Reuters
A health worker injects a man with Ebola vaccine in Goma
- Johnson & Johnson plans to start testing a potential coronavirus vaccine in people by September. The company is ramping up its manufacturing capacity at the same time.
- The vaccine could win an emergency approval as soon as early 2021, when tens of millions of doses would be available, Chief Scientific Officer Paul Stoffels told Business Insider.
- The world's largest healthcare company is hoping to produce 1 billion doses of the vaccine by the end of 2021.
- Stoffels said the company is working with the US government to build out its manufacturing, and is having ongoing discussions with contract manufacturers.
- J&J is committing more than $500 million to the project, and Stoffels expects as many as 1,000 company employees will soon be working on advancing the vaccine.
- Visit Business Insider's homepage for more stories.
In the sprint to develop a coronavirus vaccine that can halt the pandemic, the world's largest healthcare company is preparing to ramp up its efforts.
This week, Johnson & Johnson selected a lead vaccine candidate, accelerated the timeline to starting human testing, and laid out the ambitious goal of producing 1 billion doses of it by the end of 2021.
J&J has been researching a coronavirus vaccine since February. The company now aims to start testing a vaccine in humans no later than September, at least two months faster than a previous goal of November.
"My people will kill me if I commit to anything earlier than that," said Paul Stoffels, J&J's chief scientific officer, when asked if it's possible J&J could start trials before September.
"We can't commit to that," he said, adding that any further acceleration of the timeline would be measured in days, not weeks or months. "Early September is like warp speed."
Stoffels, the chief scientist at J&J, spoke to Business Insider on Monday via a video call from his home in Belgium. He explained how the pharmaceutical giant plans to tackle two critical challenges in vaccine development simultaneously: testing to see if the vaccine works and massively scaling up production to satisfy global demand.
Some biotechnology companies plan to start testing experimental coronavirus vaccines earlier than J&J. Moderna, an upstart Massachusetts biotech, has already started dosing patients in a first trial, while other companies are nearing that point in the next few weeks.
But those businesses lack the massive resources of J&J, a $350 billion company with more than 132,000 employees. Facing a pandemic, drug developers are being pressed not just for a speedy response, but for one that carries sweeping scope. A solution is only as good as the number of people who can quickly receive a pill or vaccine, and J&J's manufacturing might sets it apart from rivals on that score.
J&J is taking a risk in ramping up manufacturing before getting any clinical results
J&J's current capacity for producing this coronavirus vaccine is 300 million doses per year from one plant in the Netherlands. That is if the plant is exclusively focused on this one vaccine, and not producing the other vaccines it typically does.
Before knowing if the vaccine works in humans, J&J is looking to expand production to at least three additional plants, Stoffels said.
It takes lots of technical work to get additional facilities running. Regulators require new plants to validate their manufacturing process, testing to show the first batch is exactly the same as the 50th or 100th batch.
"That's why we have to do all the investment at risk," Stoffels said. "If we don't start now, we won't have that capacity at the end of the year."
Johnson & Johnson
Johnson & Johnson Chief Scientific Officer Dr. Paul Stoffels.
By the end of 2020, J&J plans to operate a US-based plant that can add another 300 million doses in annual production capacity, Stoffels said.
J&J will also figure out over the next two months how to work with partners to bring on additional capacity, he added. That includes potentially transferring J&J's technology process to contract manufacturers, with the goal of bringing them online by the end of 2020.
J&J could also activate other plants it has around the world, Stoffels said.
The US government is financially supporting J&J's upscaling. The Biomedical Advanced Research and Development Authority (BARDA) committed this week $421 million to building out the vaccine capacity for J&J, according to Reuters.
But J&J is also putting serious resources on the table, as Stoffels said the company is committing more than $500 million to the project.
Stoffels estimated J&J will soon have as many as 1,000 employees working on this project, spanning all the elements of drug development: research, manufacturing, statistical analysis, regulatory matters, and so on.
Overall, J&J has more than 15,000 employees in research and development, with an annual research budget of about $11 billion.
How the vaccine works and will be tested
J&J's vaccine will target the surface spike protein of the coronavirus, a popular target among vaccine programs.
There are still critical unknowns about how effective a vaccine can be against this virus. Stoffels said a critical question that human testing will answer is if J&J's vaccine prevents infection entirely, or if it primes the immune system, helping prevent people with the coronavirus from experiencing the most serious form of the disease.
"If it doesn't prevent for infection, and it still prevents for serious disease, it's still very valuable," Stoffels said.
SVB Leerink analyst Geoffrey Porges wrote in a recent note that the spike protein is a logical target for a vaccine, but its viability isn't proven. Porges wrote in a March 23 note to investors that "vaccine developers are simply taking punts in the dark" by selecting a specific protein, an appropriate but still risky approach given the urgency.
Stoffels and J&J CEO Alex Gorsky have both expressed confidence in the chances of success with the lead candidate.
"Why we say we are quite confident is that we've done this four times for HIV, RSV, Ebola, and Zika," Stoffels said.
While the company has crafted vaccines for each of these four diseases, none of them have yet to reach market or gain US regulatory approval for various reasons. In the case of Zika, the outbreak died down before researchers could perform a large-scale test of the vaccine, while clinical trials are ongoing for the HIV and RSV vaccines.
With COVID-19, J&J has found an antigen that produces antibodies that neutralize the virus, according to the company's research. The company is collaborating with BARDA and the Beth Israel Deaconess Medical Center to develop the vaccine.
Stoffels said past experience with the technology has shown neutralizing antibodies are "typically predictive" of inducing a response in animals and humans.
The first trial is now expected to start no later than September. It will enroll somewhere between 200 and 500 people, Stoffels estimated. He anticipated it will fully enroll in just one day and produce results in a month.
Stoffels said J&J and its collaborators will then pore over that data for about a week, studying the immune responses of multiple dose strengths that were tested. These results will quickly build the next study which Stoffels said would recruit 10,000, 20,000 or even 50,000 people.
Another key unknown is what the disease will look like when that trial begins.
"The one challenge we will have is we need to go where the disease is," Stoffels said. "We will have to shift over the world: Where is the infection going?"
Health authorities will have to decide who gets the vaccine first, Stoffels says
A final unknown on Stoffels' mind is who will get the vaccine first, given the incredible global demand. Stoffels expects J&J will have tens of millions of doses available in early 2021 and reach hundreds of millions of doses later in the year.
"What's needed is an agreement by authorities on who are the highest risk people who need to be vaccinated," he said.
For Stoffels, healthcare workers are on the top of his list of risk. These frontline workers are dealing with the disease on a daily basis, he said, at great risk to themselves.
That is followed by the elderly and people with certain diseases, Stoffels said, but the decision will ultimately need to be made by health authorities as production capacity is built up.
"You can't have a spike from zero to 100 million vaccines overnight," he said. "It doesn't work like that."
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