Japan Requires New Disclosures on Dangers of HPV Vaccine
Are acute disseminated encephalomyelitis (ADEM) and Guillain-Barre Syndrome (GBS) adverse reactions to HPV vaccines? Health authorities in Japan are not sure at this point, but they have chosen to apply the precautionary principle and inform medical consumers just in case. The reason for this action? During the first three years of using HPV vaccines, 3 cases of ADEM and five cases of Guillain-Barre Syndrome had been reported after Cervarix injections for which a causality to the drug could not be ruled out. As a point of reference, there have been 31 cases of ADEM and 121 reports of Guillain-Barré Syndrome filed with the United States VAERS (vaccine adverse event reporting system) after HPV vaccinations during the last seven years. The FDA has made no request that these conditions be added to the package inserts. What is wrong with this picture?