L’Express, Agence France Presse and other media in France report that two oral vaccines now recommended for newborns — Rotarix and RotaTeq — may be pulled from the country’s list of recommended vaccines following two deaths and more than 500 adverse events, 200 of them termed “serious.” These vaccines are thought to be causing intussusception, a serious condition in which the bowel folds on itself, causing a blockage and sometimes death.
The media coverage follows a report from France’s Technical Committee of Pharmacovigilance to France’s Directorate General of Health that “questioned the appropriateness of recommending widespread vaccination in France.”
In light of the dangers, France’s agency for drug safety, MSNA, this week has advised 160,000 health practitioners to warn parents of infants who had received these vaccines to be alert to signs of distress in their babies, which typically occur within 30 days of vaccination.
The two vaccines are administered to prevent against rotavirus, a common virus that ordinarily infects nearly all children by their fifth birthday. Children infected with rotavirus can develop a fever, vomiting and diarrhea.
Rotarix, manufactured by GSK, and RotaTeq, manufactured by Merck, were approved for the French market in 2006 and 2007. These vaccines, which are also licensed in Canada and the U.S., became the subject of controversy in the US in 2010 when they were found to be contaminated, leading to their temporary suspension by the Food and Drug Administration. RotaTeq has also attracted controversy because it was patented by scientist Paul Offit, an outspoken advocate for mandatory vaccinations. An earlier rotavirus vaccine, Wyeth’s RotaShield, was withdrawn from the market in 1999, nine months after it became available in the US, following more than 100 cases of intussusception and one death.