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J&J Speeds Up Covid Vaccine Plans in Sprint Against Second Wave
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June 12, 2020
https://www.bloomberg.com/news/articles/2020-06-12/j-j-speeds-up-covid-vaccine-plans-in-sprint-against-second-wave
• Drugmaker aims for final-stage test of shot in September
• J&J plans two more manufacturing deals to ramp up capacity
Johnson & Johnson is accelerating trials of its Covid-19 vaccine in what its chief scientific officer calls "a race against time" -- and against a potential second wave of the virus.
"Will it come back in the summer? We don't know. Will it come back next year? We don't know," Paul Stoffels said in an interview. "If we prepare for the minimum, it's not going to be good enough."
To head off that possibility, the U.S. pharmaceutical giant this week advanced the timetable for its proposed vaccine, saying it will start human trials in the second half of July, about two months earlier than expected. Final-stage tests could begin in September.
J&J's vaccine is one of more than 130 in development against the novel coronavirus, according to the World Health Organization. Others from the likes of Moderna Inc. are also set for final-stage human trials over the summer, as researchers race to secure protection against the virus and enable shops and schools to reopen safely.
J&J was able to move up its schedule based on the strength of preclinical results, success in manufacturing early batches and encouragement from regulatory authorities, Stoffels said.
Two Regimens
By mid-July, J&J will study both a single-shot dose, as well as a regimen that includes a second booster shot, in 1,034 healthy adults to determine which to use in large-scale testing, Stoffels said. The study, which will evaluate safety and participants' immune response, will take place in the U.S. and Belgium.
J&J is planning with the National Institute of Allergy and Infectious Diseases for a final-stage trial in mid-September, ahead of its original schedule, if the early studies go well. This phase 3 trial will aim to prove the vaccine can prevent at least 70% of Covid-19 cases, which Stoffels described as a "common, accepted target" within the industry.
J&J has previously said its vaccine could be ready for emergency use in health workers by January, and it has a $1 billion-plus agreement with the U.S. government's biomedical research unit to develop it.
The final-stage trials could include as many as 100,000 people as the company steps up efforts to "end the epidemic," Stoffels said.
Pandemic Trends
The number will depend on the infection rate in the general population at the time the test is conducted. If it's relatively high, as few as 30,000 patients might be needed. If levels are low, more participants would be required to prove the vaccine works.
J&J data crunchers are studying disease trends around the world to anticipate which locations are likely to have high enough infection rates to make a costly vaccine trial practical.
"A lot of work is going on now to predict where we need to be in mid-September and later in the year," Stoffels said. In addition to the U.S., J&J is monitoring infection data across South America, Asia, and Africa.
J&J isn't currently considering so-called challenge studies, in which volunteers treated with experimental shots are deliberately infected with virus to compress the typical trial process, Stoffels said.
Manufacturing Scale
Pharmaceutical companies, academic institutes and governments racing to develop a safe and effective vaccine are simultaneously building out manufacturing infrastructure before a proven shot is identified.
J&J has said it plans to produce 1 billion doses by the end of 2021 should its vaccine candidate prove successful. "With our current capacity, we're almost there," said Stoffels, "but we want to go further."
In April, J&J reached two deals to secure additional manufacturing capacity at facilities in Baltimore and Bloomington, Indiana. Now it's seeking to clinch two more collaborations, Stoffels said.
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