J&J’s One-Dose COVID-19 Vaccine Candidate Begins Phase III Trial

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In the U.S., most of the attention to the COVID-19 vaccine race has been on Moderna, Pfizer and BioNTech, and AstraZeneca and the University of Oxford, which are leading the way. There are a number of other major biopharma companies also working to advance their vaccine candidates, and today, Johnson & Johnson announced a major milestone. It is launching its large-scale, international Phase III trial for its vaccine candidate, JNJ-78436735.

The vaccine was developed by J&J’s Janssen Pharmaceutical Companies using its AdVac technology platform, which was also used to develop Janssen’s Ebola vaccine that was approved in Europe and to develop its Zika, RSV, and HIV vaccine candidates.

If approved, the vaccine would have a few advantages over some of the other vaccines in development. First, the J&J vaccine is believed to remain stable for two years at -20 degrees C and at least three months at 2-8 degrees C. Some of the other candidate vaccines require storage at -80 degrees C, with others -60 degrees C. This creates significant logistical problems in terms of distribution.

A second advantage, and a likely important one, is the J&J vaccine appears to require only a single dose. Several of the other candidate vaccines require two doses about 28 days apart.
In a statement about the J&J announcement, Anthony Fauci, director of the U.S. National Institute of Allergy and Infectious Diseases (NIAID), said, “Four COVID-19 vaccine candidates are in Phase III clinical testing in the United States just over eight months after SARS-CoV-2 was identified. This is an unprecedented feat for the scientific community made possible by decades of progress in vaccine technology and a coordinated, strategic approach across government, industry and academia.”

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