Influenza Season 2009

INFLUENZA SEASON 2009/2010Update and Answers to Common Questions

OUTLINE OF UPDATE

Overview of influenza pattern Overview of this years campaignVaccine Details – Seasonal & pH1N1Populations and dosagesContraindications and Adverse ReactionsVaccine Preparation Frequently Asked QuestionsMass Clinics and Ergonomics

Current as of October 21, 2009

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AGE DISTRIBUTION

Distribution by age group of persons hospitalized with laboratory-confirmed influenza

( United States, 2007--08 winter influenza season and April 15--August 11, 2009)

Seasonal Influenza

Pandemic Influenza

Current as of October 21, 2009 4

pH1N1 symptoms Very similar to seasonal

influenza Gastrointestinal

symptoms more likely in children

Among hospitalized patients Primary viral

pneumonia Prolonged ventilatory

support Secondary bacterial

infections

CLINICAL PRESENTATION:

Adapted from the Centers for Disease Control and Prevention

WHAT VACCINES WILL BE AVAILABLE THIS YEAR?

In the 2009-10 season, seasonal trivalent influenza vaccine and two pandemic monovalent (H1N1)

vaccines will be available. an adjuvanted and a non-adjuvanted H1N1 vaccine

VACCINATION AGAINST SEASONAL INFLUENZA

A/Brisbane/59/2007(H1N1), A/Brisbane/10/2007(H3N2) and B/Brisbane/60/2008):

Phase 1: Is targeted for those aged 65 years and older and residents of long-term care facilities

Phase 2: Include all others (as per the Canadian Immunization Guide), following or concurrently with administration of the A/H1N1 vaccine.

H1N1 VACCINE

Will be available for everyone who needs or wants it and is strongly recommended for:

Persons under age 65 with chronic conditions Pregnant women in the second half of pregnancy in

communities where pH1N1 influenza is actively circulating. Children 6 – 59 months of age Persons residing in rural and remote communities Health care workers Household contacts and care providers of infants < 6

months of age and of persons who are immunocompromised

PHASE 1

Seasonal vaccine (Oct. 13-mid Nov.) offered to:

People 65 years and older & residents of long term care facilities

PHASE 2A: PH1N1 VACCINE ADJUVANTED VACCINE (OCT 26)

In the first week of the program the following groups who are at highest risk will be given priority

1) those under 65 with high-risk medical conditions 2) women in the second half of pregnancy – living in

communities where H1N1 virus is actively circulating

3) residents of remote communities where access to timely health care services is very limited.

Also offer: Seasonal vaccine according to guidelines

HIGH RISK MEDICAL CONDITIONS

Heart or lung disorders requiring regular care

Includes asthma, COPD, or cystic fibrosis Kidney disease, chronic liver disease,

hepatitis, diabetes, cancer, anemia or weakened immune system

Other conditions causing difficulty breathing , swallowing or risk of choking – ie: severe brain damage, spinal cord injury, seizures or neuromuscular disorders

PHASE 2B:

In the second week health care workers children between the ages of 6 months

and 4 years (inclusive) household contacts and care providers

of infants less than 6 months old people who are immunocompromised

of all ages

PHASE 3

Thereafter vaccine may be offered to everyone else except those aged less than 6 months or those with a contraindication.

Healthy children age 5 to 18 years of age First responders (police, firefighters) Poultry and swine workers Healthy adults 19 to 64 years of age Adults 65 years of age and older.

H1N1 VACCINE DETAILS

The two A/H1N1 vaccines contain the A/California/7/2009 (H1N1)v-like antigen, and are:

Arepanrix, the adjuvanted A/H1N1 vaccine for all indications except the first half of pregnancy.

Influenza A/H1N1 2009 Monovalent vaccine (without adjuvant)

ADDED NOTES

Only adjuvanted vaccine available until early November. This product should be offered to pregnant women at 20+ weeks gestation at some risk of exposure where A/H1N1 virus is circulating.

Pregnant women under 20 weeks gestation who have chronic medical conditions should discuss the risks and benefits of receiving adjuvanted vaccine or waiting until unadjuvanted vaccine is available with their health care provider.

Once unadjuvanted vaccine is available it should be preferentially offered throughout pregnancy.

There are no known risks of using adjuvanted vaccine in pregnancy, and the recommendation to use unadjuvanted vaccine preferentially is precautionary.

CHILDREN AGED 6 MONTHS TO LESS THAN 3 YEARS

Can be offered either adjuvanted or unadjuvanted A/H1N1 vaccine in a two-dose series of 0.25 ml each.

Both of the doses should be given with the same product.

Unadjuvanted vaccine, when available, may be the preferred option for some parents and providers as this product is formulated in the same manner as seasonal influenza vaccine with which there has been ample experience in young children.

It is believed adjuvanted vaccine may be associated with a better immune response, albeit more local and systemic adverse events, as outlined in adverse events

Children under 6 months of age Neither vaccine should be given to children younger than 6

months of age.

WHY USE AN ADJUVANT

AS03 is approved in 30 countries

Safety profile is based on 39,000 subjects who have received A/H5N1avian influenza vaccine, trivalent vaccine, or pH1N1

Better immune response with less antigen (3.75 g vs. 15 g)

May provide some cross protection in case the virus changes (“drifts”)

Faster induction of immune response More immunogenic than regular vaccine

formulations in the very young and at older ages

AREPANRIX, THE ADJUVANTED A/H1N1 VACCINE

Requires mixing with the adjuvant, a milky white substance in smaller of the two vials, into larger vial containing the antigen.

Volume will be 10 doses of 0.5 ml each or 20 doses of 0.25 ml each (for young children).

After mixing, record the time and date of mixing onto the vaccine vial; must be used within 24 hours

Children 6 months to under 10 years of age should receive two 0.25 ml doses given at least 21 days apart.

Those aged 10 and older should receive one 0.5 ml dose.

INFLUENZA A/H1N1 2009 MONOVALENT VACCINE (WITHOUT ADJUVANT)

Available in Nov. Offer to pregnant clients and may also be offered to children under 3 years old.

This vaccine is formulated in the same way as Fluviral®, the seasonal trivalent vaccine from GSK.

Supplied in cartons of 10 dose vials; record the date of entry on the vial and do not use for more than 28 days.

A single 0.5 ml dose should be given to pregnant women; children under 3 years old may receive 2 doses of 0.25 ml each, given at least 21 days apart

CO-ADMINISTRATION WITH SEASONAL FLU AND PNEUMOCOCCAL VACCINES:

The A/H1N1 vaccines may be co-administered with seasonal influenza vaccine to people eligible for seasonal influenza vaccine, as well as with pneumococcal vaccines.

The A/H1N1 vaccine should be given in a separate limb from that used for other vaccines.

Those who do not wish to receive both at the same visit should be advised to receive A/H1N1 vaccine first


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ADDITIONAL RECOMMENDATIONS: pH1N1 and seasonal vaccine may be given at the same

visit, by separate injection in separate limbs. If PPV23 is given at the same time, it should be given in the same limb as seasonal vaccine.

If both seasonal and H1N1 vaccines are given, use separate limbs; give H1N1 vaccine in the non-dominant arm.

If the pH1N1 and seasonal influenza vaccines are not given at the same time, they can be given sequentially without regard to interval. People under 65 should receive the pH1N1 vaccine first, if choosing not to receive the two vaccines at the same visit.


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Age/ pregnancy pH1N1 vaccine Seasonal vaccine

6 months to under 3 0.25 ml IM, 2 doses, at least 21 days apart, adjuvanted or unadjuvanted1

0.25 ml IM, 2 doses2, 4 weeks apart

3 to 9 years old 0.25 ml IM, 2 doses, at least 21 days apart, adjuvanted

0.5 ml IM, 2 doses2 4 weeks apart for children aged 3 to 8 years old

10 years and older 0.5 ml IM, 1 dose, adjuvanted 0.5 ml IM, 1 dose for those aged 9 years and older

Pregnancy 0.5 ml IM, 1 dose, adjuvanted or unadjuvanted3

0.5 ml IM, 1 dose

Recommendations for dosing of pH1N1 vaccine compared to seasonal

influenza vaccine: by age and pregnancy

*Footnotes on slide # 10


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FOOTNOTES TO PRECEDING TABLE: 1. Children aged 6 months to < 3 years can be offered either

adjuvanted or unadjuvanted A/H1N1 vaccine in a two dose series. Both of the doses should be given with the same vaccine product. Unadjuvanted vaccine, when available, may be the preferred option for some parents and providers as this product is formulated in the same manner as seasonal influenza vaccine with which there has been ample experience in young children. Although clinical data in this age group are not yet available, it is believed adjuvanted vaccine may be associated with a better immune response, albeit more local and systemic adverse events, as outlined starting slide #25

2. Seasonal vaccine for children under 9 years old should be given in a two dose series unless the child has received seasonal vaccine in 1 or more prior season.

3. Pregnant women at 20 weeks or more gestation may receive adjuvanted vaccine early in the pH1N1 vaccine program, at which time unadjuvanted vaccine will not be available. When unadjuvanted vaccine is available, offer it preferentially to pregnant women.

NOTE RE: PREGNANCY USE:

The non-adjuvanted vaccine can be given at any time during pregnancy. There are no data on the use of adjuvanted vaccines for pregnant women.

Therefore non-adjuvanted vaccine is recommended preferentially for this group once supplies are available.

In the first few weeks of the program only adjuvanted vaccine will be available. National committees have recommended that the adjuvanted vaccine can be given in the second half of pregnancy (≥ 20 weeks gestation) when there is deemed to be a risk of influenza infection, as this outweighs any theoretical safety concerns.

Women who have chronic medical conditions that put them at risk of influenza related complications who are in the first half of pregnancy during the weeks when unadjuvanted vaccine is not available should discuss the option of receiving adjuvanted vaccine with their health care provider to consider the benefits and theoretical risks.

Vaccines without adjuvants, such as the seasonal influenza vaccine, are safe for pregnant women. The manufacturing process for the Influenza A(H1N1) Monovalent vaccine (without adjuvant) is the same process used for the seasonal influenza vaccine.

ADVERSE EVENTS

Both vaccines are associated with: local site reactions such as pain, redness and swelling at the injection

site. Pain at the injection site is very common with the adjuvanted vaccine. Systemic adverse events such as myalgia, headache and fatigue are

also reported among recipients, and are more common following the adjuvanted vaccine.

Do not report such events as Adverse Events Following Immunization.

What adverse events need to be reported? only those adverse events that are medically attended, result in hospitalization, or are severe or unusual.. BCCDC will be reviewing all reported adverse events at least weekly, and serious events daily.


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SERIOUS ADVERSE EVENTS (SAE) AFTER SEASONAL INFLUENZA VACCINES:

SAE profile of seasonal influenza vaccine Anaphylaxis (1 per 1 million doses given) Guillain-Barré syndrome (GBS) (1 per 1 million

doses given)

* These data represent an average of SAEs that have occurred in BC with annual influenza vaccination campaigns since 2004

Current as of October 21, 2009 26

COMMON ADVERSE EVENTS WITH H1N1 AS03 VACCINE

Local Symptoms

Incidence GeneralSymptoms

Incidence

Adjuvanted Vaccine

Non-adjuvanted

Vaccine

Adjuvanted Vaccine

Non-adjuvanted

Vaccine

Pain 90% 37% Arthralgia 11% 5%

Redness 1.6% 0% Fatigue 32% 26%

Swelling 6.5% 0% Fever 0% 0%

-Clinical trial subjects 18-60 years of age-Arepanrix® product leaflet. Oct 21/09-After first dose

Headache 14% 8%

Myalgia 34% 8%

Shivering 8% 3%

Sweating 10% 8%


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CONTRAINDICATIONS TO RECEIPT OF INFLUENZA VACCINE:

History of anaphylactic reaction to a previous dose of influenza vaccine or to the following vaccine components: eggs formaldehyde sodium deoxycholate thimerosal

Individuals with serious egg allergies should not be routinely vaccinated with the influenza vaccine.

If at high risk of complications of influenza, such people should be evaluated by an allergy specialist. If such an evaluation is not possible, the risk of an allergic reaction to the vaccine must be weighed against the risk of influenza disease.


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CONTRAINDICATIONS TO RECEIPT OF INFLUENZA VACCINE, CONTINUED:

History of Guillain-Barré syndrome within 8 weeks of a prior dose of influenza vaccine

Age under 6 months old

*Latex hypersensitivity is NOT a contraindication to either adjuvanted or unadjuvanted pH1N1 vaccine because the stopper is butyl rubber, latex free


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ADJUVANTED PH1N1 VACCINE Vaccine will be

distributed from GSK in 500 dose ‘shoebox’ containing 2x25 vial boxes of adjuvant, and 50 vial box of antigen

The most current product leaflet will be ‘live’ online at http://www.gsk.ca/english/html/our-products/vaccines-canada.html

Image courtesy of GSK©

http://www.gsk.ca/english/html/our-products/vaccines-canada.html




PREPARATION OF ADJUVANTED H1N1Arepanrix: Adjuvanted pH1N1 vaccine utilizes a novel GlaxoSmithKline

proprietary adjuvant called AS03 adjuvant stimulates immune response

to the antigen for better antibody response

PREPARATION

Antigen is clear, in a 10 ml vial

Adjuvant is milky white, in 3 ml vial •Requires

mixing prior to administration

•24 hour shelf life after mixing

PREPARATION OF ADJUVANTED VACCINE


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WITHDRAWING ADJUVANT: USE CARE Adjuvant vial may contain overfill – draw up

all Vials when mixed may contain – up to 12 ml Will not affect amount of antigen per dose Use all of contents If using 3 cc syringe for adjuvant, use care

to avoid pulling out plunger because of overfill

If this happens dispose of contents to avoid contamination

Potential errors in mixing and administering adjuvanted pH1N1 vaccine:


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Potential errors in mixing and administering adjuvanted pH1N1 vaccine:1) Antigen only is injected: this does NOT constitute a dose.

2) Antigen and adjuvant from separate shoeboxes are used: It is preferable to use antigen and adjuvant from one “shoebox”; however, there is no scientific reason why adjuvant from one shoebox cannot be used to mix with antigen from another; record the lot number of each component antigen AND adjuvant.

Please report errors to your local health unit. Errors will be collated centrally to identify common misunderstandings and improve instructional materials to prevent future errors.

LOT NUMBERS

Each vaccine dose is related to 3 lot numbers:

One for adjuvant – on vial

One for antigen – on vial

One for the mixture of both – on box- found on the “shoe box” outer carton containing 500 doses

OR on the outer label of the bubble pack containing 10 doses

Community Providers will be Recording EITHER both adjuvant and antigen lot number OR outer (combination) lot number in provider record

For iPHIS Record combination lot number only

Lot number of combination product will be on outer label only


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REPORTING OF NUMBER OF PERSONS IMMUNIZED EACH WEEK: Reporting of the number of people immunized

each week will be conducted from all clinics administered by public health and First Nations community health immunization service providers

Check with your local health unit on how to report

Private providers (e.g., in workplace settings) should check with local health unit about reporting back requirements

Doses given by physicians will be estimated through MSP billing claims

KEY MESSAGES:

Both seasonal and pandemic vaccine will be available • The pandemic vaccine will be freely available to all;

it is strongly recommended for those • Influenza vaccines will provide protection against the

pH1N1 virus, expected to predominate, and the seasonal trivalent viruses which may also be circulating

• Pneumococcal vaccine is strongly encouraged for the usual risk groups; these include people ≥65 years of age and those less than 65 years of age with chronic conditions. Pneumococcal infections are a known complication of both seasonal and pandemic influenza.

FREQUENTLY ASKED QUESTIONS

There have been many questions by pregnant women – “should I get the vaccine now or wait for the unadjuvanted vaccine?”

The adjuvanted vaccine : no clinical trials conducted or completed in pregnancy or young children, respectively.

The unadjuvanted vaccine: Formulated same manner as standard Fluviral® seasonal influenza vaccine made by GSK and used in BC each year


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WHAT IS THE PRESERVATIVE USED IN THE ADJUVANTED AND NON-ADJUVANTED VACCINE?

Both vaccines in 10 dose vials; therefore a preservative is needed to maintain sterility after vial entry

Both contain thimerosal as a preservative

In each 0.5 ml dose of the vaccine: Adjuvanted: 5 g thimerosal Unadjuvanted: 50 g thimerosal, the same as in a

0.5 ml dose of Fluviral®

MATURE MINOR CONSENT

We already have policies and procedures to cover mature minor consent – for school imms

Effort is made to seek parental or guardian consent prior to immunization.

Children under the age of 19 who are able to understand the risks and benefits may consent to or refuse immunizations, regardless of the parent’s or guardian’s wishes.

It is recommended that parents/guardians and their minor children discuss immunizations beforehand, and ask the nurse any questions

WHY THE FOCUS ON PREGNANT WOMEN AND THE H1N1 VACCINE

Pregnant women and new mothers are at higher risk of complications from the H1N1 flu virus.

Pregnant women in the second half of pregnancy are among those at highest risk of severe outcomes from the pandemic H1N1 virus.

Since B.C. is experiencing epidemic levels of the H1N1 virus now, pregnant women in second half of pregnancy are advised not to wait until November for unadjuvanted vaccine, but to get immunized now with the adjuvanted version.

WHO IS RECOMMENDED TO GET VACCINE FOR H1N1

It is strongly recommended that the following people receive the pH1N1 vaccine:

Children and adults under 65 years old with certain medical conditions, including: Heart or lung disorders that require regular medical care including asthma, chronic obstructive

pulmonary disease, or cystic fibrosis. Kidney disease, chronic liver disease including hepatitis, diabetes, cancer, anemia, or weakened

immune systems. Those with health concerns causing difficulty breathing, swallowing, or a risk of choking on food or

fluids, including persons with severe brain damage, spinal cord injury, seizures or neuromuscular disorders.

Pregnant women Children 6 months to 5 years of age Persons residing in remote and isolated settings and communities Health care workers Household contacts and care providers of children under 6 months of age or those with

weakened immune systems.

All others are recommended to receive the pH1N1 vaccine:

Children 5-18 years of age First responders (police and firefighters) Poultry and swine workers Adults 19-64 years of age Adults 65 years of age and over

I HAVE ALREADY HAD PH1N1 INFECTION DO I STILL NEED TO GET VACCINATED?

The vaccine is not recommended for those who had lab-confirmed pH1N1 they will have acquired natural immunity.

Give pH1N1 vaccine to individuals

whose infection was not laboratory-confirmed. Testing these individuals now is NOT indicated.

AUTOIMMUNE DISORDERS & ADJUVANT Since the squalene contained in AS03 is designed to

improve the immune response to the vaccine, there are some theoretical concerns that it may provoke a hyperactive immune response.

Animal studies have shown that arthritis can result when undiluted squalene is injected in large amounts into rats’ tails or joints.

This has not been observed in clinical trials of human subjects.

As well, another squalene containing adjuvant, MF59, has been used in >40 million recipients of the seasonal influenza vaccine called Fluad® (Novartis®) marketed in Europe and approved for use in elderly individuals, without observed excess rates of autoimmune diseases.

Federal level information, Canada wide epidemiology, planning

Provincial information on disease, BC vaccine roll out plan

Provides up to date provincial information, epidemiology, links to other resources

Immunization specific information- appropriate for patients

Provincial Health Officer’s H1N1 Site for the Physicians of B.C. http://www.hls.gov.bc.ca/pho/physh1n1.html

http://www.ImmunizeBC.ca

http://www.bccdc.ca

PH1N1 WEB SITES

http://www.hls.gov.bc.ca/pho/physh1n1.html

http://www.bccdc.ca/

Health & Medicine

Influenza Season 2009