GRAND RAPIDS — Johnson & Johnson hopes to bring a COVID-19 vaccine to market in the first half of 2021 in what would be a fraction of the time usually needed to develop and introduce a safe and effective new product.
New Brunswick, N.J.-based Johnson & Johnson (NYSE: JNJ) has been using a proven platform to develop its COVID-19 vaccine candidate that’s now undergoing a Phase 3 clinical trial involving up to 60,000 people, Chairman and CEO Alex Gorsky said in a virtual discussion Monday with the Economic Club of Grand Rapids.
The company temporarily paused the Phase 3 clinical trial last week “due to an unexplained illness in a study participant,” Gorsky said. The corporation expects to resume the trial “in the very near future.”
“We hope to be able to have hundreds of millions of doses within the early part of next year and be producing at a rate of about a billion doses (annually) by the end of next year,” Gorsky said. “In essence, we’ve taken what would normally take five to seven years and we’re trying to do that in about five to seven months without compromising safety, efficacy or accessibility. We’re making a lot of good progress, but still clearly there’s a lot more work that we need to do.”
Johnson & Johnson’s work is one of about 10 large-scale COVID-19 vaccine development projects ongoing globally among pharmaceutical companies, Gorsky said.
The corporation last week joined several global pharmaceutical companies to sign a pledge and commit “to upholding the integrity of the scientific process as we work towards potential global regulatory filings and approvals of the first vaccines for COVID-19” and prioritize safety and efficacy.
Spectrum Health President and CEO Tina Freese Decker, who chairs the Economic Club this year and interviewed Gorsky, said the focus on safety and efficacy of a vaccine is “critical.”
“Having a vaccine that no one wants to take won’t do us any good,” Freese Decker said.
In a survey of 600 voters conducted by Lansing research firm Glengariff Group Inc. for the Detroit News and Detroit television station WDIV right after the first presidential debate, 44.1 percent of respondents said they would get a COVID-19 vaccine that was approved by the U.S. Food and Drug Administration. More than 39 percent said they would not.
If their doctor recommended it, 54.7 percent of respondents said they would get the vaccine, while 34.2 percent they would not.
Gorsky said pharmaceutical companies need to educate people about a vaccine and collaborate closely with health systems, physicians, retailers and regulatory agencies on the distribution of billions of doses globally.
“You can have all of the greatest, latest, coolest technology that’s available, but if you can’t ultimately deliver it to the patient, it doesn’t make any difference,” said Gorsky, adding that assuring the safety of a vaccine “is going to take massive education so that people understand these have been tested.”
“It’s going to take a comprehensive effort and education program to ensure that patients understand that ... this is a much safer alternative than being exposed to the virus. That’s definitely going to take some work on our side to earn that kind of trust,” he said. “All of us realize that we live in very political times and any decision we make, any issue we’re dealing with, is going to be viewed through that aperture, particularly at this specific moment.”
Gorsky added that it’s “absolutely critical” for pharmaceutical companies to assure the public and governments that the best data, science and public health expertise are leading the effort.
Health care workers and first responders such as police and firefighters will likely be the first to access a vaccine, along with people who are most susceptible to COVD-19, Gorsky said.
Pharmaceutical companies would distribute a vaccine working with the federal government and “based upon a very well-outlined protocol,” he said.
“Based upon some of the production and the capacity requirements, for the first half of next year you could see these being distributed to select groups, and then I think as we move through the latter half of 2021 we would see more widespread distribution become available as we get more experience,” Gorsky said. “As people see the information, as they see that more people are gaining confidence at getting the vaccine, that will increase people’s trust and confidence more broadly and we’ll begin to see the impact as we move through the course of next year.”
In Grand Rapids, Grand River Aseptic Manufacturing Inc. will contribute to producing a COVID-19 vaccine under development by Janssen Pharmaceuticals Inc., a Belgian company owned J&J. Grand River Aseptic would fill and finish the vaccine candidate under a $160 million federal contract awarded in August to produce a new vaccine for COVID-19 through what’s known as Operation Warp Speed.
Pharmaceutical companies are regularly sharing information and data on their vaccine programs — a level of collaboration that Gorsky said he’s never seen in his more than 30 years in the industry.
Developing and bringing vaccines to market are an important component of getting the global pandemic under control, although Gorsky warned that it’s “not the silver bullet.”
“This is going to take a very holistic approach,” he said. “Unfortunately as this virus moves from pandemic to endemic, I would imagine for the better part of our lifetimes we will be dealing with it. Whether it evolves into more of a common type of flu where we’re vaccinated annually or bi-annually, that’s yet to be seen.”
