HHS reports progress on cell-based pandemic vaccines

Jan 9, 2009 (CIDRAP News) – In a progress report on federal pandemic influenza planning efforts, the US Department of Health and Human Services (HHS) says several companies working under federal contracts are on track to develop cell culture–based pandemic flu vaccines.

The 19-page progress report by HHS Secretary Mike Leavitt, posted yesterday on the HHS Web site, also says that biotechnology companies hope to have point-of-care tests that can distinguish between pandemic and seasonal flu viruses ready to submit to the Food and Drug Administration (FDA) by the end of this year.

The report is the sixth progress update since March 2006 and comes as Leavitt nears the end of his tenure as secretary. In his introduction, Leavitt wrote that HHS has accomplished a great deal over the past 33 months but still has much to do. "Preparation is a continuum. Each day that we prepare brings us closer to being ready," he said.

The report says that all six companies that HHS contracted with in 2006 to develop cell-based flu vaccines are moving toward FDA approval of their vaccines and that five are on target for reaching their contract milestones.

"Contracts with six manufacturers are leading to the capacity for US-based production of at least 240 million courses of cell-based pandemic vaccine within six months of the emergence of a pandemic influenza virus," Leavitt wrote.

In August HHS sought proposals to build domestic facilities to make seasonal and pandemic cell-based vaccines, and the agency hopes to award $500 million in contracts during fiscal year 2009, the report adds.

The agency is still reviewing proposals it received in 2007 to develop a next-generation DNA-based influenza vaccine and plans to issue a second request for proposals for recombinant vaccine development, according to the report.

As of September the federal stockpile of prepandemic H5N1 flu vaccine contained enough to vaccinate 12.2 million people, HHS says. In 2005 the agency set a goal of having enough vaccine for 20 million people.

The agency has said it hopes to stretch the nation's pandemic vaccine supply beyond initial projections by pairing it with adjuvants, additives designed to stimulate a stronger immune response and perhaps provide broader protection against a range of influenza strains. HHS, based on early research, has considered the possibility of combining an H5N1 vaccine made by one company with adjuvants from another company. It said further research is underway to test the "mix-and-match" approach.

In the meantime, HHS will continue adding prepandemic vaccine doses to the national stockpile and will move forward with buying 5.2 million doses of a GlaxoSmithKline adjuvant that it will pair with the government's existing supply of GlaxoSmithKline bulk antigen, Leavitt wrote.

The new point-of-care influenza rapid tests will allow healthcare workers in outpatient settings to distinguish quickly between seasonal and pandemic influenza, the report says. Clinical trials will start soon, and manufacturers hope to submit the devices for FDA approval by the end of the year, HHS reported.

The agency also said it expects to award contracts for a more reliable specimen collection system by the end of the year.

HHS has a goal of ensuring that the nation has a sufficient supply of antiviral drugs for 25% of the population. In December 2007 HHS met its goal of buying 50 million treatment courses of oseltamivir and zanamivir, the report says. Federal officials want states to buy enough doses, with a 25% federal subsidy, to treat another 31 million people, but so far they have purchased only 23 million courses through the program, of which 22 million have been delivered, according to the report.

As an outgrowth of federal efforts to improve global disease surveillance and laboratory capacity and training, HHS reported that China has improved its monitoring of this year's seasonal influenza cases and can now report cases weekly. "This increased level of surveillance will help lead to a quicker identification of a pandemic influenza strain, should it appear in China," the report says.

Officials have boosted federal stockpiles of personal protective equipment to 158 million masks and respirators and have allocated $100 million toward ventilators, syringes, intravenous antibiotics, gloves, gowns, and other supplies that would be needed during and influenza pandemic, Leavitt wrote. He said HHS received public comments in June on its preliminary guidance on mask and respirator use and expects to release the final document in 2010.

In March, HHS introduced a regular Webcast series to assist local and state officials and the public with pandemic planning activities. So far seven Webcasts have aired, and future sessions will touch on topics such as vaccine research and development and community pandemic planning. As many as 1,000 viewers have watched the live Webcasts, and each program has averaged about 10,000 downloads, the report says.

See also:

Mar 20, 2008, CIDRAP News story "US has enough H5N1 vaccine for 13 million people"

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