Flu Scan for Apr 30, 2014

News brief

HHS stops research on long-acting antiviral laninamivir

The Department of Health and Human (HHS) has ordered Biota Pharmaceuticals to stop research on the experimental flu antiviral drug laninamivir, the Atlanta Journal-Constitution reported yesterday.

Biota President and Chief Executive Officer Russell Plumb said the company, of Alpharetta, Ga., was surprised at the stop-work order and did not know what led to the decision. HHS issued the order after a review of the company's work on the drug.

The drug is a neuraminidase inhibitor, the same class that includes oseltamivir (Tamiflu) and zanamivir (Relenza), the two most popular antivirals for influenza.

Biota is under contract with HHS's Office of the Assistant Secretary for Preparedness and Response and the Biomedical Advanced Research and Development Authority to develop laninamivir, a long-acting drug for preventing influenza A and B.

Before the stop-work order, the company had been conducting a large phase 2 trial that involved adults with influenza. Biota's contract with HHS is designed to provide up to $231 million to complete the drug’s clinical development, the story said.
Apr 29 Atlanta Journal-Constitution story

Adjuvanted H7N9 vaccine shown fairly immunogenic in adults

Novartis researchers today said their company's adjuvanted cell-culture H7N9 influenza vaccine showed a good safety profile and yielded a moderate immune response in a phase 1 trial, according to their report in Science Translational Medicine.

The investigators divided 402 volunteers into one of four groups of increasing dosage, with all enrollees receiving two vaccine doses 3 weeks apart: (1) 3.75 micrograms (mcg) of antigen, plus 0.125 milliliters (mL) of the MF59 immune-boosting adjuvant; (2) 7.5 mcg antigen plus 0.25 mL MF59; (3) 15 mcg antigen plus 0.25 mL adjuvant; and (4) 15 mcg antigen with no adjuvant.

Seroprotection, as measured by a hemagglutination inhibition (HI) titer of 1:40 or greater, was 26%, 44%, 52%, and 3% for the four groups, respectively, 43 days after the first dose. When measured by microneutralization, seroprotection rates were 55%, 73%, 78%, and 7%, respectively.

The authors add, "Despite increased injection site pain and other mild effects with MF59, all formulations were well tolerated. These encouraging immunogenicity and safety data on the A/H7N9 vaccine provide a strong rationale for further clinical development."

Novavax reported phase 1 results of its virus-like particle H7N9 vaccine with and without adjuvant in a letter in the New England Journal of Medicine on Dec 26, 2013. And the National Institutes of Health (NIH) announced in September 2013 that phase 1/2 trials of a Sanofi Pasteur H7N9 vaccine with and without adjuvant should be completed this December.
Apr 30 Sci Transl Med abstract
Dec 26, 2013 N Engl J Med letter
Sep 18, 2013, CIDRAP News story on NIH-funded trials

News Scan for Apr 30, 2014

News brief

DHS cancels plans for BioWatch's automated air-monitoring system

Plans for the US government's "Generation 3" automated system to test the air for dangerous pathogens in US cities under the BioWatch program have been canceled over concerns about its cost and effectiveness, it was revealed recently.

Cancellation of the Gen-3 system was ordered on Apr 24 by Jeh Johson, secretary of the Department of Homeland Security (DHS), the Los Angeles Times reported. The information came from a memo circulated by Michael V. Walter, manager of BioWatch.

BioWatch has air monitoring stations in about 30 cities. Filters from the stations are collected daily and tested for pathogens, such as the bacterium that causes anthrax, that might indicate a bioterrorist attack. The Gen-3 system was described as a "lab in a box" that would automate the collection and testing, speeding detection of threats.

According to the Times, Walter said in his memo that DHS "remains committed to the BioWatch program and the importance of improving our early warning and detection technologies." And DHS spokesman S.Y. Lee said the cancellation reflected a commitment to "cost-effective acquisition without compromising our security."

The cancellation reverses a policy that continued for years under the George W. Bush and Obama administrations, the story noted.

In 2007 a DHS official told congress that Gen-3 would be "four times cheaper to operate" than the current system, the story said. But articles published by the Times in 2012 and 2013 revealed flaws in the system's durability and reliability.

Prototypes were installed in New York City's subway system in 2007 and 2008, but they were removed after city officials found their performance unsatisfactory. Also, field testing of another prototype in Chicago in 2011 showed that it could not operate more than a week at a time without manual servicing.

The problems prompted congressional hearings. In September 2012 the Government Accountability Office estimated that the annual operating costs for Gen-3 would be "about four times more" than for the existing BioWatch system, the Times reported.
Apr 25 Times story

Alberta declares three-region measles outbreak

Public health officials in Alberta have declared a measles outbreak in three regions after almost two dozen recent cases in the province, the Canadian Press reported yesterday.

The declaration allows immunization of babies 6 months to 1 year old who typically would not be vaccinated, according to a spokeswoman for Alberta Health Services. The outbreak regions are Edmonton, Calgary, and central Alberta.

The agency also recommended that children 4 years old and older receive their second dose of measles vaccine as soon as possible if they haven't yet received it.

In light of the cases during several straight weeks, spokeswoman Shannon Evans said the measure "was a necessary step to protect public health."
Apr 29 Canadian Press story