CDC SAYS STUDY SHOWS FLU VACCINE REDUCED CHILDREN'S FLU INTENSIVE CARE ADMISSIONS

FROM:  CENTERS FOR DISEASE CONTROL AND PREVENTION 

New Study Shows Flu Vaccine Reduced Children’s Risk of Intensive Care Unit Flu Admission by Three-Fourths

Getting a flu vaccine reduces a child’s risk of flu-related intensive care hospitalization by 74 percent, according to a CDC study published today in the Journal of Infectious DiseasesExternal Web Site Icon.

The study is the first to estimate vaccine effectiveness (VE) against flu admissions to pediatric intensive care units (PICU). It illustrates the important protection flu vaccine can provide to children against more serious flu outcomes. CDC recommends annual flu vaccination for everyone 6 months and older and especially for children at high risk of serious flu-related complications.
“These study results underscore the importance of an annual flu vaccination, which can keep your child from ending up in the intensive care unit,” said Dr. Alicia Fry, a medical officer in CDC’s Influenza Division. “It is extremely important that all children – especially children at high risk of flu complications – are protected from what can be a life-threatening illness."

Children younger than 5 years and children of any age with certain chronic medical conditions like asthma, diabetes or developmental delays, are at high risk of serious flu complications.

Fry’s team analyzed the medical records of 216 children age 6 months through 17 years admitted to 21 PICUs in the United States during the 2010-2011 and 2011-2012 flu seasons. They found that flu vaccination reduced a child's risk of ending up in the pediatric intensive care unit for flu by an estimated 74 percent. These findings show that while vaccination may not always prevent flu illness, it protects against more serious outcomes.

Though flu vaccination was associated with a significant reduction in risk of PICU admission, flu vaccine coverage was relatively low among the children in this study: only 18 percent of flu cases admitted to the ICU had been fully vaccinated.
More than half (55 percent) of cases had at least one underlying chronic medical condition that placed them at higher risk of serious flu-related complications.
CDC usually measures flu VE against “medically attended flu illness” – that is, how well it protects against having to go to the doctor for flu symptoms. During the 2010-2011 and 2011-2012 seasons, the midpoint VE estimates against medically attended illness were 60 percent and 47 percent respectively.

"Because some people who get vaccinated may still get sick, it's important to remember to use our second line of defense against flu: antiviral drugs to treat flu illness,” Fry said. “People at high risk of complications should seek treatment if they get a flu-like illness. Their doctors may prescribe antiviral drugs if it looks like they have influenza."

Symptoms of flu may include fever, cough, sore throat, runny or stuffy nose, body aches, headache, chills, and sometimes diarrhea and vomiting.

Flu causes hospitalizations in children each season, but how many children are affected varies, depending on the severity of the season. CDC estimates that 20,000 children younger than 5 years are hospitalized on average each year. For children younger than 18 years, published studies suggest an annual range of flu-related hospitalization rates of between one child and seven children per 10,000 children. Between 4 percent and 24 percent of hospitalized children require PICU admission.

CDC TOUTS BENEFITS OF INFLUENZA VACCINATIONS

FROM:  CENTERS FOR DISEASE CONTROL AND PREVENTION 
Influenza Illnesses and Hospitalizations Averted by Influenza Vaccination — United States, 2012–13 Influenza Season

Influenza vaccination produces a substantial health benefit in terms of preventing illness, medical visits and hospitalizations, but further raising vaccination rates and producing more effective vaccines would greatly increase the benefits realized by influenza vaccination in the United States. In this report, CDC uses a model first published in June 2013 to estimate the number of influenza-associated illnesses, medically attended illnesses and hospitalizations that were prevented last season as a result of flu vaccination. Based on this model, CDC estimates that flu vaccination in 2012-2013 reduced the numbers of flu illnesses, medically attended illnesses and hospitalizations by 17 percent over what would have occurred in the absence of influenza vaccination. This report shows the benefits of the flu vaccination program in terms of reducing flu illnesses, including serious illnesses resulting in hospitalizations.

FUNDING BIODEFENSE INFRASTRUCTURE

Photo:  Navy Petty Officer 2nd Class Eric M. Garneau prepares to administer an H1N1 flu vaccine aboard the amphibious assault ship USS Bataan while the ship is underway in the Atlantic Ocean, Dec. 5, 2009. U.S. Navy photo by Chief Petty Officer Anthony Sisti 

FROM:  U.S. DEFENSE DEPARTMENT 
DOD Funding Contributes to U.S. Biodefense Infrastructure
By Cheryl Pellerin
American Forces Press Service

WASHINGTON, Oct. 16, 2013 - The Defense Department has contributed core capabilities to a national center funded as a public-private partnership by the Department of Health and Human Services to enhance the U.S. response to infectious diseases and biological, chemical, radiological and nuclear threats.
The HHS Texas A&M Center for Innovation in Advanced Development and Manufacturing is a response in part to pandemics such as the 2009-2010 H1N1 flu -- for which traditional biomanufacturing methods took 26 weeks to produce initial vaccine doses – and the future threat of biological attacks and other public health emergencies.

According to expert witnesses testifying here Oct. 11 before the House Armed Services Committee's subcommittee on intelligence, emerging threats and capabilities, some kinds of advances in biomanufacturing processes and DNA technologies have lowered the bar for states, and even individuals, who seek to produce biological weapons.

One of the witnesses was Dr. Brett P. Giroir, principal investigator at the Texas A&M Center for Innovation, and interim vice president and chief executive officer of the Texas A&M Health Sciences Center.

"Literally, what once took weeks during medical school to produce in a multimillion-dollar laboratory can be done [today] in an afternoon on a benchtop by someone with a relatively less degree of scientific training," he told the panel. "So the barriers to entry have decreased."

Giroir's work at the Texas A&M Center for Innovation began in 2008 after nine years at the Defense Advanced Research Projects Agency.

During his first five years at DARPA, Giroir was a member of the Defense Sciences Research Council, for which he chaired or co-chaired intensive studies on chemical, biological, radiological and nuclear security and countermeasures, decontamination and warfighter performance under extreme conditions, he said in written testimony.

Then, as deputy director and later director of the DARPA Defense Sciences Office, he and a team of scientists, physicians and engineers developed a platform of research initiatives called Accelerating Critical Therapeutics, or ACT, he said.

ACT was designed to provide new, highly effective medical countermeasures and an unprecedented, flexible and rapid response to address the growing threat of genetically modified or chimeric organisms -- single organisms with two or more sets of genetically distinct cells -- for which no vaccines or countermeasures existed.

One aspect of the DARPA portfolio that was extremely challenging, even for DARPA, he said, was the ability to develop low-cost, highly flexible and adaptable biomanufacturing technologies that could provide tens of millions of doses of vaccines or medical countermeasures such as chemical-weapon antidotes within weeks of notification.

Such a capability didn't exist in the civilian or military experience, Giroir said, and profound technical and financial barriers kept the problem unsolved for several years.

"In 2008, when my assignment at DARPA was completed, I joined the Texas A&M system [and] secured a $50 million investment from the state of Texas to demonstrate those flexible manufacturing capabilities originally envisioned at DARPA," Giroir told the panel.

"Beginning in 2009," he added, "Texas A&M designed, developed, constructed and is now operating a revolutionary first-in-class, 150,000-square-foot facility that has pioneered highly flexible, adaptable and even mobile manufacturing platforms at a capital cost of about 80 percent less than the current state of the art."

The facility is called the National Center for Therapeutics, or NCTM, and a key feature there is the use of modular and mobile stand-alone biopharmaceutical clean rooms, called modular clear rooms, or MCRs. The initial MCR concept was funded by DOD through DARPA and the Army Research Office, Giroir said.

NCTM is the core facility and main site for developing and manufacturing medical countermeasures and vaccines against chemical, biological, radiological and nuclear threats for the Texas A&M Center for Innovation, he added.

Another part of the Center for Innovation's biomanufacturing infrastructure is the Caliber Biotherapeutics Facility, Giroir said. Caliber was developed and built through Texas A&M and G-CON Manufacturing, with funding from the DARPA Blue Angel Program.

According to a 2012 DARPA news release, the Blue Angel Program demonstrated a flexible and agile capability for DOD to rapidly react to and neutralize any natural or intentional pandemic disease.

Building on a previous DARPA program, Blue Angel targeted new ways to produce large amounts of high-quality, vaccine-grade protein in less than three months in response to emerging and novel biological threats. One of the research avenues explored plant-made proteins for producing a candidate vaccine.

In a milestone development under the program, researchers at Medicago Inc. in North Carolina produced in one month more than 10 million doses of an animal-model H1N1 flu-vaccine candidate based on virus-like particles, the DARPA statement said.

The work was part of a rapid-fire test that ran from March 25, 2012, to April 24, 2012, and showed that a single dose of the H1N1 vaccine candidate induced protective antibody levels in an animal model when combined with a standard immunological additive, according to DARPA.

The Texas A&M Center for Innovation has partnered with Caliber Biotherapeutics to make Caliber's plant-made pharmaceutical facility available for HHS task orders, including vaccines, Giroir told the panel.

"The facility has the capability to produce up to 20 kilograms of purified protein per month through its highly automated, Nicotiana benthamiana, a close relative of tobacco, plant-based production system," Giroir said.

"We consider this program to be the most responsive, secure and capable plant-made vaccine program currently available worldwide," he added.

Giroir said the Center for Innovation's high-level objectives are:

-- To provide a national vaccine response against pandemic flu, defined as 50 million doses delivered in 4 months, with initial doses available to the federal government in 12 weeks;

-- To perform what's called advanced development -- the final steps -- in manufacturing vaccines and medical countermeasures against chemical, biological, radiological and nuclear threats as tasked by HHS; and

-- To train the future domestic U.S. workforce.

To achieve these objectives, Texas A&M leads a multidisciplinary team with expertise that spans research to clinical trials, including GlaxoSmithKline, or GSK Vaccines, the world's largest vaccine developer, Giroir said.

The center also is expanding domestic U.S. infrastructure, he added, building a new, dedicated pandemic flu vaccine facility to meet its 50-million-dose requirements, and building a new live-virus vaccine facility at biosafety level 3, designed specifically for research with hazardous biological agents.

Giroir said Texas A&M is highly motivated to continue its history of service to the nation by supporting DOD and supplying improved vaccines and countermeasures to the warfighter.

"Of particular interest would be DOD partnerships to develop and manufacture products for their stockpile and special immunizations programs," he added, "and perhaps more importantly, to be the cornerstone for an emergency response to genetically modified or chimeric organisms [and] other unexpected agents that we believe are a growing, real threat to our national security and public health."

Because the center's contract with HHS indicates that 50 percent of its capabilities are available for non-HHS projects, there is an immediate opportunity for DOD to use center capacity and expertise already funded by HHS, Giroir said.

"We believe such collaborations would not only reduce DOD operational risks," he added, "but would reduce DOD expenditures, potentially by hundreds of millions of dollars, that could then be reallocated to provide additional vaccines, countermeasures and capabilities to our warfighters."