Re: UK Vaccine ?
Hum, hum, do not forget that is a GSK paper presented in Europe
Here is what Dr SusanC says about it
it comes from the paper above cited
There was a group of pregnant women who were asked whether they planned on taking the vaccine. None of them put up their hand. One person said she was told by her consultant to definitely take it, but then she heard all these other stories, so she isn't so sure anymore. For anyone who is pregnant and contemplating taking this vaccine, let me draw your attention to the following information taken from the file that GSK submitted for licensure, the section on
reproductive toxicology.
In this study, six groups of 48 female rats were given a single intramuscular dose on Day -30 and paired with males and 44 rats with a positive indication of mating were treated on Days 6, 8, 11 and 15 after mating. 22 were killed at Day 20 and 22 were allowed to deliver and rear their young to Day 25 of age. Measures of reproductive toxicity and maternal health were assessed. The six groups were dosed with:
- saline, 200 ul
- AS03 adjuvant, 200 ul
- saline / split H5N1/AS03, 200 ul
- split H5N1 / AS03, 200 ul
- saline whole H5N1A1, 100 ul
- whole H5N1/A1, 100 ul
There was one unexpected death in a maternal rat: however, this was judged unrelated to the vaccine. Treatment of maternal rats did not adversely affect their clinical condition, bodyweight or food consumption throughout the study. Mating performance, fertility of maternal rats, and length of gestation or ability to give birth to a live litter were unaffected. Embryo-foetal survival, growth and development were not affected by vaccination. In neonates, the reflex development was unimpaired,
but among offspring from dams treated with AS03 13 offspring from 7 litters did not show the air righting reflect before day 21 of age and this effect may be related to treatment. However, AS03 did not affect the attainment of the surface righting reflex or the ability of the offspring to show startle response reflexes or the pupil reflex. No abnormalities were evident on macro pathological examination of the offspring.
This is considered a suitable study to assess the reproductive toxicity of the vaccine.
In other words
- 13 babies from 7 litters whose mothers had been given AS03, showed a delay in a neuro-developmental test.
- GSK admits this may be related to the AS03
- and the only conclusion they can draw in this section (since they can't say the tests showed no concerns about reproductive toxicity) was that this was an appropriate study for reproductive toxicity
Well, if it IS a suitable study to assess toxicity to offsprings of pregnant women, it would follow that the results (ie
developmental delays linked to the use of the adjuvant) are valid for our assessment of risk to pregnant women.
http://www.newfluwiki2.com/diary/39...amme-misleads-the-public-on-swine-flu-vaccine
Snowy