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."
The Rev. Al Sharpton is set to lead a protest march on Wall Street to urge corporate America to resist the Trump administration’s campaign to roll back diversity, equity and inclusion initiatives. The New York civil rights leader will join clergy, labor and community leaders Thursday in a demonstration through Manhattan’s Financial District that’s timed with the anniversary of the Civil Rights-era March on Washington in 1963. Sharpton called DEI the “civil rights fight of our generation." He and other Black leaders have called for boycotting American retailers that scaled backed policies and programs aimed at bolstering diversity and reducing discrimination in their ranks.
President Donald Trump's administration last month awarded a $1.2 billion contract to build and operate what's expected to become the nation’s largest immigration detention complex to a tiny Virginia firm with no experience running correction facilities.
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Cracker Barrel said late Tuesday it’s returning to its old logo after critics — including President Donald Trump — protested the company’s plan to modernize.
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Southwest Airlines will soon require plus-size travelers to pay for an extra seat in advance if they can't fit within the armrests of one seat. This change is part of several updates the airline is making. The new rule starts on Jan. 27, the same day Southwest begins assigning seats. Currently, plus-size passengers can pay for an extra seat in advance and later get a refund, or request a free extra seat at the airport. Under the new policy, refunds are still possible but not guaranteed. Southwest said in a statement it is updating policies to prepare for assigned seating next year.
Cracker Barrel is sticking with its new logo. For now. But the chain is also apologizing to fans who were angered when the change was announced last week.
Elon Musk on Monday targeted Apple and OpenAI in an antitrust lawsuit alleging that the iPhone maker and the ChatGPT maker are teaming up to thwart competition in artificial intelligence.
