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FDA approves first-in-class oral antiplatelet drug vorapaxar
The novel antiplatelet drug vorapaxar has been approved for reducing the risk of myocardial infarction, stroke, cardiovascular death, and need for coronary revascularization procedures in patients with a previous MI or peripheral arterial disease, the Food and Drug Administration announced on May 8.
Vorapaxar is an antagonist of protease-activated receptor-1 (PAR-1), which inhibits the action of thrombin on the platelet, and is the first drug in this class to be approved. Merck Sharp & Dohme Corp. will market the drug as Zontivity. It comes in a tablet formulation.
At a meeting in January, the FDA’s Cardiovascular and Renal Drugs Advisory Committee voted 10-1 to recommend approval of vorapaxar.
"In patients who have had a heart attack or who have peripheral arterial disease, this drug will lower the risk of heart attack, stroke, and cardiovascular death," Dr. Ellis F. Unger, director of the Office of Drug Evaluation I in the FDA’s Center for Drug Evaluation and Research, said in the FDA statement. "In the study that supported the drug’s approval, Zontivity lowered this risk from 9.5% to 7.9% over a 3-year period – about 0.5% per year," he noted.
Because of the increased risk of bleeding, including life-threatening and fatal bleeding, the drug’s prescribing information includes a boxed warning about this risk and a medication guide informing patients about these risks and how to use the drug will be provided with each dispensed prescription. A history of stroke, or transient ischemic attack, and a history of intracranial bleeding are contraindications.
The novel antiplatelet drug vorapaxar has been approved for reducing the risk of myocardial infarction, stroke, cardiovascular death, and need for coronary revascularization procedures in patients with a previous MI or peripheral arterial disease, the Food and Drug Administration announced on May 8.
Vorapaxar is an antagonist of protease-activated receptor-1 (PAR-1), which inhibits the action of thrombin on the platelet, and is the first drug in this class to be approved. Merck Sharp & Dohme Corp. will market the drug as Zontivity. It comes in a tablet formulation.
At a meeting in January, the FDA’s Cardiovascular and Renal Drugs Advisory Committee voted 10-1 to recommend approval of vorapaxar.
"In patients who have had a heart attack or who have peripheral arterial disease, this drug will lower the risk of heart attack, stroke, and cardiovascular death," Dr. Ellis F. Unger, director of the Office of Drug Evaluation I in the FDA’s Center for Drug Evaluation and Research, said in the FDA statement. "In the study that supported the drug’s approval, Zontivity lowered this risk from 9.5% to 7.9% over a 3-year period – about 0.5% per year," he noted.
Because of the increased risk of bleeding, including life-threatening and fatal bleeding, the drug’s prescribing information includes a boxed warning about this risk and a medication guide informing patients about these risks and how to use the drug will be provided with each dispensed prescription. A history of stroke, or transient ischemic attack, and a history of intracranial bleeding are contraindications.
The novel antiplatelet drug vorapaxar has been approved for reducing the risk of myocardial infarction, stroke, cardiovascular death, and need for coronary revascularization procedures in patients with a previous MI or peripheral arterial disease, the Food and Drug Administration announced on May 8.
Vorapaxar is an antagonist of protease-activated receptor-1 (PAR-1), which inhibits the action of thrombin on the platelet, and is the first drug in this class to be approved. Merck Sharp & Dohme Corp. will market the drug as Zontivity. It comes in a tablet formulation.
At a meeting in January, the FDA’s Cardiovascular and Renal Drugs Advisory Committee voted 10-1 to recommend approval of vorapaxar.
"In patients who have had a heart attack or who have peripheral arterial disease, this drug will lower the risk of heart attack, stroke, and cardiovascular death," Dr. Ellis F. Unger, director of the Office of Drug Evaluation I in the FDA’s Center for Drug Evaluation and Research, said in the FDA statement. "In the study that supported the drug’s approval, Zontivity lowered this risk from 9.5% to 7.9% over a 3-year period – about 0.5% per year," he noted.
Because of the increased risk of bleeding, including life-threatening and fatal bleeding, the drug’s prescribing information includes a boxed warning about this risk and a medication guide informing patients about these risks and how to use the drug will be provided with each dispensed prescription. A history of stroke, or transient ischemic attack, and a history of intracranial bleeding are contraindications.
FDA declines to approve IV antiplatelet drug cangrelor
The Food and Drug Administration has rejected the approval of the intravenous antiplatelet drug cangrelor, suggesting that the company provide more data, according to the drug’s manufacturer.
The Medicines Company applied for approval of cangrelor for two indications: the reduction of death, MI, stent thrombosis, and ischemic-driven revascularization in patients who have not been recently treated with a thienopyridine and who are undergoing PCI; and for patients with stents who are at an increased risk for thrombotic events, such as stent thrombosis, when oral P2Y12 therapy is interrupted for surgery.
At a meeting earlier this year, the FDA’s Cardiovascular and Renal Drugs Advisory Committee voted 7-2 against approval of the first indication, and unanimously voted against approval of the second indication, citing numerous issues with clinical trials.
The company’s April 30 statement announcing the FDA decision said that the agency had suggested that the company conduct "a series of data analyses" from the CHAMPION PHOENIX study that was the basis of the PCI indication (N. Engl. J. Med. 2013;368:1303-13).
The FDA also concluded that a prospective controlled study to evaluate the risk-benefit of cangrelor for the second bridging indication with outcomes that included bleeding was needed, the statement said. For this indication, the company had submitted only a small pharmacodynamic study, which showed that a cangrelor infusion could maintain platelet inhibition similar to that achieved with clopidogrel.
In the statement Dr. Clive A. Meanwell, the company’s chairman and chief executive officer, said that "the next steps of review will focus on additional analyses in response to the FDA."
Cangrelor is a platelet P2Y12 inhibitor administered intravenously; with a half-life of 3-6 minutes, platelet function returns to normal within 1 hour of stopping the infusion of cangrelor, according to the company. The oral P2Y12 inhibitor clopidogrel has a more delayed action, with activity that lasts for days after is stopped.
The Food and Drug Administration has rejected the approval of the intravenous antiplatelet drug cangrelor, suggesting that the company provide more data, according to the drug’s manufacturer.
The Medicines Company applied for approval of cangrelor for two indications: the reduction of death, MI, stent thrombosis, and ischemic-driven revascularization in patients who have not been recently treated with a thienopyridine and who are undergoing PCI; and for patients with stents who are at an increased risk for thrombotic events, such as stent thrombosis, when oral P2Y12 therapy is interrupted for surgery.
At a meeting earlier this year, the FDA’s Cardiovascular and Renal Drugs Advisory Committee voted 7-2 against approval of the first indication, and unanimously voted against approval of the second indication, citing numerous issues with clinical trials.
The company’s April 30 statement announcing the FDA decision said that the agency had suggested that the company conduct "a series of data analyses" from the CHAMPION PHOENIX study that was the basis of the PCI indication (N. Engl. J. Med. 2013;368:1303-13).
The FDA also concluded that a prospective controlled study to evaluate the risk-benefit of cangrelor for the second bridging indication with outcomes that included bleeding was needed, the statement said. For this indication, the company had submitted only a small pharmacodynamic study, which showed that a cangrelor infusion could maintain platelet inhibition similar to that achieved with clopidogrel.
In the statement Dr. Clive A. Meanwell, the company’s chairman and chief executive officer, said that "the next steps of review will focus on additional analyses in response to the FDA."
Cangrelor is a platelet P2Y12 inhibitor administered intravenously; with a half-life of 3-6 minutes, platelet function returns to normal within 1 hour of stopping the infusion of cangrelor, according to the company. The oral P2Y12 inhibitor clopidogrel has a more delayed action, with activity that lasts for days after is stopped.
The Food and Drug Administration has rejected the approval of the intravenous antiplatelet drug cangrelor, suggesting that the company provide more data, according to the drug’s manufacturer.
The Medicines Company applied for approval of cangrelor for two indications: the reduction of death, MI, stent thrombosis, and ischemic-driven revascularization in patients who have not been recently treated with a thienopyridine and who are undergoing PCI; and for patients with stents who are at an increased risk for thrombotic events, such as stent thrombosis, when oral P2Y12 therapy is interrupted for surgery.
At a meeting earlier this year, the FDA’s Cardiovascular and Renal Drugs Advisory Committee voted 7-2 against approval of the first indication, and unanimously voted against approval of the second indication, citing numerous issues with clinical trials.
The company’s April 30 statement announcing the FDA decision said that the agency had suggested that the company conduct "a series of data analyses" from the CHAMPION PHOENIX study that was the basis of the PCI indication (N. Engl. J. Med. 2013;368:1303-13).
The FDA also concluded that a prospective controlled study to evaluate the risk-benefit of cangrelor for the second bridging indication with outcomes that included bleeding was needed, the statement said. For this indication, the company had submitted only a small pharmacodynamic study, which showed that a cangrelor infusion could maintain platelet inhibition similar to that achieved with clopidogrel.
In the statement Dr. Clive A. Meanwell, the company’s chairman and chief executive officer, said that "the next steps of review will focus on additional analyses in response to the FDA."
Cangrelor is a platelet P2Y12 inhibitor administered intravenously; with a half-life of 3-6 minutes, platelet function returns to normal within 1 hour of stopping the infusion of cangrelor, according to the company. The oral P2Y12 inhibitor clopidogrel has a more delayed action, with activity that lasts for days after is stopped.
INR test strips recalled due to reports of inaccurate results
Professional international normalized ratio test strips manufactured by Alere are being recalled because of reports of "inaccurately low" results, including several cases of bleeding-related fatalities.
The recall applies to the "Alere INRatio2 PT/INR Professional Test Strips (PN 99008G2)," according to a company statement posted on the Food and Drug Administration’s website. The company says there have been complaints of patients with an INR in the therapeutic or near-therapeutic range with the test strip, but whose INR was significantly higher, falling outside the therapeutic range, when tested by a central laboratory.
Alere has received nine serious adverse event reports for the test strips, which included three fatal cases of bleeding. In the nine cases, the results with the Alere INRatio2 PT/INR Professional Test Strips were 3.1-12.2 INR units lower than the laboratory plasma INR test results – a significant difference, according to the statement.
"The root cause for this issue has not yet been determined; therefore Alere cannot determine the patient conditions or circumstances that may contribute to the discrepancy," the statement said. The company is advising customers about the problem and to immediately stop using these products "and use an alternative method to perform PT/INR testing, such as a plasma-based laboratory INR test, an alternative Alere product, or an alternative point-of-care monitoring system from a different manufacturer."
The company is also requesting that customers send unused product back to the company.
The recall does not apply to Alere INRatio PT/INR Test Strips (PN 100071), used by patients at home. The recall was voluntary, initiated by Alere.
Adverse events or quality issues associated with this product should be reported to the FDA at www.fda.gov/medwatch or 800-332-1088. Questions about the recall and how to get replacement products should be directed to Alere at 844-292-5373; information is also available at www.inr-care.com/.
Professional international normalized ratio test strips manufactured by Alere are being recalled because of reports of "inaccurately low" results, including several cases of bleeding-related fatalities.
The recall applies to the "Alere INRatio2 PT/INR Professional Test Strips (PN 99008G2)," according to a company statement posted on the Food and Drug Administration’s website. The company says there have been complaints of patients with an INR in the therapeutic or near-therapeutic range with the test strip, but whose INR was significantly higher, falling outside the therapeutic range, when tested by a central laboratory.
Alere has received nine serious adverse event reports for the test strips, which included three fatal cases of bleeding. In the nine cases, the results with the Alere INRatio2 PT/INR Professional Test Strips were 3.1-12.2 INR units lower than the laboratory plasma INR test results – a significant difference, according to the statement.
"The root cause for this issue has not yet been determined; therefore Alere cannot determine the patient conditions or circumstances that may contribute to the discrepancy," the statement said. The company is advising customers about the problem and to immediately stop using these products "and use an alternative method to perform PT/INR testing, such as a plasma-based laboratory INR test, an alternative Alere product, or an alternative point-of-care monitoring system from a different manufacturer."
The company is also requesting that customers send unused product back to the company.
The recall does not apply to Alere INRatio PT/INR Test Strips (PN 100071), used by patients at home. The recall was voluntary, initiated by Alere.
Adverse events or quality issues associated with this product should be reported to the FDA at www.fda.gov/medwatch or 800-332-1088. Questions about the recall and how to get replacement products should be directed to Alere at 844-292-5373; information is also available at www.inr-care.com/.
Professional international normalized ratio test strips manufactured by Alere are being recalled because of reports of "inaccurately low" results, including several cases of bleeding-related fatalities.
The recall applies to the "Alere INRatio2 PT/INR Professional Test Strips (PN 99008G2)," according to a company statement posted on the Food and Drug Administration’s website. The company says there have been complaints of patients with an INR in the therapeutic or near-therapeutic range with the test strip, but whose INR was significantly higher, falling outside the therapeutic range, when tested by a central laboratory.
Alere has received nine serious adverse event reports for the test strips, which included three fatal cases of bleeding. In the nine cases, the results with the Alere INRatio2 PT/INR Professional Test Strips were 3.1-12.2 INR units lower than the laboratory plasma INR test results – a significant difference, according to the statement.
"The root cause for this issue has not yet been determined; therefore Alere cannot determine the patient conditions or circumstances that may contribute to the discrepancy," the statement said. The company is advising customers about the problem and to immediately stop using these products "and use an alternative method to perform PT/INR testing, such as a plasma-based laboratory INR test, an alternative Alere product, or an alternative point-of-care monitoring system from a different manufacturer."
The company is also requesting that customers send unused product back to the company.
The recall does not apply to Alere INRatio PT/INR Test Strips (PN 100071), used by patients at home. The recall was voluntary, initiated by Alere.
Adverse events or quality issues associated with this product should be reported to the FDA at www.fda.gov/medwatch or 800-332-1088. Questions about the recall and how to get replacement products should be directed to Alere at 844-292-5373; information is also available at www.inr-care.com/.
New Option for Severe Hypertriglyceridemia
Another omega-3 fatty acid formulation—omega-3 carboxylic acids—has been approved by the Food and Drug Administration for treating adults with severe hypertriglyceridemia, the manufacturer, AstraZeneca, announced.
The product will be available in 1-g capsules, the recommended dosages are 2 g or 4 g per day, and it will be marketed as Epanova, the statement said.
The prescribing information describes Epanova as "a fish oil–derived mixture of free fatty acids primarily composed of EPA [eicosapentaenoic acid] and DHA [docosahexaenoic acid]." The approved indication is as an adjunct to diet to reduce triglyceride levels in adults with severe hypertriglyceridemia (triglycerides of 500 mg/dL or greater).
Approval was based on the results of EVOLVE (Epanova for Lowering Very High Triglycerides), a phase III study that evaluated the effects of Epanova on triglycerides and other lipids in patients with very high triglyceride levels, according to the company.
"The effect of EPANOVA on the risk of pancreatitis or on cardiovascular mortality and morbidity has not been determined," the statement said.
AstraZeneca is pursuing approval of Epanova as a treatment for severe hypertriglyceridemia in other countries, and is planning to develop a fixed-dose combination of Epanova with a statin.
The safety and efficacy of Epanova plus statin therapy will be evaluated in the STRENGTH (Statin Residual Risk Reduction With Epanova in High Cardiovascular Risk Patients With Hypertriglyceridemia) trial, a large cardiovascular outcomes study of patients with mixed dyslipidemia who are at an increased risk of cardiovascular disease, according to the company.
The study is a randomized, double-blind, controlled trial that will compare a corn oil capsule plus a statin or Epanova plus a statin, once a day for about 3-5 years in about 13,000 patients, according to the clinicaltrials.gov website. The primary outcome will be the time to the first occurrence of any component of the composite of major adverse cardiac events (cardiovascular death, nonfatal MI, nonfatal stroke, emergent/elective coronary revascularization, or hospitalization for unstable angina).
At a meeting in October 2013, the majority of the FDA’s Endocrinologic and Metabolic Drugs Advisory Committee recommended waiting for the results of an ongoing cardiovascular outcomes trial before expanding the approval of another omega-3 fatty acid, icosapent ethyl plus a statin, for reducing triglycerides in adults with mixed dyslipidemia who are at a high risk of coronary heart disease. Panelists said the results of that study (REDUCE-IT) were needed before this indication was approved to determine if the beneficial effects of the combined treatment on lipids translated into improved cardiovascular outcomes. Icosapent ethyl, marketed as Vascepa, was approved in 2012 as a treatment for severe hypertriglyceridemia.
The Epanova prescribing information is available here.
Another omega-3 fatty acid formulation—omega-3 carboxylic acids—has been approved by the Food and Drug Administration for treating adults with severe hypertriglyceridemia, the manufacturer, AstraZeneca, announced.
The product will be available in 1-g capsules, the recommended dosages are 2 g or 4 g per day, and it will be marketed as Epanova, the statement said.
The prescribing information describes Epanova as "a fish oil–derived mixture of free fatty acids primarily composed of EPA [eicosapentaenoic acid] and DHA [docosahexaenoic acid]." The approved indication is as an adjunct to diet to reduce triglyceride levels in adults with severe hypertriglyceridemia (triglycerides of 500 mg/dL or greater).
Approval was based on the results of EVOLVE (Epanova for Lowering Very High Triglycerides), a phase III study that evaluated the effects of Epanova on triglycerides and other lipids in patients with very high triglyceride levels, according to the company.
"The effect of EPANOVA on the risk of pancreatitis or on cardiovascular mortality and morbidity has not been determined," the statement said.
AstraZeneca is pursuing approval of Epanova as a treatment for severe hypertriglyceridemia in other countries, and is planning to develop a fixed-dose combination of Epanova with a statin.
The safety and efficacy of Epanova plus statin therapy will be evaluated in the STRENGTH (Statin Residual Risk Reduction With Epanova in High Cardiovascular Risk Patients With Hypertriglyceridemia) trial, a large cardiovascular outcomes study of patients with mixed dyslipidemia who are at an increased risk of cardiovascular disease, according to the company.
The study is a randomized, double-blind, controlled trial that will compare a corn oil capsule plus a statin or Epanova plus a statin, once a day for about 3-5 years in about 13,000 patients, according to the clinicaltrials.gov website. The primary outcome will be the time to the first occurrence of any component of the composite of major adverse cardiac events (cardiovascular death, nonfatal MI, nonfatal stroke, emergent/elective coronary revascularization, or hospitalization for unstable angina).
At a meeting in October 2013, the majority of the FDA’s Endocrinologic and Metabolic Drugs Advisory Committee recommended waiting for the results of an ongoing cardiovascular outcomes trial before expanding the approval of another omega-3 fatty acid, icosapent ethyl plus a statin, for reducing triglycerides in adults with mixed dyslipidemia who are at a high risk of coronary heart disease. Panelists said the results of that study (REDUCE-IT) were needed before this indication was approved to determine if the beneficial effects of the combined treatment on lipids translated into improved cardiovascular outcomes. Icosapent ethyl, marketed as Vascepa, was approved in 2012 as a treatment for severe hypertriglyceridemia.
The Epanova prescribing information is available here.
Another omega-3 fatty acid formulation—omega-3 carboxylic acids—has been approved by the Food and Drug Administration for treating adults with severe hypertriglyceridemia, the manufacturer, AstraZeneca, announced.
The product will be available in 1-g capsules, the recommended dosages are 2 g or 4 g per day, and it will be marketed as Epanova, the statement said.
The prescribing information describes Epanova as "a fish oil–derived mixture of free fatty acids primarily composed of EPA [eicosapentaenoic acid] and DHA [docosahexaenoic acid]." The approved indication is as an adjunct to diet to reduce triglyceride levels in adults with severe hypertriglyceridemia (triglycerides of 500 mg/dL or greater).
Approval was based on the results of EVOLVE (Epanova for Lowering Very High Triglycerides), a phase III study that evaluated the effects of Epanova on triglycerides and other lipids in patients with very high triglyceride levels, according to the company.
"The effect of EPANOVA on the risk of pancreatitis or on cardiovascular mortality and morbidity has not been determined," the statement said.
AstraZeneca is pursuing approval of Epanova as a treatment for severe hypertriglyceridemia in other countries, and is planning to develop a fixed-dose combination of Epanova with a statin.
The safety and efficacy of Epanova plus statin therapy will be evaluated in the STRENGTH (Statin Residual Risk Reduction With Epanova in High Cardiovascular Risk Patients With Hypertriglyceridemia) trial, a large cardiovascular outcomes study of patients with mixed dyslipidemia who are at an increased risk of cardiovascular disease, according to the company.
The study is a randomized, double-blind, controlled trial that will compare a corn oil capsule plus a statin or Epanova plus a statin, once a day for about 3-5 years in about 13,000 patients, according to the clinicaltrials.gov website. The primary outcome will be the time to the first occurrence of any component of the composite of major adverse cardiac events (cardiovascular death, nonfatal MI, nonfatal stroke, emergent/elective coronary revascularization, or hospitalization for unstable angina).
At a meeting in October 2013, the majority of the FDA’s Endocrinologic and Metabolic Drugs Advisory Committee recommended waiting for the results of an ongoing cardiovascular outcomes trial before expanding the approval of another omega-3 fatty acid, icosapent ethyl plus a statin, for reducing triglycerides in adults with mixed dyslipidemia who are at a high risk of coronary heart disease. Panelists said the results of that study (REDUCE-IT) were needed before this indication was approved to determine if the beneficial effects of the combined treatment on lipids translated into improved cardiovascular outcomes. Icosapent ethyl, marketed as Vascepa, was approved in 2012 as a treatment for severe hypertriglyceridemia.
The Epanova prescribing information is available here.
New omega-3-fatty acid approved for severe hypertriglyceridemia
Another omega-3 fatty acid formulation – omega-3-carboxylic acids – has been approved by the Food and Drug Administration for treating adults with severe hypertriglyceridemia, the manufacturer, AstraZeneca, announced May 6.
The product will be available in 1-g capsules, the recommended dosages are 2 g or 4 g per day, and it will be marketed as Epanova, the statement said.
The prescribing information describes Epanova as "a fish oil–derived mixture of free fatty acids primarily composed of EPA [eicosapentaenoic acid] and DHA [docosahexaenoic acid]." The approved indication is as an adjunct to diet to reduce triglyceride levels in adults with severe hypertriglyceridemia (triglycerides of 500 mg/dL or greater).
Approval was based on the results of EVOLVE (Epanova for Lowering Very High Triglycerides), a phase III study that evaluated the effects of Epanova on triglycerides and other lipids in patients with very high triglyceride levels, according to the company.
"The effect of EPANOVA on the risk of pancreatitis or on cardiovascular mortality and morbidity has not been determined," the statement said.
AstraZeneca is pursuing approval of Epanova as a treatment for severe hypertriglyceridemia in other countries, and is planning to develop a fixed-dose combination of Epanova with a statin.
The safety and efficacy of Epanova plus statin therapy will be evaluated in the STRENGTH (Statin Residual Risk Reduction With Epanova in High Cardiovascular Risk Patients With Hypertriglyceridemia) trial, a large cardiovascular outcomes study of patients with mixed dyslipidemia who are at an increased risk of cardiovascular disease, according to the company.
The study is a randomized, double-blind, controlled trial that will compare a corn oil capsule plus a statin or Epanova plus a statin, once a day for about 3-5 years in about 13,000 patients, according to the clinicaltrials.gov website. The primary outcome will be the time to the first occurrence of any component of the composite of major adverse cardiac events (cardiovascular death, nonfatal MI, nonfatal stroke, emergent/elective coronary revascularization, or hospitalization for unstable angina).
At a meeting in October 2013, the majority of the FDA’s Endocrinologic and Metabolic Drugs Advisory Committee recommended waiting for the results of an ongoing cardiovascular outcomes trial before expanding the approval of another omega-3 fatty acid, icosapent ethyl plus a statin, for reducing triglycerides in adults with mixed dyslipidemia who are at a high risk of coronary heart disease. Panelists said the results of that study (REDUCE-IT) were needed before this indication was approved to determine if the beneficial effects of the combined treatment on lipids translated into improved cardiovascular outcomes. Icosapent ethyl, marketed as Vascepa, was approved in 2012 as a treatment for severe hypertriglyceridemia.
The Epanova prescribing information is available here.
Another omega-3 fatty acid formulation – omega-3-carboxylic acids – has been approved by the Food and Drug Administration for treating adults with severe hypertriglyceridemia, the manufacturer, AstraZeneca, announced May 6.
The product will be available in 1-g capsules, the recommended dosages are 2 g or 4 g per day, and it will be marketed as Epanova, the statement said.
The prescribing information describes Epanova as "a fish oil–derived mixture of free fatty acids primarily composed of EPA [eicosapentaenoic acid] and DHA [docosahexaenoic acid]." The approved indication is as an adjunct to diet to reduce triglyceride levels in adults with severe hypertriglyceridemia (triglycerides of 500 mg/dL or greater).
Approval was based on the results of EVOLVE (Epanova for Lowering Very High Triglycerides), a phase III study that evaluated the effects of Epanova on triglycerides and other lipids in patients with very high triglyceride levels, according to the company.
"The effect of EPANOVA on the risk of pancreatitis or on cardiovascular mortality and morbidity has not been determined," the statement said.
AstraZeneca is pursuing approval of Epanova as a treatment for severe hypertriglyceridemia in other countries, and is planning to develop a fixed-dose combination of Epanova with a statin.
The safety and efficacy of Epanova plus statin therapy will be evaluated in the STRENGTH (Statin Residual Risk Reduction With Epanova in High Cardiovascular Risk Patients With Hypertriglyceridemia) trial, a large cardiovascular outcomes study of patients with mixed dyslipidemia who are at an increased risk of cardiovascular disease, according to the company.
The study is a randomized, double-blind, controlled trial that will compare a corn oil capsule plus a statin or Epanova plus a statin, once a day for about 3-5 years in about 13,000 patients, according to the clinicaltrials.gov website. The primary outcome will be the time to the first occurrence of any component of the composite of major adverse cardiac events (cardiovascular death, nonfatal MI, nonfatal stroke, emergent/elective coronary revascularization, or hospitalization for unstable angina).
At a meeting in October 2013, the majority of the FDA’s Endocrinologic and Metabolic Drugs Advisory Committee recommended waiting for the results of an ongoing cardiovascular outcomes trial before expanding the approval of another omega-3 fatty acid, icosapent ethyl plus a statin, for reducing triglycerides in adults with mixed dyslipidemia who are at a high risk of coronary heart disease. Panelists said the results of that study (REDUCE-IT) were needed before this indication was approved to determine if the beneficial effects of the combined treatment on lipids translated into improved cardiovascular outcomes. Icosapent ethyl, marketed as Vascepa, was approved in 2012 as a treatment for severe hypertriglyceridemia.
The Epanova prescribing information is available here.
Another omega-3 fatty acid formulation – omega-3-carboxylic acids – has been approved by the Food and Drug Administration for treating adults with severe hypertriglyceridemia, the manufacturer, AstraZeneca, announced May 6.
The product will be available in 1-g capsules, the recommended dosages are 2 g or 4 g per day, and it will be marketed as Epanova, the statement said.
The prescribing information describes Epanova as "a fish oil–derived mixture of free fatty acids primarily composed of EPA [eicosapentaenoic acid] and DHA [docosahexaenoic acid]." The approved indication is as an adjunct to diet to reduce triglyceride levels in adults with severe hypertriglyceridemia (triglycerides of 500 mg/dL or greater).
Approval was based on the results of EVOLVE (Epanova for Lowering Very High Triglycerides), a phase III study that evaluated the effects of Epanova on triglycerides and other lipids in patients with very high triglyceride levels, according to the company.
"The effect of EPANOVA on the risk of pancreatitis or on cardiovascular mortality and morbidity has not been determined," the statement said.
AstraZeneca is pursuing approval of Epanova as a treatment for severe hypertriglyceridemia in other countries, and is planning to develop a fixed-dose combination of Epanova with a statin.
The safety and efficacy of Epanova plus statin therapy will be evaluated in the STRENGTH (Statin Residual Risk Reduction With Epanova in High Cardiovascular Risk Patients With Hypertriglyceridemia) trial, a large cardiovascular outcomes study of patients with mixed dyslipidemia who are at an increased risk of cardiovascular disease, according to the company.
The study is a randomized, double-blind, controlled trial that will compare a corn oil capsule plus a statin or Epanova plus a statin, once a day for about 3-5 years in about 13,000 patients, according to the clinicaltrials.gov website. The primary outcome will be the time to the first occurrence of any component of the composite of major adverse cardiac events (cardiovascular death, nonfatal MI, nonfatal stroke, emergent/elective coronary revascularization, or hospitalization for unstable angina).
At a meeting in October 2013, the majority of the FDA’s Endocrinologic and Metabolic Drugs Advisory Committee recommended waiting for the results of an ongoing cardiovascular outcomes trial before expanding the approval of another omega-3 fatty acid, icosapent ethyl plus a statin, for reducing triglycerides in adults with mixed dyslipidemia who are at a high risk of coronary heart disease. Panelists said the results of that study (REDUCE-IT) were needed before this indication was approved to determine if the beneficial effects of the combined treatment on lipids translated into improved cardiovascular outcomes. Icosapent ethyl, marketed as Vascepa, was approved in 2012 as a treatment for severe hypertriglyceridemia.
The Epanova prescribing information is available here.
Second ALK tyrosine kinase inhibitor approved for late-stage lung cancer
Ceritinib, an anaplastic lymphoma kinase (ALK) tyrosine kinase inhibitor, has been approved for the treatment of metastatic ALK-positive non–small cell lung cancer, in patients who have progressed on or are intolerant to crizotinib, the Food and Drug Administration announced on April 29.
The accelerated approval of ceritinib, marketed as Zykadia by Novartis, was based on the tumor response rate and duration of the response in an open label study of 163 people with metastatic ALK-positive non–small cell lung cancer (NSCLC), who had progressed during treatment with crizotinib or had not tolerated the drug; all were treated with ceritinib. Tumors shrunk in about half of the patients, an effect that lasted for a median of about 7 months, according to the FDA statement announcing the approval.
The most common side effects of the drug include diarrhea, nausea, vomiting, and abdominal pain; and elevated transaminases. The recommended dose is 750-mg dose once a day. It is available in 150-mg capsules.
Crizotinib, marketed as Xalkori, is the only other ALK tyrosine kinase inhibitor approved by the FDA; it was approved in 2011.
The FDA is approving ceritinib under the agency’s accelerated approval program, through which a drug can be approved to treat a serious or life-threatening disease based on clinical data showing effects on a surrogate endpoint that is "reasonably likely to predict clinical benefit." The manufacturer is required to conduct clinical trials to confirm the results.
The drug’s prescribing information includes the statement that "an improvement in survival or disease-related symptoms has not been established. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials."
The FDA statement cited National Cancer Institute estimates that NSCLC accounts for about 85% of lung cancers, of which only 2%-7% are ALK positive. This year, about 224,210 people in the United States will be diagnosed with lung cancer and about 159,260 people will die from lung cancer, according to NCI.
Ceritinib, an anaplastic lymphoma kinase (ALK) tyrosine kinase inhibitor, has been approved for the treatment of metastatic ALK-positive non–small cell lung cancer, in patients who have progressed on or are intolerant to crizotinib, the Food and Drug Administration announced on April 29.
The accelerated approval of ceritinib, marketed as Zykadia by Novartis, was based on the tumor response rate and duration of the response in an open label study of 163 people with metastatic ALK-positive non–small cell lung cancer (NSCLC), who had progressed during treatment with crizotinib or had not tolerated the drug; all were treated with ceritinib. Tumors shrunk in about half of the patients, an effect that lasted for a median of about 7 months, according to the FDA statement announcing the approval.
The most common side effects of the drug include diarrhea, nausea, vomiting, and abdominal pain; and elevated transaminases. The recommended dose is 750-mg dose once a day. It is available in 150-mg capsules.
Crizotinib, marketed as Xalkori, is the only other ALK tyrosine kinase inhibitor approved by the FDA; it was approved in 2011.
The FDA is approving ceritinib under the agency’s accelerated approval program, through which a drug can be approved to treat a serious or life-threatening disease based on clinical data showing effects on a surrogate endpoint that is "reasonably likely to predict clinical benefit." The manufacturer is required to conduct clinical trials to confirm the results.
The drug’s prescribing information includes the statement that "an improvement in survival or disease-related symptoms has not been established. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials."
The FDA statement cited National Cancer Institute estimates that NSCLC accounts for about 85% of lung cancers, of which only 2%-7% are ALK positive. This year, about 224,210 people in the United States will be diagnosed with lung cancer and about 159,260 people will die from lung cancer, according to NCI.
Ceritinib, an anaplastic lymphoma kinase (ALK) tyrosine kinase inhibitor, has been approved for the treatment of metastatic ALK-positive non–small cell lung cancer, in patients who have progressed on or are intolerant to crizotinib, the Food and Drug Administration announced on April 29.
The accelerated approval of ceritinib, marketed as Zykadia by Novartis, was based on the tumor response rate and duration of the response in an open label study of 163 people with metastatic ALK-positive non–small cell lung cancer (NSCLC), who had progressed during treatment with crizotinib or had not tolerated the drug; all were treated with ceritinib. Tumors shrunk in about half of the patients, an effect that lasted for a median of about 7 months, according to the FDA statement announcing the approval.
The most common side effects of the drug include diarrhea, nausea, vomiting, and abdominal pain; and elevated transaminases. The recommended dose is 750-mg dose once a day. It is available in 150-mg capsules.
Crizotinib, marketed as Xalkori, is the only other ALK tyrosine kinase inhibitor approved by the FDA; it was approved in 2011.
The FDA is approving ceritinib under the agency’s accelerated approval program, through which a drug can be approved to treat a serious or life-threatening disease based on clinical data showing effects on a surrogate endpoint that is "reasonably likely to predict clinical benefit." The manufacturer is required to conduct clinical trials to confirm the results.
The drug’s prescribing information includes the statement that "an improvement in survival or disease-related symptoms has not been established. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials."
The FDA statement cited National Cancer Institute estimates that NSCLC accounts for about 85% of lung cancers, of which only 2%-7% are ALK positive. This year, about 224,210 people in the United States will be diagnosed with lung cancer and about 159,260 people will die from lung cancer, according to NCI.
FDA proposes stricter review of surgical mesh products for prolapse repair
Surgical mesh products used for transvaginal repair of pelvic organ prolapse would be reclassified as high-risk devices, and manufacturers would have to submit approval applications, under a proposed order issued by the Food and Drug Administration.
These proposals address the serious health risks that have been associated with surgical mesh in this setting, and reflect the recommendations made by the FDA’s Obstetrics and Gynecology Devices panel at a meeting in September 2011, according to the FDA statement announcing the proposal issued on April 29.
"If these proposals are finalized, we will require manufacturers to provide premarket clinical data to demonstrate a reasonable assurance of safety and effectiveness for surgical mesh used to treat transvaginal POP [pelvic organ prolapse] repair," Dr. William Maisel, deputy director of science and chief scientist at the FDA’s Center for Devices and Radiological Health, said in the statement.
The proposal to categorize these devices as class III devices is "based on the tentative determination that general controls by themselves are insufficient to provide reasonable assurance of the safety and effectiveness of these devices, and there is sufficient information to establish special controls to provide such assurance," according to the FDA document that is being published in the Federal Register.
Surgical mesh products have been regulated as class II, moderate-risk devices, which usually are exempt from premarket review; approval of class II devices is based on whether the FDA determines that the device is "substantially equivalent" to a similar device already on the market. Class III devices require safety and effectiveness data to be submitted and reviewed for approval.
The FDA issued notifications about serious adverse events associated with the use of surgical mesh devices to repair POP in 2008 and 2011, which have included mesh erosion through the vagina, pain, infection, bleeding, dyspareunia, organ perforation, and urinary problems – as well as recurrent prolapse, neuromuscular problems, and vaginal scarring/shrinkage.
The FDA is also proposing that the urogynecologic surgical instruments that are included in the mesh implant kits be reclassified from low-risk (class I) to moderate-risk devices. The agency has identified risks associated with the use of these devices to include organ perforation or injury and bleeding, as well as "damage to blood vessels, nerves, connective tissue, and other structures." Such injuries may be due to "improperly designed and/or misused surgical mesh instrumentation," according to the document posted in the Federal Register.
Comments on the proposals can be submitted to the FDA for 90 days after the May 1 publication of the proposal in the Federal Register electronically, through www.regulations.gov; or can be sent to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Include Docket No. FDA-2014-N-0297. As of May 1, the proposal will be available here.
Surgical mesh products used for transvaginal repair of pelvic organ prolapse would be reclassified as high-risk devices, and manufacturers would have to submit approval applications, under a proposed order issued by the Food and Drug Administration.
These proposals address the serious health risks that have been associated with surgical mesh in this setting, and reflect the recommendations made by the FDA’s Obstetrics and Gynecology Devices panel at a meeting in September 2011, according to the FDA statement announcing the proposal issued on April 29.
"If these proposals are finalized, we will require manufacturers to provide premarket clinical data to demonstrate a reasonable assurance of safety and effectiveness for surgical mesh used to treat transvaginal POP [pelvic organ prolapse] repair," Dr. William Maisel, deputy director of science and chief scientist at the FDA’s Center for Devices and Radiological Health, said in the statement.
The proposal to categorize these devices as class III devices is "based on the tentative determination that general controls by themselves are insufficient to provide reasonable assurance of the safety and effectiveness of these devices, and there is sufficient information to establish special controls to provide such assurance," according to the FDA document that is being published in the Federal Register.
Surgical mesh products have been regulated as class II, moderate-risk devices, which usually are exempt from premarket review; approval of class II devices is based on whether the FDA determines that the device is "substantially equivalent" to a similar device already on the market. Class III devices require safety and effectiveness data to be submitted and reviewed for approval.
The FDA issued notifications about serious adverse events associated with the use of surgical mesh devices to repair POP in 2008 and 2011, which have included mesh erosion through the vagina, pain, infection, bleeding, dyspareunia, organ perforation, and urinary problems – as well as recurrent prolapse, neuromuscular problems, and vaginal scarring/shrinkage.
The FDA is also proposing that the urogynecologic surgical instruments that are included in the mesh implant kits be reclassified from low-risk (class I) to moderate-risk devices. The agency has identified risks associated with the use of these devices to include organ perforation or injury and bleeding, as well as "damage to blood vessels, nerves, connective tissue, and other structures." Such injuries may be due to "improperly designed and/or misused surgical mesh instrumentation," according to the document posted in the Federal Register.
Comments on the proposals can be submitted to the FDA for 90 days after the May 1 publication of the proposal in the Federal Register electronically, through www.regulations.gov; or can be sent to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Include Docket No. FDA-2014-N-0297. As of May 1, the proposal will be available here.
Surgical mesh products used for transvaginal repair of pelvic organ prolapse would be reclassified as high-risk devices, and manufacturers would have to submit approval applications, under a proposed order issued by the Food and Drug Administration.
These proposals address the serious health risks that have been associated with surgical mesh in this setting, and reflect the recommendations made by the FDA’s Obstetrics and Gynecology Devices panel at a meeting in September 2011, according to the FDA statement announcing the proposal issued on April 29.
"If these proposals are finalized, we will require manufacturers to provide premarket clinical data to demonstrate a reasonable assurance of safety and effectiveness for surgical mesh used to treat transvaginal POP [pelvic organ prolapse] repair," Dr. William Maisel, deputy director of science and chief scientist at the FDA’s Center for Devices and Radiological Health, said in the statement.
The proposal to categorize these devices as class III devices is "based on the tentative determination that general controls by themselves are insufficient to provide reasonable assurance of the safety and effectiveness of these devices, and there is sufficient information to establish special controls to provide such assurance," according to the FDA document that is being published in the Federal Register.
Surgical mesh products have been regulated as class II, moderate-risk devices, which usually are exempt from premarket review; approval of class II devices is based on whether the FDA determines that the device is "substantially equivalent" to a similar device already on the market. Class III devices require safety and effectiveness data to be submitted and reviewed for approval.
The FDA issued notifications about serious adverse events associated with the use of surgical mesh devices to repair POP in 2008 and 2011, which have included mesh erosion through the vagina, pain, infection, bleeding, dyspareunia, organ perforation, and urinary problems – as well as recurrent prolapse, neuromuscular problems, and vaginal scarring/shrinkage.
The FDA is also proposing that the urogynecologic surgical instruments that are included in the mesh implant kits be reclassified from low-risk (class I) to moderate-risk devices. The agency has identified risks associated with the use of these devices to include organ perforation or injury and bleeding, as well as "damage to blood vessels, nerves, connective tissue, and other structures." Such injuries may be due to "improperly designed and/or misused surgical mesh instrumentation," according to the document posted in the Federal Register.
Comments on the proposals can be submitted to the FDA for 90 days after the May 1 publication of the proposal in the Federal Register electronically, through www.regulations.gov; or can be sent to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Include Docket No. FDA-2014-N-0297. As of May 1, the proposal will be available here.
Approval of mercaptopurine suspension will facilitate pediatric dosing
More than 60 years after it first became available as a 50-mg tablet, an oral suspension formulation of mercaptopurine has been approved by the Food and Drug Administration.
The oral suspension formulation (20 mg/mL) – approved on April 28 for the treatment of patients with acute lymphoblastic leukemia as part of a combination regimen – will make it possible to more accurately dose pediatric patients with ALL, according to the FDA announcement of the approval.
Mercaptopurine, a nucleoside metabolic inhibitor, was initially approved in 1953, in a 50-mg tablet formulation. Until now, this has been the only formulation available, which the FDA statement points out is not an ideal dosage form for children under age 6. Compounded formulations provided by local pharmacies or splitting the 50-mg tablets have been used to dose children, but "a suspension offers the advantage of more accurately delivering the desired dose to children with a wide range of weights using a consistent administration schedule," and will make it possible to be more flexible in adjusting the dose, the FDA statement said.
Approval of the suspension was based on a clinical pharmacology study that evaluated the bioequivalence of mercaptopurine tablets with the oral suspension in healthy adults. The starting dose of mercaptopurine in multiagent combination chemotherapy maintenance regimens is 1.5 to 2.5 mg/kg (50-75 mg/m2) as a single daily dose.
The suspension is manufactured by NOVA Laboratories in the United Kingdom, and it will be distributed in the United States by Rare Disease Therapeutics under the trade name Purixan. The prescribing information is available here.
Serious adverse events associated with this product should be reported to the FDA’s MedWatch program at 800-332-1088 or www.fda.gov/medwatch/.
More than 60 years after it first became available as a 50-mg tablet, an oral suspension formulation of mercaptopurine has been approved by the Food and Drug Administration.
The oral suspension formulation (20 mg/mL) – approved on April 28 for the treatment of patients with acute lymphoblastic leukemia as part of a combination regimen – will make it possible to more accurately dose pediatric patients with ALL, according to the FDA announcement of the approval.
Mercaptopurine, a nucleoside metabolic inhibitor, was initially approved in 1953, in a 50-mg tablet formulation. Until now, this has been the only formulation available, which the FDA statement points out is not an ideal dosage form for children under age 6. Compounded formulations provided by local pharmacies or splitting the 50-mg tablets have been used to dose children, but "a suspension offers the advantage of more accurately delivering the desired dose to children with a wide range of weights using a consistent administration schedule," and will make it possible to be more flexible in adjusting the dose, the FDA statement said.
Approval of the suspension was based on a clinical pharmacology study that evaluated the bioequivalence of mercaptopurine tablets with the oral suspension in healthy adults. The starting dose of mercaptopurine in multiagent combination chemotherapy maintenance regimens is 1.5 to 2.5 mg/kg (50-75 mg/m2) as a single daily dose.
The suspension is manufactured by NOVA Laboratories in the United Kingdom, and it will be distributed in the United States by Rare Disease Therapeutics under the trade name Purixan. The prescribing information is available here.
Serious adverse events associated with this product should be reported to the FDA’s MedWatch program at 800-332-1088 or www.fda.gov/medwatch/.
More than 60 years after it first became available as a 50-mg tablet, an oral suspension formulation of mercaptopurine has been approved by the Food and Drug Administration.
The oral suspension formulation (20 mg/mL) – approved on April 28 for the treatment of patients with acute lymphoblastic leukemia as part of a combination regimen – will make it possible to more accurately dose pediatric patients with ALL, according to the FDA announcement of the approval.
Mercaptopurine, a nucleoside metabolic inhibitor, was initially approved in 1953, in a 50-mg tablet formulation. Until now, this has been the only formulation available, which the FDA statement points out is not an ideal dosage form for children under age 6. Compounded formulations provided by local pharmacies or splitting the 50-mg tablets have been used to dose children, but "a suspension offers the advantage of more accurately delivering the desired dose to children with a wide range of weights using a consistent administration schedule," and will make it possible to be more flexible in adjusting the dose, the FDA statement said.
Approval of the suspension was based on a clinical pharmacology study that evaluated the bioequivalence of mercaptopurine tablets with the oral suspension in healthy adults. The starting dose of mercaptopurine in multiagent combination chemotherapy maintenance regimens is 1.5 to 2.5 mg/kg (50-75 mg/m2) as a single daily dose.
The suspension is manufactured by NOVA Laboratories in the United Kingdom, and it will be distributed in the United States by Rare Disease Therapeutics under the trade name Purixan. The prescribing information is available here.
Serious adverse events associated with this product should be reported to the FDA’s MedWatch program at 800-332-1088 or www.fda.gov/medwatch/.
Vaccines Prevent Millions of Illnesses, but Measles Makes a Return
Vaccines will prevent an estimated 322 million illnesses, 21 million hospitalizations, and 732,000 premature deaths during the lifetimes of children born during the two decades after the Vaccines for Children Program began in 1994, according to a report by the Centers for Disease Control and Prevention.
In addition, vaccines will save an estimated $295 billion in direct costs and $1.38 trillion in societal costs, according to the analysis, published in the April 25 issue of Morbidity and Mortality Weekly Report (MMWR 2014;61:352-5). The Vaccines for Children (VFC) Program, which provides recommended vaccines to about half the children in the United States, was created in 1993 in response to a resurgence of measles during 1989-1991, caused mostly by a failure to vaccinate uninsured children at the recommended age of 12-15 months.
The VFC provides vaccines to children if they are eligible for Medicaid, are uninsured, or are American Indian or Alaskan native. Children who are underinsured and do not have vaccine coverage are also eligible. About half of the children in the United States receive vaccines through this program.
To estimate the program’s effect on health care costs and the health of all children born from 1994 to 2013, the Centers for Disease Control and Prevention (CDC) evaluated national data on immunization coverage, and used a cost-benefit model that estimated illnesses, hospitalizations, and premature deaths (not including influenza and hepatitis A).
Measles makes 2014 return
But a second MMWR report released April 24 described 58 confirmed measles cases in California during the first 4 months of this year, in children and adults from age 5 months to 60 years. That report illustrates some of the current vaccination challenges, particularly with cases related to people traveling to and from outside the United States.
California’s 58 measles cases were reported from January 2014 through April 16, 2014. It’s the highest number of cases reported for that calendar period in the state since 1995. The 129 cases reported in the United States during this period also were the largest number reported since 1996 (MMWR 2014;61:362-3). No deaths have been reported.
During a CDC media briefing on April 24, Dr. Anne Schuchat said that 34 of the 129 cases were imported cases, and occurred in residents traveling abroad or people traveling to the United States. Among those infected who were traveling to the United States, 17 people were from the Philippines, which is in the midst of a large measles outbreak – with about 20,000 confirmed or suspected cases, including 69 deaths, through February.
"Though not direct imports, most of the remaining cases are known to be linked to importation," said Dr. Schuchat, director of the CDC’s National Center for Immunization and Respiratory Diseases, and one of the authors of the VFC study.
The 129 cases of measles nationwide have been reported in 13 states. Cities and states with the highest number of cases are California, with 58 cases; New York City, with 24 cases; and Washington state, with 13 cases.
"While the story of the 1989 measles resurgence was one of poor children missing out on vaccines because they didn’t have insurance, today’s measles outbreaks are too often the result of people opting out" of vaccination, she said, noting that 84% of the cases have been in people who were not vaccinated or did not know if they had been vaccinated. This included 68% with personal-belief exemptions.
The California report shows the risk of measles spreading in health care settings, Dr. Schuchat noted. Of the California cases, 11 were transmitted in health care settings, including 6 in health care personnel.
Most of the 58 measles cases in California this year were in people who were not vaccinated (43%) or could not document that they had been vaccinated (31%), according to the report. The 25 patients who were not vaccinated included 19 who had philosophical objections to vaccination, and 3 who were too young for the vaccine. But 19% – two children and nine adults – had received two or more doses of MMR vaccine.
Most cases – 54 (93%) – were associated with imported cases, and included 13 cases of U.S. residents who had traveled internationally, 8 to the Philippines.
Travelers should vaccinate
The increase in imported cases from the Philippines "and subsequent transmission in certain settings in the United States highlight the importance of ensuring age-appropriate vaccination for persons traveling to areas where measles is endemic and maintaining high vaccination coverage at the national and local level," according to the report’s authors.
The researchers also recommend that all residents of the United States born after 1956 make sure they have received the MMR vaccine "or have serologic evidence of measles immunity."
If individuals do not have serologic evidence of immunity and are traveling outside of North America or South America, the CDC recommends one dose of MMR vaccine for infants aged 6-11 months, and two doses of MMR vaccine at least 28 days apart in children aged 1 year and older, and in adults.
There were no author disclosures for either report.
The recent measles outbreaks in New York City and California "remind us how quickly imported cases of measles can spread in communities with large numbers of unvaccinated persons," said Dr. Julia Shaklee Sammons. Because measles is highly contagious, "it is essential that providers maintain a high level of suspicion for measles in returned travelers with febrile rash illness and are able to recognize its clinical features," said Dr. Sammons of the division of infectious diseases at Children’s Hospital of Philadelphia.
When a case of measles is suspected, "early reporting and rapid control efforts are vital to prevent spread in healthcare facilities," with measures that include implementing airborne precautions immediately, she added. Clinicians should talk with their patients about measles vaccination "and remind them what is at stake if imported measles continues to land in communities of unvaccinated persons, especially for those who are too young or ineligible to be vaccinated," Dr. Sammons recommended.
These remarks were taken from an editorial published online April 24 (Ann. Int. Med. 2014 April 24 [doi: 10.7326/M14-0892]). Dr. Sammons had no disclosures.
The recent measles outbreaks in New York City and California "remind us how quickly imported cases of measles can spread in communities with large numbers of unvaccinated persons," said Dr. Julia Shaklee Sammons. Because measles is highly contagious, "it is essential that providers maintain a high level of suspicion for measles in returned travelers with febrile rash illness and are able to recognize its clinical features," said Dr. Sammons of the division of infectious diseases at Children’s Hospital of Philadelphia.
When a case of measles is suspected, "early reporting and rapid control efforts are vital to prevent spread in healthcare facilities," with measures that include implementing airborne precautions immediately, she added. Clinicians should talk with their patients about measles vaccination "and remind them what is at stake if imported measles continues to land in communities of unvaccinated persons, especially for those who are too young or ineligible to be vaccinated," Dr. Sammons recommended.
These remarks were taken from an editorial published online April 24 (Ann. Int. Med. 2014 April 24 [doi: 10.7326/M14-0892]). Dr. Sammons had no disclosures.
The recent measles outbreaks in New York City and California "remind us how quickly imported cases of measles can spread in communities with large numbers of unvaccinated persons," said Dr. Julia Shaklee Sammons. Because measles is highly contagious, "it is essential that providers maintain a high level of suspicion for measles in returned travelers with febrile rash illness and are able to recognize its clinical features," said Dr. Sammons of the division of infectious diseases at Children’s Hospital of Philadelphia.
When a case of measles is suspected, "early reporting and rapid control efforts are vital to prevent spread in healthcare facilities," with measures that include implementing airborne precautions immediately, she added. Clinicians should talk with their patients about measles vaccination "and remind them what is at stake if imported measles continues to land in communities of unvaccinated persons, especially for those who are too young or ineligible to be vaccinated," Dr. Sammons recommended.
These remarks were taken from an editorial published online April 24 (Ann. Int. Med. 2014 April 24 [doi: 10.7326/M14-0892]). Dr. Sammons had no disclosures.
The recent measles outbreaks in New York City and California "remind us how quickly imported cases of measles can spread in communities with large numbers of unvaccinated persons," said Dr. Julia Shaklee Sammons. Because measles is highly contagious, "it is essential that providers maintain a high level of suspicion for measles in returned travelers with febrile rash illness and are able to recognize its clinical features," said Dr. Sammons of the division of infectious diseases at Children’s Hospital of Philadelphia.
When a case of measles is suspected, "early reporting and rapid control efforts are vital to prevent spread in healthcare facilities," with measures that include implementing airborne precautions immediately, she added. Clinicians should talk with their patients about measles vaccination "and remind them what is at stake if imported measles continues to land in communities of unvaccinated persons, especially for those who are too young or ineligible to be vaccinated," Dr. Sammons recommended.
These remarks were taken from an editorial published online April 24 (Ann. Int. Med. 2014 April 24 [doi: 10.7326/M14-0892]). Dr. Sammons had no disclosures.
Vaccines will prevent an estimated 322 million illnesses, 21 million hospitalizations, and 732,000 premature deaths during the lifetimes of children born during the two decades after the Vaccines for Children Program began in 1994, according to a report by the Centers for Disease Control and Prevention.
In addition, vaccines will save an estimated $295 billion in direct costs and $1.38 trillion in societal costs, according to the analysis, published in the April 25 issue of Morbidity and Mortality Weekly Report (MMWR 2014;61:352-5). The Vaccines for Children (VFC) Program, which provides recommended vaccines to about half the children in the United States, was created in 1993 in response to a resurgence of measles during 1989-1991, caused mostly by a failure to vaccinate uninsured children at the recommended age of 12-15 months.
The VFC provides vaccines to children if they are eligible for Medicaid, are uninsured, or are American Indian or Alaskan native. Children who are underinsured and do not have vaccine coverage are also eligible. About half of the children in the United States receive vaccines through this program.
To estimate the program’s effect on health care costs and the health of all children born from 1994 to 2013, the Centers for Disease Control and Prevention (CDC) evaluated national data on immunization coverage, and used a cost-benefit model that estimated illnesses, hospitalizations, and premature deaths (not including influenza and hepatitis A).
Measles makes 2014 return
But a second MMWR report released April 24 described 58 confirmed measles cases in California during the first 4 months of this year, in children and adults from age 5 months to 60 years. That report illustrates some of the current vaccination challenges, particularly with cases related to people traveling to and from outside the United States.
California’s 58 measles cases were reported from January 2014 through April 16, 2014. It’s the highest number of cases reported for that calendar period in the state since 1995. The 129 cases reported in the United States during this period also were the largest number reported since 1996 (MMWR 2014;61:362-3). No deaths have been reported.
During a CDC media briefing on April 24, Dr. Anne Schuchat said that 34 of the 129 cases were imported cases, and occurred in residents traveling abroad or people traveling to the United States. Among those infected who were traveling to the United States, 17 people were from the Philippines, which is in the midst of a large measles outbreak – with about 20,000 confirmed or suspected cases, including 69 deaths, through February.
"Though not direct imports, most of the remaining cases are known to be linked to importation," said Dr. Schuchat, director of the CDC’s National Center for Immunization and Respiratory Diseases, and one of the authors of the VFC study.
The 129 cases of measles nationwide have been reported in 13 states. Cities and states with the highest number of cases are California, with 58 cases; New York City, with 24 cases; and Washington state, with 13 cases.
"While the story of the 1989 measles resurgence was one of poor children missing out on vaccines because they didn’t have insurance, today’s measles outbreaks are too often the result of people opting out" of vaccination, she said, noting that 84% of the cases have been in people who were not vaccinated or did not know if they had been vaccinated. This included 68% with personal-belief exemptions.
The California report shows the risk of measles spreading in health care settings, Dr. Schuchat noted. Of the California cases, 11 were transmitted in health care settings, including 6 in health care personnel.
Most of the 58 measles cases in California this year were in people who were not vaccinated (43%) or could not document that they had been vaccinated (31%), according to the report. The 25 patients who were not vaccinated included 19 who had philosophical objections to vaccination, and 3 who were too young for the vaccine. But 19% – two children and nine adults – had received two or more doses of MMR vaccine.
Most cases – 54 (93%) – were associated with imported cases, and included 13 cases of U.S. residents who had traveled internationally, 8 to the Philippines.
Travelers should vaccinate
The increase in imported cases from the Philippines "and subsequent transmission in certain settings in the United States highlight the importance of ensuring age-appropriate vaccination for persons traveling to areas where measles is endemic and maintaining high vaccination coverage at the national and local level," according to the report’s authors.
The researchers also recommend that all residents of the United States born after 1956 make sure they have received the MMR vaccine "or have serologic evidence of measles immunity."
If individuals do not have serologic evidence of immunity and are traveling outside of North America or South America, the CDC recommends one dose of MMR vaccine for infants aged 6-11 months, and two doses of MMR vaccine at least 28 days apart in children aged 1 year and older, and in adults.
There were no author disclosures for either report.
The recent measles outbreaks in New York City and California "remind us how quickly imported cases of measles can spread in communities with large numbers of unvaccinated persons," said Dr. Julia Shaklee Sammons. Because measles is highly contagious, "it is essential that providers maintain a high level of suspicion for measles in returned travelers with febrile rash illness and are able to recognize its clinical features," said Dr. Sammons of the division of infectious diseases at Children’s Hospital of Philadelphia.
When a case of measles is suspected, "early reporting and rapid control efforts are vital to prevent spread in healthcare facilities," with measures that include implementing airborne precautions immediately, she added. Clinicians should talk with their patients about measles vaccination "and remind them what is at stake if imported measles continues to land in communities of unvaccinated persons, especially for those who are too young or ineligible to be vaccinated," Dr. Sammons recommended.
These remarks were taken from an editorial published online April 24 (Ann. Int. Med. 2014 April 24 [doi: 10.7326/M14-0892]). Dr. Sammons had no disclosures.
Vaccines will prevent an estimated 322 million illnesses, 21 million hospitalizations, and 732,000 premature deaths during the lifetimes of children born during the two decades after the Vaccines for Children Program began in 1994, according to a report by the Centers for Disease Control and Prevention.
In addition, vaccines will save an estimated $295 billion in direct costs and $1.38 trillion in societal costs, according to the analysis, published in the April 25 issue of Morbidity and Mortality Weekly Report (MMWR 2014;61:352-5). The Vaccines for Children (VFC) Program, which provides recommended vaccines to about half the children in the United States, was created in 1993 in response to a resurgence of measles during 1989-1991, caused mostly by a failure to vaccinate uninsured children at the recommended age of 12-15 months.
The VFC provides vaccines to children if they are eligible for Medicaid, are uninsured, or are American Indian or Alaskan native. Children who are underinsured and do not have vaccine coverage are also eligible. About half of the children in the United States receive vaccines through this program.
To estimate the program’s effect on health care costs and the health of all children born from 1994 to 2013, the Centers for Disease Control and Prevention (CDC) evaluated national data on immunization coverage, and used a cost-benefit model that estimated illnesses, hospitalizations, and premature deaths (not including influenza and hepatitis A).
Measles makes 2014 return
But a second MMWR report released April 24 described 58 confirmed measles cases in California during the first 4 months of this year, in children and adults from age 5 months to 60 years. That report illustrates some of the current vaccination challenges, particularly with cases related to people traveling to and from outside the United States.
California’s 58 measles cases were reported from January 2014 through April 16, 2014. It’s the highest number of cases reported for that calendar period in the state since 1995. The 129 cases reported in the United States during this period also were the largest number reported since 1996 (MMWR 2014;61:362-3). No deaths have been reported.
During a CDC media briefing on April 24, Dr. Anne Schuchat said that 34 of the 129 cases were imported cases, and occurred in residents traveling abroad or people traveling to the United States. Among those infected who were traveling to the United States, 17 people were from the Philippines, which is in the midst of a large measles outbreak – with about 20,000 confirmed or suspected cases, including 69 deaths, through February.
"Though not direct imports, most of the remaining cases are known to be linked to importation," said Dr. Schuchat, director of the CDC’s National Center for Immunization and Respiratory Diseases, and one of the authors of the VFC study.
The 129 cases of measles nationwide have been reported in 13 states. Cities and states with the highest number of cases are California, with 58 cases; New York City, with 24 cases; and Washington state, with 13 cases.
"While the story of the 1989 measles resurgence was one of poor children missing out on vaccines because they didn’t have insurance, today’s measles outbreaks are too often the result of people opting out" of vaccination, she said, noting that 84% of the cases have been in people who were not vaccinated or did not know if they had been vaccinated. This included 68% with personal-belief exemptions.
The California report shows the risk of measles spreading in health care settings, Dr. Schuchat noted. Of the California cases, 11 were transmitted in health care settings, including 6 in health care personnel.
Most of the 58 measles cases in California this year were in people who were not vaccinated (43%) or could not document that they had been vaccinated (31%), according to the report. The 25 patients who were not vaccinated included 19 who had philosophical objections to vaccination, and 3 who were too young for the vaccine. But 19% – two children and nine adults – had received two or more doses of MMR vaccine.
Most cases – 54 (93%) – were associated with imported cases, and included 13 cases of U.S. residents who had traveled internationally, 8 to the Philippines.
Travelers should vaccinate
The increase in imported cases from the Philippines "and subsequent transmission in certain settings in the United States highlight the importance of ensuring age-appropriate vaccination for persons traveling to areas where measles is endemic and maintaining high vaccination coverage at the national and local level," according to the report’s authors.
The researchers also recommend that all residents of the United States born after 1956 make sure they have received the MMR vaccine "or have serologic evidence of measles immunity."
If individuals do not have serologic evidence of immunity and are traveling outside of North America or South America, the CDC recommends one dose of MMR vaccine for infants aged 6-11 months, and two doses of MMR vaccine at least 28 days apart in children aged 1 year and older, and in adults.
There were no author disclosures for either report.
The recent measles outbreaks in New York City and California "remind us how quickly imported cases of measles can spread in communities with large numbers of unvaccinated persons," said Dr. Julia Shaklee Sammons. Because measles is highly contagious, "it is essential that providers maintain a high level of suspicion for measles in returned travelers with febrile rash illness and are able to recognize its clinical features," said Dr. Sammons of the division of infectious diseases at Children’s Hospital of Philadelphia.
When a case of measles is suspected, "early reporting and rapid control efforts are vital to prevent spread in healthcare facilities," with measures that include implementing airborne precautions immediately, she added. Clinicians should talk with their patients about measles vaccination "and remind them what is at stake if imported measles continues to land in communities of unvaccinated persons, especially for those who are too young or ineligible to be vaccinated," Dr. Sammons recommended.
These remarks were taken from an editorial published online April 24 (Ann. Int. Med. 2014 April 24 [doi: 10.7326/M14-0892]). Dr. Sammons had no disclosures.
FROM A CDC MEDIA BRIEFING
CDC: Vaccines prevent millions of illnesses, but measles makes a return
Vaccines will prevent an estimated 322 million illnesses, 21 million hospitalizations, and 732,000 premature deaths during the lifetimes of children born during the two decades after the Vaccines for Children Program began in 1994, according to a report released April 24 by the Centers for Disease Control and Prevention.
In addition, vaccines will save an estimated $295 billion in direct costs and $1.38 trillion in societal costs, according to the analysis, published in the April 25 issue of Morbidity and Mortality Weekly Report (MMWR 2014;61:352-5). The Vaccines for Children (VFC) Program, which provides recommended vaccines to about half the children in the United States, was created in 1993 in response to a resurgence of measles during 1989-1991, caused mostly by a failure to vaccinate uninsured children at the recommended age of 12-15 months.
The VFC provides vaccines to children if they are eligible for Medicaid, are uninsured, or are American Indian or Alaskan native. Children who are underinsured and do not have vaccine coverage are also eligible. About half of the children in the United States receive vaccines through this program.
To estimate the program’s effect on health care costs and the health of all children born from 1994 to 2013, the Centers for Disease Control and Prevention (CDC) evaluated national data on immunization coverage, and used a cost-benefit model that estimated illnesses, hospitalizations, and premature deaths (not including influenza and hepatitis A).
Measles makes 2014 return
But a second MMWR report released April 24 described 58 confirmed measles cases in California during the first 4 months of this year, in children and adults from age 5 months to 60 years. That report illustrates some of the current vaccination challenges, particularly with cases related to people traveling to and from outside the United States.
California’s 58 measles cases were reported from January 2014 through April 16, 2014. It’s the highest number of cases reported for that calendar period in the state since 1995. The 129 cases reported in the United States during this period also were the largest number reported since 1996 (MMWR 2014;61:362-3). No deaths have been reported.
During a CDC media briefing on April 24, Dr. Anne Schuchat said that 34 of the 129 cases were imported cases, and occurred in residents traveling abroad or people traveling to the United States. Among those infected who were traveling to the United States, 17 people were from the Philippines, which is in the midst of a large measles outbreak – with about 20,000 confirmed or suspected cases, including 69 deaths, through February.
"Though not direct imports, most of the remaining cases are known to be linked to importation," said Dr. Schuchat, director of the CDC’s National Center for Immunization and Respiratory Diseases, and one of the authors of the VFC study.
The 129 cases of measles nationwide have been reported in 13 states. Cities and states with the highest number of cases are California, with 58 cases; New York City, with 24 cases; and Washington state, with 13 cases.
"While the story of the 1989 measles resurgence was one of poor children missing out on vaccines because they didn’t have insurance, today’s measles outbreaks are too often the result of people opting out" of vaccination, she said, noting that 84% of the cases have been in people who were not vaccinated or did not know if they had been vaccinated. This included 68% with personal-belief exemptions.
The California report shows the risk of measles spreading in health care settings, Dr. Schuchat noted. Of the California cases, 11 were transmitted in health care settings, including 6 in health care personnel.
Most of the 58 measles cases in California this year were in people who were not vaccinated (43%) or could not document that they had been vaccinated (31%), according to the report. The 25 patients who were not vaccinated included 19 who had philosophical objections to vaccination, and 3 who were too young for the vaccine. But 19% – two children and nine adults – had received two or more doses of MMR vaccine.
Most cases – 54 (93%) – were associated with imported cases, and included 13 cases of U.S. residents who had traveled internationally, 8 to the Philippines.
Travelers should vaccinate
The increase in imported cases from the Philippines "and subsequent transmission in certain settings in the United States highlight the importance of ensuring age-appropriate vaccination for persons traveling to areas where measles is endemic and maintaining high vaccination coverage at the national and local level," according to the report’s authors.
The researchers also recommend that all residents of the United States born after 1956 make sure they have received the MMR vaccine "or have serologic evidence of measles immunity."
If individuals do not have serologic evidence of immunity and are traveling outside of North America or South America, the CDC recommends one dose of MMR vaccine for infants aged 6-11 months, and two doses of MMR vaccine at least 28 days apart in children aged 1 year and older, and in adults.
There were no author disclosures for either report.
The recent measles outbreaks in New York City and California "remind us how quickly imported cases of measles can spread in communities with large numbers of unvaccinated persons," said Dr. Julia Shaklee Sammons. Because measles is highly contagious, "it is essential that providers maintain a high level of suspicion for measles in returned travelers with febrile rash illness and are able to recognize its clinical features," said Dr. Sammons of the division of infectious diseases at Children’s Hospital of Philadelphia.
When a case of measles is suspected, "early reporting and rapid control efforts are vital to prevent spread in healthcare facilities," with measures that include implementing airborne precautions immediately, she added. Clinicians should talk with their patients about measles vaccination "and remind them what is at stake if imported measles continues to land in communities of unvaccinated persons, especially for those who are too young or ineligible to be vaccinated," Dr. Sammons recommended.
These remarks were taken from an editorial published online April 24 (Ann. Int. Med. 2014 April 24 [doi: 10.7326/M14-0892]). Dr. Sammons had no disclosures.
The recent measles outbreaks in New York City and California "remind us how quickly imported cases of measles can spread in communities with large numbers of unvaccinated persons," said Dr. Julia Shaklee Sammons. Because measles is highly contagious, "it is essential that providers maintain a high level of suspicion for measles in returned travelers with febrile rash illness and are able to recognize its clinical features," said Dr. Sammons of the division of infectious diseases at Children’s Hospital of Philadelphia.
When a case of measles is suspected, "early reporting and rapid control efforts are vital to prevent spread in healthcare facilities," with measures that include implementing airborne precautions immediately, she added. Clinicians should talk with their patients about measles vaccination "and remind them what is at stake if imported measles continues to land in communities of unvaccinated persons, especially for those who are too young or ineligible to be vaccinated," Dr. Sammons recommended.
These remarks were taken from an editorial published online April 24 (Ann. Int. Med. 2014 April 24 [doi: 10.7326/M14-0892]). Dr. Sammons had no disclosures.
The recent measles outbreaks in New York City and California "remind us how quickly imported cases of measles can spread in communities with large numbers of unvaccinated persons," said Dr. Julia Shaklee Sammons. Because measles is highly contagious, "it is essential that providers maintain a high level of suspicion for measles in returned travelers with febrile rash illness and are able to recognize its clinical features," said Dr. Sammons of the division of infectious diseases at Children’s Hospital of Philadelphia.
When a case of measles is suspected, "early reporting and rapid control efforts are vital to prevent spread in healthcare facilities," with measures that include implementing airborne precautions immediately, she added. Clinicians should talk with their patients about measles vaccination "and remind them what is at stake if imported measles continues to land in communities of unvaccinated persons, especially for those who are too young or ineligible to be vaccinated," Dr. Sammons recommended.
These remarks were taken from an editorial published online April 24 (Ann. Int. Med. 2014 April 24 [doi: 10.7326/M14-0892]). Dr. Sammons had no disclosures.
Vaccines will prevent an estimated 322 million illnesses, 21 million hospitalizations, and 732,000 premature deaths during the lifetimes of children born during the two decades after the Vaccines for Children Program began in 1994, according to a report released April 24 by the Centers for Disease Control and Prevention.
In addition, vaccines will save an estimated $295 billion in direct costs and $1.38 trillion in societal costs, according to the analysis, published in the April 25 issue of Morbidity and Mortality Weekly Report (MMWR 2014;61:352-5). The Vaccines for Children (VFC) Program, which provides recommended vaccines to about half the children in the United States, was created in 1993 in response to a resurgence of measles during 1989-1991, caused mostly by a failure to vaccinate uninsured children at the recommended age of 12-15 months.
The VFC provides vaccines to children if they are eligible for Medicaid, are uninsured, or are American Indian or Alaskan native. Children who are underinsured and do not have vaccine coverage are also eligible. About half of the children in the United States receive vaccines through this program.
To estimate the program’s effect on health care costs and the health of all children born from 1994 to 2013, the Centers for Disease Control and Prevention (CDC) evaluated national data on immunization coverage, and used a cost-benefit model that estimated illnesses, hospitalizations, and premature deaths (not including influenza and hepatitis A).
Measles makes 2014 return
But a second MMWR report released April 24 described 58 confirmed measles cases in California during the first 4 months of this year, in children and adults from age 5 months to 60 years. That report illustrates some of the current vaccination challenges, particularly with cases related to people traveling to and from outside the United States.
California’s 58 measles cases were reported from January 2014 through April 16, 2014. It’s the highest number of cases reported for that calendar period in the state since 1995. The 129 cases reported in the United States during this period also were the largest number reported since 1996 (MMWR 2014;61:362-3). No deaths have been reported.
During a CDC media briefing on April 24, Dr. Anne Schuchat said that 34 of the 129 cases were imported cases, and occurred in residents traveling abroad or people traveling to the United States. Among those infected who were traveling to the United States, 17 people were from the Philippines, which is in the midst of a large measles outbreak – with about 20,000 confirmed or suspected cases, including 69 deaths, through February.
"Though not direct imports, most of the remaining cases are known to be linked to importation," said Dr. Schuchat, director of the CDC’s National Center for Immunization and Respiratory Diseases, and one of the authors of the VFC study.
The 129 cases of measles nationwide have been reported in 13 states. Cities and states with the highest number of cases are California, with 58 cases; New York City, with 24 cases; and Washington state, with 13 cases.
"While the story of the 1989 measles resurgence was one of poor children missing out on vaccines because they didn’t have insurance, today’s measles outbreaks are too often the result of people opting out" of vaccination, she said, noting that 84% of the cases have been in people who were not vaccinated or did not know if they had been vaccinated. This included 68% with personal-belief exemptions.
The California report shows the risk of measles spreading in health care settings, Dr. Schuchat noted. Of the California cases, 11 were transmitted in health care settings, including 6 in health care personnel.
Most of the 58 measles cases in California this year were in people who were not vaccinated (43%) or could not document that they had been vaccinated (31%), according to the report. The 25 patients who were not vaccinated included 19 who had philosophical objections to vaccination, and 3 who were too young for the vaccine. But 19% – two children and nine adults – had received two or more doses of MMR vaccine.
Most cases – 54 (93%) – were associated with imported cases, and included 13 cases of U.S. residents who had traveled internationally, 8 to the Philippines.
Travelers should vaccinate
The increase in imported cases from the Philippines "and subsequent transmission in certain settings in the United States highlight the importance of ensuring age-appropriate vaccination for persons traveling to areas where measles is endemic and maintaining high vaccination coverage at the national and local level," according to the report’s authors.
The researchers also recommend that all residents of the United States born after 1956 make sure they have received the MMR vaccine "or have serologic evidence of measles immunity."
If individuals do not have serologic evidence of immunity and are traveling outside of North America or South America, the CDC recommends one dose of MMR vaccine for infants aged 6-11 months, and two doses of MMR vaccine at least 28 days apart in children aged 1 year and older, and in adults.
There were no author disclosures for either report.
Vaccines will prevent an estimated 322 million illnesses, 21 million hospitalizations, and 732,000 premature deaths during the lifetimes of children born during the two decades after the Vaccines for Children Program began in 1994, according to a report released April 24 by the Centers for Disease Control and Prevention.
In addition, vaccines will save an estimated $295 billion in direct costs and $1.38 trillion in societal costs, according to the analysis, published in the April 25 issue of Morbidity and Mortality Weekly Report (MMWR 2014;61:352-5). The Vaccines for Children (VFC) Program, which provides recommended vaccines to about half the children in the United States, was created in 1993 in response to a resurgence of measles during 1989-1991, caused mostly by a failure to vaccinate uninsured children at the recommended age of 12-15 months.
The VFC provides vaccines to children if they are eligible for Medicaid, are uninsured, or are American Indian or Alaskan native. Children who are underinsured and do not have vaccine coverage are also eligible. About half of the children in the United States receive vaccines through this program.
To estimate the program’s effect on health care costs and the health of all children born from 1994 to 2013, the Centers for Disease Control and Prevention (CDC) evaluated national data on immunization coverage, and used a cost-benefit model that estimated illnesses, hospitalizations, and premature deaths (not including influenza and hepatitis A).
Measles makes 2014 return
But a second MMWR report released April 24 described 58 confirmed measles cases in California during the first 4 months of this year, in children and adults from age 5 months to 60 years. That report illustrates some of the current vaccination challenges, particularly with cases related to people traveling to and from outside the United States.
California’s 58 measles cases were reported from January 2014 through April 16, 2014. It’s the highest number of cases reported for that calendar period in the state since 1995. The 129 cases reported in the United States during this period also were the largest number reported since 1996 (MMWR 2014;61:362-3). No deaths have been reported.
During a CDC media briefing on April 24, Dr. Anne Schuchat said that 34 of the 129 cases were imported cases, and occurred in residents traveling abroad or people traveling to the United States. Among those infected who were traveling to the United States, 17 people were from the Philippines, which is in the midst of a large measles outbreak – with about 20,000 confirmed or suspected cases, including 69 deaths, through February.
"Though not direct imports, most of the remaining cases are known to be linked to importation," said Dr. Schuchat, director of the CDC’s National Center for Immunization and Respiratory Diseases, and one of the authors of the VFC study.
The 129 cases of measles nationwide have been reported in 13 states. Cities and states with the highest number of cases are California, with 58 cases; New York City, with 24 cases; and Washington state, with 13 cases.
"While the story of the 1989 measles resurgence was one of poor children missing out on vaccines because they didn’t have insurance, today’s measles outbreaks are too often the result of people opting out" of vaccination, she said, noting that 84% of the cases have been in people who were not vaccinated or did not know if they had been vaccinated. This included 68% with personal-belief exemptions.
The California report shows the risk of measles spreading in health care settings, Dr. Schuchat noted. Of the California cases, 11 were transmitted in health care settings, including 6 in health care personnel.
Most of the 58 measles cases in California this year were in people who were not vaccinated (43%) or could not document that they had been vaccinated (31%), according to the report. The 25 patients who were not vaccinated included 19 who had philosophical objections to vaccination, and 3 who were too young for the vaccine. But 19% – two children and nine adults – had received two or more doses of MMR vaccine.
Most cases – 54 (93%) – were associated with imported cases, and included 13 cases of U.S. residents who had traveled internationally, 8 to the Philippines.
Travelers should vaccinate
The increase in imported cases from the Philippines "and subsequent transmission in certain settings in the United States highlight the importance of ensuring age-appropriate vaccination for persons traveling to areas where measles is endemic and maintaining high vaccination coverage at the national and local level," according to the report’s authors.
The researchers also recommend that all residents of the United States born after 1956 make sure they have received the MMR vaccine "or have serologic evidence of measles immunity."
If individuals do not have serologic evidence of immunity and are traveling outside of North America or South America, the CDC recommends one dose of MMR vaccine for infants aged 6-11 months, and two doses of MMR vaccine at least 28 days apart in children aged 1 year and older, and in adults.
There were no author disclosures for either report.
FROM A CDC MEDIA BRIEFING
