Early stage trials of Johnson & Johnson's experimental coronavirus vaccine show it generated an immune response in nearly all volunteers, with minimal side-effects, after a single dose.
The company expects to report details of more advanced trials later this month and is hoping to apply for authorization from the US Food and Drug Administration soon after. Researchers who tested the vaccine in a combined Phase 1-2 trial -- mostly meant to show safety -- found either one or two doses of the vaccine generated both antibody and T-cell responses against the coronavirus. The trials were not designed to show whether the vaccine protected people against either infection or symptoms of coronavirus -- that's what the ongoing Phase 3 trials are designed to do. Writing in the New England Journal of Medicine, an international team of researchers who tested the vaccine in around 800 volunteers said the early stage trials showed it was safe and probably should work.
The researchers -- in the Netherlands, the United States and Belgium -- tested the vaccine in a group of people 65 and older and a group ages 18 to 55. Vaccination elicited neutralizing antibodies -- expected to stop the virus from infecting cells -- in 90% of all participants by the 29th day after the first dose of vaccine and in all of them by two months after the first dose. The levels of these antibodies stayed stable for at least 71 days, they reported.
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"The Company anticipates announcing topline Phase 3 data for its single-dose Janssen COVID-19 vaccine candidate in late January 2021; however, as this trial is dependent on disease events, the timing is approximate," Johnson & Johnson said in a statement. But with the pandemic raging in the US and Europe, vaccine experts say, answers are coming quickly for vaccine trials.
"If the single-dose vaccine is shown to be safe and effective, the Company expects to submit an application for Emergency Use Authorization with the U.S. Food and Drug Administration shortly afterwards, with other regulatory applications around the world to be made subsequently," Johnson & Johnson added.
In another promising development for vaccine science, Johnson & Johnson says its vaccine -- a single shot tested against a complex barrage of newly emerged COVID-19 variants -- is 66% effective at preventing symptomatic disease and 85% effective against preventing severe illness.
A team of scientists at the company were "elated" and "joyful" when they saw the results, Dr. Mathai Mammen, M.D., Ph.D., the global head of Janssen Research & Development, told ABC News.
"We're a single shot ... And now we've produced data that say that our vaccine is highly effective, 85% effective against severe COVID, 100% effective against hospitalization or death," Mammen said.
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The Johnson & Johnson trial, launched in September, was conducted in the United States, South Africa and Latin America. Although unforeseen at the time, this massive clinical experiment comprised of more than 44,000 volunteers took place in countries were new COVID-19 variants would emerge shortly thereafter, often taking over the prior versions of the virus.
South Africa in particular is home to a variant that seems not only more transmissible, but is also seemingly able to blunt the effect of other existing vaccines. Latin America, meanwhile, is home to a more transmissible Brazilian variant that shares some of the same mutations.
"It's a much more complex pandemic now than it was months ago," Barouch said.
Broken down by region, the Johnson & Johnson vaccine, in the trial, was 72% effective in the U.S., 66% in Latin America and 57% in South Africa.
Mamment said the company is "very fortunate" to have chosen South Africa as one of the homes for its trial, because it gave them the opportunity to show that their vaccine works even against a variant that may one day become dominant.
So now, Mamment said, "I'm thinking not so much about the South African strain, but rather about other mutations that might pop up."
He's particularly encouraged by the fact that all volunteers saw a significant benefit in taking a vaccine that eliminates the possibility of being hospitalized with or dying of COVID-19.
In the trial, the Johnson & Johnson vaccine proved to be roughly 66% effective at stopping a person from developing COVID-19 with symptoms. But it was 85% effective at preventing severe illness that could send a person to the hospital.
Johnson & Johnson applied for an emergency use authorization from the Food and Drug Administration for its coronavirus vaccine after releasing data last week showing it was about 66% effective in protecting against the virus.
If J&J’s application is approved, it would be the third Covid-19 vaccine authorized for emergency use in the U.S. behind those developed by Pfizer-BioNTech and Moderna. Pfizer’s vaccine was authorized by the FDA on Dec. 11, and Moderna’s was authorized a week later. ...
U.S. officials and Wall Street analysts are eagerly anticipating the authorization of J&J’s vaccine, which could happen as early as this month....
Unlike Pfizer’s and Moderna’s vaccines, which require two doses given about three to four weeks apart, J&J’s medication only requires one dose, easing logistics for health-care providers.
One good thing about the J and J vaccine is that J and J is an enormous company, and if they decide to dedicate the resources they can ramp up very quickly.
I hope they do.
-------------------------------- Life is short. Play with your dog.
The United States stands ready to deliver up to 4 million doses of Johnson & Johnson’s Covid-19 vaccine as soon as next week if the Food and Drug Administration authorizes the shot for emergency use, the Biden administration’s Covid-19 response team said Wednesday.
“The governors are carefully planning their efforts and are getting ready for the possible new vaccine,” Jeff Zients, President Joe Biden’s Covid czar, said at a news briefing. “If authorized, we’re ready to roll out this vaccine without delay.”
“If the EUA is granted, we will waste no time getting this life-saving vaccine into the arms of Americans,” he said, referring to the emergency use authorization that would allow the U.S. to start distributing the shots.
The administration plans on allocating between 3 million to 4 millions doses of J&J’s one-shot Covid vaccine next week if the FDA grants the EUA, which could come as soon as this weekend. A senior administration official told CNBC on Tuesday that states will be given 2 million doses if authorized.
Zients said that the remaining allocations will mostly go to retail chain pharmacies and community health centers, which are sent doses directly from the federal government alongside the states.
J&J aims to deliver 20 million doses by the end of March, Zients said, and the administration is working with the company “to accelerate the pace and time frame by which they deliver the full 100 million doses” by the end of June.
Earlier on Wednesday, FDA staff endorsed J&J’s vaccine for emergency use. The staff report is meant to brief the FDA’s Vaccines and Related Biological Products Advisory Committee, which will meet Friday to review J&J’s request for emergency use authorization.
After a day of deliberating on the efficacy of the Janssen’s Ad26.COV2.S COVID-19 vaccine, the VRBPAC voted 22 to 0 to recommend the vaccine be granted an EUA.
This recommendation paves the way for the FDA to decide on whether it will do so, and the decision on the EUA could come as early as tomorrow.
20 million doses by the end of March is more than 5% of the population, a lot more than that percentage of the adult population. Add that to the people already vaccinated, and those who will receive one of the existing vaccines by the end of March, and you're starting to get somewhere. Maybe more than 20% total.
