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Source: http://www.cidrap.umn.edu/news-persp...an-nov-18-2019
News Scan for Nov 18, 2019
Ebola in the DRC; MERS infects Saudi man; Innovative duodenoscope; Hand, foot, & mouth disease vaccine
Filed Under:
Ebola; VHF; MERS-CoV; Healthcare-Associated Infections; Enterovirus, Non-Polio
Ebola sickens 4 more in the DR Congo
After 3 days with no new cases, the Democratic Republic of the Congo (DRC) today reported 4 more Ebola cases, raising the outbreak total to 3,296 illnesses, according to the World Health Organization (WHO) online Ebola dashboard.
Health officials are still investigating 422 suspected cases. Two more people died from their infections, bringing the fatality count to 2,195.
In other outbreak developments, following the Nov 14 launch of the second Ebola vaccine—the two-dose regimen (Ad26.ZEBOV, MVA-BN Filo) from Johnson & Johnson—in Goma, 147 people have received it, the DRC's Ebola technical committee (CMRE) said yesterday in its daily update. The number of people who have received Merck's VSV-EBOV vaccine since August 2018 has risen to 253,234.
WHO online Ebola dashboard
Nov 17 CMRE report
Camel contact noted in latest Saudi MERS case
Saudi Arabia's Ministry of Health (MOH) today reported one more MERS-CoV case, which involves a 71-year-old man in the city of Al Khurma in Taif region, located in the western part of the country.
An investigation found that the man had contact with camels, and his MERS-CoV (Middle East respiratory syndrome coronavirus) exposure is classified as primary, meaning he probably wasn't exposed to another sick patient.
So far this month, Saudi Arabia has reported 10 MERS-CoV cases, compared with 14 in October and 4 in September.
As of the end of October, the WHO has received reports of 2,482 cases, at least 854 of them fatal. Saudi Arabia has been by far the hardest-hit country.
Nov 18 Saudi MOH report
FDA clears duodenoscope with fewer parts needing disinfection
The Food and Drug Administration (FDA) has cleared a new type of duodenoscope that has fewer parts needing disinfection, according to an agency news release.
The Pentax Medical Video ED34-i10T2 duodenoscope, made by Pentax of America, Montvale, New Jersey, is designed to provide visualization of the upper gastrointestinal (GI) tract to treat bile duct disorders and other upper GI problems. It contains a disposable "elevator component," which is a lever that allows the operator to raise or lower accessories from the scope's tip to perform biopsies and other procedures.
"Duodenoscopes with a disposable elevator component represent another major step toward lowering the risk of infection among patients who undergo procedures with these devices,” said Jeff Shuren, MD, JD, director of the FDA's Center for Devices and Radiological Health. "We encourage manufacturers of these devices to continue to pursue innovations that will help reduce risk to patients, and also encourage hospitals and other health care facilities where these procedures are performed to begin or continue transitioning to devices with disposable components that are easier to reprocess."
The duodenoscope, which is threaded through a patient's mouth into the top of the small intestine, has many small working parts that can be difficult to clean. The device can trap contaminated tissue or fluid in its crevices, and if not thoroughly cleaned and disinfected it can transmit pathogens between patients, the FDA said.
Nov 15 FDA news release
Phase 4 trial in China shows 90% protection for enterovirus 71 vaccine
A phase 4 postmarketing study in China has demonstrated a 90% effectiveness and a good safety profile for of an inactivated enterovirus 71 (EV71) vaccine against hand, foot, and mouth disease (HFMD) in children under 6 years old, according to results published today in Clinical Infectious Diseases.
The large trial involved 155,995 children aged 6 months to 71 months from 70 healthcare facilities, with 40,724 receiving two doses of an inactivated EV71 vaccine 1 month apart and the rest serving as the control group. The researchers monitored the children for HFMD for 14 months after the second dose. The EV71 HFMD vaccine is licensed in China but not in the United States.
The investigators found an overall vaccine effectiveness of 89.7% (95% confidence interval, 24.0% to 98.6%), with a 4.58% rate of adverse events. Passive surveillance showed a 0.31% rate of common minor reactions.
The authors say the results are similar to those found in a phase 3 trial of the vaccine and conclude, "The clinical protection and safety of the EV71 vaccine were demonstrated in the immunization of a large population."
Nov 18 Clin Infect Dis study
News Scan for Nov 18, 2019
Ebola in the DRC; MERS infects Saudi man; Innovative duodenoscope; Hand, foot, & mouth disease vaccine
Filed Under:
Ebola; VHF; MERS-CoV; Healthcare-Associated Infections; Enterovirus, Non-Polio
Ebola sickens 4 more in the DR Congo
After 3 days with no new cases, the Democratic Republic of the Congo (DRC) today reported 4 more Ebola cases, raising the outbreak total to 3,296 illnesses, according to the World Health Organization (WHO) online Ebola dashboard.
Health officials are still investigating 422 suspected cases. Two more people died from their infections, bringing the fatality count to 2,195.
In other outbreak developments, following the Nov 14 launch of the second Ebola vaccine—the two-dose regimen (Ad26.ZEBOV, MVA-BN Filo) from Johnson & Johnson—in Goma, 147 people have received it, the DRC's Ebola technical committee (CMRE) said yesterday in its daily update. The number of people who have received Merck's VSV-EBOV vaccine since August 2018 has risen to 253,234.
WHO online Ebola dashboard
Nov 17 CMRE report
Camel contact noted in latest Saudi MERS case
Saudi Arabia's Ministry of Health (MOH) today reported one more MERS-CoV case, which involves a 71-year-old man in the city of Al Khurma in Taif region, located in the western part of the country.
An investigation found that the man had contact with camels, and his MERS-CoV (Middle East respiratory syndrome coronavirus) exposure is classified as primary, meaning he probably wasn't exposed to another sick patient.
So far this month, Saudi Arabia has reported 10 MERS-CoV cases, compared with 14 in October and 4 in September.
As of the end of October, the WHO has received reports of 2,482 cases, at least 854 of them fatal. Saudi Arabia has been by far the hardest-hit country.
Nov 18 Saudi MOH report
FDA clears duodenoscope with fewer parts needing disinfection
The Food and Drug Administration (FDA) has cleared a new type of duodenoscope that has fewer parts needing disinfection, according to an agency news release.
The Pentax Medical Video ED34-i10T2 duodenoscope, made by Pentax of America, Montvale, New Jersey, is designed to provide visualization of the upper gastrointestinal (GI) tract to treat bile duct disorders and other upper GI problems. It contains a disposable "elevator component," which is a lever that allows the operator to raise or lower accessories from the scope's tip to perform biopsies and other procedures.
"Duodenoscopes with a disposable elevator component represent another major step toward lowering the risk of infection among patients who undergo procedures with these devices,” said Jeff Shuren, MD, JD, director of the FDA's Center for Devices and Radiological Health. "We encourage manufacturers of these devices to continue to pursue innovations that will help reduce risk to patients, and also encourage hospitals and other health care facilities where these procedures are performed to begin or continue transitioning to devices with disposable components that are easier to reprocess."
The duodenoscope, which is threaded through a patient's mouth into the top of the small intestine, has many small working parts that can be difficult to clean. The device can trap contaminated tissue or fluid in its crevices, and if not thoroughly cleaned and disinfected it can transmit pathogens between patients, the FDA said.
Nov 15 FDA news release
Phase 4 trial in China shows 90% protection for enterovirus 71 vaccine
A phase 4 postmarketing study in China has demonstrated a 90% effectiveness and a good safety profile for of an inactivated enterovirus 71 (EV71) vaccine against hand, foot, and mouth disease (HFMD) in children under 6 years old, according to results published today in Clinical Infectious Diseases.
The large trial involved 155,995 children aged 6 months to 71 months from 70 healthcare facilities, with 40,724 receiving two doses of an inactivated EV71 vaccine 1 month apart and the rest serving as the control group. The researchers monitored the children for HFMD for 14 months after the second dose. The EV71 HFMD vaccine is licensed in China but not in the United States.
The investigators found an overall vaccine effectiveness of 89.7% (95% confidence interval, 24.0% to 98.6%), with a 4.58% rate of adverse events. Passive surveillance showed a 0.31% rate of common minor reactions.
The authors say the results are similar to those found in a phase 3 trial of the vaccine and conclude, "The clinical protection and safety of the EV71 vaccine were demonstrated in the immunization of a large population."
Nov 18 Clin Infect Dis study