Shiloh
Editor, Senior Moderator
Source: http://www.cidrap.umn.edu/news-perspective/2015/06/news-scan-jun-04-2015
News Scan for Jun 04, 2015
ILI case definitions; PulseNet funding; Flublok granted exclusivity
Filed Under:
Influenza, General; Influenza Vaccines; Foodborne Disease
[h=3]Study supports use of WHO cases definition for ILI[/h] Scientists from Singapore and Australia found that the revised World Health Organization (WHO) case definition for influenza-like illness (ILI) bested case definitions from the US Centers for Disease Control and Prevention (CDC) and the European Centre for Disease Protection and Control (ECDC), according to their report today in Eurosurveillance.
They tested the definitions on a cohort of 727 patients in Singapore during the first wave of the 2009 H1N1 pandemic. The patients had two to three blood samples taken and symptoms reviewed every 2 weeks from June to October 2009. Using a fourfold rise in titer as designating seroconversion, they found that 36 patients had presumptive 2009 H1N1 flu.
The WHO revised its case definition in January 2014.
The investigators found that the modified WHO protocol had a sensitivity of 36%, a specificity of 97%, and a positive predictive value (PPV) of 42%. That compares with 39%, 95%, and 31%, respectively, for the CDC criteria and 61%, 85%, and 18% for the ECDC case definition. The negative predictive value for the WHO and CDC definitions was 97%, and for the ECDC protocol it was 95%. The PPV for the pre-2014 WHO definition was 39%.
The authors conclude, "Our analysis supports the use of the revised WHO ILI case definition, which includes only cough in the presence of fever defined as body temperature ≥ 38?C for influenza surveillance."
Jun 4 Eurosurveillance report
Jun 4 Eurosurveillance editorial on the report
[h=3]Groups ask Congress for more PulseNet funding[/h] Nine health and consumer groups last week petitioned Congress to boost funding for PulseNet, the national foodborne disease database, Food Safety News reported today.
The Obama administration's proposed budget asks for a $2.1-million increase over the $48 million allocated for the CDC's food safety activities in 2015, which include PulseNet. The advocacy groups, however, want to see an increase of $7 million to provide continuous improvements.
The groups are the Center for Foodborne Illness Research & Prevention, the Center for Science in the Public Interest, the Consumer Federation of America, the Consumers Union, Food & Water Watch, the National Consumers League, STOP Foodborne Illness, The Pew Charitable Trusts, and Trust for America?s Health. They wrote to Rep. Tom Cole (R-Okla.) and Sen. Roy Blunt (R-Mo.), chairmen of each chamber's Subcommittee on Labor, Health and Human Services, Education and Related Agencies Appropriations.
Jun 4 Food Safety News story
[h=3]FDA grants 12-year regulatory exclusivity to Flublok[/h] Protein Sciences Corp. announced that, in a rare move, the Food and Drug Administration (FDA) is granting exclusive marketing rights to its Flublok influenza vaccine for 12 years, the first vaccine awarded this status, the company said in a press release yesterday.
The FDA's determination of regulatory exclusivity means that no product similar to Flublok can be approved by the FDA before January 16, 2025. "The FDA's designation prevents a generic product maker from capitalizing on the hard work of our team," said Manon Cox, president and CEO of Protein Sciences.
The decision is only the third such exclusivity granted by the FDA under the Affordable Care Act, the company said.
Jun 3 Protein Sciences Corp. press release
News Scan for Jun 04, 2015
ILI case definitions; PulseNet funding; Flublok granted exclusivity
Filed Under:
Influenza, General; Influenza Vaccines; Foodborne Disease
[h=3]Study supports use of WHO cases definition for ILI[/h] Scientists from Singapore and Australia found that the revised World Health Organization (WHO) case definition for influenza-like illness (ILI) bested case definitions from the US Centers for Disease Control and Prevention (CDC) and the European Centre for Disease Protection and Control (ECDC), according to their report today in Eurosurveillance.
They tested the definitions on a cohort of 727 patients in Singapore during the first wave of the 2009 H1N1 pandemic. The patients had two to three blood samples taken and symptoms reviewed every 2 weeks from June to October 2009. Using a fourfold rise in titer as designating seroconversion, they found that 36 patients had presumptive 2009 H1N1 flu.
The WHO revised its case definition in January 2014.
The investigators found that the modified WHO protocol had a sensitivity of 36%, a specificity of 97%, and a positive predictive value (PPV) of 42%. That compares with 39%, 95%, and 31%, respectively, for the CDC criteria and 61%, 85%, and 18% for the ECDC case definition. The negative predictive value for the WHO and CDC definitions was 97%, and for the ECDC protocol it was 95%. The PPV for the pre-2014 WHO definition was 39%.
The authors conclude, "Our analysis supports the use of the revised WHO ILI case definition, which includes only cough in the presence of fever defined as body temperature ≥ 38?C for influenza surveillance."
Jun 4 Eurosurveillance report
Jun 4 Eurosurveillance editorial on the report
[h=3]Groups ask Congress for more PulseNet funding[/h] Nine health and consumer groups last week petitioned Congress to boost funding for PulseNet, the national foodborne disease database, Food Safety News reported today.
The Obama administration's proposed budget asks for a $2.1-million increase over the $48 million allocated for the CDC's food safety activities in 2015, which include PulseNet. The advocacy groups, however, want to see an increase of $7 million to provide continuous improvements.
The groups are the Center for Foodborne Illness Research & Prevention, the Center for Science in the Public Interest, the Consumer Federation of America, the Consumers Union, Food & Water Watch, the National Consumers League, STOP Foodborne Illness, The Pew Charitable Trusts, and Trust for America?s Health. They wrote to Rep. Tom Cole (R-Okla.) and Sen. Roy Blunt (R-Mo.), chairmen of each chamber's Subcommittee on Labor, Health and Human Services, Education and Related Agencies Appropriations.
Jun 4 Food Safety News story
[h=3]FDA grants 12-year regulatory exclusivity to Flublok[/h] Protein Sciences Corp. announced that, in a rare move, the Food and Drug Administration (FDA) is granting exclusive marketing rights to its Flublok influenza vaccine for 12 years, the first vaccine awarded this status, the company said in a press release yesterday.
The FDA's determination of regulatory exclusivity means that no product similar to Flublok can be approved by the FDA before January 16, 2025. "The FDA's designation prevents a generic product maker from capitalizing on the hard work of our team," said Manon Cox, president and CEO of Protein Sciences.
The decision is only the third such exclusivity granted by the FDA under the Affordable Care Act, the company said.
Jun 3 Protein Sciences Corp. press release