- Janssen Pharmaceutical Companies, a division of Johnson & Johnson, plans to begin human trials of its COVID-19 vaccine this month.
- The first clinical trial participants will be healthy adults.
- Moving to the next phase of clinical trials depends on both the results of this phase and the progression of the pandemic.
Clinical trials are well underway for three COVID-19 vaccine candidates being funded by the United States. Moderna and AstraZeneca have begun human trials, and Johnson & Johnson plans to do so by the end of July.
Even with over $2 billion worth of funding from the government’s Biomedical Advanced Research and Development Authority (BARDA), getting a vaccine through human trials isn’t easy. Large-scale testing must show a vaccine is both safe and can actually provide immunity against the SARS-CoV-2 virus that causes COVID-19.
Verywell talked to Jerome Custers, Senior Scientific Director of Vaccine Research at Johnson & Johnson, to learn what the process involves and what will make human trials successful.
Markers of Success
The most important parameter in a human trial, according to Custers, is safety.
“In our first clinical trial, we will vaccinate healthy adults, and those people will be monitored very strictly for safety,” Custers says. “In addition to that, we’re looking to see if our vaccine is able to induce a strong immune response and produce antibodies against the coronavirus.”
Custers says antibodies can be measured from blood samples. Researchers will take blood samples from trial participants before they are given the vaccine, a week or two after vaccination, and then at regular intervals after that.
“We have data from animals—monkeys, mice, and hamsters—that confirmed what we thought we would see and are encouraging us to continue in this direction.”
Creating and Testing a Vaccine
The direction Custers refers to is the use of something called AdVac technology. Using this vaccine platform, Johnson & Johnson scientists remove a piece of the genetic sequence from the adenovirus, which causes the common cold. Then, they insert genetic code from COVID-19.
Johnson & Johnson has used the same AdVac platform to develop vaccines for Ebola, HIV, RSV, and Zika, which combined, have been trialed safely in over 50,000 people. With COVID-19, however, the company is trying to do it on a much larger scale and a much more abbreviated timeline.
“A billion vaccines is still the goal,” Custers says.
While the first in-human clinical trials were initially slated for September, the company announced on June 10 that it would bump them up to the second half of July. This phase, considered a Phase 1/2a clinical trial, will involve 1,045 volunteers. Typically, this takes several months to years. But Johnson & Johnson is already looking ahead to Phase 3, which Moderna and AstraZeneca plan to enter this summer.
Beginning Phase 3 clinical trials is contingent on good results from Phase 1/2a.
“We are thinking that Phase 3 trials will include several tens of thousands of people,” Custers says. “But that will largely depend on how that pandemic develops. The incident rate of infection is going down.”
Currently, Phase 1/2a clinical trials are planned to take place in the U.S. and Belgium. Belgium has seen a steady decline in confirmed COVID-19 cases since April, when cases peaked at over 2,000 on a single day. Throughout the month of June, new cases hovered around 100 per day.
“Of course, we are happy that’s happening, but it will also make showing that the vaccine can prevent infection much more difficult,” Custers says. “You need a certain incidence rate to be able to do that.”
Custers says that, if needed, Johnson & Johnson could move testing to areas where infection rates are still high.
“It’s very hard to assess what the situation will be like in a couple months when we actually need to decide,” Custers says. “We’re monitoring the situation. We think it will be a potential issue for all the COVID-19 vaccines in development.”
Learning From Other Vaccines
In addition to the vaccines receiving BARDA funding in the US, there are approximately 140 COVID-19 vaccines in development around the world. Custers explains the race for a vaccine isn’t a competition—it’s a collaboration.
“No one knows who will be successful, so it’s important for the world to have multiple shots on goal, as we tend to say,” he says. “It’s also important because we learn from each other. We’re all in different stages and have slightly different approaches. The data we generate—in preclinical data, animal studies, and clinical studies—will enable all of us to move as quickly as possible.”
While Johnson & Johnson and other biopharmaceutical companies are working as quickly as possible to create a usable vaccine, a definitive timeline is still impossible to give.
Custers says a number of factors influence timing. “Will the vaccines currently in development be successful?” he says. “Will we be able to show those vaccines work—is the COVID-19 incidence somewhere in the world high enough to be able to show the vaccine can protect people sufficiently?”
Even if both of those answers are yes, the scale of production is another challenge.
“We need to make a sufficient amount of vaccine,” Custers says. “At the beginning, there won’t be enough of the vaccine to offer it to the general public. I imagine healthcare workers and people at an increased risk of contracting COVID-19 will get the vaccine first. It’s not really up to us as a company.”
Custers says deploying a vaccine—assuming it has proven safe and effective—depends on when Johnson & Johnson receives emergency use authorization at a government level, like from the Food and Drug Administration.
Custers says his team is working hard to meet these supply demands.
“We are doing things in parallel. Manufacturing is ongoing, and we’re upscaling to be able to make as many vaccine doses as soon as possible,” he says. “Usually, you only do that when you know the vaccine is working.”
He says that while much remains uncertain, Johnson & Johnson is optimistic about their vaccine candidate.
“It’s very rewarding and motivating to work on this vaccine and be able to contribute something,” he says. “It’s a once in a lifetime opportunity—hopefully.”
COVID-19 update for Aug. 13: Here's the latest on coronavirus in B.C. – Vancouver Sun
Article content continued
The government says it is taking the $31 million from $170 million left in the Smart Cities Challenge program.
The Canadian Press
As B.C. deals with a surge in coronavirus cases, a new poll finds residents are more likely than their provincial counterparts to say they want to see tighter restrictions.
The Angus Reid Institute poll, published Thursday, found Canadians in the four Atlantic provinces were the most satisfied with their region’s pandemic restrictions, while those in B.C., Saskatchewan and Manitoba were more likely to say they want tighter restrictions in order to keep COVID-19 spread down.
While nearly half of British Columbians (48 per cent) say the restrictions in B.C. are “about right,” 14 per cent say “they go too far” and 38 per cent say they “don’t go far enough.”
That compares to just 28 per cent overall of Canadians who think there should be tighter restrictions. In Manitoba, that number climbs to 40 per cent, while in Atlantic Canada it’s just 19 per cent.
Provincial health officials announced 85 new COVID-19 cases on Wednesday, the third-highest one-day total since the coronavirus came to British Columbia.
Wednesday’s updated numbers from Dix and Henry include one new death — the province’s first in 12 days. 196 people have died from the coronavirus in British Columbia.
Here are a number of information and landing pages for COVID-19 from various health and government agencies.
–with files from The Canadian Press
Albertans growing less satisfied with provincial COVID-19 response, new survey says; 76 new cases – Calgary Herald
Article content continued
There are some signs the worrying trend could be abating, including Alberta’s announcement Thursday that there were 76 new cases of the coronavirus in the province, down from 121 Wednesday.
The new cases were the result of about 7,750 tests, equivalent to a one per cent positive rate. They bring Alberta’s running total since the start of the pandemic to 11,969, including 10,713 people who have now officially recovered from the virus.
Active cases in Alberta dipped slightly Thursday to 1,036, with more cases in the Alberta Health Services Edmonton zone (475) than any other provincial health region. The Calgary zone has 314 active cases.
A total of 220 Albertans have now died of COVID-19 after the province reported three new deaths Thursday. One death was of a woman in her 80s at Edmonton’s Good Samaritan Southgate Care Centre, bringing that facility’s toll from the virus to 29, the most of anywhere in Alberta.
The other two deaths were of a man in his 90s at the Heimstaed Seniors Lodge in La Crete, about 670 kilometres north of Edmonton, and another man in his 90s who lived in the Central zone and was not connected to any continuing-care site.
Alberta’s hospitalizations stayed steady Thursday, with 50 Albertans in hospital with COVID-19, 12 of whom are receiving treatment in intensive-care units.
Aside from the unsteady case numbers, Angus Reid also indicated that the province’s plan for a return to school for K-12 students in September may be partly responsible for the dipping approval rate. Parents and teachers have heavily criticized the plan from Alberta Education, saying measures are insufficient to protect students and teachers given large class sizes and stagnant funding.
76 new confirmed cases of COVID-19 in Alberta on Thursday, 3 additional deaths – Global News
Alberta Health said Thursday that an additional 76 COVID-19 cases have been confirmed in the province, as well as three additional deaths.
A woman in her 80s from the Good Samaritan Southgate Care Centre has died, marking the 29th death at that location.
A man in his 90s from Heimstaed Seniors Lodge in the North zone and a man in his 90s from Central zone also died. The man from the Central zone was not linked to a continuing care centre, Alberta Health said.
Alberta has now had 220 deaths related to COVID-19.
COVID-19: Hinshaw provides update on testing in Alberta, urges teachers and staff to get tested before September
The Edmonton zone continues to have more cases than any other zone in the province as the number of active cases in that city climbed slightly to 475 on Thursday.
There were 314 active cases reported in the Calgary zone, 88 cases in the Central zone, the South zone had 52 cases and there were 104 cases reported in the North zone.
Three active cases weren’t assigned to a particular zone.
There were 50 Albertans in hospital, with many of those (21) in the Edmonton zone. Of those in hospital, 12 were in intensive care.
COVID-19: Dr. Deena Hinshaw explains how to clean and store cloth masks
To date, the province has performed 793,114 coronavirus tests and 10,713 Albertans have recovered from the virus.
The numbers reflect results reported by 11:59 p.m. Wednesday.
© 2020 Global News, a division of Corus Entertainment Inc.
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