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Archive for the 'Influenza A (H1N1) Updates' Category


High Dose Influenza Vaccine Still Available

June 9th, 2010 by Mike Edwards

High dose influenza vaccine for people 65 and older is still available, with more information in this weekly CDC Mortality and Morbidity Report.  Sanofi Pasteur, the manufacturer of the vaccine sold under the name Fluzone High Dose™, recently sent a letter to health care professionals that offers more information about the vaccine ( letter is in pdf format and may take a moment to download (3.89mb ).

Newly Licensed Influenza Virus Vaccine Designed for Older Adults

February 26th, 2010 by Mike Edwards

Sanofi Pasteur recently received licensure of Fluzone® High-Dose (Influenza Virus Vaccine), which the vaccine maker says is designed to generate a more robust immune response to influenza in people 65 years of age and older. Data show people 65 years of age and older are more likely to die or be hospitalized from influenza and its complications than younger adults.  While the 65-plus age group only represents about 15 percent of the US population, it accounts for 90 percent of all deaths due to seasonal influenza and its complications. More information about Fluzone® High-Dose Vaccine is available below or read the Fluzone Brochure containing full prescribing information.

Influenza Disease Information
People 65 years of age and older are more likely to die or be hospitalized from influenza and its complications than younger adults.1-3 In fact, while those 65 years of age and older only represent 15% of the US population, they account, on average, for 90% of all deaths due to seasonal influenza and its complications. Recent studies show that people 65 years of age and older have weakened immune systems and do not respond to the standard-dose vaccine as well as younger adults.4
Fluzone High-Dose Vaccine
Fluzone High-Dose vaccine was designed specifically to generate a more robust immune response to influenza in people 65 years of age and older.  See attached product brochure and Prescribing Information (PI) for more information regarding Fluzone High-Dose vaccine.
Providers have access to Fluzone High-Dose vaccine for the 2010-2011 season and can order the vaccine through http://www.vaccineshoppe.com
Indication
Fluzone High-Dose vaccine is indicated for active immunization of persons 65 years of age and older against influenza disease caused by influenza virus subtypes A and type B contained in the vaccine. This indication is based on the immune response elicited by Fluzone High-Dose vaccine; there have been no controlled clinical studies demonstrating a decrease in influenza disease after vaccination with Fluzone High-Dose vaccine.
Safety Information
The most common local and systemic adverse reactions to Fluzone High-Dose vaccine include soreness, pain, and swelling at the vaccination site; fever, headache, malaise, and myalgia. Other adverse reactions may occur. Fluzone High-Dose vaccine should not be administered to anyone with a history of hypersensitivity to any vaccine component, including eggs and egg products. Fluzone High-Dose vaccine should not be administered to individuals who have a prior history of Guillain-Barré syndrome (GBS). Vaccination with Fluzone High-Dose vaccine may not protect all individuals
Before administering Fluzone High-Dose vaccine, please see accompanying brochure with full Prescribing Information.

State Continues H1N1 Vaccination Program

January 15th, 2010 by Mike Edwards

State public health officials this week called for public and private providers to continue to offer H1N1 vaccinations even though H1N1 activity has been declining since peaking in October. State Health Director Jeffrey Engel, MD, said the state had received more than 3.5 million doses of vaccine, and all doses had been shipped to approved providers in North Carolina. Speaking during a statewide Web conference with local public health directors, Dr. Engel said the vaccination effort would likely continue through March. The CDC recently expanded the effort by providing vaccine to clinics hosted by big box retailers. Dr. Engel said businesses, church groups, and colleges would be encouraged to host vaccination clinics to ensure as many people as possible would be immunized. More information about H1N1 vaccine is available at http://www.immunizenc.com/.

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Health Directors Push for More H1N1 Vaccine

December 29th, 2009 by Kristen Shipherd

State Health Director Jeffrey Engel, MD, said he has joined health directors across the country  in supporting the CDC’s initiative to get more H1N1 vaccine out to the public. Read more in this news release from NCDHHS.

Voluntary Recall of H1N1 Vaccine Involves 18,000 Doses in NC

December 18th, 2009 by Mike Edwards

The NC Division of Public Health announced Tuesday that it was contacting 132 health care providers who received H1N1 pediatric vaccine from four lots that were voluntarily recalled by the manufacturer, Sanofi Pasteur. The state received 17,900 doses from the approximately 800,000 doses impacted by the recall. “There are no safety concerns with these lots of H1N1 vaccine,” State Epidemiologist Megan Davies, MD, said.  “The concern is that the recalled vaccine may not be strong enough to provide full immunity.” Sanofi Pasteur determined that the antigen content, which is the component in the vaccine that causes immunity to a virus, is slightly below the specified range. The CDC says the vaccine in these lots still offers protection against H1N1 influenza. The CDC does not recommend doctors re-administer flu shots to those who received vaccine from these lots. More information is available on the voluntary recall at: http://www.cdc.gov/h1n1flu/vaccination/syringes_qa.htm.

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State Expands Availability of H1N1 Vaccine

December 11th, 2009 by Mike Edwards

The NC Division of Public Health announced Tuesday the expansion of the H1N1 vaccination effort.  State Public Health Director Jeffrey Engel, MD, advised health care providers, retail pharmacies and local health departments during a statewide videoconference that the H1N1 vaccine be made available to everyone.  Prior to the announcement, the vaccine had been limited to designated high risk groups. Since the outbreak of H1N1 began last April, North Carolina has reported 74 deaths associated with the  illness. Helath officials continue to urge people to get both seasonal and H1N1 vaccines, even though the latest Influenza Surveillance Periodic Report (No. 9, 12-9-09) indicates that influenza activity in NC continues to steadily decline from the high levels reported in September. Health officials continue to urge people to get both the seasonal and H1N1 vaccines. Information about where to get flu shots is available at: http://www.flu.nc.gov/epi/gcdc.

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Mini-Poster Helps Educate Medicare Beneficiaries about Flu Vaccines

December 4th, 2009 by Mike Edwards

CMS has made available a mini-poster designed to inform seniors and vulnerable populations that Medicare and Medicaid cover both the seasonal and H1N1 flu vaccines. You can download the poster here.  Physicians can refer Medicare, Medicaid and other patients to more information about seasonal and H1N1 flu vaccines at http://www.flu.gov/. Information for providers who want to bill Medicare for the flu vaccines can be obtained at www.cms.hhs.gov/adultimmunizations.

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State Issues Memo Concerning Oseltamivir-Resistant H1N1 Influenza

November 24th, 2009 by Mike Edwards

State Epidemiologist Megan Davies, MD, has issued a memo to all NC health care providers about the use of oseltamivir for treatment of H1N1 influenza virus infections.  The memo was prompted by a cluster of infections involving oseltamivir-resistant H1N1 influenza among patients on a single hospital ward in North Carolina.  The cases are not related to three cases of oseltamivir-resistant H1N1 influenza infections previously identified in the state.  Read Dr. Davies’ memo here.

H1N1 Vaccine Continues to Trickle into NC

November 6th, 2009 by Mike Edwards

More doses of H1N1 vaccine were expected to arrive on Thursday, according to state public health officials who participated in a statewide H1N1 briefing on Tuesday.  About 115, 000 doses arrived last week, with more shipments expected each week through November and December. To date, about 750,000 doses have been administered across the state.

H1N1 Information and Guidance for Professionals is available at: http://www.epi.state.nc.us/epi/gcdc/H1N1flu.html

Information on where to get flu shots can be found at: http://www.flu.nc.gov/epi/gcdc/.

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State Epidemiologist Issues Information on Severe Influenza in Pregnancy and FDA Emergency Use Authorization for Peramivir

October 29th, 2009 by Mike Edwards

State Epidemiologist Megan Davies, MD, issued a one-page guidance on Tuesday for physicians, Severe Influenza in Pregnancy: Consultation and Reporting (click the title to read the guidance).  The guidance provides information for clinical consultation and resources, along with guidance on monitoring and reporting severe influenza infections in pregnant and postpartum women.

Dr. Davies also distributed a message from the CDC, issued on October 25, 2009, concerning the US Food and Drug Administration (FDA) issuing an emergency use authorization (EUA) for the use of 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. Read the CDC message here.

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Thousands Vaccinated, with More Vaccine on the Way

October 29th, 2009 by Mike Edwards

State health officials reported this week that 441,000 doses of H1N1 vaccine have been administered in North Carolina over the past four weeks. State Health Director Jeffrey Engel, MD, announced during a statewide H1N1 briefing on Tuesday that additional vaccine is expected to arrive in the state next week and will be distributed to local health departments and districts. More shipments are expected in coming weeks, with the CDC indicating that larger supplies will likely arrive in late November or early December, which should cover all people needing or wanting to be vaccinated. See the latest H1N1 briefing at: http://www.epi.state.nc.us/epi/gcdc/H1N1/SERTbriefings.html. You can also access the briefings at a link titled “H1N1 Operational Briefings,” on the Guidance for Professionals page at http://www.flu.nc.gov/.

At the moment, priority is being given to high risk target populations that include pregnant women, caregivers of children younger than six months of age, health care workers, people from six months to 24 years of age, and persons aged 25-64 years who have health conditions associated with higher risk of medical complications from influenza.  Additional information is available at: http://www.cdc.gov/h1n1flu/vaccination/acip.htm.

Physicians with questions about H1N1 vaccine can call the CDC’s 24-hour Clinical Consultation Line at 404-368-2133. This line is only for physicians and health care professionals who are taking care of pregnant women with severe influenza infections.  It is not for other clinical questions or for vaccine information.  Patients can be directed to the Public Careline at 1-800-662-7030 or http://www.flu.nc.gov/.

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DHHS Seeks to Limit H1N1 Spread at State Facilities as Flu Activity Remains Widespread

October 23rd, 2009 by Mike Edwards

State-operated hospitals, residential schools, developmental disability centers, neuro-medical treatment centers and alcohol and drug treatment centers have implemented steps to limit the spread of the H1N1 influenza virus.  Effective today, all state facilities will actively screen all staff and visitors to identify people exhibiting signs of respiratory infections. Visitors with flu symptoms will not be permitted to visit patients or residents until they are no longer sick.  Employees who develop fever or influenza-like symptoms are being told to stay home or, if already on the job, make arrangements to leave and avoid contact with other employees and patients/residents. Several private hospitals have already implemented similar procedures, with some facilities not allowing visitors age 18 or younger.  Flu-related information and updates will be made available on the state’s facilities website at: http://www.ncdhhs.gov/mhfacilities/index.htm.

H1N1 continues to be the predominant flu strain seen by the State Public Health Laboratory as the new flu seasons enters its third week this Sunday. The latest Influenza Summary labels the level of influenza activity in North Carolina  as widespread.  More influenza-related information from the state Communicable Disease Branch is available at: http://www.epi.state.nc.us/epi/gcdc/flu.html. Additional information concerning pandemic H1N1 influenza is available at: http://www.flu.nc.gov/ and at http://www.cdc.gov/h1n1, where you will find information about vaccine supply and clinical guidance for administering flu vaccine.

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More H1N1 Vaccine Heading to NC

October 16th, 2009 by Kristen Shipherd

State public health officials are awaiting more shipments of H1N1 flu vaccine as initial supplies have been depleted at clinics across the state. Supplies of the vaccine are being shipped to North Carolina and other states from the federal stockpile and are expected to arrive next week. Once the vaccine arrives in North Carolina, it is shipped to local health departments and private clinics that have agreed to administer the vaccine. Members of the state Communicable Disease Branch staff updated the state’s H1N1 response during a statewide Web briefing for local health departments on Tuesday.  H1N1 remains the predominate strain that is seen at emergency departments and private clinics, with virtually no signs of seasonal flu at this time. More information about the state’s H1N1 pandemic flu response is found at:   http://www.epi.state.nc.us/epi/gcdc/H1N1flu.html and at: http://www.flu.nc.gov.

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State Changing the Way It Reports Flu Hospitalizations and Deaths; CDC Issues Updated Guidance on H1N1

October 9th, 2009 by Mike Edwards

North Carolina is changing the way it reports flu deaths and hospitalizations, in response to a new nationwide directive from the Centers for Disease Control and Prevention. Starting this week, the state is reporting hospitalizations and deaths from all influenza-like illnesses, including both H1N1 and seasonal influenza. The state will no longer be reporting separately the number of hospitalizations and deaths among patients with lab-confirmed pandemic H1N1.  Read the complete news release from NC DHHS at www.ncmedsoc.org.

The CDC this week issued an updated Q&A on the H1N1 virus for clinicians, including more details about the supply and distribution of H1N1 vaccine.  The guidance is found at:
http://www.cdc.gov/h1n1flu/vaccination/clinicians_qa.htm.

The 2008-2009 flu season officially ended on Saturday, October 3, 2009. State Influenza Surveillance Coordinator Torrey McLean said, “This was by far the most unusual of the eight seasons of influenza surveillance that I personally have worked with, due to the national pandemic of A (H1N1) influenza during the last five months.  The fact that the season ended with a high level of influenza activity reported throughout the state makes effective surveillance during this new 2009-2010 season, which began on October 4th, extremely important.”  North Carolina has 96 sentinels in 55 counties and a large number of participating hospital emergency departments.

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Rule Change Proposed for Temporary Order Issued September 24

October 2nd, 2009 by Mike Edwards

The NC Department of Health and Human Services (DHHS) is asking physicians and other public health partners to comment on a proposed temporary rule change for Rule 10A NCAC 41A .0101.  The state Commission for Public Health will hold a public hearing on the proposed rule change at 2:30 p.m. on Tuesday, October 13, 2009 in the Cardinal Room, 5605 Six Forks Road in Raleigh.

The proposed rule change will keep influenza death in adults reportable when the Temporary Order expires, 90 days after October 1, 2009. Please note the information regarding the public hearing and the public comment period. The temporary rule would remain into effect for 270 days, which goes beyond the expected duration of the coming influenza season. A decision has not been made at this time as to whether to keep influenza death in adults reportable as a permanent rule change.

As stated in the notice:

Comment Procedures:  Comments from the public shall be directed to:  Chris G. Hoke, JD, 1931 Mail Service Center, Raleigh, NC 27699-1931; phone (919) 707-5006; email Chris.Hoke@dhhs.nc.gov.  The comment period begins October 1, 2009 and ends October 22, 2009.

Read the proposed rule change at: http://www.ncoah.com/rules/proposedtemp/10ANCAC41A.0101-ProposedTemp.doc.

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