The Janssen Vaccine Containing HPBCD May be Approved by the FDA

The Janssen COVID-19 vaccine is produced by using a specific type of virus called adenovirus type 26 (Ad26) which can cause a temporary spike in a person's body when they receive it.

The Janssen COVID-19 vaccine is offered in a suspension in a multi-dose vial, preservative-free. In addition to virus particles encoding the AD26 vector for SARS-CoV-2 S glycoprotein, each 0.5 mL dose of Janssen Covid-19 vaccine contains the following non-active ingredients: 2.19 mg sodium chloride, 0.14 mg citrate monohydrate, 2.02 mg citrate trisodium dihydrate, 0.16 mg polysorbate 80, 25.5 mg Hydroxypropyl Betadex, and 2.04 mg ethanol.The administration protocol is a single dose of 0.5mL.

The data supporting the effectiveness of the EUA included a comparative analysis of 39,321 participants. Among these participants, one-half received the vaccine, and the remaining half received a placebo with saline. In general, the vaccine is still effective 14 days after vaccination, and the effective rate is 66% after 28 days.

Injection Grade Hydroxypropyl Betadex produced by Zhiyuan Biotech has obtained DMF No.030168 at FDA, will also be expected to play a role in this antiviral campaign.