News Scan for Aug 18, 2015

Vaccine hesitancy
FDA on contaminated scopes
More chikungunya cases
Anthrax vaccine contract

WHO takes on vaccine hesitancy

Those who refuse or delay vaccines constitute a growing, urgent challenge around the world, the World Health Organization (WHO) said in a statement today.

The agency highlights the problem in a special issue of Vaccine published today, noting the role of vaccine hesitancy in limiting vaccine coverage and exploring ways to tackle it. The WHO said that 1 in 5 children globally do not receive life-saving immunizations, some because their parents are leery of the intervention. An estimated 1.5 million children die each year from vaccine-preventable diseases.

Vaccine hesitancy is complex and varied, the agency said. It is influenced by factors such as misinformation, complacency, convenience, and confidence.

The authors of an editorial in the special issue wrote, "As the recent Ebola crisis tragically brought to light, engaging with communities and persuading individuals to change their habits and behaviours is a lynchpin of public health success. Addressing vaccine hesitancy is no different."

In the journal, WHO experts propose steps to increase our understanding of vaccine hesitancy and suggest ways that organizations can increase acceptance, share effective practices, and develop new tools to address the problem. Effective communication is one way to dispelling fears, addressing concerns, and promoting acceptance, they say.
Aug 18 WHO statement
Aug 18 Vaccine special issue


FDA sends warning letters on scopes tied to drug-resistant illnesses

The US Food and Drug Administration (FDA) last week issued warning letters to three firms that produce duodenoscopes linked to multidrug-resistant hospital infections, the first step toward legal action if contamination problems aren't addressed, USA Today reported yesterday.

The agency said that it issued warning letters on Aug 12 to Olympus, Pentax, and FujiFilm for violating multiple manufacturing and quality-control standards in producing their duodenoscopes. The FDA also cited Olympus and Pentax for failing to properly notify federal authorities after the companies learned of infections tied to their scopes.

The agency also noted that FujiFilm and Pentax may not have obtained proper regulatory approval for their scopes, something for which Olympus had already been cited. Failure to correct the problems can lead to administrative actions, fines, and lawsuits, the story noted.

Contaminated scopes have sickened dozens of patients and killed more than 12, the story said. Duodenoscopes are used to treat gallstones and other ailments and are passed down the throat.

"The FDA takes these violations very seriously and will continue to monitor these firms to ensure they take appropriate corrective action," FDA spokeswoman Jennifer Dooren said in a statement. The firms are planning their next steps.
Aug 17 USA Today report


Chikungunya outbreak in Americas grows by 5,700 cases

The Pan American Health Organization (PAHO) late last week reported 5,700 new cases of chikungunya in the Caribbean and Americas, bringing the outbreak total to 1,634,535.

The new total includes 480,860 suspected and 15,947 confirmed locally acquired cases and 781 imported cases reported in 2015, or 497,588 total, according to an Aug 14 PAHO update. The previous week's update noted 5,881 new cases.

Colombia, which has reported thousands of cases per week for the past several months, reported the largest increase with 3,690 new cases, bringing its outbreak total this year to 316,563. Venezuela reported 1,425 new cases for a 2015 outbreak total of 14,203. Many countries, however, have not reported cases in weeks.

Three new fatalities were reported, bringing the 2015 death toll to 64.

The epidemic began in December 2013 with the first locally acquired chikungunya case ever reported in the Americas, on St. Martin in the Caribbean.
Aug 14 PAHO update


Pfenex signs BARDA contract for next-generation anthrax vaccine

Pfenex, Inc., announced yesterday that it has signed a 5-year contract worth up to $143.5 million with the US Department of Health and Human Services Biomedical Advanced Research and Development Authority (BARDA) to develop a next-generation anthrax vaccine.

The San Diego-based pharmaceutical company said in a press release that the vaccine, Px563L, is a mutant recombinant protective antigen (rPA) anthrax vaccine.

The base contract covers manufacturing a supply of the vaccine and a phase 1a clinical study. Milestone options include a phase 1b clinical study, a phase 2 study, a nonclinical efficacy study, and the development of processes to transfer and optimize technology and validate and monitor the consistency of vaccine lots.

Bertrand Liang, MD, PhD, chief executive officer of Pfenex, said the contract offers the potential to dramatically speed the production of large amounts of a stable rPA anthrax vaccine for the US government.

Over the past several years, federal officials have been pursuing, for a potential bioterror attack, the development of a new version of the anthrax vaccine that can provide immunity in fewer doses and with fewer side effects.
Aug 17 Pfenex press release

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