A report has been submitted to France's Directorate General of Health that raises a number of concerns about adverse effects after the vaccination for gastroenteritis, which is given to newborns.
It comes after the national drugs agency MSNA reported that two babies had died following the vaccination back in 2012 and 2014, revealed on Tuesday by French newspaper La Canard Enchaîné.
According to the report the babies died of an “intussusception” – a serious intestinal condition that sees one portion of the bowel slide into another.
It added that the vaccines Rotarix and RotaTeq, used to prevent infections in babies, have caused a number of worrying side effects, including the two deaths.
The two vaccinations, which are given orally, have been administered to babies since May 2006 and January 2007 respectively.
Since then 508 confirmed reports of adverse effects have been made, including 201 that were logged as “serious”.
The authors of the report from the Technical Committee of “Pharmacovigilance” have questioned whether all babies need to receive the vaccination.
Health authorities are expected to review the findings of the report in the coming days.