Washington Editor

WASHINGTON - The secretary of Health and Human Services (HHS) Friday said she is directing $1 billion in already budgeted funds to be used for clinical studies and commercial-scale production of vaccine antigen and adjuvants that could be used against the 2009 H1N1 swine-origin influenza A virus.

HHS Secretary Kathleen Sebelius said HHS would place new orders under existing contracts with manufacturers that hold licenses in the U.S. for flu vaccines.

"Our goal throughout this new H1N1 outbreak has been to stay one step ahead of the virus," Sebelius said.

Anne Schuchat, interim deputy director for science and public health at the Centers for Disease Control and Prevention, said her agency Friday had received a candidate vaccine virus from one institution.

"This was created by combining the genes of the novel H1N1 virus that are responsible for eliciting protection to influenza with other parts from other viruses that are needed for high growth in eggs," a process known as reassortment, she explained during a media briefing Friday.

In addition, Schuchat said, the CDC and the FDA have created a candidate virus using reverse genetics.

"Here at CDC, we are performing analysis of the egg-derived and the reverse genetics-derived candidate viruses to make sure that they are able to simulate optimal immune responses and that their ability to do that remains in tack," she said.

Schuchat said that by the end of this month, suitable viruses will be sent to manufacturers to begin work developing candidate vaccine seed for production of pilot lots.

The CDC has estimated that the H1N1 virus may have infected up to 100,000 people in the U.S., Schuchat said. However, the agency Friday officially reported 6,552 laboratory-confirmed or probable cases in the U.S., with nine deaths.

The World Health Organization (WHO) reported Friday that the H1N1 flu virus had spread to 42 countries, with 11,168 laboratory-confirmed cases and 86 deaths.

Keiji Fukuda, WHO's interim assistant director-general for health security and environment, said that while manufacturers should be ready to produce vaccines by early July, one of the issues currently unknown is how much antigen will be needed for the vaccine to be immunogenic.

"We don't know if it is the same as avian flu vaccines or whether closer to seasonal influenza," Fukuda said.

The WHO currently is re-evaluating its criteria for declaring a full-blown pandemic, which is known as phase 6.

Several countries attending the World Health Assembly meeting in Geneva last week urged WHO to tweak its pandemic criteria, given that it was based more on concerns over the H5N1 avian flu, which has been thought to be more deadly than the current H1N1 strain striking the globe.

While the current criteria, which were developed by a large body of scientists from numerous countries over a significant period of time, are "quite good" and "quite clear," Fukuda said, "there is nothing like reality to really tell you whether something is working or not."

Fukuda insisted that WHO is not attempting to change the rules, but adapting to the current situation.

CDC scientists last week also published a paper in the journal Science that described for the first time in detail the antigenic and genetic characteristics of the 2009 H1N1 swine-origin influenza A virus.

The paper also explained the history and evolution of human and swine influenza viruses in North America and other areas of the world.

"From our analysis, we have confirmed that the novel H1N1 virus likely originated from pigs based on the data that each of the genetic components of this virus are most closely related to corresponding influenza virus genes identified from swine influenza viruses," said Nancy Cox, chief of the CDC's Influenza Division. "We found that the new H1N1 viruses are antigenically similar to each other, that is, they react with antibodies in a similar way. They are rather homogeneous. However, they are antigentically very different from human seasonal H1N1 viruses."

She noted that those findings clearly indicated that seasonal influenza vaccines may not protect humans from the H1N1 swine-origin flu virus.

The study, Cox told reporters, reinforced the fact that "swine are an important reservoir of influenza viruses with potential to cause significant respiratory outbreaks or even a possible pandemic in humans."

Results of the study, she added, show the global need for more systematic surveillance of influenza viruses in pigs.

The authors of the study analyzed full or partial genome sequences from more than 70 novel H1N1 viruses, including 17 viruses isolated in Mexico and 59 viruses from 12 states in the U.S., Cox noted.

"Our analysis showed that the novel virus contains a combination of gene segments that had not been reported among swine or human influenza viruses in the United States or elsewhere, and the novel aspect was that two of the genes, the matrix protein gene and the neuraminidase gene segment, appeared to be derived from Eurasian swine viruses previously not detected outside Eurasia," she explained.

While the analysis showed that all of the gene segments were derived from swine influenza viruses, "at this time we do not know if the virus entered the human population directly from swine or via an intermediate host," Cox said. Nor did the analysis provide clear evidence for certain the exact host that the viruses might previously have circulated in to obtain its current properties, she added.

Cox said that veterinary scientists at the U.S. Department of Agriculture and elsewhere in the world are now "looking very carefully" to see if they have in their freezers samples from pigs or other animals that might provide the missing links and information about intermediate viruses that could help narrow down the time and place of emergence of this novel influenza virus.

In the antigenic analysis, Cox said, the CDC scientists found that the H1N1 viruses are "very homogenous" in their antigenic properties and in their genetic properties.

That information, she noted, makes health officials' job of coming up with a reference candidate vaccine virus much easier.

"We see much less variation among these new H1N1 viruses than we do for typical seasonal influenza viruses," Cox said.

The CDC last week also released an analysis of serum samples from more than 350 people in various age groups ranging from 6 months to older than 60, which suggested that adults may have some degree of preexisting cross-reactive antibody to the novel H1N1 flu virus, especially among older adults.

However, officials said they did not know if such antibodies provide any protection against the virus.

CDC officials said that a possible explanation to the preexisting immunity in adults is that they may have had previous exposure, either through infection or vaccination to an influenza A H1N1 virus that was more closely related to the new swine-origin strain than are contemporary seasonal H1N1 strains.

Health officials also noted last week that people who are obese appear to be more susceptible to the H1N1 swine flu.

HHS, Justice Combating Medicare Fraud

Health and Human Services (HHS) and the Justice Department last week launched an interagency task force aimed at combating Medicare and Medicaid fraud, which costs the nation billions of dollars each year.

The task force, known as the Health Care Fraud Prevention and Enforcement Action Team, or HEAT, which consists of senior HHS and Justice officials, will use electronic claims data to track down Medicaid and Medicare cheaters.

Officials last week said the government also is expanding its federal strike force teams that target Medicare fraud at the local level. Currently the strike teams have operations in South Florida and Los Angeles.

The government will now locate new strike force teams in Detroit and Houston, Attorney General Eric Holder said during a press briefing with reporters.

He noted that the South Florida strike force team has convicted 146 Medicare violators and secured $186 million in criminal fines and civil recoveries. In Los Angeles, 37 Medicare violators have been charged with criminal health care fraud offenses, resulting in more than $55 million ordered in restitution to the program, Holder said.

While most health care providers follow the law and properly file claims, the government "cannot and will not allow billions of dollars to be stolen from Medicare and Medicaid through fraud, waste and serious abuse of the system," said HHS Secretary Kathleen Sebelius.

President Obama's fiscal year 2010 budget includes $311 million to strengthen program integrity activities within the Medicare and Medicaid programs - a 50 percent increase from the 2009 funding. Holder said that boost in funding could result in $2.7 billion in savings to the government and help support the president's health reform plan.

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