Well, now that the summer is over and Congress is back from their "recess" I decided it was time to bring back the Weekly Roundup as there is more happening in DC than usual and I'm more back in the groove for regular postings. It has been an unusual September in Washington – cooler temperatures than normal outside, hotter temperatures than normal on the Hill.
- FDA Approves H1N1 Vaccines – In what seems to be an amazingly short time, the manufacturing sector has produced, and the FDA has approved, several H1N1 vaccines that can now go into production and soon distribution. The FDA has set up a section of its Web site to feature the approved vaccines and to provide answers to questions that people may have about them. There was a posting on Eye on FDA this week about it also, urging that someone, either public or a private entity, take on the responsibility of an education campaign if there is an expectation that people should step forward and take the vaccine.
- NEJM Study on Cross Resistance to H1N1 - The New England Journal of Medicine published a very interesting study on cross-resistance to H1N1 this week looking at blood samples of donated blood to examine those who had been vaccinated in 1976 ro with recent seasonal vaccinations. They did not find the seasonal vaccines to be of any benefit, and those under 30 years of age had no cross-resistance, but some older adults did have pre-exisiting cross-over antibodies.
- FDA Clears New Blood Test for Ovarian Cancer – On September 11, the FDA announced that the agency was clearing a new blood test for ovarian cancer called OVA1 developed by Vermillion, Inc. in conjunction with researchers at The Johns Hopkins University at Balitmore.