FDA Issues Emergency Use Authorization for Third COVID-19 Vaccine

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As we reported on CDN blog FDA approval for Janssen vaccine containing HPBCD was expected in late February.

The Janssen COVID-19 Vaccine is manufactured using a specific type of virus called adenovirus type 26 (Ad26). The vaccine uses Ad26 to deliver a piece of the DNA, or genetic material, that is used to make the distinctive “spike” protein of the SARS-CoV-2 virus. While adenoviruses are a group of viruses that are relatively common, Ad26, which can cause cold symptoms and pink eye, has been modified for the vaccine so that it cannot replicate in the human body to cause illness. After a person receives this vaccine, the body can temporarily make the spike protein, which does not cause disease, but triggers the immune system to learn to react defensively, producing an immune response against SARS-CoV-2.
Product Description:
The Janssen COVID-19 Vaccine is supplied as a suspension in multi-dose vials. The Janssen COVID-19 Vaccine does not contain a preservative. Each 0.5 mL dose of the Janssen COVID-19 Vaccine is formulated to contain 5×1010 virus particles of the Ad26 vector encoding the S glycoprotein of SARS-CoV-2. Each dose of the Janssen COVID-19 Vaccine also includes the following inactive ingredients 2.19 mg sodium chloride, 0.14 mg citric acid monohydrate, 2.02 mg trisodium citrate dihydrate, 0.16 mg polysorbate-80, 25.5 mg 2-hydroxypropyl-beta-cyclodextrin, 2.04 mg ethanol. Each dose may also contain residual amounts of host cell proteins (≤0.15 mcg) and/or host cell DNA (≤3 ng). The dosing regimen is a single dose of 0.5 mL.

The effectiveness data to support the EUA include an analysis of 39,321 participants in the ongoing randomized, placebo-controlled study being conducted in South Africa, certain countries in South America, Mexico, and the U.S. who did not have evidence of SARS-CoV-2 infection prior to receiving the vaccine. Among these participants, 19,630 received the vaccine and 19,691 received saline placebo. Overall, the vaccine was approximately 67% effective in preventing moderate to severe/critical COVID-19 occurring at least 14 days after vaccination and 66% effective in preventing moderate to severe/critical COVID-19 occurring at least 28 days after vaccination. 

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