H1N1 vaccinations scheduled to begin in three weeks in US.

H1N1 vaccinations scheduled to begin in three weeks in US.

Bloomberg News (9/14, Randall, Gale) reports, "Swine flu vaccinations may begin in three weeks, earlier than previously anticipated, after the first US tests found a single shot to be effective in eight to 10 days, US health officials said. The first shots may be available by the end of this month and administered to patients the first week of October, said Nancy Cox, director of the flu division at the US Centers for Disease Control and Prevention in Atlanta." Previously, "health officials had...planned for vaccinations to begin in mid-October, requiring two shots administered three weeks apart." The piece continues to describe early outbreaks in the US, and relates the testing procedures that led authorities to determine that a single dose would be sufficient to inoculate patients.

HHS Secretary Kathleen Sebelius also said that "the nation's first round of swine flu shots could begin sooner than expected, with some vaccine available as early as the first week of October," the AP(9/14) reports. She said, "We're on track to have an ample supply rolling by the middle of October. But we may have some early vaccine as early as the first full week in October. We'll get the vaccine out the door as fast as it rolls off the production line."

Sebelius "said she is confident that an ample supply of H1N1 vaccine shots will be available to the public by mid-October," the Washington Times (9/14, Lengell) adds. Her "optimism is a shift from last month, when the government was bracing for production delays of the vaccine." This year, "flu viruses are circulating unusually early," though of the cases reported, "98 percent are from H1N1, said Dr. Anne Schuchat of the Centers for Disease Control and Prevention."

USA Today (9/14, Sternberg) notes Sebelius' comments, adding that "Nancy Cox of the Centers for Disease Control and Prevention said the first shipments will be small and reserved for priority groups such as young people and pregnant women." Cox "said evidence that one shot offers protection was a big confidence-booster that prompted the government to speed up its timetable." Bloomberg News (9/14, Murray) and Voice of America (9/14) also report on Secretary Sebelius' comments.

Study indicates peramivir may be as effective against flu as Tamiflu. The AP (9/14, Marchione) reports, "Researchers delivered a double dose of good news Sunday in the fight against flu: successful tests of what could become the first new flu medicine in a decade, and the strongest evidence yet that such drugs save lives, not just shorten illness. A single intravenous dose of the experimental drug, peramivir, cleared up flu symptoms as well as five days of Tamiflu pills did, a large study in Asia found." The piece continues to detail other research presented at an American Society for Microbiology conference in California on Sunday, including studies pointing to the lifesaving utility of Tamiflu. The conference "is the first big meeting of infectious disease specialists since the new H1N1 swine flu emerged in April. Treatment options are getting huge attention because it will take a month or more for people to get swine flu vaccine and have time to develop immunity from the shot."

Drug Approvals

FDA approves antibiotic telavancin.

Bloomberg News (9/12, Matsuyama) reported, "Theravance Inc. and Astella Pharma Inc. said they received US approval to market a new antibiotic for hard-to-treat skin infections such as methicillin-resistant Staphylococcus aureus, or MRSA." The FDA approved telavancin as "a once-daily infusion," which will "be sold as Vibativ."

The San Francisco Business Times (9/13, Leuty) reported that the approval includes "a 'black box' warning for pregnant women." The FDA sought "more data" from Theravance "even after an advisory committee late last year signed off on telavancin" because MRSA "has become increasingly resistant to generic vancomycin." Reuters (9/14, Nishitani) also covers the story.

FDA approves diabetic insulin spray for IND program.

MedPage Today (9/11, Petrochko) reported, "The FDA has approved Oral-lyn, an insulin spray treatment for type I and type II diabetes, for its Investigational New Drug program." The spray "delivers prandial insulin orally through a device similar to an asthma inhaler, which sprays it on the inside of the cheek." MedPage added, "Researchers have spent much time looking for alternative means of dispensing insulin to diabetics, and the IND program allows patients with serious or life-threatening conditions, and without suitable alternative treatment, to access drugs otherwise available only to those in a clinical trial."