The boxed warning is reproduced in full in the ' Information for health professionals ' section below. See the ' Information for consumers ' section below for more details. Zostavax is a live, attenuated varicella-zoster virus vaccine that is used to prevent shingles in patients aged 50 years and older and prevention of nerve pain associated with the virus in patients aged 60 years and older.
The TGA has been closely monitoring reports of disseminated vaccine strain varicella zoster infection and has published several safety alerts in response to three deaths related to this condition following vaccination with Zostavax. Investigation of this safety concern has found that the benefits of Zostavax continue to outweigh the risks, but additional risk mitigation is required. Zostavax is a live vaccine and should not be used in people with a weakened immune system, as it can cause serious illness and death from infection with the vaccine virus.
Tell your doctor if you are taking medicines that may weaken your immune system including high-dose corticosteroids or cancer medicines, or other treatment. If you become unwell after vaccination, you should seek medical attention and tell your doctor that you have recently received Zostavax. Varicella-zoster virus is the virus that causes chickenpox and shingles. Infection with varicella-zoster virus can be localised to an area of skin, but can also take a more serious, generalised form that affects a wider area of the body.
It explains how the Committee for Medicinal Products for Human Use CHMP assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Zostavax. Zostavax is a vaccine that is available as a powder and solvent to be made up into a solution for injection.
The active substance is the attenuated weakened varicella-zoster virus. Zostavax is used to vaccinate people aged 50 years or older, to prevent herpes zoster also known as zoster or shingles and the long-lasting nerve pain that may follow the disease post-herpetic neuralgia.
Zostavax is given as a single dose injected under the skin or into the muscle, preferably around the shoulder. In patients who have bleeding problems, the vaccine should be given under the skin. Herpes zoster, or shingles, is a disease caused by the reactivation of the varicella-zoster virus, the same virus that causes chickenpox.
Shingles develops in people who have had chickenpox earlier in life, generally as a child. Sometimes, after many years, and for reasons which are not fully understood, the virus becomes active again, and the patient develops shingles, a painful, blistering rash typically in one part of the body.
The rash takes usually several weeks to clear, and may be followed by severe long-lasting pain post-herpetic neuralgia in the area where the rash was. The risk of developing shingles increases with age and seems to be linked to a decline in the specific immunity protection against varicella-zoster virus. The main study of Zostavax compared the vaccine with placebo a dummy vaccine in around 39, patients aged between 59 and 99 years. The study was a double-blind trial, which means that neither the doctor nor the patient knew what treatment the patient was receiving.
The patients were followed for 2 to 4. The main measure of effectiveness was based on the number of people who developed shingles and post-herpetic pain. Studies are ongoing to assess the duration of protection from one dose of Zostavax and the need, if any, for booster doses. There are no comprehensive data on the effectiveness of Zostavax in treating herpes zoster once it occurs, and the vaccine is not licensed for this indication.
Skip directly to site content Skip directly to page options Skip directly to A-Z link. Vaccines and Preventable Diseases. Section Navigation. Facebook Twitter LinkedIn Syndicate. Consider delaying vaccination with Shingrix in such circumstances.
If an adult age 50 or older has had zoster with postherpetic neuralgia or ophthalmic complications, when can they receive zoster vaccine? Once they are no longer acutely ill, they can be vaccinated with Shingrix. There is no evidence that vaccine will have therapeutic effect for a person with existing zoster or postherpetic neuralgia. How long should we wait before giving zoster vaccine to a patient who has had a blood transfusion?
There is no waiting period for administering Shingrix following transfusion. Shingrix contains no live virus so may be given at any time after receipt of a blood product. Should zoster vaccine be given to a person who is currently receiving immunosuppressive treatment?
Immunosuppression is not included as a contraindication in the manufacturers' package insert. However, immunocompromised people and those on moderate to high doses of immunosuppressive therapy were excluded from the clinical efficacy studies so data were lacking on efficacy and safety in this group at the time of licensure.
ACIP has not yet made a recommendation regarding the use of Shingrix in these patients, but is anticipated to do so in the future. I have a patient who is eligible for zoster vaccination who is going to be receiving chemotherapy soon. What are the guidelines in such a situation? The risk for zoster and its severe morbidity and mortality is much greater for immunosuppressed people. A 2-dose series of Shingrix should be administered as soon as possible while the person's immune system is intact.
When can a patient previously on immunosuppressive chemotherapy receive zoster vaccine? ACIP has not specifically addressed the use of Shingrix in this situation but it is prudent to defer Shingrix until the patient's immune system has recovered from the treatment. Can someone with hepatitis C receive zoster vaccine? Hepatitis C infection is not a contraindication for Shingrix vaccination. However, if someone with hepatitis C is receiving a medication that can cause immunosuppression, they should consult with their healthcare provider and consider delaying vaccination with Shingrix until they have completed treatment.
Can a person age 60 years or older with a diagnosis of an autoimmune disease, such as lupus or rheumatoid arthritis, receive zoster vaccine? Shingrix can be administered in this situation. A year-old patient is having major back surgery next week. He is requesting zoster vaccine today. Can I give him the vaccine? We have a year-old patient who is taking mg of valacyclovir Valtrex daily. Can she receive zoster vaccine? Acyclovir, famciclovir, and valacyclovir are antiviral drugs that are active against herpesviruses.
These drugs will have no effect on Shingrix, which does not contain live varicella virus. If my patient is taking Tamiflu oseltamivir , can she receive zoster vaccine? Although oseltamivir is an antiviral drug, it is only effective against influenza A and B viruses. Shingrix does not contain live virus and will not be affected by oseltamivir. Administering Vaccines Back to top How are zoster vaccines administered?
Discard reconstituted vaccine if not used within 6 hours or if frozen. If Shingrix is reconstituted with other than the supplied adjuvant solution, it should be repeated. The dose can be repeated immediately. There is no interval that must be met between these doses.
A patient was inadvertently given Shingrix by the subcutaneous rather than the intramuscular route. Does the dose need to be repeated? Shingrix has been shown to be immunogenic when given by the subcutaneous route. A dose erroneously given by this route does not need to be repeated. When reconstituted, the volume of Shingrix is more than 0. Should the entire volume of reconstituted vaccine be administered or just 0. The Shingrix adjuvant solution may contain up to 0.
The entire volume of the adjuvant solution should be withdrawn and used to reconstitute the lyophilized vaccine. After mixing, withdraw the recommended dose of 0. Discard any reconstituted vaccine left in the vial. Can pharmacists in all states administer zoster vaccine? According to the American Pharmacist Association, all states allow pharmacists to administer zoster vaccine. Not all pharmacists provide vaccination services, and of those who do, not all administer zoster vaccine.
It is best to call the pharmacy ahead of time to find out if they have Shingrix to administer to your patients. The vaccine must be administered in the pharmacy. Do NOT instruct the patient to transport the vaccine from the pharmacy back to your office. This could damage the potency of the vaccine. A year-old patient was inadvertently given varicella vaccine instead of Shingrix. Should the patient still be given Shingrix? If so, how long an interval should occur between the 2 doses? CDC recommends that if a provider mistakenly administers varicella vaccine to a person for whom zoster vaccine is indicated, no specific safety concerns exist, but the dose should not be considered valid.
Shingrix should be administered at least 8 weeks after receipt of the varicella vaccine. However, if Shingrix is administered less than 8 weeks after the varicella vaccine, it does not need to be repeated.
Avoid such errors by checking the vial label 3 times to make sure you're administering the product you intended. If Shingrix is erroneously given to a child for prevention of varicella, the dose is invalid, but is there a waiting period before a valid dose of varicella vaccine can be given?
Is it OK to give a dose of varicella vaccine as soon as the error is discovered? There is no waiting period. The varicella vaccine dose can be given at any time after the Shingrix dose. We inadvertently gave a year-old healthcare worker Shingrix rather than varicella vaccine for work. Does this dose count?
The Shingrix vaccine does not count as a vaccination against primary varicella infection chickenpox. The first varicella vaccine dose can be given at any time after the Shingrix dose.
The second dose of varicella vaccine should be given 4 to 8 weeks after the first dose. You should always check the label 3 times to ensure you are administering the product intended. While giving a dose of Shingrix the syringe came loose from the needle and part of the dose was lost. Will the patient be protected with this partial dose or does it need to be repeated? A dose less than the full 0. If the patient is still in the office the dose can be repeated immediately.
If the repeat dose cannot be given on the same day CDC recommends that it should be given 4 weeks after the invalid dose. My medical assistant inadvertently administered a 0.
The dose did not contain any antigen. When can we administer a properly reconstituted dose? The CDC zoster subject matter experts recommend that in this situation you should wait 4 weeks before giving a repeat dose. Several doses antigen and diluent of Shingrix were mistakenly stored in our office freezer.
One of these doses was administered to a patient. Is this dose valid and if not, when can it be repeated? Any Shingrix, either antigen or diluent, that is exposed to freezing temperature should not be used.
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