Infarmed suspended vaccines RotaTeq and Prevnar 13 for suspected adverse reaction
Translation (by Google):
The National Authority of Medicines and Health Products (Infarmed) determined, as a precautionary measure, the immediate suspension of the use of vaccines RotaTeq and Prevnar 13 for suspected serious adverse reactions in children.
According to an information circular Infarmed was suspended Lot no. º 1590AA/0671579 with valid until May 31, 2013, the oral solution RotaTeq against rotavirus, a major cause of gastroenteritis in children and Lot no. No. F73745 (917,690), valid until May 31, 2014, the injectable vaccine Prevnar 13 for the prevention of pneumonia.
"Since these medications are dispensed in pharmacies and administered by health care professionals, entities that have lots of these drugs should not dispense or administer, until completion of the assessment resulting from this situation," the note concludes that authority.
According to today's edition of the Journal News, Infarmed this decision is related to the death, on Monday, a baby of six months in a nursery in Camarate, Loures, which had been recently vaccinated.
According to the Director-General of Health, Francis George, quoted the same day, the child's body was autopsied on Tuesday in the delegation of the Southern Institute of Forensic Medicine, whose experts are "trying to understand what happened" and "will clarify the causes of death, "ensuring that this is the only recorded case of this nature.