Rotavirus vaccines in France : because of three infant death and too many serious side effects vaccines are no longer recommended for routine children immunization
Since the vaccination againts rotavirus is recommended by WHO in all the world and since it was already introduced in the vaccination schedule of many countries, I think safety information must be shared.
In France two vaccines Rotarix ® from GSK and Rotateq® commercialized by Merck-Sanofi joint venture are recommended for routine use in children since 2013 but were not reimbursed by public insurance.
The French Technical Committee for Pharmacovigilance met and issued a first report on December 9, 2014 on rotavirus vaccines safety monitoring and transmitted it to the National Agency of Drug Safety (ANSM). Despite alerting observations of the committee about the vaccine safety the agency didn’t throw alert until march, the 30, just a few hours before the information was published in a satirical newspaper. The committee expressed concern about the worrying rate of serious side effects notifications with the two vaccines and questioned about the appropriateness of recommendations. It pointed specially to two deaths following vaccination due to very severe forms of intussusceptions. It also took into account a third death following rotavirus vaccination due to necrotizing enterocolitis in an infant treated by Varitect® (a human varicella-zoster immunoglobulin) . A final report by the pharmacovigilance comettee was issued in February . It was estimated that 491000 infants had been vaccinated since 2006. In total, there were 508 side effects notifications (103,8/ 100 000) of which 201 serious side effects ( 39,57%, 40,9/100 000). 75% of the total side efffects were digestive . There were 47 intussusceptions too and among them 14 (29,80%) required chirurgical treatment. Most of them occurred after the first dose and the median age for post-vaccinal intussusceptions was 3 months. 21 of the 35 cases of intussusceptions with the vaccine Rotarix occurred during the first 7 days following vaccination and 6 of 12 for Rotateq. Two of the infants with intussusceptions died, one was vaccinated by Rotarix and the other by Rotateq. The infant death caused by Rotarix occurred in 2012 but GSK, in charge of the enhanced pharmacovigilance plan for Rotarix as it was allowed by the 2010/84/UE directive , declared it to public pharmacovigilance only in December 2014.
The conclusion of the pharmacovigilance committee was that the rate of side effects were worrying when compared to other pediatric vaccines. It noted also that the intussusceptions were more severe, probably, in part, because they occurred in younger infants.
The number of spontaneous intussusceptions by year for infants younger than one year was estimated to be about 200-250 in France , or 0,25 to 0,3 per 1000. During the five previous years only one death of intussusception was registered in French hospitals.
The vaccines were commercialized in France since 2006 and 2007 and the coverage was estimated from 5 to 9% depending on the years considered, since the parents had to pay the vaccine themselves. In 2013 and 2014 public health authorities and the two pharmaceutical companies negotiated the price of the vaccines in view of their introduction in the vaccination infant schedule and their reimbursement by public health insurance.
Following these events, health authorities refused to recommend and reimburse rotavirus vaccines.
It is noteworthy that clinical trials have never demonstrated a reduction in all cause mortality with these vaccines, neither in high nor in low income countries .
Merck and GSK rotavirus vaccines were prequalified by WHO and are going to be introduces by GAVI in low income countries .
 Réunion du Comité technique de Pharmacovigilance – CT012015023
Séance du mardi 10 février 2015 de 09h30 à 17h00 en salles 1 & 2
Competing interests: No competing interests