Another Ukraine H1N1 Update.

Well, it looks like Drudge is finally reporting on the Ukraine H1N1 outbreak. (This should have been picked up by all of the major media by now. )

 

Here is the latest from recombinomics:

 

Ukraine Dead Increase to 239 - Still No Sequences
Recombinomics Commentary 20:26
November 12, 2009

1,253,558 Influenza/ARI

65.615 Hospitalizations

239 Deaths

The above numbers are from the latest update from the Ukraine Ministry of Health.  The number of deaths increased 26 to 239, so 50 new deaths have been reported in the past 2 days.  Although the virus continues to spread (only 5 of the 27 reporting areas have not topped the epidemic threshold) many of the deaths are still being reported from the hard hit areas in western Ukraine(see map).  However, the biggest jump in cases was 6.096 in Kiev to 89,339.

The steady increase in the high level of deaths continues to raise concerns about genetic changes in the H1N1.  In this morning's press conference the WHO discussed the need for prompt treatment with Tamiflu, but did not address genetic changes in Ukraine. Only general statements on the stability of the H1N1 were made in response to questions on genetic changes in Ukraine. Today's conference is a week after the last comments on the Ukraine H1N1 sequences which indicated that there were no large changes, but an update would be forthcoming in a "few days".  It has now been over a week and no updates on genetic changes have been forthcoming.

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In other news, the FDA is still authorizing minimally tested H1N1 vaccine for use on infants and children:

FDA NOTE TO CORRESPONDENTS

For Immediate Release: Nov. 12, 2009

Media Inquiries: Pat El-Hinnawy, (301) 796-4763, patricia.el-hinnawy@fda.hhs.gov
Consumer Inquiries: 888-INFO-FDA

FDA Expands Approved Use of H1N1 Vaccines to Include Infants and Children

The U.S. Food and Drug Administration has approved the use of the CSL Limited’s 2009 H1N1 influenza vaccine to include children ages 6 months and older. This vaccine was previously approved only for use in adults, ages 18 years and older.

“Because children are among those most vulnerable to the 2009 H1N1 virus, having a broader range of children’s vaccines available is an important step in responding to the H1N1 outbreak,” said Margaret A. Hamburg, M.D., commissioner of food and drugs.

The company’s 2009 H1N1 vaccine is manufactured and tested using the same well-established licensing processes that have been in place for many years for the company’s seasonal flu vaccine. The expanded approval also covers the company’s seasonal flu vaccine.

The approval was based on a study of the company’s seasonal flu vaccine in children showing the vaccine's safety and efficacy in inducing antibodies to protect against influenza. These efficacy findings supported approval under FDA's accelerated approval regulation, which helps safe and effective medical products for serious or life-threatening diseases to become available sooner to the public.

Common adverse events experienced by children after administration of seasonal and H1N1 vaccines typically include pain, redness and swelling at the injection site as well as, in some cases, irritability, loss of appetite and drowsiness.

As with any medical product, unexpected or rare serious adverse events may occur. FDA is collaborating with the U.S. Department of Health and Human Services, including the Centers for Disease Control and Prevention, and other government agencies to enhance the capacity for adverse event safety monitoring during and after the 2009 H1N1 vaccination program.

Because CSL’s seasonal and H1N1 monovalent vaccines contain a small amount of egg protein, they should not be administered to anyone allergic to eggs or egg products.

The vaccines will be available in single-dose, preservative-free, pre-filled syringes and in multi-dose vials that contain thimerosal, a mercury derivative, as a preservative.

Both vaccines are manufactured by CSL Ltd. of Australia.

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Feel free to read between the lines on that latest FDA announcement. I.E. "We'll approve the vaccine because the previous products appear safe and we'll do adverse event monitoring after the fact to see how many kids the minimally tested vaccine screwed up."

 

Your tax dollars at work.