Some clients might ask why a novel adjuvant was introduced at this timeIt is not completely novel as you saw in the last slide: pre-licensed as “prepandemrix” in all 27 European states, Malaysia and Hong Kong. Using an adjuvanted vaccine allows us to protect ourselves by protecting our neighbors- more antigen is available for other countriesObviously this decision also has humanitarian implications, it is estimated that the US is using 50% of the world antigen supply for this virus due to their decision to use an non-adjuvanted productAn interesting feature of the use of AS03 is that it increases the range of protection in trials- meaning that if there is antigenic drift, immunized persons may still have some protection, this is not seen in antigen only vaccine.Some clients might ask why a novel adjuvant was introduced at this timeIt is not completely novel as you saw in the last slide: pre-licensed as “prepandemrix” in all 27 European states, Malaysia and Hong Kong. Using an adjuvanted vaccine allows us to protect ourselves by protecting our neighbors- more antigen is available for other countriesObviously this decision also has humanitarian implications, it is estimated that the US is using 50% of the world antigen supply for this virus due to their decision to use an non-adjuvanted productAn interesting feature of the use of AS03 is that it increases the range of protection in trials- meaning that if there is antigenic drift, immunized persons may still have some protection, this is not seen in antigen only vaccine.
Instructions for mixing and administration of the vaccine:**Do not use larger than a 20 gauge needle to withdraw as this may lead to coring of the stopper, resulting in rubber falling into the vaccine1. Before mixing the two components, both vials should be shaken and inspected visually for any foreign particulate matter and/orAn abnormal physical appearance. In the event of either being observed, discard the vaccine.2. The vaccine is mixed by withdrawing the contents of the vial containing the emulsion(adjuvant) by means of a 20-21 gauge needle and 5 ml or larger syringe (A 3 ml syringe can be used, but care needs to be taken as the plunger is almost fully drawn out from the syringe and may become unstable), and by adding it to the vial containing the antigen suspension.3. After the addition of the emulsion to the suspension, the mixture should be well shaken. Themixed vaccine is a whitish emulsion. In the event of other variation being observed, discard the vaccine.4. The volume of Arepanrix (5 ml) after mixing corresponds to 10 doses of vaccine 5. The vial should be shaken prior to withdrawing each dose6. Each vaccine dose of 0.5 ml is withdrawn into a 25 gauge 1” needle and a 3 ml syringe for injection ( may use 1” 25 gauge needle and 1 ml syringe for those 10 and under)7. After mixing, use the vaccine within 24 hours and do not store above 25°C.
Influenza Season 2009/2010 Update and Answers to Common Questions
Outline of update Overview of influenza pattern Overview of this years campaign Vaccine Details – Seasonal & pH1N1 Populations and dosages Contraindications and Adverse Reactions Vaccine Preparation Frequently Asked Questions Mass Clinics and Ergonomics
Current as of October 21, 2009 3 Age Distribution Seasonal Influenza Pandemic Influenza Distribution by age group of persons hospitalized with laboratory-confirmed influenza ( United States, 2007--08 winter influenza season and April 15--August 11, 2009)
Current as of October 21, 2009 4 Clinical presentation:
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
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
Current as of October 21, 2009 20 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.
Current as of October 21, 2009 21 Recommendations for dosing of pH1N1 vaccine compared to seasonal influenza vaccine: by age and pregnancy *Footnotes on slide # 10
Current as of October 21, 2009 22 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.
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.
Current as of October 21, 2009 25 Serious Adverse Events (SAE) after seasonal influenza vaccines:
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.
Current as of October 21, 2009 28 Contraindications to receipt of influenza vaccine, continued:
History of Guillain-Barré syndrome within 8 weeks of a prior dose of influenza vaccine
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:
Current as of October 21, 2009 34 Potential errors in mixing and administering adjuvanted pH1N1 vaccine: Antigen only is injected: this does NOT constitute a dose. 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:
Lot number of combination product will be on outer label only
Current as of October 21, 2009 38 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
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
Current as of October 21, 2009 41 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 gthimerosal Unadjuvanted: 50 gthimerosal, the same as in a 0.5 ml dose of Fluviral®
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.
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.
pH1N1 web sites Federal level information, Canada wide epidemiology, planning Provincial information on disease, BC vaccine roll out plan http://www.bccdc.ca Provides up to date provincial information, epidemiology, links to other resources http://www.ImmunizeBC.ca 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