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Maria Cano - One of the best experts on this subject based on the ideXlab platform.
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safety review of tetanus toxoid reduced diphtheria toxoid acellular pertussis vaccines tdap in adults aged 65 years vaccine adverse event reporting system vaers united states september 2010 december 2018
Vaccine, 2020Co-Authors: Penina Haber, Pedro L Moro, Graca M Dores, Silvia Perezvilar, Paige L Marquez, Maria CanoAbstract:Abstract Introduction The Advisory Committee on Immunization Practices (ACIP) recommends vaccination with tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis vaccine (Tdap) in persons ≥65 years of age. To date, few studies have assessed the safety of Tdap in this population. We aimed to summarize reports submitted to the Vaccine Adverse Event Reporting System (VAERS) following receipt of Tdap in this age group. Methods We searched for and analyzed U.S. VAERS reports of Tdap among individuals ≥65 years of age submitted from September 1, 2010 through December 31, 2018. We classified reports according to concurrent vaccination, seriousness, and outcome (death, non-death) and determined the frequency of reported adverse events (AEs). For serious reports, we reviewed available medical records. Data mining analyses were undertaken to detect disproportionality in reporting. Results VAERS received a total of 1,798 reports following Tdap, of which 104 (6%) were serious. The most common AEs were Injection Site Erythema (26%; n = 468), Injection Site pain (19%; n = 335), Injection Site swelling (18%; n = 329), and Erythema (18%; n = 321). We identified seven deaths; none were attributed to Tdap. Among serious non-death reports, nervous system disorders (35.1%; n = 34) and infections and infestations (n = 18.6%; n = 18) were most commonly reported. Data mining did not identify any vaccine-AE combination reported more frequently than expected. Conclusions We did not identify any new safety concern over nearly a decade of recommended Tdap use among adults ≥65 years of age. Findings from this post-marketing review are consistent with prior post-marketing observations and pre-licensure studies.
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Postlicensure Safety Surveillance of Recombinant Zoster Vaccine (Shingrix) - United States, October 2017-June 2018.
MMWR. Morbidity and mortality weekly report, 2019Co-Authors: Elisabeth M Hesse, Paige Lewis, Tom T Shimabukuro, Beth F. Hibbs, Kathleen Dooling, Ravi Goud, Maria CanoAbstract:Recombinant zoster vaccine (RZV; Shingrix), an adjuvanted glycoprotein vaccine, was licensed by the Food and Drug Administration (FDA) and recommended by the Advisory Committee on Immunization Practices for adults aged ≥50 years in October 2017 (1). The previously licensed live-attenuated zoster vaccine (ZVL; Zostavax) is recommended for adults aged ≥60 years. RZV is administered intramuscularly as a 2-dose series, with an interval of 2-6 months between doses. In prelicensure clinical trials, 85% of 6,773 vaccinated study participants reported local or systemic reactions after receiving RZV, with approximately 17% experiencing a grade 3 reaction (Erythema or induration >3.5 inches or systemic symptoms that interfere with normal activity). However, rates of serious adverse events (i.e., hospitalization, prolongation of existing hospitalization, life-threatening illness, permanent disability, congenital anomaly or birth defect, or death) were similar in the RZV and placebo groups (2). After licensure, CDC and FDA began safety monitoring of RZV in the Vaccine Adverse Event Reporting System (VAERS) (3). During the first 8 months of use, when approximately 3.2 million RZV doses were distributed (GlaxoSmithKline, personal communication, 2018), VAERS received a total of 4,381 reports of adverse events, 130 (3.0%) of which were classified as serious. Commonly reported signs and symptoms included pyrexia (fever) (1,034; 23.6%), Injection Site pain (985; 22.5%), and Injection Site Erythema (880; 20.1%). No unexpected patterns were detected in reports of adverse events or serious adverse events. Findings from early monitoring of RZV are consistent with the safety profile observed in prelicensure clinical trials.
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post licensure safety surveillance of 23 valent pneumococcal polysaccharide vaccine in the vaccine adverse event reporting system vaers 1990 2013
Vaccine, 2016Co-Authors: Elaine R Miller, Pedro L Moro, Maria Cano, Paige Lewis, Marthe Bryantgenevier, Tom T ShimabukuroAbstract:Abstract Background 23-Valent pneumococcal polysaccharide vaccine, trade name Pneumovax ® 23 (PPSV23), has been used for decades in the Unites States and has an extensive clinical record. However, limited post-licensure safety assessment has been conducted. Objective To analyze reports submitted to the Vaccine Adverse Event Reporting System (VAERS) following PPSV23 from 1990 to 2013 in order to characterize its safety profile. Methods We searched the VAERS database for US reports following PPSV23 for persons vaccinated from 1990 to 2013. We assessed safety through: automated analysis of VAERS data, crude adverse event (AE) reporting rates based on PPSV23 doses distributed in the US market, clinical review of death reports and reports involving vaccine administered to pregnant women, and empirical Bayesian data mining to assess for disproportional reporting. Results During the study period, VAERS received 25,168 PPSV23 reports; 92% were non-serious, 67% were in females and 86% were in adults aged ≥19 years. When PPSV23 was administered alone, fever (43%), Injection Site Erythema (28%) and Injection Site pain (25%) were the most commonly reported non-serious AEs in children. Injection Site Erythema (32%), Injection Site pain (27%) and Injection Site swelling (23%) were the most commonly reported non-serious AEs in adults. Of serious reports (2129, 8% of total), fever was most commonly reported in both children (69%) and adults (39%). There were 66 reports of death, four in children and 62 in adults. Clinical review of death reports did not reveal any concerning patterns that would suggest a causal association with PPSV23. No disproportional reporting of unexpected AEs was observed in empirical Bayesian data mining. Conclusions We did not identify any new or unexpected safety concerns for PPSV23. The VAERS data are consistent with safety data from pre-licensure clinical trials and other post-licensure studies.
Tom T Shimabukuro - One of the best experts on this subject based on the ideXlab platform.
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Postlicensure Safety Surveillance of Recombinant Zoster Vaccine (Shingrix) - United States, October 2017-June 2018.
MMWR. Morbidity and mortality weekly report, 2019Co-Authors: Elisabeth M Hesse, Paige Lewis, Tom T Shimabukuro, Beth F. Hibbs, Kathleen Dooling, Ravi Goud, Maria CanoAbstract:Recombinant zoster vaccine (RZV; Shingrix), an adjuvanted glycoprotein vaccine, was licensed by the Food and Drug Administration (FDA) and recommended by the Advisory Committee on Immunization Practices for adults aged ≥50 years in October 2017 (1). The previously licensed live-attenuated zoster vaccine (ZVL; Zostavax) is recommended for adults aged ≥60 years. RZV is administered intramuscularly as a 2-dose series, with an interval of 2-6 months between doses. In prelicensure clinical trials, 85% of 6,773 vaccinated study participants reported local or systemic reactions after receiving RZV, with approximately 17% experiencing a grade 3 reaction (Erythema or induration >3.5 inches or systemic symptoms that interfere with normal activity). However, rates of serious adverse events (i.e., hospitalization, prolongation of existing hospitalization, life-threatening illness, permanent disability, congenital anomaly or birth defect, or death) were similar in the RZV and placebo groups (2). After licensure, CDC and FDA began safety monitoring of RZV in the Vaccine Adverse Event Reporting System (VAERS) (3). During the first 8 months of use, when approximately 3.2 million RZV doses were distributed (GlaxoSmithKline, personal communication, 2018), VAERS received a total of 4,381 reports of adverse events, 130 (3.0%) of which were classified as serious. Commonly reported signs and symptoms included pyrexia (fever) (1,034; 23.6%), Injection Site pain (985; 22.5%), and Injection Site Erythema (880; 20.1%). No unexpected patterns were detected in reports of adverse events or serious adverse events. Findings from early monitoring of RZV are consistent with the safety profile observed in prelicensure clinical trials.
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post licensure safety surveillance of 23 valent pneumococcal polysaccharide vaccine in the vaccine adverse event reporting system vaers 1990 2013
Vaccine, 2016Co-Authors: Elaine R Miller, Pedro L Moro, Maria Cano, Paige Lewis, Marthe Bryantgenevier, Tom T ShimabukuroAbstract:Abstract Background 23-Valent pneumococcal polysaccharide vaccine, trade name Pneumovax ® 23 (PPSV23), has been used for decades in the Unites States and has an extensive clinical record. However, limited post-licensure safety assessment has been conducted. Objective To analyze reports submitted to the Vaccine Adverse Event Reporting System (VAERS) following PPSV23 from 1990 to 2013 in order to characterize its safety profile. Methods We searched the VAERS database for US reports following PPSV23 for persons vaccinated from 1990 to 2013. We assessed safety through: automated analysis of VAERS data, crude adverse event (AE) reporting rates based on PPSV23 doses distributed in the US market, clinical review of death reports and reports involving vaccine administered to pregnant women, and empirical Bayesian data mining to assess for disproportional reporting. Results During the study period, VAERS received 25,168 PPSV23 reports; 92% were non-serious, 67% were in females and 86% were in adults aged ≥19 years. When PPSV23 was administered alone, fever (43%), Injection Site Erythema (28%) and Injection Site pain (25%) were the most commonly reported non-serious AEs in children. Injection Site Erythema (32%), Injection Site pain (27%) and Injection Site swelling (23%) were the most commonly reported non-serious AEs in adults. Of serious reports (2129, 8% of total), fever was most commonly reported in both children (69%) and adults (39%). There were 66 reports of death, four in children and 62 in adults. Clinical review of death reports did not reveal any concerning patterns that would suggest a causal association with PPSV23. No disproportional reporting of unexpected AEs was observed in empirical Bayesian data mining. Conclusions We did not identify any new or unexpected safety concerns for PPSV23. The VAERS data are consistent with safety data from pre-licensure clinical trials and other post-licensure studies.
Pedro L Moro - One of the best experts on this subject based on the ideXlab platform.
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safety review of tetanus toxoid reduced diphtheria toxoid acellular pertussis vaccines tdap in adults aged 65 years vaccine adverse event reporting system vaers united states september 2010 december 2018
Vaccine, 2020Co-Authors: Penina Haber, Pedro L Moro, Graca M Dores, Silvia Perezvilar, Paige L Marquez, Maria CanoAbstract:Abstract Introduction The Advisory Committee on Immunization Practices (ACIP) recommends vaccination with tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis vaccine (Tdap) in persons ≥65 years of age. To date, few studies have assessed the safety of Tdap in this population. We aimed to summarize reports submitted to the Vaccine Adverse Event Reporting System (VAERS) following receipt of Tdap in this age group. Methods We searched for and analyzed U.S. VAERS reports of Tdap among individuals ≥65 years of age submitted from September 1, 2010 through December 31, 2018. We classified reports according to concurrent vaccination, seriousness, and outcome (death, non-death) and determined the frequency of reported adverse events (AEs). For serious reports, we reviewed available medical records. Data mining analyses were undertaken to detect disproportionality in reporting. Results VAERS received a total of 1,798 reports following Tdap, of which 104 (6%) were serious. The most common AEs were Injection Site Erythema (26%; n = 468), Injection Site pain (19%; n = 335), Injection Site swelling (18%; n = 329), and Erythema (18%; n = 321). We identified seven deaths; none were attributed to Tdap. Among serious non-death reports, nervous system disorders (35.1%; n = 34) and infections and infestations (n = 18.6%; n = 18) were most commonly reported. Data mining did not identify any vaccine-AE combination reported more frequently than expected. Conclusions We did not identify any new safety concern over nearly a decade of recommended Tdap use among adults ≥65 years of age. Findings from this post-marketing review are consistent with prior post-marketing observations and pre-licensure studies.
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post licensure safety surveillance of 23 valent pneumococcal polysaccharide vaccine in the vaccine adverse event reporting system vaers 1990 2013
Vaccine, 2016Co-Authors: Elaine R Miller, Pedro L Moro, Maria Cano, Paige Lewis, Marthe Bryantgenevier, Tom T ShimabukuroAbstract:Abstract Background 23-Valent pneumococcal polysaccharide vaccine, trade name Pneumovax ® 23 (PPSV23), has been used for decades in the Unites States and has an extensive clinical record. However, limited post-licensure safety assessment has been conducted. Objective To analyze reports submitted to the Vaccine Adverse Event Reporting System (VAERS) following PPSV23 from 1990 to 2013 in order to characterize its safety profile. Methods We searched the VAERS database for US reports following PPSV23 for persons vaccinated from 1990 to 2013. We assessed safety through: automated analysis of VAERS data, crude adverse event (AE) reporting rates based on PPSV23 doses distributed in the US market, clinical review of death reports and reports involving vaccine administered to pregnant women, and empirical Bayesian data mining to assess for disproportional reporting. Results During the study period, VAERS received 25,168 PPSV23 reports; 92% were non-serious, 67% were in females and 86% were in adults aged ≥19 years. When PPSV23 was administered alone, fever (43%), Injection Site Erythema (28%) and Injection Site pain (25%) were the most commonly reported non-serious AEs in children. Injection Site Erythema (32%), Injection Site pain (27%) and Injection Site swelling (23%) were the most commonly reported non-serious AEs in adults. Of serious reports (2129, 8% of total), fever was most commonly reported in both children (69%) and adults (39%). There were 66 reports of death, four in children and 62 in adults. Clinical review of death reports did not reveal any concerning patterns that would suggest a causal association with PPSV23. No disproportional reporting of unexpected AEs was observed in empirical Bayesian data mining. Conclusions We did not identify any new or unexpected safety concerns for PPSV23. The VAERS data are consistent with safety data from pre-licensure clinical trials and other post-licensure studies.
Elaine R Miller - One of the best experts on this subject based on the ideXlab platform.
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post licensure safety surveillance of 23 valent pneumococcal polysaccharide vaccine in the vaccine adverse event reporting system vaers 1990 2013
Vaccine, 2016Co-Authors: Elaine R Miller, Pedro L Moro, Maria Cano, Paige Lewis, Marthe Bryantgenevier, Tom T ShimabukuroAbstract:Abstract Background 23-Valent pneumococcal polysaccharide vaccine, trade name Pneumovax ® 23 (PPSV23), has been used for decades in the Unites States and has an extensive clinical record. However, limited post-licensure safety assessment has been conducted. Objective To analyze reports submitted to the Vaccine Adverse Event Reporting System (VAERS) following PPSV23 from 1990 to 2013 in order to characterize its safety profile. Methods We searched the VAERS database for US reports following PPSV23 for persons vaccinated from 1990 to 2013. We assessed safety through: automated analysis of VAERS data, crude adverse event (AE) reporting rates based on PPSV23 doses distributed in the US market, clinical review of death reports and reports involving vaccine administered to pregnant women, and empirical Bayesian data mining to assess for disproportional reporting. Results During the study period, VAERS received 25,168 PPSV23 reports; 92% were non-serious, 67% were in females and 86% were in adults aged ≥19 years. When PPSV23 was administered alone, fever (43%), Injection Site Erythema (28%) and Injection Site pain (25%) were the most commonly reported non-serious AEs in children. Injection Site Erythema (32%), Injection Site pain (27%) and Injection Site swelling (23%) were the most commonly reported non-serious AEs in adults. Of serious reports (2129, 8% of total), fever was most commonly reported in both children (69%) and adults (39%). There were 66 reports of death, four in children and 62 in adults. Clinical review of death reports did not reveal any concerning patterns that would suggest a causal association with PPSV23. No disproportional reporting of unexpected AEs was observed in empirical Bayesian data mining. Conclusions We did not identify any new or unexpected safety concerns for PPSV23. The VAERS data are consistent with safety data from pre-licensure clinical trials and other post-licensure studies.
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serum sickness like reaction associated with inactivated influenza vaccination among thai health care personnel risk factors and outcomes
Clinical Infectious Diseases, 2009Co-Authors: Anucha Apisarnthanarak, Timothy M Uyeki, Elaine R Miller, Linda M MundyAbstract:Fourteen (3%) of 495 Thai health care personnel were identified as having a serum sickness-like reaction in 2008 after receipt of inactivated influenza vaccine manufactured in Thailand. These health care personnel experienced fever, myalgia, centrifugal arthralgias, and Injection Site Erythema. A history of allergic reactions to food or drugs (adjusted odds ratio, 5.9; 95% confidence interval, 1.54-25.4) was independently associated with a serum sickness-like reaction.
Daniel A. Scott - One of the best experts on this subject based on the ideXlab platform.
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immunogenicity safety and tolerability of 13 valent pneumococcal conjugate vaccine followed by 23 valent pneumococcal polysaccharide vaccine in recipients of allogeneic hematopoietic stem cell transplant aged 2 years an open label study
Clinical Infectious Diseases, 2015Co-Authors: Catherine Cordonnier, Vani Sundaraiyer, William C. Gruber, Christine Juergens, Per Ljungman, Johan Maertens, Dominik Selleslag, Peter C Giardina, Keri Clarke, Daniel A. ScottAbstract:Background. Life-threatening Streptococcus pneumoniae infections often occur after hematopoietic stem cell transplant (HSCT); vaccination is important for prevention. Methods. In an open-label study, patients (n = 251) 3–6 months after allogeneic HSCT received 3 doses of 13-valent pneumococcal conjugate vaccine (PCV13) at 1-month intervals, a fourth dose 6 months later, and 1 dose of 23-valent pneumococcal polysaccharide vaccine (PPSV23) 1 month later. Immunogenicity at prespecified time points and vaccine safety were assessed. Results. In the evaluable immunogenicity population (N = 216; mean age, 37.8 years), geometric mean fold rises (GMFRs) of immunoglobulin G geometric mean concentrations from baseline to postdose 3 showed significant increases in antibody levels across all PCV13 serotypes (GMFR range, 2.99–23.85; 95% confidence interval lower limit, >1); there were significant declines over the next 6 months, significant increases from predose 4 to postdose 4 (GMFR range, 3.00–6.97), and little change after PPSV23 (GMFR range, 0.86–1.12). Local and systemic reactions were more frequent after dose 4. Six patients experienced serious adverse events possibly related to PCV13 (facial diplegia, Injection-Site Erythema and pyrexia, autoimmune hemolytic anemia, and suspected lack of vaccine efficacy after dose 3 leading to pneumococcal infection), PCV13 and PPSV23 (Guillain-Barre syndrome), or PPSV23 (cellulitis). There were 14 deaths, none related to study vaccines. Conclusions. A 3-dose PCV13 regimen followed by a booster dose may be required to protect against pneumococcal disease in HSCT recipients. Dose 4 was associated with increased local and systemic reactions, but the overall safety profile of a 4-dose regimen was considered acceptable. Clinical Trials Registration. {"type":"clinical-trial","attrs":{"text":"NCT00980655","term_id":"NCT00980655"}}NCT00980655.