Spain supends batch of Gardasil
This article was originally published in Scrip
Spain's health ministry has suspended the use of a batch of Sanofi Pasteur MSD's human papillomavirus vaccine Gardasil, it announced this week. The move comes after the Valencian health authority reported two possible cases of adverse reactions on Friday.
Two girls suffered convulsions after receiving a second dose of the vaccine through the region's vaccination programme; both doses came from batch number NH52670. The national medicines agency, AEMPS, and Sanofi Pasteur MSDare investigating the events and the possible causes. "Only the suspicious batch is under investigation and there is no reason for concern over other lots," the health ministry told Scrip. The investigation should be concluded within the next few days, it said.
75,582 doses of the batch have been distributed throughout Spain. Regional health authorities bought 21,300 of the doses for their vaccination programmes while the rest were bought by pharmacies, says Valencia's health authority.
Around 1.5 million doses of the vaccine have been distributed throughout Spain and until now there have been no reports of any adverse reactions, says the ministry. The autonomous regions are continuing with vaccinations using Gardasil while AEMPS is keeping other European medicines agencies up to date with any developments.
Sanofi-Pasteur emphasises that the batch in question has not been withdrawn and that it passed through rigorous quality controls. "In both cases the girls received the vaccine together with other girls without observing any adverse events, and in both cases other medical conditions have been observed and are being investigated," says the company. It also points out that there has been no "evidence for concern" over the vaccine since its launch in 2006.
Valencia's health authority has set up a telephone line to respond to concerns from the public about the human papillomavirus vaccine.