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.

J&J’s Phase III ENSEMBLE trial will evaluate the safety and efficacy of a single dose compared to placebo in up to 60,000 adults ages 18 years and older, with “significant representation from those that are over age 60.” It expects to enroll volunteers in Argentina, Brazil, Chile, Colombia, Mexico, Peru, South Africa and the U.S. It also expects to include people with and without comorbidities linked to increased risk for progression to severe disease. In the U.S., it will include significant representation of Black, Hispanic/Latinx, American Indian and Alaskan Native volunteers.

“As COVID-19 continues to impact the daily lives of people around the world, our goal remains the same—leveraging the global reach and scientific innovation of our company to help bring an end to this pandemic,” said Alex Gorsky, chairman and chief executive officer of J&J. “As the world’s largest healthcare company, we are bringing to bear our best scientific minds, and rigorous standards of safety, in collaboration with regulators, to accelerate the fight against this pandemic. This pivotal milestone demonstrates our focused efforts toward a COVID-19 vaccine that are built on collaboration and deep commitment to a robust scientific process. We are committed to clinical trial transparency and to sharing information related to our study, including details of our study protocol.”

Because the pandemic has become increasingly politicized, and President Trump continues to insist a vaccine will be available before the November 3, 2020 presidential election despite statements by numerous experts and the companies themselves that this is unlikely, companies involved in vaccine development have pledged to adhere to the strictest scientific procedures. Many have also posted their trial protocols in order to provide more transparency. The J&J study protocol can be found here.

Reportedly, the U.S. Food and Drug Administration (FDA) is considering implementing a more stringent new standard for emergency use authorization (EUA) of a COVID-19 vaccine to assuage these concerns. This would also make it almost impossible for any vaccine to be cleared before the election. In that the highly politicized process has led to deep skepticism over the safety of the vaccine, some polls have suggested that as much as half of the U.S. population will refuse to get the vaccine.

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.”

He went on to say, “It is likely that multiple COVID-19 vaccine regimens will be required to meet the global need. The Janssen candidate has showed promise in early-stage testing and may be especially useful in controlling the pandemic if shown to be protective after a single dose.”

J&J believes it will take six to eight weeks to enroll and dose 60,000 participants.

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