Consumer medicine information

Q-Vax

Coxiella burnetii vaccine

BRAND INFORMATION

Brand name

Q-Vax

Active ingredient

Coxiella burnetii vaccine

Schedule

S4

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using Q-Vax.

What is in this leaflet?

This leaflet answers some common questions about Q-VAX®. It does not contain all the available information. It does not take the place of talking to your doctor or other health professional.

Keep this leaflet. You may want to read it again.

All medicines, including vaccines, have risks and benefits. Your doctor considers the risks of you having Q-VAX® Fever Vaccine and the benefits they expect it will have for you.

If you have any concerns about this vaccine, ask your doctor or other health professional.

What Q-VAX® is used for

Q-VAX® Q fever Vaccine is given by injection under the skin, usually in the upper arm. It is used to help protect people against the infection "Q fever.”

Q fever is caused by bacteria (called Coxiella burnetii) which can be caught by humans from animals that carry the infection. These bacteria can cause illness in humans, sometimes mild, sometimes severe.

Vaccination with Q-VAX® is recommended for people working with cattle, sheep or goats, or products from these animals, for example

  • abattoir workers, and visitors
  • veterinary personnel
  • stockyard workers
  • farmers
  • shearers
  • animal transporters
  • laboratory workers handling potentially infected veterinary samples or visiting abattoirs
  • people who cull and process kangaroos.

The risk of becoming infected with Q fever is highest in the first few years of exposure. Workers who are at risk of contracting Q fever should be immunised as soon as possible after they commence work.

How Q-VAX® works

Q-VAX® works by causing your body to produce its own protection against the Coxiella burnetii bacteria that cause Q fever. After you are vaccinated with Q-VAX® your immune system is able to destroy the Q fever organism if you come into contact with it. This prevents you from getting Q fever. However, your body does take several weeks after vaccination to fully develop this protection against Q fever.

Protection by vaccination requires one dose of Q-VAX® Vaccine. Protection lasts for many years.

You must not be given Q-VAX® Vaccine more than once.

As with all vaccines, 100% protection cannot be guaranteed.

However, most people will be protected against Q fever.

The risk of having a severe unwanted reaction from Q-VAX® is small. The risks from NOT being vaccinated against Q fever may be serious.

Before you are given Q-VAX®

Before you are given Q-VAX® Vaccine, your doctor will give you a skin test and a blood test to check if you are already immune to Q fever

When you must NOT be given Q-VAX® Vaccine

Do not have Q-Vax® Vaccine if:

  • you have previously been vaccinated with Q-VAX®
  • you have had Q fever
  • you have been exposed to the bacteria and you have had a Q fever-like illness
  • you have not had the required Q Fever skin test AND blood test
  • the skin test OR the blood test show your doctor that you already have immunity against Q fever.

Note: Do not have Q-VAX® Vaccine unless both your skin test AND blood test are negative.

Tests required before having Q-VAX®

  • skin test

and

  • blood test.

The Q-VAX® Skin test is a small injection (0.1mL) in your forearm. The forearm must then be checked by your health professional seven days after the test injection. If the skin test is positive, a small lump will be present.

For the blood test, your blood sample is examined in a specialised laboratory. The test results are sent to your doctor.

Positive skin and/or blood tests show that you are already protected against Q fever. (The illness Q fever may be mild and difficult to diagnose. You may have had Q fever without realising it.)

If either or both of the skin and blood tests are positive, it is important that you DO NOT HAVE THE Q-VAX® VACCINATION. If you are already immune to Q fever, Q-VAX® vaccination may cause a severe reaction.

Do not have Q-VAX® if you have or previously had an allergy to:

  • eggs
  • any of the ingredients listed at the end of this leaflet.

Symptoms of an allergic reaction may include

  • shortness of breath, wheezing or difficulty breathing
  • swelling of the face, lips, tongue or other parts of the body
  • skin rash, itching or hives.

Q-VAX® is not recommended for use in children.

There is no information on the use of Q-VAX® in people who have poor immunity or are on treatment that lowers immunity.

Do not have Q-VAX® after the expiry date (EXPIRY) printed on the pack.

Do not have Q-VAX® if the packaging is torn or shows signs of tampering.

If you are not sure whether you should have Q-VAX®, talk to your doctor.

Tell your doctor if you have ever reacted to any vaccination with any of the following:

  • severe allergic reaction
  • difficulty breathing
  • swelling of the throat
  • fainting or collapse
  • fits or convulsions
  • high temperature (greater than 38.5 degrees C)
  • severe skin reaction at the injection site, including severe bruising.

Tell your doctor if you have allergies to:

  • any other medicines
  • any other substances, such as foods, preservatives or dyes.

Tell your doctor if you have worked with farm animals or been in contact with animal carcasses.

Tell your doctor if you are pregnant or intend to become pregnant. There is no information on the use of Q-VAX® in pregnancy. It is recommended that vaccination is deferred. Your doctor will discuss the possible risks and benefits with you.

Tell your doctor if you are breast-feeding. There is no information on the use of Q-VAX® during breastfeeding.

Your doctor will discuss the possible risks and benefits of having Q-VAX®.

Taking other medicines

Tell your doctor if you are taking any other medicines, including any that you buy without a prescription from your pharmacy, supermarket or health food shop.

How Q-VAX® is given

Remember: you should not be given Q-VAX® Vaccine unless your skin test and blood test are both negative.

Q-VAX® vaccination is given by injection by a trained health professional. It is injected just underneath the skin, usually in your upper arm.

How much is given

Q-VAX® Vaccine is pre-filled in a single-use syringe. This contains one 0.5mL dose.

Overdose is unlikely as your doctor gives you the vaccination.

One vaccination only is given.

You should NOT be given a booster dose of Q-VAX® Vaccine.

A second dose may cause a severe reaction.

Follow the advice (see below) about keeping a record of this vaccination.

If you have any concerns, ask your doctor.

After having Q-VAX®

Things you must do

You must be given Q-VAX® by a trained health professional, where there are facilities to manage any allergic reaction.

Allergy to Q-VAX® is uncommon, but allergy to any vaccine may occur.

Keep an updated record of all your vaccinations.

Ask the doctor to give you a written record of the injection stating the date, dose and batch number of the vaccine.

If you develop any medical problems after being given Q-VAX®, tell your doctor.

Q-VAX® is unlikely to affect your ability to drive or operate machinery.

Side effects

Tell your doctor as soon as possible if you do not feel well after receiving Q-VAX®.

All medicines, including vaccines, can have side effects. Q-VAX® vaccination may cause unwanted side effects in some people. Sometimes they are serious, most of the time they are not. You may need medical treatment if you get some of the side effects.

Ask your doctor to answer any questions you may have.

Tell your doctor if you notice any of the following and they worry you:

  • reactions around the injection site such as redness, itchiness, pain or discomfort, warmth, burning or stinging, swelling or the formation of hard lumps or scars (up to 6 months after vaccination)
  • headaches
  • fever
  • aching muscles
  • fatigue
  • generally feeling unwell
  • nausea
  • vomiting
  • diarrhoea
  • increased sweating.

These side effects are usually mild.

Serious side effects are rare.

Tell your doctor immediately if you notice any of the following:

  • infection or an abscess at the injection site
  • painful, swollen joints
  • sudden extreme tiredness or weakness
  • swollen glands
  • feeling faint.

These may be serious side effects. You may need urgent medical attention.

Other side effects not listed above may occur in some patients. Tell your doctor if you notice anything that is making you feel unwell.

Do not be unduly alarmed by the list of possible side effects. You may not experience any of them.

Storing Q-VAX®

Q-VAX® is usually stored in the doctor's surgery or clinic. However, if you need to store Q-VAX®:

  • Keep it where children cannot reach it
  • Keep Q-VAX® in the original pack until it is time for it to be given
  • Keep it in the refrigerator between 2 degrees C and 8 degrees C and protect it from light. Do not freeze Q-VAX®.

Product description

What it looks like

  • Q-VAX® Q fever Vaccine is supplied in a pre-filled glass syringe containing 0.5 mL of a slightly cloudy colourless liquid.

Each Q-Vax® Vaccine syringe is supplied in a moulded plastic blister with peel-off paper cover.

Do not use if the blister is damaged or missing.

  • Q-VAX® Skin Test is supplied in a glass vial containing 0.5 mL of a clear colourless liquid.

The Q-Vax® Skin Test vial has a removable plastic cap covering the top of the vial. Do not use if the removable plastic cap is damaged or missing.

Ingredients

Active ingredient:

Q-VAX® Q fever vaccine

  • Each 0.5mL dose of vaccine contains no less than 25 micrograms of killed Coxiella burnetii organisms.

Q-VAX® Skin Test

  • Each diluted 0.1 mL dose contains 16.7 nanograms of killed Coxiella burnetii organisms.

Other ingredients:

  • sodium chloride
  • monobasic sodium phosphate
  • dibasic sodium phosphate
  • thiomersal.
  • water for injections

Q-VAX® may also contain traces of

  • formalin
  • egg proteins
  • sucrose.

Q-VAX® does NOT contain:

  • lactose
  • gluten
  • tartrazine
  • any other azo dyes or
  • latex.

Ask your doctor or other health professional if you are unsure about anything or want more information about Q-VAX®.

Name and Address of Sponsor

Q-VAX® is sponsored by:

Seqirus Pty Ltd
ABN 26 160 735 035
63 Poplar Road, Parkville
Victoria 3052
AUSTRALIA

Registration numbers

Q-VAX® Q fever Vaccine
AUST R 100517

Q-VAX® Skin Test
AUST R 100518

Q-VAX® is a registered trademark of Seqirus UK Limited or its affiliates.

Date of preparation
27 June 2019

Published by MIMS November 2019

BRAND INFORMATION

Brand name

Q-Vax

Active ingredient

Coxiella burnetii vaccine

Schedule

S4

 

1 Name of Medicine

Inactivated Coxiella burnetii as active ingredient.

2 Qualitative and Quantitative Composition

Q-Vax is a purified suspension of formalin-inactivated, Coxiella burnetii prepared from the Phase I Henzerling strain of the organism grown in the yolk sacs of embryonated eggs. Trace amounts of ovalbumin (< 1 microgram) may also be present.
Q-Vax Vaccine contains ≥ 25 microgram of antigen in 0.5 mL of aqueous solution.
Q-Vax Skin Test contains ≥ 2.5 microgram of antigen per 0.5 mL of aqueous solution. Prior to administration, Q-Vax Skin Test is diluted with Sodium Chloride injection to ensure that 16.7 ng (nanograms) of antigen is delivered per 0.1 mL intradermal dose. (See Section 4.2 Dose and Method of Administration).
Each 0.5 mL Q-Vax Vaccine also contains sodium chloride 4.1 mg, monobasic sodium phosphate dihydrate 120 microgram, dibasic sodium phosphate dodecahydrate 245 microgram thiomersal as preservative 50 microgram and water for injections to 0.5 mL.
Each 0.1 mL Q-Vax Skin Test dose after dilution also contains sodium chloride 0.9 mg, monobasic sodium phosphate dihydrate 0.8 microgram, dibasic sodium phosphate dodecahydrate 1.6 microgram, thiomersal as preservative 333 nanogram and water for injections to 0.1 mL.

3 Pharmaceutical Form

Q-Vax Q-Fever Vaccine is a clear to slightly opaque, colourless suspension for subcutaneous injection.
Q-Vax Skin test is a clear to slightly opaque, colourless suspension for dilution prior to intradermal injection.

4 Clinical Particulars

4.1 Therapeutic Indications

Q-Vax Vaccine is indicated for the immunisation of susceptible adults at identifiable risk of infection with Q fever.
Abattoir workers (and those closely associated with the meat industry), farmers, veterinarians, stockyard workers, shearers, animal transporters and many others exposed to cattle, sheep or goats or their products should be considered for vaccination.
Note also that Q fever has occurred among persons culling and processing kangaroos and that laboratory personnel handling potentially infected veterinary specimens, or visiting abattoirs, are at risk.
Q-Vax Skin Test is indicated for the prescreening of potential vaccine recipients for prior sensitisation to Q fever antigens.
It is essential to test for sensitisation to Q fever antigens using Q-Vax Skin Test in every individual prior to immunisation (see Section 4.4 Special Warnings and Precautions for Use).

4.2 Dose and Method of Administration

Q-Vax Vaccine.

Q-Vax Vaccine should not be administered until the results of serology and skin testing are known (see Section 4.4 Special Warnings and Precautions for Use). Q-Vax should be given only to those who have no demonstrable evidence of sensitisation to Q fever antigens.
The dose of Q-Vax Vaccine is 0.5 mL given by subcutaneous (not intramuscular) injection. The container should be gently shaken before use.
The vaccine should never be administered intravenously.
No information is available on paediatric use.
Revaccination must never be undertaken due to the possibility of severe hypersensitivity reactions.

Q-Vax Skin Test.

Preparation.

Skin Test solution should be prepared by diluting 0.5 mL of the Q-Vax Skin Test in 14.5 mL of sodium chloride injection (to a final volume of 15 mL). The diluted Q-Vax Skin Test should be freshly prepared, stored at 4°C and used within six hours.

Administration.

The dose administered for skin testing is 0.1 mL of the diluted Q-Vax Skin Test. This should be injected intradermally into the volar surface of the mid-forearm.

4.3 Contraindications

Q-Vax should not be administered to:
Persons who have a history of Q fever.
Persons who have been previously vaccinated with Q fever vaccine.
Persons who have a history of likely exposure followed by an illness strongly suggestive of Q fever.
Persons with positive serology for Q fever antibody or a positive Q fever skin test.
Persons with known hypersensitivity to egg proteins or any component of the medicinal product.

4.4 Special Warnings and Precautions for Use

Prior to immunisation, all potential vaccinees must have a serum antibody estimation and a skin test reported; administration of Q-Vax to those who are already sensitised to Q fever antigens can cause serious hypersensitivity reactions.
As with other injectable vaccines, including Q-Vax Skin Test solution, appropriate medical treatment and supervision should always be available in case of anaphylactic reactions. Adrenaline should always be readily available whenever the injection is given.
Q-Vax should never be administered intravenously.
There is no information available on the efficacy and safety of Q-Vax in immunodeficient or immunosuppressed individuals.
Those who have a confirmed positive antibody test or a positive skin reaction must not be given Q-Vax (see Prevaccination testing).
If the skin test is negative or equivocal and antibodies are present at low titres (reported as a borderline laboratory test result), it cannot be concluded that the subject has adequate protective immunity against Q fever. The low level presence of antibodies may be nonspecific or due to technical factors of the assay. The risk/ benefit decision of being vaccinated or not should be individually assessed and discussed with the subject, in order to decide whether potential adverse events following vaccination outweigh the potential risk to that subject from Q fever infection and its associated complications.
It should be noted that a very small number of people may have had Q fever in the past and yet show no response to serological or skin testing. Such persons may have severe reactions to Q-Vax. For this reason, subjects should be carefully questioned regarding the possibility of previous exposure to Q fever and the duration of such exposure.
Workers who are at risk of contracting Q fever should be immunised prior to commencement of work or as soon as possible after they commence work as the risk of infection is highest in the first few years.
Vaccination during the incubation period of Q fever does not prevent the onset of the disease.
Despite the significant efficacy of Q-Vax in clinical trials, cases of Q fever following vaccination have been reported (see Section 5.1 Pharmacodynamic Properties, Clinical trials).

Prevaccination testing.

Serology. People who are being considered for Q fever vaccination must have serum antibody testing. Subjects in whom antibodies are unequivocally positive should not be given Q-Vax (see Section 4.4 Special Warnings and Precautions for Use).
Skin test.

Preparation.

Skin Test solution should be prepared by diluting 0.5 mL of the Q-Vax Skin Test in 14.5 mL of sodium chloride injection (to a final volume of 15 mL). The diluted Q-Vax Skin Test should be freshly prepared, stored at 4°C and used within six hours.

Administration.

The dose administered for skin testing is 0.1 mL of the diluted Q-Vax Skin Test. This should be injected intradermally into the volar surface of the mid-forearm.
A positive reaction is indicated by any induration at the site of injection read seven days after the test dose. Any person with a positive reaction must not be vaccinated.

Use in the elderly.

No data available.

Paediatric use.

No data available.

Effects on laboratory tests.

No data available.

4.5 Interactions with Other Medicines and Other Forms of Interactions

No data available.

4.6 Fertility, Pregnancy and Lactation

Effects on fertility.

No data available.
(Category B2)
Safety of use in pregnancy has not been established. Deferral of vaccination is recommended.
 No data available.

4.7 Effects on Ability to Drive and Use Machines

The effect of this medicine on person's ability to drive and use machines were not assessed as part of its registration.

4.8 Adverse Effects (Undesirable Effects)

Vaccination of already immune subjects may result in severe local or general reactions, with the possibility of local abscess formation.

Clinical trial data.

In a clinical trial in South Australia the following adverse events were recorded amongst 464 persons who received Q-Vax. See Table 1.
There was a single case report of abscess formation at the injection site.

Postmarketing data.

A range of adverse reactions has been reported with clinical use of Q-Vax. The reactions are summarised below and categorised by frequency according to the following definitions. Very common: ≥ 1/10; common: < 1/10 and ≥ 1/100; uncommon: < 1/100 and ≥ 1/1,000; rare: < 1/1,000 and ≥ 1/10,000 and very rare: < 1/10,000.

Blood and lymphatic system disorders.

Very rare: lymphadenopathy.

Nervous system disorders.

Common: headache. Very rare: dizziness.

Gastrointestinal disorders.

Uncommon: nausea, vomiting and diarrhoea.

Skin and subcutaneous tissue disorders.

Common: delayed skin reaction (presenting up to 6 months after vaccination) at injection site (either vaccination and/or skin test site). Uncommon: hyperhidrosis.

Musculoskeletal and connective tissue disorders.

Uncommon: myalgia. Very rare: arthralgia.

General disorders and administration site conditions.

Very common: injection site inflammation (e.g. erythema, pain, warmth and swelling). Uncommon: injection site induration and/or oedema, pyrexia, malaise, fatigue. Rare: injection site abscess formation, granuloma. Very rare: chills, chronic fatigue syndrome.

Reporting suspected adverse effects.

Reporting suspected adverse reactions after registration of the medicinal product is important. It allows continued monitoring of the benefit-risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions at www.tga.gov.au/reporting-problems.

4.9 Overdose

For information on the management of overdose, contact the Poisons Information Centre on 13 11 26 (Australia).

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

Mechanism of action.

Q fever is caused by Coxiella burnetii, an obligate, intracellular, Gram-negative coccobacillus. The C. burnetii is shed in the products of conception, and on the neonate of the infected animal. It may also be present in the udder and milk of infected animals and is passed on within their faeces and urine. Infection is transmitted to humans primarily by inhalation of infected airborne particles or dust during the handling or processing of these materials or by close proximity to infected animals and their products.
Administration of inactivated Coxiella burnetii in Q-Vax vaccine stimulates production of an immune response in the vaccinated individual. The immune response provides protection against clinical illness in a high proportion of vaccinated individuals, but may not be effective in some individuals.
Early antibody response to the vaccine is predominantly with the IgM subclass; IgG antibodies appear later. Although the seroconversion rate is low (50-80%) and antibody levels are transient, cell mediated immunity develops. Clinical trials have demonstrated a high degree of efficacy (see Section 5.1 Pharmacodynamic Properties, Clinical trials). As Q fever is often asymptomatic or misdiagnosed due to its non-specific nature, many abattoir workers develop immunity to Q fever without an obvious illness.
The duration of protective immunity following immunisation is unknown, but is believed to be in excess of five years.
Revaccination must never be undertaken due to the possibility of severe hypersensitivity reactions (see Section 4.3 Contraindications).

Clinical trials.

A randomised, blind, controlled study comparing Q-Vax and influenza vaccine for the prevention of Q fever amongst 200 workers in three Queensland abattoirs was undertaken, using sequential analysis for determining the efficacy of Q-Vax. A statistically significant difference in the incidence of symptomatic Q fever was noted 15 months after commencement of vaccination, with 7 cases in those given the control vaccine and no cases in those given Q-Vax. At 15 months, 24% of those who had not been vaccinated and had not developed symptomatic infection had serological evidence of exposure to Q fever, indicating subclinical infection.
A retrospective cohort study in three South Australian abattoirs was undertaken to compare the incidence of Q fever in vaccinated and unvaccinated subjects between 1985 and 1990. There were two cases of Q fever amongst 2555 vaccinated employees compared with 55 cases in 1365 unvaccinated subjects. Both cases of Q fever in the vaccinated group occurred within two weeks of receiving the vaccine. For workers who were vaccinated, the mean duration of employment following vaccination was 1.9 years; 203 workers were employed for all five years of the study. Protection against clinical infection over this period was demonstrated.
Although the dose in each of these studies was nominally 30 microgram, one batch which contained only 20 microgram in each dose was shown to be as effective. However, as with all vaccines, 100% effectiveness for generation of protective immunity against Q fever cannot be guaranteed (see Section 4.4 Special Warnings and Precautions for Use).

5.2 Pharmacokinetic Properties

Not applicable.

5.3 Preclinical Safety Data

Genotoxicity.

No data available.

Carcinogenicity.

No data available.

6 Pharmaceutical Particulars

6.1 List of Excipients

See Section 2 Qualitative and Quantitative Composition.

6.2 Incompatibilities

Incompatibilities were either not assessed or not identified as part of the registration of this medicine.

6.3 Shelf Life

In Australia, information on the shelf life can be found on the public summary of the Australian Register of Therapeutic Goods (ARTG). The expiry date can be found on the packaging.

6.4 Special Precautions for Storage

Q-Vax Vaccine and Q-Vax Skin Test should be protected from light and stored at 2°- 8°C. Refrigerate. Do not freeze.

6.5 Nature and Contents of Container

AUST R 100517.
Q-Vax Vaccine is available as a pre-filled syringe containing ≥ 25 microgram of antigen, in 0.5 mL solution.
The syringe and all associated syringe components do not contain natural rubber latex. The Q-Vax Vaccine syringe is supplied in a moulded plastic blister with peel-off paper cover. Do not use if the blister pack encasing the syringe is damaged or missing.
AUST R 100518.
Q-Vax Skin Test is available as a pre-filled vial containing ≥ 2.5 microgram of antigen, in 0.5 mL solution. Q-Vax Skin Test must be diluted prior to use in pre-vaccination screening (see Section 4.2 Dose and Method of Administration). The vial and all associated components do not contain natural rubber latex. The Q-Vax Skin Test vial is packaged with a plastic tear away cap covering the vial septum. Do not use if the tear away cap on the vial is damaged or missing.

6.6 Special Precautions for Disposal

In Australia, any unused medicine or waste material should be disposed of in accordance with local requirements.

6.7 Physicochemical Properties

Not applicable.

7 Medicine Schedule (Poisons Standard)

S4.

Summary Table of Changes