Swine Flu Part II

or “Train Wreck..Continued“.

Testing on healthy adults ages 18-65 began on August 10th.

If the first eight days of adult testing don’t raise any safety concerns, researchers will begin testing the vaccine in healthy children ages 6 months to 18 years.

Generally, researchers would wait longer before moving to test a vaccine in children, says Dr. Ina Stephens, a pediatric infectious disease specialist at the University of Maryland Center For Vaccine Development.

“For a lot of reasons this is not a typical vaccine trial,” says Stephens, whose center is one of the locations of the clinical trials. “Because of the urgency for getting this vaccine approved for public use, we need to hurry … we’re looking mostly for safety data.”

Healthy adults, healthy children. No pregnant women. That’s who this is being tested on.

Inclusion Criteria:

• Are males or non-pregnant females aged 6 months to 17 years, inclusive.
• Subjects of child-bearing potential must agree to practice adequate contraception that may include, but is not limited to, abstinence, barrier methods such as condoms, diaphragms, spermicides, intrauterine devices, and licensed hormonal methods during the study for at least 30 days following the last vaccination.
• The subject must be in good health as determined by axillary (

Okay, healthy people who aren’t pregnant. Got it. Now tell me again…

Q Who should be vaccinated against swine flu?

A Eventually, everyone, except for people who have the same allergies — primarily, allergy to eggs — that make annual flu shots dangerous for them. But for now, the first vaccine batches are reserved for those most at-risk: health care and emergency workers; pregnant women; people caring for infants younger than 6 months old; people 6 months to 24 years old; and anyone younger than 65 who has a weakened immune system or such medical conditions as asthma, diabetes or morbid obesity.

Test it on healthy people who aren’t pregnant, then recommend it for pregnant and sickly people. Right. “I’m from the government, and I’m here to help you.” comes to mind for some reason.

Testing on children 6 months and older began in mid-August. That’s a good thing, right? They’re already running tests, so by the time flu season really hits we’ll have some test results to look at.

Or not.

From the ClinicalTrials.gov website:

Peds Sanofi H1N1 Influenza Vaccine Administered at Two Dose Levels

Study Start Date:	August 2009
Estimated Study Completion Date:	April 2010
Estimated Primary Completion Date:	April 2010 (Final data collection date for primary outcome measure)

Well, that’s reassuring.

Oh look, they’re doing one to “help determine how and when the H1N1 flu shot should be given with the seasonal flu shot to make it most effective.” That sounds awesome, when will we see the results for that one?

Study Start Date:	August 2009
Estimated Study Completion Date:	June 2010
Estimated Primary Completion Date:	June 2010 (Final data collection date for primary outcome measure)

Oops.

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