News media have been suggesting a large Norwegian study shows flu shots reduce foetal death and do so without harm to the foetus but a close look at the study throws doubt on this assessment. First of all, the flu shot studied was not one of the seasonal influenza vaccines that are reformulated and produced annually, but 2009-2010 H1N1 ‘pandemic’ vaccine. Furthermore, the main analysis of the study focused on data about women who’d received Pandemrix H1N1 vaccine which contains the powerful adjuvant, AS03.
But even beyond that, we question the reliability of the authors’ conclusion that, “The risk of fetal death was reduced with vaccination during pregnancy, although this reduction was not [statistically] significant.” Similarly, we question their conclusion that, “Pandemic influenza virus infection in pregnancy was associated with an increased risk of fetal death.” Why? In the full text of the study, we are told: “Exposure to influenza was defined as a contact with a primary care physician that led to a diagnosis of influenza (code R80 in the International Classification of Primary Care; criteria are listed in the Supplementary Appendix).” The appendix tells us that these criteria for influenza ‘clinical diagnosis’ did not necessarily require lab confirmation and even if lab tests were used, code R80 specifies the unreliable viral culture or serology tests. Note that, including influenza virus, more than 200 viruses as well as other pathogens and non-infectious agents can cause influenza-like illness. Also note that, comparing the results of their study to those of two others, one in Canada and the other in Denmark, the authors state: “Unlike these earlier studies, our study showed an increased risk of fetal death after maternal infection with influenza virus, especially among women with a clinical diagnosis of influenza”. Given the lenient parameters for clinical diagnosis of influenza, is it fair to ask if the diagnoses might have been influenced by clinicians’ strongly held belief that Pandemrix was beneficial, ie if a vaccinated mothers’ foetus died, the diagnosis tended to be something other than influenza? With this and the unreliable lab tests in mind, how can we be sure that all the diagnoses of influenza in unvaccinated pregnant women and all the diagnoses of influenza in women whose foetuses died were correct?
A third conclusion of the Norwegian study was that, “Vaccination itself was not associated with increased fetal mortality”. (Note that, according to an analysis by the National Coalition of Organized Women which was followed up by a study in Human & Experimental Toxicology, in the USA, “Vaccine-related fetal demise reports from VAERS increased 2,440% – from 7 cases in 2007/8 to the 178 in 2009/10.” But those effects aren’t comparable to the conclusion of the Norwegian study because Norway administered only pandemic vaccine to pregnant women, not both seasonal and pandemic vaccine as was done in USA and, unlike Norway, USA used pandemic vaccine without AS03 adjuvant.) However, even if Pandemrix didn’t cause foetal death, we expect its AS03 adjuvant might make it riskier than seasonal influenza vaccines without oil-based adjuvant. On the other hand, AS03 would also make Pandemrix more likely to be effective than the seasonal vaccines. Recalling that the authors of the Norwegian study could only conclude that Pandemrix “may have” reduced foetal death, it seems highly unlikely that less-effective seasonal influenza vaccines could reduce them.
Regardless of all the aforementioned problems, the media used the study to once again ramp up the fear factor and promote general and generous use of flu shots for pregnant women. For instance, although a GlobalPost article about the Norwegian study is largely factual about its stated results, if anyone reads only the title – ‘Flu vaccine not linked to fetal death: study’ – and the first paragraph of the article, they’ll likely think the study refers to seasonal influenza vaccine. This is especially so since the flu shot being used in January 2013 when the article was published was the seasonal type. The title of a MedPageToday article does include the word, “Pandemic”, but an ‘Action Points’ sidebar omits it, stating: “This large observational study from Norway suggests no adverse risk to the fetus from maternal flu vaccinations during the 2nd or 3rd trimester.” A comment by John Treanor MD of the University of Rochester Medical Center included in the article also gives the impression that the results of the Norwegian study could be extrapolated to influenza vaccines in general. However, in an accompanying video, Treanor suggests the results may not be relevant to a country such as USA which has a less homogeneous population than that of Norway. Another ‘expert’ completely ignored the discrepancies between pandemic vaccine used for pregnant women in Norway and any type of flu shot injected into anyone in USA. The Vancouver Sun article which relays her message ends with, “…this study should ease any worries about the flu shot, said Dr. Denise Jamieson of the Centers for Disease Control and Prevention. ‘The vaccine is safe,’ she said.”
Saying “The vaccine is safe.” is light years away from saying that the Pandemrix vaccine given to Norwegian pregnant women during the pandemic of 2009 “was not associated with increased fetal mortality! Referring to a 2011 study in Neurology, Dr Sherri Tenpenny states: “Neurological complications that have been described after influenza vaccination, include Guillain-Barre syndrome, chronic inflammatory demyelinating polyneuropathy (CIDP), acute disseminated encephalomyelitis, acute transverse myelitis, optic neuritis, cerebellar ataxia, giant cell arteritis, dermatomyositis, hypoglossal palsy, peripheral facial palsy, vasculitic ulnar mononeuropathy and oculomotor mononeuropathy.” She also refers to a 2012 study in Allergy Asthma Proc which found “an overall trend toward higher rates of hospitalization in subjects who got the flu shot, especially children with asthma.”
Concerning the Norwegian study’s conclusion that Pandemrix didn’t appear to harm a foetus (despite its powerful adjuvant and other dubious ingredients), that’s not to say that it didn’t foster conditions which could promote future illness. And, of course, there’s always the possibility that strongly held beliefs about beneficience of vaccination (in this case beliefs of the mother) could affect vaccination outcomes. But how long could such a ‘placebo effect’ endure after repeated artificial stimulation of a child’s immune system by recommended infant/childhood vaccines?
To be sure, influenza and other infections should be avoided in pregnant women. But rather than exposing themselves and their future children to risky chemical and other ingredients, wouldn’t it be better for them to forego flu shots and, instead, maintain strong immunity naturally?
