par Lynn Shapiro
, Writer | August 12, 2009
A swine flu vaccine is expected to hit the market by the fall of 2009, thanks to aggressive efforts on the part of government officials and vaccine manufacturers.
On August 7, Sanofi Pasteur said it submitted a new drug application (NDA) to the FDA for licensure of its influenza A (H1N1) vaccine.
Sanofi began testing its vaccine August 6. The trials will recruit approximately 2,000 healthy participants and will also evaluate the safety and potential benefits of adding an adjuvant to the pandemic vaccine, a Sanofi spokeswoman says.
So far, no vaccines with adjuvants have been approved in the U.S., but the CDC would like to see one made to stretch the vaccine's effectiveness, as the agency gears up for a swine flu outbreak when flu season starts this fall.
Diagnostic Tests Inaccurate
In other news, CDC reported last week that swine flu diagnostic tests are missing many cases of the virus.
The accuracy of the tests ranged from 40 percent to 69 percent in detecting swine flu, CDC said. The findings confirm CDC's warnings that tests conducted in physicians' offices are inaccurate in diagnosing the H1N1 strain of influenza.
CDC says that it's safer to diagnose the virus based on symptoms and on the fact that the virus is spreading in a community or country.
"The recent appearance and worldwide spread of novel influenza A (H1N1) virus has highlighted the need to evaluate commercially available, widely used, rapid influenza diagnostic tests," CDC researchers say.
CDC scientists tested three popular diagnostics -- BinaxNow, made by Inverness Medical Innovations, Becton Dickinson's Directigen EZ Flu A+B test and Quidel's QuickVue, according to news accounts.
CDC uses a highly accurate test to diagnose H1N1, dubbed real-time reverse transcription-polymerase chain reaction, or rRT-PCR, which examines a person's DNA to see if flu is present.
Several companies are taking the opportunity to develop DNA tests that would rapidly and accurately diagnose various strains of flu. For instance, GlaxoSmithKline and Enigma Diagnostics reportedly are developing DNA tests to identify specific flu strains, using polymerase chain reaction technology (PCR). Seegene, based in South Korea and Maryland reportedly is manufacturing a PCR test for hospitals that can quickly detect various strains of influenza and spot resistance to antiviral medicines, as well.
DxNA, based in Utah, has submitted a new drug application to the FDA to approve its GeneSTAT PCR test. And Osmetech (based in London, with operations in the U.S.) has requested FDA accelerated approval for a test it says can detect 18 bacterial and viral infections, including swine flu.