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Lucas Franki is an associate editor for MDedge News, and has been with the company since 2014. He has a BA in English from Penn State University and is an Eagle Scout.
PNSP rates did not increase after PCV13 introduction
Streptococcus pneumoniae did not grow more resistant to penicillin after the introduction of 13-valent pneumococcal conjugate vaccine, though geographic differences remained, according to Cheryl P. Andam, Ph.D., and her associates.
Data from the Active Bacterial Core surveillance system on 285 patients before introduction of PCV13 and from 339 patients after PCV13 introduction were used in the study. Patients were from California, Colorado, Connecticut, Georgia, Maryland, Minnesota, New Mexico, New York, Oregon, and Tennessee. New Mexico, Maryland, and Georgia saw the largest increases in penicillin-nonsusceptible pneumococcus (PNSP) rates, while Colorado, New York, and Connecticut saw decreases. No change was seen in the nationwide PNSP rate.
Preintroduction of PCV13, geographic heterogeneity in serotype distribution, and serotype-specific differences in penicillin resistance were equally responsible for geographic variation in PNSP rates. Although no significant change was seen after introduction, influence of serotype-specific differences did decrease slightly while geographic heterogeneity of PSNP serotypes increased.
“Further long-term nationwide surveillance of serotype dynamics is required to assess the multiple ecologic factors that influence antibiotic resistance in the pneumococcus in the conjugate vaccine era,” the investigators concluded.
Find the full research letter in Emerging Infectious Diseases (doi: 10.3201/eid2306.161331).
Streptococcus pneumoniae did not grow more resistant to penicillin after the introduction of 13-valent pneumococcal conjugate vaccine, though geographic differences remained, according to Cheryl P. Andam, Ph.D., and her associates.
Data from the Active Bacterial Core surveillance system on 285 patients before introduction of PCV13 and from 339 patients after PCV13 introduction were used in the study. Patients were from California, Colorado, Connecticut, Georgia, Maryland, Minnesota, New Mexico, New York, Oregon, and Tennessee. New Mexico, Maryland, and Georgia saw the largest increases in penicillin-nonsusceptible pneumococcus (PNSP) rates, while Colorado, New York, and Connecticut saw decreases. No change was seen in the nationwide PNSP rate.
Preintroduction of PCV13, geographic heterogeneity in serotype distribution, and serotype-specific differences in penicillin resistance were equally responsible for geographic variation in PNSP rates. Although no significant change was seen after introduction, influence of serotype-specific differences did decrease slightly while geographic heterogeneity of PSNP serotypes increased.
“Further long-term nationwide surveillance of serotype dynamics is required to assess the multiple ecologic factors that influence antibiotic resistance in the pneumococcus in the conjugate vaccine era,” the investigators concluded.
Find the full research letter in Emerging Infectious Diseases (doi: 10.3201/eid2306.161331).
Streptococcus pneumoniae did not grow more resistant to penicillin after the introduction of 13-valent pneumococcal conjugate vaccine, though geographic differences remained, according to Cheryl P. Andam, Ph.D., and her associates.
Data from the Active Bacterial Core surveillance system on 285 patients before introduction of PCV13 and from 339 patients after PCV13 introduction were used in the study. Patients were from California, Colorado, Connecticut, Georgia, Maryland, Minnesota, New Mexico, New York, Oregon, and Tennessee. New Mexico, Maryland, and Georgia saw the largest increases in penicillin-nonsusceptible pneumococcus (PNSP) rates, while Colorado, New York, and Connecticut saw decreases. No change was seen in the nationwide PNSP rate.
Preintroduction of PCV13, geographic heterogeneity in serotype distribution, and serotype-specific differences in penicillin resistance were equally responsible for geographic variation in PNSP rates. Although no significant change was seen after introduction, influence of serotype-specific differences did decrease slightly while geographic heterogeneity of PSNP serotypes increased.
“Further long-term nationwide surveillance of serotype dynamics is required to assess the multiple ecologic factors that influence antibiotic resistance in the pneumococcus in the conjugate vaccine era,” the investigators concluded.
Find the full research letter in Emerging Infectious Diseases (doi: 10.3201/eid2306.161331).
FROM EMERGING INFECTIOUS DISEASES
FDA: Fluoroquinolone use not linked to retina detachment, aortic problems
The Food and Drug Administration has found no evidence of a link between fluoroquinolone usage and retinal detachment or aortic aneurysm and dissection, according to a new Drug Safety Communication update on potential serious, disabling side effects of oral and injectable fluoroquinolone antibiotics.
Fluoroquinolones are used to treat acute bacterial sinusitis, acute bacterial exacerbation of chronic bronchitis, and uncomplicated urinary tract infections.
However, after reviewing patient cases and study findings, the FDA said the evidence didn’t support an association between fluoroquinolone usage and potential retinal or aortic dangers, according to its May 10, 2017, Drug Safety Communication update.
Serious side effects associated with fluoroquinolone use include hallucination, depression, suicidal thoughts, tendinitis and tendon rupture, a “pins and needles” feeling in the arms and legs, joint pain and swelling, skin rash, and severe diarrhea.
“We will continue to assess safety issues with fluoroquinolones, and will update the public if additional actions are needed,” the FDA said in a statement.
The Food and Drug Administration has found no evidence of a link between fluoroquinolone usage and retinal detachment or aortic aneurysm and dissection, according to a new Drug Safety Communication update on potential serious, disabling side effects of oral and injectable fluoroquinolone antibiotics.
Fluoroquinolones are used to treat acute bacterial sinusitis, acute bacterial exacerbation of chronic bronchitis, and uncomplicated urinary tract infections.
However, after reviewing patient cases and study findings, the FDA said the evidence didn’t support an association between fluoroquinolone usage and potential retinal or aortic dangers, according to its May 10, 2017, Drug Safety Communication update.
Serious side effects associated with fluoroquinolone use include hallucination, depression, suicidal thoughts, tendinitis and tendon rupture, a “pins and needles” feeling in the arms and legs, joint pain and swelling, skin rash, and severe diarrhea.
“We will continue to assess safety issues with fluoroquinolones, and will update the public if additional actions are needed,” the FDA said in a statement.
The Food and Drug Administration has found no evidence of a link between fluoroquinolone usage and retinal detachment or aortic aneurysm and dissection, according to a new Drug Safety Communication update on potential serious, disabling side effects of oral and injectable fluoroquinolone antibiotics.
Fluoroquinolones are used to treat acute bacterial sinusitis, acute bacterial exacerbation of chronic bronchitis, and uncomplicated urinary tract infections.
However, after reviewing patient cases and study findings, the FDA said the evidence didn’t support an association between fluoroquinolone usage and potential retinal or aortic dangers, according to its May 10, 2017, Drug Safety Communication update.
Serious side effects associated with fluoroquinolone use include hallucination, depression, suicidal thoughts, tendinitis and tendon rupture, a “pins and needles” feeling in the arms and legs, joint pain and swelling, skin rash, and severe diarrhea.
“We will continue to assess safety issues with fluoroquinolones, and will update the public if additional actions are needed,” the FDA said in a statement.
FDA approves abaloparatide for postmenopausal osteoporosis
The Food and Drug Administration has approved abaloparatide (Tymlos) for postmenopausal women with osteoporosis at high risk for fracture.
Abaloparatide was approved based on 18-month results from the ACTIVE trial and 6-month results from the ACTIVExtend trial. Patients in the ACTIVE trial showed an relative risk reduction of 86% for new vertebral fractures and 43% for nonvertebral fractures, compared with placebo, according to a statement from manufacturer Radius Health. Results were similar regardless of age, years since menopause, presence or absence of prior fracture (vertebral or nonvertebral), and bone mineral density at baseline.
Find the full statement on the Radius Health website.
The Food and Drug Administration has approved abaloparatide (Tymlos) for postmenopausal women with osteoporosis at high risk for fracture.
Abaloparatide was approved based on 18-month results from the ACTIVE trial and 6-month results from the ACTIVExtend trial. Patients in the ACTIVE trial showed an relative risk reduction of 86% for new vertebral fractures and 43% for nonvertebral fractures, compared with placebo, according to a statement from manufacturer Radius Health. Results were similar regardless of age, years since menopause, presence or absence of prior fracture (vertebral or nonvertebral), and bone mineral density at baseline.
Find the full statement on the Radius Health website.
The Food and Drug Administration has approved abaloparatide (Tymlos) for postmenopausal women with osteoporosis at high risk for fracture.
Abaloparatide was approved based on 18-month results from the ACTIVE trial and 6-month results from the ACTIVExtend trial. Patients in the ACTIVE trial showed an relative risk reduction of 86% for new vertebral fractures and 43% for nonvertebral fractures, compared with placebo, according to a statement from manufacturer Radius Health. Results were similar regardless of age, years since menopause, presence or absence of prior fracture (vertebral or nonvertebral), and bone mineral density at baseline.
Find the full statement on the Radius Health website.
FDA approves midostaurin for adult patients with FLT3+ AML
The Food and Drug Administration has approved midostaurin for the treatment of FLT3 mutation–positive acute myeloid leukemia (FLT3+ AML) in adult patients in combination with standard cytarabine and daunorubicin induction and cytarabine consolidation.
Approval was based on results from a randomized, double-blind, placebo-controlled trial of 717 patients with previously untreated FLT3+ AML. The hazard ratio for overall survival in patients receiving midostaurin, compared with a placebo, was 0.77 (P = .016). A companion diagnostic tool, the LeukoStrat CDx FLT3 Mutation Assay manufactured by Invivoscribe Technologies, was also approved.
Midostaurin was also approved for the treatment of aggressive systemic mastocytosis, SM with associated hematological neoplasm, or mast cell leukemia. This indication approval was based on a single-arm, open-label study of midostaurin 100 mg, taken orally twice daily. Complete plus incomplete remission rates were 38% for ASM and 16% for SM with associated hematological neoplasm. Common adverse events included nausea, vomiting, diarrhea, edema, musculoskeletal pain, abdominal pain, fatigue, upper respiratory tract infection, fever, headache, and dyspnea.
The recommended dose of midostaurin in AML is 50 mg twice daily with food on days 8 to 21 of each cycle of induction and consolidation chemotherapy followed by 50 mg with food as a single agent for up to 12 months. The recommended dose for the treatment of adults with aggressive SM, SM with associated hematological neoplasm, or mast cell leukemia is 100 mg twice daily with food, the FDA said.
Midostaurin will be marketed as Rydapt by Novartis Pharmaceuticals.
The Food and Drug Administration has approved midostaurin for the treatment of FLT3 mutation–positive acute myeloid leukemia (FLT3+ AML) in adult patients in combination with standard cytarabine and daunorubicin induction and cytarabine consolidation.
Approval was based on results from a randomized, double-blind, placebo-controlled trial of 717 patients with previously untreated FLT3+ AML. The hazard ratio for overall survival in patients receiving midostaurin, compared with a placebo, was 0.77 (P = .016). A companion diagnostic tool, the LeukoStrat CDx FLT3 Mutation Assay manufactured by Invivoscribe Technologies, was also approved.
Midostaurin was also approved for the treatment of aggressive systemic mastocytosis, SM with associated hematological neoplasm, or mast cell leukemia. This indication approval was based on a single-arm, open-label study of midostaurin 100 mg, taken orally twice daily. Complete plus incomplete remission rates were 38% for ASM and 16% for SM with associated hematological neoplasm. Common adverse events included nausea, vomiting, diarrhea, edema, musculoskeletal pain, abdominal pain, fatigue, upper respiratory tract infection, fever, headache, and dyspnea.
The recommended dose of midostaurin in AML is 50 mg twice daily with food on days 8 to 21 of each cycle of induction and consolidation chemotherapy followed by 50 mg with food as a single agent for up to 12 months. The recommended dose for the treatment of adults with aggressive SM, SM with associated hematological neoplasm, or mast cell leukemia is 100 mg twice daily with food, the FDA said.
Midostaurin will be marketed as Rydapt by Novartis Pharmaceuticals.
The Food and Drug Administration has approved midostaurin for the treatment of FLT3 mutation–positive acute myeloid leukemia (FLT3+ AML) in adult patients in combination with standard cytarabine and daunorubicin induction and cytarabine consolidation.
Approval was based on results from a randomized, double-blind, placebo-controlled trial of 717 patients with previously untreated FLT3+ AML. The hazard ratio for overall survival in patients receiving midostaurin, compared with a placebo, was 0.77 (P = .016). A companion diagnostic tool, the LeukoStrat CDx FLT3 Mutation Assay manufactured by Invivoscribe Technologies, was also approved.
Midostaurin was also approved for the treatment of aggressive systemic mastocytosis, SM with associated hematological neoplasm, or mast cell leukemia. This indication approval was based on a single-arm, open-label study of midostaurin 100 mg, taken orally twice daily. Complete plus incomplete remission rates were 38% for ASM and 16% for SM with associated hematological neoplasm. Common adverse events included nausea, vomiting, diarrhea, edema, musculoskeletal pain, abdominal pain, fatigue, upper respiratory tract infection, fever, headache, and dyspnea.
The recommended dose of midostaurin in AML is 50 mg twice daily with food on days 8 to 21 of each cycle of induction and consolidation chemotherapy followed by 50 mg with food as a single agent for up to 12 months. The recommended dose for the treatment of adults with aggressive SM, SM with associated hematological neoplasm, or mast cell leukemia is 100 mg twice daily with food, the FDA said.
Midostaurin will be marketed as Rydapt by Novartis Pharmaceuticals.
FDA issues warning to companies selling illegal cancer treatments
The Food and Drug Administration has issued a warning to 14 U.S. companies that are illegally selling more than 65 products purported to prevent, diagnose, treat, or cure cancer, according to an FDA safety alert.
Product types include pills, topical creams, ointments, oils, drops, syrups, teas, and diagnostic tools. The affected products are usually sold online or through social media.
Find the full safety alert on the FDA website.
The Food and Drug Administration has issued a warning to 14 U.S. companies that are illegally selling more than 65 products purported to prevent, diagnose, treat, or cure cancer, according to an FDA safety alert.
Product types include pills, topical creams, ointments, oils, drops, syrups, teas, and diagnostic tools. The affected products are usually sold online or through social media.
Find the full safety alert on the FDA website.
The Food and Drug Administration has issued a warning to 14 U.S. companies that are illegally selling more than 65 products purported to prevent, diagnose, treat, or cure cancer, according to an FDA safety alert.
Product types include pills, topical creams, ointments, oils, drops, syrups, teas, and diagnostic tools. The affected products are usually sold online or through social media.
Find the full safety alert on the FDA website.
Preterm infants face increased pertussis risk
Pertussis is more likely in infants who are born prematurely, compared with infants carried to term, according to Dr. Øystein Rolandsen Riise of the Norwegian Institute of Public Health, Oslo, and associates.
Using data from the Medical Birth Registry of Norway, 713,166 children were monitored until the age of 2 years from 1998 to 2010, during which time 968 cases of pertussis were laboratory confirmed. The incidence rate in term infants was 67.9 cases per 100,000 person-years, and was 115.2 cases per 100,000 person-years for preterm infants. The overall incidence rate ratio (IRR) of pertussis for preterm infants was 1.65, compared with term infants.
Hospitalization due to pertussis also was significantly more likely in preterm infants, with an overall IRR of 1.99, and infants born at 23-27 weeks again faced a greatly increased risk, with an IRR of 5.28.
Three-dose vaccine effectiveness against reported pertussis was 88.8% in term infants and 93% in preterm infants.
“Early and timely pediatric vaccinations as well as other strategies to prevent transmission to preterm infants are of utmost importance,” the investigators wrote.
Find the full study in the Pediatric Infectious Disease Journal (2017 May. doi: 10.1097/INF.0000000000001545).
Pertussis is more likely in infants who are born prematurely, compared with infants carried to term, according to Dr. Øystein Rolandsen Riise of the Norwegian Institute of Public Health, Oslo, and associates.
Using data from the Medical Birth Registry of Norway, 713,166 children were monitored until the age of 2 years from 1998 to 2010, during which time 968 cases of pertussis were laboratory confirmed. The incidence rate in term infants was 67.9 cases per 100,000 person-years, and was 115.2 cases per 100,000 person-years for preterm infants. The overall incidence rate ratio (IRR) of pertussis for preterm infants was 1.65, compared with term infants.
Hospitalization due to pertussis also was significantly more likely in preterm infants, with an overall IRR of 1.99, and infants born at 23-27 weeks again faced a greatly increased risk, with an IRR of 5.28.
Three-dose vaccine effectiveness against reported pertussis was 88.8% in term infants and 93% in preterm infants.
“Early and timely pediatric vaccinations as well as other strategies to prevent transmission to preterm infants are of utmost importance,” the investigators wrote.
Find the full study in the Pediatric Infectious Disease Journal (2017 May. doi: 10.1097/INF.0000000000001545).
Pertussis is more likely in infants who are born prematurely, compared with infants carried to term, according to Dr. Øystein Rolandsen Riise of the Norwegian Institute of Public Health, Oslo, and associates.
Using data from the Medical Birth Registry of Norway, 713,166 children were monitored until the age of 2 years from 1998 to 2010, during which time 968 cases of pertussis were laboratory confirmed. The incidence rate in term infants was 67.9 cases per 100,000 person-years, and was 115.2 cases per 100,000 person-years for preterm infants. The overall incidence rate ratio (IRR) of pertussis for preterm infants was 1.65, compared with term infants.
Hospitalization due to pertussis also was significantly more likely in preterm infants, with an overall IRR of 1.99, and infants born at 23-27 weeks again faced a greatly increased risk, with an IRR of 5.28.
Three-dose vaccine effectiveness against reported pertussis was 88.8% in term infants and 93% in preterm infants.
“Early and timely pediatric vaccinations as well as other strategies to prevent transmission to preterm infants are of utmost importance,” the investigators wrote.
Find the full study in the Pediatric Infectious Disease Journal (2017 May. doi: 10.1097/INF.0000000000001545).
Infliximab safe for recently vaccinated Kawasaki patients
Infliximab is safe to use in infants and young children with Kawasaki disease (KD) who have recently received live viral vaccinations, reported Aaron M. Lee, MS, and his associates at Rady Children’s Hospital-San Diego.
The study included 38 children, aged either less than 18 months or 4-6 years, who received either a 5 mg/kg or a 10 mg/kg dose of infliximab within 90 days of receiving a live vaccination of MMR, varicella-zoster virus, or rotavirus. During a 90-day follow-up period, no serious infections requiring antimicrobial therapy or hospitalization were reported. A single patient who received an MMR/VZV vaccine 42 days before infliximab treatment developed urticaria 15 minutes after the infliximab transfusion began, which was resolved with hydroxyzine.
“The data presented here suggest that a single dose of infliximab can be safely administered to acute KD patients regardless of recent live virus vaccination,” the investigators concluded.
Find the full report in the Pediatric Infectious Disease Journal (2017 Apr;36(4):435-7).
Infliximab is safe to use in infants and young children with Kawasaki disease (KD) who have recently received live viral vaccinations, reported Aaron M. Lee, MS, and his associates at Rady Children’s Hospital-San Diego.
The study included 38 children, aged either less than 18 months or 4-6 years, who received either a 5 mg/kg or a 10 mg/kg dose of infliximab within 90 days of receiving a live vaccination of MMR, varicella-zoster virus, or rotavirus. During a 90-day follow-up period, no serious infections requiring antimicrobial therapy or hospitalization were reported. A single patient who received an MMR/VZV vaccine 42 days before infliximab treatment developed urticaria 15 minutes after the infliximab transfusion began, which was resolved with hydroxyzine.
“The data presented here suggest that a single dose of infliximab can be safely administered to acute KD patients regardless of recent live virus vaccination,” the investigators concluded.
Find the full report in the Pediatric Infectious Disease Journal (2017 Apr;36(4):435-7).
Infliximab is safe to use in infants and young children with Kawasaki disease (KD) who have recently received live viral vaccinations, reported Aaron M. Lee, MS, and his associates at Rady Children’s Hospital-San Diego.
The study included 38 children, aged either less than 18 months or 4-6 years, who received either a 5 mg/kg or a 10 mg/kg dose of infliximab within 90 days of receiving a live vaccination of MMR, varicella-zoster virus, or rotavirus. During a 90-day follow-up period, no serious infections requiring antimicrobial therapy or hospitalization were reported. A single patient who received an MMR/VZV vaccine 42 days before infliximab treatment developed urticaria 15 minutes after the infliximab transfusion began, which was resolved with hydroxyzine.
“The data presented here suggest that a single dose of infliximab can be safely administered to acute KD patients regardless of recent live virus vaccination,” the investigators concluded.
Find the full report in the Pediatric Infectious Disease Journal (2017 Apr;36(4):435-7).
FROM THE PEDIATRIC INFECTIOUS DISEASE JOURNAL
FDA approves deutetrabenazine for Huntington’s-associated chorea
The Food and Drug Administration has approved deutetrabenazine (Austedo) for the treatment of chorea associated with Huntington’s disease, according to an announcement by the drug’s manufacturer, Teva Pharmaceutical.
The random, sudden, involuntary twisting and writhing movements of chorea constitute perhaps the most striking symptom of Huntington’s disease and affect about 90% of the roughly 35,000 Americans with the fatal neurodegenerative disorder. Deutetrabenazine is only the second product approved to treat Huntington’s in any capacity, and it is the first in nearly a decade.
The most common side effects of deutetrabenazine were somnolence, diarrhea, dry mouth, and fatigue. Deutetrabenazine is contraindicated in patients with hepatic impairment; patients taking monoamine oxidase inhibitors (MAOIs), or within 14 days of discontinuing MAOI therapy; patients taking reserpine or within 20 days of discontinuing reserpine; and patients taking tetrabenazine. Deutetrabenazine can cause worsening of mood and is not recommended for suicidal patients or patients with improperly treated depression.
“Chorea associated with Huntington’s disease has a significant impact on those living with the disease and their families. The FDA’s approval of Austedo represents an important new treatment option for people with HD and highlights the need for more therapeutic resources for this underserved patient community,” Louise Vetter, CEO of the Huntington’s Disease Society of America, said in the company’s announcement.
The Food and Drug Administration has approved deutetrabenazine (Austedo) for the treatment of chorea associated with Huntington’s disease, according to an announcement by the drug’s manufacturer, Teva Pharmaceutical.
The random, sudden, involuntary twisting and writhing movements of chorea constitute perhaps the most striking symptom of Huntington’s disease and affect about 90% of the roughly 35,000 Americans with the fatal neurodegenerative disorder. Deutetrabenazine is only the second product approved to treat Huntington’s in any capacity, and it is the first in nearly a decade.
The most common side effects of deutetrabenazine were somnolence, diarrhea, dry mouth, and fatigue. Deutetrabenazine is contraindicated in patients with hepatic impairment; patients taking monoamine oxidase inhibitors (MAOIs), or within 14 days of discontinuing MAOI therapy; patients taking reserpine or within 20 days of discontinuing reserpine; and patients taking tetrabenazine. Deutetrabenazine can cause worsening of mood and is not recommended for suicidal patients or patients with improperly treated depression.
“Chorea associated with Huntington’s disease has a significant impact on those living with the disease and their families. The FDA’s approval of Austedo represents an important new treatment option for people with HD and highlights the need for more therapeutic resources for this underserved patient community,” Louise Vetter, CEO of the Huntington’s Disease Society of America, said in the company’s announcement.
The Food and Drug Administration has approved deutetrabenazine (Austedo) for the treatment of chorea associated with Huntington’s disease, according to an announcement by the drug’s manufacturer, Teva Pharmaceutical.
The random, sudden, involuntary twisting and writhing movements of chorea constitute perhaps the most striking symptom of Huntington’s disease and affect about 90% of the roughly 35,000 Americans with the fatal neurodegenerative disorder. Deutetrabenazine is only the second product approved to treat Huntington’s in any capacity, and it is the first in nearly a decade.
The most common side effects of deutetrabenazine were somnolence, diarrhea, dry mouth, and fatigue. Deutetrabenazine is contraindicated in patients with hepatic impairment; patients taking monoamine oxidase inhibitors (MAOIs), or within 14 days of discontinuing MAOI therapy; patients taking reserpine or within 20 days of discontinuing reserpine; and patients taking tetrabenazine. Deutetrabenazine can cause worsening of mood and is not recommended for suicidal patients or patients with improperly treated depression.
“Chorea associated with Huntington’s disease has a significant impact on those living with the disease and their families. The FDA’s approval of Austedo represents an important new treatment option for people with HD and highlights the need for more therapeutic resources for this underserved patient community,” Louise Vetter, CEO of the Huntington’s Disease Society of America, said in the company’s announcement.
Ebola vaccine maintains immune response after 1 year
People who received an Ebola virus vaccine maintained immune response one year after vaccination, according to a research letter from Rebecca L.Winslow, MRCGP, of the University of Oxford (UK) and her associates.
The immune response of 64 vaccine recipients of European descent 360 days after receiving either adenovirus type 26 vector vaccine encoding Ebolavirus glycoprotein (Ad26.ZEBOV) followed by modified vaccinia virus Ankara vector vaccine (MVA-BN-Filo), or MVA-BN-Filo followed by Ad26.ZEBOV. The 360 day follow-up occurred 120 days after the previous follow-up, during which time no significant adverse events were reported.
“Immune responses may differ in a sub-Saharan African population; these vaccine candidates are being assessed in this region. Additional research is also warranted to explore the persistence of immunity beyond 1 year following immunization and response to booster doses of vaccine,” the investigators concluded.
Find the full research letter in JAMA (doi: 10.1001/jama.2016.20644)
People who received an Ebola virus vaccine maintained immune response one year after vaccination, according to a research letter from Rebecca L.Winslow, MRCGP, of the University of Oxford (UK) and her associates.
The immune response of 64 vaccine recipients of European descent 360 days after receiving either adenovirus type 26 vector vaccine encoding Ebolavirus glycoprotein (Ad26.ZEBOV) followed by modified vaccinia virus Ankara vector vaccine (MVA-BN-Filo), or MVA-BN-Filo followed by Ad26.ZEBOV. The 360 day follow-up occurred 120 days after the previous follow-up, during which time no significant adverse events were reported.
“Immune responses may differ in a sub-Saharan African population; these vaccine candidates are being assessed in this region. Additional research is also warranted to explore the persistence of immunity beyond 1 year following immunization and response to booster doses of vaccine,” the investigators concluded.
Find the full research letter in JAMA (doi: 10.1001/jama.2016.20644)
People who received an Ebola virus vaccine maintained immune response one year after vaccination, according to a research letter from Rebecca L.Winslow, MRCGP, of the University of Oxford (UK) and her associates.
The immune response of 64 vaccine recipients of European descent 360 days after receiving either adenovirus type 26 vector vaccine encoding Ebolavirus glycoprotein (Ad26.ZEBOV) followed by modified vaccinia virus Ankara vector vaccine (MVA-BN-Filo), or MVA-BN-Filo followed by Ad26.ZEBOV. The 360 day follow-up occurred 120 days after the previous follow-up, during which time no significant adverse events were reported.
“Immune responses may differ in a sub-Saharan African population; these vaccine candidates are being assessed in this region. Additional research is also warranted to explore the persistence of immunity beyond 1 year following immunization and response to booster doses of vaccine,” the investigators concluded.
Find the full research letter in JAMA (doi: 10.1001/jama.2016.20644)
FROM JAMA
FDA: Recall of select EpiPen products
Meridian Medical Technologies has issued a voluntary recall for 13 lots of EpiPen products, according to a press release from the U.S. Food and Drug Administration.
The voluntary recall includes EpiPen and EpiPen Jr. Auto-Injector distributed between Dec. 17, 2015, and July 1, 2016 by Mylan Specialty. Products included in the recall may contain a defective part which would prevent the device from activating.
Consumers who need their EpiPens should keep them until a they obtain a replacement, the FDA recommended.
Find the full press release on the FDA website.
Meridian Medical Technologies has issued a voluntary recall for 13 lots of EpiPen products, according to a press release from the U.S. Food and Drug Administration.
The voluntary recall includes EpiPen and EpiPen Jr. Auto-Injector distributed between Dec. 17, 2015, and July 1, 2016 by Mylan Specialty. Products included in the recall may contain a defective part which would prevent the device from activating.
Consumers who need their EpiPens should keep them until a they obtain a replacement, the FDA recommended.
Find the full press release on the FDA website.
Meridian Medical Technologies has issued a voluntary recall for 13 lots of EpiPen products, according to a press release from the U.S. Food and Drug Administration.
The voluntary recall includes EpiPen and EpiPen Jr. Auto-Injector distributed between Dec. 17, 2015, and July 1, 2016 by Mylan Specialty. Products included in the recall may contain a defective part which would prevent the device from activating.
Consumers who need their EpiPens should keep them until a they obtain a replacement, the FDA recommended.
Find the full press release on the FDA website.