A family brings their elderly mother to a nursing home. The nurses bathe her and set her in a chair at a window.
After a while, she slowly starts to lean over sideways in her chair. Two attentive nurses immediately straighten her up. Again, she starts to tilt to the other side. The nurses rush back to put her upright. This goes on all morning.
Later, the family arrives and asks, “Are they treating you all right?”
“It’s pretty nice,” the old woman replies. “Except they won’t let you fart.”

But I digress……

This is a warning to all of us about CTs and radiation thereof.  It seems that someone at FDA discovered that there was at least one case where a patient received 8 times the radiation for a head CT.  They’re concerned that there may be no protocols and this case is just the tip of the iceberg.

http://omniphysicians.com/2009/10/09/head-cts-too-many-rays-8-times-too-many/

The proportion of ILI deaths and hospitalizations are at epidemic levels.  From April to October, we are at 1,544 ILI deaths, 12,300+ hospitalizations.

http://omniphysicians.com/2009/10/09/national-and-regional-summary-of-ili/

http://omniphysicians.com/2009/10/09/ili-hospitalizations-and-deaths-in-usa-so-far/

Take a look at these graphs.  Not much is happening in our region when you compare it with the southwestern states.  It’ll probably get worse before it gets better, people. 

http://omniphysicians.com/2009/10/09/region-5-ili-outpatient-visits/

Paul R.

 Audience: Radiological, Neurological and emergency medicine healthcare professionals

[Posted 10/09/2009] FDA notified healthcare professionals that it has become aware of radiation overexposures during perfusion CT imaging performed to aid in the diagnosis of stroke at a particular facility, the patients receiving radiation doses that were approximately eight times the expected level. While this event involved a single kind of diagnostic test at one facility, the magnitude of these overdoses and their impact on the affected patients were significant. This situation may reflect more widespread problems with CT quality assurance programs and may not be isolated to this particular facility or this imaging procedure (CT brain perfusion). If patient doses are higher than the expected level, but not high enough to produce obvious signs of radiation injury, the problem may go undetected and unreported, putting patients at increased risk for long-term radiation effects.

FDA encourages every facility performing CT imaging to review its CT protocols and be aware of the dose indices normally displayed on the control panel. These indices include the volume computed tomography dose index and the dose-length product. For each protocol selected, and before scanning the patient, carefully monitor the dose indices displayed on the control panel. To prevent accidental overexposure, make sure that the values displayed reasonably correspond to the doses normally associated with the protocol. Confirm this again after the patient has been scanned. Patients should follow their doctor’s recommendations for receiving CT scans. While unnecessary radiation exposure should be avoided, a medically-needed CT scan has benefits that outweigh the radiation risks.

Read the MedWatch safety summary, including a link to the FDA Initial Notification, at:

http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm186105.htm 

Link:  http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm186105.htm

CT Brain Perfusion Scans Safety Investigation: Initial

 Notification

Audience: Radiological, Neurological and emergency medicine healthcare professionals

[Posted 10/09/2009] FDA notified healthcare professionals that it has become aware of radiation overexposures during perfusion CT imaging performed to aid in the diagnosis of stroke at a particular facility, the patients receiving radiation doses that were approximately eight times the expected level. While this event involved a single kind of diagnostic test at one facility, the magnitude of these overdoses and their impact on the affected patients were significant. This situation may reflect more widespread problems with CT quality assurance programs and may not be isolated to this particular facility or this imaging procedure (CT brain perfusion). If patient doses are higher than the expected level, but not high enough to produce obvious signs of radiation injury, the problem may go undetected and unreported, putting patients at increased risk for long-term radiation effects.

FDA encourages every facility performing CT imaging to review its CT protocols and be aware of the dose indices normally displayed on the control panel. These indices include the volume computed tomography dose index and the dose-length product. For each protocol selected, and before scanning the patient, carefully monitor the dose indices displayed on the control panel. To prevent accidental overexposure, make sure that the values displayed reasonably correspond to the doses normally associated with the protocol. Confirm this again after the patient has been scanned. Patients should follow their doctor’s recommendations for receiving CT scans. While unnecessary radiation exposure should be avoided, a medically-needed CT scan has benefits that outweigh the radiation risks.

[10/08/2009 - Safety Investigation of CT Brain Perfusion Scans: Initial Notification - FDA]

Link:  http://www.cdc.gov/mmwr/preview/mmwrhtml/mm5839a3.htm

MMWR October 9, 2009 / 58(39);1100-1101

Update on Influenza A (H1N1) 2009 Monovalent Vaccines

On September 15, 2009, four influenza vaccine manufacturers received approval from the Food and Drug Administration for use of influenza A (H1N1) 2009 monovalent influenza vaccines in the prevention of influenza caused by the 2009 pandemic influenza A (H1N1) virus.* Both live, attenuated and inactivated influenza A (H1N1) 2009 monovalent vaccine formulations are available; each contains the strain A/California/7/2009(H1N1)pdm. None of the approved influenza A 2009 (H1N1) monovalent vaccines or seasonal influenza vaccines contains adjuvants (1–5). CDC’s Advisory Committee on Immunization Practices has made recommendations previously for which persons should be the initial targets for immunization with influenza A (H1N1) 2009 monovalent vaccines and has issued guidelines on decisions for expansion of vaccination efforts to other population groups (6). Children aged 6 months–9 years receiving influenza A (H1N1) 2009 monovalent vaccines should receive 2 doses, with doses separated by approximately 4 weeks; persons aged ≥10 years should receive 1 dose (1–4).

The approved age groups for use of inactivated influenza A (H1N1) monovalent influenza vaccines differ by manufacturer (Table). Three manufacturers that produce inactivated vaccines approved for prevention of seasonal influenza (6) also produce formulations of influenza A (H1N1) 2009 monovalent influenza vaccines. Vaccine produced by CSL Limited is approved for use in persons aged ≥18 years (1), vaccine produced by Novartis Vaccines and Diagnostics Limited is approved for persons aged ≥4 years (2), and vaccine produced by Sanofi Pasteur, Inc. is approved for persons aged ≥6 months (3). A live attenuated influenza vaccine (LAIV) manufactured by MedImmune LLC is approved for persons aged 2–49 years (1). The 2009 (H1N1) monovalent LAIV has the same age range for use as the seasonal LAIV and should not be used to vaccinate children aged <2 years, adults aged >49 years, pregnant women, persons with underlying medical conditions that confer a higher risk for influenza complications, or children aged <5 years old with one or more episodes of wheezing in the past year (5).

Influenza A (H1N1) 2009 monovalent vaccine approvals were made on the basis of standards developed for vaccine strain changes for seasonal influenza vaccines, adherence to manufacturing processes, product quality testing, and lot release procedures developed for seasonal vaccines. The age groups, precautions, and contraindications approved for the influenza A (H1N1) 2009 monovalent vaccine are identical to those approved for seasonal vaccines. All influenza vaccines available in the United States for the 2009–10 influenza season are produced using embryonated hen’s eggs and contain residual egg protein.

Preliminary data indicate that the immunogenicity and safety of these vaccines are similar to those of seasonal influenza vaccines. An immunogenicity study of an inactivated influenza A (H1N1) monovalent vaccine manufactured by CSL Limited (Parkville, Victoria, Australia) demonstrated that by day 21 after vaccination, antibody titers of 1:40 or more (hemagglutination-inhibition assay) were observed in 116 (97%) of 120 adults who received the 15 μg dose. Local discomfort (e.g., injection site tenderness or pain) was reported by 46% of subjects, and one or more systemic symptoms (e.g., headache, malaise, or myalgia) by 45% of subjects (7). This safety profile is consistent with results from studies of the seasonal influenza vaccine manufactured by CSL Limited (8). In studies of other seasonal inactivated influenza vaccines, rates of adverse events were not significantly different from placebo injections except for arm soreness and redness at the injection site (9). The National Institute of Allergy and Infectious Diseases (NIAID) reported preliminary results of a study among children aged 6 months–18 years. Among children aged 6–35 months, 3–9 years, and 10–17 years immunized with a 15 μg inactivated influenza A 2009 (H1N1) monovalent vaccine (Sanofi Pasteur, Inc., Swiftwater, PA), 25%, 36% and 76%, respectively, developed antibody titers of 1:40 or more (hemagglutination-inhibition assay) after a single dose of vaccine.† Immunogenicity and safety study results similar to those observed for seasonal vaccines also have been reported by the other manufacturers (MedImmune LLC, Gaithersburg, MD and Novartis Vaccines and Diagnostics, Limited, Liverpool, UK, unpublished data, 2009).

Influenza activity attributed to 2009 H1N1 viruses has increased during September 2009 and is expected to continue through the fall and winter influenza season. Surveillance data indicate that the 2009 H1N1 viruses have not undergone substantial antigenic change since they were first characterized in April 2009 and should be well-matched to the monovalent vaccine strain (10). Influenza A (H1N1) 2009 monovalent vaccines will be available in many areas by mid-October. Vaccines against seasonal influenza are available now, and immunization programs and providers should begin or continue administering seasonal influenza vaccines as recommended (5,6). Additional data from clinical trials will be available over the coming weeks, and immunization providers should periodically look for updates on use of influenza A (2009) H1N1 monovalent vaccines at http://www.cdc.gov/flu.

References

1. CSL Biotherapies, Inc. Influenza A (H1N1) 2009 monovalent vaccine [Package insert]. King of Prussia, PA: CSL Biotherapies Inc.; 2009. Available at http://www.fda.gov/downloads/biologicsbloodvaccines/vaccines/approvedproducts/ucm182401.pdf. Accessed October 7, 2009.
2. Novartis Vaccines and Diagnostics, Ltd. Influenza A (H1N1) 2009 monovalent vaccine [Package insert]. Cambridge, MA: Novartis Vaccines and Diagnostics, Ltd.; 2009. Available at http://www.fda.gov/downloads/biologicsbloodvaccines/vaccines/approvedproducts/ucm182242.pdf. Accessed October 7, 2009.
3. Sanofi Pasteur, Inc. Influenza A (H1N1) 2009 monovalent vaccine [Package insert]. Swiftwater, PA: Sanofi Pasteur Inc.; 2009. Available at http://www.fda.gov/downloads/biologicsbloodvaccines/vaccines/approvedproducts/ucm182404.pdf. Accessed October 7, 2009.
4. MedImmune, LLC. Influenza A (H1N1) 2009 monovalent vaccine live, intranasal [Package insert]. Gaithersburg, MD: MedImmune, LLC.; 2009. Available at http://www.fda.gov/downloads/biologicsbloodvaccines/vaccines/approvedproducts/ucm182406.pdf. Accessed October 7, 2009.
5. CDC. Prevention and control of seasonal influenza with vaccines: recommendations of the Advisory Committee on Immunization Practices (ACIP), 2009. MMWR 2009;58(No. RR-8).
6. CDC. Use of influenza A (H1N1) 2009 monovalent vaccine: recommendations of the Advisory Committee on Immunization Practices (ACIP), 2009. MMWR 2009;58(No. RR-10).
7. Greenberg ME, Lai MH, Hartel GF, et al. Response after one dose of a monovalent influenza A (H1N1) 2009 vaccine—preliminary report. N Engl J Med 2009 [E-pub]. Available at http://content.nejm.org/cgi/reprint/NEJMoa0907413.pdf?resourcetype=HWCIT. Accessed October 7, 2009.
8. Talbot HK, Keitel W, Cate TR, et al. Immunogenicity, safety and consistency of new trivalent inactivated influenza vaccine. Vaccine 2008;26:4057–61.
9. Nichol KL, Margolis KL, Lind A, et al. Side effects associated with influenza vaccination in healthy working adults: a randomized, placebo-controlled trial. Arch Intern Med 1996;156:1546–50.
10. CDC. Update: influenza activity—United States, April–August 2009. MMWR 2009;58:1009–12.

[Posted 10/09/2009] GlaxoSmithKline (GSK) and FDA notified healthcare professionals of a report of the death of a patient with influenza who received Relenza (zanamivir) Inhalation Powder which was solubilized and administered by mechanical ventilation. Relenza (zanamivir) Inhalation Powder is not intended to be reconstituted in any liquid formulation and is not recommended for use in any nebulizer or mechanical ventilator.

GSK is aware that Relenza Inhalation Powder is being removed from its FDA-approved packaging and dissolved in various solutions for the purpose of nebulizing zanamivir for inhalation by patients with influenza who are unable to take oral medications or unable to inhale Relenza Inhalation Powder using the Diskhaler. Relenza or zanamivir for nebulization have not been approved by the FDA. The safety, effectiveness, and stability of zanamivir use by nebulization have not been established.

Relenza Inhalation Powder should only be used as directed in the prescribing information by using the Diskhaler device provided with the drug product. Relenza Inhalation Powder is a mixture of zanamivir active drug substance and lactose drug carrier. This formulation is not designed or intended to be administered by nebulization. There is a risk that the lactose sugar in this formulation can obstruct proper functioning of mechanical ventilator equipment.

Read the MedWatch safety summary, including a link to the Dear Healthcare Professional Letter, at:

http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm186081.htm

Relenza (zanamivir) Inhalation Powder

Audience: Infectious disease healthcare professionals, hospital risk managers

[Posted 10/09/2009] GlaxoSmithKline (GSK) and FDA notified healthcare professionals of a report of the death of a patient with influenza who received Relenza (zanamivir) Inhalation Powder which was solubilized and administered by mechanical ventilation. Relenza (zanamivir) Inhalation Powder is not intended to be reconstituted in any liquid formulation and is not recommended for use in any nebulizer or mechanical ventilator.

GSK is aware that Relenza Inhalation Powder is being removed from its FDA-approved packaging and dissolved in various solutions for the purpose of nebulizing zanamivir for inhalation by patients with influenza who are unable to take oral medications or unable to inhale Relenza Inhalation Powder using the Diskhaler. Relenza or zanamivir for nebulization have not been approved by the FDA. The safety, effectiveness, and stability of zanamivir use by nebulization have not been established.

Relenza Inhalation Powder should only be used as directed in the prescribing information by using the Diskhaler device provided with the drug product. Relenza Inhalation Powder is a mixture of zanamivir active drug substance and lactose drug carrier. This formulation is not designed or intended to be administered by nebulization. There is a risk that the lactose sugar in this formulation can obstruct proper functioning of mechanical ventilator equipment. Link:  http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm186081.htm

[10/09/2009 - Dear Healthcare Professional Letter - GlaxoSmithKline]

Link:   http://www.cdc.gov/flu/weekly/

During week 39 (September 27-October 3, 2009), influenza activity increased in the U.S.

• 2,968 (27.4%) specimens tested by U.S. World Health Organization (WHO) and National Respiratory and Enteric Virus Surveillance System (NREVSS) collaborating laboratories and reported to CDC/Influenza Division were positive for influenza.
• 99% of all subtyped influenza A viruses being reported to CDC were 2009 influenza A (H1N1) viruses.
• The proportion of deaths attributed to pneumonia and influenza (P&I) was at the epidemic threshold.
• Nineteen influenza-associated pediatric deaths were reported. Sixteen of these deaths were associated with 2009 influenza A (H1N1) virus infection and three were associated with influenza A virus, for which subtype is undetermined.
• The proportion of outpatient visits for influenza-like illness (ILI) was above the national baseline. Regions 3 through 10 reported ILI above region-specific baseline levels; Regions 1 and 2 were below region-specific baselines.
• Thirty-seven states reported geographically widespread influenza activity, Guam and 11 states reported regional influenza activity, two states, the District of Columbia, and Puerto Rico reported local influenza activity, and the U.S. Virgin Islands did not report.

* HHS regions (Region 1: CT, ME, MA, NH, RI, VT; Region 2: NJ, NY, Puerto Rico, US Virgin Islands; Region 3: DE, DC, MD, PA, VA, WV; Region 4: AL, FL, GA, KY, MS, NC, SC, TN; Region 5: IL, IN, MI, MN, OH, WI; Region 6: AR, LA, NM, OK, TX; Region 7: IA, KS, MO, NE; Region 8: CO, MT, ND, SD, UT, WY; Region 9: AZ, CA, Guam, HI, NV; and Region 10: AK, ID, OR, WA)
† Elevated means the % of visits for ILI is at or above the national or region-specific baseline
‡ National data are for current week; regional data are for the most recent three weeks
§ Includes all 50 states, the District of Columbia, Guam, Puerto Rico, and U.S. Virgin Islands
¥ The majority of influenza A viruses that cannot be sub-typed as seasonal influenza viruses are 2009 A (H1N1) influenza viruses upon further testing

Link:  http://www.cdc.gov/flu/weekly/regions2008-2009/senreg5.htm

COMPARED TO

Link:  http://www.cdc.gov/h1n1flu/updates/us/#iligraph

Percentage of Visits for Influenza-like Illness (ILI) Reported by the U.S. Outpatient Influenza-like Illness Surveillance Network (ILINet), National Summary 2008-2009 and Previous Two Seasons
(Posted October 9, 2009, 4:00 PM ET, for Week Ending October 3, 2009)

Link:  http://www.cdc.gov/h1n1flu/update.htm

2009 H1N1 Flu: Situation Update

October 09, 2009, 4:00 PM ET

Link:  http://www.cidrap.umn.edu/cidrap/content/influenza/swineflu/news/oct0909cdc.html

Oct 9, 2009 (CIDRAP News) – “Seventy-six children and teenagers have died of H1N1 flu since the novel strain emerged in April, the Centers for Disease Control and Prevention (CDC) said today, representing both an increase of 19 in a week and a total that rivals the child deaths for entire past flu seasons.

And with the pandemic strain becoming establishing across the country, widespread in 37 states compared with 27 last week, deaths and case counts are expected to rise.

“In the past 3 years, the total pediatric influenza deaths ranged from 46 to 88,” Dr. Anne Schuchat, director of the CDC’s National Center for Immunization and Respiratory Diseases, said in a press briefing. “It is only the beginning of October. Of course, the flu season will often last all the way to May, and so it is very early for us to predict exactly what is going to happen……..”

Link:  http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm186257.htm

FDA NEWS RELEASE

For Immediate Release: Oct. 9, 2009

Media Inquiries: Shelly Burgess, 301-796-4651, shelly.burgess@fda.hhs.gov
Consumer Inquiries: 888-INFO-FDA

FDA Approves Berinert to Treat Abdominal Attacks, Facial Swelling Associated With Hereditary Angioedema

The U.S. Food and Drug Administration today approved Berinert, the first treatment for acute abdominal attacks and facial swelling associated with a rare and potentially life-threatening genetic disease called hereditary angioedema (HAE).

Berinert is approved for adults and adolescents with HAE, which can occur spontaneously or during stress, surgery, or infection in patients diagnosed with HAE. The symptoms during abdominal attacks include severe abdominal pain, nausea, vomiting, cramps, and diarrhea.

“Berinert will enhance the treatment options for individuals who experience acute abdominal attacks and facial swelling associated with hereditary angioedema,” said Karen Midthun, M.D., acting director of FDA’s Center for Biologics Evaluation and Research.

Berinert is a protein product derived from human plasma. It regulates clotting and inflammatory reactions that, when impaired, can lead to local tissue swelling. In a clinical trial of 124 adults and adolescents with C1 esterase, inhibitor deficiency, Berinert was shown to be effective at treating the symptoms of acute moderate to severe abdominal attacks and facial swelling in patients with HAE.

Berinert is contraindicated in patients with a history of life-threatening hypersensitivity reaction to C1 esterase inhibitor preparations.  The most serious adverse reaction reported in clinical studies was an increase in the severity of pain associated with HAE. The most common adverse reactions include subsequent HAE attack, headache, abdominal pain, nausea, muscle spasms, pain, diarrhea and vomiting.

Berinert is manufactured by CSL Behring, Inc., Marburg, Germany.

#

Link:  http://www.cdc.gov/h1n1flu/highrisk.htm

Link:  http://www.cdc.gov/h1n1flu/vaccination/vaccine_keyfacts.htm

Key Facts About 2009 H1N1 Flu Vaccine

October 7, 2009, 8:00 PM ET

A flu vaccine is the single best way to protect against influenza illness. This season, there is a seasonal flu vaccine to protect against seasonal flu viruses and a 2009 H1N1 vaccine to protect against the 2009 H1N1 influenza virus (sometimes called “swine flu”).

This page contains information about the 2009 H1N1 flu vaccine.

There are two kinds of 2009 H1N1 vaccines being produced:

• A 2009 H1N1 “flu shot” — an inactivated vaccine (containing killed virus) that is given with a needle, usually in the arm. The indications for who can get the 2009 H1N1 flu shot are the same as for seasonal flu shots. The flu shot is approved for use in people 6 months of age and older, including healthy people, people with chronic medical conditions and pregnant women. The same manufacturers who produce seasonal flu shots are producing 2009 H1N1 flu shots for use in the United States this season. The 2009 H1N1 flu shot is being made in the same way that the seasonal flu shot is made.

• The 2009 H1N1 nasal spray flu vaccine — a vaccine made with live, weakened viruses that do not cause the flu (sometimes called LAIV for “live attenuated influenza vaccine”). The indications for who can get the 2009 H1N1 nasal spray vaccine are the same as for seasonal nasal spray vaccine. LAIV is approved for use in healthy* people 2 years to 49 years of age who are not pregnant. The nasal spray vaccine for use in the United States is being made by MedImmune, the same company that makes the seasonal nasal spray vaccine called “FluMist®.” The 2009 H1N1 nasal spray vaccine is being made in the same way as the seasonal nasal spray vaccine.

About 2 weeks after vaccination, antibodies that provide protection against 2009 H1N1 influenza virus infection will develop in the body.

The 2009 H1N1 vaccine will not protect against seasonal influenza viruses.

When to Get Vaccinated
Vaccination against 2009 H1N1 should begin as soon as vaccine is available and continue throughout the influenza season, into December, January, and beyond. This is because the timing and duration of flu activity can vary. Flu seasons can last as late as April or May. By early October 2009, extensive 2009 H1N1 flu activity was being reported in the United States. It’s possible that there may be waves of 2009 H1N1 activity during the 2009-2010 flu season that hit communities more than once over the course of the season. While 2009 H1N1 viruses are likely to be the most common cause of influenza this season, CDC still expects that seasonal influenza viruses will circulate and continues to recommend that people get a seasonal flu vaccine to protect against seasonal flu viruses. The ACIP has issued separate recommendations on who should get the 2009-10 seasonal vaccine

Vaccine Supply
The U.S. government has purchased 250 million doses of 2009 H1N1 vaccine, so anyone who wants to get the vaccine will have the opportunity to do so. Vaccine will be made available as quickly as possible as it rolls off the production lines, so initially, the vaccine will be available in limited quantities.

Who Should Get Vaccinated
CDC’s Advisory Committee on Immunization Practices (ACIP), a panel made up of medical and public health experts, met July 29, 2009, to make recommendations on who should receive the 2009 H1N1 vaccine when it becomes available. While the federal government has purchased enough vaccine so that anyone who wants to get vaccinated can, ACIP’s statement on the “Use of Influenza A (H1N1) 2009 Monovalent Vaccine” recommends that vaccination efforts should focus first on people in five target groups who are at higher risk for 2009 H1N1 influenza or related complications, are likely to come in contact with influenza viruses as part of their occupation and could transmit influenza viruses to others in medical care settings, or are close contacts of infants younger than 6 months (who are too young to be vaccinated). These five target groups make up an estimated 159 million people in the United States.

Initial Target Groups Are:
When vaccine is first available, ACIP recommends that programs and providers administer vaccine to people in the following five target groups (order of target groups does not indicate priority):

• pregnant women,
• people who live with or provide care for infants younger than 6 months (e.g., parents, siblings, and day care providers),
• health care and emergency medical services personnel,
• people 6 months through 24 years of age, and,
• people 25 years through 64 years of age who have certain medical conditions that put them at higher risk for influenza-related complications.

No shortage of 2009 H1N1 vaccine is expected, but vaccine availability and demand can be unpredictable and initially the vaccine may be available in limited quantities.  Because the amount of vaccine available at first will be small, the ACIP also made recommendations regarding which people within the groups listed above should be prioritized if the vaccine is initially available in extremely limited quantities. For more information see the ACIP recommendations on the Use of Influenza A (H1N1) 2009 Monovalent Vaccine at http://www.cdc.gov/mmwr/preview/mmwrhtml/rr58e0821a1.htm

Once the demand for vaccine for the target groups has been met at the local level, ACIP recommends that programs and providers begin vaccinating everyone from the ages of 25 through 64 years. Current studies indicate that the risk for infection among persons 65 and older is less than the risk for younger age groups. However, once vaccine demand among younger age groups has been met, ACIP recommends that programs and providers should offer vaccination to people 65 or older.

The ACIP has issued separate recommendations on who should get the 2009-10 seasonal vaccine.

Who Should Not Be Vaccinated
There are some people who should not get any flu vaccine without first consulting a physician. These include:

• People who have a severe allergy to chicken eggs.
• People who have had a severe reaction to an influenza vaccination.
• People who developed Guillain-Barré syndrome (GBS) within 6 weeks of getting an influenza vaccine previously. (For information, see General Questions and Answers on Guillain-Barré syndrome (GBS).
• Children younger than 6 months of age (influenza vaccine is not approved for this age group), and
• People who have a moderate-to-severe illness with a fever (they should wait until they recover to get vaccinated.)

Vaccine Effectiveness
The ability of a flu vaccine to protect a person depends on the age and health status of the person getting the vaccine, and the similarity or “match” between the viruses or virus in the vaccine and those in circulation. CDC analyzes circulating inflluenza viruses on an ongoing basis to determine how closely matched they are to vaccine viruses and publishes the information weekly in FluView. In addition,  every year CDC monitors vaccine effectiveness. For more information about flu vaccine effectiveness, see How Well Does the Seasonal Vaccine Work? 

Vaccine Side Effects (What to Expect)
The same side effects typically associated with the seasonal flu shot and the seasonal nasal spray vaccine are expected with the 2009 H1N1 flu shot and 2009 H1N1 nasal spray vaccine.

These are:

The flu shot: The viruses in the flu shot are killed (inactivated), so you cannot get the flu from a flu shot. Some minor side effects that could occur are:

• Soreness, redness, or swelling where the shot was given
• Fever (low grade)
• Aches

If these problems occur, they begin soon after the shot, are usually mild, and usually last 1 to 2 days. Almost all people who receive influenza vaccine have no serious problems from it. However, on rare occasions, flu vaccination can cause serious problems, such as severe allergic reactions. As of July 1, 2005, people who think that they have been injured by the flu shot can file a claim for compensation from the National Vaccine Injury Compensation Program (VICP).

The nasal spray: The viruses in the nasal-spray vaccine are weakened and do not cause severe symptoms often associated with influenza illness. (In clinical studies, transmission of vaccine viruses to close contacts has occurred only rarely.)
In children, side effects from LAIV can include:

• runny nose
• wheezing
• headache
• vomiting
• muscle aches
• fever

In adults, side effects from LAIV can include

• runny nose
• headache
• sore throat
• cough

For more information about vaccine side effects and safety see General Questions and Answers on 2009 H1N1 Influenza Vaccine Safety.

More Information

• 2009 H1N1 Flu Shot: Vaccine Information Statement (VIS) 
• 2009 H1N1 Nasal Spray: Vaccine Information Statement (VIS) 
• Seasonal Flu Shot: Vaccination Information Statement (VIS)
• Seasonal Nasal Spray: Vaccination Information Statement (VIS)

Link:  http://www.ems1.com/ems-products/Infection-Control/articles/596095-Ohio-governor-authorizes-EMTs-to-vaccinate-in-H1N1-emergency/

By Misti Crane
The Columbus Dispatch

COLUMBUS, Ohio — “As flu continues to sicken an unprecedented number of people for this time of year, Ohio leaders said they’re working to get antiviral drugs to health departments and hospitals.

Ohio Department of Health officials this week sent some of the state’s stockpile of Tamiflu and Relenza out to help ensure that there’s enough medication for those most at risk of serious complications from the H1N1 virus, also known as swine flu.

Gov. Ted Strickland also signed an emergency proclamation yesterday that allows emergency medical workers to vaccinate people. EMTs don’t normally vaccinate, but special arrangements have been made this year to ensure there are enough people trained to administer H1N1 shots and nasal vaccine…..”