by Christina England
September 14, 2009
This week the FDA approved Cervarix for the USA. So now the USA will be lucky enough to have two HPV vaccines to choose from. Both Cervarix and Gardasil will be competing head to head in a ‘war of the vaccines’. The Food and Drug Administrators were seen to vote overwhelmingly in favour of Cervarix being safe and effective in women and children 10 – 25 years.
“Panelists say newer studies suggest the vaccine is safe but they recommend follow- up studies to monitor miscarriages and inflammatory- muscular problems reported by a small number of patients.” Daily News – FDA approves second cervical cancer vaccine, Cervarix for preventing HPV in women The Associated Press. 10th September 2009.
This will have been recommended because of what is written in the CERVARIX Human Papillomavirus Bivalent (Types 16 and 18) Vaccine, Recombinant Vaccines and Related Biological Products Advisory Committee (VRBPAC) Briefing Document September 9, 2009 which I was lucky enough to receive a link to a copy through one of my colleagues from ICAP-International Coalition of Advocates for the People, from the Netherlands.
Once again it seems that women and children are just ‘lab rats’ for GSK to test on. It says in section 6
Given the natural history of HPV disease, reduction in cervical cancer due to vaccination will take years and even decades. GSK has developed a model using a standardized approach (details of methodology are currently undergoing independent review by the Centres for Disease Control and Prevention [CDC]) in order to estimate how Cervarix may impact future cervical cancer incidence and related deaths in US girls and women.”
Further down in original studies it is interesting to note :- (SAE = Serious Adverse Event)
“Of the 43 subjects who withdrew due to SAEs, study discontinuation resulted from a fatal event in 28 subjects (11 subjects in HPV group and 17 subjects in pooled controls; one subject in HAV720 group withdrew because of the death of her child due to congenital heart disease). See Section 7.3.5 for further details of all fatal events reported all clinical studies in which Cervarix has been administered. The other 15 subjects withdrew due to non-fatal SAEs, none of which were considered as causally related to vaccination by the study investigator”
“The most commonly individual SAEs reported during the vaccination period were:
Spontaneous pregnancy loss (including incomplete and complete spontaneous loss and missed abortion) with 59 subjects (1.87 per 1000 subjects) in HPV group and 51 subjects (2.15 per 1000 subjects) in the control group,
Appendicitis with 25 subjects (0.79 per 1000 subjects) in the HPV group and 27 subjects (1.14 per 1000 subjects) in the control group,
Dengue fever with 10 subjects (0.32 per 1000 subjects) in the HPV group and 10 (0.42 per 1000 subjects) in the control group,”
I found the most worryingly results were deaths although these were played down.
In the analysis of all clinical studies in which Cervarix has been administered (up to the data lock-point of August 31, 2008), 37 subjects were reported with a fatal outcome:20 subjects of 31,472 subjects (0.64 per 1000 subjects) in the HPV group and 17 subjects of 23,700 subjects (0.72 per 1000 subjects) in the control group. The median interval between the date of last vaccination and the date of death was 1.5 years (range 30 days to 3.3 years). Of note, the mean duration of follow-up was 2.2 years in HPV group and 2.5 years in the control group.
A summary of the number of deaths by group classified by its underlying cause is presented in Table 34. All the fatalities in vaccinated subjects occurred more than 1 month after the last study vaccine administration, with a median interval between the date of last vaccination and the date of death of 1.5 years (range 30 days to 3.3 years). Road traffic accidents (10 cases) and suicides (7 cases) were the most common underlying causes of death.
In the group that received Cervarix, the following case fatalities were reported:
Road traffic accidents (5 cases): with intervals ranging from 124 to 386 days from last vaccination to death,
Homicide (2 cases): with intervals of 217 days and 826 days from last vaccination to death,
Suicide (2 cases, one case reported as gun shot wound possibly related to suicide)with 148 and 686 days from last vaccination to death,
Neoplasms: gestational trophoblastic neoplasia (onset 151 days after last dose),ovarian cancer (onset 1,127 days after last dose) and cervical cancer (46 year old in Study HPV-015 with normal cytology at enrollment but HPV-18 DNA positive,developed metastatic cervical cancer 205 days after last dose; study population of HPV-015 mainly consists of healthy women but includes also a subset of women with previous history of HPV infection),
Autoimmune diseases (3 cases): systemic lupus rythematosus (SLE) with Candida sepsis (SLE pre-existing with renal complications 6 months after first dose leading to sepsis and eventually death 21 months after the first and only dose), inflammatory bowel disease (IBD) with pyoderma gangrenosum (IBD diagnosed 2 months after third dose with multiple complications and eventually a pyoderma gangrenosum with a fatal outcome 22 months after last dose) and Crohn´s disease with toxic megacolon and septic shock (Crohn´s disease diagnosed 16 months after second dose,complicated with toxic megacolon and septic shock with fatal outcome 17 months after the second and last dose),
Infectious diseases (3 cases): septicemia (onset 758 days after last dose), bacterial septicemia (onset 770 days after last dose) and acquired immune deficiency syndrome(onset 254 days after last dose),
Cardiovascular disorders (2 cases): vascular thromboembolism (onset 1167 days after last dose) and acute myocardial infarction (onset 485 days after last dose).