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

2009 H1N1 Influenza Vaccine Supply

Status

November 3, 2009, 12:00 PM ET

For Planners: Vaccine Allocation and Distribution Q&A

For the Public: 2009 H1N1 Influenza Vaccine Q&A, Supply and Distribution

Vaccine Shipment Status
by Project Area
Posted October 30, 2009, 12:00 PM ET

Project Areas***	Total Doses Shipped as of 10/28/09**
Alabama	212,700
Alaska	57,700
American Samoa	0
Arizona	332,800
Arkansas	201,100
California	2,025,700
Chicago	212,700
Colorado	255,300
Connecticut	187,000
Delaware	50,000
District of Columbia	49,000
Federal Worker Program*	82,300
Florida	750,300
Georgia	443,200
Guam	9,500
Hawaii	65,000
Idaho	113,300
Illinois	784,900
Indiana	460,800
Iowa	160,600
Kansas	117,100
Kentucky	178,900
Louisiana	253,800
Maine	84,100
Marshall Islands	0
Maryland	306,900
Massachusetts	404,500
Michigan	556,800
Micronesia	8,100
Minnesota	290,300
Mississippi	136,500
Missouri	250,000
Montana	49,000
Nebraska	111,200
Nevada	135,100
New Hampshire	58,600
New Jersey	597,200
New Mexico	116,100
New York	560,200
New York City	511,100
North Carolina	440,900
North Dakota	37,000
Northern Mariana Islands	2,400
Ohio	595,200
Oklahoma	168,200
Oregon	186,500
Pennsylvania	718,600
Philadelphia	93,500
Puerto Rico	42,900
Republic of Palau	1,300
Rhode Island	48,200
South Carolina	186,400
South Dakota	62,100
Tennessee	430,000
Texas	1,170,400
Utah	144,900
Vermont	52,100
Virgin Islands	5,400
Virginia	489,700
Washington	334,900
West Virginia	114,900
Wisconsin	333,000
Wyoming	32,100
*For more information, please visit: http://www.opm.gov/pandemic/memos/h1n1_20090930.asp**There is a lag time between allocation, ordering, and shipment of doses as project areas place orders and those orders are processed and shipped.***Project areas reflect CDC Public Health Emergency Response (PHER) Grantees

Link:  http://abcnews.go.com/Health/SwineFluNews/cdc-flu-mask-decision-based-flawed-study-authors/story?id=8966585

ABC News:  In a surprise twist, authors…retracted findings of a study that found N95 respirators were better than surgical masks at preventing flu.

After a re-analysis prompted by questions from reviewers, the findings were no longer significant, said Holly Seale of the University of New South Wales in Sydney, Australia.

The original study, presented earlier this year, formed the basis of some recommendations on the use of masks in a health care setting.

The retraction — near the end of a presentation at the annual meeting of the Infectious Diseases Society of America — prompted a “rush to the microphones” by those involved in flu prevention, one expert said.

The findings appeared to differ — not only from previous reports, but also from the abstract submitted to this meeting, said Dr. Andrew Pavia of the University of Utah.

Seale acknowledged those differences and agreed that the original results no longer stand. She was not immediately available for additional comment.

The lead author of the study, Raina MacIntyre, also of the University of New South Wales, did not attend the meeting here.

The retraction took experts here by surprise, although many had been critical of some statistical aspects of the study, according to Dr. Neil Fishman of the University of Pennsylvania.

“I think there was little bit of shock that there was such a large change (in the results),” he told MedPage Today after the session.

The study was first presented in San Francisco earlier this year.

The N95 respirators are more costly than simple surgical masks and are in shorter supply. As well, there are costs involved if hospitals try to comply with guidance, he said.

The original Australian finding was a surprise to many experts, Fishman said, because it did not accord with other findings or with clinical experience.

A Canadian study in the Journal of the American Medical Association in October found no difference between fit-tested N95 masks and surgical masks.

The analysis, led by Mark Loeb of McMaster University in Hamilton, Ontario, was a true randomized trial among nurses in eight tertiary care hospitals in Canada.

In contrast, the Australian study, conducted in China, was a cluster randomized trial in which the unit of analysis was the hospital, Fishman said.

But the Australians were criticized because their control group of nine hospitals was not selected randomly, he said.

When the data were re-analyzed excluding those hospitals, the differences between N95 respirators and surgical masks were no longer significant, Seale reported.

“When the P-value was adjusted for clustering and multiple testing,” she reported, there was “no significant difference between N95 respirators and medical masks.”

Fishman said most clinical experience suggests that flu is spread by large droplets and should be blocked by even a simple barrier such as a surgical mask.

Link:  http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm188870.htm

Relenza: Consumer Questions and Answers

Q.  What is Relenza and what is it approved for?

A. Relenza (zanamivir) is an antiviral drug.  It works by attacking the flu virus to keep it from multiplying in your body and reducing the symptoms of the flu. It can sometimes keep you from getting the flu if you take it before you get sick.  

The term “flu” refers to illness caused by the influenza virus. The flu is a respiratory infection that can cause symptoms such as fever, chills, aches and pains, cough, and sore throat. The flu can range from mild common cold symptoms, to the typical “flu” symptoms described above, to life-threatening pneumonia and other complications, including secondary bacterial infections.

Relenza is used to treat people 7 years of age and older who have the flu (influenza A and B viruses). Relenza is also used for prevention (prophylaxis) of the flu in people age 5 years or older.

Q. Is Relenza a substitute for the flu vaccine?

A. No.  Getting the flu vaccine is the best way to protect against getting the flu and controlling the spread of the flu.

More information on the Seasonal and 2009 H1N1 flu vaccines is available on the flu vaccination page on the Flu.gov website.
(see http://www.flu.gov/individualfamily/vaccination/index.html ).

Q. What do the terms treatment of the flu and prevention (prophylaxis) of the flu mean?

A. Treatment is used when a person is given Relenza because they have the signs and symptoms of the flu or have been diagnosed with the flu. Relenza has been shown to lessen the amount of time people are sick with the flu.

Prevention (prophylaxis) is when someone who does not have flu symptoms is given Relenza to help stop them from getting the flu because they are exposed to or come into close contact with someone (for example live with or take care of someone) who has the flu.

Q.  Do I take Relenza the same way for treatment and prevention (prophylaxis) of the flu?

A. No. The number of times a day (frequency) and the number of days (duration) that you take Relenza are different for treatment and prevention (prophylaxis) of the flu. Your healthcare providers will tell you how to take Relenza. Take it exactly as your healthcare provider prescribes.

Q.  What should I do if I continue to have or start to develop flu symptoms while taking Relenza?

A. If your flu symptoms do not go away, or if you get new symptoms while taking Relenza, contact your healthcare provider. Other illnesses cause people to have symptoms similar to the flu, or may occur at the same time as the flu, and they might need other treatment.

Q. How is Relenza supplied?
A. Relenza is a powder that you inhale into your mouth using a device called a Diskhaler. The powder is in a pouch called a blister. There are 4 blisters on each circular medication pack (Rotadisks). Each blister contains 5 mg of medicine. Each box of Relenza contains five Rotadisks.

 Q. How many blisters are used for a dose?
A. Two (2) blisters are used for each dose.  The 4 blisters on the Rotadisk are enough medicine for 2 doses.  Your doctor will tell you how many times a day and for how many days you should take the medicine.

Q. Are there instructions for people who have never used an inhaler?
A. Yes, each box of Relenza has a Patient Instructions for Use leaflet that explains how to take Relenza using the Diskhaler device. These instructions are not a substitute for education and demonstration by your healthcare provider. Your healthcare provider will tell you how to use Relenza. Use it exactly as your healthcare provider prescribes. To help make sure Relenza is used the right way by children, it should be used only under adult supervision.  The supervising adult must understand how to use the Diskhaler device.
To help you use Relenza the right way, the manufacturer, GlaxoSmithKline, also created a video on their website that demonstrates the proper use of the Relenza Diskhaler device, (see http://www.relenza.com/using-relenza-videos.html).

Q. Are there any other special instructions to remember?
A. Yes, it is important to remember to puncture both the top and bottom of the blister using the Diskhaler before inhaling the medication into your mouth.  Relenza should never be used with any other device but the Diskhaler. The blisters of medicine should never be opened and mixed into a liquid.

Q. Are there people who should not take Relenza?

A. Yes. Relenza is not for people who have chronic lung diseases such as asthma or chronic obstructive pulmonary disease (COPD). Also, since the Relenza powder contains lactose, people who have an allergy to lactose should not use Relenza.

Talk with your healthcare provider if you have concerns about using Relenza.

Q. Should women who are pregnant or nursing take Relenza?

A. Relenza may be of benefit for some pregnant and nursing women with 2009 H1N1 influenza. At this time, the U.S. Centers for Disease Control and Prevention (CDC) recommends that pregnant women who are sick from 2009 H1N1 influenza may develop more serious illness and should get be treated with a flu drug.  Pregnant and nursing women are advised to talk with a healthcare professional before using Relenza.

More information is available at flu.gov (see http://www.flu.gov/individualfamily/parents/pregnant5tips.html).

Q. What are the most common side effects of Relenza?

A. The most common side effects of Relenza are:

• diarrhea          
• nausea
• vomiting
• headache
• dizziness
• nasal irritation
• cough
• ear, nose, and throat infections.

Q. What are the serious side effects of Relenza?

A. Some people have more trouble breathing while using Relenza, especially if you have chronic lung disease. If you have more trouble breathing after using Relenza, you should stop using Relenza and get medical help right away.

Children and teenagers with the flu may be at a higher risk for seizures, confusion, or abnormal behavior early during their illness. These serious side effects may happen shortly after beginning Relenza or may happen in people when the flu is not treated. These serious side effects are uncommon but may result in accidental injury to the patient. People who take Relenza should be watched for signs of unusual behavior and a healthcare provider should be contacted right away if a patient shows any unusual behavior while taking Relenza.

Rare cases of allergic reactions, including serious skin rashes, have happened in people who use Relenza. If a rash develops, stop Relenza and contact a healthcare provider right away.
Report any side effects and medication errors from Relenza to FDA at 1-800-FDA-1088.

Q.  Where can I get more information about Relenza and 2009 H1N1?

A. The following links provide additional information on Relenza
FDA 2009 H1N1 webpage -  http://www.fda.gov/NewsEvents/PublicHealthFocus/ucm150305.htm
Flu.gov page –  http://www.flu.gov
CDC 2009 H1N1 flu page –  http://www.cdc.gov/h1n1flu/
Relenza website -  http://www.relenza.com

Link:  http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm188859.htm

Tamiflu: Consumer Questions and Answers

Q.  What is Tamiflu and what is it approved for?

A. Tamiflu (oseltamivir phosphate) is an antiviral drug.  It works by attacking the flu virus to keep it from multiplying in your body and by reducing the symptoms of the flu. Tamiflu can sometimes keep you from getting the flu if you take it before you get sick.

The term “flu” refers to illness caused by the influenza virus. The flu is a respiratory infection that can cause symptoms such as fever, chills, aches and pains, cough, and sore throat. The flu can range from mild common cold symptoms, to the typical “flu” symptoms described above, to life-threatening pneumonia and other complications, including secondary bacterial infections.

Tamiflu is used to treat people 1 year of age and older who have the flu (influenza A and B viruses). Tamiflu is also used for prevention (prophylaxis) of the flu in people 1 year of age and older. During the 2009 H1N1 influenza (“swine flu”) public health emergency, FDA authorized the use of Tamiflu in children less than 1 year of age.

Q. Is Tamiflu a substitute for the flu vaccine?

A. No.  Getting the flu vaccine is the best way to protect against getting the flu and controlling the spread of the flu.

More information on the Seasonal and 2009 H1N1 flu vaccines is available on the flu vaccination page on the Flu.gov website. 

(see http://www.flu.gov/individualfamily/vaccination/index.html).

Q. What do the terms treatment of the flu and prevention (prophylaxis) of the flu mean? 

A. Treatment is used when a person is given Tamiflu because they have the signs and symptoms of the flu or have been diagnosed with the flu. Tamiflu has been shown to lessen the amount of time people are sick with the flu.

Prevention (prophylaxis) is when someone who does not have flu symptoms is given Tamiflu to help stop them from getting the flu because they are exposed to or come into close contact with someone (for example live with or take care of someone) who has the flu.

Q. Do I take Tamiflu the same way for treatment and prevention (prophylaxis) of the flu?

A. No. The number of times a day (frequency) and the number of days (duration) that you take Tamiflu are different for treatment and prevention of the flu. Your healthcare provider will tell you how to take Tamiflu. Take it exactly as your healthcare provider prescribes.

Q. What should people do if they continue to have or start to develop flu symptoms while taking Tamiflu?

A. If flu symptoms do not go away, or if new symptoms develop while taking Tamiflu, people should contact their healthcare provider. Other illnesses cause people to have symptoms similar to the flu, or may occur at the same time as the flu, and they might need other treatment.

Q. Does Tamiflu come in a liquid as well as capsules?

A. Yes, Tamiflu is available as a liquid (oral suspension) and as oral capsules of different sizes. Your healthcare provider will prescribe the strength that is right for you.

Q. Do I need to make the Tamiflu liquid (oral suspension)?

A. No, a pharmacist should mix Tamiflu liquid before giving it to you.  If you get a bottle with only powder in it, you should return the medication to the pharmacy so it can be mixed correctly.

Q. Is there enough Tamiflu suspension?

A. For the 2009-2010 flu season there is not enough of the liquid Tamiflu made by the manufacturer.  Some pharmacies may need to make a liquid for patients.  The strength of the liquid made by the pharmacy may be different than the liquid from the manufacturer.  You should always follow the directions on the medicine label for how much and how often to give the medication.  You should speak with your healthcare provider if you have any questions.

Q.  Does the liquid (oral suspension) need to be refrigerated?

A. Yes, liquid Tamiflu (oral suspension) should be stored in the refrigerator. Ask the pharmacist how long to keep the medicine, and then throw away the unused medicine after that time. You should only use the medication for as long as your healthcare provider has directed.

Q. Does liquid Tamiflu (oral suspensions) need to be shaken? 

A. Yes, shake liquid Tamiflu well each time before you give it.

Q. What do I use to give liquid Tamiflu (oral suspension)? 

A. The pharmacist should give you a syringe to measure the dose of liquid Tamiflu.  Some syringes for oral use have markings in milligrams (mg) and some have markings in milliliters (mL).  You and your pharmacist should look at the syringe and compare it to the directions on the medicine label. The unit of measure (mg or mL) on the medicine label should match the unit of measure (mg or mL) on the syringe.  You should be able to use the syringe to measure the right amount (mg or mL) that is written on the medicine label.  If you can not measure the right amount with the syringe you were given, then you should ask the pharmacist to give you a different syringe with different markings.

Q. What type of syringe should I use to give my child Tamiflu orally?

A. Parents or caregivers of children younger than one year of age will always need to use a syringe marked in milliliters (mL).  If you have questions about how to give the medicine you should speak with your healthcare provider.

Q. What should I do if I am given Tamiflu capsules but can not swallow them?

A. If you have trouble swallowing Tamiflu capsules, you should tell your healthcare provider.  If liquid Tamiflu is not available and you have capsules that give the right dose (30 mg, 45 mg or 75 mg), you may pull open the Tamiflu capsules and mix the powder with a small amount of sweetened liquid such as regular or sugar-free chocolate syrup. You don’t have to use chocolate syrup but thick, sweet liquids work best at covering up the taste of the medicine.

Q. Should women who are pregnant or nursing take Tamiflu?

A. Tamiflu may be of benefit for some pregnant and nursing women with 2009 H1N1 influenza. At this time, the U.S. Centers for Disease Control and Prevention (CDC) recommends that pregnant women who are sick from 2009 H1N1 influenza may develop more serious illness and should be treated with a flu drug.   Pregnant and nursing women are advised to talk with a healthcare professional before using Tamiflu.

More information is available at flu.gov (see http://www.flu.gov/individualfamily/parents/pregnant5tips.html).

Q. What are the most common side effects of Tamiflu?

A. The most common side effects of Tamiflu are nausea and vomiting. Usually, nausea and vomiting are not severe and happen in the first 2 days of treatment. Taking Tamiflu with food may lessen the chance of getting these side effects. Other side effects include stomach (abdominal) pain, nosebleeds, headache, and feeling tired (fatigue).

Q. What are the serious side effects of Tamiflu?

A. Children and teenagers with the flu may be at a higher risk for seizures, confusion, or abnormal behavior early during their illness. These serious side effects may happen shortly after beginning Tamiflu or may happen in people when the flu is not treated. These serious side effects are not common but may result in accidental injury to the patient. People who take Tamiflu should be watched for signs of unusual behavior and a healthcare provider should be contacted right away if the patient shows any unusual behavior while taking Tamiflu.

Rare cases of allergic reactions, including serious skin rashes, have happened in people who take Tamiflu. If a rash develops, stop taking Tamiflu and contact a healthcare provider right away.
FDA encourages consumers to report any side effects and medication errors from Tamiflu to FDA at 1-800-FDA-1088.�
Q.  Where can I get more information about Tamiflu and 2009 H1N1?

A. The following links provide additional information on Tamiflu:

FDA 2009 H1N1 webpage – http://www.fda.gov/NewsEvents/PublicHealthFocus/ucm150305.htm
Flu.gov page – http://www.flu.gov
CDC 2009 H1N1 flu page – http://www.cdc.gov/h1n1flu/
Tamiflu website – http://www.tamiflu.com