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.
There are some true medical contraindications and precautions to getting vaccinated though. Still, it is important to remember that even more things are simply “conditions incorrectly perceived as contraindications to vaccination.”
Contraindications To Vaccinating Your Kids
There are actually some good reasons to delay or skip one or a few of your child’s vaccines, but only in some very specific situations.
These very specific situations are called contraindications and are what count as medical exemptions.
“A vaccine should not be administered when a contraindication is present; for example, MMR vaccine should not be administered to severely immunocompromised persons.”
CDC on Vaccine Contraindications and Precautions
Fortunately, there are not that many of these contraindications, they are usually specific to just one or a few vaccines, and they are usually, but not always, temporary.
That’s why it would be really unusual to get a true permanent medical exemption for all vaccines. Even if you had a severe allergy to a vaccine that contained yeast, latex, or gelatin, since vaccines contain different ingredients, you would very likely be able to safely get the others.
Remember, your doctor can’t, or at least shouldn’t, just make up contraindications and exemptions to help you avoid getting your kids vaccinated and help you keep them in school.
“I do not believe vaccines had anything to do with my child’s autism. I never noticed any change in his speech, behavior or development with vaccines. I believe the protection and benefits of vaccines far outweigh the risks!”
Michele Han, MD, FAAP
Autism, for example, has been shown to not be associated with vaccines, so it is not a contraindication to getting vaccinated. That’s why many parents vaccinate and protect their autistic kids!
Precautions To Vaccinating Your Kids
In addition to contraindications to getting vaccinated, there is an accompanying list of precautions.
“A precaution is a condition in a recipient that might increase the risk for a serious adverse reaction, might cause diagnostic confusion, or might compromise the ability of the vaccine to produce immunity (e.g., administering measles vaccine to a person with passive immunity to measles from a blood transfusion administered up to 7 months prior). A person might experience a more severe reaction to the vaccine than would have otherwise been expected; however, the risk for this happening is less than the risk expected with a contraindication. In general, vaccinations should be deferred when a precaution is present. However, a vaccination might be indicated in the presence of a precaution if the benefit of protection from the vaccine outweighs the risk for an adverse reaction.”
CDC on Vaccine Contraindications and Precautions
Again, we are fortunate that most of the conditions that are listed as precautions are temporary.
In fact, the most common is having a “moderate or severe acute illness with or without fever.”
Don’t want to get your child vaccinated when he or she has a severe illness?
Your pediatrician usually doesn’t want to vaccinate your child in that situation either.
It is easy enough to wait a few days or a week to get vaccinated, when the illness has passed, keeping in mind that a “mild acute illness with or without fever” is neither a precaution nor a contraindication to getting vaccinated. So you can still get your child their recommended vaccines if they just have a cold, stomach bug, or ear infection, etc.
What to Know About Precautions and Contraindications to Vaccines
Although there are some true medical exemptions or contraindications and precautions to getting vaccinated, most are vaccine specific and many are temporary, so they shouldn’t keep you from getting your child at least mostly vaccinated and protected.
More on Precautions and Contraindications to Vaccines
Many people first heard the term intussusception after it became associated with Rotashield, the first rotavirus vaccine, back in 1999.
What is Intussusception?
Intussusception is a type of intestinal blockage that occurs when one part of a child’s intestine in pulled into or slides into another.
This leads to younger children, typically between the ages of 3 months and 3 years, developing colicky abdominal pain (severe pain that comes and goes) and loose stools that are filled with blood and mucous.
Fortunately, if caught early, it can be both diagnosed and treated with an air contrast enema.
Do Rotavirus Vaccines Cause Intussusception?
Intussusception in children is not a new condition. In fact, Samuel Mitchel reported treating children with intussusception as early as 1838!
So what causes intussusception?
Surprisingly, in most cases, we just don’t know why kids get intussusception.
We do know that it occurs in about 1 in 100,000 US infants, with about 2,000 cases being diagnosed and treated each year.
“There is also a small risk of intussusception from rotavirus vaccination, usually within a week after the first or second dose. This additional risk is estimated to range from about 1 in 20,000 to 1 in 100,000 US infants who get rotavirus vaccine.”
CDC on Questions & Answers about Intussusception and Rotavirus Vaccine
And we know that getting a rotavirus vaccine adds a small extra risk for intussusception.
And it is not just the original Rotashield vaccine, which was withdrawn, but the rotavirus vaccines that we now use that have also been linked to intussusception. The difference is that the risk is much less with the newer rotavirus vaccines.
“Given the magnitude of declines in rotavirus disease compared with this small increase in intussusception, the benefits of rotavirus vaccination outweigh the increase risk of intussusception.”
Tate et al on Intussusception Rates Before and After the Introduction of Rotavirus Vaccine
This small risk must also be viewed against the many benefits of the rotavirus vaccines.
“Rotavirus is the leading cause of severe gastroenteritis among young children worldwide, and was estimated to account for approximately one-third of the estimated 578,000 deaths from childhood gastroenteritis and more than 2 million hospitalizations and 25 million outpatient clinic visits among children <5 years of age each year in the pre-vaccine era.”
Parashar et al on Value of post-licensure data on benefits and risks of vaccination to inform vaccine policy: The example of rotavirus vaccines
It is also still not clear if the rotavirus vaccines actually “trigger” intussusception or if they simply cause it to occur earlier in infants that would have gotten it anyway. That’s because while the latest studies have found excess cases shortly after the first dose of vaccine, studies looking at intussusception trends “have not consistently demonstrated an overall increase in rates post-vaccination.” So there were the same number of total cases, even with the few extra cases right after the kids were vaccinated.
Also, it is thought that wild type rotavirus infections can also trigger intussusception, so the rotavirus vaccines might prevent those cases.
Most importantly though, remember that even if the rotavirus vaccines cause an extra 35 to 100 hospitalizations a year because of intussusception, they are preventing up to 70,000 hospitalizations from severe rotavirus diarrheal disease that occurred in the pre-vaccine era. The vaccines are also preventing about 20-60 deaths from rotavirus disease, while intussusception is rarely life-threatening.
Because of a small risk of intussusception, parents should be aware of the symptoms and signs of intussusception and that they may appear six to eight days after an infant’s first dose of rotavirus vaccine.
Still, although reports to VAERS are underreported, they are almost certainly not underreported by as much as some folks believe.
Have you heard the claim that only 1% of serious vaccine reactions are reported to VAERS?
That’s not true.
That claim is based on an old study about drug reactions and was not specific to vaccines.
We also know that underreporting is less common for more severe adverse reactions than for those that are more mild. For example, one study found that up to 68% of cases of vaccine-associated poliomyelitis (a table injury) were reported to VAERS, while less than 1% of episodes of rash following the MMR vaccine were reported.
That’s not to say that only severe or serious adverse reactions should be reported.
But since VAERS watches “for unexpected or unusual patterns in adverse event reports,” it still works even if each and every side effect isn’t reported.
Reports to VAERS are underreported.
VAERS still works well though.
Again, that’s because VAERS doesn’t need each and every adverse event to be reported for the system to work and to help it identify vaccines that might not be safe.
“Despite its limitations, VAERS effectively detected a possible problem soon after introduction of RRV-TV in the United States.”
Lynn R. Zanardi, et al on Intussusception Among Recipients of Rotavirus Vaccine: Reports to the Vaccine Adverse Event Reporting System
We saw that with the RotaShield vaccine. After nearly 20 years of research, the first rotavirus vaccine was approved by the FDA on August 31, 1998. About seven months later, in March 1999, the ACIP published their formal recommendations that all infants get RotaShield on a three dose schedule, when they are two, four, and six months old.
By June 11, 1999, VAERS had received 12 reports of intussusception related to the RotaShield vaccine and by July 13, its use was temporarily suspended, as the CDC continued to investigate.
Once the CDC announced the temporary suspension, even more reports of intussusception after RotaShield were made to VAERS. Those extra reports likely mean that intussusception was being underreported initially, but it still triggered the temporary suspension and extra studies that eventually got the manufacturer to withdraw the vaccine.
“VAERS is used to detect possible safety problems – called “signals” – that may be related to vaccination. If a vaccine safety signal is identified through VAERS, scientists may conduct further studies to find out if the signal represents an actual risk.”
CDC on How VAERS is Used
Early signals in VAERS also helped detect a very small increase in the risk of febrile seizures among toddlers who got the 2010-11 flu vaccine combined with either Prevnar or a DTaP vaccine.