By working with the PHLS, the third party in the collaboration, Wyeth ensured not only that its studies had the most positive spin possible, but also that the product would be given a blessing to be test marketed on a mass basis through this new surveillance system. As Hall says, no one would know the effectiveness of the vaccine until it was mass marketed. In effect, the government is carrying out the best post market testing that Wyeth could ever have dreamt of.
Illness from the jab
The vaccine is highly safe, says the DoH, or "harmless", as Heikki Peltola put it. That is an assertion that no one can make about any vaccine, let along a brand new one that is neither tried nor tested. Although the meningitis C vaccine was tested on 6000 British children, and more than 21,000 people outside the UK, these were short term tests, lasting at most a few weeks, and many of the trials remain unpublished that is, unavailable to anyone outside of Wyeth or the government.
In the largest of the three published trials shown to WDDTY, all conducted partly or entirely by the Public Health Laboratory Service among 114 infants vaccinated at two, three or four months, side effects were only recorded for seven days by parents and a health nurse (J Infect Dis, 1999; 179: 1569-72). Any symptoms outside this window of time probably would not have been associated with the vaccine. Nevertheless, within the small cohort of babies, 26 of those receiving the lower dose and 53 of those receiving the higher dose had systemic symptoms within the first 24 hours from one of three shots.
Although "systemic symptoms" were not defined, they presumably mean that the children were generally ill after the jab. According to this report, more than one fifth of the jabs 79 out of a total of 344 jabs made babies in the vaccine groups ill. Seven of the low dose group and eight of the high dose group more than 13 per cent developed a fever higher than 38 degrees centigrade. Five of the babies had persistent crying for more than one hour in the first day after the vaccine. Nine babies had erythema (reddening of the skin) of more than 2.5 cm and eight had swelling of more than 2.5 cm.
These latter side effects which consisted of mainly swelling at the injection site were noted to be less than those caused by the Hib vaccine, leading to the often quoted remark that this vaccine produces fewer reactions than other ones.
In its data sheet, Wyeth reports that systemic reactions usually include crying, irritability, drowsiness, impaired sleeping, anorexia, diarrhoea and vomiting, all conditions that are "common" after vaccination. Nevertheless, the company points out, "there was no evidence that these were related to Meningitec, rather than concomitant vaccines, particularly DTP vaccines" as most of these have been given at the same time.
Those reactions the company admits "may possibly be related to the vaccine" include headache and myalgia in adults and irritability and drowsiness in younger children.
One baby was hospitalised for a viral illness following the second vaccination, although the PHLS maintains that this illness was not attributable to the vaccine. One baby given the old A and C polysaccharide jab developed a generalized rash, "mild" facial swelling, cough and coryzal (acute rhinitis) symptoms within five hours after vaccination, although these symptoms resolved within two days after oral antihistamines were given. This baby had no evidence of antibodies to A or C meningococcus in other words, the vaccine didn't work on him. The researchers again concluded that these adverse events, despite happening within hours of the jab, were "not vaccine related".