NIH permits MERS-CoV, some flu GOF studies to resume
In the latest gain-of-function (GOF) research news, the National Institutes of Health (NIH) has allowed five such studies involving a mouse model for MERS-CoV and two influenza studies to continue after a 2-month moratorium, NPR reported today.
The term "GOF" generally refers to experiments that involve enhancing the pathogenicity, transmissibility, or host range of a pathogen in hopes of understanding disease and developing vaccines and drugs. In October the Obama administration suspended funding for GOF studies involving flu, MERS-CoV (Middle East respiratory syndrome coronavirus), and the SARS coronavirus, and earlier this week experts met to discuss the moratorium and other GOF issues.
MERS researchers at that meeting, held at the National Academy of Sciences in Washington, DC, defended their work, which involves developing a mouse model for human disease and convinced some skeptics, NPR reported. And yesterday the NIH told scientists, including Matthew Frieman, PhD, of the University of Maryland, that their requests for waivers from the moratorium have been approved and that their MERS-CoV mouse experiments could resume.
An NIH spokeswoman said in an e-mail to NPR that, in addition to the MERS studies, "exceptions were granted for two flu studies. Investigators have been (or will be shortly) informed and an official letter will be sent." The story did not specify what flu studies they were.
Officials report H5N8 outbreak in Germany, H5N1 in India
An outbreak of H5N8 avian flu has affected almost 18,000 turkeys at a fattening farm in Germany, and a duck has tested positive for H5N1 in northern India, officials reported.
The outbreak in Germany—which was first mentioned in a vague media report 2 days ago and is the second involving H5N8 in 6 weeks—involves a farm near Cloppenburg in Lower Saxony in the northwestern corner of the country, not far from the Netherlands, according to a report posted by the World Organization for Animal Health (OIE). The previous farm outbreak, reported to the OIE on Nov 6, was in northeastern Germany and was Europe's first involving H5N8.
In the latest event, 4,088 turkeys became sick and 199 died from the virus in an outbreak that began Dec 15. The remainder of the flock of 17,887 birds was destroyed to prevent disease spread. Samples tested positive on Dec 16.
In addition to the two outbreaks, the OIE on Nov 26 reported that H5N8 had been identified in a wild duck on the Isle of Rugen in the Baltic Sea just off the coast of northeastern Germany.
Dec 17 OIE report
In related news, officials in Chandigarh in northern India have confirmed H5N1 avian flu in a wild duck in the city's Sukhna Lake, where more than 30 ducks and geese have died in recent days, India Today reported today.
Officials are likely to start culling the flock of nearly 250 birds to prevent disease spread, the story said. The public will be kept away from the lake for at least 2 to 3 days.
A local government spokesman said the situation is being closely monitored, and officials are restricting the movement of ducks and geese in the area.
Kerala state, on the southwestern tip of India, has reported four recent H5N1 outbreaks in domestic ducks.
Dec 18 India Today story
Employees of tainted-steroid compounder charged with murder
Second-degree murder charges were lodged yesterday against one of the owners and the head pharmacist of New England Compounding Center (NECC), a now-defunct drug supplier in Massachusetts where an outbreak of fungal meningitis and other spinal infections that seriously sickened more than 700 people and killed 64 in 2012-13 originated, according to media sources.
All 14 employees of NECC were indicted by a US district court grand jury, with 11 of them arrested yesterday, including 3 members of the family that owned the pharmacy. The head pharmacist was an in-law of that family, said a story in the New Hampshire Union Leader.
The company was supposedly a compounding pharmacy, meaning it would mix drugs individually for patients on the basis of a physician's prescription. The drug in question, methylprednisolone acetate used for spinal injections, was claimed to be sterile and safe for injection.
The indictment charges that NECC actually was manufacturing and distributing the agents, some made from expired medications, in bulk for patients without prescriptions or with fraudulent prescriptions concocted by the company after the fact once their practices were under scrutiny.
In addition, procedures were not followed to ensure that the drugs were sterile, and one of the "clean" rooms at the plant was found to house mold and bacteria.
US Attorney Carmen Ortiz said the case was an "unprecedented national tragedy," according to a CBS News Boston story.
The Centers for Disease Control and Prevention (CDC) along with other federal, state, and local agencies, investigated the outbreak beginning in September 2012; its final report says illnesses related to NECC drugs numbered 751 from 20 states, with 64 deaths. NECC closed in October 2012. The company owners also face charges of racketeering as well as criminal contempt for alleged illegal financial dealings.
Dec 17 New Hampshire Union Leader story
Dec 17 CBS Boston story
Final (Oct 23, 2013) CDC outbreak report
Compelling results of experimental shingles vaccine trial
A 97.2% reduction in the risk of shingles achieved with the investigational shingles vaccine HZ/su from drug maker GSK may point the way toward its joining the only shingles vaccine now on the market, Zostavax, at some point, says a Reuters story today.
The promising HZ/su results came during an ongoing phase 3 clinical trial, ZOE-50, comprising 16,000 people in 18 countries, says a press release from GSK. The 97.2% risk reduction with HZ/su as compared with placebo occurred in adults 50 years of age and older.
The Reuters story says Zostavax has an efficacy of 69.8% in individuals 50 to 59 years old, with lower efficacy in older people. However, notes the story, different designs of clinical trials may not make for fair comparison of the efficacy numbers.
HZ/su works by combining a protein found on the shingles virus, gE, with an adjuvant called ASO1B made by US biotech firm Agenus. Zostavax, which was approved by the US Food and Drug Administration in 2006, is a live-attenuated virus vaccine.
Further data from the ZOE-50 trial are forthcoming. The GSK release says additional trials of HZ/su efficacy in people 70 years of age and older as well as immunocompromised individuals are under way.