More than 100 children in Romania have been sickened by a tuberculosis vaccine made in Denmark, the European Centre for Disease Prevention and Control said in a report on its website today.
The children had symptoms including swollen lymph nodes and abscesses, and 50 of the 115 children have been hospitalized since March, the Stockholm-based ECDC said, citing Romanian media reports. Romanian Health Minister Raed Arafat said in a televised address yesterday that TB vaccinations would stop until the cause of the side effects is determined.
The vaccine was made by Statens Serum Institut, a Copenhagen-based unit of Denmark’s health ministry, Nils Strandberg Pedersen, the institute’s chief executive officer, said by phone today. Lymph node swelling is a “completely normal” side effect of the bacille Calmette-Guerin vaccine that the institute has made for more than 50 years, Pedersen said.
“Whether the number is above the threshold that is normally seen, I cannot say,” Pedersen said, adding that the institute had received “only a few reports of side effects” so far. “Abscesses are more rare, but also seen as a consequence of the vaccine.”
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