Archive for December, 2009

FDA PRESS RELEASE

For Immediate Release: Dec. 23, 2009

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

FDA Approves a High Dose Seasonal Influenza Vaccine Specifically Intended for People Ages 65 and Older
Accelerated approval process used in vaccine approval

The U.S. Food and Drug Administration today approved Fluzone High-Dose, an inactivated influenza virus vaccine for people ages 65 years and older to prevent disease caused by influenza virus subtypes A and B.

People in this age group are at highest risk for seasonal influenza complications, which may result in hospitalization and death. Annual vaccination remains the best protection from influenza, particularly for people 65 and older.

Fluzone High-Dose was approved via the accelerated approval pathway. FDA’s accelerated approval pathway helps safe and effective medical products for serious or life-threatening diseases become available sooner. In clinical studies, Fluzone High-Dose demonstrated an enhanced immune response compared with Fluzone in individuals 65 and older.

As part of the accelerated approval process, the manufacturer is required to conduct further studies to verify that the Fluzone High-Dose will decrease seasonal influenza disease after vaccination.

“As people grow older, their immune systems typically become weaker,” said Karen Midthun, M.D., acting director of the FDA’s Center for Biologics Evaluation and Research. “This is the first influenza vaccine that uses a higher dose to induce a stronger immune response that is intended to better protect the elderly against seasonal influenza.”

Fluzone High-Dose, manufactured by Sanofi Pasteur Inc., is formulated so that each 0.5 mL dose contains a total of 180 micrograms (mcg) of influenza virus hemagglutinin (HA) which is made up of 60 mcg of each of the three influenza virus strains.

Other currently licensed seasonal influenza vaccines for adults are formulated to contain a total of 45 mcg of influenza virus hemagglutinin (15 mcg HA from each of the three influenza strains per dose). Sanofi Pasteur, also manufactures Fluzone, a seasonal vaccine for the United States approved for use in individuals ages 6 months and older.

As expected, because of the higher HA content, non-serious adverse events were more frequent after vaccination with Fluzone High-Dose compared with Fluzone. Common adverse events experienced during clinical studies included pain, redness and swelling at the injection site and headache, muscle aches, fever and malaise. The rate of serious adverse events was comparable between Fluzone High-Dose and Fluzone.

People with hypersensitivity to egg proteins or life-threatening reactions after previous administration of any influenza vaccine should not be vaccinated with Fluzone High-Dose.

Fluzone High-Dose is administered as a single injection in the upper arm and is available in single dose pre-filled syringes without preservative.

Source: fda.gov

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As if there wasn’t already enough concern surrounding the H1N1 flu vaccine here we go again. Health officials are recalling 800,000 doses of the H1N1 flu vaccine for children after tests indicated they may not even be potent enough to protect against the virus.

Doctors were notified today by the Centers for Disease Control and Prevention about the recall manufactured by Sanofi Pasteur. The recalled doses are the pre-filled syringes meant for children ages six months to approximately three years old.

The lots passed potency tests when they initially shipped however tests are now indicating the potency waned thereafter. Health officials do not think children need to be revaccinated.

Is it out of line to ask even if it was recommended that they were vaccinated again would that dose be potent enough?

Source: biztimes.com

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Between the Christmas holiday and the whole Tiger Woods’ scandal (dare this be mentioned in the same sentence) have we forgotten about one of the oldest winter woes? The cold and flu are still going strong even though we haven’t heard too much about them lately.

Here are a few tips to help you (hopefully) make it through the season.

Keep your distance – your family and your friends, you love them but do you love their germs too? If they appear to be sick staying a good 3 to 6 feet away will decrease your chance of getting sick. Hopefully if they’re sick they’ll stay home but just in case.

Wash your hands – tried and true, we all know frequent hand washing with warm water and soap puts up a huge fight against germs. If you’re at a loss for a good ole hand washing carry a pocket size hand sanitizer with you.

Maintain a healthy lifestyle – get your zees, if you miss too much sleep you can wear down your immune system. Eat a healthy diet and if you’re going to splurge do so in proportion (we all love a Christmas cookie or two but ten or twelve in a sitting is overboard). Stay hydrated by drinking plenty of water. If you’re going to drink alcohol limit your intake to one or two drinks per day. Keep up with your exercise routine to help relieve stress and maintain your weight.

Source: EHSToday.com

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Do you enjoy running? Do you live in the NYC area or will be there on March 21, 2010? If so, get your running shoes ready.

On March 21, the Fresh Air Fund-Racers will be taking it to the streets in the NYC Half-Marathon. There’s limited availability so if you’re interested register here on the double!

Every year The Fresh Air Fund gives thousands of inner-city children the priceless gift of fun and opens the door to a lifetime of opportunities. Whether a country trip with a host family or an educational stay at one of The Fresh Air Fund camps their programs are providing lifelong memories and friendships.

Source: FreshAirHoliday.org, nyrr.org

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December 1st is World AIDS Day. World AIDS Day was established by the World Health Organization in 1988. This day allows governments, national AIDS programs, faith organizations, community organizations, and individuals an opportunity to raise awareness and focus attention on the global AIDS epidemic.

According to the CDC at the end of 2006 an estimated 1.1 million people were living with diagnosed or undiagnosed HIV infection in the United States. Worldwide an estimated 33 million people are living with HIV.

It doesn’t have to be World AIDS Day to take action against HIV/AIDS but now is as good as any day to start. Here are some ideas on how you can take action today:

• Get tested for HIV – there are home HIV tests now available
• Practice safer methods to prevent HIV – don’t share needles, use condoms
• Decide not to engage in high risk behaviors – alcohol/drug abuse which could impair your judgment, sharing needles, unprotected sex
• Talk about HIV prevention with family, friends and colleagues – there is endless HIV educational material out there, it’s just a matter of getting it out there
• Provide support to people living with HIV/AIDS – do not discriminate, don’t be afraid
• Get involved with or host an event for World AIDS Day in your community – it can be any day really, there’s National Women & Girls AIDS Awareness Day, National HIV Testing Day, etc.

Sources: cdc.gov, hhs.gov

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