News Scan for Sep 15, 2015

New FDA head nominated
Plague case in Michigan
Ebola vaccine funding
Nursing home antibiotic use

Deputy director nominated for top FDA post

President Barack Obama today nominated deputy commissioner Robert Califf, MD, as the next Food and Drug Administration (FDA) commissioner, Bloomberg News reported. If approved by the Senate, Califf would replace Margaret Hamburg, MD, who stepped down in March after serving 6 years.

Before being appointed deputy FDA commissioner in March, Califf worked at Duke University since 1982. He served as vice chancellor; directed the Duke University Clinical Research Institute, which he founded in 2006; and taught as a professor of medicine. The White House announced the nomination in a statement listing several nominees for high-profile administration posts.

When Califf was appointed deputy commissioner it was widely assumed he would be nominated to replace Hamburg, Bloomberg reported.
Sep 15 Bloomberg News report
Sep 15 White House statement


Michigan woman contracts first-ever Midwest plague illness

A Michigan woman has contracted bubonic plague while hiking in Colorado, the Denver Post reported today. The woman, from Marquette County in the state's Upper Peninsula, represents the first case ever confirmed in a Midwest state, officials said.

A spokesperson for the Michigan Department of Health and Human Services said the woman has been treated. Health officials said the case poses no threat to the general public, the Detroit Free Press reported yesterday.

"In this case, the infection resides in a lymph node," Terry Frankovich, MD, MPH, medical director for the Marquette County Health Department, told the Free Press. "Theoretically, the illness can move to bloodstream or to a lung infection, but this individual had localized infection, so there's no concern about transmission," she added.

Chaffee County Public Health said today that the woman contracted the plague while attending the Gentlemen of the Road music festival in Salida over the weekend of Aug 21, the Post story said. Andrea Carlstrom, health department director, said the US Centers for Disease Control and Prevention (CDC) has determined that the woman likely contracted the disease while hiking the Methodist Mountain Trail System.

Carlstrom said a dog also contracted plague in that area over the Jul 4 weekend and passed the disease to its owner. Both dog and owner have been treated and are recovering, she said.

The case in Michigan is the 14th US plague case this year, 4 of which have been fatal, including 2 in Colorado, the Post reported. The CDC has logged an average of about 5 plague cases a year since 2000, with a high of 17 in 2006 and 10 reported last year. The most number of plague-related deaths in a year during that span, however, was only 2.
Sep 15 Denver Post story
Sep 14 Detroit Free Press story
CDC plague data


Johnson & Johnson awarded $28.5 for prime-boost Ebola vaccine

Johnson & Johnson subsidiary Crucell Holland BV, one of its Janssen Pharmaceutical Companies, has been awarded $28.5 million from the Biomedical Advanced Research and Development Authority (BARDA) to help in developing its Ebola prime-boost vaccine regimen, the company said in a press release yesterday.

The regimen, currently in clinical trials, uses a prime, Ad26.ZEBOV, from Crucell and a boost, MVA-BN-Filo, from Bavarian Nordic. BARDA is part of the Department of Health and Human Services (HHS). Prime-boost vaccines involve an initial dose that primes the immune system to develop antibodies, then a booster dose days later that can strengthen the immune response.

The award to the New Jersey–based company involves a 5-year commitment, with options for an additional $40.5 million for manufacturing and related steps.

Bavarian Nordic of Copenhagen, in a separate news release, said its share of the award is $9 million, with options for an additional $24 million.

US, UK, and African phase 1 studies of the prime-boost regimen began in December 2014. UK and French phase 2 trials started in July, and plans are "well advanced" for a safety and immunogenicity study in Sierra Leone and additional phase 2 studies outside the outbreak area in Africa.

Janssen, partnering with Bavarian Nordic, has produced more than 800,000 regimens and is able to make 2 million more this year, the company said in the release.
Sep 14 Johnson & Johnson press release
Sep 14 Bavarian Nordic news release
Sep 14 HHS news release on the award


CDC releases tools for nursing homes to combat antibiotic misuse

The CDC today recommended that all nursing homes improve their antibiotic prescribing practices and cut inappropriate use to protect residents from antibiotic-resistant infections such as Clostridium difficile, the agency said in a press release.

To assist the institutions, the CDC released a new resource "Core Elements of Antibiotic Stewardship in Nursing Homes" that provides a number of practical steps to implement or enhance a program. The resource expands on similar recommendations the CDC published last year for acute-care hospitals.

"We encourage nursing homes to work in a step-wise manner implementing one or two activities at first, then gradually adding new strategies from each core element over time," said Nimalie Stone, MD, CDC medical epidemiologist for long-term care. "Taking any of these actions to improve antibiotic use in a nursing home will help protect against antibiotic-resistant infections and more effectively treat infections."

Of the approximately 4.1 million Americans living in nursing homes, up to 70% receive at least one course of antibiotics during a year. And up to 75% of them are prescribed incorrectly, the CDC said.

"Superbugs that are hard to treat pose a health risk to all Americans, particularly the elderly whose bodies don’t fight infection as well," said CDC Director Tom Frieden, MD, MPH. "One way to keep older Americans safe from these superbugs is to make sure antibiotics are used appropriately all the time and everywhere, particularly in nursing homes."
Sep 15 CDC press release
CDC "Core Elements" resource

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