FDA's Prevnar Approval Information - Mothering Forums

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#1 of 4 Old 12-11-2008, 02:01 PM - Thread Starter
 
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http://www.fda.gov/cber/products/prevnar.htm

Anyone seen this website? I just found it recently. The "clinical review" might be of interest for some, I found much more information on the pre-licensure clinical trials in these documents than on the package insert.

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#2 of 4 Old 12-11-2008, 05:35 PM
 
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Thanks for posting this!

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#3 of 4 Old 12-12-2008, 12:49 PM
 
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Can you quote some interesting parts please?

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#4 of 4 Old 12-12-2008, 02:57 PM - Thread Starter
 
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I don't have quotes, because you can't copy and paste from it, but these are my notes...

Prevnar Clinical Trials Safety Data
*One large trial involving infants vaccinated at 2, 4, 6 and 12-15 months, divided equally into two groups (about 17,000 each): vaccines on current schedule and Men C or vaccines on current schedule and PCV7
-Reactions surveyed at 48-72 hours and 14 days after each dose
-Emergency room and outpatient clinic visits surveyed at 30 and 60 days
*In group that received PCV7:
-40 participants dropped from study due to seizure activity, 1 for allergic reaction (a total of 127 dropped due to an adverse event)

I am pretty sure this was not mentioned in the package insert (because they did not complete the series.) That's a significant number to me.

-Seizures within 3 days: 8 (twice as much as control group), within 14: 21 (similar to control group), within 30: 32 (similar to control group)

This was not included in the package insert either. I read that there was a "slightly" increased risk of seizures in the first three days compared to controls. It may be similar to the control group, which is what matters to the FDA, but 72 seizures in any kid who got at least one dose is still a worrisome number to me. I'm looking at the risk of vaccinating at all. No mention is made of the total number of seizures within 30 days because there was no increased risk between the two types.

-Seizure rate within 3 days of vaccination with PCV7 and concurrent vaccinations calculated to be 1 in 7,000 doses

Which you can divide by 4... This is not mentioned in the package insert as far as I know.

-24 hospitalizations within 3 days of a dose: bronchiolitis (5), asthma (2), pneumonia (2) otitis media (1)
-162 ER visits within 3 days of a dose: febrile illness (20), otitis media (15), pneumonia (6) asthma (4), febrile seizure (3)

PCV7 is supposed to protect against pneumonia and earaches.

-Within 4-911 days, children without this diagnosis prior to enrollment vs. after: 1 case of diabetes, 10 cases of thrombocytopenia

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