Unless you have a true contraindication to getting vaccinated, until a disease is eradicated, the benefits of a vaccine will typically be far greater than its risks.
The switch from the live, oral polio vaccine to the inactivated vaccine is a good example of when this wasn’t the case though. Since OPV could rarely cause vaccine-associated paralytic polio (VAPP), once polio was well controlled in the United States, the risk of this side effect became greater than the benefit of continuing to use the vaccine, but only because we had an alternative polio vaccine that didn’t cause VAPP.
Similarly, the original rotavirus vaccine was withdrawn because the extra risk of intussusception, even though it was small, was thought to be greater than the benefits of the vaccine.
In the great majority of cases though, to think that getting vaccinated is a bigger risk than getting a vaccine preventable disease, you have to buy into the anti-vaccine hype:
The rotavirus vaccines are typically given when infants are two to six months old.
The first dose can be given as early as 6 weeks or as late as 15 weeks though.
And the final dose can be given as late 8 months (32 weeks).
Why Can’t My 9-Month-Old Get the Rotavirus Vaccine?
What happens if your child didn’t get their rotavirus vaccine on time?
While these vaccines are usually given on either a two and four month (Rotarix) or two, four, and six month (RotaTeq) schedule, as you can see above, there is some flexibility in that timing.
Still, the first dose of the rotavirus vaccine can’t be given any later than 15 weeks and the final dose can’t be given any later than 8 months though, so there is no way that a nine-month-old would be able to get vaccinated.
What would happen if your child did?
“Vaccination should not be initiated for infants aged 15 weeks and 0 days or older because of insufficient data on safety of dose 1 of rotavirus vaccine in older infants. The minimum interval between doses of rotavirus vaccine is 4 weeks; no maximum interval is set. All doses should be administered by age 8 months and 0 days.”
Prevention of Rotavirus Gastroenteritis Among Infants and Children Recommendations of the Advisory Committee on Immunization Practices
The rotavirus vaccines are only licensed at these specific ages, so were not studied in older infants and toddlers. If your 9-month-old did receive a rotavirus vaccine, it would be considered a vaccination error and should be reported.
So why not study them in older kids?
Since severe rotavirus infections mostly occur in younger children between the ages of 4 and 23 months, it doesn’t make any sense to wait until they are older to get them vaccinated.
“To minimize potential risk of intussusception, the World Health Organization (WHO) recommends that rotavirus immunization should be initiated by age 15 weeks and completed before age 32 weeks.”
Age restrictions for rotavirus vaccination: evidence-based analysis of rotavirus mortality reduction versus risk of fatal intussusception by mortality stratum
Also, although the risk is low, a small risk of intussusception after getting the rotavirus vaccine is thought to increase with increasing age of the first dose.
So did France take the rotavirus vaccine off of their schedule?
Technically, France hadn’t yet added the rotavirus vaccine to their schedule, but it had been available since 2006 and they did formally recommend infants get vaccinated beginning in November 2013.
That recommendation was suspended in April 2015, after they recorded 47 cases of intussusception over an 8 year period. This included 14 cases that required surgery and tragically, two deaths, including one child who died at home without getting any medical care. The other developed intussusception after the third dose of vaccine, which is not usually linked to any increased risk.
It is important to note that at least 80 other countries, including the United States, Finland, Germany, Norway, and the UK, haven’t stopped using the rotavirus vaccine.
In France alone, for example, it is estimated that rotavirus vaccines could prevent 30,000 emergency room visits, 14,000 hospitalizations, and 8 to 17 deaths each year, all in children under the age of three years.
And even without the rotavirus vaccine, there are about 200 to 250 spontaneous intussusceptions each year in France. Fortunately, infants with intussusception can almost always be successfully treated, often without surgery.
Why Did France Take the Rotavirus Vaccine off Their Schedule?
It actually makes no sense that France stopped recommending that infants get vaccinated with one of the rotavirus vaccines.
The decision was widely condemned and there are calls to reassess the decision and put the rotavirus vaccine back on the schedule in France.
“After the surprising decision of the CTV-HCSP of April 2015 to suspend its own recommendation for widespread vaccination against Rotavirus (following a false and misleading pharmacovigilance report) against the international recommendations, we advise you to read the meta-analysis on efficacy (in comparative studies) and the effectiveness (field efficacy) of these vaccines.”
The benefits of the rotavirus vaccines far outweigh its risks.
“The estimated benefits of vaccination in our study greatly exceed the estimated risks and our results should contribute to provide further evidence for discussions around rotavirus vaccination in France.”
Larmrani et al A benefit–risk analysis of rotavirus vaccination, France, 2015
Why did France take the rotavirus vaccines off their schedule?
That’s a good question.
Another good question? How many infants have died of rotavirus infections since they did? And when will they put the vaccine back on the schedule? Fortunately, the rotavirus vaccines are still available in France, they weren’t banned as some folks say.
In 1998, France suspended the routine vaccination of teens against hepatitis B because of the possible association of the vaccine with multiple sclerosis. This was done amid “pressure from anti-vaccine groups and reports in the French media have raised concerns about a link between HBV immunisation and new cases or relapses of MS and other demyelinating diseases,” even though “scientific data available do not support a causal association between HBV immunisation and central nervous system diseases, including MS.”
“In 1998, official concerns were first voiced over a possible association between hepatitis B virus (HBV) vaccination and multiple sclerosis (MS). Despite a number of studies that have demonstrated no such association, ten years on the French population’s confidence in the vaccine remains shaken and immunization rates of infants have stagnated beneath 30%. With a chronic carriage of the virus estimated at 0.68%, it seems unlikely that France will be able to control the circulation of the virus. ”
Marta Balinska on Hepatitis B vaccination and French Society ten years after the suspension of the vaccination campaign: how should we raise infant immunization coverage rates?
Do you know where all of this has left France now?
With high rates of vaccine-preventable disease (15,000 cases of measles in 2011, with 16 cases of encephalitis and 6 deaths) and a move towards vaccine mandates. As of January 2018, all infants and toddlers in France must receive DTaP, Hib, HepB, pneumococcal, MMR, and meningococcal C vaccines.
What to Know About France Taking the Rotavirus Vaccine off Their Schedule
In no longer recommending the rotavirus vaccines, officials in France actually put infants at greater risk for sickness and death.
More on France Taking the Rotavirus Vaccine off Their Schedule
It is mostly because they think that anything bad that happens after someone is vaccinated, even if it is weeks or months later, must have been caused by the vaccine.
“Differentiation between coincidence and causality is of utmost importance in this respect. This is not always easy, especially when an event is rare and background rates are not available.”
Heininger on A risk-benefit analysis of vaccination
Of course, this discounts that fact that most people have a basic risk, often called the background rate, for developing most of these very same conditions, and they can just coincide with getting vaccinated.
Put more simply, the “reaction” would have happened whether or not they had been vaccinated.
“…when a number of well-controlled studies were conducted during the 1980s, the investigators found, nearly unanimously, that the number of SIDS deaths temporally associated with DTP vaccination was within the range expected to occur by chance. In other words, the SIDS deaths would have occurred even if no vaccinations had been given.”
WHO on Six Common Misconceptions About Immunization
That doesn’t mean that everything automatically gets blamed on coincidence though.
Is It a Vaccine Reaction?
When trying to determine if a child has had a vaccine reaction, experts typically go through a series of questions, looking at the evidence for and against :
How soon after the vaccine was given did the reaction occur? Was it minutes, hours, days, weeks, months, or years later?
Is there any evidence that something else could have caused the reaction?
Is there a known causal relation between the reaction and the vaccine?
Is there evidence that the vaccine does not have a causal association with the reaction?
Do any lab tests support the idea that it was a vaccine reaction?
Why is it important to consider these and other questions?
Because most of us are very good at jumping to conclusions, are quick to place blame, and like to know the reasons for why things happen.
We don’t like to think that things are just caused by coincidence.
Post hoc ergo propter hoc (after this, therefore, because of this).
We are especially good at linking events and often automatically assume that one thing caused another simply because it occurred afterwards.
It is incident to physicians, I am afraid, beyond all other men, to mistake subsequence for consequence.
Dr Samuel Johnson
But we also know that correlation does not imply causation. And because of the great benefits of vaccines, it is important to find strong evidence for a correlation before we blame vaccines for a reaction.
Too often though, the opposite happens. Despite strong evidence against a correlation, parents and some pediatricians still blame vaccines for many things, from SIDS and encephalitis to autism.
Background Rates vs Vaccine Reactions
Although anti-vaccine folks are always calling for vaccinated vs unvaccinated studies to further prove that vaccines are indeed safe, much of that work is already done by looking at the observed rate of possible reactions and comparing them to the background rate of reactions and conditions.
We often know how many people are expected to develop certain conditions, from seizures and type 1 diabetes mellitus to acute transverse myelitis and juvenile and rheumatoid arthritis.
“On the basis of the reviewed data, if a cohort of 10 million individuals was vaccinated in the UK, 21.5 cases of Guillain-Barré syndrome and 5.75 cases of sudden death would be expected to occur within 6 weeks of vaccination as coincident background cases. In female vaccinees in the USA, 86.3 cases of optic neuritis per 10 million population would be expected within 6 weeks of vaccination. 397 per 1 million vaccinated pregnant women would be predicted to have a spontaneous abortion within 1 day of vaccination.”
Black et al on Importance of background rates of disease in assessment of vaccine safety during mass immunisation with pandemic H1N1 influenza vaccines
Intussusception is a good example of this.
This might surprise some folks, but we diagnosed and treated kids with intussusception well before the first rotavirus vaccines were ever introduced. And then, it was only after the risk of intussusception after vaccination exceeded the background rate that experts were able to determine that there was an issue.
“Knowledge of the background incidence rates of possible adverse events is a crucial part of assessing possible vaccine safety concerns. It allows for a rapid observed vs expected analysis and helps to distinguish legitimate safety concerns from events that are temporally associated with but not necessarily caused by vaccination.”
Gadroen et al on Baseline incidence of intussusception in early childhood before rotavirus vaccine introduction, the Netherlands, January 2008 to December 2012
Fortunately, studies have never found an increased risk above the background rate for SIDS, non-febrile seizures, and other things that anti-vaccine folks often blame on vaccines. So when these things happen on the same day or one or two days after getting vaccinated, it almost certainly truly is a coincidence. It would have happened even if your child had not been vaccinated, just like we see these things happen in the days before a child was due to get their vaccines.
For example, using background incidence rates in Danish children, one study found that if you vaccinated a million children with a new flu vaccine, you could expect that naturally, after seven days, you would see:
facial nerve palsy – one case
seizures – 36 cases
multiple sclerosis – one case
type 1 diabetes – three cases
juvenile and rheumatoid arthritis – three cases
After six weeks, those numbers of course go up. In addition to 4 kids developing MS, 20 develop diabetes, 19 develop arthritis, and 218 have seizures, and there would have been at least two deaths of unknown cause.
Would you blame the flu shot for these things?
What flu shot?
This was a “hypothetical vaccine cohort” that used 30 years of data from the Danish healthcare system to figure out background rates of each condition.
“In addition, the expected number of deaths in Japan following an estimated 15 million doses of H1N1 vaccine administered would be >8000 deaths during the 20 days following vaccination, based on the crude mortality rate.”
McCarthy et al on Mortality Rates and Cause-of-Death Patterns in a Vaccinated Population
Looking at background rates is especially helpful when folks report about vaccine deaths.
Using the Japan example that McCarthy studied, if they had looked at background rates, then all of a sudden, the 107 deaths they found after 15 million doses of H1N1 vaccine were given in 2009 would not have been so alarming. Background rates would have predicted a much, much higher number of deaths to naturally occur in that time period simply based on crude mortality rates.
Vaccines are safe and many of the things that folks think are vaccine reactions can be explained by looking at the background rates for these conditions and understanding that they would have happened anyway.