FDA approves four H1N1 vaccines.

The Wall Street Journal (9/16, Dooren, Favole) and many other news sources report that HHS Secretary Kathleen Sebelius announced Tuesday that the FDA has approved H1N1 vaccines made by Novartis AG, a unit of Sanofi-Aventis SA, CSL Ltd., and MedImmune, an AstraZeneca PLC unit.  ABC World News (9/15, story 8, 0:20, Gibson) reported that “the government is aiming for a rollout by early next month, and says there should eventually be enough vaccine available for everyone.”  In its lead story, CBS Evening News (9/15, lead story, 2:50, Couric) called it “the biggest immunization campaign in US history.   Sebelius announced the approvals at a hearing of the House Energy and Commerce Committee, saying that “some vaccine might arrive by the first week in October, with ‘ample supplies’ by mid-October,” the Miami Herald (9/15, Tasker) reported. She said, “It appears that the vaccine we’re producing is working quite well.”   CDC director Thomas Frieden, MD, also noted the timeline, saying, “We think the first doses of some of the vaccine forms should be available in about three weeks,” CNN (9/16) reports. “Previously, the CDC had been predicting the vaccine would not be available before middle or late October.”   The Los Angeles Times (9/16, Maugh) points out that the US “has ordered enough vaccine for 195 million doses, meaning that ‘we will have enough vaccine available for everyone,’ Sebelius said.” The vaccines “will be shipped to national distribution centers,” USA Today (9/16, Sternberg) explains. The shots will then become available at outlets such as “public health clinics, doctors’ offices, schools, pharmacies, and grocery stores” depending on the state.  NBC Nightly News (9/15, lead story, 2:40, Williams) noted, however, that due to “problems with a 1976 vaccination campaign against a different swine flu threat…Sebelius heard questions” yesterday “about the safety of the new vaccine.” She told Congress, “We are assured by the scientist that lots of steps have been taken along the way to make sure that this will be a safe procedure.”  According to the AP (9/16, Neergaard), Sebelius also said that physicians should not “hand out prescriptions for anti-flu medicines to be used to prevent flu…because ‘it could make them sicker in the long run.'” She “stressed” that “Tamiflu [oseltamivir] and Relenza [zanamivir] should be used for treatment only.”  The FDA said that the four licensed vaccines “induce a robust immune response in most healthy adults eight to 10 days after a single dose,” AFP (9/16) reports. Apart from the four vaccines approved Tuesday, Sebelius “fully anticipate[s]” a fifth form of the vaccine to be licensed, Bloomberg News (9/16, Larkin) notes. Bloomberg adds that GlaxoSmithKline PLC is likely the manufacturer of that vaccine.   The Financial Times (9/16, Jack), Canada’s CBC News (9/16), New York’s Newsday (9/16, Ricks), and the Dow Jones Newswire (9/16, Horobin) also cover the story.

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