Upgrade: As of June 10, 2010, the Spanish Agency for Medicines and Health Products (AEMPS) has recommended as a precaution not to start vaccination against rotavirus gastroenteritis with 'Rotateq'.
We informed you a few weeks ago about the preventive withdrawal of the Rotarix rotavirus vaccine, and now we have to give an account of how this question has ended on which research has continued. The use of oral rotavirus vaccines is no longer restricted..
The vaccination portal of the Spanish Association of Pediatrics indicates that the European Medicines Agency (EMA), in a press release that refers to the topics covered by the Committee for Medicinal Products for Human Use (CHMP) indicates that
there is no evidence that the unexpected presence of porcine circovirus (PCV) in batches of rotavirus vaccines, Rotarix® and RotaTeq®, represents a risk to human health.
Recommends, therefore, do not restrict the use of any of the two oral vaccines available against rotavirus.
We recall that the Rotarix brand was "retained" in Spain and other countries because DNA residues of a virus called porcine circovirus 1 (PCV-1) were found in the vaccine, and suspicions also fell on another of the vaccines against rotavirus, Rotateq.
Although WHO already pointed out that no change in the administration of the Rotarix vaccine was necessary, as was the EMA, but the AEP followed the FDA line, which did recommend the suspension of the Rotarix vaccine in the United States.
The Committee for Medicinal Products for Human Use expects more information from manufacturers about the cause of the DNA residue findings and the measures being taken to correct them. So we will be aware of the new data available to account for the new recommendations, if any.
At the moment, what is confirmed is that both Rotarix and Rotateq can now be used without restrictions, although the shadow of suspicion does not disappear so easily in these health issues that affect our children and that raises ineffable doubts.
