December 16, 2009
Note: There is NO PROBLEM WITH THE SAFETY OF THE VACCINE – just the potency.
Children who received a vaccine from the manufacturer DO NOT NEED TO BE IMMUNIZED AGAIN.
Maybe French manufacturer SANOFI PASTEUR should slow down production. They are the manufacturers that bragged they can make 10M vaccines per week and a total of 170M vaccines year. And they promise 90% efficacy (children and adults) with one dose.
Doesn’t seem to be the case here.
The vaccines for children were not potent enough (tested 12% too low) so they are recalling 800K doses of vaccine meant for children ages 6 months to 35 months, who receive only 1/2 the dose. Children over 3 receive the full dose.
How often they test the potency of the vaccine?
In order for vaccine to move to next phase of production it [the vaccine] has to pass all tests and at the end, it has to pass another battery of tests before it can be shipped out. [The company also keeps samples of each batch of vaccine] to periodically test them to see if they stay within specification until expiration date.
Allegedly there was no problem with the initial testing – of 4 lots sent in early November. However on Dec 7th, they discovered that the samples failed – how was not specified. They then notified the CDC (all the H1N1 vaccines are going through the CDC unlike the seasonal vaccine that goes from manufacturer to dispenser) to have them retested and it was determined they were 12% not potent enough.
For a man made vaccine they sure screwed it all up.
They don’t know how much of the vaccine still exists so here is the pertinent recall info.
- Sanofi Pasteur if they come from the following lots:
- The vaccine was manufactured in Sanofi Pasteur’s Swiftwater, Pennsylvania, factory.
- • 0.25 mL pre-filled syringes, 10-packs (NDC . 49281-650-25, sometimes coded as 49281-0650-25): UT023DA, UT028DA, UT028CB.
- • 0.25 mL pre-filled syringes, 25-packs (NDC . 49281-650-70, sometimes coded as 49281-0650-70): UT030CA.