Circovirus and impact of temporary withdrawal of rotavirus vaccines in Spain.

The Spanish Medicines and Health Products Agency (AEMPS) did not authorize the release of new batches of rotavirus vaccines onto the Spanish market since March 29 (Rotarix®) and June 10 (Rotateq®), 2010, respectively, due to problems of good manufacturing practice (GMP). On November 4, 2010, AEMPS again allowed the release of batches of the RotaTeq® vaccine. Until March 2010, the average vaccination coverage against rotavirus in Spain had reached 40%. We have tried to estimate the impact of the temporary withdrawal of these vaccines from the Spanish market in terms of disease burden and associated costs. During the five months in which neither of the rotavirus vaccines was distributed in Spanish pharmacies, 84,450 children were not vaccinated against rotavirus and remain at risk, leading to a total avoidable cost between 1,901,498 and 2,172,941 euros. The impact of the temporary withdrawal of rotavirus vaccines in Spain may have been outstanding. The influence of this event in rotavirus vaccination trust may have been even more important.