Why Did France Take the Rotavirus Vaccine off Their Schedule?

Have you heard that France took the rotavirus vaccine off their immunization schedule?

Why?

It was supposedly because two babies died of intussusception after being vaccinated.

Rotavirus Vaccines and Intussusception

Intussusception? Wasn’t that just a risk from RotaShield, the original rotavirus vaccine?

While the risk was higher with RotaShield, the current rotavirus vaccines do have a small risk of intussusception.

france-immunization-schedule
The French immunization schedule is published in the Bulletin épidémiologique hebdomadaire and has never included the rotavirus vaccine.

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.

Why not?

Because the risks of a natural rotavirus infection are much greater than the risk of intussusception. In other words, the benefits of the vaccine exceed its risks.

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.”

InfoVac Bulletin Novembre 11/2016

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?

News of the Newark kids going to Paris to get Pasteur's rabies vaccine made the front page of the New York Times.
In 1885, four boys from New Jersey went all of the way to France to get Pasteur’s new rabies vaccine, which wasn’t yet available in the US.

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.

Of course, this isn’t the first time that France impulsively suspended a vaccine.

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

 

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