Nuclear Oncology

Batch immobilized papillomavirus vaccine
The Ministry of Health has ordered the temporary suspension of administration of a batch of Gardasil, a vaccine against human papilloma virus, which causes cervical cancer, after Valencia detected in the two possible cases of adverse effects two girls from Valencia, one of those affected have been transferred to the plant and the other remains in the ICU, where it is stable within the seriousness.

After a conference call convened by the Ministry of Health with all the Autonomous Communities, which reported the incident, was taken to temporarily suspend the administration of the lot NH52670 related to these reactions. Health services are evaluated from the last 6 the relationship between vaccination and adverse effects presented.

The research process has been developed with full coordination and collaboration between the departments of Public Health and the Ministry of Valencia, according to this related batch departamento.Del have 75,582 doses distributed in Spain. Of these, 21,300 have been acquired by public administrations to manage in the context of their immunization programs, 21,272 of them in the Valencia region, 20 in Madrid and eight in Extremadura. The rest was distributed through retail pharmacies to all women who are not included in the vaccination schedules, ie, in excess of 14 years.

As reported by the Public Health Directorate Extremadura, eight doses acquired by public administrations in the region have failed to divide and are immobilized. In addition, the inspection services are analyzing the pharmacy if a dose of the lot are retired. Overall, Spain has already distributed 1,146,458 doses of vaccine this brand, Gardasil, but until now has been referred to any red flag about the safety of this vaccine.

The laboratory Sanofi Pasteur MSD, the vaccine manufacturer, has ensured that the adverse effects detected in these two girls “are not causal but casual” and could have been caused by other factors yet to be determined, according to Europa Press said a spokesman for the company.

For its part, the Autonomous Communities will continue the process of vaccination against human papilloma virus normally, using different doses of the other lots involved in the two cases, as specified by the Ministry of Health.
Similarly, public health services will strengthen the epidemiological surveillance system in order to quickly detect any other related situation.

The Agency for Medicines and Health Products is analyzing these events to clarify the possible relationship that may exist between these cases and the vaccine.
The Agency is in contact with the network of European agencies and the European Medicines Agency, to keep them promptly informed of the progress of his analysis. This vaccine is licensed in all European Union countries.
Similarly, the Ministry, in coordination with the company producing the vaccine-related, has ordered the detention in pharmacy channel of all possible doses distributed in the lot as they complete the investigations referred to health authorities.