News Scan for Jan 31, 2014

News brief

CDC outlines steps for emergency use of IV zanamivir

The US Centers for Disease Control and Prevention (CDC) yesterday released information detailing how clinicians can get investigational intravenous (IV) zanamivir (Relenza) for severely ill flu patients. The drug is in phase 3 clinical trials and can only be obtained by enrolling patients in ongoing clinical trials or an emergency investigational new drug request.

Ongoing surveillance of circulating flu strains shows that oseltamivir (Tamiflu) resistance is low so far, but it can emerge during or after oseltamivir treatment in patients with prolonged virus shedding, such as those who are severely immunocompromised, the CDC said. So far neuraminidase-resistance testing activities have found 21 oseltamivir-resistant 2009 H1N1 viruses among 2,254 (0.9%) samples, according to the CDC’s latest flu surveillance report.

Tests show that most oseltamivir-resistant 2009 H1N1 viruses so far are sensitive to zanamivir.

The CDC said it recommends that IV zanamivir be considered for severely ill patients with oseltamivir-resistant 2009 H1N1 infections or for those who can't absorb oral oseltamivir because of known or suspected gastric stasis, malabsorption, or gastrointestinal bleeding.

Clinicians who want to get IV zanamivir for those patients can call a GlaxoSmithKline help desk number, staffed around the clock, to see if patients are eligible for a clinical trial and to obtain information on the steps needed to obtain an emergency use authorization from the Food and Drug Administration
Jan 30 CDC information on IV zanamivir
Jan 31 CDC FluView report

Substantial portion of elderly with ILI have respiratory syncytial virus

Respiratory syncytial virus (RSV) is an important respiratory pathogen in older patients with moderate to severe influenza-like illness (ILI), according to a large international study of elderly community-dwelling individuals published in the Journal of Infectious Diseases.

The study population comprised participants in the INFLUENCE65 clinical trial, which studied influenza vaccine efficacy in people 65 or older in 15 countries in America, Europe, and East Asia.

Active surveillance of 36,132 subjects by means of weekly or biweekly phone contact or home visits from the first-season surveillance period (Nov 15, 2008, through Apr 30, 2009) was carried out. The subjects were told to report any ILI meeting a prescribed definition, and nose and throat swabs were collected from those reporting ILI.

A total of 4,582 samples were collected (from 5,389 ILI episodes); 556 samples (12%) from subjects who fulfilled criteria for moderate to severe disease (ie, pneumonia, hospitalization, or maximum daily influenza symptom severity score [ISS] of over 2) were tested by multiplex reverse-transcription polymerase chain reaction.

A total of 320 (57.6%) of the 556 samples showed any virus; 104 of the 556 samples (18.7%) were influenza A, 82 (14.7%) rhinovirus/enterovirus, 41 (7.4%) RSV, and 32 each (5.6%) coronavirus and human metapneumovirus. Most of the RSV-positive samples (39) were single infections.

RSV prevalence was 12.6% (8 of 63) in ILI with hospitalization, 7.1% (2 of 28) in ILI with pneumonia, and 6.7% (32 of 480) in ILI with maximum ISS of over 2. There was a significant association between country and RSV detection (P = .004); prevalence ranged from 2.0% (1 of 50 samples) in Mexico to 17.1% (12 of 70) in the Czech Republic.

The authors note that prevention of viral infections such as RSV in addition to prevention of influenza could decrease severe illnesses in the elderly.
Jan 29 J Infect Dis study

Food Safety Scan for Jan 31, 2014

News brief

FDA files rule on sanitary transport of food

The US Food and Drug Administration (FDA) today filed a rule on sanitary transportation "to ensure that transportation practices do not create food safety risks," the agency said in the proposed rule.

The rule is part of the FDA Food Safety Modernization Act, and is the act's seventh and final rule. Today's filing complies with a court-ordered Jan 31 deadline, according to a Food Safety News (FSN) story today.

The rule, "Sanitary Transportation of Human and Animal Food," says that it "builds on current safe food transport practices and is focused on ensuring that persons engaged in the transportation of food that is at the greatest risk for contamination during transportation follow appropriate sanitary transportation practices."

It establishes requirements for vehicle and transportation equipment, transportation operations, information exchange, training, and written procedures and records. It specifically addresses improper refrigeration, inadequate vehicle cleaning, and inadequate protection of food during transport.

The rule "would allow the transportation industry to continue to use best practices concerning cleaning, inspection, maintenance, loading and unloading of, and operation of vehicles and transportation equipment," the FDA said in the rule.

It does not apply to transportation of fully packaged shelf-stable foods, live food animals, or raw agricultural commodities when transported by farms. Those who transport food en route to another country are likewise exempt.

In a blog post today, FDA deputy commissioner Michael R. Taylor, JD, wrote, "Truthfully, it's uncommon for a foodborne illness to be caused by contamination during transportation. But we have received reports of unsanitary practices, and we want to minimize this potential source of illness."

The comment period on the rule will be open through May 31, and the FDA plans to three public meetings on the rule in February and March.

The FDA also announced today that it is extending the comment period for proposed rules on preventive controls for pet food and animal feed and its draft risk assessment from Feb 26 to Mar 31.
Jan 31 FDA rule
Jan 31 FSN story
Jan 31 Michael Taylor blog post

CDC confirms norovirus sickened 600+ on cruise ship

The US Centers for Disease Control and Prevention (CDC) said today that its labs have confirmed that the gastrointestinal illness that struck more than 600 passengers and crew aboard a Royal Caribbean cruise ship was norovirus, as suspected.

The agency said in a press release sent to reporters that no specific source of the virus has been confirmed and quite possibly won't be. The ship, carrying more than 4,000 passengers and crew members, was on a Caribbean cruise. It was disinfected after it returned to its home port in New Jersey, according to media reports.

"This outbreak represents one of the largest norovirus outbreaks in the past 20 years," the CDC said.

In related news, a ship from Princess Cruises returned early to Houston from the Caribbean yesterday after more than 160 of 3,104 passengers developed GI illness, USA Today reported today. CDC officials will also investigate the cause of that outbreak, the story said.

The CDC recorded just nine outbreaks of GI illness on ships in 2013, down from 16 in 2012 and more than 30 as recently as 2006, USA Today reported.
Jan 31 USA Today story