A single company has obtained the rights to a vaccine-producing technology that may prove crucial in a fight against pandemic influenza and insists it will make it widely available in an emergency. And U.S. officials have revised a vaccine policy to stretch supplies.
MedImmune in Gaithersburg, Maryland, announced last week that it has licensed patents for so-called reverse genetics from Mount Sinai School of Medicine in New York City. The company already had rights to other patents for the technology. Reverse genetics makes possible the production of seed vaccine faster and more safely than the traditional means of making seed vaccine in eggs. If MedImmune waives licensing fees for developing countries during a pandemic, as it has pledged, "there should be no downside," says infectious disease expert Andrew Pavia of the University of Utah, Salt Lake City.
Meanwhile, the Food and Drug Administration (FDA) said last month that the agency will not require that a pandemic flu vaccine containing an immuneresponse-boosting additive called an adjuvant go through a trial testing its efficacy at preventing infection. Instead, FDA will require only evidence of safety and an immune response to license such a vaccine. That could stretch scarce vaccine supplies in a pandemic. "It is very important that FDA has clarified its position," says Pavia. The United States is currently conducting clinical trials of vaccines with an adjuvant against the deadly H5N1 avian influenza strain that has killed more than 70 people.
