By now, readers know this writer is a staunch advocate for proper informed consent following the informed consent process. Previously, the injectable vaccine AUDENZ for H5N1 manufactured by Seqirus was reviewed to inform the public about the product. While it was a long read, the package insert for AUDENZ proved there were not enough participants to represent the population, placebo-controlled trials were only conducted in one study, and the one-year follow-up was not long enough to uncover potential serious adverse events relating to development of autoimmune diseases. Understandably, reading package inserts is not particularly “attention-grabbing” and can be quite boring and tedious. However, it is the only way you will receive all the information you need to give proper informed consent, which includes denying taking a product. Because of the volume of data to be covered in the AREPANRIS package insert, it will be covered in two parts.
In this article, the approval letter and package insert for AREPANRIX will be reviewed. The only approval letter for AREPANRIX on the Food and Drug Administration (FDA) website is dated October 18, 2024. This letter references another letter dated April 19, 2024, which requested a supplement to their license regarding packaging to include the proprietary name of AREPANRIX. There should be another letter indicating the initial FDA approval for this vaccine. Without the initial approval letter, there is no additional information to be gleaned besides the package insert.
AREPANRIX, manufactured by GlaxoSmithKline (GSK), is approved for active immunization for the prevention of disease caused by the Influenza A virus H5N1 subtype contained the vaccine for individuals 6 months and older. AREPANRIX comes in two vials that must be mixed before administration: one contains the H5N1 antigen and the other contains the AS03 adjuvant. The AS03 adjuvant will be explained in Part II. For individuals ages 6 months through 17 years, two doses of 0.25 ml are injected intramuscularly 21 days apart. For individuals ages 18 years and older, two doses of 0.5 ml are injected intramuscularly 21 days apart. (Sections 1 through 2.2)
Hellbound and Down 