Paper provided by MHRA for Joint Committee on Vaccination and Immunisation October 2012:
|
|
- Neil Richard Mitchell
- 5 years ago
- Views:
Transcription
1 Paper provided by MHRA for Joint Committee on Vaccination and Immunisation October 2012: VACCINE-ASSOCIATED SUSPECTED ADVERSE REACTIONS REPORTED VIA THE YELLOW CARD SCHEME DURING 2011 September 2012
2 CONTENTS Page INTRODUCTION [1] 1. SECTION 1: YELLOW CARD DATA [2] 1.1. Routine Childhood Vaccines Menitorix (MenC/Hib combination) [2] Prevenar 13 (Pneumococcal conjugate vaccine) [4] Pediacel and Infanrix IPV HIB (DTaP/IPV/Hib) [6] MMR Vaccine [8] Meningitis C Vaccine [10] Repevax / Infanrix IPV (d/dtap/ipv) [12] Revaxis (dt/ipv) [14] Human Papillomavirus Vaccine [16] 1.2. Other Vaccines Hepatitis B Vaccine [18] Seasonal Influenza Vaccine [20] Pneumococcal polysaccharide vaccine [23] BCG Vaccine [25] Varivax and Varilrix (Varicella Zoster Virus) [27] 2. SECTION 2: KEY ISSUES CONSIDERED BY THE COMMISSION ON HUMAN MEDICINES (CHM) AND/OR ITS EXPERT ADVISORY GROUPS DURING 2011 AND TO DATE 2.1. Update on Pandemrix vaccine and Narcolepsy [29] 2.2. CSL/Enzira seasonal flu vaccine and febrile convulsions [30]
3 Introduction This paper was prepared by the Medicines and Healthcare products Regulatory Agency (MHRA) for the October 2012 Meeting of the Joint Committee of Vaccination and Immunisation (JCVI). Section 1 of this paper provides an update on UK suspected adverse reactions (ADRs) associated with routine and/or commonly used vaccines reported to the MHRA/CHM via the Yellow Card Scheme during the time period of 1st January 2011 to 31st December Section 2 provides an update on vaccine safety issues considered by the Commission on Human Medicines (CHM) and/or its Expert Advisory Groups during 2011 and to date. It should be noted that a report of a suspected ADR to the MHRA/CHM does not necessarily mean that it has been caused by the vaccine. Many factors have to be taken into account in assessing the relationship between a vaccine and suspected reaction such as the possible role of underlying or undiagnosed illness or infection. The data contained in this report may therefore include some known side effects as well as purely coincidental events. For this reason, these data must not be considered as a list of known vaccine side effects. The recognised side effects of all vaccines are described in the product information (Summary of Product Characteristics [SPC] and Patient Information Leaflet [PIL]). These are provided with the vaccine and are available for viewing on the electronic Medicines Compendium (emc) website [ Furthermore, due to variable levels of reporting and as the precise number of individuals immunised is not included in this report, the number of ADR reports received should not be used as a basis for estimating the incidence of ADRs or for comparing relative safety of vaccines. For some routine childhood vaccines, exposure estimates in this report are based on 2010/11 uptake data 1, extrapolated to the relevant UK birth cohort. Exposure for non-routine vaccines has not been estimated in this report. As the reporting rates are broad estimates, as they do not take into account exposure outside of the routine schedule and are not adjusted for age-specific exposure, no firm conclusions can be drawn on relative ADR reporting rates over time. Yellow Card reports may contain more than one serious ADR. Seriousness is determined by regulatory criteria based on the medical condition (MedDRA Dictionary serious) 2. Yellow Card data covers the whole of the UK. Prepared: August 2012 Vigilance and Risk Management of Medicines (VRMM) Medicines and Healthcare products Regulatory Agency MedDRA - the Medical Dictionary for Regulatory Activities - is a standardised, medically validated adverse event terminology system used within the international medicines regulatory environment. 1
4 1. YELLOW CARD DATA 1.1 Routine Childhood Vaccines Menitorix (MenC/Hib combination) Menitorix was introduced into the routine childhood schedule in September 2006 as a single dose MenC/Hib booster at around 12 months of age. Although this was a novel combination, prior to introduction there was extensive worldwide experience with the similar monocomponent Hib and MenC vaccines conjugated to tetanus toxoid (e.g. Hiberix and Neisvac-C vaccines). The total number of suspected ADRs reported in association with Menitorix over the last 3 years is shown below (table 1) exposure is based on the assumption of 92% uptake (one dose) for an annual birth cohort of 800, Table 1: Total number of Menitorix reports received (serious reports in brackets) Total number of reports 26 (9) 27 (13) 18 (13) Total number of reactions 67 (11) 74 (18) 40 (22) Total fatal Exposure 630, , ,000 ERR per 100,000 doses 4.1 (1.4) 3.9 (1.9) 2.4 (1.8) ERR = Estimated Reporting Rate Figure 1 shows the serious ADRs reported in each MedDRA System Organ Class (SOC), as a percentage of the total ADRs, for the last three years. Reporting rates have remained consistently very low. As only 13 reports contained a reaction classified as serious, relative percentage changes should be interpreted with caution. Five of the serious reports related to consequences of meningococcal infection (2 Meningococcal Infection, 1 Meningitis, 1 Meningococcal Sepsis ), which were probable vaccine failures. There was 1 fatal case reported in 2011, of vaccination failure and meningitis in a patient who received vaccination with MenC/Hib and Meningitis C vaccines. As with all vaccines, meningitis C vaccination may not be 100% successful and isolated cases of failure following primary vaccination are not unexpected. The remaining 8 reports were spread across 6 SOCs, and concerned isolated events which were most likely coincidental with vaccination. Conclusion: No significant new safety issues were identified during
5 Percentage of serious reports (%) Figure 1: Percentage of serious reactions per SOC associated with Menitorix vaccine Blood and lymphatic system disorders Cardiac disorders Congenital, familial and genetic disorders Ear and labyrinth disorders Endocrine disorders Eye disorders Gastrointestinal disorders Hepatobiliary disorders Immune system disorders Infections and infestations Injury, poisoning and procedural complications General Disorders and administration site conditions Investigations Metabolism and nutrition disorders Musculoskeletal and connective tissue disorders Neoplasms benign, malignant and unspecified (incl cysts and polyp) Nervous system disorders Pregnancy, puerperium and perinatal conditions Psychiatric disorders Renal and urinary disorders Reproductive system and breast disorders Respiratory, thoracic and mediastinal disorders Skin and subcutaneous tissue disorders Surgical and medical procedures Vascular disorders System Order Class (SOC) 3
6 Prevenar 13 (pneumococcal conjugate vaccine) Prevenar vaccine (PCV7) (which contained antigens against seven pneumococcal strains) was introduced into the routine childhood schedule in September In April 2010 Prevenar vaccine, was replaced by Prevenar 13 (PCV13), which contains antigens against 13 strains, to broaden protection against pneumococcal disease exposure is based on the assumption of 93% uptake for primary doses and 87% uptake for booster dose for an annual birth cohort of 800,000. Table 2: Total number of Prevenar reports (serious reports in brackets) Total number of reports 86 (27) 91(35) 181 (135) Total number of reactions 218 (39) 253(53) 504 (195) Total fatal Exposure 1,800,000 1,368,000 1,463,200 ERR per 100,000 doses 4.8 (1.5) 6.7 (2.6) 12.4 (9.2) ERR = Estimated Reporting Rate The increase in reports recorded in 2011 is driven by a batch of 95 vaccine failure reports received from one manufacturer. These reports originate from enhanced follow up of all cases of invasive pneumococcal disease (IPD) by the Health Protection Agency (HPA) over the 4-5 years since PCV7 was introduced, although these were identified and reported by the manufacturer during Such reports are routinely evaluated by the HPA to determine effectiveness of the vaccination programme. Removing these 95 reports from the 2011 data gives a total of 86 reports (40 serious) for 2011 and a ERR of 5.9 (2.7 serious) per 100,000 doses which is in line with the reporting rates for 2009 and Data presented to the JCVI Pneumococcal sub-committee meeting in May indicated that Prevenar 7 and Prevenar 13 are similar in effectiveness against the common 7 serotypes in the vaccines and that there has been a decline by around one half in IPD in children aged under 5 years of age due to the additional 6 serotypes found in Prevenar 13. The remaining 40 reports were spread across 13 SOCs, and concerned mainly isolated events which were either known rare side effects of primary immunisation or events coincidental with vaccination. There were 3 reports of pneumococcal infection with a fatal outcome, one of which was due to a non-vaccine serotype and two were reported as a vaccine failure. The two remaining reports with a fatal outcome were due to undiagnosed congenital heart failure and multiple congenital abnormalities and were not attributable to the vaccine. Figure 2 shows the serious ADRs reported in each SOC, as a percentage of the total ADRs, for the last three years. Conclusion: No significant new safety issues were identified during May-2012.pdf 4
7 Percentage of serious reports (%) Figure 2: Percentage of serious reactions per SOC associated with Prevenar vaccine Blood and lymphatic system disorders Cardiac disorders Congenital, familial and genetic disorders Ear and labyrinth disorders Endocrine disorders Eye disorders Gastrointestinal disorders Hepatobiliary disorders Immune system disorders Infections and infestations Injury, poisoning and procedural complications General Disorders and administration site conditions Pregnancy, puerperium and perinatal conditions Investigations Metabolism and nutrition disorders Musculoskeletal and connective tissue disorders Neoplasms benign, malignant and unspecified (incl cysts and polyp) Nervous system disorders Psychiatric disorders Renal and urinary disorders Reproductive system and breast disorders Respiratory, thoracic and mediastinal disorders Skin and subcutaneous tissue disorders Social Circumstances Surgical and medical procedures Vascular disorders System Order Class (SOC) 5
8 Pediacel and Infanrix IPV Hib (DTPa/IPV/Hib) Pediacel is the routine DTPa/IPV/Hib vaccine, administered at 2, 3 and 4 months of age. Infanrix IPV Hib (DTaP IPV Hib) vaccine was used from September 2007 to March 2009 as part of a Haemophilus influenzae type B (Hib) catch-up campaign as a preschool booster. This accounted for the increased number of reports in 2009 (note: exposure in 2009 was based only on DTPa/IPV/Hib vaccine as a 3 dose primary course since estimates on exposure to Infanrix IPV Hib were not available). No Infanrix IPV Hib cases have been received since The total number of suspected ADRs reported in association with DTPa/IPV/Hib for the last 3 years is shown below (table 3) exposure is based on the assumption of 95% uptake (3 doses) for an annual birth cohort of 800,000. Table 3: Total number of DTaP/IPV/Hib vaccine reports and doses distributed (serious reports in brackets) Total number of reports 122 (40) 64 (29) 82 (44) Total number of reactions 314 (66) 187 (46) 261 (78) Total fatal Exposure (doses) 1,950,000 2,166,000 2,280,000 ERR per 100,000 doses 6.3 (2.1) 2.9 (1.3) 3.6 (1.9) ERR = Estimated Reporting Rate Figure 3 shows the serious ADRs reported in each SOC, as a percentage of the total ADRs, for the last three years. Reporting rates have remained consistently very low. The 44 serious reports were spread over 13 SOCs. As in previous years, most related to Nervous System Disorders and include the known rare side effects of fits, hypotonichyporesponsive episodes and syncope, all of which recovered. The remaining serious reports concerned a wide range of isolated events which were either known rare side effects or likely coincidental with vaccination. Conclusion: No significant new safety issues were identified during
9 Percentage of serious reports (%) Figure 3: Percentage of serious reactions per SOC associated with DTPa/IPV/Hib vaccine Blood and lymphatic system disorders Cardiac disorders Congenital, familial and genetic disorders Ear and labyrinth disorders Endocrine disorders Eye disorders Gastrointestinal disorders Hepatobiliary disorders Immune system disorders Infections and infestations Injury, poisoning and procedural complications General Disorders and administration site conditions Pregnancy, puerperium and perinatal conditions Investigations Metabolism and nutrition disorders Musculoskeletal and connective tissue disorders Neoplasms benign, malignant and unspecified (incl cysts and polyp) Nervous system disorders Psychiatric disorders Renal and urinary disorders Reproductive system and breast disorders Respiratory, thoracic and mediastinal disorders Skin and subcutaneous tissue disorders Surgical and medical procedures Vascular disorders System Order Class (SOC) 7
10 MMR vaccine The first routine childhood dose of MMR vaccine is administered at months of age, with a second dose from 3 years 4 months. The total number of suspected ADRs reported in association with MMR vaccination for the last 3 years is shown below (table 4) exposure is based on the assumption of 89% uptake for dose 1 and 83% for dose 2 for an annual birth cohort of 800,000. Note: the exposure estimates are based on only routine childhood use and do no estimate usage in older age groups, or use in catch-up campaigns. Exposure is therefore an underestimate. Table 4: Total number of MMR vaccine reports and doses distributed (serious reports in brackets) Total number of reports 145 (72) 125 (65) 144 (86) Total number of reactions 431 (113) 406 (123) 412 (147) Total fatal Exposure 1,204,000 1,307,200 1,408,800 ERR per 100,000 doses 12.0 (6.0) 9.6 (5.0) 10.2 (6.1) ERR = Estimated Reporting Rate Figure 4 shows the serious ADRs reported in each SOC, as a percentage of the total ADRs, for the last three years. Reporting rates have remained consistently very low. The 86 serious reports were spread over 22 SOCs. The increase in Pregnancy, puerperium and perinatal conditions and Congenital conditions is accounted for by reports received via the HPA Vaccines in Pregnancy registry. There is no evidence of risks to pregnancy or the foetus following inadvertent use in pregnancy, and such reports are likely coincidental events. The remaining serious reports concerned a wide range of isolated events which were either known rare side effects or likely coincidental with vaccination. The majority of Nervous System Disorders related to loss of consciousness and syncope (4 Hypotonia, 3 Syncope and 1 Loss of Consciousness ).The majority of these cases were a consequence of fainting after the injection. 6 cases relating to convulsions were also reported in Syncope and convulsions are listed for the MMR vaccines. Conclusion: No significant new safety issues were identified during
11 Percentage of serious reports (%) Figure 4: Percentage of serious reactions per SOC associated with MMR vaccine Blood and lymphatic system disorders Cardiac disorders Congenital, familial and genetic disorders Ear and labyrinth disorders Endocrine disorders Eye disorders Gastrointestinal disorders Hepatobiliary disorders Immune system disorders Infections and infestations Injury, poisoning and procedural complications General Disorders and administration site conditions Pregnancy, puerperium and perinatal conditions Investigations Metabolism and nutrition disorders Musculoskeletal and connective tissue disorders Neoplasms benign, malignant and unspecified (incl cysts and polyp) Nervous system disorders Psychiatric disorders Renal and urinary disorders Reproductive system and breast disorders Respiratory, thoracic and mediastinal disorders Skin and subcutaneous tissue disorders Social Circumstances Surgical and medical procedures Vascular disorders System Order Class (SOC) 9
12 Meningitis C vaccine Meningococcal group C conjugate vaccine is recommended for use at 3 and 4 months of age as a primary course (2 dose schedule) (with a MenC/Hib booster at months). The total number of suspected ADRs reported in association with Meningococcal group C conjugate vaccine for the last 3 years is shown below (table 5) exposure is based on the assumption of 93.4% uptake (2 doses) for an annual birth cohort of 800,000. Table 5: Total number of Meningitis C vaccine reports and doses distributed (serious reports in brackets) Total number of reports 44 (13) 49 (24) 59 (34) Total number of reactions 93 (21) 133 (46) 204 (70) Total fatal Exposure (doses) 1,290,000 1,413,600 1,494,400 ERR per 100,000 doses 3.4 (1.0) 3.5 (1.7) 3.9 (2.3) ERR = Estimated Reporting Rate Figure 5 shows the serious ADRs reported in each SOC, as a percentage of the total ADRs, for the last 3 years. Reporting rates have remained consistently very low. The 34 serious reports were spread over 12 SOCs and concerned a wide range of isolated events which were either known rare side effects or likely coincidental with vaccination. There was one fatal case associated with Meningitis C vaccine in 2011, of Meningitis in a patient who received Menjugate and Neisvac-C vaccines. This is the same case as discussed in the Men C/Hib section of this paper (page 2). Conclusion: No significant new safety issues were identified during
13 Percentage of serious reports (%) Figure 5: Percentage of serious reactions per SOC associated with Meningitis C vaccine Blood and lymphatic system disorders Cardiac disorders Congenital, familial and genetic disorders Ear and labyrinth disorders Endocrine disorders Eye disorders Gastrointestinal disorders Hepatobiliary disorders Immune system disorders Infections and infestations Injury, poisoning and procedural complications General Disorders and administration site conditions Pregnancy, puerperium and perinatal conditions Investigations Metabolism and nutrition disorders Musculoskeletal and connective tissue disorders Neoplasms benign, malignant and unspecified (incl cysts and polyp) Nervous system disorders Psychiatric disorders Renal and urinary disorders Reproductive system and breast disorders Respiratory, thoracic and mediastinal disorders Skin and subcutaneous tissue disorders Surgical and medical procedures Vascular disorders System Order Class (SOC) 11
14 Repevax (dtap/ipv)/infanrix IPV (DTaP/IPV) Infanrix IPV or Repevax is recommended as a routine pre-school booster vaccine. The exposure rate for Repevax and Infanrix IPV were not calculated for 2009 as these vaccines were not routinely used due to use of DTaP/IPV/Hib as pre-school booster during the Hib catch-up campaign. Reversion back to Infanrix IPV Hib/Repevax explains the increase in reports received in The number of reports received and the estimated reporting rate have both decreased for exposure is based on the assumption of 85% uptake (1 dose) for an annual birth cohort of 800,000. Table 6: Total number of reports and doses distributed (serious reports in brackets) Total number of reports 30 (5) 68 (18) 43 (17) Total number of reactions 69 (10) 185 (32) 136 (30) Total fatal Exposure n/a 612, ,200 ERR per 100,000 doses n/a 11.1 (2.9) 6.3 (2.5) ERR = Estimated Reporting Rate Figure 6 shows the serious ADRs reported in each SOC, as a percentage of the total ADRs, for the last 3 years. As only 17 reports contained a reaction classified as serious, relative percentage changes should be interpreted with caution. The serious reports were spread over 9 SOCs and concerned a wide range of isolated events which were either known rare side effects or likely coincidental with vaccination. Reports of infections were mainly injection site reactions and nervous system disorders were mostly the consequences of fainting. Conclusion: No significant new safety issues have been identified during
15 Percentage of serious reports (%) Figure 6: Percentage of serious reactions per SOC associated with d/dtap/ipv vaccine Blood and lymphatic system disorders Cardiac disorders Congenital, familial and genetic disorders Ear and labyrinth disorders Endocrine disorders Eye disorders Gastrointestinal disorders Hepatobiliary disorders Immune system disorders Infections and infestations Injury, poisoning and procedural complications General Disorders and administration site conditions Pregnancy, puerperium and perinatal conditions Investigations Metabolism and nutrition disorders Musculoskeletal and connective tissue disorders Neoplasms benign, malignant and unspecified (incl cysts and polyp) Nervous system disorders Psychiatric disorders Renal and urinary disorders Reproductive system and breast disorders Respiratory, thoracic and mediastinal disorders Skin and subcutaneous tissue disorders Social Circumstances Surgical and medical procedures Vascular disorders System Order Class (SOC) 13
16 Revaxis (dt/ipv) Revaxis is a booster vaccine given to young people aged between 13 and 18, as well as being used for adult boosters. The total number of suspected ADRs reported in association with dt/ipv vaccine for the last 3 years is shown below (table 7). An estimate of exposure is not given in this paper due to likely widespread use in a wide range of age groups outside of the routine childhood programme. Table 7: Total number of Revaxis reports and doses distributed (serious reports in brackets) Total number of reports 103 (60) 92 (43) 98 (39) Total number of reactions 399 (120) 279 (70) 277 (55) Total fatal Exposure (doses) n/a n/a n/a ERR per 100,000 doses n/a n/a n/a ERR = Estimated Reporting Rate n/a: Data not available at the time of writing this report. The serious reports were spread over 22 SOCs and concerned a wide range of isolated events which were either known rare side effects or likely coincidental with vaccination. The majority of nervous system disorders related to the signs and symptoms of fainting and possibly other anxiety-related events. Conclusion: No significant new safety issues have been identified during
17 Percentage of serious reports (%) Figure 7: Percentage of serious reactions per SOC associated with Revaxis vaccine Blood and lymphatic system disorders Cardiac disorders Congenital, familial and genetic disorders Ear and labyrinth disorders Endocrine disorders Eye disorders Gastrointestinal disorders Hepatobiliary disorders Immune system disorders Infections and infestations Injury, poisoning and procedural complications General Disorders and administration site conditions Pregnancy, puerperium and perinatal conditions Investigations Metabolism and nutrition disorders Musculoskeletal and connective tissue disorders Neoplasms benign, malignant and unspecified (incl cysts and polyp) Nervous system disorders Psychiatric disorders Renal and urinary disorders Reproductive system and breast disorders Respiratory, thoracic and mediastinal disorders Skin and subcutaneous tissue disorders Social Circumstances Surgical and medical procedures Vascular disorders System Order Class (SOC) 15
18 Human Papillomavirus vaccines (Cervarix and Gardasil ) A routine immunisation programme for human papillomavirus (HPV) was started across the UK in September 2008 for 12 to 13 year-old girls. This also included a catchup campaign for older teenagers. The vaccine of choice in the UK was Cervarix, which protects against infection with HPV types 16 and 18. On introduction of the vaccine, the MHRA put in place a proactive pharmacovigilance strategy to monitor the safety of Cervarix vaccine as it was used in the UK. After use of more than 4.5 million doses of Cervarix in the UK alone, the Commission on Human Medicines advised that no serious new risks have been identified in association with Cervarix and the balance of risks and benefits of the vaccine remains positive. Further information regarding HPV vaccine, including MHRA s public safety assessment report on the first two years of the HPV immunisation programme, can be found on the MHRA website at From September 2012 Gardasil, with HPV types 6,11, 16 and 18, will replace Cervarix within the national immunisation programme. A safety review of the UK experience with Cervarix was considered by the CHM and its Expert Advisory Groups (EAGs) in August/September Overall no new safety issues were identified and the CHM endorsed the conclusions of the report that the benefit risk balance of Cervarix remains positive. The MHRA website will be updated with the new data within the coming months. The total number of suspected ADRs reported in association with human papillomavirus vaccine for the last 3 years is shown below (table 8). Table 8: Total number of Human Papillomavirus vaccine reports (serious reports in brackets) Total number of reports 1934 (610) 1802 (397) 1081 (249) Total number of reactions 4774 (820) 3800 (560) 2439 (391) Total fatal One suspected ADR with a fatal outcome was reported in 2011, for Gardasil. This was a case of acute T-cell lymphoblastic leukaemia. A causal association with vaccination has not been established and this was likely coincidental. In September 2012 the CHM and its EAGs considered a safety review of the HPV vaccine Cervarix. The Commission endorsed the conclusions of the report that the benefit/risk balance of Cervarix remains positive and that no new safety signals were identified (see section 3). Conclusion: No significant new safety issues have been identified during
19 Percentage of serious reports (%) Figure 9: Percentage of serious reactions per SOC associated with Human Papillomavirus vaccine Blood and lymphatic system disorders Cardiac disorders Congenital, familial and genetic disorders Ear and labyrinth disorders Endocrine disorders Eye disorders Gastrointestinal disorders Hepatobiliary disorders Immune system disorders Infections and infestations Injury, poisoning and procedural complications General Disorders and administration site conditions Pregnancy, puerperium and perinatal conditions Investigations Metabolism and nutrition disorders Musculoskeletal and connective tissue disorders Neoplasms benign, malignant and unspecified (incl cysts and polyp) Nervous system disorders Psychiatric disorders Renal and urinary disorders Reproductive system and breast disorders Respiratory, thoracic and mediastinal disorders Skin and subcutaneous tissue disorders Social Circumstances Surgical and medical procedures Vascular disorders System Order Class (SOC) 17
20 1.2 Other vaccines Hepatitis B vaccine Hepatitis B vaccine is recommended in populations deemed to be at risk of contracting the disease. The total number of suspected ADRs reported in association with single hepatitis B vaccine for the last 3 years is shown below (table 9). Table 9: Total number of Hepatitis B vaccine reports and doses distributed (serious reports in brackets) Total number of reports 104 (62) 77 (41) 121 (49) Total number of reactions 385 (118) 181 (61) 408 (100) Total fatal Exposure (doses) n/a n/a n/a ERR per 100,000 doses n/a n/a n/a ERR = Estimated Reporting Rate n/a: Data not available at the time of writing this report. Estimated exposure data for the vaccine were not available at the time of writing this report and as such, ERRs have not been calculated. The serious reports were spread over 24 SOCs and concerned a wide range of isolated events which were either known rare side effects or likely coincidental with vaccination. Conclusion: No significant new safety issues have been identified during
21 Percentage of serious reports (%) Figure 10: Percentage of serious reactions per SOC associated with Hepatitis B vaccine Blood and lymphatic system disorders Cardiac disorders Congenital, familial and genetic disorders Ear and labyrinth disorders Endocrine disorders Eye disorders Gastrointestinal disorders Hepatobiliary disorders Immune system disorders Infections and infestations Injury, poisoning and procedural complications General Disorders and administration site conditions Pregnancy, puerperium and perinatal conditions Investigations Metabolism and nutrition disorders Musculoskeletal and connective tissue disorders Neoplasms benign, malignant and unspecified (incl cysts and polyp) Nervous system disorders Psychiatric disorders Renal and urinary disorders Reproductive system and breast disorders Respiratory, thoracic and mediastinal disorders Skin and subcutaneous tissue disorders Social Circumstances Surgical and medical procedures Vascular disorders System Order Class (SOC) 19
22 Seasonal Influenza Vaccine Influenza vaccine is offered to at-risk populations in the community on a yearly basis, including the elderly and those at increased risk of complications of influenza infection 5. The total number of suspected ADRs reported in association with seasonal influenza vaccine for the last 3 years is shown below (table 10). In line with the other data in this report, this relates to calendar years (rather than influenza seasons). As in previous years, exposure has been estimated simply at an upper level of 14m doses. Reporting rates have remained consistently very low. Table 10: Total number of Influenza reports and doses distributed (serious reports in brackets) Total number of reports 214 (119) 331 (189) 458 (252) Total number of reactions 709 (205) 1108 (311) 1506 (398) Total fatal Exposure 14,000,000 14,000,000 14,000,000 ERR per 100,000 doses 1.5 (0.9) 2.4 (1.4) 3.3 (1.8) ERR = Estimated Reporting Rate Figure 11 shows the serious ADRs reported in each SOC, as a percentage of the total ADRs, for the last three years. The distribution of adverse reactions has stayed relatively constant over the last three years, with the majority of serious reactions occurred within the Musculoskeletal and Connective Tissue Disorders SOC and the Nervous System Disorders SOC. There were ten suspected ADRs with a fatal outcome in There were three cases of Death, two cases of Stillbirth, and single cases of Bronchopneumonia, Respiratory failure, Completed suicide, Ovarian cancer and Guillain-Barre Syndrome. A causal association with the influenza vaccines has not been established for any of these cases the vaccine is largely given to those at high background risk of morbidity regardless of vaccination, and coincidental medical events are to be expected. In October 2011 Baxter s influenza vaccine Preflucel was recalled due to an increased risk of hypersensitivity, flu-like symptoms and ocular reactions. This vaccine, manufactured using cells rather than eggs, was the preferred vaccine in those with confirmed anaphylaxis to eggs. The root cause has been identified and corrective actions will be implemented before the vaccine is reintroduced e99 20
23 Please refer to section 2.2 for information regarding CSL influenza vaccines and an association with febrile convulsions, and information regarding Pandemrix vaccine and an association with narcolepsy. Conclusion: Other than the issues relating to CSL and Baxter vaccine outlined below, no significant new safety issues have been identified during
24 Percentage of serious reports (%) Figure 11: Percentage of serious reactions per SOC associated with Influenza vaccine Blood and lymphatic system disorders Cardiac disorders Congenital, familial and genetic disorders Ear and labyrinth disorders Endocrine disorders Eye disorders Gastrointestinal disorders Hepatobiliary disorders Immune system disorders Infections and infestations Injury, poisoning and procedural complications General Disorders and administration site conditions Pregnancy, puerperium and perinatal conditions Investigations Metabolism and nutrition disorders Musculoskeletal and connective tissue disorders Neoplasms benign, malignant and unspecified (incl cysts and polyps) Nervous system disorders Psychiatric disorders Renal and urinary disorders Reproductive system and breast disorders Respiratory, thoracic and mediastinal disorders Skin and subcutaneous tissue disorders Social Circumstances Surgical and medical procedures Vascular disorders System Order Class (SOC) 22
25 Pneumococcal polysaccharide vaccine (PPV) The total number of suspected ADRs reported in association with pneumococcal polysaccharide vaccine for the last 3 years is shown below (table 11). Table 11: Total number of Pneumococcal polysaccharide vaccine reports and doses distributed (serious reports in brackets) Total number of reports 43 (13) 67 (34) 61 (26) Total number of reactions 120 (17) 199 (51) 234 (38) Total fatal Exposure n/a n/a n/a ERR per 100,000 doses n/a n/a n/a ERR = Estimated Reporting Rate n/a: Data not available at the time of writing this report. The distribution data for the vaccine during 2011 were not available at the time of writing this report and as such, ERRs have not been calculated. Figure 12 shows the serious ADRs reported in each SOC, as a percentage of the total ADRs, for the last three years. The majority of serious reactions occurred within the Musculoskeletal and Connective Tissue Disorders SOC. The most reported serious reaction in this SOC is Myalgia (5 cases), which is a recognised reaction to PPV vaccination. The SPC with the second highest proportion of serious reactions was the Infections and Infestations SOC, mainly due to known injection-site reactions. There was one fatal report associated with pneumococcal polysaccharide vaccine in 2011, of Lung Adenocarcinoma Stage IV, reported from the literature 7. A causal association with the PPV or Meningitis C vaccine has not been established and this was likely coincidental. Conclusion: No significant new safety issues have been identified during Angelos Kyriacou, Nolan Arulraj, Haren Varia. Acute abdomen due to spontaneous splenic rupture as the first presentation of lung malignancy: a case report. Journal of Medical Case Reports 23
26 Percentage of serious reports (%) Figure 12: Percentage of serious reactions per SOC associated with Pneumococcal Polysaccharide vaccine Blood and lymphatic system disorders Cardiac disorders Congenital, familial and genetic disorders Ear and labyrinth disorders Endocrine disorders Eye disorders Gastrointestinal disorders Hepatobiliary disorders Immune system disorders Infections and infestations Injury, poisoning and procedural complications General Disorders and administration site conditions Pregnancy, puerperium and perinatal conditions Investigations Metabolism and nutrition disorders Musculoskeletal and connective tissue disorders Neoplasms benign, malignant and unspecified (incl cysts and polyp) Nervous system disorders Psychiatric disorders Renal and urinary disorders Reproductive system and breast disorders Respiratory, thoracic and mediastinal disorders Skin and subcutaneous tissue disorders Social Circumstances Surgical and medical procedures Vascular disorders System Order Class (SOC) 24
27 BCG vaccine The aim of the UK BCG immunisation programme is to immunise those at increased risk of developing severe disease and/or of exposure to TB infection The total number of suspected ADRs reported in association with BCG vaccine for the last 3 years is shown below (table 12). Exposure figures are based on data from England 8. Table 12: Total number of BCG reports and doses distributed (serious reports in brackets) Total number of reports 23 (12) 40 (24) 36 (17) Total number of reactions 42 (19) 76 (25) 72 (26) Total fatal Exposure (doses) 239, , ,316 ERR per 100,000 doses 10.5 (5.8) 17.9 (10.7) 16 (7.6) ERR = Estimated Reporting Rate n/a: Data not available at the time of writing this report. Figure 13 shows the serious ADRs reported in each SOC, as a percentage of the total ADRs, for the last three years. The majority of serious reactions related to known possible side effects of lymphadenitis and disseminated BCG infection. Conclusion: No significant new safety issues have been identified during
28 Percentage of serious reports (%) Figure 13: Percentage of serious reactions per SOC associated with BCG vaccine Blood and lymphatic system disorders Cardiac disorders Congenital, familial and genetic disorders Ear and labyrinth disorders Endocrine disorders Eye disorders Gastrointestinal disorders Hepatobiliary disorders Immune system disorders Infections and infestations Injury, poisoning and procedural complications General Disorders and administration site conditions Pregnancy, puerperium and perinatal conditions Investigations Metabolism and nutrition disorders Musculoskeletal and connective tissue disorders Neoplasms benign, malignant and unspecified (incl cysts and polyp) Nervous system disorders Psychiatric disorders Renal and urinary disorders Reproductive system and breast disorders Respiratory, thoracic and mediastinal disorders Skin and subcutaneous tissue disorders Surgical and medical procedures Vascular disorders System Order Class (SOC) 26
29 Varivax, Varilrix and Zostavax (Varicella Zoster virus) vaccines Since 2003, the UK recommendation includes vaccinating non-immune healthcare workers who themselves will derive benefit as they will be protected from contact with infectious patients. Varicella vaccine is also recommended for healthy susceptible close household contacts of immunocompromised patients. Zostavax is indicated for prevention of shingles and post-herpetic neuralgia in those aged over 50 years. Table 13: Total number of Varicella Zoster vaccine reports (serious reports in brackets) Total number of reports 13 (6) 12 (8) 5 (3) Total number of reactions 38 (10) 33 (13) 17 (6) Total fatal Exposure n/a n/a n/a ERR per 100,000 doses n/a n/a n/a ERR = Estimated Reporting Rate n/a: Data not available at the time of writing this report. The usage data for the vaccines was not available at the time of writing this report and as such, ERRs have not been calculated. As can be seen, very few ADR reports have been submitted for varicella vaccines. The few serious reactions related to possible vaccine failure. In relation to vaccine failures, the Summaries of Product Characteristics (SPCs) for Varivax and Varilrix were updated in 2008 to include a two-dose schedule in order to provide longer-term protection. Conclusion: No significant new safety issues have been identified during
30 Percentage of serious reports (%) Figure 14: Percentage of serious reactions per SOC associated with Varicella Zoster vaccine Blood and lymphatic system disorders Cardiac disorders Congenital, familial and genetic disorders Ear and labyrinth disorders Endocrine disorders Eye disorders Gastrointestinal disorders Hepatobiliary disorders Immune system disorders Infections and infestations Injury, poisoning and procedural complications General Disorders and administration site conditions Pregnancy, puerperium and perinatal conditions Investigations Metabolism and nutrition disorders Musculoskeletal and connective tissue disorders Neoplasms benign, malignant and unspecified (incl cysts and polyp) Nervous system disorders Psychiatric disorders Renal and urinary disorders Reproductive system and breast disorders Respiratory, thoracic and mediastinal disorders Skin and subcutaneous tissue disorders Surgical and medical procedures Vascular disorders System Order Class (SOC) 28
31 2. SECTION 2: ISSUES CONSIDERED BY THE COMMISSION ON HUMAN MEDICINES (CHM) AND/OR ITS EXPERT ADVISORY GROUPS DURING 2011 AND TO DATE 2.1 Pandemrix and Narcolepsy In August 2010, several reports of narcolepsy in Sweden and Finland following use of Pandemrix swine flu vaccine came to light. At the time, there had been no reports of narcolepsy in the UK or other countries following the vaccine. This safety signal prompted an EU wide safety review. As EU Rapporteur for Pandemrix, the MHRA led on the safety review. This regulatory review concluded in July 2011, with a recommendation that Pandemrix vaccine may only be used in persons aged under 20 years if seasonal trivalent vaccine is not available and if there is a particular need to immunise against H1N1. No restrictions on use in adults were imposed, and the overall balance of risks and benefits remains favourable. Underpinning the risk assessment were three epidemiological studies carried out in Sweden and Finland, where most reports of narcolepsy following the vaccine have occurred. Pandemrix was the only vaccine used in these countries. The studies suggested a six to thirteen-fold increased risk of narcolepsy amongst vaccinated children, with a vaccine-attributable risk of three to seven extra cases of narcolepsy per 100,000 doses. No increased risk in those aged above 19 years has been identified. Throughout the EU review, questions have been raised around whether changes in diagnostic practice, bias or confounding may have explained the results. However, the review concluded that any such factors could not fully account for the observed level of risk. It was also concluded that this association was likely due to some sort of temporal/geographic interaction between vaccine and environmental factors during the peak of the pandemic. Any such co-factors remain unknown, but it is speculated that concurrent respiratory infections, including H1N1 itself, may have played a role. Genetic predisposition may also have been an influence. These factors remain unknown, and further studies are ongoing to explore this. Since July 2011, further epidemiological data have emerged from other EU countries. Data released in Ireland in April 2012 were broadly in line with data from Sweden and Finland. New data from France also support this. The new French study was also the first to suggest a possible, albeit smaller, risk in adults. It remains unclear if these adult data are robust, or if this can be extrapolated to age groups above 21 years. We are in the process of clarifying these uncertainties in the adult data. Another study (VAESCO) pooling data from 8 EU countries did not find a statistically significant increased risk in adults in any country other than France. The VAESCO study found an increased risk in children and adolescents only in Sweden and Finland, however, this study had several limitations. This safety signal is so far not apparent for other types of influenza vaccine, and the safety review is specific to Pandemrix vaccine. Vaccines used outside of Europe, including a similar GSK vaccine used in Canada and unadjuvanted vaccines used elsewhere have so far not been associated with this signal. 29
32 The annual seasonal, trivalent flu vaccines have not been associated with the development of narcolepsy, and there are no new safety concerns associated with these vaccines. More information on the EU review of narcolepsy can be found at ews_detail_ jsp&murl=menus/news_and_events/news_and_events.jsp&mid=w C0b01ac058004d5c CSL/Enzira seasonal flu vaccine and febrile convulsions In Australia in April 2010, an excess risk of febrile convulsions was found to be associated with a brand of flu vaccine called Fluvax, manufactured by CSL. A similar CSL vaccine was on the UK market branded as Enzira or as CSL Biotherapies generic influenza vaccine in the 2010/11 influenza vaccine campaign. Therefore, prior to use in the UK during 2010/11, the licence for Enzira/CSL Biotherapies generic influenza vaccine was restricted for use only in those aged 5 years and over. Although there was no suggestion that other influenza vaccines supplied in the UK may be associated with a similar risk, as a precaution the MHRA implemented enhanced passive surveillance to closely monitor the safety of all influenza vaccines used in the UK during the 2010/11 campaign. This analysis found no indication of an excess risk of febrile convulsions in children following use of other (non-csl/pfizer) seasonal flu vaccines in the UK. For further information regarding this issue please refer to the MHRA s Public Assessment Report on seasonal flu vaccines and febrile seizures, available at ningsandmessagesformedicines/con Cervarix HPV vaccine end of routine programme safety review In September 2012 the CHM and its EAGs considered a safety review of the HPV vaccine Cervarix since it was first routinely used in the national immunisation programme in September 2008 for the prevention of premalignant cervical lesions and cervical cancer in adolescent girls. From September 2012 Cervarix will be replaced by Gardasil which covers four HPV strains. Over 6 million doses of Cervarix have been administered in the UK with uptake figures among the highest in the world. With over 6213 adverse reaction (ADR) reports for Cervarix and for reports where the HPV brand was not specified, this gave a reporting rate of approximately 1 report per 1,000 doses administered which was not considered unexpected for a vaccine that was so widely used within a novel immunisation programme. 30
33 The safety of Cervarix has been subject to an enhanced pharmacovigilance strategy and the success of the strategy was recognised by the CHM. The CHM endorsed the conclusions of the report that the benefit/risk balance of Cervarix remains positive and that no other new signals were identified that warranted regulatory action. As with all vaccines, the safety of Cervarix and Gardasil will remain under constant monitoring by the MHRA. 31
Paper provided by MHRA for Joint Committee on Vaccination and Immunisation October 2013:
Paper provided by MHRA for Joint Committee on Vaccination and Immunisation October 2013: VACCINE-ASSOCIATED SUSPECTED ADVERSE REACTIONS REPORTED VIA THE YELLOW CARD SCHEME DURING 2012/13 September 2013
More informationGuidelines for the immunisation of children following treatment with Standard-Dose Chemotherapy
Guidelines for the immunisation of children following treatment with Standard-Dose Chemotherapy Version 2.0 Approved by Haem / Onc Senior Clinical Management team Date Approved March 2015 Ratified by:
More informationChildhood Immunisations Template Guide 2016
Childhood Immunisations Template Guide 2016 1 Template Control Page Childhood Immunisations Template Guide Title Childhood Immunisations Author CEG Version 9 Description Supports the schedule of Childhood
More informationChildhood Immunisations Template Guide 2017
Childhood Immunisations Template Guide 2017 1 Template Control Page Childhood Immunisations Template Guide Title Childhood Immunisations Author CEG Description Supports the schedule of Childhood Immunisations
More informationUNSCHEDULED VACCINATION OF CHILDREN AND YOUNG PEOPLE WHO HAVE OUTSTANDING ROUTINE IMMUNISATIONS. Service Specification
UNSCHEDULED VACCINATION OF CHILDREN AND YOUNG PEOPLE WHO HAVE OUTSTANDING ROUTINE IMMUNISATIONS Service Specification National Enhanced Service Specification For The Unscheduled Vaccination Of Children
More informationCVU: What s new? 2 nd December 2013
CVU: What s new? 2 nd December 2013 Dr Margie Danchin Paediatrician, Department of General Medicine, RCH Senior Research Fellow, MCRI Senior Fellow, Department of Paediatrics, The University of Melbourne
More informationNational Immunisation News
National Immunisation News The newsletter of the HSE National Immunisation Office July 2016 Changes to the Primary Childhood Immunisation Programme The National Immunisation Advisory Committee (NIAC) has
More informationabcdefghijklm abcde abc a `ÜáÉÑ=jÉÇáÅ~ä=lÑÑáÅÉê=aáêÉÅíçê~íÉ= HAEMOPHILUS INFLUENZAE TYPE B (HIB) VACCINE FOR YOUNG CHILDREN CATCH-UP PROGRAMME
abcdefghijklm `ÜáÉÑ=jÉÇáÅ~ä=lÑÑáÅÉê=aáêÉÅíçê~íÉ= HAEMOPHILUS INFLUENZAE TYPE B (HIB) VACCINE FOR YOUNG CHILDREN CATCH-UP PROGRAMME This letter explains a Haemophilus influenzae type b (Hib) vaccination
More informationWhat are the new active vaccine recommendations in the Canadian Immunization Guide?
154 CCDR 17 April 2014 Volume 40-8 https://doi.org/10.14745/ccdr.v40i08a03 1 What are the new active vaccine recommendations in the Canadian Immunization Guide? Warshawsky B 1 and Gemmill I 2 on behalf
More informationGuidelines for immunisation of children following treatment with high dose chemotherapy and Haematopoietic Stem Cell Transplantation (HSCT)
Guidelines for immunisation of children following treatment with high dose chemotherapy and Haematopoietic Stem Cell Transplantation (HSCT) Version 2.0 Approved by Haem / Onc Senior Clinical Management
More informationThe National Immunisation Schedule Update and Current issues. Dr Brenda Corcoran National Immunisation Office.
The National Immunisation Schedule Update and Current issues Dr Brenda Corcoran National Immunisation Office www.immunisation.ie Objectives To outline immunisation schedules in Ireland Primary childhood
More informationThe National Immunisation Schedule Update and Current issues. Dr Brenda Corcoran National Immunisation Office.
The National Immunisation Schedule Update and Current issues Dr Brenda Corcoran National Immunisation Office : Dates vaccines introduced into the Irish immunisation schedule Vaccine 1937-1999 Date introduced
More informationTEMPORARY PROGRAMME PERTUSSIS VACCINATION FOR PREGNANT WOMEN
TEMPORARY PROGRAMME PERTUSSIS VACCINATION FOR PREGNANT WOMEN Richard Smithson Neil Irvine Maureen McCartney Consultant Health Protection October 2012 Pertussis/whooping cough The disease Whooping Cough
More informationDirector of Public Health Board Paper No. 13/13
Greater Glasgow and Clyde NHS Board Director of Public Health Board Paper No. 13/13 Report of the Director of Public Health : Major Development to Immunisation Programmes in Scotland Implications for NHSGGC
More informationVaccinations for Adults
Case: Vaccinations for Adults Lisa Winston, MD University of California, San Francisco San Francisco General Hospital A 30-year old healthy woman comes for a routine visit. She is recently married and
More informationMedDRA Overview A Standardized Terminology
MedDRA Overview A Standardized Terminology Patrick Revelle Director, MedDRA MSSO 6 May 2010 MedDRA is a registered trademark of the International Federation of Pharmaceutical Manufacturers and Associations
More informationHealthy People 2020 objectives were released in 2010, with a 10-year horizon to achieve the goals by 2020.
Appendix 1: Healthy People 2020 Immunization-related Objectives Healthy People provides science-based, 10-year national objectives for improving the health of all Americans. For three decades, Healthy
More information2017/18 Immunisation programmes list of additional and enhanced services
2017/18 Immunisation programmes list of additional and enhanced services 2017/18 Vaccination and Immunisation list of additional and enhanced services Version number: 1 First published: April 2017 Prepared
More informationHuman Papillomavirus Immunisation Programme. Background
Human Papillomavirus Immunisation Programme Background Recommending the use of a human papillomavirus (HPV) vaccine was first signalled in the New Zealand Cancer Control Strategy Action Plan 2005-2010.
More informationThe schedule for childhood vaccination is:(web link to NHS Childhood Immunisation Schedule for 2008
Immunisations and vaccinations Immunisation is an effective public health intervention for promoting good health and protecting individuals and populations against serious disease and infection through
More informationThe National Immunisation Schedule. Dr Brenda Corcoran.
The National Immunisation Schedule Update and Current issues Dr Brenda Corcoran National Immunisation Office Objectives To outline immunisation schedules in Ireland Primary childhood schedule Vaccine uptake
More informationPneumococcal vaccination in UK: an update. Dr Richard Pebody Immunisation Department Health Protection Agency Centre for Infections
Pneumococcal vaccination in UK: an update Dr Richard Pebody Immunisation Department Health Protection Agency Centre for Infections Leading infectious causes of mortality, 2000 WHO estimates 3.5 Deaths
More informationTake advantage of preventive care to help manage your health
UnitedHealthcare Preventive Plan Design Employee Take advantage of preventive care to help manage your health Preventing disease and detecting health issues at an early stage, if they occur, are important
More informationAppendix An Assessment Tool to Determine the Validity of Vaccine Doses
Appendix 4.4 - An Assessment Tool to Determine the Validity of Vaccine Doses Note: Refer to the Canadian Immunization Guide and New Brunswick (NB) immunization program directives for recommendations for
More informationCurrent National Immunisation Schedule Dr Brenda Corcoran National Immunisation Office.
Current National Immunisation Schedule 2012 Dr Brenda Corcoran National Immunisation Office Objectives To outline immunisation schedules in Ireland Primary childhood schedule Vaccine uptake rates School
More informationACIP Meeting Update, New Recommendations and Pending Influenza Season
ACIP Meeting Update, New Recommendations and Pending Influenza Season February 17 th 2011 www.immunizetexas.com ACIP Upcoming Agenda and New Recommendations ACIP (February 23-24 th 2011) Topics for meeting
More informationSyrian Programme Refugees Advice on assessment of immunisation status and recommendations for additional immunisation
Syrian Programme Refugees Advice on assessment of immunisation status and recommendations for additional immunisation Background Information Immunisation services in Syria Syria had good immunisation services,
More informationVaccine administration. Dr Brenda Corcoran National Immunisation Office
Vaccine administration Dr Brenda Corcoran National Immunisation Office School immunisation programme Workshop 21 st April 2015 Overview Contraindications/ Precautions Adverse events 4 in 1 vaccine HPV
More informationSAMPLE. PGD reviewed by: Dr Tim Patterson, Chris Faldon, John Maloney, Adrian Mackenzie
Patient Group Direction for the Supply or Administration of combined Diphtheria, Tetanus, acellular Pertussis, inactivated Polio vaccine and Haemophilus type b conjugate Vaccine (Infanrix-IPV-HIB) to children
More informationThe National Immunisation Schedule Update and Current issues. Dr Brenda Corcoran National Immunisation Office.
The National Immunisation Schedule Update and Current issues Dr Brenda Corcoran National Immunisation Office Objectives To outline immunisation schedules in Ireland Primary childhood schedule Vaccine uptake
More informationimmunisation in New Zealand
This appendix details the history of. Section A1.1 is a brief summary of when each vaccine was introduced to the National Immunisation Schedule (the Schedule). This summary includes vaccines which were
More informationNational Pandemic Vaccination Programme
March 2010 National Pandemic Vaccination Programme Swine Flu Vaccination Programme Pneumococcal Catch-up Campaign Measles Outbreak National Immunisation Guidelines NIO Website HPV Vaccine Campaign Vaccine
More information3 rd dose. 3 rd or 4 th dose, see footnote 5. see footnote 13. for certain high-risk groups
Figure 1. Recommended immunization schedule for persons aged 0 through 18 years 2013. (FOR THOSE WHO FALL BEHIND OR START LATE, SEE THE CATCH-UP SCHEDULE [FIGURE 2]). These recommendations must be read
More information2016/17 Vaccination and Immunisation list of additional services and enhanced services
2016/17 Vaccination and Immunisation list of additional services and enhanced services 2016/17 Vaccination and Immunisation list of additional services and enhanced services Version number: 1 First published:
More informationTake advantage of preventive care to help manage your health
Take advantage of preventive care to help manage your health Preventing disease and detecting health issues at an early stage, if they occur, are important to living a healthy life. Following the recommended
More informationImmunisation Subcommittee of PTAC Meeting held 18 February 2015
Immunisation Subcommittee of PTAC Meeting held 18 February 2015 (minutes for web publishing) Immunisation Subcommittee minutes are published in accordance with the Terms of Reference for the Pharmacology
More informationAnnual Immunisation and Vaccine Preventable Diseases Report for Northern Ireland
Annual Immunisation and Vaccine Preventable Diseases Report for Northern Ireland 2016-17 Acknowledgements The Public Health Agency immunisation team would like to thank everyone who works so hard across
More information16 November 2017 National Immunisation Advisory Committee Recommendations for the 2017/2018 Influenza Vaccination Campaign
16 November 2017 National Immunisation Advisory Committee Recommendations for the 2017/2018 Influenza Vaccination Campaign Please note the National Immunisation Advisory Committee (NIAC) has updated the
More informationInfluenza Vaccine Safety Monitoring Update
Influenza Vaccine Safety Monitoring Update Advisory Committee on Immunization Practices October 28, 2010 Tom Shimabukuro, MD, MPH, MBA Immunization Safety Office Division of Healthcare Quality Promotion,
More informationRotavirus. Factsheet for parents. Immunisation for babies up to a year old
Rotavirus Factsheet for parents This factsheet describes the rotavirus infection and the vaccine that protects against it. It also provides the background to the development and introduction of the vaccination
More information2018/19 Immunisation programmes list of additional and enhanced services
2018/19 Immunisation programmes list of additional and enhanced services 2018/19 Vaccination and Immunisation list of additional and enhanced services Version number: 1 First published: April 2018 Prepared
More informationA study on Metformin (1, 1-Dimethylbiguanidemonohydrochloride) reported adverse events as observed in Eudravigilance database
A study on Metformin (1, 1-Dimethylbiguanidemonohydrochloride) reported adverse events as observed in Eudravigilance database Contract Research Organization / Terzetto Pharma Metrics NIVETHA CHELLAPATHY
More informationPatient Group Direction For the supply and administration of
Patient Group Direction For the supply and administration of HAEMOPHILUS INFLUENZAE TYPE B AND MENINGOCOCCAL C CONJUGATE VACCINE (HIB-MenC) MENITORIX Vaccine By Registered Nurse/Midwife/Health Visitor
More informationNew Jersey Department of Health Vaccine Preventable Disease Program Childhood and Adolescent Recommended Vaccines
New Jersey Department of Health Vaccine Preventable Disease Program Childhood and Adolescent Recommended Vaccines Antigens Vaccine Approved Age Daptacel Diphtheria, Tetanus, and acellular Pertussis (DTaP)
More informationNational Immunisation News The Newsletter of the HSE National Immunisation Office
March 2018 1 National Immunisation News The Newsletter of the HSE National Immunisation Office Thank you for all of your support throughout 2017. We would like to share some of the highlights of the last
More informationWhat DO the childhood immunization footnotes reveal? Questions and answers
What DO the childhood immunization footnotes reveal? Questions and answers Stanley E. Grogg, DO, FACOP, FAAP he Advisory Committee on Immunization Practices (ACIP) recommends the childhood vaccination
More informationFull Novartis CTRD Results Template
Full Novartis CTRD Results Template Sponsor Novartis Generic Drug Name vildagliptin Therapeutic Area of Trial Type 2 diabetes Approved Indication Type 2 diabetes Protocol Number CLAF237A23137E1 Title A
More information7.0 Nunavut Childhood and Adult Immunization Schedules and Catch-up Aids
7.0 Nunavut Childhood and Adult Immunization Schedules and Catch-up Aids Contents Introduction Nunavut Recommended Childhood Immunization Schedule Nunavut Routine Adult Immunization Schedule Nunavut Immunization
More informationSafety monitoring of vaccines. Jeremy Labadie MD vaccine safety specialist
Safety monitoring of vaccines Jeremy Labadie MD vaccine safety specialist vaccines are special immunization programmes pharmacovigilance & vaccines vaccines & AEFI causality assessment of AEFI UMC and
More informationObjectives. Immunity. Diphtheria. Immunization Update July 22, Individual Immunity
Immunization Update July 22, 2008 Presented by Robert Brayden, MD Associate Professor, UCHSC Child Health Clinic, The Children s s Hospital Hosted by: Community Health Association of Mountain/Plains States
More informationSAMPLE. PGD Reviewed by: Chris Faldon, John Maloney, Tim Patterson, Adrian MacKenzie, Claire Stein
Patient Group Direction for the supply or administration of haemophilus influenzae type B and meningococcal conjugate vaccine to children requiring immunisation as part of the national childhood vaccination
More informationPertussis immunisation for pregnant women
Pertussis immunisation for pregnant women Introduction The routine childhood immunisation programme has been very effective in reducing the overall numbers of cases of pertussis. Before the introduction
More informationBabyJabs Vaccines. All vaccines are mercury- free We use aluminium- free vaccines wherever possible
BabyJabs Vaccines All vaccines are mercury- free We use aluminium- free vaccines wherever possible BabyJabs is a dedicated children s immunisation service, offering a choice of single and small combination
More informationImmunisation for pre-school children. three years and four months old
Immunisation for pre-school children three years and four months old Introduction This leaflet contains the facts about the diphtheria, tetanus, pertussis and polio booster vaccine, and the second MMR
More informationRecommended Health Screenings
Recommended Health Screenings UnitedHealthcare appreciates the preventive care you deliver to our members. Please use the below health screening chart to schedule screenings based on the member s age and
More informationThe HPV Vaccination Programme Early intervention in cancer prevention Northern Ireland
The HPV Vaccination Programme Early intervention in cancer prevention Northern Ireland Immunisations Very cost effective intervention Give vaccine before exposure to disease UK has life course approach
More informationVaccination against shingles for adults aged 70 and 79 years of age Q&A s for healthcare professionals
Vaccination against shingles for adults aged 70 and 79 years of age Q&A s for healthcare professionals Background In 2010, the Joint Committee on Vaccination and Immunisation (JCVI) 1 were asked by the
More informationBackground Rationale for resource
Background The Joint Committee on Vaccination and Immunisation 1 reviewed all the available medical, epidemiological and economic evidence as well as vaccine safety and efficacy relevant to offering a
More informationGENERAL PRACTITIONER DATA PACK GUIDANCE
RESTRICTED For CQC internal use only This should NOT be shared outside CQC GENERAL PRACTITIONER DATA PACK GUIDANCE PRIMARY CARE DATA PACKS AND INSPECTION TEAM - November 2015 - Table of Contents Introduction...
More informationabcdefghijklm abcde abc a eé~äíü=aéé~êíãéåí=
abcdefghijklm eé~äíü=aéé~êíãéåí= Dear Colleague IMPORTANT CHANGES TO THE CHILDHOOD IMMUNISATION PROGRAMME We are writing to you with further information about the changes to the routine childhood immunisation
More informationWhat s New MedDRA Version 13.1
What s New MedDRA Version 13.1 Acknowledgements ACKNOWLEDGEMENTS MedDRA is a registered trademark of the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA). Adobe is a registered
More informationBackground Rationale for resource
Slide 1 Background The Joint Committee on Vaccination and Immunisation 1 reviewed all the available medical, epidemiological and economic evidence as well as vaccine safety and efficacy relevant to offering
More informationChanges to the Meningococcal C conjugate (MenC) vaccine schedule. Questions and Answers
Changes to the Meningococcal C conjugate (MenC) vaccine schedule Questions and Answers Background The meningococcal C (MenC) vaccination programme was first introduced into the UK routine immunisation
More informationMandates and More. Julie Morita, M.D. Deputy Commissioner Chicago Department of Public Health. Chicago Department of Public Health
Mandates and More Julie Morita, M.D. Deputy Chicago Department of Public Health Why are vaccines required for school entry? School Vaccine Requirements Small pox vaccine required in Massachusetts 1855
More informationHistory and aims of immunisation. Dr Anna Clarke Department of Public Health Dr. Steevens Hospital Dublin 8
History and aims of immunisation Dr Anna Clarke Department of Public Health Dr. Steevens Hospital Dublin 8 Objectives To examine the history of immunisation To explain the aim of immunisation To develop
More informationNational Immunisation NEWS The newsletter of the National Immunisation Office Directorate of Population Health
Page 1 of 8 National Immunisation News February 2008 National Immunisation NEWS The newsletter of the National Immunisation Office Directorate of Population Health 2008: Issue 5 HSE National Cold Chain
More informationThe National Immunisation Schedule Update and Current issues. Dr Brenda Corcoran National Immunisation Office.
The National Immunisation Schedule Update and Current issues Dr Brenda Corcoran National Immunisation Office Objectives To outline immunisation schedules in Ireland Primary childhood schedule Vaccine uptake
More informationPreventative Vaccines. Vaccines for Special Populations. Vaccinations for Adults: An Update. Vaccines Generally Available in the U.S.
Vaccinations for Adults: An Update Preventative Vaccines Need to be extremely safe Even greater issue as disease prevalence wanes or uncommon diseases targeted Lisa G. Winston, MD University of California,
More informationNational Immunisation News The newsletter of the HSE National Immunisation Office
February 2015 National Immunisation News The newsletter of the HSE National Immunisation Office CONTENTS Changes to the PCI programme Uptake statistics Pneumovax name change Flu season Common queries School
More informationTake advantage of preventive care to help manage your health
Take advantage of preventive care to help manage your health Preventing disease and detecting health issues at an early stage, if they occur, are important to living a healthy life. Following the recommended
More informationCHILDHOOD VACCINATION
EPI (3) Age of Child How and Where is it given? CHILDHOOD VACCINATION Nicolette du Plessis Block 10 28/02/2012 10 weeks DTaP-IPV/Hib (2) Diphtheria, Tetanus, Acellular pertussis, Inactivated polio vaccine,
More informationSCIMP GP Quick Guide to Immunisation changes for
SCIMP GP Quick Guide to Immunisation changes for 2013-14 Version 1.0 31.7.13 This document summarises the changes to the immunisation schedules that will impact on General Practices for 2013-14, particularly
More informationVaccinations For Paediatric Patients Treated With Standard-Dose Chemotherapy And Haemopoietic Stem Cell Transplantation (HSCT) Recipients
Vaccinations For Paediatric Patients Treated With Standard-Dose Chemotherapy And Haemopoietic Stem Authors: Dr Soonie R.Patel, Professor Rod Skinner and Professor Paul T.Heath Date: Review date: December
More information2/20/2019. The need for adult vaccinations. Update on Adult Immunizations. The Need for Adult Vaccinations. Objectives:
The need for adult vaccinations Update on Adult Immunizations Objectives: Recall the latest recommendations on adult vaccinations Detail the importance of adult vaccinations I m not a kid.. Why are you
More informationImmunisations in Adult End stage kidney disease update 2016
Additional Notes During work up (predialysis or dialysis) Awaiting (live donor or on deceased donor list) Post Renal Transplant on immunosuppression Vaccinate Annually: Influenza (eg Influvac, Flurix)
More informationBeating cervical cancer
Beating cervical cancer The HPV vaccine questions and answers for parents of girls in Year 9 and 10 This Q&A on the HPV vaccine supports the leaflet that your daughter should have been given at school.
More informationVaccination against pertussis (whooping cough) an update for registered healthcare practitioners Questions and Answers
Vaccination against pertussis (whooping cough) an update for registered healthcare practitioners Questions and Answers April 2016 Health Protection Scotland is a division of NHS National Services Scotland.
More informationBabyJabs Vaccines. All vaccines are mercury-free We use aluminium-free vaccines wherever possible
BabyJabs Vaccines All vaccines are mercury-free We use aluminium-free vaccines wherever possible BabyJabs is a dedicated children s immunisation service, offering a choice of single and small combination
More informationCyprus Experience. Dr. Elena Papamichael Ministry of Health
Cyprus Experience Dr. Elena Papamichael Ministry of Health Cyprus became independent on1960. On 1974, Turkish troops invaded in the island disturbing the willing for peaceful living. Since then, Turkey
More informationNHS Greater Glasgow & Clyde SOP No. BMT Haemopoietic Stem Cell Transplantation Services Vaccination Policy
This policy was written with advice from Dr S Ahmed, Consultant in Public Health, Greater Glasgow & Clyde. We would like to thank him for his guidance. 1. Background It is recommended by EBMT and CDC that
More informationPrivate Market Vaccines
Private Market Vaccines 1 What do you recommend Best protection for my child Best protection for adults Best protection for occupational health 2 Not on the national schedule.. Rotavirus Varicella Meningococcal
More informationChapter/ Guideline Reference. Date of Recommendation. Recommendation
Date of Recommendation Chapter/ Guideline Reference Recommendation Clinical Update: Confirmed for 20th January. Booking open on RCPI website. Videolink available on RCPI website. Notification to be sent
More informationThe National Immunisation Schedule Update and Current issues November Dr Brenda Corcoran National Immunisation Office.
The National Immunisation Schedule Update and Current issues November 2013 Dr Brenda Corcoran National Immunisation Office Objectives To outline immunisation schedules in Ireland Primary childhood schedule
More informationBabyJabs Vaccines. All vaccines are mercury-free We use aluminium-free vaccines wherever possible
BabyJabs Vaccines All vaccines are mercury-free We use aluminium-free vaccines wherever possible BabyJabs is a dedicated children s immunisation service, offering a choice of single and small combination
More informationImmunisation Update for Occupational Health
Immunisation Update for Occupational Health Dr Gayatri Amirthalingam Immunisation, Hepatitis & Blood Safety department Public Health England 29 th April 2016 Session Outline Epidemiology of vaccine preventable
More informationNational Immunisation News The Newsletter of the HSE National Immunisation Office
December 2017 National Immunisation News The Newsletter of the HSE National Immunisation Office Contents Flu Vaccine Campaign 2017/2018 Flu vaccine campaign 2017/2018 Updated NIAC Guidelines for influenza
More informationChanges to the meningococcal C conjugate (MenC) vaccine schedule 2014 first-time university entrants under the age of 25
Changes to the meningococcal C conjugate (MenC) vaccine schedule 2014 first-time university entrants under the age of 25 An update for registered healthcare practitioners August 2014 Quality Education
More informationImmunization Report Public Health September 2013
Immunization Report Public Health September 2013 Daycare, school entry and school program immunization enrollment rates, up to 2012 Table of Contents 1. Introduction... 2 2. Data Source... 2 3. Limitations...
More informationPatient Group Direction For The Administration Of H1N1 (Swine Flu) vaccine
n Patient Group Direction For The Administration Of H1N1 (Swine Flu) vaccine October 2009 PGD version template-2009.1 Page 1 of 8 Rationale Patient Group Direction For The Administration Of H1N1 (Swine
More informationTake advantage of preventive care to help manage your health
Take advantage of preventive care to help manage your health UnitedHealthcare is dedicated to helping people live healthier lives, and we encourage our members to receive age and gender appropriate preventive
More informationChanges to the National Immunisation Schedule
17 December 2013 Changes to the National Immunisation Schedule PHARMAC is pleased to announce decisions related to the National Immunisation Schedule (NIS) that will take effect from 1 July 2014. This
More informationIMMUNISATION PROGRAMMES IN NHS GREATER GLASGOW AND CLYDE
NHS Greater Glasgow & Clyde NHS BOARD MEETING Jennifer Reid and Dr Syed Ahmed 16 th August 2016 Paper No: 16/51 Insert Title of NHS Board Paper Here IMMUNISATION PROGRAMMES IN NHS GREATER GLASGOW AND CLYDE
More informationEnhanced immunisation schedule Victoria
Children from March 2016 Age Disease Vaccine brand Birth Hepatitis B H-B-Vax-II Paediatric 2 months - from 6 weeks Diphtheria-tetanus-pertussis, poliomyelitis-hepatitis B- Reconstitute Site given Route
More informationPREVENTIVE IMMUNIZATIONS. PREVENTIVE IMMUNIZATIONS These codes do not have a diagnosis code requirement for preventive benefits to apply.
An immunization that does not fall under one of the exclusions in the Certificate of Coverage is considered covered after the following conditions are satisfied: (1) FDA approval; (2) explicit ACIP recommendation
More informationWorcestershire 2011/12 Childhood Immunisation Action Plan
Worcestershire /12 Childhood Immunisation Action Plan 1. INTRODUCTION 1.1. NHS Worcestershire (NHSW) has been set aspirational immunisation childhood immunisation targets for /12 that are unlikely to be
More informationVaccination Decision Making: What Providers Need to Know
Objectives Vaccination Decision Making: What Providers Need to Know Kelli Smith, RN, BSN Iowa Department of Public Health Immunization Program Catch-up Schedule: how to most efficiently bring persons up-to-date
More informationThe hexavalent DTaP/IPV/Hib/HepB combination vaccine
The hexavalent DTaP/IPV/Hib/HepB combination vaccine Factsheet for healthcare professionals about the neonatal selective immunisation programme for babies at risk of hepatitis B Background All babies born
More information- Infanrix hexa (DTPa-HBV-IPV/Hib): GSK Biologicals combined diphtheria, tetanus, acellular pertussis, hepatitis
The study listed may include approved and non-approved uses, formulations or treatment regimens. The results reported in any single study may not reflect the overall results obtained on studies of a product.
More information