Obstetricians and primary care physicians throughout the world will no-doubt be lauding the result of a recent publication, “Neonatal outcomes after influenza immunization during pregnancy: a randomized controlled trial,” which can be downloaded free at the time of this publication HERE, and the abstract can be viewed HERE. This study will be cited by doctors, advisory panels, and pharmaceutical drug reps. as they work to increase vaccination rates and sales using pregnant mothers as receptacles.
Expectant mothers will be told that getting a flu shot while they are pregnant is not only safe, but will protect from one of the possible consequences of influenza while pregnant – low birth weight.
How many doctors will ever read the abstract, let alone the full text? In the hectic environment of medical practice, they will take someone else’s word for it, and reassure unsuspecting mothers that the vaccine is the way to go.
There are several serious problems with this study, the least of which is that it was funded by the Bill and Melinda Gates foundation and several pharmaceutical companies. Bill did, after all declare this the “decade of vaccination,” after delivering a check in the amount of 10 Billion dollars to make it happen. Much of his donation is hitting India and Africa in order to purchase oral polio vaccines and vaccine delivery trucks to reach remote villages. Now, influenza vaccines for pregnant mothers is on the way into the pipeline. Rumor has it that he is a candidate for a NOBEL PRIZE, for providing millions of infants and children with live oral polio vaccines. Well, it seems the fetus is now on his radar and this new article displays the misinformation typical of the rally to inject pregnant mothers with untested vaccines. This article references the main study, which was also funded by his foundation.
Before too many doctors take the infotainment in this study at face value, let’s review some of the issues in design and interpretation.
Problem number one: This study is headlined as a “randomized controlled trial.” Most unsuspecting doctors, upon seeing the title will think that this study met bench-mark gold-standard design criteria for validity. After all, we’ve been told that the best way to test an intervention is through this type of study.
By definition, a randomized controlled trial is: A study design that randomly assigns participants into an experimental group or a control group. As the study is conducted, the only expected difference between the control and experimental groups in a randomized controlled trial (RCT) is the outcome variable being studied. The variables being studied should be the only variables between the experimental group and the control group.
The problem with calling this study ‘controlled’ has to do with what is used as the control. Hold onto your hats folks, because you are going to love this…the control injection for the other half of this study population was a 23-valent pneumococcal vaccine given to mothers in their third trimester. This is the period of gestation when heart valves, thyroid, adrenal glands, muscles, lungs, brain, eyes and nervous systems are maturing, and testicles are descending. By now most of us are not shocked, because this is part-and-parcel with the smoke-and-mirrors pseudo-science of vaccinology, and the integrity of those involved.
The other question is, is there a ‘variable’ between the two groups? If both groups are being vaccinated, how can the difference be assessed, in terms of safety, adverse outcomes, and protection from infection? They are comparing granny smith to golden delicious, where in a controlled study, the idea is to compare apples to no-apples.
So to summarize, there were 340 pregnant women in the study, done by – get this…”the Mother’s Gift project.” Half of the mothers in their third trimester received an inactivated influenza vaccine and the other half received a 23-valent pneumococcal polysaccharide vaccine as the “control.” Hopefully, by now you are starting to get annoyed. If not, keep reading. Then…after delivery, the infants were injected with either a Hib vaccine or a 23-valent pneumococcal vaccine, in addition to the usual childhood vaccination schedule at 6, 10, and 14 weeks.
Problem number two: The study was, for some reason done in Bangladesh, and it was a secondary analysis of data generated from the ORIGINAL STUDY to evaluate the immunogenicity of pneumococcal vaccination on pregnant mothers and infants.
At baseline, almost a quarter of babies (24%) in Bangladesh are born with LOW BIRTH WEIGHT. In contrast, in the USA approximately 8.2% of pregnancies result in low birth weight. In the developing world, low birth weight stems from deficiencies in maternal health and nutrition, and only rarely – from influenza infections. There is no Bangladesh-specific reference for gestational age, so… the authors note, “we used a North American standard.” Most thoughtful people would consider that Bangladeshi infants are overall smaller than American, European, Canadian etc. infants, and that a standard used on them ought to be their own, not a North American standard. Granted, as of 2011, Bangladesh has a very high INFANT MORTALITY RATE, ranked at number 47, compared to 167 in the USA. Bangladesh is the eighth most populous country in the world and, after only a few microstates and small island nations, has the highest population density. In such a densely populated country, it should be easy to enroll enough mothers to have a true control group, don’t you think? It seems to me that there are far more benevolent and effective means to help the Bangladeshis, especially given that we know nothing of the longer-term effects on the child for these vaccines – and that nobody is planning to look.
Are you thinking what I’m thinking…? “Why don’t Bill and Melinda spill billions of dollars into improving living conditions and implementing programs that would assure sustainable nutrition, clean water, and sanitation in the third world, rather than vaccinating anything with two legs?” So now, what do you think of generalizing these results to the rest of the world?
There are some other noteworthy issues in this study. Namely, it states that there were NO differences in the numbers of stillbirths between the groups. But clearly listed in Figure 1, there were 3 stillbirths in the influenza-vaccinated group and none in the pneumococcal-vaccinated group. That’s three stillbirths out of 172 or 1.7 percent. In addition, there were eight infants excluded from data evaluation in the influenza group and one in the pneumococcal group. As always, I must wonder why these infants were excluded and what the data would look like with that 4.6% of infants included.
Apparently, the marvelous effect of the influenza vaccine was not profound enough just looking at the pneumococcal vs. influenza vaccines, so they further divided the groups by influenza season vs. non-season, thus shrinking the final comparison group down to 58 infants. In the analysis of the groups during influenza season, the results showed a mean birth weight of 3178 g in the influenza vaccine group, which was a whopping 7% higher than 2978 g in the control (pneumococcal vaccinated) group. But here’s the kicker; low birth weight in USA is considered less than 2500 g, so the mean in this sham-study group (influenza) didn’t even meet the criteria for low birth weight. But rest assured, this vaccine will be offered, probably along with the 23-valent pneumococcal vaccine, and vigorously pushed upon pregnant mothers all over the world – with the promise of having a nice big healthy baby. But what of the toddler, or the teenager? Today, the WHO is trying to solve problems regarding MYSTERIOUS DISEASES in children aged 5-15, and they don’t seem to be coming up with any answers. How many of these children do you think have had their immune systems compromised by previous vaccinations? And will the WHO even consider that vaccines could be a contributing factor?
The package insert for influenza vaccine, as it reads now, says:
* Safety and effectiveness have not been established in pregnant women or nursing mothers.
* In a clinical study of children <3 years of age, antibody titers were lower after FLUARIX than after an active comparator.
*There are, however, no adequate and well-controlled studies in pregnant women.
*Because animal reproduction studies are not always predictive of human response, FLUARIX should be given to a pregnant woman only if clearly needed.
*In a reproductive and developmental toxicity study, the effect of
safety and efficacy have not been established in pregnant women.
…AND will stay just as it is. Who reads it anyway, besides a parent after a vaccine has destroyed their child’s life…hopefully in time to protect the next child?
The authors conclude:
“The pneumococcal vaccine that was used as a control may have had an independent positive effect on the outcomes among infants. If that were the case, the observed difference between the two vaccine groups would be an underestimate of the true effect of influenza vaccine compared with placebo.”
But that’s an assumption. My question would be, “Did the influenza vaccine increase that baby’s weight or did the pneumococcal vaccine decrease the ‘placebo’ baby’s weight?” If the pneumococcal vaccine had negative effects, then that would minimize the observed effects seen in the influenza-vaccinated group. We’ll never know, unless someone funds a true placebo study, preferably on rats, not pregnant Bangladeshi mothers and their infants.