Delayed-start analysis: Mild Alzheimer's disease patients in solanezumab trials, 3.5 years. Alzheimer's & Dementia: Translational Research & Clinical Interventions. In press. 2015.
Efficacy of an adjuvanted herpes zoster subunit vaccine in older adults. N Engl J Med. 2015 May 28;372(22):2087-96.
It was a nice treat to have one of the study authors from the Zoster vaccine trial, Dr. Jan McElhaney, join us live via the Ontario Telemedicine Network and Twitter (@vitality_md) for commentary.
We continue to grow and now have close to 550 followers!
Missed the discussion? You can get the transcript of the #GeriMedJC tweet chat here.
Thanks again to all those who participated in the Tweet chat:
SHINGRIX vaccine is unsafe and its approval must be revoked
ReplyDeletehttps://www.zenodo.org/record/1038302
The FDA Briefing Document (Sep 13 2017) for the FDA VRBPAC meeting below details supraventricular tachycardia and tachyarrhythmia as serious adverse events (SAE) in SHINGRIX vaccinated subjects, detected during vaccine clinical studies.
https://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/BloodVaccinesandOtherBiologics/VaccinesandRelatedBiologicalProductsAdvisoryCommittee/UCM575190.pdf
The vaccine package insert (Revised: 10/2017) below, OMITS any reference to supraventricular tachycardia or tachyarrhythmia.
https://www.fda.gov/downloads/BiologicsBloodVaccines/Vaccines/ApprovedProducts/UCM581605.pdf
So doctors administering SHINGRIX are being kept in the dark about this SAE. Doctors will therefore fail to report these adverse events to the Vaccine Adverse Event Reporting System (VAERS).
So not only have the FDA and GSK FAILED to properly evaluate the safety of this vaccine as detailed below, they are also hiding the safety problems they already found.