Johnson & Johnson Starts Late-Stage COVID-19 Vaccine Trial
Johnson & Johnson announced on Wednesday that it has begun its phase three trial testing for its potential COVID-19 vaccine.
The drugmaker is the fourth company backed by the Trump administration's COVID-19 vaccine program Operation Warp Speed.
Other drugmaking companies that are included are Moderna, Pfizer, and AstraZeneca.
More than 60,000 adult participants across the 215 areas in the country will be involved in the late-stage trials, according to the National Institute of Allergy and Infectious Diseases.
Participants will be randomly chosen to receive a dose of a potential vaccine or a placebo, which will determine whether the vaccine is safe and effective.
Institute director and country's top infectious disease expert, Dr. Anthony Fauci said that four COVID-19 vaccine candidates are in phase 3 trials.
Fauci said that this is an unprecedented feat for the scientific community, which made possible by decades of progress in vaccine technology.
He added that this included a coordinated, strategic approach across government, industry and academia.
"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," Fauci said.
Johnson & Johnson, which is a parent company of Janssen, has said that it is using the same technologies it used to develop its experimental Ebola vaccine.
It includes combing genetic material from the coronavirus with a modified adenovirus, which is known to cause common colds in humans.
Preclinical studies showed that J&J's potential Covid-19 vaccine can produce a promising response in nonhuman primates and hamsters.
Paul Stoffels, J&J's chief scientific officer, said that the early-stage data shows the immune response in humans and was "comparable to animals," which were protected.
The early-stage trial data will be released instantly.
In addition, Stoffels said that the COVID-19 vaccine showed to be well-tolerated, with symptoms such as fever that subsides within 48 hours.
The late-stage trial will include those with and without other illness associated with an increased risk for progression of severe COVID-19.
Stoffels added thata they will aim to enroll participants in Argentina, Brazil, Chile, Colombia, Mexico, Peru, South Africa and the United States.
He said that there are a lot of what they call "readiness cohorts," where they have predetermined in high risk areas the particular populations they want to target.
Stoffels noted that the data team have been working hard to find out where in the United States they can get access to the people and parts of the population at high risk and diverse.
U.S. President Trump said on Monday that Pfizer, Moderna, and AstraZeneca are progressing well.
Trump said that J&J's potential COVID-19 vaccine will probably be a little later.
The U.S. Department of Health and Human Services said earlier that it reached a deal with Janssen worth around $1 billion for 100 million doses of its vaccine.
The deal also allows the federal government to order additional 200 million doses.
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