Last year, approximately 162 million doses of the H1N1 vaccine were distributed and roughly 90 million were administered. What happened to the remaining 72 million doses? The federal government estimates that as many as 40 million of those vaccines have expired, and the rest are sitting in cold storage somewhere.

Under the government’s Voluntary Central Vaccine Recovery Program, physicians in May were allowed to ship expired H1N1 vaccine doses, free of charge, to a facility contracted with the U.S. Department of Health and Human Services (HHS) and the Centers for Disease Control and Prevention (CDC). Physicians will get another chance to unload their expired vaccines sometime this fall, the CDC said.

As for H1N1 vaccines that haven’t expired, physicians should hold on to them until sufficient quantity of the 2010-2011 seasonal vaccine is available, HHS spokesman Bill Hall said. These doses can still be used in patients at high risk for contracting the virus, such as those traveling to the Southern Hemisphere, according to the CDC.

CDC’s Advisory Committee on Immunization Practices (ACIP) recommends that for the 2010–2011 flu season, children aged 6 months to 8 years who did not receive any doses of a monovalent 2009 influenza A(H1N1) vaccine should receive two doses of a 2010-11 seasonal influenza vaccine, regardless of previous influenza vaccination history.

The 2009 H1N1 virus, which was first identified April 2009, will be included in the 2010-2011 seasonal influenza vaccine starting this fall, according to the Food and Drug Administration (FDA).

The World Health Organization (WHO) has recommended that the Northern Hemisphere’s 2010–2011 seasonal influenza vaccine contain the following three vaccine viruses:

• an A/California/7/2009 (H1N1)–like virus,
• an A/Perth/16/2009 (H3N2)–like virus, and
• a B/Brisbane/60/2008–like virus.

Approximately 170 million doses of seasonal flu vaccine expected to be available in the United States this year should begin shipping sometime in late September, according to an ACIP June 2010 meeting presentation.

Physicians will soon have a new test they can use to diagnose patients with the 2009 H1N1 influenza virus. Developed by the U.S. Centers for Disease Control and Prevention (CDC) and authorized for use June 22 by the U.S. Food and Drug Administration (FDA), the new test will replace the previous real-time RT-PCR diagnostic test used during the 2009 H1N1 pandemic.

The new test, called the CDC Influenza 2009 A(H1N1)pdm Real-Time RT-PCR Panel (IVD), can detect human infections with 2009 H1N1 virus with sensitivity and specificity greater than 96 percent for upper respiratory specimens, according to the CDC. Upper respiratory specimens are easily obtainable in a doctor’s office.

Here’s how it works: Amplified viral genetic material generates a fluorescent signal, which is then detected and analyzed by a diagnostic instrument called the Applied Biosystems 7500 Fast DX Realtime PCR Instrument. The test panel and diagnostic system can provide results within four hours, and multiple samples can be tested at the same time.

The CDC did not give a specific date for when physicians will be able to order the new test from CDC-qualified laboratories for detecting 2009 H1N1 flu, but in all likelihood it will be available by the start of the next flu season.

The Centers for Disease Control and Prevention (CDC) is releasing updated interim guidance on infection control measures to prevent transmission of 2009 H1N1 influenza in health care facilities. This guidance applies to the special circumstances of the current 2009 H1N1 pandemic and expands on earlier guidance.

Revisions from earlier guidance include: criteria for identification of suspected influenza patients; recommended time away from work for health care personnel; changes to isolation precautions based on tasks and anticipated exposures; expansion of information on the hierarchy of controls which ranks preventive interventions in the following order of preference: elimination of exposures, engineering controls, administrative controls, and personal protective equipment; and changes to guidance on use of respiratory protection.

Why Update This Guidance Now?

“When the interim infection control guidance for 2009 H1N1 was posted, substantial uncertainties existed regarding the severity of disease and health impact of the novel H1N1 influenza strain, a high proportion of the population was susceptible to the new virus, and the vaccine was not available,” the CDC said. “Circumstances have changed significantly since then. First, a safe and effective vaccine has become widely available. Second, we now have information about the number of cases of disease, hospitalizations, and deaths caused by 2009 H1N1, which can be compared to historical seasonal influenza data.” The current circumstances, the CDC said, justify an update of the recommendations.

In updating this particular guidance, the CDC also will consolidate recommendations for prevention of seasonal flu in health care facilities into a comprehensive, easily accessible document.

To Whom Does This New Guidance Apply?

This guidance applies to health care personnel working in the following settings:  acute care hospitals, nursing homes, skilled nursing facilities, physician’s offices, urgent care centers, outpatient clinics, and home healthcare agencies.  It also includes those working in clinical settings within non-healthcare institutions, such as school nurses or personnel staffing clinics in correctional facilities.

The updated interim guidance still needs to be reviewed by federal government who are experts in the field of medicine. Final guidance will be published in the Federal Register and the CDC will post a notice on its website.

The 2010-2011 seasonal influenza vaccine in the United States will include a pandemic 2009 H1N1 virus in the composition. Unlike this past year, however, the H1N1 inclusion will not likely limit availability. The Advisory Committee on Immunization Practices (ACIP) is recommending the vaccine for everyone 6 months of age and older.

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Nearly a million doses of H1N1 vaccine for infants and toddlers (ages 6 months – 3 years) were recalled on Tuesday. The vaccine reportedly lost strength since its distribution throughout the country last month. The vaccine was strong when the shots were originally shipped, according to the manufacturer, Sanofi Pasteur; however, tests done weeks later revealed the potency had fallen about 12 percent below the government standard.

By now, most of the shipment has already been used, but doctors are asked to return any unused doses.

Officials with the U.S. Food and Drug Administration (FDA), the Centers for Disease Control and Prevention (CDC) and Sanofi Pasteur say the strength of the vaccine is still high enough to protect children who received it. Parents can rest assured that already injected vaccine dosages are safe and effective, according to Dr. Anne Schuchat, a  CDC flu expert.

Pneumonia is a common malady that often takes lives, particularly among the elderly due to their weakened immune systems and already-compromised health. By definition, according to the Merck Manual Online, “Pneumonia is an infection of the small air sacks of the lungs known as the alveoli and the tissues around them.” That’s about the gist of it, but you should also know what type of pneumonia you are coding. A quick look at the entry for Pneumonia in the ICD-9-CM alphabetic Index to Diseases verifies the numerous types of pneumonia, including viral, bacterial, and aspiration.

To complicate matters even more, says reimbursement specialist Laura Smith, CPC, CPC-I, “when looking up pneumonia in the ICD-9-CM index, you will notice some types of pneumonia require two codes — one to identify the infectious agent and a second to identify the resulting type of pneumonia.” For example, the index entry for rheumatic pneumonia shows 390 [517.1]. “The brackets identify the manifestation code,” says Smith, “which should always be coded second. Remember to verify codes in the Tabular List of the ICD-9-CM manual.”

Hospital- or institutional-acquired pneumonia is common and most likely caused by Staphylococcus aureus. “Pneumonia caused by the staphylococcus bacteria would be coded as 482.4x Pneumonia due to Staphylococcus,” says Smith, “with a fifth digit required to specify the strain.”

Another type of pneumonia, aspiration pneumonia, results from inhaling solids or liquids and is often common among the elderly due to difficulties swallowing as a result of stroke or the later stages of dementia. “Aspiration pneumonia is coded as ICD-9-CM code 507.x Pneumonitis due to solids and liquids,” Smith advises, “with a fourth digit required to specify the inhaled substance.”

Of course, this time of year you’re likely to see an increased amount of pneumonia due to complications from flu. For influenza with pneumonia, you would use code 487.0.

If, however, the physician’s documentation simply states “pneumonia, bacterial, hospital acquired, or community acquired” and does not state the type of bacteria, “you would use code 482.9 Bacterial pneumonia unspecified,” concludes Smith.

The U.S. Food and Drug Administration (FDA) has approved a new seasonal influenza vaccine. Agriflu can be used for the prevention of disease caused by flu virus subtypes A and B in people ages 18 and older.

Agriflu was approved using the FDA’s accelerated approval pathway after manufacturer Novartis Vaccines and Diagnostics in Siena, Italy demonstrated the vaccine’s effectiveness in preventing seasonal influenza.

Agriflu is preservative-free and available in single dose, pre-filled syringes administered intramuscularly.

The FDA announced its approval of Agriflu in a Nov. 27 press release, posted on its Web site.

The U.S. Food and Drug Administration (FDA) has approved the use of CSL Limited’s 2009 H1N1 influenza vaccine to include children ages 6 months and older. The vaccine was previously approved only for use in adults, ages 18 years and older. The expanded approval also covers the Australian company’s seasonal flu vaccine.

The vaccines will be available in single-dose, preservative-free, pre-filled syringes, and multi-dose vials.

The U.S. Food and Drug Administration (FDA) approved, Oct. 19, the use of the seasonal influenza vaccine Fluarix for children ages 3 to 17 years. This vaccine, which contains inactivated (killed) influenza A and B viruses, was previously approved for use in adults, ages 18 years and older.

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The U.S. Food and Drug Administration (FDA) announced Oct. 23, in response to a request from the U.S. Centers for Disease Control and Prevention (CDC), it has issued an emergency use authorization (EUA) for the investigational antiviral drug peramivir intravenous (IV) in certain adult and pediatric patients with confirmed or suspected 2009 H1N1 influenza infection who are admitted to a hospital.

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