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Johnson & Johnson’s COVID-19 Vaccine Enters Phase 3 US Trials

Phase 3 trial testing began for Johnson & Johnson’s coronavirus vaccine on Wednesday. If all goes planned, the company will provide the potential first vaccine for the disease available in the United States.

The Trump administration is backing J&J along with three other pharmaceutical companies as a part of their COVID-19 vaccine program entitled Operation Warp Speed. Previously, 8Moderna, AstraZeneca, and Pfizer entered into late stage testing with presidential backing.

According to the National Institute of Allergy and Infectious Diseases, 60,000 volunteers will be enrolled in the trial at up to almost 215 clinical research sites in the United States and internationally.  By random selection, some participants will be given the vaccine and others will receive a placebo. This will allow researchers to determine whether the vaccine is effective and safe.

“Four COVID-19 vaccine candidates are in Phase 3 clinical testing in the United States just over eight months after SARS-CoV-2 was identified,” Institute director Dr. Anthony Fauci stated.

“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 continued. “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.”

Janssen is a subcompany under J&J and is using the same technology previously used in an Ebola vaccine. The vaccine is being developed by combining a modified adenovirus that is known to cause the common cold with genetic material from the coronavirus. 

J&J’s potential COVID-19 vaccine has shown promise in preclinical trials with both hamsters and non-human primates.

J&J’s chief scientific officer, Paul Stoffels, held a conference call with reporters on Tuesday where he shared some of the early-stage trial data. He told reporters that the trial-data would be released “imminently” and that it shows a human immune response that is “comparable to animals which were protected.” He continued sharing that minor symptoms like fever seemed to resolve after 48 hours.

What to Expect

While J&J plans to recruit 60,000 diverse participants, it is expected to take somewhere between six weeks and two months. Participants will be enrolled in the United States, Peru, Colombia, Brazil, Argentina, Chile, Mexico, and South Africa. Participants include those both with and without underlying conditions associated with an increased risk for progression to severe COVID-19.

President Donald Trump has stated that there may be a safe vaccine available by October with all Americans receiving the vaccine by April. 

When directly asked by Fox News which drugmaker would be the first to win U.S. approval on Monday, the President stated that Moderna, AstraZeneca, and Pfizer were in the lead with Johnson & Johnson close behind.

Disease experts and public health officials do not think that a vaccine will be the sole solution to eliminating COVID-19.  They believe an array of both drugs and vaccines will be needed to completely eradicate the virus.

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