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Four Companies Receive Approval
The Food and Drug Administration (FDA) has approved the applications from four vaccine makers, according to the secretary of the Department of Health and Human Services, Kathleen Sebelius.
She announced Tuesday that there should be enough of flu-fighting drugs to go around and a vaccination program will begin in mid-October.
The total cost to the U.S. government for the vaccines is more than $1 billion for about 195 million H1N1 vaccine shots to be made by five companies.
The four applications come from Sanofi-Aventis SA, CSL Ltd, MedImmune, and Novartis AG. GlaxoSmithKline PLC is still working on its version.
The vaccine is recommended to first be given to pregnant women, school children, and anyone with compromised health conditions such as diabetes, heart or lung disease.
Researchers believe a single injection should be enough to protect against the virus, offering protection in a week to 10 days.
Final data is still coming in from clinical trials on the Sanofi-Aventis vaccine to determine the right dosage.
Chicken eggs are used during production of the H1N1 vaccine, so people with allergies to chicken eggs should not receive the swine flu vaccine, says the FDA.
Almost all of the influenza viruses identified in 2009 are swine flu H1N1 variety. Many people report they feel symptoms of the flu after first getting a shot.
If there are problems besides a rash or body aches, or injection site soreness, drug makers have liability protection under the Public Readiness & Emergency Preparedness Act (PREP Act), passed by Congress in 2005.
Injuries that result for the quickly formulated flu vaccine will be referred to the Federal Vaccine Court which protects vaccine makers and forces consumers to stand in line to have their case heard.
Eleven states are reporting widespread flu activity including Alaska, Arizona, Florida, Georgia, Louisiana, Maryland, Mississippi, North Carolina, Oklahoma, South Carolina, and Tennessee, as well as Guam.
Thimerosal
Still controversial – which formulations contain the mercury-based preservative, thimerosal, as well as shot boosters called adjuvants that contain aluminum.
The Centers for Disease Control and Prevention (CDC) says the 2009 H1N1 influenza vaccine will be manufactured in several formulations. Some multi-dose vials will contain thimerosal, the mercury-based preservative that prevents the growth of bacteria.
Some manufacturers will also produce a single-dose unit, which should not contain the preservative. Sanofi-Aventis, one drug maker, says it plans to market a thimerosal-free version of the vaccine.
The National Vaccine Information Center has more on the controversy. Additionally, the live virus spray created by MedImmune will not contain thimerosal, the group says.
Thimerosal is still present in trace amounts in many childhood vaccines, often given at the same time, despite the CDCs insistence that no new vaccine licensed for use in children has the ingredient.
The Johns Hopkins Bloomberg - Institute of Vaccine Safety breaks down the 2008 formulations.
Make A Backup Plan Now
WebMD reports there are a few things you should do now in case the flu hits your house.
- 1. Make a backup plan- who will take care of your kids? Of you? How can you get class work?
- 2. Keep fever reducers in the home. Face masks are known to reduce contact with the flu virus. Do not use a mask over and over again.
- 3. Stock up on comfort foods, tea, chicken, soup, crackers. You will not feel like grocery shopping if the flu hits.
- 4. Wash your hands often to avoid getting the flu in the first place. Purchase a good soap or gel that you will have a tendency to use
- 5. Stock up on books and DVDs in case you are stuck at home.
- 6. While most swine flu cases are mild – know when symptoms are more severe in children: Trouble breathing, having a blue or gray skin color, and severe vomiting, irritable. For adults, shortness of breath, pain in the abdomen and chest, confusion, dizziness. Keep your doctor on speed dial. #