Guest guest Posted October 30, 2009 Report Share Posted October 30, 2009 CANADA - Fluviral S/F - ID Biomedical (Shire) Interesting CDC says 36,000 in US (and previous emails show you how inflated that number is) Canada says " The number of deaths attributable to the flu and its complications varies yearly. It is estimated that, on average, between 500 and 1500 Canadians die from the flu or flu related complications every year 1. " http://www.phac-aspc.gc.ca/im/influenza-eng.php http://www.phac-aspc.gc.ca/publicat/ccdr-rmtc/08vol34/acs-3/index-eng.php Several influenza vaccines that are currently marketed in Canada contain minute quantities of thimerosal, which is used as a preservative(98). One thimerosal-free vaccine (Influvac™, Solvay Pharma), approved for persons 18 years of age, is available in Canada(98). http://pharmalive.com/News/index.cfm?articleid=576680 With 25 mcg of Mercury Production of influenza vaccine this year was complicated by the introduction of three new influenza strains for the 2008-2009 season: A/Brisbane/59/2007 (H1N1)-like strain, A/Brisbane/10/2007 (H3N2)-like strain and B/Florida/4/2006-like strain. Fortunately, this factor did not result in any delays in delivering doses for the season. About FLUVIRAL® FLUVIRAL® conforms to the current requirements of the World Health Organization (WHO). FLUVIRAL®, split-virion influenza vaccine, is used for active immunization against influenza disease caused by the influenza subtypes A and type B contained in the vaccine. FLUVIRAL® is indicated for the active immunization against influenza caused by influenza virus in adults and children 6 months of age or older. GlaxoKline: A Canadian Vaccines Leader GlaxoKline is the leading Canadian influenza vaccine manufacturer, and will supply the majority of the Canadian government's seasonal influenza vaccines purchases until 2010 Fluviral S/F Produced and commercialized in Canada by ID Biomedical Fluviral S/F: influenza virus vaccine trivalent, inactivated split-viron prepared in eggs. The number of deaths attributable to the flu and its complications varies yearly. It is estimated that, on average, between 500 and 1500 Canadians die from the flu or flu related complications every year 1. Vaccination is the most effective way to protect people from the influenza. With a good match between the strains in the vaccine and those in circulation, influenza vaccination has been shown to prevent laboratory-confirmed influenza illness in approximately 70% to 90% of healthy children and adults 2. Efficacy for the higher risk segment High risk groups (patients with cardiac or pulmonary disorders, diabetes renal disease, cancer, immunosuppression, anemia, hemoglobinopathy), and persons aged 65, or over, and any resident of a nursing home are at particular risk as the occurrence of severe complication, even mortality, is significantly higher in this subset of the population. Vaccination in this segment is of great importance since it can save many lives. Pandemic ID Biomedical has been chosen by the government of Canada to assure a state of national readiness in case of an influenza pandemics and to provide influenza vaccine for all Canadians if such an event were to happen. Canada is one of the few countries in the world that has such a program in place. Influenza pandemics occur infrequently, but when they do they can have severe and lethal consequences. There have been three in the twentieth century: in 1918, 1957, and 1968. The Spanish flu pandemic in 1918 claimed more than 20 million lives worldwide. Each year, the World Health Organization identifies the most relevant flu strains for worldwide vaccine production and recommends which strains should be incorporated into the annual vaccine. However, an entirely different strain of flu can periodically emerge. Only the rapid production of a new vaccine can provide protection for the population. Creating a state of readiness in Canada requires the development of sufficient infrastructure and capacity to provide influenza vaccine for 100% of domestic vaccine needs in the event of an influenza pandemic. 1 www.hc-sc.ca Health Canada Influenza Information Sheet. October 2002 2 National Advisory Committee on Immunization (NACI ), Statement on influenza vaccination for the 2003- 2004 season, Canada Communicable Disease Report Volume 29 ACS-4 15 August 2003 ******* from 2005/2006 (couldn't find this years, but usually no changes other than strains) http://www.phb.ca/influenza/UIIP2005-2006/UIIP%20Package/PDF%20files%20-%20Engli\ sh/Monographs/Fluviral_E.pdf (this is a PDF and this is copy of the text so formatting is not very good) BELOW are 1. The Strains included in this years 2. Formaldehyde 3. grown on hen's eggs 4. thimerosal - The vaccine also contains 0.01% thimerosal as a preservative, 5. sodium deoxycholate (what I can glean is that this is a bile salt that is used as a detergent and can dissolve cell membranes) FLUVIRAL ® (2005-2006) INFLUENZA VIRUS VACCINE TRIVALENT, INACTIVATED SPLIT-VIRION PREPARED IN EGGS For active immunization against influenza. Strains: A/New Caledonia/20/99 A/New York/55/2004 B/Jiangsu/10/2003 Inactivated with formaldehyde DESCRIPTION FLUVIRAL ® , is a trivalent, split-virion influenza vaccine prepared from virus grown in the allantoic cavity of embryonated hens' eggs. The virus is inactivated with ultraviolet light treatment followed by formaldehyde, purified by centrifugation and disrupted with sodium deoxycholate. FLUVIRAL ® is used for active immunization against influenza strains A/New Caledonia/20/99, A/New York/55/2004 and B/Jiangsu/10/2003. CAFV08/PI 8.11 approved A/New York/55/2004 B/Jiangsu/10/2003 Keep between 2 °C and 8 °C DIN 02015986 HEALTH PROFESSIONAL INFORMATION Strength Clinically Relevant Nonmedicinal Ingredients 15 µg influenza virus Haemagglutinin/strain/ 0.5 mL dose INDICATIONS AND CLINICAL USE FLUVIRAL®, split-virion influenza vaccine, is indicated for the active immunization against influenza strains A/New Caledonia/20/99, A/New York/55/2004 and B/Jiangsu/10/2003. The National Advisory Committee on Immunization (CCDR, June 15, 2004) recommends administration of influenza vaccines to the following groups: oAdults and children with: ochronic cardiac or pulmonary disorders (including bronchopulmonary dysplasia, cystic fibrosis and asthma) severe enough to require regular medical follow-up CAFV08/PI 8.11 approved or hospital care; chronic cardiac and pulmonary disorders in persons over the age of 45 are by far the most important risk factors for influenza-related mortality; oother chronic conditions such as diabetes and other metabolic diseases, cancer, immunodeficiency (including HIV infection) or immunosuppression, renal disease or hemoglobinopathy and anaemia. oResidents of nursing homes and other chronic care facilities. oPeople over 65 years of age. o Healthy persons aged 6 months to 64 years. oChildren and adolescents (aged 6 months to 18 years) with conditions treated for long periods with acetylsalicylic acid. oPersons infected with human immunodeficiency virus (HIV). oPeople capable of transmitting influenza to those at high risk of developing influenza-related complications, including the following: oHealth care providers who work in facilities and community settings, such as physicians, nurses, and emergency response workers; oHealth care and other service providers who have contact with residents of continuing care facilities or residences; oThose who provide home care for persons in high-risk groups; oThose who provide services within closed or relatively closed settings to persons at high risk; oHousehold contacts (adults and children) of people at high risk of influenza complications (including contacts of children <6 months and children 6 to 23 months) as well as pregnant women expected to deliver during influenza season; oThose providing regular childcare to children aged 0 to 23 months, whether in or out of the home; oPeople who provide essential community services. oPregnant women in high-risk groups. oPeople at high risk of influenza complications embarking on foreign travel to destinations where influenza is likely to be circulating. oHealthy working adults (employers and their employees). oPeople in direct contact with poultry infected with avian influenza during culling operations. Pediatrics: Healthy children aged 6 to 23 months are at increased risk of influenza-associated hospitalization compared with healthy older children and young adults. Children and adolescents (aged 6 months to 18 years) treated for long periods with ASA may be at increased risk of Reye Syndrome after influenza infection. Geriatrics (=65 years of age): The risk of severe morbidity and mortality related to influenza is moderately increased in healthy persons over 65 years of age but is not nearly as great as in persons with chronic underlying disease. HIV-Infected Persons: Limited information exists regarding the frequency and severity of influenza illness among HIV-infected persons, but reports suggest that symptoms may be prolonged and the risk for complications increased for some HIV-infected persons. Because influenza can result in serious illness and complications, vaccination is a prudent precaution and will result in protective antibody levels in many recipients. However, the antibody response to vaccine may be low in persons with advanced HIV-related illnesses; giving a second dose of vaccine 4 or more weeks after the first does not improve the immune response for these persons. Further studies are also required to determine whether influenza immunization can adversely affect patients infected with HIV. To date, some studies indicate that influenza immunization can be associated with transient increases in plasma HIV concentration, but no study has demonstrated an adverse effect of this temporary change on HIV disease progression. Pregnant women: Vaccination is recommended for pregnant women in high-risk groups (see above section). Vaccine is considered safe for pregnant women - regardless of their stage of pregnancy. Although excess morbidity and mortality were observed among pregnant women during the pandemic outbreaks in 1918-19 and 1957-58, further studies are needed to determine whether pregnancy per se is a risk factor that warrants routine influenza immunization. Pregnant women should be immunized in their third trimester if they are expected to deliver during influenza season, as they will become household contacts of their newborn (children < 6 months of age are at increased risk of complications from influenza). Breast-feeding mothers: Influenza immunization does not adversely affect the health of breast-feeding mothers or their infants. Breast-feeding is not a contraindication for influenza immunization. People at high risk of influenza complications embarking on foreign travel to destinations where influenza is likely to be circulating should be vaccinated with the most current available vaccine. In the tropics, influenza can occur throughout the year. In the southern hemisphere, peak activity occurs from April through September. In the northern hemisphere, peak activity occurs from November through March. Employers and their employees should consider yearly influenza immunization for healthy working adults as this has been shown to decrease work absenteeism because of respiratory and other illnesses. Concern has been raised regarding the possibility that a pandemic influenza strain may emerge through human-avian gene reassortment within workers directly involved in poultry culling operations, who may become simultaneously infected with a human influenza virus strain and an avian influenza virus strain. This is a theoretical concern, given that this gene reassortment has not been documented to date. FLUVIRAL® protects against human but not avian influenza strains. Immunization is recommended for those directly involved in the destruction (culling) of avian influenza-infected poultry before the culling operation. Direct involvement may be defined as sufficient contact with infected poultry to allow transmission of avian virus to the exposed person. The relevant individuals include those performing the cull as well as others (such as supervising veterinarians and inspectors) who may be directly exposed to the avian virus. Those persons who would be expected by reason of their employment to come into direct contact with infected poultry during culling operations in the event of potential avian influenza outbreaks should be immunized with trivalent influenza vaccine on a yearly basis prior to the human influenza season (CCDR, June 15, 2004). CONTRAINDICATIONS oKnown or suspected hypersensitivity to FLUVIRAL ® , to thimerosal, or to any other ingredient in the formulation or component of the container. For a complete listing, see the DOSAGE FORMS, COMPOSITION AND PACKAGING section. oVaccination is not recommended for subjects who develop anaphylactic type reactions when they eat eggs (urticaria (hives), oedema of the mouth and throat, difficulty in breathing, hypotension and shock). Allergic reactions are extremely rare and usually attributable to extreme sensitivity to certain components of the vaccine, probably to trace amounts of residual egg protein. Subjects whose allergy to eggs is not of the anaphylactic type, as well as those who are allergic to chicken and to feathers may be vaccinated. oSubjects with an acute respiratory infection or with any other active infection or serious febrile illness. On the other hand, a minor indisposition such as a mild infection of the upper respiratory tract is not necessarily a contraindication to vaccination. oImmunization should be delayed in a patient with an active neurologic disorder, but should be considered when the disease process has been stabilized. WARNINGS AND PRECAUTIONS. oSterile epinephrine hydrochloride solution 1:1000 should always be readily available in case an acute anaphylactic reaction should occur. General Increase of serum theophylline to toxic levels following the administration of influenza vaccine has been recorded in individuals who take oral theophylline as a maintenance therapy. Some doctors recommended a cessation of theophylline or a reduction in dose for 24 hours following vaccination. The administration of influenza vaccine may also delay the hepatic metabolism of other medications such as oral anticoagulants. False-positive HIV antibody tests were reported after immunization with the 1991/92 influenza vaccines. However, the incidence of false-positive tests declined with the development of different tests so that such false-positive HIV antibody tests are not likely to be a problem now. Immune It is possible that the protective immune response following influenza vaccination may not develop in subjects undergoing immunosuppressive therapy. Corticosteroid therapy can result in immunosupression although the exact dose and duration of therapy required to suppress the immune system is not well defined. Persons treated with high doses of systemic steroids, e.g., =2 mg/kg/day of prednisone orally for more than 2 weeks, or = 60 mg prednisone/day in an adult, should be considered to have a compromised immune system. Local Skin Reactions at Vaccination Sites Soreness and redness at the injection site may occur and may last for up to two days. Prophylactic acetaminophen may decrease the frequency of pain at the injection site. Respiratory Revaccination of individuals who have previously experienced oculo-respiratory symptoms is safe. Previously affected individuals should be encouraged to be revaccinated. The risk of recurrence of oculo-respiratory symptoms after revaccination is minimal compared to the serious threat posed by influenza. Please refer to most current NACI recommendations regarding revaccination of subjects who experienced more severe oculo-respiratory syndrome (see references). Special Populations Pregnant Women: The National Advisory Council on Immunization considers influenza vaccine safe in pregnancy. Pediatrics: In infants < 6 months of age, influenza vaccine is less immunogenic than in infants and children aged 6 to 18 months. Therefore, immunization with currently available influenza vaccine is not recommended for infants < 6 months. ADVERSE REACTIONS Adverse Drug Reaction Overview Subvirion, or split-virion, vaccines contain purified portions of the virus rather than the entire virus. Generally, these have been shown to be associated with fewer adverse effects in children and young adults, while maintaining immunogenicity similar to that of whole virus preparations. Because of their lower rates of side effects, only split virus preparations are recommended for children under 13 years of age. Immediate, allergic-type responses, such as hives, angioedema, allergic asthma, or systemic anaphylaxis occur extremely rarely. These reactions probably result from sensitivity to some vaccine component - most likely residual egg proteins (see CONTRAINDICATIONS). The most common FLUVIRAL® adverse drug reactions are soreness at the injection site, headache and muscle aches. Reactions are generally mild and of limited duration. Prophylactic acetaminophen may decrease the frequency of some side effects in adults. Clinical Trial Adverse Drug Reactions Because clinical trials are conducted under very specific conditions the adverse reaction rates observed in the clinical trials may not reflect the rates observed in practice and should not be compared to the rates in the clinical trials of another drug. Adverse drug reaction information from clinical trials is useful for identifying drug-related adverse events and for approximating rates. The data in the table below have been derived from three studies with three lots of ID Biomedical split-virion vaccine (A, B, C) compared to another subvirion vaccine (D) and to a whole virion vaccine (E) from ID Biomedical. Local and systemic reactions are reported after vaccination with a split-virion influenza vaccine. There were very few reports of fever as defined by temperature over 38°C. Soreness at the injection site was the most frequently reported symptom, and was generally rated as mild and resolved the day after vaccination. For systemic symptoms, headache and muscle aches were the most common. As with local symptoms, these were generally reported as mild and of limited duration. Prophylactic acetaminophen may decrease the frequency of some side effects in adults. Post-Market Adverse Drug Reactions In October 2000 the vaccine adverse event surveillance system in Canada received reports of individuals developing red eyes and respiratory symptoms occurring shortly after influenza vaccination. For surveillance purposes the public health authorities defined a new influenza vaccine associated syndrome, the so-called Oculo-Respiratory Syndrome (ORS), and increased surveillance for this was initiated by Health Canada. The symptoms associated with the ORS are red eyes, respiratory symptoms and facial oedema Most cases are mild in severity and resolve spontaneously regardless of the influenza vaccine administered. According to Health Canada's surveillance information, in the 2000-2001 immunization campaign, 260 cases of ocular and/or respiratory symptoms were reported for every million doses of FLUVIRAL® distributed, and only 88 cases (approx.0.009%) presenting both ocular and respiratory symptoms. Despite the enhanced surveillance and increased public awareness, the reported cases declined significantly during the following years. In the 2002- 2003 season the number of cases of ocular and respiratory symptoms decreased to 29 cases (approx. 0.003%) for every million doses of FLUVIRAL® distributed. ORS symptoms had been reported with other influenza vaccines in the US and Europe prior to the incident in Canada in 2000. The enhanced surveillance by Health Canada in 2000-2003, the observations from independent investigators and ID Biomedical investigations confirmed that ocular and respiratory symptoms could be associated with any influenza vaccines. Revaccination of subjects with history of ocular or respiratory symptoms is also considered to be safe regardless of the influenza vaccine used for the initial vaccination or the revaccination. There have been reports of other neurological illnesses, including facial paralysis, encephalitis, encephalopathy, demyelinating disease and labyrinthitis, associated with other influenza vaccines. Any relationship, other than temporal, to the vaccine has not been established. Unlike the 1976-77 swine influenza vaccine, subsequent vaccines prepared from other virus strains have not been clearly associated with an increased frequency of Guillain-Barrésyndrome. Influenza vaccine is not known to predispose to Reye's syndrome. Notification of reactions It is desirable that all unusual reactions, arising from any vaccination whatsoever, or following shortly thereafter, be reported to the manufacturer of the product and to the provincial epidemiologist. Drug Interactions Drug-Drug Interactions The metabolism of oral theophylline or oral anticoagulants may be affected by vaccination with FLUVIRAL® (see WARNINGS AND PRECAUTIONS). The target groups for influenza and pneumococcal vaccination overlap considerably. Health care providers should take the opportunity to vaccinate eligible persons against pneumococcal disease during the same visit at which influenza vaccine is given. The concurrent administration of the two vaccines at different sites does not increase the risk of side effects. Pneumococcal vaccine, however, is not administered annually, as in the case of influenza vaccine. Children at high risk may receive influenza vaccine at the same time but at a different site from that used for routine pediatric vaccines. DOSAGE AND ADMINISTRATION Recommended Dose and Dosage Adjustment Influenza vaccine dosage, by age group Age Group Dosage Route † 6 - 35 months 1 x 0.25 mL or 2 x 0.25 mL* IM 3 - 8 years 1 x 0.50 mL or 2 x 0.50 mL* IM 9 years and older 1 x 0.50 mL IM † The recommended site of vaccination is the deltoid muscle for adults and older children. The preferred site for infants and young children is the anterolateral aspect of the thigh. *Two doses administered at least one month apart are recommended for children younger than 9 years of age receiving influenza vaccine for the first time. Since the likelihood of febrile convulsions is greater in children aged 6 to 35 months, special care should be taken in weighing relative risks and benefits in this group. CAFV08/PI 8.11 approved Check the expiry date of the vaccine carefully. Any vaccine beyond its expiry date should not be used. Administration FLUVIRAL® vaccine must not be administered intravenously. Shake the multidose vial vigorously each time before withdrawing a dose of vaccine. Proper aseptic technique should be used for withdrawal of each dose from the multidose vial. Once entered, return the multidose vial to the recommended storage conditions, between 2°C and 8°C. Once entered, the multidose vial should be discarded after 28 days. A separate sterile syringe and needle or a sterile disposable unit should be used for each injection to prevent transmission of hepatitis B, HIV, or other infectious agents from one person to another. Disinfect the skin at the site of injection with a suitable antiseptic and wipe dry with sterile cotton wool. The injection of FLUVIRAL ® should be given intramuscularly, usually into the deltoid muscle. Do not inject influenza vaccine intravenously. All vaccinees should be observed for about 15 minutes after vaccination. If an anaphylactic reaction develops, sterile epinephrine hydrochloride (1:1000) should be administered. OVERDOSAGE In a study by Matzkin and Nili (1984), following administration of a dose of flu vaccine 10 times greater than the recommended dose of 0.5 mL, adverse events were not significantly different between study and control subjects. There have been reports of patients who received higher than recommended doses of FLUVIRAL®. The adverse events noted in these patients were similar to those reported from patients who had received the recommended dose. ACTION AND CLINICAL PHARMACOLOGY Mechanism of Action FLUVIRAL ® , split-virion inactivated influenza vaccine, promotes an active immunization against influenza strains A (H1N1 and H3N2) and B. Within seven days after injection of the vaccine there is an increase in circulating antibody to the viral haemagglutinin and peripheral blood lymphocytes are primed to respond to in vitro stimulation by vaccine antigens. As with other inactivated influenza vaccines, immunization is based on the humoral component of the specific immunological defense system, namely immunoglobulin G (IgG) antibodies against viral hemagglutinin (HA) and neuraminidase antigens. The effectiveness of inactivated influenza vaccines correlates with the age and immunocompetence of the vaccine recipient and the degree of similarity between the virus strains used in the preparation of the vaccines and those prevailing in the population. Cytotoxic T lymphocyte response occurs after administrations of either killed or live virus vaccines and is detectable in the absence of demonstrable antibody response. Pharmacodynamics/Pharmacokinetics No pharmacodynamics studies and no pharmacokinetics studies have been conducted with FLUVIRAL ® in accordance with its status as a vaccine. Duration of Effect Both humoral and cell-mediated responses are thought to play a role in immunity to influenza. Immunity declines over the year following vaccination. The production and persistence of antibody after vaccination depends on numerous factors, including age, prior and subsequent exposure to antigens, presence of immunodeficiency states, and polymorphisms in HLA class II molecules. Humoral antibody levels, which correlate with vaccine protection, are generally achieved by 2 weeks after immunization. It is postulated that immunity after administration of the inactivated vaccine lasts < 1 year. However, in the elderly, antibody levels may fall below protective levels within 4 months. Data are not available to support a recommendation for the administration of a second dose of influenza vaccine in elderly individuals in order to boost immunity. (CCDR, June 15, 2004) STORAGE AND STABILITY FLUVIRAL ® must be stored between 2°C and 8°C. Do not freeze. Freezing destroys activity. Do not use vaccine that has been frozen. Do not use vaccine after expiration date. Once entered, the multidose vial should be discarded after 28 days. SPECIAL HANDLING INSTRUCTIONS The vaccine should be well shaken prior to use (see DOSAGE AND ADMINISTRATION section). FLUVIRAL ® and materials used during vaccination should be disposed of in the same way as other drugs administered by injection. Since split-virion influenza vaccine is an inactivated vaccine, it presents no risk of contaminating the work area during manipulation. DOSAGE FORMS, COMPOSITION AND PACKAGING The composition of FLUVIRAL ® is established in agreement with the recommendations of the Canadian National Advisory Committee on Immunization (NACI) and the World Health Organization (WHO). For the 2005-2006 season, each dose of 0.5 mL of the split-virion influenza vaccine contains: 15 µg haemagglutinin of Strain A/New Caledonia/20/99 (H1N1), 15 µg haemagglutinin of Strain A/New York/55/2004 (H3N2), 15 µg haemagglutinin of Strain B/Jiangsu/10/2003. The vaccine also contains 0.01% thimerosal as a preservative, and trace residual amounts of egg proteins and sodium deoxycholate. Antibiotics are not used in the manufacture of this vaccine. FLUVIRAL ® is supplied in 5 mL vials holding 10 x 0.5 mL doses. Also available in 0.5 mL unidose syringes. REFERENCES 1. National Advisory Committee on Immunization (NACI): Statement on Influenza Vaccination for the 2005-2006 Season. Canada Communicable Disease Report, http://www.phac-aspc. gc.ca/publicat/ccdr-rmtc. To be published in 2005. ID Biomedical Corporation 2323, Parc Technologique Blvd. Quebec City, QC Canada G1P 4R8 Quote Link to comment Share on other sites More sharing options...
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