Flu Scan for Aug 19, 2013

News brief

FDA approves GlaxoSmithKline's second four-strain flu vaccine

GlaxoSmithKline (GSK) has won US Food and Drug Administration (FDA) approval of its second four-strain influenza vaccine, FluLaval Quadrivalent, making it the fourth such vaccine on the US market.

Quadrivalent flu vaccines contain two influenza B strains as well as two A strains (H1N1 and H3N2), with the aim of improving protection by targeting both of the common B lineages. In recent years it has been difficult to predict which lineage, Victoria or Yamagata, would predominate in any given season.

FluLaval Quadrivalent, which is made in Quebec, is approved for children ages 3 and older and for adults, GSK said in its Aug 16 announcement. The trivalent version of FluLaval was previously approved only for adults, and the FDA's action marks the first time that all GSK flu shots are approved for ages 3 and older.

The company said it anticipates making a "limited amount" of the new vaccine available this season and is now taking orders. Earlier this month GSK officials said they expected to provide up to 10 million doses of their other quadrivalent vaccine, Fluarix Quadrivalent, this season.

FluLaval Quadrivalent will be available in multidose vials, while Fluarix Quadrivalent is sold in prefilled syringes, GSK said. The newly approved vaccine is currently licensed only in the United States.

Other quadrivalent flu vaccines on the US market are made by MedImmune and Sanofi Pasteur.
Aug 16 GSK press release
Aug 5 CIDRAP News story on quadrivalent flu vaccines

Cambodian boy dies of H5N1

A 9-year-old boy in Cambodia died of H5N1 avian influenza yesterday, the Chinese news agency Xinhua reported today. The boy's diagnosis was confirmed Aug 9 after his hospitalization for fever, cough, vomiting, abdominal pain, and dyspnea.

The boy's village, in the northwestern province of Battambang, had seen recent deaths of chickens and ducks, the story said. He reportedly had carried dead and sick birds to his sister for cooking before his illness began.

With the boy's death, Cambodia has had 16 H5N1 with 10 deaths this year, and since 2004 the country has seen 37 cases with 29 deaths, according to the story.
Aug 19 Xinhua report

WHO sees few flu hot spots; H1N1 is most common strain

Flu activity in much of the world is low, but it is increasing in a few areas, the World Health Organization (WHO) said in an Aug 16 epidemiologic update.

Areas reporting activity upticks include parts of the Southern Hemisphere—Australia, New Zealand, and the Pacific Islands—where overall flu activity has been lower than usual this year. The WHO said so far there is no clear sign that activity in those areas has peaked.

Peru reported a sharp rise in 2009 H1N1 virus activity in the middle of July, though flu activity is decreasing in other countries in the region, the WHO said. Argentina has had more flu-like illness cases this season than the average for the previous 5 years, but the number has started to decline.

Flu activity in most of the Northern Hemisphere, including the United States, Europe, and northern Asia, is at low interseasonal levels, the WHO said.

In a virologic update today, the agency said the most frequently detected seasonal flu virus at the global level is 2009 H1N1, followed closely by H3N2. Testing showed that 12% of flu viruses are influenza B. H1N1 has predominated in Central and South America, with some countries reporting H3N2 circulation. Australia and New Zealand reported increasing influenza B detections.
Aug 16 WHO flu epidemiologic update
Aug 19 WHO flu virologic update

H7 avian flu reported on Italian farm

An outbreak of highly pathogenic H7 avian influenza has been reported on a commercial layer chicken farm in Italy, according to an Aug 15 notice from the World Organization for Animal Health (OIE).

The infection has affected 105,000 of 128,000 susceptible birds on the farm, for a morbidity rate of 82.03%. Four thousand birds are reported dead, for a mortality rate of 3.81%.

The farm is located in the Emilia-Romagna region of Italy, about 50 kilometers northeast of Bologna. Further diagnostic testing to determine the virus's neuraminidase type is under way, as is an epidemiologic investigation.

Authorities have set up protection and surveillance zones around the farm and have begun destroying the remaining birds in the flock, says the report. Plans also call for disinfecting the premises.
OIE report

News Scan for Aug 19, 2013

News brief

Report: Saudi Arabia has two more MERS cases

Saudi Arabia has identified two more cases of MERS-CoV (Middle East respiratory syndrome coronavirus) infection, according to a brief, machine-translated report today from the Saudi Ministry of Health (MOH). They are the first cases reported since Aug 1.

The two cases are in the Riyadh region, according to the report, which was posted on FluTrackers, an infectious disease message board. The patients are 50 and 59 years old, have multiple chronic diseases, and are being treated in hospital intensive care units.

The translated statement gave no information on the patients' gender, illness onset dates, occupations, or possible exposures.

The illnesses raise Saudi Arabia's MERS total to 76 cases, with 39 deaths, according to translated MOH information. The global count of MERS cases has now reached 96, of which 47 have been fatal, according to the US Centers for Disease Control and Prevention. The new cases have not yet been noted by the World Health Organization.

Of the three latest cases reported before today, two were in the Riyadh region.
Aug 19 translated report via FluTrackers
CDC MERS page

US Cyclospora infections surpass 600

The US Centers for Disease Control and Prevention (CDC) today said it has received reports of 10 more Cyclospora infections, including the first case reported from Tennessee. The additional cases raise the CDC's national total to 586 and the number of affected states to 20.

Health officials in Texas, the state with the most infections, in an update said 267 infections have been reported there, which is 23 more than the CDC's count for that state. Including those cases boosts the nation's total to 609.

Of 440 patients with available information, 36 (8%) were hospitalized, the CDC said. Patient ages range from 1 to 92 years, with a median of 51 Fifty-five percent of patients are female. The latest illness onset was Jul 31, though most patients got sick from the middle of June through early July.

It's still not clear if cases in all of the states are related to outbreaks in Iowa and Nebraska, where restaurant-related clusters of infections were linked to a bagged lettuce mixture supplied by a Taylor Farms facility in Mexico.
Aug 19 CDC update
Aug 19 Texas update

FDA repeats warning about NuVision's sterile products

The US Food and Drug Administration (FDA) recently reminded health providers that they should not administer any sterile products made and distributed by NuVision Pharmacy, a compounder based in Dallas. In an Aug 16 statement, the FDA said its latest advisory is related to a May 18 recommendation that healthcare staff check their supplies for the company's sterile products and refrain from using them.

The FDA sent a letter to the company in July outlining poor sterile production practices observed by its inspectors in April and asking the company to recall all of its sterile products that haven't passed their expiration dates.

In April the company recalled methylcobalamin injection and lyophilized injection products because of inspection problems and FDA reports of fever, flu-like illness, and injection-site soreness related to one of the recalled products. However, the FDA said the company has refused to recall its other sterile products and that the agency can't require the company to take the step.

A statement on NuVision's Web site says the FDA is inspecting compounding pharmacies using standards for manufacturers and that it is not a manufacturer. The firm said it is in compliance with standards for compounding pharmacies and that state laws don't require compounding pharmacies to follow manufacturing standards. The company also says its injectables are tested by a third-party lab before dispensing and that it is not recalling all of its sterile injectables.
Aug 16 FDA announcement
NuVision statement