULTRA

Freezer

-90°C to -60°Cuntil expiry printed on the label, or the extended expiry in AVI

Prior to thawing,

-90°C to -60°Cfor 12 months Lab grade freezer-25°C to -15°C for up to 2 weeksDo not store at this temperature

Storage:

Thawed, Undiluted

+2°C to +8°C for up to 31 days

AND/OR

up to +25°C for 2 hours +2°C to +8°C for up to 10 weeks

AND/OR

up to +25°C for 12 hours

DiluentYesNo

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