July 23, 2009
US To Test Swine Flu Vaccine
US officials are looking to launch clinical trials of a swine flu vaccine before the winter flu season begins.
"With the emergence of the 2009 H1N1 influenza virus, we have undertaken a collaborative and efficient process of vaccine development that is proceeding in stepwise fashion," said Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases.The United States has been hit the hardest by the A(H1N1) virus, with over 40,600 cases and 263 deaths.
The Centers for Disease Control and Prevention (CDC) has already delivered a seed virus to manufacturers to begin testing with new vaccines.
According to Fauci, they intend to "quickly evaluate these pilot lots to determine whether the vaccines are safe and to assess their ability to induce protective immune responses."
"These data will be factored into the decision about how and if to implement a 2009 H1N1 flu immunization program this fall," Fauci told the AFP.
Officials are concerned that the traditional flu season will accelerate the number of swine flu cases across the US.
"The trials are being conducted in a compressed timeframe in a race against the possible autumn resurgence of 2009 H1N1 flu infections that may occur at the same time as seasonal influenza virus strains begin to circulate widely in the Northern Hemisphere," the CDC issued in a statement.
The agency plans to administer the vaccines to volunteers as early as the second week of August. The National Institutes of Health (NIH) will direct the study of the vaccine.
The NIH's main study sites will include hospitals in Baltimore, Iowa City, St. Louis, Houston, Cincinnati, Atlanta, Seattle, Nashville, and Kansas City.
Initial volunteers for the vaccines will be between 18 to 64 years of age, or 65 and over. According to the CDC, the volunteers will be given two vaccines 21 days apart. One has been created by Sanofi Pasteur, and a second created by CSL Biotherapies.
"If early information from those trials indicates that these vaccines are safe, similar trials in healthy children (aged six months to 17 years old) will begin," the statement said.
A separate trial will have volunteers take an H1N1 vaccine and a dose of seasonal flu vaccine.
Additional manufacturers will conduct company led tests on their vaccines, including a non-shot nasal spray vaccine.
Other nations, including Australia, have already begun administering trial vaccines of swine flu.
The pandemic has killed over 700 people since spreading from Mexico earlier this year.
On the Net: