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.
Meanwhile, the Financial Times (FT) reported on August 7 that bogus cures for swine flu are being touted on the Internet, and that FDA is aggressively policing the snake-oil products.
For example, Rebuilder Medical Technology received an FDA warning for a shampoo contained in its $129 "SilverCure protection kit" claiming to prevent swine flu from gathering on hair, FT said. FT reported that FDA says it considers the false cures to be a public health threat and is aggressively pursuing the fraudulent products.
The FDA warning letters require a response from companies within 48 hours, compared to the normal 15-day standard for other products facing recall. And once the products are recalled, they remain on the FDA website to discourage other fraudulent manufacturers from advertising, FT reported.
Costa Rican President Has Swine Flu
In other news this week, Costa Rican President and Nobel Peace Prize winner Oscar Arias, said Tuesday that he has swine flu. The 69-year-old president said in a statement that he was quarantined at home and is being treated with the anti-flu medicine oseltamivir. Arias suffers from asthma so is at high risk than most for developing respiratory complications.
"Aside from the discomfort of the fever and sore throat, I feel in good shape and in full capacity to carry out my work by telecommuting," Arias said in a statement.
CDC Alters Recommendations
Finally, last week, WHO reported 162,230 confirmed cases of the pandemic H1N1 virus and 1,154 deaths globally. CDC says more than a million people in the U.S. have been infected.
Meanwhile, CDC recently changed its recommendation for people suffering from swine flu. The agency now recommends that people (in non-health care settings) with influenza-like illness remain at home until at least 24 hours after they are free of fever (100° F [37.8°C]), or signs of a fever without the use of fever-reducing medications.
This is a change from the previous recommendation that ill persons stay home for 7 days after illness onset or until 24 hours after the resolution of symptoms, whichever was longer, CDC says. The new recommendation applies to camps, schools, businesses, mass gatherings, and other community (non-hospital and public) places where most people are not at high risk for influenza complications.
"This guidance does not apply to health care settings where the exclusion period should be continued for 7 days from symptom onset or until the resolution of symptoms," the agency says.
"This revision for the community setting is based on epidemiologic data about the overall risk of severe illness and death and attempts to balance the risks of severe illness from influenza and the potential benefits of decreasing transmission through the exclusion of ill persons with the goal of minimizing social disruption," the agency says. "This guidance will continue to be updated as more information becomes available."
New Resources Available
New resources for health care professionals are now available from the CDC:
Sources: CDC, WHO, Financial Times and other news reports
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