Johnson & Johnson is now the fourth company to begin late-stage human trials in the U.S. with its COVID-19 vaccine candidate. The company is enrolling up to 60,000 volunteers from around the world to be a part of the trial, but unlike the other top vaccine candidates, this vaccine will be administered in just one dose, a potential game-changer when and if the vaccine is rolled out to the public.
"What's very special here is that it works as a single dose," said Johnson & Johnson's chief scientific officer, Dr. Paul Stoffels. "So we have studied up front in the lab and in animal models and then in volunteers and we have been able to show that with a single dose we get a very good response as well as a good safety profile."
Stoffels noted that the ability to produce a one-dose vaccine will be the culmination of a decade of work developing similar vaccines for other outbreaks, like Ebola and Zika. The potency of the vaccine is extremely important, he said.
"The pandemic goes around and when you want to have influence on the progress of the pandemic, you have to be able to stop it as fast as possible," said Stoffels. "Therefore, a single dose with a fast activity will help limit the pandemic and the transmission faster."
He noted the single dose may also offer study results much faster than a study with a two-dose vaccine. "We can start counting the results after 15 days, so the vaccine protects within 15 days."
"Sixty thousand [participants] to make sure we have a good, robust evaluation of the safety and the efficacy in all parts of society," he said.
That study population will come from over 215 locations around the world and include people of all ages as well as people that are considered high-risk.
"We do it around the world — in the U.S., in Latin America, and in South Africa — so that there is a very good representation from the global population in the study," said Stoffels.
When asked about a potential timeline, he said the company needs four to five months to look through the trial data, which would put researchers on pace for the end of 2020 or early 2021. If trials are successful, he expects the vaccine will be available to high-risk populations in the first quarter of next year.
As drugmakers around the country face questions over the accelerated timeline of vaccine creation, Johnson & Johnson is taking the unusual step of releasing the blueprints of its trials in hopes of raising confidence in its vaccine candidate. Dr. Stoffels said that Johnson & Johnson will release a manuscript with data from earlier phase trials in the next few days.
"A lot of people are nervous about the vaccine and we want to be as open as possible about what we do," said Stoffels, who notes that researchers will be able to review their process to see "how consistently and deeply we have prepared this study in order to evaluate it."
"I think to get confidence we need to be very transparent on everything that's happening within and around this study so that people can learn from it."
A big-screen adaptation of the anime “Chainsaw Man” has topped the North American box office, beating a Springsteen biopic and “Black Phone 2.” The movie earned $17.25 million in the U.S. and Canada this weekend. “Black Phone 2” fell to second place with $13 million. Two new releases, the rom-com “Regretting You” and “Springsteen — Deliver Me From Nowhere,” earned $12.85 million and $9.1 million, respectively. “Chainsaw Man – The Movie: Reze Arc” is based on the manga series about a demon hunter. It's another win for Sony-owned Crunchyroll, which also released a “Demon Slayer” film last month that debuted to a record $70 million.
The Federal Aviation Administration says flights departing for Los Angeles International Airport were halted briefly due to a staffing shortage at a Southern California air traffic facility. The FAA issued a temporary ground stop at one of the world’s busiest airports on Sunday morning soon after U.S. Transportation Secretary Sean Duffy predicted that travelers would see more flights delayed as the nation’s air traffic controllers work without pay during the federal government shutdown. The hold on planes taking off for LAX lasted an hour and 45 minutes and didn't appear to cause continued problems. The FAA said staffing shortages also delayed planes headed to Washington, Chicago and Newark, New Jersey on Sunday.
Boeing workers at three Midwest plants where military aircraft and weapons are developed have voted to reject the company’s latest contract offer and to continue a strike that started almost three months ago. The strike by about 3,200 machinists at the plants in the Missouri cities of St. Louis and St. Charles, and in Mascoutah, Illinois, is smaller in scale than a walkout last year by 33,000 Boeing workers who assemble commercial jetliners. The president of the International Association of Machinists says Sunday's outcome shows Boeing hasn't adequately addressed wages and retirement benefits. Boeing says Sunday's vote was close with 51% of union members opposing the revised offer.
The stunning indictment that led to the arrest of more than 30 people — including Miami Heat guard Terry Rozier and other NBA figures — has drawn new scrutiny of the booming business of sports betting in the U.S. The multibillion-dollar industry has made it easy for sports fans — and even some players — to wager on everything from the outcome of games to that of a single play with just a few taps of a cellphone. But regulating the rapidly-growing industry has proven to be a challenge. Professional sports leagues’ own role in promoting gambling has also raised eyebrows.
Tesla, the car company run by Elon Musk, reported Wednesday that it sold more vehicles in the past three months after boycotts hit hard earlier this year, but profits still fell sharply. Third-quarter earnings fell to $1.4 billion, from $2.2 billion a year earlier. Excluding charges, per share profit of 50 cents came in below analysts' estimate. Tesla shares fell 3.5% in after-hours trading. Musk said the company's robotaxi service, which is available in Austin, Texas, and San Francisco, will roll out to as many as 10 other metro areas by the end of the year.
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